Fmea Hip

General Informatiom
SFMEA Info : Inputs and Outputs

DFMEA Info : Inputs and Outputs
Shared S / DFMEA Output
PFMEA Info : Inputs and Outputs
Shared S / D / PFMEA Outputs
Reference
Basic APQP Tool Methodology
Integration
Prototype Control Plan
System / Asm. / Comp. "Tuning"

Prelim. / Final B.O.M. Preliminary Process
Prelim. / Final Dwgs. map developed.
S/DFMEA
- Core team developed.
- Define System / Asm. / Component
"Non-optimal" "Functional blocks".
- Perform Functional block analysis.
- Develop System / Asm. / Component DFMEA.
- Existing Process Capability review. DFM / DFA Required??
Technical Review. - Extract Fault trees (if required). Sys./Asm./Comp.
- Develop "Critical Characteristics" listing. Diagnostics input
to service manual.
"Acceptable" PFMEA
- Core team developed.
- Process "mapping" reviewed and updated.
"Non-optimal" Proposed mfg. tooling requirements.
("Poke-Yoke") - Process functional block analysis.
- Develop Process FMEA. Develop operator
- Develop design and process "Critical instructions.
Technical Review. Characteristics" listing.
"Acceptable"
PRE LAUNCH CONTROL PLAN
- Q.E. , MFG. Team.
- Review critical characteristics listing.
- Generate Plan:
- Items.
- Frequency.
- SPC controls (as required).
- Develop Insp. Tooling Requirements.
Technical Review. "Automated / non-automated"?
Decision made. (Review "P.O." and "Severity" criteria.)
- Calibration Requirements and Frequency
GAGE R & R
- Q.E. , D.E. , MFG. Team.
- Identify target Tooling / equipment.
- Define the frequency analysis is to be performed.
Technical Review. - Conduct and record R&R results.
"Acceptable"
Prelim. Prod. Process
Capability Assessments (FTC)

Process Technical Review .
"Acceptable" Sign-off
FINAL PROCESS CONT. PLAN
Technical Review. Production Validation
"Acceptable"
Production Release.
Ongoing Production Process Continuous Improvement
Capability Assessments Efforts.
I've heard
of the
APQP
process ,
show me
where
FMEA
figures in
to the
scheme of
things.

APQP and
FMEA Process
Case Study :
Hip Socket Replacement
IUSB
2/01 - 11/02
System Considerations

Regulatory Inputs
Design Considerations
System Inputs
Functional Block
System FMEA
Fault Trees
Design Verification Plan & Report
Regulatory Inputs
MEDICAL DEVICE REGULATIONS 21 CFR Part 888 Table of Contents (Index)
Parent PageDevice Advice HomeDevice Advice Assistance & HelpDSMA HomeCDRH
HomeFDA HomeFDA SearchCDRH Comments
21 CFR Part 888
Code of Federal Regulations Online via GPO Access. (This page last updated: April 16, 1998)
PART 888 - ORTHOPEDIC DEVICESTop of page
Subpart A - General Provisions
Sec.
888.1 Scope.
888.3 Effective dates of requirement for premarket approval.
888.5 Resurfacing technique.
888.6 Degree of constraint.
888.9 Limitations of exemptions from section 510(k) of the act.
Subpart B - Diagnostic Devices
888.1100 Arthroscope.
888.1240 AC-powered dynamometer.
888.1250 Nonpowered dynamometer.
888.1500 Goniometer.
888.1520 Nonpowered goniometer.
Subpart C - [Reserved]
Subpart D - Prosthetic Devices
888.3000 Bone cap.
888.3010 Bone fixation cerclage.
888.3015 Bone heterograft.
888.3020 Intramedullary fixation rod.
888.3025 Passive tendon prosthesis.
888.3027 Polymethylmethacrylate (PMMA) bone cement.
888.3030 Single/multiple component metallic bone fixation appliances and accessories.
888.3040 Smooth or threaded metallic bone fixation fastener.
888.3050 Spinal interlaminal fixation orthosis.
888.3060 Spinal intervertebral body fixation orthosis.
888.3100 Ankle joint metal/composite semiconstrained cemented prosthesis.
888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
888.3150 Elbow joint metal/metal or metal/polymer constrained cemented prosthesis.
888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
888.3200 Finger joint metal/metal constrained uncemented prosthesis.
888.3210 Finger joint metal/metal constrained cemented prosthesis.
888.3220 Finger joint metal/polymer constrained cemented prosthesis.
888.3230 Finger joint polymer constrained prosthesis.
888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
888.3320 Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis.
888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
888.3360 Hip joint femoral (hemi-hip) acetabular metallic cemented or uncemented prosthesis.
Regulatory Inputs
888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
888.3410 Hip joint metal/polymer semi-constrained resurfacing cemented prosthesis.
888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.
888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
888.3500 Knee joint femorotibial metal/composite semi-constrained cemented
888.3510 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained prosthesis.
888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
888.3720 Toe joint polymer constrained prosthesis.
888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
888.3750 Wrist joint carpal lunate polymer prosthesis.
888.3760 Wrist joint carpal scaphoid polymer prosthesis.
888.3770 Wrist joint carpal trapexium polymer prosthesis.
888.3780 Wrist joint polymer constrained prosthesis.
888.3790 Wrist joint polymer constrained prosthesis.
888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
Subpart E - Surgical Devices
888.4150 Calipers for clinical use.
888.4200 Cement dispenser.
888.4210 Cement mixer for clinical use.
888.4220 Cement monomer vapor evacuator.
888.4230 Cement ventilation tube.
888.4300 Depth gauge for clinical use.
888.4540 Orthopedic manual surgical instrument.
888.4580 Sonic surgical instrument and accessories/attachments.
888.4600 Protractor for clinical use.
888.4800 Template for clinical use.
888.5850 Nonpowered orthopedic traction apparatus and accessories.
888.5890 Noninvasive traction component.
888.5940 Cast component.
888.5960 Cast removal instrument.
888.5980 Manual cast application and removal instrument.
WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 2000]
From the U.S. Government Printing Office via GPO Access
Regulatory Inputs
[CITE: 21CFR888.3300]
[Page 459]

TITLE 21--FOOD AND DRUGS

SERVICES--(Continued)

PART 888--ORTHOPEDIC DEVICES--Table of Contents

Subpart D--Prosthetic Devices

Sec. 888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
(a) Identification. A hip joint metal constrained cemented or
uncemented prosthesis is a device intended to be implanted to replace a
hip joint. The device prevents dislocation in more than one anatomic
plane and has components that are linked together. This generic type of
device includes prostheses that have components made of alloys, such as
cobalt-chromium-molybdenum, and is intended for use with or without bone
cement (Sec. 888.3027). This device is not intended for biological
fixation.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. A PMA or
a notice of completion of a PDP is required to be filed with the Food
and Drug Administration on or before December 26, 1996 for any hip joint
metal constrained cemented or uncemented prosthesis that was in
commercial distribution before May 28, 1976, or that has, on or before
December 26, 1996 been found to be substantially equivalent to a hip
joint metal constrained cemented or uncemented prosthesis that was in
commercial distribution before May 28, 1976. Any other hip joint metal
constrained cemented or uncemented prosthesis shall have an approved PMA
or a declared completed PDP in effect before being placed in commercial
distribution.
[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996]
Regulatory Inputs
Code of Federal Regulations Online via GPO Access. (This page last updated: April 16, 1998)
Regulatory Inputs
Regulatory Inputs
Design Considerations
www.medmedia.com/o14/52.htm
Wheeless' Textbook of Orthopaedics Main Menu Home Page
Cemented Femoral Stems:
- See: Total Hip Replacement Menu:
- Cemented Femoral Component: Loosening:
- Collar: in THR
- Optimal Cementing Technique
- Removal of Cemented Femoral Stems:
- Indications:
- cemented femoral stems probably remain gold standard for total hip arthroplasty;
- most indicated in older patients (more than 65 yrs), but are also used in younger patients since there is some indications
that cemented stems are less prone to develop osteolysis;
- useful for patients w/ "stove pipe" type femur, previous fracture, or previous osteotomy since these
patients would not be expected to achieve a tight fit which is necessary for ingrowth;
- may be indicated poor bone quality such as RA, osteoporosis, or Paget's disease;
- outcomes:
- in the study by JJ Callaghan MD et al (J Bone Joint Surg [Am] 82-A: 487-97, 2000) the authors followed Charnley Total Hip Arthroplasty
patients (with cement) with a minimum 25 year follow up;
- of the 327 hips for which the outcome was known after a minimum of 25 years, 295 (90 %) had retained the original implants until
the patient died or until the most recent follow-up examination;
- of the 62 hips in patients who lived for at least 25 years after the surgery, 48 (77 %) had retained the original prosthesis;
- Cemented Component Design:
- prosthesis should have relatively smooth surfaces, w/ no sharp edges, so that sites of stress concentration are eliminated from both prosthesis and cement;
- a prosthesis that is broader laterally than medially may help to diffuse the compressive stress medially;
- cobalt-chromium alloy stems are used in most stems, since they generate less particulate debris than titanium implants;
- Component Surface:
- there is controversy about how much bonding should occur between the cement and the femoral stem;
- excessive bonding between the cement and stem may transfer wt bearing stress to the bone-cement interface, leading to loosening;
- in contrast, excessive motion between the cement-metal interface, may lead to excessive osteolysis and rapid loosening;
- some are proponents of smooth surface, which may allow subsidence and thereby keeps the cement in compressive loading;
- many components have a matt finish, which allows some mechanical interlock with the cement;
- in the study by DW Howie et al (JBJS Vol 80-B, 1998), 4/20 matt coated stems had been revised for aseptic loosening whereas 0/20 polished stems had been
revised (9 year minimum follow up);
- references:
- Loosening of matt and polished cemented femoral stems. DW Howie et al. JBJS. Vol 80-B. No 4. July 1998 p 573.
Influence of Cement Technique on the Interface Strength of Femoral Components
Michael F. Shepard, MD J. Michael Kabo, PhD Jay R. Lieberman, MD
CORR 2000;2000:26-35
The optimal surface finish for polymethylmethacrylate cemented femoral components remains
controversial. Concerns about early debonding of the prosthesis-cement interface have led
surgeons to use roughened surfaces to enhance the cement-prosthesis bond.
However, loosening of roughened stems is associated with the generation of excessive wear
debris. The purpose of the current study was to determine whether the time to cementation
influenced the cement-prosthesis bond of four roughened cobalt chrome surfaces (60 grit-blasted,
10 grit-blasted, 10 grit-blasted with polymethylmethacrylate precoating, glass bead-blasted)
and one polished cobalt chrome surface. Fixation strength was assessed using mechanical
pushout and tensile testing. Roughened and polymethylmethacrylate precoated surfaces had
significantly greater tensile and shear strengths at early cementation times compared with
polished surfaces. However, roughened components had significant decreases in tensile and
shear strengths as cementation time increased from 2 to 4 minutes and 2 to 6 minutes.
In contrast, tensile and shear strengths for the polished surface were significantly lower
than for the roughened surfaces and did not change with longer cementation times.
When using a roughened or precoated cemented femoral component, the surgeon should consider
cementing earlier with wetter cement to maximize the cement-prosthesis bond.
When implanting a polished femoral component, it is preferable that the cement is doughy,
because the cement-prosthesis bond is not influenced by the wetness of the cement and it
is easier to maintain the orientation of the femoral component.
- Cement Mantle:
- current recommendations are to have at least 2 mm of a uniform cement mantle around the femoral component;
- in the study by RP Joshi et al (JBJS Vol 80-B, 1999), the authors found that a 3 mm cement mantle around the femoral component, and a
6 mm mantle around the acetabular component were associated with the lowest incidence of osteotlysis;
- references:
- Changes in the calcar femoris in relation to cement technology in total hip replacement.
F Bocco et al. COOR. Vol 128. 1977. p 287-295.
- The cement mantle in total hip arthroplasty. Analysis of long-term radiographic results.
- Osteolysis after Charnely primary low friction arthroplasty. A comparison of two matched paired groups.
RP Joshi et al. JBJS Vol 80-B. No 4. July 1998. p 585.
- Grading of Cement Technique: (Barrack et. al. JBJS 1992 and Mulroy et.al. 1995)
- grade A: meduallary canal completely filled w/ cement (white out).
- grade B: a slight radiolucency exists at the bone cement interface.
- grade C: a radiolucency of more than 50% at the bone cement interface.
- grade D: a radiolucency involving more than 100% of the interface between bone and cement in any projection, including absence of cement distal to the stem tip;
- note: this grading system has been criticized since it is somewhat influenced by the amount of cancellous bone removed during reaming and broaching;
- when the entire cancellous bed is removed, there will often be "white out" (indicating good cementing technique), and yet
there will be no cancellous foothold for the cement;
- cement mantle:
- as noted by Mulroy et.al. 1995, a femoral cement mantle less than 1 mm and defects in the cement mantle are associated with early loosening;
- Jasty et al 1990, noted that cement voids and stem abutment against the femur (indicating an inadequate cement mantel) were associated w/ loosening;
- similarly, Maloney et al 1990, note that circumferential cement mantles with component centralization prevents loosening;
- references:
- Bone lysis in well fixed cemented femoral components. Maloney WJ et al, JBJS Vol 72-B. 1990. p 966-970.
System Inputs
Key Environment Key Regulatory Key Customer Wants / Needs
E1 Temperature : NA R1 FDA 21 CFR Part 888 C1 Warranted 10 years : non-fatigue in interval
E2 Vibration : NA C2 Easily installed (Easily formed ; adjustable)
E3 Mech. Shock : NA C3 Various sizes to choose from (L&R)
E4 Mech. Load : 200# C4 Clean , Dry , Finished as received
E5 Altitude : NA C5 Volume : 10,000 / year
E6 Corrosive : C6 Std. Pack : 28 / case (each hermetically
E7 Foreign Material : Dust , sealed in own bag)
E8 Humidity : 0% - 100% C7 Free from shipment damage
E9 Fluids : Alcohol , C8 Low Weight
E10 Elec. Load : NA C9 Cost : $450.00/piece
E11 EMC / RFI : NA C10 Hypoallergenic
E12 ESD : NA C11 : Weight : < 7 oz.
E13 Other : NOTE : Titanium cost =$100.00 / pound $43.75
Key Severity Table Classification
4 Non Compliance to Reg. Requirements Key Use when :
Hazard to End User CC Sev = 4
3 Extreme Customer Dissatisfaction SC Sev < 4 & RPN >/= 60
Loss of function
2 Cleanliness Issues
Customer Delay Issues
1 No Effect
"More than 120,000 - 160,000 artificial hip joints are being implanted annually in the United States."
David G. Murray, M.D.
Panel and Conference Chairperson
Professor and Chairman
Department of Orthopedic Surgery
State University of New York Health Sciences Center
Syracuse, New York
"Because the medical community has been asked to become increasingly fiscally responsible, cost analysis is being applied to every aspect of health care
delivery. When evaluating the expenditures associated with total hip arthroplasty, attention has been concentrated on implant costs. The United States market
for hip and knee implants is approximately $1.6 billion annually with a range in price of a primary total hip prosthesis between $2,000 and $6,000. With Medicare
paying for 59 percent of all total hip replacements in 1994, the Diagnosis Related Group (DRG) payment method predominates the reimbursement for this procedure.
The DRG method reimburses a hospital a fixed fee for a primary total hip replacement, approximately $9,000. The DRG payment covers the cost of the implant and
does not vary with the amount of money spent for the implant.In general, if we are searching for an inexpensive DRG stem, then a cemented stem must be chosen.
Porous cementless stems currently do not have low-priced options. In fact, the most expensive cemented stem is about the same price as the least expensive
porous cementless stem. The average price of a cemented stem is $1,537 with a range from $400 to $2,150, while cementless stem prices average $2,656 with a range
from $2,130 to $3,450. The first option in choosing a low-priced cemented implant is selecting the material type and manufacturing method. Implants fall into two
basic manufacturing methods; casting and forging. Forging is more expensive, but results in a stronger, more fatigue resistant stem. For example, a forged
chromium-cobalt stem has, on average, 50 percent more tensile and fatigue strength than a cast chromium-cobalt stem."
Richard A. Berger, MD, is adult reconstruction fellow, department of orthopaedic
surgery, Rush Medical College, Chicago.
J oshua J . J acobs, MD, is associate professor, of orthopaedic surgery, Rush
Medical College, Chicago.
"The operation usually takes 2 to 4 hours."
System Functional Block
Design Functional Block Diagram
Display or list: DFMEA No.: Page 1 of 1
Design Supvr. : Class Physical interfacing hardware. Rev. Lvl.: Rev. Date:
Design Engr.: Class Potential interfering hardware Proj. HI1 Customer: Any
Reliability Eng.: Class Fasteners & attachments ("Fi"). Year: 2001 Date:
Operational Environment Extremes : Show blocks not part of the analysis System / Item Name : Hip Implant
Reference applicable internal/customer test spec. and section number. in this fashion:
Temperature : NA Corrosive: ASTM B117 EMC/RFI : NA Level : Line Legend : Hydraulic /
Vibration: NA Foreign Mat'l.: NA ESD: NA System Mechanical: Electrical : Pneumatic :
Shock: NA Humidity: 0% - 100% Other 1 Applicable .Federal/Local Regulation(s):
Mech . Load: 1200 # Fluids : Alcohol, Other 2 FDA
Altitude: NA Elec. Load: NA Eng. Spec.:
Legend
A1 Pelvic Flange
A2 Socket Replacement
Pelvic Flange F1 (1 Place) A3 Pelvic Bone Flange
A4 Polyethylene Liner
A5 Femoral Ball Replacement
F1 Threaded Attachment
F2 F2 Crimp Attachment
Hip Bone F3 Cement Attachment
Socket F4 Slip Fit
F1 (5 Places)
F3 ( 2 Places)
F3
F4
Pelvic
Bone
F1 (6 Places)

A1
A2
A3
A4 A5
.
Design Functional Block Diagram
Display or list: DFMEA No.: Page 1 of 1
Design Supvr. : Class Physical interfacing hardware. Rev. Lvl.: Rev. Date:
Design Engr.: Class Potential interfering hardware Proj. HI1 Customer: Any
Reliability Eng.: Class Fasteners & attachments ("Fi"). Year: 2001 Date:
Operational Environment Extremes : Show blocks not part of the analysis System / Item Name : Hip Implant
Reference applicable internal/customer test spec. and section number. in this fashion:
Temperature : NA Corrosive: EMC/RFI : NA Level : Line Legend : Hydraulic /
Vibration: NA Foreign Mat'l.: NA ESD: NA System Mechanical: Electrical : Pneumatic :
Shock: Humidity: 0% - 100% Other 1 Applicable .Federal/Local Regulation(s):
Mech . Load: Fluids : Alcohol, Other 2 FDA
Altitude: NA Elec. Load: NA Eng. Spec.:
.
.
System Feature - Function Analysis
Feature Function Customer Wants &
Needs
Regulatory
Requirements
Environment
Strength Load bearing C1,C8 R1 E1,E4
Size & Configuration Adaptable to patient size C3 R1
Finish Cosmetic , hypoallergenic , C4,C10 R1 E7,E8,E9
bonding surface , lubricating surface ,
corrosion resistance
A1 : Pelvic Flange (upper) Provide mounting and attachment C1,C3 R1 E1,E4
interface to upper pelvic bone flange.
Positions/locates and retains F1 (1 place). C1,C3 R1 E1,E4
Easily installed. C2,C3 R1
A2 : Socket Replacement Cup Provide mounting and attachment C1,C3 R1 E1,E4
interface to pelvic bone socket.
Positions/locates and encapsulates C1,C3 R1 E1,E4
A4.
Recieves ,supports and provides mounting C1,C3 R1 E1,E4
interface to A5.
Positions/locates and retains F1 (5 places). C1,C3 R1 E1,E4
Provides reactant (bonding)
Interface with F3.
A3 : Pelvic Flange (lower) Provide mounting and attachment C1,C3 R1 E1,E4
interface to lower pelvic bone flange.
Positions/locates and retains F1 (6 places). C1,C3 R1 E1,E4
A4 : Polyethelyene Liner Provides mounting interface to A2 and A5. C1,C3 R1 E1,E4
Provides wear surface between A2 C1,C3 R1 E1,E4
and A5.
Provides attachment & sealing interface C1 R1 E1,E4
to A2. Provides reactant (bonding)
Interface with F3.
Minimizes frictional wear at A2 to A5 C1 R1 E1,E4
interface.
Hypoallergenic. C4,C10 R1 E7,E8,E9
A5 : Femoral Ball Replacement Provides mounting interface (F5) C1,C3 R1 E1,E4
to A2 and A4.
Withstands corrosive influences. C4 R1 E7,E8,E9
Provides mounting and attachment C1,C3 E1,E4
interface to femoral stem.
Smooth finish. C1 R1 E1,E4
Load bearing. C1,C3 R1 E1,E4
F1 / F2 : Threaded attachment Provides mounting interface to A1,A2 and C1,C3 R1 E1,E4
A3.
Secures A1,A2,A3 to respective C1,C3 R1 E1,E4
Pelvic bone joints.
Withstands corrosive influences. C4 E7,E8,E9
Smooth finish. C1 R1 E1,E4
Load bearing. C1,C3 R1 E1,E4
F3 : Cement Secures A2 to femoral bone socket (2 places). C1 R1 E1,E4
Retains A4 to A2 over uniform surface. C1 R1 E1,E4
Load bearing. Provides strength to femoral C1 R1 E1,E4
bone.
Withstands corrosive influences. C4 E7,E8,E9
Easily installed. C2
F4 : Slip fit Allows multi-axial loading , rotation C1 R1 E1,E4
between A2 and A5.
17
Potential
Failure Mode and Effects Analysis
System FMEA Number 12345678
Component Prepared By Class
Process Design Responsibility Class FMEA Date (Orig.) 3/7/2001
Model Year(s)/Project 01 Hip Socket Replacement Key Date 4/1/2001 FMEADate (Rev.) NA
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
A1 : Pelvic Flange
(upper) : Provide
mounting and attachment
interface to upper pelvic
bone flange.
Yield / Fatigue of
attachment
interface
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
Incompatability (DI)
(A1).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
MW 4/01/01. PCR#1 adds
inspection
requirements.

3
Materials
Incompatability (MI)
(A1).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 12
No further design
action. Material Lot
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
3 SC
Improper installation
procedure followed. 5
Note in
procedural
manual.
Not Applicable.
10 150
Forward concern to
customer.
MW 4/01/01. Forwarded on
3/12/01. No further
action.
Positions/locates and
retains F1/F2 (1 place).
Displaced Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
(A1).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.

3
Dimensional
(F1/F2 to A1).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Materials
(A1 to F1/F2).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 12
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
3 SC
procedure followed
(Torque on F1/F2).
5
Note in
procedural
manual.
Not Applicable.
10 150
Forward concern to
customer.
3/12/01. No further
action.
Easily installed. Not easily
installed.
Excessive installation
time.
2 SC
Dimensional
(improper device
configuration used).
5
Note in
procedural
manual.
Maintainability
Simulation.
Not Applicable.
10 100
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.

2 SC
procedure followed .
5
Note in
procedural
manual.
Not Applicable.
10 100
Forward concern to
customer.
3/12/01. No further
action.
18
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
A2 : Socket
Replacement Cup :
Provide mounting and
attachment interface to
pelvic bone socket.
Yield / Fatigue of
attachment
interface
Hazard to end user.
4 CC
Dimensional
(A2).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
4 CC
Materials
(A2).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
4 CC
Physiochemical
Instability (PI) (To
Cement Materials F3).
3
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.Fluids
Compatability
Test.
2 24
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
4 CC
Dimensional
Incompatability (DI).
(F1) 2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
4 CC
Materials
Incompatability (MI).
(F1)
3
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 24
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
4 CC
procedure followed
(F1 Torque ; Wrong
A2 configuration
used). 5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
encapsulates A4.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
Incompatability
(DI).(A2 )
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
19
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
3 SC
procedure followed
(Wrong A2
configuration
used;Wrong A4
5
Forward
concern to
customer. Note
in procedural
manual.
Not Applicable.
10 150
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
3
Dimensional
Incompatability
(DI).(A4 )
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
Provide mounting /support
and attachment interface to
A5.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
Incompatability
(DI).(A2 to A5 )
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Materials
(A2/A5).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 12
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
3 SC
procedure followed
(Wrong A2/A5
5
Note in
procedural
manual.
Not Applicable.
10 150
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
retains F1 (5 places).
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
Incompatability
(DI).(A2 to F1 )
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Materials
(F1).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 12
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
20
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
3 SC
procedure followed
(Wrong A2/F1
5
Note in
procedural
manual.
Not Applicable.
10 150
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
Provides reactant
(bonding) Interface with F3.
Adhesive
Yield/Fatigue
Hazard to end user.
4 CC
Physiochemical
Instability (PI)
(Cement Materials
incompatability) (F3).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
4 CC
procedure followed
(Wrong F3 Mixture /
content specified).
5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer.
3/12/01. No further
action.
installed.
time.
2 SC
Dimensional
(improper device
5
Note in
procedural
manual.
Maintainability
Simulation.
Not Applicable.
10 100
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
A3 : Pelvic Flange
(lower) : Provide
interface to lower pelvic
bone flange.
Yield / Fatigue of
attachment
interface
Hazard to end user.
4 CC
Dimensional
(A3).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
4 CC
Materials
(A3).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
1 2
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
4 CC
procedure followed
(Wrong configuration
used).
5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
21
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
retains F1 (6 places).
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
(A3 to F1).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Dimensional
(F1 to A3).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Materials
(A3/F1).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 12
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
installed.
time.
2 SC
procedure followed
used).
5
Note in
procedural
manual.
Maintainability
Simulation.
Not Applicable.
10 100
Forward concern to
customer. Distinct
containers and
labeling.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
Strength : Strength -
Provides structural
support.
Yield/Fatigue. Hazard to end user.
4 CC
Materials
(A1/A2/A3/F1/F2/F3).I
mproper Materials
specified.
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
Size & Configuration :
Adaptable to patient size
Non adaptable Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.Distinc
t containers and
labeling.
MW 4/01/01. PCR#1.
ECR#23165
specifies package
configuration. No
further action.
Finish (Coating)
: Hypoallergenic
Non-
Hupoallergenic
Potential Blood
Poisoning.Hazard to
end user.
4 CC
Improper materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
22
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Smooth surface :Provide
bonding surface to A4 and
F3
Adhesive
Yield/Fatigue
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Improper surface
finish specified.
2
Limit Stack
Analysis (LSA).
Cleanliness and
Burr free note
on detail
drawing.
Life Cycle
Durability.
2 12
No further design
action. 100% on line
deburr operation.
inspection
requirements.
3 SC
procedure followed
(Contaminants
introduced at
interfaces).
5
Note in
procedural
manual.
Not Applicable.
10 150
Forward concern to
customer.
3/12/01. No further
action.
Corrosion resistance Corrosion. Potential Blood
Poisoning.Hazard to
end user.
4 CC
Improper plating
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test. 96 Hr. Salt
Spray test.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
Contaminant Free Contamination Potential Blood
Poisoning.Hazard to
end user.
4 CC
Inadequate
cleanliness provisions
provided / specified.
3
Cleanliness and
Burr free note
on detail
drawing.
Not Applicable.
3 36
No further design
action. Clean
operation prior to
hermetic pack.
MW 4/01/01. ECR#98567 adds
notes. PCR#2
adds clean
operation.
A4 : Polyethelyene Liner
: Provides mounting
interface to A2 and A5.
Displaced. Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No Action. Not
Class responsible.
Not Applicable. Not Applicable.
3 SC
procedure followed
used).
5
Note in
procedural
manual.
Not Applicable.
10 150
Forward concern to
customer.
3/12/01. No further
action.
Provides wear surface
between A2 and A5.
Excessive wear Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Improper materials
specified.
3
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test.
3 9
No Action. Not
Class responsible.
23
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Provides attachment
interface to A2 .
Yield/Fatigue of
attachment
interface
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability. Fluids
Compatability
test.
2 12
No Action. Not
Class responsible.
Provides reactant
(bonding) Interface with F3.
Adhesive
Yield/Fatigue
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Physiochemical
Instability (PI) (A3 to
F3 Materials
incompatability)
.Incorrect Materials
specified.
3
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test.
3 9
No further design
action. A3 Material
Lot Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
Minimizes frictional wear at
A2 to A5 interface.
Excessive wear Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect Materials
specified.
3
Mettalurgical
lab analysis.
Life Cycle
Durability.
3 9
No Action. Not
Class responsible.
Hypoallergenic. Non-
Hupoallergenic
Potential Blood
Poisoning.Hazard to
end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability.
2 16
No Action. Not
Class responsible.
installed.
time.
2
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Simulation.
Life Cycle
Durability.
2 8
No Action. Not
Class responsible.
2 SC
procedure followed
used).
5
Note in
procedural
manual.
Not Applicable.
10 100
Forward concern to
customer. Distinct
containers and
labeling fpr
A1/A2/A3.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
A5 : Femoral Ball
Replacement : Provides
mounting interface (F5) to
A2 and A4.
Yield / Fatigue of
attachment
interface
Hazard to end user.
4 CC
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 16
No Action. Not
Class responsible.
24
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
4 CC
procedure followed
used).
5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer. Distinct
containers and
labeling fpr
A1/A2/A3.
3/12/01.
ECR#23165
specifies package
configuration. No
further action.
Corrosion resistance Corrosion. Potential Blood
Poisoning.Hazard to
end user.
4 CC
Improper plating
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test. 96 Hr. Salt
Spray test.
2 16
No Action. Not
Class responsible.
Provides mounting and
attachment interface to
femoral stem.
Yield / Fatigue of
attachment
interface
Hazard to end user.
4 CC
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability. Fluids
Compatability
test.
2 16
No Action. Not
Class responsible.
4 CC
procedure followed
used). 5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer.
3/12/01.
Smooth finish. Rough Excessive wear at
interface.Eventual
loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Improper surface
finish specified.
2
Limit Stack
Analysis (LSA).
Cleanliness and
Burr free note
on detail
drawing.
Life Cycle
Durability.
2 12
No Action. Not
Class responsible.
Load bearing. Yield / Fatigue of
attachment
interface
Hazard to end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test.
2 16
No Action. Not
Class responsible.
Hupoallergenic
Potential Blood
Poisoning.Hazard to
end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test.
2 16
No Action. Not
Class responsible.
25
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
installed.
time.
2
Dimensional
(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Simulation.
Life Cycle
Durability.
2 8
No Action. Not
Class responsible.
2 SC
procedure followed
used).
5
Note in
procedural
manual.
Not Applicable.
10 100
Forward concern to
customer.
3/12/01.
F1 / F2 : Threaded
attachment : Provides
mounting interface to
A1,A2 and A3.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
F1/F2 to
A1/A2/A3(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration For
A1/A2/A3.
inspection
requirements.
Secures A1,A2,A3 to
respective Pelvic bone
joints.
Yield / Fatigue of
attachment
interface
Hazard to end user.
4 CC
Materials
(F1/F2). Improper
Materials specified. 2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 16
No Action. Not
Class responsible.
Hupoallergenic
Potential Blood
Poisoning.Hazard to
end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability.
2 16
No Action. Not
Class responsible.
Withstands corrosive
influences.
Corrosion. Potential Blood
Poisoning.Hazard to
end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability. Fluids
Compatability
test. 96 Hr. Salt
Spray test.
2 16
No Action. Not
Class responsible.
Smooth finish. Excessive wear at
interface.Eventual
loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Improper surface
finish specified.
2
Limit Stack
Analysis (LSA).
Cleanliness and
Burr free note
on detail
drawing.
Life Cycle
Durability.
2 12
No Action. Not
Class responsible.
26
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Load bearing. Yield/Fatigue. Hazard to end user.
4 CC
Materials
(F1/F2). Improper
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test. 2 16
No Action. Not
Class responsible.
installed.
time.
2
Dimensional
F1/F2 to A1/A2/A3
(Improper F1/F2
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Simulation.
Life Cycle
Durability.
2 8
No further design
action. SPC
attachment
configuration For
A1/A2/A3.
inspection
requirements.
2 SC
procedure followed
used). 5
Note in
procedural
manual.
Not Applicable.
10 100
Forward concern to
customer.
3/12/01.
F3 : Cement : Secures A2
to femoral bone socket (2
places).
Adhesive
Yield/Fatigue
Hazard to end user.
4 CC
Materials
(F3). Improper
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test. 4
No further design
Certifications for
A1/A2/A3.
MW 4/01/01. SREA23
authorizes MLCs.
4 CC
Improper content
specified (F3).
3
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test.
3 36
No Action. Not
Class responsible.
Not Applicable.
4 CC
procedure followed
(Wrong cement used /
Improper content). 5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer.
3/12/01.
4 CC
Contamination at
attachment interfaces.
5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer.
3/12/01.
27
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hupoallergenic
Potential Blood
Poisoning.Hazard to
end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability.
2 16
No Action. Not
Class responsible.
Load bearing. Provides
strength to femoral bone.
Yield / Fatigue Hazard to end user.
4 CC
Materials
(F3). Improper
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test. 2 16
No Action. Not
Class responsible.
4 CC
Improper content
specified (F3).
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test.
2 16
No Action. Not
Class responsible.
4 CC
procedure followed
(Wrong cement used /
Improper content). 5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer.
3/12/01.
4 CC
Contamination at
attachment interfaces.
5
Note in
procedural
manual.
Not Applicable.
10 200
Forward concern to
customer.
3/12/01.
Withstands corrosive
influences.
Corrosion. Potential Blood
Poisoning.Hazard to
end user.
4 CC
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability. Fluids
Compatability
test. 96 Hr. Salt
Spray test.
2 16
No Action. Not
Class responsible.
installed.
time.
2
Incorrect Materials
specified.
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Maintainability
Simulation.
Life Cycle
Durability.
1 8
No Action. Not
Class responsible.
28
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
F4 : Slip fit : Allows multi-
axial loading , rotation
between A2 and A5.
Does not allow
multi-axial loading
, rotation.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Dimensional
A1/A2/A3(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Life Cycle
Durability. Fluids
Compatability
test.
2 12
No further design
action. SPC
attachment
configuration.
Distinct containers
and labeling.
inspection
requirements.
ECR#23165
specifies package
configuration. No
further action.
installed.
time.
2
Dimensional
A1/A2/A3(Improper
configuration
specified).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Simulation.
Life Cycle
Durability.
2 8
No further design
action. SPC
attachment
configuration.
Distinct containers
and labeling.
inspection
requirements.
ECR#23165
specifies package
configuration. No
further action.
2 SC
procedure followed
used). 5
Note in
procedural
manual.
Not Applicable.
10 100
Forward concern to
customer.
3/12/01.

SFMEA Statistics 0<rpn<9 7 0<rpn<9 7 AIAG "O"Conversion
Characteristics Count rpn<19 54 10<rpn<19 47 6.7E-07 0.000001
# CC's 37 Causes rpn<29 56 20<rpn<29 2 6.7E-06 0.000334
# SC's 15 Total rpn<39 58 30<rpn<39 2 6.7E-05 0.000467
Total : 52 82 rpn<49 58 40<rpn<49 0 0.0005 0.000000
Sum of modes considered : 45 rpn<59 58 50<rpn<59 0 0.0025 0.060000
29
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential Effect(s)
of Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
System
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Index / Criteria # rpn<69 58 60<rpn<69 0 0.0125 0.000000
PO=1 1 rpn<79 58 70<rpn<79 0 0.05 0.000000
PO=2 50 rpn<89 58 80<rpn<89 0 0.125 0.000000
PO=3 7 rpn<99 58 90<rpn<99 0 0.33333 0.000000
PO=4 0 rpn<125 66 100<rpn<125 8 0.5 0.000000
PO=5 24 rpn<250 82 126<rpn<250 16
PO=6 0 rpn<299 82 251<rpn<299 0 Sum "U" 0.060801 Claims / 1000
PO=7 0 rpn>299 0 rpn>299 0 Reliability 60.80086
PO=8 0 0.939199
PO=9 0
PO=10 0
S=1 0
S=2 13
S=3 32
S=4 37
D=1 2
D=2 50
D=3 5
D=4 0
D=5 0
D=6 0
D=7 0
D=8 0
D=9 0
D=10 24

0
5
10
15
20
25
30
35
40
45
50
F
r
e
q
u
e
n
c
y

RPN
Hip Socket PRA
30
31
32
33
34
35
36
37
38
39
40
41
42
43
SFMEA EFFECT :
Loss of function. Extreme physical discomfort and customer dissatisfaction.
Item/ Function Potential Failure Mode
S
e
v
C
l
a
s
s
Potential Cause(s)/ Mechanism(s) of
Failure
O
c
c
u
r
D
e
t
e
c
R
P
N
A1 : Pelvic Flange (upper) : Provide mounting and attachment interface to upper
pelvic bone flange.
Yield / Fatigue of attachment interface
3
Dimensional Incompatability (DI) (A1).
2 2 12
3 Materials Incompatability (MI) (A1). 2 2 12
3 SC
Improper installation procedure
followed.
5 10 150
Positions/locates and retains F1/F2 (1 place). Displaced
3
Dimensional Incompatability (DI) (A1).
2 2 12
3
Dimensional Incompatability (DI)
(F1/F2 to A1).
2 2 12
3
Materials Incompatability (MI) (A1 to
F1/F2).
2 2 12
3 SC
Improper installation procedure followed
(Torque on F1/F2).
5 10 150
A2 : Socket Replacement Cup : Positions/locates and encapsulates A4. Displaced
3
Dimensional Incompatability (DI).(A2 )
2 2 12
3 SC
(Wrong A2 configuration used;Wrong
A4 configuration used).
5 10 150
3
Dimensional Incompatability (DI).(A4 )
2 2 12
Provide mounting /support and attachment interface to A5. Displaced
3
Dimensional Incompatability (DI).(A2 to
A5 )
2 2 12
3
Materials Incompatability (MI) (A2/A5).
2 2 12
3 SC
(Wrong A2/A5 configuration used). 5 10 150
Positions/locates and retains F1 (5 places). Displaced
3
Dimensional Incompatability (DI).(A2 to
F1 )
2 2 12
3 Materials Incompatability (MI) (F1). 2 2 12
3 SC
(Wrong A2/F1 configuration used). 5 10 150
A3 : Pelvic Flange (lower) : Positions/locates and retains F1 (6 places). Displaced
3
Dimensional Incompatability (DI) (A3 to
F1).
2 2 12
3
Dimensional Incompatability (DI) (F1 to
A3).
2 2 12
3
Materials Incompatability (MI) (A3/F1).
2 2 12
Size & Configuration : Adaptable to patient size Non adaptable
3
(Improper configuration specified).
2 2 12
Finish (Coating) Smooth surface :Provide bonding surface to A4 and F3 Adhesive Yield/Fatigue
3
Improper surface finish specified.
2 2 12
3 SC
(Contaminants introduced at
interfaces).
5 10 150
A4 : Polyethelyene Liner : Provides mounting interface to A2 and A5. Displaced.
3
2 2 12
3 SC
(Wrong configuration used). 5 10 150
Provides wear surface between A2 and A5. Excessive wear 3 Improper materials specified. 3 3 9
Provides attachment interface to A2 . Yield/Fatigue of attachment interface
3
2 2 12
Provides reactant (bonding) Interface with F3. Adhesive Yield/Fatigue
3
Physiochemical Instability (PI) (A3 to
F3 Materials incompatability) .Incorrect
Materials specified.
3 3 9
Minimizes frictional wear at A2 to A5 interface. Excessive wear 3 Incorrect Materials specified. 3 3 9
A5 : Femoral Ball Replacement : Smooth finish. Rough 3 Improper surface finish specified. 2 2 12
F1 / F2 : Threaded attachment : Provides mounting interface to A1,A2 and A3. Displaced
3
Dimensional Incompatability (DI) F1/F2
to A1/A2/A3(Improper configuration
specified).
2 2 12
Smooth finish. 3 Improper surface finish specified. 2 2 12
F4 : Slip fit : Allows multi-axial loading , rotation between A2 and A5. Does not allow multi-axial loading ,
rotation. 3
A1/A2/A3(Improper configuration
specified).
2 2 12
PO=1 0 AIAG "O"Conversion
PO=2 22 0.00000067 0.000000
PO=3 3 0.00000667 0.000147
PO=4 0 0.00006667 0.000200
PO=5 7 0.0005 0.000000
PO=6 0 0.0025 0.017500
PO=7 0 0.0125 0.000000
PO=8 0 0.05 0.000000
PO=9 0 0.125 0.000000
PO=10 0 0.33333333 0.000000
0.5 0.000000
Sum "U" 0.017847 Claims / 1000
Reliability 17.85
0.982153
SFMEA EFFECT :
44
Hazard to end user.
Item/ Function Potential Failure Mode
S
e
v
C
l
a
s
s
Potential Cause(s)/ Mechanism(s) of
Failure
O
c
c
u
r
D
e
t
e
c
R
P
N
A2 : Socket Replacement Cup : Provide mounting and attachment interface to
pelvic bone socket.
Yield / Fatigue of attachment
interface
4 CC
(A2).
2 2 16
4 CC
Materials Incompatability (MI)
(A2).
2 2 16
4 CC
Physiochemical Instability (PI) (To
Cement Materials F3).
3 2 24
4 CC
Dimensional Incompatability (DI).
(F1)
2 2 16
4 CC
Materials Incompatability (MI).
(F1)
3 2 24
4 CC
followed (F1 Torque ; Wrong A2
5 10 200
Provides reactant (bonding) Interface with F3. Adhesive Yield/Fatigue
4 CC
Physiochemical Instability (PI)
(Cement Materials
incompatability) (F3).
2 2 16
4 CC
followed (Wrong F3 Mixture /
content specified).
5 10 200
A3 : Pelvic Flange (lower) : Provide mounting and attachment interface to
lower pelvic bone flange.
interface
4 CC
(A3).
2 2 16
4 CC
(A3).
2 1 2
4 CC
followed (Wrong configuration
used).
5 10 200
Strength : Strength - Provides structural support. Yield/Fatigue.
4 CC
(A1/A2/A3/F1/F2/F3).Improper
Materials specified.
2 2 16
Finish (Coating) : Hypoallergenic Non-Hupoallergenic 4 CC Improper materials specified. 2 2 16
Corrosion resistance Corrosion. 4 CC Improper plating specified. 2 2 16
Contaminant Free Contamination
4 CC
Inadequate cleanliness provisions
provided / specified. 3 3 36
Hypoallergenic. Non-Hupoallergenic 4 CC Incorrect Materials specified. 2 2 16
A5 : Femoral Ball Replacement : Provides mounting interface (F5) to A2 and A4. Yield / Fatigue of attachment
interface 4 CC
(Improper configuration specified). 2 2 16
4 CC
used).
5 10 200
Corrosion resistance Corrosion. 4 CC Improper plating specified. 2 2 16
Provides mounting and attachment interface to femoral stem. Yield / Fatigue of attachment
interface 4 CC
(Improper configuration specified). 2 2 16
4 CC
used).
5 10 200
Load bearing. Yield / Fatigue of attachment
interface
4 CC
Incorrect Materials specified.
2 2 16
F1 / F2 : Threaded attachment : Secures A1,A2,A3 to respective Pelvic bone
joints.
interface 4 CC
(F1/F2). Improper Materials
specified.
2 2 16
Withstands corrosive influences. Corrosion. 4 CC Incorrect Materials specified. 2 2 16
Load bearing. Yield/Fatigue.
4 CC
(F1/F2). Improper Materials
specified.
2 2 16
F3 : Cement : Secures A2 to femoral bone socket (2 places). Adhesive Yield/Fatigue
4 CC
(F3). Improper Materials
specified.
1 4
4 CC
Improper content specified (F3).
3 3 36
4 CC
followed (Wrong cement used /
Improper content).
5 10 200
4 CC
Contamination at attachment
interfaces.
5 10 200
Load bearing. Provides strength to femoral bone. Yield / Fatigue
4 CC
(F3). Improper Materials
specified.
2 2 16
4 CC
Improper content specified (F3).
2 2 16
4 CC
followed (Wrong cement used /
Improper content).
5 10 200
4 CC
Contamination at attachment
interfaces.
5 10 200
Withstands corrosive influences. Corrosion. 4 CC Incorrect Materials specified. 2 2 16
PO=2 20 0.00000067 0.000001
PO=3 2 0.00000667 0.000133
PO=4 0 0.00006667 0.000133
PO=5 9 0.0005 0.000000
PO=6 0 0.0025 0.022500
PO=7 0 0.0125 0.000000
PO=8 0 0.05 0.000000
PO=9 0 0.125 0.000000
PO=10 0 0.33333333 0.000000
0.5 0.000000
Sum "U" 0.022767 Claims / 1000
Reliability 22.77
0.977233
Component Considerations
Component Design FMEA
Fault Trees
46
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/ Design Function-
Process Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
A3 : "A"- Width of Lower
pelvic flange; "B-F" - Length
of Lower pelvic flange ; R1 -
Angular articulation of Lower
pelvic flange ; L2- Length
from end of part at A3 to
centerline of A2 : Provide
mounting interface to Lower
pelvic bone flange.Easily
Installed.
Displaced Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
tolerancing specified
"A".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.

3
Incorrect
dimensioning /
"B-F".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"R1".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"L2".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
H1-Height of A3 relative to
base of A2 ; a1-Angle A3
relative to base of A2; R2-
Blend radius of A1 to A2 :
Provide mounting interface to
Lower pelvic bone flange.
Easily Installed.
Displaced Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"H1".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"a1".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
47
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
3
Incorrect
dimensioning /
"R2".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
Flange hole (6 places) :OD-
Diameter of hole ;ID-Diameter
of hole;R3-Lead in
chamfer;MM1-Minimum
distance of flange hole from
end of part;S1-Maximum
span of hole centerlines :
Provide mounting and
attachment interface of A3 to
Lower pelvic bone flange.
Positions/locates and retains
F1 (6 places). Easily Installed.
Yield / Fatigue of
attachment
interface
Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction. 3
Incorrect
dimensioning /
"OD
:oversized/undersized
".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.

3
Incorrect
dimensioning /
"R3 :undersized".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"MM1 :too short".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"S1 :too narrow".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
48
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
A1- W1 Width of Upper
pelvic bone flange; H2 Height
from R4 (blend radius) ;H3
Height from base of A2 to R4
;R4 -Blend radius of A1
relative to A2 ; L3 - Length
from end of part at A1 to
centerline of A2 : Provide
mounting interface to Upper
pelvic bone flange. Easily
Installed.
Displaced. Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"W1 :too
narrow/long".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"H2 :too long / short".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"R4 :too small / large".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"L3 :too long / short".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
49
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Flange hole (1 places) :OD-
Diameter of hole ;ID-Diameter
of hole;R5-Lead in
chamfer;MM2-Minimum
distance of flange hole from
end of part;S1-Maximum
span of hole centerline from
end of A1 : Provide mounting
and attachment interface of
A1 to Lower pelvic bone
flange.Positions/locates and
retains F2 (1 places). F2
Easily installed.
Yield/Fatigue of
attachment
interface.
Difficult
installation. F2
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"OD :too large /
small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"ID :too large / small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"R5 :too large / small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"MM2 :too short".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
"S1 :too narrow".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
50
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
3
Incorrect number of
holes specified (too
few).
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
A2- OD Diameter of socket
receptacle;R6 Inside Radius
of socket receptacle (defines
height of receptacle):Provide
mounting interface to Pelvic
bone socket. Provides size to
suit patients needs. Positions
/ locates and encapsulates
A4 (A4 Easily installed).
Recieves,supports and
provides mounting interface
to A5. Slip Fit (F4)..Easily
Installed.
Yield/Fatigue of
attachment
interface.
Difficult
Installation.Loss
of / limited
function. Extreme
physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"R6 :too small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
A2- OD Diameter of socket
receptacle;R6 Inside Radius
of socket receptacle (defines
height of receptacle):Provide
mounting interface to Pelvic
bone socket. Provides size to
suit patients needs. Positions
/ locates and encapsulates A4
(A4 Easily installed).
Recieves,supports and
provides mounting interface
to A5. Slip Fit (F4)..Easily
Installed.
A4 & A5
displaces. Hazard
to end user.
4 CC
Incorrect
dimensioning /
"R6 :too large".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
51
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Socket Dome hole (6 places:
2 rows of 3 holes each on
face facing A3) :OD-Diameter
of hole ;ID-Diameter of
hole;R7-Lead in chamfer;S2
adjacent hole to hole
centerline spacing within and
across rows ; D0 Hole shank
depth from outside socket
face to bottom of R7 :Provide
interface of A2 to Hip bone
socket. Positions/locates and
Easily installed.
Yield/Fatigue of
attachment
interface.
Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user.
4 CC
Incorrect
dimensioning /
"OD :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
Easily installed.
4 CC
Incorrect
dimensioning /
"ID :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
52
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Easily installed.
4 CC
Incorrect
dimensioning /
"R7 :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
Easily installed.
4 CC
Incorrect
dimensioning /
"S2 :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
53
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Easily installed.
4 CC
Incorrect
dimensioning /
"D0 :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
Socket Cement Triangular
hole (2 places on face facing
A1) :OD-Diameter of hole
inclusion between adjacent
legs ;R8(3 places)-radial
transition of hole adjacent
legs;L -Length of adjacent
legs prior to radial transition
R8 ; S2 adjacent hole to hole
centerline spacing :Provide
socket. In conjunction with
A2 surface area : Provides
access and bonding interface
to F3.
Yield/Fatigue of
attachment
interface.
Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"OD :too small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
54
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
3
Incorrect
dimensioning /
"L :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
3
Incorrect
dimensioning /
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
L1-Overall length of A1,A2,A3
: Provide size to suit patient
needs. Easily installed.
Displaced. Difficult
installation. F1/F2
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"L1 :too large/small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Life Cycle
Durability.
2 12
No further design
action. SPC
attachment
configuration.
inspection
requirements.
R9 - All sharp edges and radii
:Support finish , burr free.
Rough. Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect
dimensioning /
"R9 :too small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Cleanliness and
Burr free note
on detail
drawing.
Life Cycle
Durability.
2 16
No further design
action. SPC
attachment
configuration.
inspection
requirements.
F1-Surface finish :Provide
smooth bonding interface
between A2 and F3.
Rough. Adhesive
Yield/Fatigue.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction.
3
Incorrect
dimensioning /
"F1 :too small".
2
Limit Stack
Analysis (LSA).
System
Mockup.
Maintainability
Analysis.
Cleanliness and
Burr free note
on detail
drawing.
Life Cycle
Durability.
2 12
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
55
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
M- Materials : Provide
strength.
Yield/Fatigue Hazard to end
user.
4 CC
Incorrect materials
specified.
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
P-Coating: Corrosion
resistance.
Corrosion Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect coating
specified.
2
Mettalurgical
lab analysis.
Life Cycle
Durability.
Fluids
Compatability
test. 96 Hr. Salt
Spray test.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
Hupoallergenic
Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect materials
specified. 2
Mettalurgical
lab analysis.
Life Cycle
Durability. 2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
Contaminant free. Contamination Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect
requirements
specified.
2
Cleanliness and
Burr free note
on detail
drawing.
Not Applicable.
2 16
No further design
Certifications.
MW 4/01/01. SREA23
authorizes MLCs.
T1-Thickness of A1 , A2 & A3
: Provide strength .
Yield / Fatigue Hazard to end
user.
4 CC
Incorrect
dimensioning /
"T1 :too small".
2
Mettalurgical
lab analysis.
Finite Element
Analysis (FEA).
Life Cycle
Durability.
2 16
No further design
action. SPC
thickness .Material
Lot Certifications.
inspection
requirements.
SREA23
authorizes MLCs.

56
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
DFMEA Statistics 0<rpn<9 0 0<rpn<9 0 AIAG "O"Conversion
Characteristics Count rpn<19 41 10<rpn<19 41 6.7E-07 0.000000
Total : 12 41 rpn<49 41 40<rpn<49 0 0.0005 0.000000
PO=1 0 rpn<79 41 70<rpn<79 0 0.05 0.000000
PO=2 41 rpn<89 41 80<rpn<89 0 0.125 0.000000
PO=3 0 rpn<99 41 90<rpn<99 0 0.33333 0.000000
PO=4 0 rpn<125 41 100<rpn<125 0 0.5 0.000000
PO=5 0 rpn<250 41 126<rpn<250 0
PO=6 0 rpn<299 41 251<rpn<299 0 Sum "U" 0.000273 Claims / 1000
PO=7 0 rpn>299 0 rpn>299 0 Reliability 0.27347
PO=8 0 0.999727
PO=9 0
PO=10 0
S=1 0
S=2 0
S=3 29
S=4 12
D=1 0
D=2 41
D=3 0
D=4 0
D=5 0
D=6 0
D=7 0
D=8 0
D=9 0
D=10 0
0
5
10
15
20
25
30
35
40
45
F
r
e
q
u
e
n
c
y

RPN
Hip Socket Component PRA
57
Potential
Core Team :
Class
Action Results
Design Item-Process
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Component
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
RPN
58
DFMEA EFFECT :
Loss of function. Extreme physical discomfort and customer dissatisfaction.
Item/ Function
Potential Failure
Mode
S
e
v
C
l
a
s
s Potential Cause(s)/ Mechanism(s) of Failure
O
c
c
u
r
D
e
t
e
c
R
P
N
A3 : "A"- Width of Lower pelvic flange; "B-F" - Length of Lower pelvic flange ; R1 - Angular articulation of Lower
pelvic flange ; L2- Length from end of part at A3 to centerline of A2 : Provide mounting interface to Lower
pelvic bone flange.Easily Insta
Displaced
3
Incorrect dimensioning / tolerancing specified
"A". 2 2 12
3
"B-F".
2 2 12
3
"R1".
2 2 12
3
"L2".
2 2 12
H1-Height of A3 relative to base of A2 ; a1-Angle A3 relative to base of A2; R2- Blend radius of A1 to A2 :
Provide mounting interface to Lower pelvic bone flange. Easily Installed.
Displaced
3
"H1". 2 2 12
3
"a1".
2 2 12
3
"R2".
2 2 12
Flange hole (6 places) :OD-Diameter of hole ;ID-Diameter of hole;R3-Lead in chamfer;MM1-Minimum distance of
flange hole from end of part;S1-Maximum span of hole centerlines : Provide mounting and attachment interface
of A3 to Lower pelvic bone flange. Pos
Yield / Fatigue of
attachment interface 3
"OD :oversized/undersized". 2 2 12
3
"R3 :undersized".
2 2 12
3
"MM1 :too short".
2 2 12
3
"S1 :too narrow".
2 2 12
A1- W1 Width of Upper pelvic bone flange; H2 Height from R4 (blend radius) ;H3 Height from base of A2 to R4
;R4 -Blend radius of A1 relative to A2 ; L3 - Length from end of part at A1 to centerline of A2 : Provide mounting
interface to Upper pelvic bone f
Displaced.
3
"W1 :too narrow/long". 2 2 12
3
2 2 12
3
2 2 12
3
"R4 :too small / large".
2 2 12
3
"L3 :too long / short".
2 2 12
Flange hole (1 places) :OD-Diameter of hole ;ID-Diameter of hole;R5-Lead in chamfer;MM2-Minimum distance of
flange hole from end of part;S1-Maximum span of hole centerline from end of A1 : Provide mounting and
attachment interface of A1 to Lower pelvic bo
Yield/Fatigue of
attachment
interface.
3
"OD :too large / small". 2 2 12
3
"ID :too large / small".
2 2 12
3
"R5 :too large / small".
2 2 12
3
"MM2 :too short".
2 2 12
3
"S1 :too narrow".
2 2 12
3
Incorrect number of holes specified (too few).
2 2 12
A2- OD Diameter of socket receptacle;R6 Inside Radius of socket receptacle (defines height of
receptacle):Provide mounting interface to Pelvic bone socket. Provides size to suit patients needs. Positions /
locates and encapsulates A4 (A4 Easily installed)
Yield/Fatigue of
attachment
interface.
3
"R6 :too small". 2 2 12
Socket Cement Triangular hole (2 places on face facing A1) :OD-Diameter of hole inclusion between adjacent
legs ;R8(3 places)-radial transition of hole adjacent legs;L -Length of adjacent legs prior to radial transition R8 ;
S2 adjacent hole to hole centerline spacing :Provide mounting and attachment interface of A2 to Hip bone
socket. In conjunction with A2 surface area : Provides access and bonding interface to F3.
Yield/Fatigue of
attachment
interface. 3
"OD :too small".
2 2 12
3
2 2 12
3
"L :too large/small".
2 2 12
3
2 2 12
L1-Overall length of A1,A2,A3 : Provide size to suit patient needs. Easily installed. Displaced.
3
"L1 :too large/small".
2 2 12
F1-Surface finish :Provide smooth bonding interface between A2 and F3. Rough.
3
"F1 :too small".
2 2 12
PO=2 29 0.00000067 0.000000
PO=3 0 0.00000667 0.000193
PO=4 0 0.00006667 0.000000
PO=5 0 0.0005 0.000000
PO=6 0 0.0025 0.000000
PO=7 0 0.0125 0.000000
PO=8 0 0.05 0.000000
PO=9 0 0.125 0.000000
PO=10 0 0.33333333 0.000000
0.5 0.000000
Sum "U" 0.000193 Claims / 1000
Reliability 0.193
0.999807

59 DFMEA EFFECT :
Hazard to end user.
Item/ Function
Potential Failure
Mode
S
e
v
C
l
a
s
s Potential Cause(s)/ Mechanism(s) of Failure
O
c
c
u
r
D
e
t
e
c
R
P
N
A2- OD Diameter of socket receptacle;R6 Inside Radius of socket receptacle (defines height of
receptacle):Provide mounting interface to Pelvic bone socket. Provides size to suit patients needs. Positions /
locates and encapsulates A4 (A4 Easily installed)
Yield/Fatigue of
attachment
interface.
4 CC
"R6 :too large". 2 2 16
Socket Dome hole (6 places: 2 rows of 3 holes each on face facing A3) :OD-Diameter of hole ;ID-Diameter of
hole;R7-Lead in chamfer;S2 adjacent hole to hole centerline spacing within and across rows ; D0 Hole shank
depth from outside socket face to bottom
Yield/Fatigue of
attachment
interface.
4 CC
"OD :too large/small". 2 2 16
4 CC
2 2 16
4 CC
2 2 16
4 CC
2 2 16
4 CC
2 2 16
R9 - All sharp edges and radii :Support finish , burr free. Rough.
4 CC
"R9 :too small".
2 2 16
M- Materials : Provide strength. Yield/Fatigue 4 CC Incorrect materials specified. 2 2 16
P-Coating: Corrosion resistance. Corrosion 4 CC Incorrect coating specified. 2 2 16
Hypoallergenic. Non-Hypoallergenic
4 CC
Incorrect materials specified.
2 2 16
Contaminant free. Contamination 4 CC Incorrect requirements specified. 2 2 16
T1-Thickness of A1 , A2 & A3 : Provide strength . Yield / Fatigue
4 CC
"T1 :too small".
2 2 16
PO=2 12 0.00000067 0.000000
PO=3 0 0.00000667 0.000080
PO=4 0 0.00006667 0.000000
PO=5 0 0.0005 0.000000
PO=6 0 0.0025 0.000000
PO=7 0 0.0125 0.000000
PO=8 0 0.05 0.000000
PO=9 0 0.125 0.000000
PO=10 0 0.33333333 0.000000
0.5 0.000000
Sum "U" 0.000080 Claims / 1000
Reliability 0.08
0.999920
60
Special Characteristics List from Design
Component
Model Year(s)/Project Key Date
Design Item-Process Function/
Design Function-Process Requirements*
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
D
e
t
e
c
R
P
N
Recommended
Action(s)
Related
Process
Steps
A2- OD Diameter of socket receptacle;R6 Inside
Radius of socket receptacle (defines height of
receptacle):Provide mounting interface to Pelvic
bone socket. Provides size to suit patients
needs. Positions / locates and encapsulates A4
(A4 Easily installed)
A4 & A5
displaces. Hazard
to end user.
4 CC
Incorrect
dimensioning /
"R6 :too large".
2 2 16
No further design
action. SPC
attachment
configuration.
Socket Dome hole (6 places: 2 rows of 3 holes
each on face facing A3) :OD-Diameter of hole ;ID-
Diameter of hole;R7-Lead in chamfer;S2
adjacent hole to hole centerline spacing within
and across rows ; D0 Hole shank depth from
outside socket face to bottom
Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user.
4 CC
Incorrect
dimensioning /
"OD :too large/small".
2 2 16
No further design
action. SPC
attachment
configuration.
4 CC
Incorrect
dimensioning /
2 2 16
No further design
action. SPC
attachment
configuration.
4 CC
Incorrect
dimensioning /
2 2 16
No further design
action. SPC
attachment
configuration.
4 CC
Incorrect
dimensioning /
2 2 16
No further design
action. SPC
attachment
configuration.

4 CC
Incorrect
dimensioning /
2 2 16
No further design
action. SPC
attachment
configuration.
R9 - All sharp edges and radii :Support finish ,
burr free.
Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect
dimensioning /
"R9 :too small".
2 2 16
No further design
action. SPC
attachment
configuration.
M- Materials : Provide strength. Hazard to end
user. 4 CC
Incorrect materials
specified. 2 2 16
No further design
Certifications.
P-Coating: Corrosion resistance. Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect coating
specified. 2 2 16
No further design
Certifications.
Hypoallergenic. Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect materials
specified. 2 2 16
No further design
Certifications.
Contaminant free. Potential Blood
Poisoning.Hazard
to end user.
4 CC
Incorrect
requirements
specified.
2 2 16
No further design
Certifications.
T1-Thickness of A1 , A2 & A3 : Provide strength . Hazard to end
user.
4 CC
Incorrect
dimensioning /
"T1 :too small".
2 2 16
No further design
action. SPC
thickness .Material
Lot Certifications.
Design Verification Plan Report
Date: 3/10/2001
System Assembly Program Design Engineer
Hip Socket Implant 12345678 2001 Class
Subsystem Component Latest Design Level Concurred
Original Release Customer signature goes here
Completion
Test Name/ Design Sample Size Start Timing Timing
Source Acceptance Criteria Test Results Level Reqd Tested Sched Actual Sched Actual
Limit Stack analysis , System
mockup.
Within specified
dimensional ranges.
TBD 0 20 20 3/31/2001 3/31/2001 10/31/2001 10/31/2001
Lo & Hi Temp Life Cycle Durability No visible cracks / shift in
microstructure > 5%.
TBD 0 20 20 3/31/2001 3/31/2001 10/31/2001 10/31/2001
Met Lab evaluation. Within specified material
ranges.
TBD 0 10 10 3/31/2001 3/31/2001 10/31/2001 10/31/2001
96 Hr Salt Spray test. No visible corrosion.
TBD 0 15 15 3/31/2001 3/31/2001 10/31/2001 10/31/2001
Maintainability simulation. Within specified
procedural installation
ranges.
TBD 0 10 10 3/31/2001 3/31/2001 10/31/2001 10/31/2001
Fluids Compatability Test No visible plating
degradation /
discoloration.
TBD 0 10 10 3/31/2001 3/31/2001 10/31/2001 10/31/2001
Revision: Revision Date: Page 61 of 171 Document Number:
Design Verification Plan Report
Customer signature goes here
Remarks
LTR#2213
LTR#2214
MER#1563
LTR#2215
MTR#1111
LTR#2217
Revision: Revision Date: Page 62 of 171 Document Number:
Summary : SFMEA vs. DFMEA
System FMEA (SFMEA)
SFMEA Statistics
Characteristics Count
# CC's 37 Causes Ours External
# SC's 15 Total 82 31 51
Total : 52
Sum of modes considered : 45
Sum "U" 0.060801
Reliability Claims / 1000
0.939199 60.80
Component FMEA (DFMEA)
DFMEA Statistics
Characteristics Count
# CC's 12 Causes Ours
# SC's 0 Total 41
Total : 12
Sum of modes considered : 16
Sum "U" 0.000273
Reliability Claims / 1000
0.999727 0.27
Process Considerations
Process Inputs
Process Flow Diagram
Process FMEA
Process Fault Trees
Control Plan
Hip Socket Bill of Materials
Qty. Description Materials $ / Pc.
1 Blank Stock Titanium $43.75 Cum Scrap
Engineering & Materials cost : $53.00 Potential
Materials Routing Tools Listing
Per Station
Station Description Line Rate Ops./
shift
Setup
Hrs.
Lbr. /Trans per
Part
Mach. Hrs. Description Qty. Tool$ / Stat.
RI Obtain & verify Certs. 120/hr 1 0.00000 $0.63 0.00000 Weigh Scale 1 $1,200.00
Receiving Insp. Inspect raw materials as received (Sheet
stock).
Digital Calipers 1 $1,500.00 $1.25
Re-package parts to send out. Route to dock. 1 $0.63 Height Gage 1 $450.00 $1.40
Hardness tester 1 $1,500.00
ECT0 Transport parts to EC1. 1 $0.15 NA
EC1
Water jet (cut) parts to size.
1000/hr 1 $0.08 NA
Package parts for shipment. Package certs.
$0.08 $1.55
ECT1
Transport parts to Manufacturing.
1 $0.15 NA $1.70
RI
Obtain & verify Certs.
120/hr 1 0.00000 $0.63 0.00000 Weigh Scale 1 $1,200.00
Receiving Insp. Inspect raw materials as received.
Digital Calipers 1 $1,500.00

Re-package parts to send out. Route to dock.
1 $0.63 Height Gage 1 $450.00 $2.95
ECT2
Transport parts out for heat treat.
1 $0.15 NA $3.10
EC2A
Heat treat at 900F for 4 hrs.
1000/hr 1 $0.08 NA

$0.08 $3.25
ECT2
1 $0.15 NA $3.40
RI
120/hr 1 0.00000 $0.63 0.00000 $4.03
$4.03
S1O1
Polish : Radius wafers around edges to improve draw.
10/hr 1 0.00000 $2.50 0.00833
Polisher
1
$8,000.00
$6.53
S2O1
Draw sect. A2 to full height. Scribe lines at base to check for
cracks.
10/hr 1 1.00000 $2.50 0.10000
Large Press
1
$180,000.00
Inspect ovality. Digital Micrometers
$1,500.00
Fixture
1 $500.00
Height gage
1 $450.00
S2O2
Inspect for cracks
102707 $9.03
S3O1
Inspect Dome thickness (3 pcs.)
1 0.75000 $5.00 0.06667 Digital Calipers 1 $1,500.00
S3O2
Center drill , drill , ream top dome hole.
Mill , Reamer 1 $20,000.00
S3O3
Drill wire triangular holes in A2.
Mill
S3O4
Deburr triangular holes in A2 for wire EDM.
Hand grinder. 1 $150.00
S3O5
Draw.
102707 1
S3O6
Inspect drilled holes.
Gage pins. 4 $140.00 $14.03
ECT3
Transport parts out for heat treat (ECT2).
1 $0.15 NA $14.18
EC2B
Heat treat at 900F for 4 hrs.
1000/hr 1 $0.08 NA

$0.08 $14.33
ECT4
1 $0.15 NA
RI
120/hr 1 0.00000 $0.63 0.00000
$15.10
S4O1
Wire EDM. Wire cut profiles (A1,A2,A3) and triangular
windows in A2
2.25/hr
1
1.00000
$33.33
0.44444 Wire EDM. $40,000.00
S4O2
Inspect parts to print.
S5O1
Standard Mill. Mill side profiles
5/hr 1
1.00000
$15.00
0.20000
Mill 1 $30,000.00
S5O2
Deburr milled surfaces.
Hand grinder. 1 $150.00
S5O3
Inspect for cracks.
NA $63.43
S6O1
Small Press. Punch holes in flange A3 to final size.
25/hr
1
1.00000
$3.00
0.04000 Small Press. Templates &
punches.
1 $40,000.00
S6O2
Inspect hole diameters.
S6O3
Inspect distance of holes to edge of part.
S7O1
Standard Mill. Countersink holes in flanges.
8/hr 1
0.50000
$9.38
0.12500
Mill 1 $30,000.00
S7O2
Inspect countersinks (centered).
S7O3
Inspect countersinks (Dia.).
Gage pins. 1 $35.00 $75.81
S8O1
Polish. Break edges in grooves , windows and on wire cut
edge.
15/hr 1 0.00000 $5.00 0.06667 Hand grinder. 1 $150.00
$80.81
S9O1
Polish. Pre-form flange and hook.
25/hr 1
0.25000
$3.00
0.04000
Fixture. 1 $3,500.00
S9O2
Inspect material thickness in hook areas.
S10O1
Small Press. Form flange and hook.
25/hr 1
0.50000
$3.00
0.04000
Small Press. 1 $60,000.00
S10O2
Inspect material thickness in hook areas.
S11O1
Polish. Perform final bend (a1) on large flange A3.
10/hr
1
0.50000
$7.50
0.10000 Fixture.
1 $3,500.00
S11O2
Inspect Thickness , bends and hole Dia. Micrometers , Pin
gages.Fixture.
1 $2,650.00 $94.31
S12O1
Polish. Trim hook end (A1) to length. Polish to length.
10/hr
1 0.25000
$7.50
0.10000 Hand Grinder. 1 $150.00
S12O2
Add full radius on end of hook (A1).
Fixture. 1 $3,500.00 $101.81
S13O1
Standard Mill. Drill and countersink hole in A1. 15/hr 1 0.25000 $5.00 0.06667
Mill 1 $30,000.00
S13O2
Inspect hole in A1.
Plug Gage . 1 $35.00 $106.81
S14O1
Standard Mill. Drill all dome holes in A2. 3/hr 1 1.00000 $25.00 0.33333
Mill 1 $30,000.00
S14O2
Inspect Dome holes in A2.
Plug Gage . 1 $35.00 $131.81
S15O1
Standard Mill. Countersink dome holes in A2. 35/hr 1 0.50000 $2.14 0.02875
Mill 1 $30,000.00
S15O2
Inspect Dome holes in A2.
Gage Pin. 1 $35.00 $133.95
S16O1
Polish. Break edges. 3/hr 1 0.00000 $2.14 0.33333 Hand Grinder.
1 $150.00 $136.09
S17O1
Tumble Finish. Gravi-flo parts in brown media for 1 Hr.
120/hr
1 0.25000
$0.63
0.00833 Tumbler 1 $28,500.00
$136.72
R1
Re-package parts to send out. Route to dock. 1 0.00000
$0.63
0.00000
$137.34
ECT5
Transport parts out for Medcast check (Zyglo). 1
$0.15 NA $137.49
EC2
Inspect parts for cracks (Zyglo Dye Penetrant test).
1000/hr
1
$0.08 NA $137.57
ECT6
Transport parts to Manufacturing. 1
$0.15 NA $137.72
RI
120/hr
1 0.00000
$0.63
0.00000
Receiving Insp. Check for cracks.
$138.34
Hip Socket Bill of Materials
Qty. Description Materials $ / Pc.
1 Blank Stock Titanium $43.75 Cum Scrap
Engineering & Materials cost : $53.00 Potential
Materials Routing Tools Listing
Per Station
Station Description Line Rate Ops./
shift
Setup
Hrs.
Lbr. /Trans per
Part
Mach. Hrs. Description Qty. Tool$ / Stat.
S18O1
Blast. Cosmetic blast (30 grit ALOX).
120/hr
1 0.25000
$0.63
0.00833
Blaster 1 $40,000.00 $138.97
$0.63 Profilometer 1 $350.00
S19O1
Compile and review Master Record packet.
120/hr
1 0.00000
$0.63
0.00833
S19O2
Inspect for discoloration. Re-blast as needed.
1
S19O3
Inspect thickness in hook areas.
S19O4
Inspect radius.
Radius gage. 1 $35.00
S19O5
Inspect edges.
$140.22
S20O1
Clean , Pack and Ship. Clean parts.
120/hr
1 0.00000
$0.63
0.00833
S20O2
Pack parts in bubble bags.
S20O3
Pack bags in box.
S20O4
Identify box (Label / Part number).
Label Machine. 1 $3,500.00
S20O5
Put heat code on V of C.
S20O6
Audit device Master record (SOP 3027).
$140.84
R1
Route parts to dock to send out. 1 0.00000
$0.63
0.00000
$141.47
ECT7
Transport parts out for Biomet for finish. 1
$0.15 $141.62
Totals :
39 9.00 $141.62 $2.13 51.00 $606,815.00
Logistics Our cost / pc : $255.30 Net Profit / Kit : Dunnage totes @ $50.00 / tote $60.68
10,000 / year / Part Number Actual customer $450.00 $194.70
42 / day / part number sale price / part MARR = 15 % Actual ROI = 176.26%
6 Part Numbers
Process Functional Block / Flow Chart
Design (Rel.) Eng. : CLASS Legend : PFMEA No.: P12345678 Page 1 of 1
Mfg. Quality Eng.: CLASS Start/Stop Process: Movement: Transportation: Rev. Lvl.: 0 Rev. Date:
Prod. Quality Eng.: CLASS Activity Step: Operation/Machine: Delay: D Cust.: ANY Mfg. Loc:
Mfg. Industrial Eng.: CLASS Decision Point: Inspection: Rework/Salvage: R / S Proj.: HI1
Mfg. Tooling Eng.: CLASS Waiting/Storage: Operation w/ Automated Insp.: Year: 2001 Date:
System / Item Name : Hip Socket Sub assembly station(s):
Replacement Process Type: Assembly Machining Specialty
START R1 ECT0
R / S (D)
EC1 ECT1 R1 ECT2 EC2 ECT2 R1 S101 S201
S301 S302 S303 S304 S305

S202

R / S (D) R / S (D) R / S R / S
R1 ECT4 EC2 ECT3
R / S
R / S S306
R / S

S902 S901 S801 S702 S701 S602 S601 S503 S502 S501 S402 S401
S703 S603
R / S R / S R / S R / S
S10O1
R / S R / S R / S R / S R / S
S10O2 S11O1 S11O2 S12O1 S12O2 S13O1 S13O2 S14O1 S14O2 S15O1 S15O2 S16O1 S17O1
R / S R / S R / S R / S R / S
S20O2 S20O1 S19O5 S19O4 S19O2 S19O1 S18O1 R1 ECT6 EC4 ECT5
R1
S19O3
S20O3 S20O4 S20O5 S20O6 R1 ECT7
FINISH
71
Potential
System FMEA Number P12345678
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
R1 :Obtain & verify Certs. Misplaced /
ommitted.
Rework / Delay
2
Operator Error.
Inadequate Operator
guidelines specified.
3
Operator
Instructions
with Visual
Aids.
100%
Insp.Weekly
CFT review
feedback.
2 12
No further action at
this time.
Receiving Insp. Inspect raw
materials as received (Sheet
stock).
Thickness not
checked.
Rework / Delay
(Displaces.
Hazard to end
user ).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.
Incorrect
thickness
conveyed.
Rework / Delay
(Displaces.
Hazard to end
user ).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.
Re-package parts to send
out. Route to dock.
Incorrect pack
provided.
Components /
Material damaged
in transit.
2
Operator Error.
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits.
Weekly CFT
review
feedback.
2 12
this time.
ECT0 : Transport parts to
EC1.
Delay in
shipment.
Lost time Flow
and delayed on
time delivery.
Customer
dissatisfaction.
2
Transport / Plant
carrier breakdown.
3
Scheduled PM. Scheduled
PM.
2 12
this time.
Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Barcode
Traceability.
Certs. Weekly
CFT review
feedback.
2 12
this time.
72
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits.Weekly
CFT review
feedback.
2 12
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits.Weekly
CFT review
feedback.
2 12
this time.
EC1: Water jet (cut) parts to
size.
Cut too large Rework / Delay
2
Improper machine /
tool setup.
Inadequate Operator
Inadequate PM.
3
Operator
Instructions
with Visual
Aids.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 12
this time.

Cut too small Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction) .
3
Improper machine /
tool setup.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction) .
3
Improper machine /
tool setup.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 18
this time.
73
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Not cut Rework / Delay
2
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 8
this time.
Route discrepant material to
salvage for process internally
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
guidelines specified. 3
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
review
feedback.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback.
2 24
this time.
EC1: Package parts for
shipment. Package certs.
Cert ommitted Rework / Delay
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100 % Insp at
R1. Weekly
CFT review
feedback.
2 12
this time.

Wrong cert
provided
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100 % Insp at
R1. Weekly
CFT review
feedback.
2 24
this time.
Incorrect parts
packaged.
Rework / Delay
(Displaces.
Hazard to end
user). 4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
100 % Insp at
R1. Weekly
CFT review
feedback.
Barcode
Traceability.
2 24
this time.
ECT1: Transport parts to
Manufacturing.
Delay in
shipment.
Delay
2
Transport / Plant
carrier breakdown. 3
PM. 2 12
this time.

Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
74
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits.Weekly
CFT review
feedback.
2 12
this time.
Scrap
3
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits.Weekly
CFT review
feedback.
2 18
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100 %
Insp at R1.
Weekly CFT
review
feedback.
Barcode
Traceability.
2 12
this time.
RI : Obtain & verify Certs. Verification
ommitted.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
100 % Insp.
Barcode
Traceability.
Weekly CFT
review
feedback.
2 24
this time.
Incorrect
verification
transferred.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
100 % Insp.
Barcode
Traceability.
Weekly CFT
review
feedback.
2 24
this time.
75
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
RI : Receiving Insp. Inspect
raw materials as received
(Thickness , size).
Thickness not
checked.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.
Incorrect
thickness
conveyed.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.
Size not checked. Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
76
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Incorrect size
conveyed.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
salvage for process
externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
2 24
this time.
Route material missing certs
to salvage for re-process.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback.
2 24
this time.
RI: Re-package parts to send
out for heat treat. Route to
dock.
Incorrect pack. Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback. 2 12
this time.
Not routed to
dock. Routed to
line.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback..
Red Tags at
station.
2 24
this time.
Incorrect parts
routed for
transfer.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback.
2 12
this time.
ECT2 : Transport parts out for
heat treat.
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.
Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
2 12
this time.
77
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
2 12
this time.
EC2A : Heat treat at 900F for
4 hrs.
Not treated /
partially treated.
Scrap (Displaces.
Hazard to end
user ).
4 CC
Improper machine /
tool setup.
Inadequate Operator
Inadequate PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 16
this time.
Incorrect treat. Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Improper machine /
tool setup.
Inadequate Operator
Inadequate PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 24
this time.
EC2A : Package parts for
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT Reviews
and feedback.
2 12
this time.
Wrong cert
provided
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT Reviews
and feedback.
2 24
this time.
Incorrect parts
packaged.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT Reviews
and feedback.
2 24
this time.
Manufacturing.
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.
Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
78
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
2 12
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
Reviews and
feedback.
2 12
this time.
ommitted.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT Reviews
and feedback.
2 24
this time.
Incorrect
verification
transferred.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT Reviews
and feedback.
2 24
this time.
raw materials as received.
Inspection
ommitted.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback.
2 24
this time.
to salvage for hold.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback.
2 24
this time.
salvage for process
externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Weekly CFT
Reviews and
feedback. Red
Tags at
station.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 24
this time.
79
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S1O1 : Polish : Radius wafers
around edges to improve
draw.
Radius ommitted. Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction) .
3
Improper machine /
Tool setup.
Inadequate fixturing
provided. Operator
Error. Inadequate
Operator guidelines
specified. Inadequate
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 12
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error. Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 12
this time.
Excessive radius
provided.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction) .
3
Improper machine /
Tool setup.
provided. Operator
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 18
this time.
80
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S2O1 : Draw sect. A2 to full
height. Scribe lines at base to
check for cracks.
Underdrawn. Scrap (Difficult
installation. Loss
of function. A4 &
A5 displace ,
Hazard to end
user).
4 CC
Improper machine /
Tool setup. Operator
Error. Inadequate
Operator guidelines
PM. Incorrect drawing
compound (lube)
specified /
used.Inadequate PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C/Np Chart /
Lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
Scheduled
PM.
2 16
Review feasability
for multi-stage Prog.
Die.
MW 4/24/01
Overdrawn. Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C/Np Chart /
Lot. Yearly
Operator
Qualification.
Weekly CFT
review
feedback.Sch
eduled PM.
2 24
Review feasability
Die.
MW 4/24/01
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C/Np Chart /
Lot. Yearly
Operator
Qualification.
Weekly CFT
review
feedback.Sch
eduled PM.
2 18
Review feasability
Die.
MW 4/24/01
S2O2 : Inspect for cracks Not inspected for
cracks.
Rework / Delay
(Displaces.
Hazard to end
user). 4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
C/Np Chart /
Lot. Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
81
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 24
this time.
S3O1 : Inspect Dome
thickness (3 pcs.)
Not inspected for
thickness. Parts
too thick.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.
Not inspected for
thickness. Parts
too thin.
Scrap (Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.
Rework / Delay
(Displaces.
Hazard to end
user). 4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
82
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 24
this time.
S3O2 : Center drill , drill ,
ream top dome hole.
Hole not drilled /
partially drilled.
Rework / Delay.
Flange holes
drilled out of
alignment further
on in
process.(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
Inadequate fixturing /
tooling provided.
Operator Error.
Inadequate Operator
Incorrect cutting fluid
specified / used. 2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Hole drilled out of
location.
Scrap. Flange
holes drilled out
of alignment
further on in
process.(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
83
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay.
Flange holes
drilled out of
alignment further
on in
process.(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Hole drilled
oversized.
Scrap.
(Displaces.
Hazard to end
user).
4 CC
Improper machine /
Error. Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Improper machine /
Error. Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
84
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hole drilled
undersized.
Rework / Delay.
Flange holes
drilled out of
alignment further
on in
process.(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
specified / used. 2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Hole not reamed. Rework / Delay.
Flange holes
drilled out of
alignment further
on in
process.(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Hole reamed out
of location.
Scrap. (Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
85
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay.
Flange holes
drilled out of
alignment further
on in
process.(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S3O3 : Drill wire triangular
holes in A2.
Hole(s) not drilled
/ partially drilled.
Rework / Delay.
(Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Hole(s) drilled out
of location.
Scrap.
(Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
86
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay.
(Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Hole(s) drilled
oversized.
Scrap.
(Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Scrap.
(Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
87
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hole(s) drilled
undersized.
Scrap.
(Insufficient
access. Non-
optimal cement
coverage and
bonding potential.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
tooling provided.
Operator Error.
Inadequate Operator
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
S3O4 : Deburr triangular
holes in A2 for wire EDM.
Hole(s) not
deburred / under
de-burred.
Rework / Delay
(Potential Blood
Poisoning.Hazard
to end user) .
4 CC
tooling provided.
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.
Hole(s) over de-
burred.
Scrap
3
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
2
tooling provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot.Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
88
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S3O5 : Draw. Overdrawn. Scrap. (Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
Review feasability
Die.
MW 4/24/01
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
Review feasability
Die.
MW 4/24/01
Underdrawn. Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
compound (lube)
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
Review feasability
Die.
MW 4/24/01
S3O6 : Inspect drilled holes. Drill hole
inspection
ommitted.
Rework / Delay.
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
89
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 18
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Red Tags at
station.
Weekly CFT
Review
Feedback.
2 18
this time.
90
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Manufacturing (EC2).
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.
Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
EC2B : Heat treat at 900F for
4 hrs.
Not treated /
partially treated.
Scrap (Displaces.
Hazard to end
user ).
4 CC
Improper machine /
tool setup. Operator
Error. Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
91
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Incorrect treat. Scrap (Displaces.
Hazard to end
user ).
4 CC
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
EC2B : Package parts for
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
2 12
this time.
Wrong cert
provided
Rework / Delay
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
2 12
this time.
Incorrect parts
packaged.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Insp. At R1.
Weekly CFT
review
feedback.
2 24
this time.
Manufacturing .
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.
Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
92
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Pack damaged in
shipment.
Scrap
3
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
ommitted.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Incorrect
verification
transferred.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
raw materials as received.
Inspection
ommitted.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
93
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
to salvage for hold.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
salvage for process
externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
S4O1 : Wire EDM. Wire cut
profiles (A1,A2,A3) and
triangular windows in A2
Overcut on
profiles.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM. Improper cutting
fluid specified / used.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled Pm.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Undercut on
profiles.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
94
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Profiles not cut. Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Overcut on
windows.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
95
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Undercut on
windows.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Windows not cut. Scrap
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
96
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
2
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 8
this time.
S4O2 : Inspect parts to print. Not inspected . Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
Yearly
Operator
Qualification.
Weekly CFT
2 18
this time.
97
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
/ externally.
Not routed to
salvage.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 18
this time.
Not re-processed
internally.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S5O1 : Standard Mill. Mill
side profiles
Side profiles over
milled.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.

Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
98
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Side profiles
under milled.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
fixturing provided.
Inadequate Operator
Inadequate PM.
Improper cutting fluid
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Side profiles not
milled.
Rework / Delay.
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
S5O2 : Deburr milled
surfaces.
Surfaces not de-
burred / under de-
burred.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Inadequate tooling /
fixturing provided.
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Surfaces over de-
burred.
Scrap
3
fixturing provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
3
fixturing provided.
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
99
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S5O3 : Inspect for cracks. Not inspected for
cracks.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay
3
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S6O1 : Small Press. Punch
holes in flange A3 to final
size.
Hole(s) not
punched /
partially punched.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
compound (lube)
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.

100
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hole(s) punched
out of location.
Scrap. (Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Hole(s) punched
oversized.
Scrap. (Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
101
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hole(s) punched
undersized.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
compound (lube)
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Scheduled PM.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
S6O2 : Inspect hole
diameters.
Hole(s) diameters
not inspected .
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
102
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station. 2 18
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
103
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S6O3 : Inspect distance of
holes to edge of part.
Hole(s) locations
not inspected .
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
104
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S7O1 : Standard Mill.
Countersink holes in flanges.
Hole(s) not
countersunk /
partially
countersunk.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
fixturing provided.
Inadequate Operator
Inadequate PM.
Improper cutting fluid
specified / used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.

Hole(s)
countersink out of
location.
Scrap. (Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
105
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Hole(s)
countersink
oversized.
Scrap. (Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
S7O2 : Inspect countersinks
(centered).
Not inspected for
countersink
centering.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.

106
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
this time.
107
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Not re-processed
internally.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S7O3 : Inspect countersinks
(Dia.).
Not inspected for
countersink
diameter.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
108
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
Loss of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S8O1 : Polish. Break edges
in grooves , windows and on
wire cut edge.
Groove edges not
broke /
underbroke.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

109
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Groove edges
overbroke.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Window edges
not broke /
underbroke.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Window edges
overbroke.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
110
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Wire cut edges
not broke /
underbroke.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Wire cut edges
overbroke.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
111
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S9O1 : Polish. Pre-form
flange and hook.
Flange and hook
not pre-formed /
under formed.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

Flange and hook
over formed.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S9O2 : Inspect material
thickness in hook areas.
Hook area
thickness not
inspected /partial
inspection..
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
112
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 18
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S10O1 : Small Press. Form
flange and hook.
Flange and hook
not formed /
under formed.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

113
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Flange and hook
over formed.
Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S10O2 : Inspect material
thickness in hook areas.
Hook area
thickness not
inspected /partial
inspection..
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
114
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 18
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S11O1 : Polish. Perform final
bend (a1) on large flange A3.
Bend ommitted /
underbent.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

115
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Overbent. Scrap. (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S11O2 : Inspect Thickness ,
bends and hole Dia.
Thickness not
inspected /partial
inspection..
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.

Bend not
inspected.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
116
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hole dia. Not
inspected.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 18
this time.
117
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Not re-processed
internally.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S12O1 : Polish. Trim hook
end (A1) to length. Polish to
length.
Hook end not
trimmed to length
/ undertrimmed.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

Hook end
overtrimmed.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
118
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hook end not
polished to
length.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Hook end over
polished.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
S12O2 : Add full radius on
end of hook (A1).
Radius ommitted /
too small.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

119
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Radius too large. Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S13O1 : Standard Mill. Drill
and countersink hole in A1.
Hole not drilled /
partially drilled.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

Hole drilled out of
location.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
120
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Hole drilled
oversized.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Hole drilled
undersized.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
121
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Hole not
countersunk /
partially
countersunk.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Error. Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Hole countersink
out of location.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Hole countersink
oversized.
Scrap (Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
122
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S13O2 : Inspect hole in A1. Hole dia. Not
inspected.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
123
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 18
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. Loss
of function.
Extreme physical
discomfort and
customer
dissatisfaction ).
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
S14O1: Standard Mill. Drill all
dome holes in A2.
Hole(s) not drilled
/ partially drilled.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Hole drilled out of
location.
Scrap
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
124
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Hole drilled
oversized.
Scrap (Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Hole drilled
undersized.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified. Improper
cutting fluid specified
/ used.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.
S14O2 : Inspect Dome holes
in A2.
Hole(s) dia. Not
inspected.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.

125
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
126
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S15O1 : Standard Mill.
Countersink dome holes in
A2.
Hole(s) not
countersunk /
partially
countersunk.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Hole(s)
countersink out of
location.
Scrap (Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Hole(s)
countersink
oversized.
Scrap (Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
127
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S15O2 : Inspect Dome holes
in A2.
Hole(s) dia. Not
inspected.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
128
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Not re-processed
internally.
Rework / Delay
(Difficult
installation. F1
displaces / galls.
A2
displaces.Hazard
to end user) .
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S16O1 : Polish. Break edges. Edges not
polished /
partially polished.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Edges over
polished.
Scrap
2
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay
2
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
specified.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
S17O1 : Tumble Finish. Gravi-
flo parts in brown media for 1
Hr.
Not tumbled. Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Not tumbled for
correct period.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
129
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
R1 : Re-package parts to
send out. Route to dock.
Not packaged
correctly.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
review
feedback.
2 12
this time.

Wrong parts
packed.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
review
feedback.
2 24
this time.
Not routed to
dock for transfer.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
review
feedback.
2 12
this time.
Incorrect parts
routed for
transfer.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
review
feedback.
2 24
this time.
Medcast check (Zyglo).
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.

Wrong parts
shipped.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
review
feedback.
2 24
this time.
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At
Medcast.
Weekly CFT
review
feedback.
2 12
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At
Medcast.
Weekly CFT
review
feedback.
2 12
this time.
130
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
EC2 : Inspect parts for cracks
(Zyglo Dye Penetrant test).
Not inspected for
cracks.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
C / Np chart /
lot. Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Good material
rejected.
Scrap
3
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
Rework / Delay
2
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 8
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
EC2 : Package parts and
certs. For shipment.
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
2 12
this time.
Wrong cert
provided
Rework / Delay
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
2 12
this time.
Incorrect parts
packaged.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
2 24
this time.
131
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Manufacturing.
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.

Wrong parts
shipped.
Rework / Delay
2
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
2 12
this time.
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. At R1.
Weekly CFT
review
feedback.
2 12
this time.
ommitted.
Rework / Delay
(Displaces.
Hazard to end
user). 4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
Barcode
traceability.
2 24
this time.

Incorrect
verification
transferred.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
100% Insp. At
R1. Weekly
CFT review
feedback.
Barcode
traceability.
2 12
this time.
132
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
to salvage for process
internally / externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
RI : Receiving Insp. Check for
cracks.
Not inspected for
cracks.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
Not processed
internally.
Discrepant
material
introduced to line.
Scrap / Delay.
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
133
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
S18O1 : Blast. Cosmetic blast
(30 grit ALOX).
Not blasted . Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Improper machine /
Tool setup.
provided. Operator
Error.Inadequate
Operator guidelines
PM.
2
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Blasted with
incorrect grit.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Improper machine /
Error. Inadequate
Operator guidelines
PM.
3
Operator
Instructions
with Visual
Aids. Operator
training and
qualification on
equipment.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S19O1 : Compile and review
Master Record packet.
Not compiled. Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.

Incorrect packet
compiled.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Not reviewed /
insufficiently
reviewed.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S19O2 : Inspect for
discoloration. Re-blast as
needed.
Not inspected for
dis-coloration.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.

Not re-blasted
when required.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 16
this time.
134
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Re-blasted when
not required.
Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
S19O3 : Inspect thickness in
hook areas.
Hook area
thickness not
inspected /partial
inspection..
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.

Good material
rejected.
Scrap
3
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 18
this time.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 12
this time.
135
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
Not processed
internally.
Discrepant
material
introduced to line.
Scrap / Delay.
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S19O4 : Inspect radius. Radius not
inspected.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids. Operator
training on
inspection
equipment.
Calibrated
equipment.
Specified Cal.
Interval.
SPC / Lot.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. 2 24
this time.

/ externally.
Not routed to
salvage.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
Not re-processed
internally.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S19O5 : Inspect edges. Edges not
inspected.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.

136
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
/ externally.
Not routed to
salvage.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback. Red
tags at station.
2 24
this time.
Not re-processed
internally.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Yearly
Operator
Qualification.
Weekly CFT
review
feedback.
2 24
this time.
S20O1 : Clean , Pack and
Ship. Clean parts.
Parts not cleaned
/ partially
cleaned.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
Incorrect cleaning
materials specified /
used. Excessive
contamination in area.
2
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 16
Class 5 clean room. MW 10/14/01
Reprocess parts (clean) if
contaminated.
Not re-processed
internally.
Rework / Delay.
(Potential Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
2
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 16
this time.
S20O2 : Pack parts in bubble
bags.
Part(s) not
packed in bubble
bag.
Contamination of
parts. (Potential
Blood
Poisoning.Hazard
to end user).
4 CC
Operator Error.
Inadequate Operator
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback. 2 24
this time.

S20O3 : Pack bags in box. Wrong part(s)
packed in box.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 24
this time.

Box underpacked. Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 12
this time.
Box over packed. Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 12
this time.
S20O4 : Identify box (Label /
Part number).
Label ommitted. Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 12
this time.

137
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Incorrect label
installed.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 24
this time.
Label damaged /
contaminated.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. Biomet.
Weekly CFT
reviews and
feedback.
2 12
this time.
S20O5 : Put heat code on V
of C.
Heat code
ommitted.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 24
this time.

S20O6 : Audit device Master
record (SOP 3027).
Not audited /
partially audited.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 12
this time.

R1 : Route parts to dock to
send out.
Not routed to
dock for transfer.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 12
this time.

Incorrect parts
routed for
transfer.
Rework / Delay
2
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 12
this time.
Biomet for finish.
Delay in
shipment.
Delay
2
Transport / Plant
PM. 2 12
this time.
Wrong parts
shipped.
Rework / Delay
(Displaces.
Hazard to end
user).
4 CC
Operator Error.
Inadequate Operator
3
Operator
Instructions
with Visual
Aids.
Weekly CFT
reviews and
feedback.
2 24
this time.
Pack damaged in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. Biomet.
Weekly CFT
reviews and
feedback.
2 12
this time.
138
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Cert lost in
shipment.
Rework / Delay
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
Operator
Instructions
with Visual
Aids.
Quarterly
Pack /
Shipment
Audits. 100%
Insp. Biomet.
Weekly CFT
reviews and
feedback.
2 12
this time.

PFMEA Statistics 0<rpn<9 3 0<rpn<9 3 AIAG "O"Conversion
139
Potential
Core Team :
Class
Action Results
Design Item-Process
Function/Design
Function-Process
Requirements*
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
Current
Process
Design
Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Characteristics Count Average rpn<19 240 10<rpn<19 237 6.7E-07 0.000000
Total : 100 1292 rpn<49 324 40<rpn<49 0 0.0005 0.000000
PO=1 0 rpn<79 324 70<rpn<79 0 0.05 0.000000
PO=2 63 rpn<89 324 80<rpn<89 0 0.125 0.000000
PO=3 261 rpn<99 324 90<rpn<99 0 0.33333 0.000000
PO=4 0 rpn<125 334 100<rpn<125 0 0.5 0.000000
PO=5 0 rpn<250 324 126<rpn<250 0
PO=6 0 rpn<299 324 251<rpn<299 0 Sum "U" 0.017821 Claims / 1000 Less Recv. Insp.& Transport
PO=7 0 rpn>299 0 rpn>299 0 Reliability 17.82108 11.20741
PO=8 0 0.982179
PO=9 0
PO=10 0
S=1 0
S=2 79
S=3 145
S=4 100
D=1 0
D=2 324
D=3 0
D=4 0
D=5 0
D=6 0
D=7 0
D=8 0
D=9 0
D=10 0
0
50
100
150
200
250
F
r
e
q
u
e
n
c
y

RPN
PFMEA PRA
140
Process Fault Tree : Recv. Insp. & Transportation
Effect : Hazard to end user
Design Item-Process
Function/Design Function-
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r Prevention (Preventive Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
R1: Receiving Insp. Inspect raw
materials as received (Sheet stock).
4
Operator Error.
Inadequate Operator
3
Operator Instructions with Visual Aids.
Operator training on inspection
equipment. Calibrated equipment.
Specified Cal. Interval.
2 24
No further action at this
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
RI : Obtain & verify Certs.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
RI : Receiving Insp. Inspect raw
materials as received (Thickness ,
size).
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
Route discrepant material to salvage
for process externally.
4
Operator Error.
Inadequate Operator
3
2 24
time.
Route material missing certs to
salvage for re-process.
4
Operator Error.
Inadequate Operator
3
2 24
time.
RI: Re-package parts to send out for
heat treat. Route to dock.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
materials as received.
4
Operator Error.
Inadequate Operator
3
2 24
time.
salvage for hold.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
materials as received.
4
Operator Error.
Inadequate Operator
3
2 24
time.
salvage for hold.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
R1 : Re-package parts to send out.
Route to dock.
4
Operator Error.
Inadequate Operator
3
2 24
time.
141
Design Item-Process
Function/Design Function-
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
D
e
t
e
c
R
P
N
Recommended
Action(s)
4
Operator Error.
Inadequate Operator
3
2 24
time.
S2O1 : Draw sect. A2 to full height.
Scribe lines at base to check for
cracks.
4
Improper machine /
Error. Inadequate
Operator guidelines
compound (lube)
specified /
used.Inadequate PM.
2
Operator training and qualification on
equipment.
2 16
Review feasability for multi-
stage Prog. Die.
ECT5 : Transport parts out for Medcast
check (Zyglo).
4
Operator Error.
Inadequate Operator
3
2 24
time.
EC2 : Package parts and certs. For
shipment.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
RI : Route material missing certs to
salvage for process internally /
externally.
4
Operator Error.
Inadequate Operator
3
2 24
time.
RI : Receiving Insp. Check for cracks.
4
Operator Error.
Inadequate Operator
3
2 24
time.
for process internally / externally.
4
Operator Error.
Inadequate Operator
3
2 24
time.
4
Operator Error.
Inadequate Operator
3
2 24
time.
ECT7 : Transport parts out for Biomet
for finish.
4
Operator Error.
Inadequate Operator
3
2 24
time.
Index / Criteria AIAG "O"Conversion
PO=1 0 0.00000067 0.000000
PO=2 1 0.00000667 0.000007
PO=3 29 0.00006667 0.001933
PO=4 0 0.0005 0.000000
PO=5 0 0.0025 0.000000
PO=6 0 0.0125 0.000000
PO=7 0 0.05 0.000000
PO=8 0 0.125 0.000000
PO=9 0 0.33333333 0.000000
PO=10 0 0.5 0.000000
S=2 0 Sum "U" 0.001940
S=3 0 Reliability
S=4 30 0.998060
142
Effect : Customer / Internal Dissatisfaction
Design Item-Process
Function/Design
Function-Process
Requirements*
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
R1 :Obtain & verify Certs.
2
Operator Error.
Inadequate Operator
3
Operator Instructions
with Visual Aids. 2 12
this time.
Re-package parts to send
out. Route to dock. 2
Operator Error.
Incorrect pack
specified.
3
this time.
EC1.
2
Transport / Plant
carrier breakdown.
3
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Incorrect pack
specified.
3
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
ECT1: Transport parts to
Manufacturing. 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
3
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 18
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
raw materials as received
(Thickness , size).
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
Operator training on
inspection
equipment.
Calibrated
equipment. Specified
Cal. Interval.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
inspection
equipment.
Calibrated
equipment. Specified
Cal. Interval.
2 12
this time.
RI: Re-package parts to send
out for heat treat. Route to
dock. 2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
this time.
heat treat. 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
this time.
143
Design Item-Process
Function/Design
Function-Process
Requirements*
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
Manufacturing. 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
Manufacturing (EC2). 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
Manufacturing . 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
3
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 18
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
R1 : Re-package parts to
send out. Route to dock.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
144
Design Item-Process
Function/Design
Function-Process
Requirements*
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
4
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 24
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
Medcast check (Zyglo). 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
EC2 : Package parts and
certs. For shipment.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
Manufacturing. 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
RI : Receiving Insp. Check for
cracks.
3
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 18
this time.
2
Operator Error.
Inadequate Operator
3
with Visual Aids.
2 12
this time.
R1 : Route parts to dock to
send out. 2
Operator Error.
Inadequate Operator
3
this time.
2
Operator Error.
Inadequate Operator
3
this time.
Biomet for finish. 2
Transport / Plant
Scheduled PM.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
2
Operator Error.
Inadequate Operator
Incorrect pack
specified.
3
with Visual Aids.
2 12
this time.
145
Design Item-Process
Function/Design
Function-Process
Requirements*
S
e
v
Potential
Cause(s)/
Mechanism(s) of
Failure
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
PO=1 0 0.00000067 0.000000
PO=2 0 0.00000667 0.000000
PO=3 53 0.00006667 0.003534
PO=4 0 0.0005 0.000000
PO=5 0 0.0025 0.000000
PO=6 0 0.0125 0.000000
PO=7 0 0.05 0.000000
PO=8 0 0.125 0.000000
PO=9 0 0.33333333 0.000000
PO=10 0 0.5 0.000000
S=2 49 Sum "U" 0.003534 Claims / 1000
S=3 3 Reliability 3.53351
S=4 1 0.996466
146
Process Fault Tree : Less Recv. Insp. & Transportation
Design Item-Process
Function/Design
Function-Process
Requirements*
S
e
v
Potential Cause(s)/
Mechanism(s) of Failure
O
c
c
u
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
EC2A : Heat treat at 900F for
4 hrs. 4
Improper machine / tool setup.
Inadequate Operator guidelines
specified. Inadequate PM.
2
equipment.
2 16
this time.
4
specified. Inadequate PM.
3
equipment.
2 24
this time.
S2O2 : Inspect for cracks
4
Operator Error. Inadequate
Operator guidelines specified.
3
2 24
this time.
/ externally.
4
Operator guidelines specified. 3
2 24
this time.
4
3
2 24
this time.
S3O1 : Inspect Dome
thickness (3 pcs.)
4
3
2 24
this time.
4
3
2 24
this time.
4
3
2 24
this time.
/ externally.
4
2 24
this time.
4
3
2 24
this time.
S3O2 : Center drill , drill ,
ream top dome hole. 4
Improper machine / Tool setup.
3
equipment.
2 24
this time.
4
3
equipment.
2 24
this time.
S3O4 : Deburr triangular
holes in A2 for wire EDM.
4
Inadequate fixturing / tooling
provided. Operator Error.
specified.
2
equipment.
2 16
this time.
EC2B : Heat treat at 900F for
4 hrs.
4
Inadequate PM.
2
equipment. Scheduled PM.
2 16
this time.
4
Inadequate PM.
3
2 24
this time.
4
Inadequate PM.
3
2 24
this time.
4
Inadequate PM.
3
2 24
this time.
EC2B : Package parts for
4
3
2 24
this time.
S5O2 : Deburr milled
surfaces.
4
Inadequate tooling / fixturing
specified.
2
equipment.
2 16
this time.
S5O3 : Inspect for cracks.
4
2
2 16
this time.
/ externally.
4
2 24
this time.
4
3
2 24
this time.
S14O1: Standard Mill. Drill all
dome holes in A2.
4
Inadequate fixturing provided.
Operator Error.Inadequate
Inadequate PM. Improper cutting
2
equipment.
2 16
this time.
4
Inadequate PM.
3
equipment.
2 24
this time.
4
3
equipment.
2 24
this time.
4
3
equipment.
2 24
this time.
147
Design Item-Process
Function/Design Function-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
EC1: Water jet (cut) parts to size.
3
specified.
3
this time.
3
specified.
3
this time.
EC1: Package parts for shipment.
Package certs.
2
3
with Visual Aids.
2 12
this time.
2
3
with Visual Aids.
2 12
this time.
EC2A : Package parts for shipment.
Package certs.
2
3
with Visual Aids.
2 12
this time.
S1O1 : Polish : Radius wafers around
edges to improve draw.
3
Inadequate PM.
2
with Visual Aids.
Operator training and
qualification on
equipment.
2 12
this time.
3
Inadequate PM.
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S2O1 : Draw sect. A2 to full height.
Scribe lines at base to check for cracks.
3
Inadequate PM. Incorrect drawing
compound (lube) specified /
used.Inadequate PM.
2
with Visual Aids.
qualification on
equipment.
2 12
Review feasability
Die.
MW 4/24/01
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
Review feasability
Die.
MW 4/24/01
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
Review feasability
Die.
MW 4/24/01
S2O2 : Inspect for cracks
4 CC
3
with Visual Aids.
2 24
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S3O2 : Center drill , drill , ream top dome
hole.
3
specified. Incorrect cutting fluid
specified / used.
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified / used.
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
148
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S3O3 : Drill wire triangular holes in A2.
3
specified / used.
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified / used.
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
S3O4 : Deburr triangular holes in A2 for
wire EDM.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
2
specified.
3
with Visual Aids.
qualification on
equipment.
2 12
this time.
S3O5 : Draw.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
Review feasability
Die.
MW 4/24/01
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
Review feasability
Die.
MW 4/24/01
3
compound (lube) specified / used.
2
with Visual Aids.
qualification on
equipment.
2 12
Review feasability
Die.
MW 4/24/01
S3O6 : Inspect drilled holes.
3
3
with Visual Aids.
inspection equipment.
Calibrated equipment.
2 18
this time.
149
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
Route discrepant material to salvage for
process internally / externally.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
EC2B : Package parts for shipment.
Package certs.
2
3
with Visual Aids.
2 12
this time.
2
3
with Visual Aids.
2 12
this time.
S4O1 : Wire EDM. Wire cut profiles
(A1,A2,A3) and triangular windows in A2
3
3
with Visual Aids.
qualification on
equipment. Scheduled
Pm.
2 18
this time.
3
3
with Visual Aids.
qualification on
PM.
2 18
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
150
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
2
2
with Visual Aids.
qualification on
PM.
2 8
this time.
S4O2 : Inspect parts to print.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S5O1 : Standard Mill. Mill side profiles
3
Inadequate PM.
3
with Visual Aids.
qualification on
PM.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
PM.
2 18
this time.
3
fixturing provided. Inadequate
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
S5O2 : Deburr milled surfaces.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
specified.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S5O3 : Inspect for cracks.
3
2
with Visual Aids.
2 12
this time.
3
2
with Visual Aids.
2 12
this time.
S6O1 : Small Press. Punch holes in
flange A3 to final size.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
151
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
Inadequate PM.
3
with Visual Aids.
qualification on
PM.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
PM.
2 18
this time.
3
Inadequate PM.
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
Inadequate PM.
2
with Visual Aids.
qualification on
PM.
2 12
this time.
3
2
with Visual Aids.
qualification on
PM.
2 12
this time.
S6O2 : Inspect hole diameters.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S6O3 : Inspect distance of holes to edge
of part.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
152
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
S7O1 : Standard Mill. Countersink holes
in flanges.
3
fixturing provided. Inadequate
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S7O2 : Inspect countersinks (centered).
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S7O3 : Inspect countersinks (Dia.).
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S8O1 : Polish. Break edges in grooves ,
windows and on wire cut edge.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
153
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S9O1 : Polish. Pre-form flange and hook.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S9O2 : Inspect material thickness in hook
areas.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S10O1 : Small Press. Form flange and
hook.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
154
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S10O2 : Inspect material thickness in
hook areas.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S11O1 : Polish. Perform final bend (a1)
on large flange A3.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S11O2 : Inspect Thickness , bends and
hole Dia.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
155
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S12O1 : Polish. Trim hook end (A1) to
length. Polish to length.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
S12O2 : Add full radius on end of hook
(A1).
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S13O1 : Standard Mill. Drill and
countersink hole in A1.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
156
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
S13O2 : Inspect hole in A1.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
3
3
with Visual Aids.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
S14O1: Standard Mill. Drill all dome
holes in A2.
3
Inadequate PM.
3
with Visual Aids.
qualification on
equipment.
2 18
this time.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
157
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
S15O2 : Inspect Dome holes in A2.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
S16O1 : Polish. Break edges.
2
3
with Visual Aids.
qualification on
equipment.
2 12
this time.
2
3
with Visual Aids.
qualification on
equipment.
2 12
this time.
EC2 : Inspect parts for cracks (Zyglo Dye
Penetrant test).
3
Inadequate PM.
2
with Visual Aids.
qualification on
equipment.
2 12
this time.
2
Inadequate PM.
2
with Visual Aids.
qualification on
equipment.
2 8
this time.
EC2 : Package parts and certs. For
shipment.
2
3
with Visual Aids.
2 12
this time.
2
3
with Visual Aids.
2 12
this time.
S19O1 : Compile and review Master
Record packet.
2
3
with Visual Aids.
2 12
this time.
S19O2 : Inspect for discoloration. Re-
blast as needed.
2
3
with Visual Aids.
2 12
this time.
S19O3 : Inspect thickness in hook areas.
3
3
with Visual Aids.
2 18
this time.
2
3
with Visual Aids.
2 12
this time.
S20O1 : Clean , Pack and Ship. Clean
parts.
4 CC
Incorrect cleaning materials
specified / used. Excessive
2
with Visual Aids.
2 16
Class 5 clean room. MW 10/14/01
Reprocess parts (clean) if contaminated.
4 CC
2
with Visual Aids.
2 16
this time.
S20O2 : Pack parts in bubble bags.
4 CC
3
with Visual Aids.
2 24
this time.
S20O3 : Pack bags in box.
4 CC
3
with Visual Aids.
2 24
this time.
2
3
with Visual Aids.
2 12
this time.
2
3
with Visual Aids.
2 12
this time.
S20O4 : Identify box (Label / Part
number).
2
3
with Visual Aids.
2 12
this time.
2
Incorrect pack specified.
3
this time.
S20O6 : Audit device Master record
(SOP 3027).
2
3
with Visual Aids.
2 12
this time.
PO=1 0 0.00000067 0.000000
PO=2 48 0.00000667 0.000320
158
Design Item-Process
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Prevention
(Preventive
Controls)
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility &
Target
Completion Date
PO=3 131 0.00006667 0.008734
PO=4 0 0.0005 0.000000
PO=5 0 0.0025 0.000000
PO=6 0 0.0125 0.000000
PO=7 0 0.05 0.000000
PO=8 0 0.125 0.000000
PO=9 0 0.33333333 0.000000
PO=10 0 0.5 0.000000

S=2 31 Sum "U" 0.009054 Claims / 1000
S=3 143 Reliability 9.05393
S=4 5 0.990946
159
Special Characteristics List from Process
Process Design Responsibility Class
Model Year(s)/Project Key Date 4/1/2001
Core Team :
Class
Design Item-Process Function/Design Function-Process
Requirements*
Potential Effect(s) of Failure
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
R1 :Receiving Insp. Inspect raw materials as received (Sheet stock). Rework / Delay (Displaces.
Hazard to end user ).
4 CC
3
Audit. Operator label
initial. Yearly
operator
qualification.Red tag
process. Barcode
traceability.
2 24
Rework / Delay (Displaces.
Hazard to end user ).
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
Route discrepant material to salvage for process internally /
externally.
Hazard to end user). 4 CC
Red Tags at station.
Weekly CFT review
feedback.
2 24
Weekly CFT Reviews
and feedback. 2 24
EC1: Package parts for shipment. Package certs. Rework / Delay (Displaces.
Hazard to end user).
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
RI : Obtain & verify Certs. Rework / Delay (Displaces.
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
RI : Receiving Insp. Inspect raw materials as received (Thickness ,
size).
4 CC
3
SPC / Lot. Yearly
Operator
Qualification. Weekly
CFT review
feedback.
2 24
4 CC
3
SPC / Lot. Yearly
Operator
CFT review
feedback.
2 24
Route discrepant material to salvage for process externally. Rework / Delay (Displaces.
2 24
Route material missing certs to salvage for re-process. Rework / Delay (Displaces.
Weekly CFT Reviews
and feedback. 2 24
RI: Re-package parts to send out for heat treat. Route to dock. Rework / Delay (Displaces.
4 CC
3
Weekly CFT Reviews
and feedback. Red
Tags at station.
2 24
EC2A : Heat treat at 900F for 4 hrs. Scrap (Displaces. Hazard to
end user ).
4 CC
Inadequate Operator
Inadequate PM.
2
R chart. Incoming
and in process lot
certifications. Yearly
operator
process.Barcode
traceability.
2 16
160
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
4 CC
Inadequate Operator
Inadequate PM.
3
R chart. Incoming
and in process lot
operator
process.Barcode
traceability.
2 24
EC2A : Package parts for shipment. Package certs. Rework / Delay (Displaces.
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
4 CC
3
100% Insp. At R1.
Operator label
initial.Yearly operator
process.Barcode
traceability.
2 24
4 CC
3
100% Insp. At R1.
Operator label
process.Barcode
traceability.
2 24
RI : Receiving Insp. Inspect raw materials as received. Rework / Delay (Displaces.
4 CC
3
100% Insp. At R1.
Operator label
process.Barcode
traceability.
2 24
Route material missing certs to salvage for hold. Rework / Delay (Displaces.
Weekly CFT Reviews
and feedback. 2 24
4 CC
3
Weekly CFT Reviews
and feedback. Red
Tags at station.
2 24
Weekly CFT Review
Feedback.
2 24
S2O1 : Draw sect. A2 to full height. Scribe lines at base to check for
cracks.
Scrap (Difficult installation.
Loss of function. A4 & A5
displace , Hazard to end
user).
4 CC
Inadequate PM. Incorrect
drawing compound (lube)
specified / used.Inadequate
PM.
2
Xbar & R chart.Yearly
Operator
CFT review
feedback. Scheduled
PM.
2 16
S2O2 : Inspect for cracks Rework / Delay (Displaces.
4 CC
3
Visual , In process
Checksheet. Yearly
operator
qualification.Weekly
CFT Reviews and
feedback. Red Tags
at station.
2 24
externally.
4 CC
3
Operator label
process.Barcode
traceability.
2 24
161
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
4 CC
3
Operator label
process.Barcode
traceability.
2 24
S3O1 : Inspect Dome thickness (3 pcs.) Rework / Delay (Displaces.
4 CC
3
Operator
CFT review
feedback. Scheduled
PM.
2 24
Scrap (Displaces. Hazard to
end user).
4 CC
3
Operator
CFT review
feedback. Scheduled
PM.
2 24
4 CC
3
Operator
CFT review
feedback. Scheduled
PM.
2 24
externally.
4 CC
3
Operator label
process.Barcode
traceability.
2 24
4 CC
3
Operator label
process.Barcode
traceability.
2 24
Scrap. (Displaces. Hazard to
end user).
4 CC
3
Operator
CFT review
feedback. Scheduled
PM.
2 24
S3O2 : Center drill , drill , ream top dome hole. Rework / Delay (Displaces.
4 CC
3
Operator
CFT review
feedback. Scheduled
PM.
2 24
S3O4 : Deburr triangular holes in A2 for wire EDM. Rework / Delay (Potential
Blood Poisoning.Hazard to
end user) .
4 CC
Inadequate Operator
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
EC2B : Heat treat at 900F for 4 hrs. Scrap (Displaces. Hazard to
end user ).
4 CC
Inadequate PM.
2
R chart. Incoming
and in process lot
operator
process.Barcode
traceability.
2 16
162
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
4 CC
Inadequate PM.
3
R chart. Incoming
and in process lot
operator
process.Barcode
traceability.
2 24
Scrap (Displaces. Hazard to
end user ).
4 CC
Inadequate PM.
3
R chart. Incoming
and in process lot
operator
process.Barcode
traceability.
2 24
4 CC
Inadequate PM.
3
R chart. Incoming
and in process lot
operator
process.Barcode
traceability.
2 24
EC2B : Package parts for shipment. Package certs. Rework / Delay (Displaces.
4 CC
3
initial. Yearly
operator
process. Barcode
traceability.
2 24
4 CC
3
Yearly Operator
CFT review
feedback.
2 24
RI : Receiving Insp. Inspect raw materials as received. Rework / Delay (Displaces.
4 CC
3
Operator label
process.Barcode
traceability.
2 24
Route material missing certs to salvage for hold. Rework / Delay (Displaces.
4 CC
3
Yearly Operator
CFT review
feedback.
2 24
4 CC
3
Yearly Operator
CFT review
feedback. Red tags
at station.
2 24
S5O2 : Deburr milled surfaces. Rework / Delay (Displaces.
4 CC
Inadequate Operator
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
S5O3 : Inspect for cracks. Rework / Delay (Displaces.
4 CC
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
externally.
4 CC
3
Operator label
process.Barcode
traceability.
2 24
163
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
4 CC
3
Operator label
process.Barcode
traceability.
2 24
S14O1: Standard Mill. Drill all dome holes in A2. Rework / Delay (Difficult
installation. F1 displaces /
galls. A2 displaces.Hazard to
end user) .
4 CC
Inadequate PM. Improper
cutting fluid specified / used.
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
Rework / Delay (Difficult
end user) .
4 CC
Inadequate PM.
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
Scrap (Difficult installation. F1
displaces / galls. A2
displaces.Hazard to end
user).
4 CC
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
end user) .
4 CC
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
end user) .
4 CC
Improper cutting fluid specified
/ used.
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
S14O2 : Inspect Dome holes in A2. Rework / Delay (Difficult
end user) .
4 CC
3
In process
checksheet.Yearly
Operator
CFT review
feedback. Red tag
process.
2 24
externally.
end user) .
4 CC
3
Yearly Operator
CFT review
feedback. Red tags
at station.
2 24
end user) .
4 CC
3
Yearly Operator
CFT review
feedback.
2 24
S15O1 : Standard Mill. Countersink dome holes in A2. Rework / Delay (Difficult
end user) .
4 CC
Inadequate PM. Improper
cutting fluid specified / used.
2
In process check
sheet.. Yearly
Operator
CFT review
feedback.
2 16
user).
4 CC
Inadequate PM.
3
In process check
sheet.. Yearly
Operator
CFT review
feedback.
2 24
164
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
end user) .
4 CC
Inadequate PM.
3
In process check
sheet.. Yearly
Operator
CFT review
feedback.
2 24
user).
4 CC
3
In process check
sheet. Yearly
Operator
CFT review
feedback.
2 24
end user) .
4 CC
3
In process check
sheet.. Yearly
Operator
CFT review
feedback.
2 24
S15O2 : Inspect Dome holes in A2. Rework / Delay (Difficult
end user) .
4 CC
3
In process
checksheet.Yearly
Operator
CFT review
feedback. Red tag
process.
2 24
externally.
end user) .
4 CC
3
Yearly Operator
CFT review
feedback. Red tags
at station.
2 24
end user) .
4 CC
3
Yearly Operator
CFT review
feedback.
2 24
S16O1 : Polish. Break edges. Rework / Delay. (Potential
end user).
4 CC
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
S17O1 : Tumble Finish. Gravi-flo parts in brown media for 1 Hr. Rework / Delay. (Potential
end user).
4 CC
Inadequate PM.
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
Rework / Delay. (Potential
end user).
4 CC
Inadequate PM.
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
R1 : Re-package parts to send out. Route to dock. Rework / Delay (Displaces.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
ECT5 : Transport parts out for Medcast check (Zyglo). Rework / Delay (Displaces.
Weekly CFT review
feedback. 2 24
165
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
EC2 : Inspect parts for cracks (Zyglo Dye Penetrant test). Rework / Delay (Displaces.
4 CC
Inadequate PM.
2
Visual. In process
checksheet. Yearly
Operator
CFT review
feedback. Red tags
at station.
2 16
externally.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
EC2 : Package parts and certs. For shipment. Rework / Delay (Displaces.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
4 CC
3
100% Insp. At R1.
Weekly CFT review
feedback. Barcode
traceability.
2 24
Route material missing certs to salvage for process internally /
externally.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
RI : Receiving Insp. Check for cracks. Rework / Delay (Displaces.
4 CC
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
externally.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
Discrepant material
introduced to line. Scrap /
Delay. (Displaces. Hazard to
end user).
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
S18O1 : Blast. Cosmetic blast (30 grit ALOX). Rework / Delay. (Potential
end user).
4 CC
Inadequate PM.
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
end user).
4 CC
Inadequate PM.
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
S19O1 : Compile and review Master Record packet. Rework / Delay (Displaces.
4 CC
3
Yearly Operator
CFT review
feedback.
2 24
4 CC
3
Yearly Operator
CFT review
feedback.
2 24
166
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
S19O2 : Inspect for discoloration. Re-blast as needed. Rework / Delay. (Potential
end user).
4 CC
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
end user).
4 CC
2
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 16
S19O3 : Inspect thickness in hook areas. Rework / Delay (Displaces.
4 CC
3
Operator
CFT review
feedback. Scheduled
PM.
2 24
externally.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
Discrepant material
introduced to line. Scrap /
Delay. (Displaces. Hazard to
end user).
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
S19O4 : Inspect radius. Rework / Delay (Displaces.
4 CC
3
In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
externally.
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
S19O5 : Inspect edges. Rework / Delay. (Potential
end user).
4 CC
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
externally.
end user).
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
end user).
4 CC
3
Operator label and
CFT Reviews and
feedback. Red Tags
at station.
2 24
167
Core Team :
Class
Requirements*
S
e
v
C
l
a
s
s
Potential Cause(s)/
O
c
c
u
r
Current Process
Design Controls
(Detective
Controls)
D
e
t
e
c
R
P
N
S20O1 : Clean , Pack and Ship. Clean parts. Rework / Delay. (Potential
end user).
4 CC
Incorrect cleaning materials
specified / used. Excessive
2
Incoming and in
process contaminant
check. 100% wash
and dry prior to
pack.Yearly operator
qualification. Red tag
process. Dock audit.
2 16
Reprocess parts (clean) if contaminated. Rework / Delay. (Potential
end user).
4 CC
Weekly CFT reviews
and feedback. 2 16
S20O2 : Pack parts in bubble bags. Contamination of parts.
(Potential Blood
Poisoning.Hazard to end
user).
4 CC
3
Incoming and in
process contaminant
check. 100% wash
and dry prior to
pack.Yearly operator
qualification.
Operator label
initial.Red tag
process. Barcode
traceability.
2 24
S20O3 : Pack bags in box. Rework / Delay (Displaces.
4 CC
3
Yearly operator
qualification.
Operator label
initial.Red tag
process. Barcode
traceability.
2 24
S20O4 : Identify box (Label / Part number). Rework / Delay (Displaces.
4 CC
3
Yearly operator
qualification.
Operator label
initial.Red tag
process. Barcode
traceability.
2 24
S20O5 : Put heat code on V of C. Rework / Delay (Displaces.
4 CC
3
Yearly operator
qualification.
Operator label
initial.Red tag
process. Barcode
traceability.
2 24
ECT7 : Transport parts out for Biomet for finish. Rework / Delay (Displaces.
4 CC
3
Visual , In process
Checksheet. Yearly
operator
CFT Reviews and
feedback. Red Tags
at station.
2 24
CONTROL PLAN
Prototype Pre-launch Production Key Contact/Phone Date (Orig.) Date (Rev.)
Control Plan Number 10/22/2002
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (if req'd)
12345678 Class
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (if req'd)
Supplier/Plant Supplier Code Other Approval/Date (if req'd) Other Approval/Date (if req'd)
IUSB
Special Characteristics CC Critical (Sev = 4) SC Significant ( Sev < 4 & RPN >/= 60)
Part Feature / Process Name/ Machine, Device, Characteristics Special Methods
Process Operation Jig, Tools No. Product Process Char. Product/Process Evaluation/ Sample Control Reaction Plan
Number Description for Mfg. Class. Specification/Tolerance Measurement Technique Size Freq. Method
A2 : S201
OD Diameter of socket
receptacle;R6 Inside
Radius of socket
receptacle : Draw
sect. To full height.
123456 : Micrometer
; XXYTZ5 : Fixture ;
99999876 : Height
Gage.
1 X X CC
Ref dwg. 12345678 OD Micrometer . (4) spot
meas. About periphery ,
Subtract min. & max. and plot
ovality. Measure height to
assess radius.
100%
Insp.
Shift
X bar & R chart. Yearly
operator qualification.
Red tag process.
Containment , Rework /
Scrap. Weekly CFT
reviews and feedback.
A2 : S302 , S306 , S1401 , S1501
Socket Dome hole
:OD-Diameter of hole
;ID-Diameter of hole
Pin gages :
29292989 &
39393989 2 X CC
Ref dwg. 12345678 Min & Max Pin gage on hole
diameters. Go / No Go.
100%
Insp.
Shift
In process
Checksheet. Yearly
operator
process.
Containment , Rework
small / Scrap large.
Weekly CFT reviews and
feedback.
A2 : S306 , S1402 , S1502
S2 adjacent hole to
hole centerline
spacing within and
across rows ;
Plug gage :
AXCD567
3 X CC
Ref dwg. 12345678 Go / No Go. 100%
Insp.
Shift
In process
Checksheet. Yearly
operator
process.
small / Scrap
large.Weekly CFT
A2
D0 Hole shank depth
from outside socket
face to bottom
XXYTZ5 : Fixture ;
99999876 : Height
Gage. 4 X CC
Ref dwg. 12345678 Dimensional
5 Hourly
operator
process.
small / Scrap
large.Weekly CFT
R9 : S1904 Radii
Radius gage :
66667898
5 X CC
Ref dwg. 12345678 Go / No Go. 100%
Insp.
Shift
In process
Checksheet. Yearly
operator
process.
small / Scrap large /
small.Weekly CFT
M : R1 , EC2A , EC2B Materials : Hardness
AKATZ5 : Hardness
Tester .
6 X CC
Ref dwg. 12345678 Hardness Test
5 Shift
R chart. Incoming and
in process lot
operator
process.Barcode
traceability.
.Weekly CFT reviews
and feedback.
S 202 , S503 , R1
Materials : Integrity ,
Inspect for cracks.
NA
7 X CC
Ref dwg. 12345678 Visual 100%
Insp.
Shift
Visual , In process
Checksheet. Yearly
operator
process.
Containment , Scrap
.Weekly CFT reviews
and feedback.
EC2
External Supplier .
7 X CC
Ref dwg. 12345678 Zyglo penetrant tester. 100%
Insp.
Shift
Visual , In process
Checksheet. Yearly
operator
process.
Containment , Scrap
.Weekly CFT reviews
and feedback.
P : S304 , S502 , S1601 ,S1701, S1801 ,
S1902 , S1904 , S1905 , ECT7
Coating / Finish :
Polish , break edges ;
Tumble finish , Gravi-
flo parts ; Cosmetic
Blast ; Inspect for
discoloration
ABCTZ5 :
Profilometer
8 X X CC
Ref dwg. 12345678 Profilometer. 100%
Insp.
Shift
Visual , In process
Checksheet. Yearly
operator qualification.
Red tag process.
.Weekly CFT reviews
and feedback.
REVISION: REVISION DATE: PAGE 168 OF 171 DOCUMENT NUMBER:
CONTROL PLAN
Prototype Pre-launch Production Key Contact/Phone Date (Orig.) Date (Rev.)
Control Plan Number 10/22/2002
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (if req'd)
12345678 Class
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (if req'd)
Supplier/Plant Supplier Code Other Approval/Date (if req'd) Other Approval/Date (if req'd)
IUSB
Special Characteristics CC Critical (Sev = 4) SC Significant ( Sev < 4 & RPN >/= 60)
Part Feature / Process Name/ Machine, Device, Characteristics Special Methods
Process Operation Jig, Tools No. Product Process Char. Product/Process Evaluation/ Sample Control Reaction Plan
Number Description for Mfg. Class. Specification/Tolerance Measurement Technique Size Freq. Method
S2001 , S2002
Hypoallergenic : Clean
parts
WWWW112 :
Analyzer ; V8YU324 :
Dessicator ;
KK3241Q : Scale
9 X X CC Ref dwg. 12345678 Chemical Analyzer and
dessicator.
5 Shift
Incoming and in
process contaminant
check. 100% wash
and dry prior to pack.
Yearly operator
process. Dock Audit.
Containment , Rework /
Rewash .Weekly CFT
Contaminant free. 9 X X CC
T1 : R1 , S301 , S1903
Thickness of A1 , A2 &
A3
9987678 Digital
Calipers
10 X X CC
Ref dwg. 12345678 Dimensional 100%
Insp.
Shift
operator
process. Barcode
traceability.
Containment , Scrap
thin.Weekly CFT reviews
and feedback.
R1 : EC2A , EC2B
Verify
certifications.Route
missing certs to
salvage for hold.
NA
11 X CC
Process Instruction #120 Visual at each location. 100%
Insp.
Shift
Operator label initial.
Yearly operator
process. Barcode
traceability.
Containment , Return /
Rework .Weekly CFT
R1 , S202 , S301 , S503 , S1402 , S1502 ,
EC2 , S1903 , S1904 , S1905
Route discrepant
material to salvage for
process internally /
externally.
NA
12 X CC
Insp.
Shift
Red tag process. In
process Checksheet.
Yearly operator
process.
feedback.
EC1 , EC2A , EC2B , R1 , EC2
Package parts and
certifications for
shipment.
NA
13 X CC
Process Instruction #122 Visual at each location. Batch
Shift
Audit. Barcode
traceability.Red tag
process.
feedback.
S2002 , S2004 , S2005
Final package for
shipment. Material
segregation and
package labeling.
Place heat code.
NA
14 X CC
Insp.
Shift
Operator label initial.
Yearly operator
process. Barcode
traceability.
Rework .Weekly CFT
S1901
Compile and review
Master record packet.
Final audit.
NA
15 X CC
Process Instruction #124 Dock Audit. Visual at dock
location.
100%
Insp.
Shift Operator label initial.
Yearly operator
process. Barcode
traceability.
Rework .Weekly CFT

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