Académique Documents
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2015
This presentation was developed by General Motors Corporation Global Purchasing Supply Chain.
All rights reserved. No part of this material may be reproduced in any form, or by any method,
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GM 1
Global Supplier Quality
MISSIO N :
To b e l ead ers o f an en terp ri se ap p ro ach to ensure
our suppliers achieve launch and quality excellence.
GM 2
BIQS
• Common Principles
• Common Methods
• Common Processes
GM
3
BIQS 1
Nonconforming Material / Material
Identification
GM 4
Nonconforming Material / Material Identification
Are all material including the NC and suspected identified properly by tagging
or by location ?
IDENTIFY STOCK IDENTIFYING “BAD”
STOCK
Identify all parts that are removed
Part removed from the line/process/department Nonconforming parts MUST be
• Tag or Mark each part or container Clearly Identified. (Examples- Tag
from the
so parts are clearly identified. parts with red tags, permanently
line/process/ Ensure the Tag or Mark is robust marker or paint parts Red). Do not
department and must require effort to remove. use stickers as they fall off in plant
• Tagging good stock is just as environments. A LOCK BOX or locked
important as tagging bad stock to area is also acceptable for Identifying
reduce mishandling. BAD parts.
IDENTIFYING
“GOOD” STOCK
QUARANTINE “BAD”
STOCK Conforming parts need to be identified
Quarantine Suspect/Nonconforming with a Green tag if it’s a fully finished
Non- parts from good parts in all areas of part that is GOOD. Parts that are not
conforming the Plant or Warehouse to prevent FINISHED also must be identified
material mishandling of parts. Place parts in with a IN-PROCESS tag stating
a locked area or wrap parts with where in the process the part was
handling/ caution tape, again so they are removed (example: Removed
Containment CLEARLY IDENTIFIED. Operations 10, Ready for Operations
20).
GM 5
Nonconforming Material / Material Identification
All Suppliers are responsible for ensuring non-conforming material does not reach the customer.
COMMUNICATE
ROBUST CONTAINMENT
If ANY GM facility is at risk of IDENTIFYING STOCK
Non- being presented with non- Identify robust
conforming conforming material, inform See Material containment process,
material all key GM contacts Identification slide and obtain appropriate
(SQE,SQA) immediately, at approvals from GM SQ
identified ALL potentially affected and Engineering.
facilities globally
PERMANENT FIX Ensure compliance with the Initiate containment with the Work with key
Complete following material control assistance of the following GM customer
root cause process Audit (Slide 4) and checklists contacts to initiate
and Break containment worksheet.
-Point containment at
solution their facility(s) if
activities. Containment potentially
checklist
Dept. affected.
Containment W/S
CONTAIN AT YOUR
ROBUST MATERIAL FACILITY/YOUR TIER CONTAIN AT GM
CONTROL SUPPLIERS FACILITY(S) FACILITY(S)
Burr on flange
PRODUCT CONTAINMENT SCOPE
IDENTIFY ALL AREAS WHERE SUSPECT PRODUCT COULD BE LOCATED
Tag
WIP Storage Areas 1000 P.S. 1000 P. Smith
Outside Processing - (Plating) 1000 C.J. 1000 C. Jones
Scrap Bins 42 K.C. 42 C. Jones
Rework Areas 0 B.T. 0 C. Jones
Shipping Dock 0 K.C. 0 C. Jones
Heat T reater 0 P.S. 0 C. Jones
At Customer 0 B.T. 0 C. Jones
In T ransit 0 B.T. 0 C. Jones
Service Parts Operations 0 P.S. 0 C. Jones
Location
GM
8
CONTROL OF NONCONFORMING PRODUCT
GM
9
Nonconforming Material / Material Identification
GM 10
BIQS 2
Layered Process Audit
GM 11
Layered Process Audit (LPA)
• LPA is an effective tool to assure compliance to standardized procedures at
each workstation such as SW , CNC compliance , E.P verification .
• LPA process is owned by management who assure effective implementation of
LPA in all levels and use the LPA process for Continuous improvement .
• LPA should have daily activity by team member /leader .
• Management should participate on audit activity on go and see on shop floor
on frequent basis ( Ex: monthly base ) .
• Customer specific and quality focus checks from FR issues should be
reviewed by all layers including management .
• Top Management ensure effective corrective actions and counter measures.
GM 12
Layered Process Audit (LPA)
Process explanation
GM 13
Layered Process Audit (LPA)
LPA Check sheet example
HEADER: Enter the System Name
Product line or an area of the Plant
1. Molding
2. Paint/Coating
3. Assembly
4. Warehouse/Shipping
In this Example the
Section #1:
Manufacturer
COMMON Work Station Questions
would have (4) four
unique one page
Section #2: audit forms/files, to
UNIQUE Quality Focused
Questions cover all processes.
Section #3:
COMMON Manufacturing System
Questions
GM 14
Layered Process Audit (LPA)
LPA Check sheet example 2 :
100% 47 50
90% 43 43 45 • LPA results for all
80% 40
70% 35 levels are
60%
50%
27
23 24
30
25
summarized on
22
40%
16 16
20 19
20 monthly basis for
14
30%
20%
15
10
continuous
10% 5 improvement .
0% 0
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
% IN COMPLIANCE: 88% 68% 95% 96% 97% 84% 95% 95% 94% 95% 95% 89%
# OF ITEMS ON ASSESSMENT: 20 15 20 30 20 10 20 25 20 20 20 20
# OF ASSESSMENTS 20 9 28 15 20 10 20 20 20 20 20 20
TOTAL # OF ITEMS ASSESSED: 400 135 560 450 400 100 400 500 400 400 400 400
# OF ITEMS IN COMPLIANCE: 353 92 533 434 386 84 380 477 376 381 378 357
NON CONFORMANCES 47 43 27 16 14 16 20 23 24 19 22 43
GM 16
Layered Process Audit (LPA)
What goes wrong? Lessons learned.
• Mixed with product or process audit (1/month)
• Audit list is not flexible (once fixed)
• Containment activity is not in LPA
• Deviations corrected during audit are not documented (NC)
• “Daily ticking activity” but no real audit
• Result of 5 minutes instead of complete shift
• Workstation not being checked in different shifts
• Corrective actions not defined/followed (best is a hand written action plan)
• Stayed on daily level, not layered
• No management follow up
• Only applied to manufacturing not across entire organization
GM 17
BIQS 3
PFMEA
BIQS 4
PFMEA – Risk Reduction & Annual
Review
GM 18
PFMEA & Risk Reduction
General Notes:
• PFMEA Should be available for all part numbers /processes .
• PFMEA should Cover all processes including material handling , packing & labeling .
• PFMEA should cover the rework , Bypass processes .
• Each Failure mode has one Severity number .
• Each failure Mode might have more than one cause .
• Each cause has its RPN number .
• S,O, D numbers should be taken based on PFMEA tables references .
(Example: PFMEA AIAG 4th edition tables)
Handling Failure
modes are Failure mode
considered might have
multiple causes
GM 20
PFMEA & Risk Reduction
• PURPOSE:
• Reduce the risk of a initial quality failures
• Error proofing past quality failures
• Ensure that Failure Modes have proper controls (prevention/detection) and work properly
• SCOPE:
• Assembly Area
• Manufacturing Operations
• Shipping / Receiving
• All Operations
• Other Support Functions
• RESPONSIBILITY (Examples):
• Ownership
• Engineering Manager
• Operations Manager
• Contingency Plan for All Situations
GM 21
PFMEA & Risk Reduction
GM 22
PFMEA & Risk Reduction
(Example of risk reduction.)
• The use of an RPN threshold is NOT a recommended practice for
determining the need for actions, so it also will depends on Severity ranking.
• For example, if the customer applied an arbitrary threshold of 100 to the following,
the supplier would be required to take action on the characteristic B with the RPN of
112.
• In this example, the RPN is higher for characteristic B than characteristic A. However,
the priority should be to work on A with the higher severity of 9, although its RPN is
90 which is lower and below the threshold.
• There is no specific RPN value that requries mandatory action. i.e; PFMEA is a live
document..
GM 23
PFMEA & Risk Reduction
Risk Limiting Method as an example for Risk Reduction
Priority Level
Based on Severity Zone (Severity vs. Occurrence) and Detection Level (Severity vs. Detection)
Priority Level 1: Highest level of risk, should review for potential risk reduction activity
Priority Level 2: Medium level of risk, next group to review for potential risk reduction activity
Priority Level 3: Lowest level of risk, risk reduction activity not necessary.
Detection
• Severity Zone: comparing the severity and occurrence numbers
• Detection Zone: comparing the severity and detection numbers
10 3 1 1 1 1 1 1 1 1 1 10 3 2 1 1 1 1 1 1 1 1
Priority Level
Occurrence
9 3 1 1 1 1 1 1 1 1 1 9 3 2 1 1 1 1 1 1 1 1
3 2 2 3
7 3 2 2 2 1 1 1 1 1 1 7 3 3 3 3 2 2 2 2 1 1
6 3 2 2 2 1 1 1 1 1 1 6 3 3 3 3 3 3 2 2 1 1 2 1 2 3
5 3 3 2 2 2 2 1 1 1 1 5 3 3 3 3 3 3 3 3 2 2
4 3 3 3 3 2 2 1 1 1 1 4 3 3 3 3 3 3 3 3 2 2 1 1 1 2
3 3 3 3 3 3 3 2 2 1 1 3 3 3 3 3 3 3 3 3 3 3
2 3 3 3 3 3 3 3 3 2 2 2 3 3 3 3 3 3 3 3 3 3 1 2 3
1 3 3 3 3 3 3 3 3 3 3 1 3 3 3 3 3 3 3 3 3 3 Severity Zone
1 2 3 4 5 6 7 8 9 10 1 2 3 4 5 6 7 8 9 10 (Sev over Occ)
Severity Severity
24 GM
PFMEA & Risk Reduction
• Management is not involved & does not allocate resources for regular reviews.
• PFMEAs not used for continuous improvement - only updated when problems occur.
25
BIQS 5
Bypass Management
GM 26
Bypass Management
Requirements
GM 27
Bypass Management
Bypass Process
Any time the process is altered outside the approved documented control plan,
suppliers shall establish a Bypass Process Control procedure that:
• Defines the minimum requirements for bypassing an existing
manufacturing process.
• Defines minimum requirements for verification of the original process
when exiting the bypass.
GM 28
Bypass Management
Bypass Process
The Process Bypass Control procedure should incorporate the following:
• The process methods/controls defined for bypassing an existing
manufacturing process are approved by the Operations Manager
(process owner), the Engineering Manager and the Quality Manager.
• A list of processes approved for bypass are maintained through the
Document Control Process.
• The PFMEA and Control Plan include the bypass process.
• Standardized Work Instructions are established for the bypass
process.
• A form of communication is posted at each active bypass point.
• Bypass process should be covered in LPA and FR to ensure PFMEA , CP
,SW , setting process during and after bypass .
GM 29
Bypass Management
(Example)
Manufacturing Process
Backup Worksheet
GM 30
BIQS 6
Error Proof Verification
GM 31
Error Proofing Verification
Error Proofing
Objective: Function & use of error proofing devices are verified on a scheduled basis based on risk.
.
What is Error Proofing? How?
• A method of implementing a fail-safe mechanism to detect • Cross functional team using risk analysis to define where to
or/and prevent errors in a process from producing defects apply error proofing.
that severely or adversely impact customers and results in • A list of all Error Proofing devices (which includes location) is
waste during manufacturing, assembly, or testing. available.
GM 32
Error Proofing Verification
Benefits
Summary
GM 33
Error Proofing Verification
(Example)
Sensor
for gasket Sensor for
2 lamp 1
Sensor
Sensor for
for
lamp 2 gasket 3
Defected sample missing all items. Test pass if 5 sensors give negative results.
GM 34
Error Proofing Verification
• Error proofing disabled - too many parts rejected or considered false fails
GM 35
BIQS 7
Gage Calibration / Measurement
System Analysis
GM 36
Gage Calibration / Measurement System Analysis
Gage Definitions :
Gage—Any device used to obtain measurement, or assess the conformance of a
part or characteristic relative to specifications.
Adjustment—A set of operations to bring a gage into a state of performance
suitable for its use.
Calibration—A set of operations that compares and evaluates under specified
conditions, the relationship between a gage and a traceable standard
Certification—A set of operations to document the results of a calibration,
indicating conformance or non-conformance to specifications.
Master– a device used to check and/or adjust a gage to a specified value.
Mastering—A set of operations to verify that the gage results agree with the master.
GM 37
Gage Calibration / Measurement System Analysis
R & R Study Example
The angle variation of each operator measurement must be placed into the R&R table to
have the appropriate evaluation. The specification for the study is 1 degree minimum,
and 5 degrees maximum.
GM 38
BIQS 8
Fast Response & Team Problem Solving
GM 39
Fast Response & Team Problem Solving
Fast Response:
GM 40
Fast Response & Team Problem Solving
FR Tracking Board Example:
Points to Review:
Ownership
Exit Criteria
Overall Status
Next Report Out Date ABC Company - Quality Fast Response Tracking Board EXIT CRITERIA
STATUS KEY
1) Required but not initiated
R 2) Target Date Missed
Y Initiated but not complete
Target Timing, Status, & Date Green G Complete
24 H 7D 14 D 34 D 35 D 40 D N/A Not Applicable
Forecasted Closed
Field Rep Ranking
Customer Closed
Lessons Learned
Corrective Action
Corrective Action
(Institutionalized)
Layered Process
Program/Product
STATUS (RYG)
Proof/Detection
Who Answered
Containment -
Standard Work
Date Opened
Implemented
PFMEA / CP
Root Cause
Concern # /
Who Called
OVERALL
Breakpoint
By Owner
Customer
Validated
Identified
Updated
ITEM #
Owner
Audits
Name
Error
Date
date
Issue Description Action Plan / Countermeasure
G G G G G G G Y Y
1/10 PRR Hood Brkt Material Contaminated F. LaFeve 2/21 Need operator approval and training completion Y
1/11 1/18 1/24 1/24 1/25 2/13 2/15 2/20 2/20
1 Amore Mason 312869 24241198 for Work Instructions across shifts 2/19 25-Jan
Internal Radio Spt.
G G G G G G G
1/15 CAR 08- Brkt Burrs B. Adams CLOSED NA NA G
1/15 2/16 2/10 2/20 2/10 2/17 2/20
2 Sykes Jones 626 15891477 2/24 21-Feb 18-Feb
Hinge
G G G R G R R R
1/21 PRR Assy Parts mislocated on assembly McIntosh 2/22 N/A PLL Program Logic for Error Prevention device R
1/22 1/26 2/1 2/17 2/21 2/17 2/21 2/24
3 Kurtz Arnold 313123 21119878 to reprogrammed by 2/21. J. Busch - M.E. 3/2
FORD Seat Brkt
G G G G Y Y Y Y Y
1/22 NCR MNOP- Mixed Parts J. McGrath 2/22 Need to confirm LPA results and Process Y
1/22 1/24 1/27 1/27 2/21 2/20 2/20 2/20 2/21
4 Ferrer Stelzer 4219 13456-AF Documents updated. LL System input. 3/3 2-Feb
Internal Hinge
Paint dots found on loose & mis- G G G G R G G
LPA not Validated on 3rd shift. - J. Biden to
2/3 CAR 08- Assy J. McGrath 2/23 N/A NA R
built parts 2/4 2/7 2/8 2/8 2/23 2/28 2/8
5 Dowdall Mehall 632 21119878 confirm Cor. Act. By 2/22 3/15
Need Corp. Office approval on P.O. to obtain
G G Y Y Y Y Y Y Y
2/14 PRR ICS Supt. Loose 7mm bolt on front cover B. Adams 2/21 vendor intallation of Torque Monitor Upgrade. Y
2/15 2/7 2/21 2/21 3/14 3/12 3/13 3/14 3/14
6 Singh Patel 313517 99923889 Bob D. to obtain authorization. 3/26
GM 41
Fast Response & Team Problem Solving
Team Problem Solving Safety People
PROBLEM SOLVING FORM
Quality Responsiveness Cost Environmental
Author: Date: Problem Tracking # Lot#/CSN/Julian Date:
found
1. Problem Description (High level vague statement)
Have a defined process for Problem Solving which 2. Problem Definition (Detailed specific statement) Freq: 100% Sporadic One Time
Immediate Containment Activity: Short-Term Fix Person Resp. Target Date Status Breakpoint
Yes
Yes
No
No
N/A
N/A
3 Correct parts used? Yes
4 Are the parts in specification? Yes
No
No
N/A
N/A
Learned.
Why
Why
Why
Real Root
Cause
Countermeasure tracking -
Verification Process (How did you verify the countermeasure worked?)
working days defect free
Has a Quality Alert been posted? Yes No N/A 1 2 3 4 5
Have PFMEAs been completed/updated ? (Failure mode comprehended) Yes No N/A 6 7 8 9 10
Old RPN#_____________ New RPN#____________ 11 12 13 14 15
Could the communication of this problem and its solution possibly prevent other departments from Yes
incurring the same problem? If YES - check relevant boxes and send a copy of this form to those Machining Casting Supplier ME/PFA
departments. No
Participants: Author (Signature & date required for closure) Group / Shift Leader (Info only) Area Manager / Leadership (Info only)
Shift 1
Shift 2
Shift 3
Comments:
GM 42
Fast Response & Team Problem Solving
GM 43
BIQS 10
Quality Focused Checks
GM 44
Quality Focused Checks
= Meets Standard
= Deviation Found
N/A = Not Applicable
= Issue Corrected
GM 45
Quality Focused Checks
LPA is used when to follow Quality focus checks for customer and
significant internal issues , also used to follow KPC , Delta …etc.
Example 1 : Review LPA sheet example slide no 13
Example 2 :
GM 46
BIQS 11
Standardized Work
GM 47
Standardized Work
GM 48
Standardized Work
• Definition:
• A user friendly document that provides detailed information on a specific element of
work to ensure the successful execution of that element.
• Purpose:
• To provide detailed training information for new team members.
• To bridge the gap between engineering information and shop floor knowledge.
• To provide a written history of that element.
• To provide a baseline for auditing, problem solving, continuous improvement,
rebalancing of work and documentation transfer.
GM 49
Standardized Work
Symbols for Delta
(Examples) Operations
SOS JES
• Standard Operation Sheet is created for customer auditor and not for
• training of new operator
• supporting Layered Audit
• analyzing jobs for improvement opportunity
• problem solving
• Gage R&R was not done for attribute gages or not repeated
GM 51
BIQS 12
Process Change Control
BIQS 14
Change Control – Production Trial Run
GM 52
Process Change Control
Change process
All suppliers shall have a procedure for Plant Process Changes:
• Changes should be documented utilizing a plant process change form
(reference Powertrain PPCR example).
• All process change ( Internal or external ) forms shall be controlled through
a Document Control Process.
• The procedure shall cover both Planned and Emergency changes
(Typically temporary modification to process/standard work due to
unplanned situations, such as downtime, stockout, authorized
customer rework, schedule fluctuations, etc.).
GM 53
Process Change Control
(EXAMPLE)
Plant Process Change Request Form
Rev. Date: 10/5/07 PLANT PROCESS CHANGE REQUEST PPCR NO.
IF "YES", COMPLETE Manufacturing Process SECTION 3: DETERMINE WHICH FUNCTIONAL GROUPS NEED TO RESPOND TO THIS CHANGE
Backup Worksheet (in S:\ECO\FORMS) CHECK ANY ITEMS THAT MAY BE APPLICABLE / IMPACTED: RESPONSE DUE DATE:
ENVIRONMENTAL ENGINEERING: FOR QUESTIONS ON ASSESSING ENVIRONMENTAL IMPACT, CONTACT ENVIRONMENTAL ENGINEER.
WHAT IS THE AIM OF THIS CHANGE? WHY SHOULD WE WORK ON THIS NOW? CONTACT: SIGNATURE:
IS THERE AN ENVIRONMENTAL IMPACT? YES NO
CM, P PRODUCT MODIFIED BY AN ENGINEERING CHANGE TO DESIGN RECORDS, SPECIFICATIONS OR MATERIALS. PPAP (PRELIMINARY REVIEW): CONTACT: SIGNATURE:
CUSTOMER'S EASE OF ASSEMBLY CUSTOMER'S AUDITS/TESTS CUSTOMER'S PROCESS OR TOOLING
CM, P USE OF ANOTHER OPTIONAL CONSTRUCTION OR MATERIAL THAN WAS USED IN THE PREVIOUSLY APPROVED PART. ERROR PROOFING AUDIT DUNNAGE/PACKAGING CONTROL PLAN (INSP. METH./FREQ.)
CM, P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE WHERE, IN THE JUDGEMENT OF TECHNICAL IMPORTANT: 1. THIS SECTION REQUIRES SIGN-OFF IF ANY OF THE ABOVE ITEMS OR IF ANY OF THE "P" ITEMS FROM SECTION 2 APPLY.
2. AFTER CONTACTING THE SQA, FORWARD THIS FORM AND A PPAP WARRANT TO THE SQA, AS APPLICABLE.
EXPERTS, THE POTENTIAL EXISTS TO IMPACT PRODUCT INTEGRITY (e.g. MATERIAL PROPERTIES, SURFACE FINISH ... ETC.). 3. THE SQA IS TO SIGN THIS SECTION AS APPROVAL OF ALL REVIEWED PRE-IMPLEMENTATION PLANS FOR FULFILLING PPAP REQTS.
ADVISE PRODUCTION OF IMPENDING CHANGE? YES CONTACT:
P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE. SECTION 3 REVIEW FOR APPROVAL THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
CORRECTION OF A DISCREPANCY ON A PREVIOUSLY SUBMITTED PART. APPROVED BY: PRINT NAME SIGN DATE
P
(LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
P PRODUCTION FROM TOOLING AND EQUIPMENT TRANSFERRED TO A DIFFERENT PLANT LOCATION OR FROM AN ADDITIONAL PLANT LOCATION. SECTION 4: OTHER INSTRUCTIONS / COMMENTS
P PRODUCTION FOLLOWING REFURBISHMENT OR REARRANGEMENT OF EXISTING TOOLING OR EQUIPMENT.
P CHANGE IN SOURCE FOR SUBCONTRACTED PARTS, MATERIALS, DUNNAGE OR SERVICES (e.g. HEAT-TREATING, PLATING, PAINTING, ETC.)
P PRODUCT RE-RELEASED AFTER TOOLING HAS BEEN INACTIVE FOR VOLUME PRODUCTION FOR TWELVE MONTHS OR MORE.
SECTION 5A: TO IMPLEMENT PPAP WARRANT APPROVED (IF APPLIC.)
P FOLLOWING A CUSTOMER REQUEST TO SUSPEND SHIPMENT DUE TO A SUPPLIER QUALITY CONCERN.
THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
P PRODUCTION FROM NEW OR MODIFIED TOOLS (EXCEPT PERISHABLE TOOLS), DIES, MOLDS, PATTERNS ... ETC., APPROVED BY: PRINT NAME SIGN DATE
(LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
INCLUDING ADDITIONAL OR REPLACEMENT TOOLING.
THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
NO ITEMS APPLICABLE CHANGE ALREADY PDT/CIT APPROVED APPROVED BY: PRINT NAME SIGN DATE
(MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)
IF YOU CHECKED ANY "CM" ITEM(S): 1) DO NOT CONTINUE TO SECTION 3 UNTIL FURTHER NOTIFIED BY YOUR PDT/CIT LEADER.
POST-IMPLEMENTATION SIGNATURE BY CHANGE LEADER
2) FORWARD THIS SHEET TO THE MANUFACTURING ENGINEERING CLERK. ACTUAL IMPLEMENTATION DATE BREAKPOINT (IF APPLIC.)
(USE ENG. # OR DATE)
IF YOU CHECKED ONLY "P" ITEM(S): CONTINUE TO SECTION 3. COMPLETE PPAP SECTION (MANDATORY).
SECTION 5B: FINAL APPROVAL
IF YOU CHECKED NO ITEMS: CONTINUE TO SECTION 3. COMPLETE PPAP SECTION AS APPLICABLE. THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
APPROVED BY: PRINT NAME SIGN DATE
CORRESPONDING GMPT CMP TRACKING NUMBER (LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
APPROVED BY: PRINT NAME SIGN DATE
(MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)
GM 54
Change Control – Production Trial Run
Production Trial Run (PTR) process
Suppliers shall establish and utilize a defined PTR process that provides the
following elements to ensure successful PTR execution:
• Standardized Communication and Documentation
• Build Readiness Reviews utilizing a cross functional Team
• Quality Reviews before and after the change
GM 55
Change Control – Production Trial Run
GM 56
Change Control – Production Trial Run
(EXAMPLE: Production Trial Run)
GM 57
BIQS 13
Verification Station (Final
Inspection/CARE/ GP12)
GM 58
Final Inspection /CARE/ GP12
General :
GM 59
Final Inspection /CARE/ GP12
(Example: VS)
Shop Floor Management
Defects Leaving VS Station - Feedback
Defects Entering VS Dock Audit/Containment/Field Rep-Liaison Issues
Inspection of product (Attribute/Variable) Formal Customer Complaints - Reports
Prioritizing of defects Team Performance Data, FTQ & SCRAP Trend
Alarm Escalation Procedure Charts (over time), Direct Run, Safety.
Immediate Responses – Record of Calls for
help and escalation.
Leadership meeting every shift
Meeting Assignments
Pareto Analysis, Defects over time
Attendees Sign-in Sheet
Problem Solving –
Driving fixes into station - BIQ
Team select new problems based on
pareto analysis, assignable cause.
Team reports out weekly on status
Tracking R, Y, G Reviewed for
roadblocks, problem escalation.
GM 60
Final Inspection /CARE/ GP12
Quality Feedback/ Feed Forward: (Example)
GM 61
BIQS 15
Andon System Implementation
GM 62
Andon System Implementation
Accept
Do not Build a Defect!
Ship
Solve Problems Through Teamwork!
GM 63
Andon System Implementation
Andon System :
GM 64
BIQS 16
Alarm and Escalation
GM 65
Alarm & Escalation
Definition :
GM 66
Alarm & Escalation
(Examples)
Limits posted in the station
Specified caution and alarm Scrap board has good 5S and visual
limits linked with cost of 1 unit . management for caution & alarm
limits .
GM 67
Alarm & Escalation
Plant
Management Responder
Re
Superintendent /
sp
ion
on
Shift Manager
se
lat
Supervisor
ca
(Group Leader)
Es
Team Leader
Team Member
GM 68
BIQS 17
Visual Controls
BIQS 18
Visual Standards – Communicated and
Understood
GM 69
Visual Control & Visual Standards
General:
• Visual Standards such as Boundary samples , Quality alerts , master parts should
be communicated to all team .
• Visual Standard documents should be controlled .
• Visual standards should be updated based on FR and customer feedback .
(Examples) (Product Quality Standard)
GM 70
Visual Control & Visual Standards
(Examples)
Boundary Samples showing good
and Bad borders posted in shop floor .
GM 71
BIQS 19
Process Control Plan
BIQS 20
Process Control Plan Implemented
GM 72
PCP & PCP Implemented
FLOW DIAGRAM
PCP relation with PFMEA & WI
1
3
PFMEAs
4
Core Team
• “PICTURE” OF PROCESS
• SHOWS FLOW OF PROCESS
• FOUNDATION FOR PFMEA,
CONTROL PLANS, TOOL
LAYOUTS, WORK STATION
LAYOUTS, ET.
• LISTS EACH OPERATION
• CURRENT CONTROLS
• ENHANCED CONTROLS FROM RECOMMENDED
ACTIONS
PER OPERATION:
• KPCs, KCCs
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS FOR NON-
CONFORMING PRODUCT
PER OPERATION:
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS OF NON-
CONFORMING PRODUCT
GM 73
PCP & PCP Implemented
Example:
(A: PFMEA)
failure mode about temperature
Detection method
using variable
gauge
GM 74
PCP & PCP Implemented
Example:
(B: PCP)
Temperature control using gauge
Frequency of control
Check sheet used to
register the records
GM 75
BIQ 21
Process Capability
Review
GM 76
Process capability Review
CONTROL, CAPABILITY
AND PERFORMANCE
X
X X
X X X X X
X XX X X X
X X X X X X
GM 77
Process capability Review
GM 78
Process capability Review
Example:
GAEf-A23 Rev A
FFCpk Validation
INSPECTION ALLOWABLE ALLOWABLE
TARGET UPPER LOWER NUMBER OF
PROCESS NAME: AC backup Bowling Green LEVEL LIMIT LIMIT TRIALS
500 520 480 30
TRIAL 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
ACTUAL 499 501 500 500 500 501 501 500 501 499 500 500 500 501 500 501 500 500 500 500 501 501 499 500 500
(X-Xbar)^2 1.5211 0.5878 0.0544 0.0544 0.0544 0.5878 0.5878 0.0544 0.5878 1.5211 0.0544 0.0544 0.0544 0.5878 0.0544 0.5878 0.0544 0.0544 0.0544 0.0544 0.5878 0.5878 1.5211 0.0544 0.0544
TRIAL 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50
ACTUAL 500 500 501 501 500
(X-Xbar)^2 0.0544 0.0544 0.5878 0.5878 0.0544 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
TRIAL 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75
ACTUAL
(X-Xbar)^2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
TRIAL 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100
ACTUAL
(X-Xbar)^2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
30
25
NUMBER OF OCCURENCES
20
15
Series1
10
0
480 484 488 492 496 500 504 508 512 516 520
-5 GM 79
LEVEL
BIQ 22
Rework Repair
Confirmation
GM 80
Rework & Repair Confirmation
Re-Introduction
• Product removed from the approved process flow should be reintroduced into the
process stream at or prior to the point of removal.
• Best practice would suggest that you do not run product more than twice.
GM
81
81
Rework & Repair Confirmation
Example:
82
82
BIQ 23
Feedback – Feed
Forward
GM 83
Feedback - Feed forward
Content Format
•Variance to standard •Common
•Containment •Visual
•Breakpoint
Timing •Countermeasure
•Immediate
•Daily
•Weekly
•Monthly
GM 84
Feedback - Feed forward
Customer/Supplier Communications
Supplier
•Feedforward changes in product & process
•Feedforward problems that will affect customer
•Implement immediate containment - follow up
with problem solving & communicate results
•Deliver products that meet standard
Supplier Customer
Customer
•Communicate current standard requirements
•Provide immediate feedback on any problems
•Feedback results of supplier problem solving
GM 85
Feedback - Feed forward
Example:
Quality Alerts should be posted and communicated in the production and inspection
areas .
Quality Alert Quality Alert
GM 86
Feedback - Feed forward
Example:
GM 87
BIQ 24
Training
GM 88
Training
Training & Development Planning
• Leaders should utilize annual training plans to develop their employees (including
entire staff of manufacturing and support function areas).
Special consideration should be given for New Hires, personnel assigned to a new
role or position and temporary employees.
• Training should exist for employees and be based on a needs assessment (i.e.
organizational goals, individual training needs etc.).
• Use training tools such as:
• Scheduling and Tracking
• Flexibility Charts (to validate training and assess training needs)
• Training Evaluations etc.
• Training plans should include areas such as:
• Health, Safety & Environment
• BIQS
• Technical Training
• Leadership Development
• Launch Specific Training (if applicable) etc.
GM 89
Training
GM 90
Training
Flexibility Chart
Example:
GM 91
BIQ 25
Contamination
Control
GM 92
CONTAMINATION CONTROL
Sources of Contamination
GM 93
CONTAMINATION CONTROL
Example: Fluid in Original Packaging
‘Supplier’/ Plant needs to
develop Standardized
work (checking methods) ‘Customer’ needs , correct
to Confirm shipped Material which is clean & free
material. from debris/damage.
What do
they
Examples of items checked need?
-Material-Number
-Lot-Number
-expiration date
-seal not damaged
Container, hoses and connections
Brake fluid samples are taken for
water, oil, solids.
- Freezing point/correct mixing ratio
cooling fluid and washer fluid
- Are all pipes and air/con
assemblies protected against dirt
& moisture?
GM 94
CONTAMINATION CONTROL
Component Contamination
GM 95
CONTAMINATION CONTROL
GM 96
BIQ 26
Maintenance
GM 97
Maintenance
Strategy and Organization
• Scope adressed
• Process Equipment
• Handling devices / conveyors
• Facilities
• ….
Handling devices
Buildings
Tank
PROCESS
Fork-lift truck
GM
Fluides 98
Maintenance
Maintenance: types
• Corrective Maintenance:
• Maintenance performed after a breakdown detection
• Purpose: Ensure the re-start of the equipment as soon as possible (even with
degraded solutions)
• Preventive Maintenance:
• Maintenance performed according to predefined frequencies or on the basis
of predefined criteria (nb of cycles…)
• Purpose: Reduce the probability of breakdowns or the wear of the equipment.
Example: Aircraft Maintenance
• Predictive Maintenance - Condition Based Maintenance (specific type of
preventive maintenance):
• Maintenance based on the measurement of key parameters on the
equipment
• Example: Vibration Analysis on rotating machines, Fluids
Corrective Maintenance
analysis,
thermography on electrical equipment.
Risk of
breakdown Condition Based Maintenance
Preventive Maintenance
GM 99
Maintenance
GM 100
Maintenance
Spare Parts Management
• Identification of the critical spare parts
• Criteria to define critical spare parts shall be defined according to
procedure by organization
• List update shall be conducted periodically based on maintenance
results
GM 101
Maintenance
Maintenance performance measurements
MTBF Mean Time Before Failure
MTBF gives information on the reliabiliy
Operation Time
of the equipment MTBF =
Nb of breakdowns
Time
MTTR
MTTR gives information on the maintenability
of the equipement (maintenance friendly) Mean Time To Repair/Recovery
Reparation Time
MTTR =
Nb of breakdowns
GM 102
BIQ 27
FIFO/Material
Handling Process
GM 103
FIFO/Material Handling Process
FIFO present in all operations
• Minimize inventory and allows traceability of material.
• FIFO present in ALL OPERATIONS (Including repacking, kitting, buffers, WIP, and any
staging areas).
• Visual aids support all operations and standardized work.
• FIFO rotation – FIFO should occur on a daily basis unless otherwise noted by the plant
(in these cases FIFO may occur on a weekly basis).
• Ensure that FIFO is part of layered audit process.
• FIFO processes are documented and are part of standardized work.
FIFO Material In All Storage Locations
Material In FIFO Order Oldest Material to Operator First
Full Full
CMA Full Full
Empty
Empty
Supplier
Overflow
GM 104
FIFO/Material Handling Process
GM 106
BIQ 28
Shipping Approved
Packaging
GM 107
Shipping Approved Packaging
GM 108
Shipping Approved Packaging
What is mislabeling ?
GM 109
Shipping Approved Packaging
C Potential O D
Action Results
Part Description_________________________
c
Cause (s )/ t Re com m e nde d Actions
Function / Failur e Effe ct(s ) of e a c Proce ss P & Targe t e c e P
M echanism (s ) e Action(s) Take n
Re quire m ent M ode Failure v s u Contr ols c N Com pletion Date v c t N
s of Failur e r t
Operation
1
Description KPC KCC 2
1 3
2
3
GM 110
Shipping Approved Packaging
GM 111
BIQ 29
Supplier
Management
GM 112
Supplier Management
• Suppliers need to use quality data for sourcing decisions , select new suppliers .
• For current tiered suppliers , Tier one should use systematic problem solving tools
when issues occurred , also Tiered suppliers issues should be communicated in
FR meetings .
• Tier one should send structure feedback to tiered supplier performance regularly .
• Tier one should establish system and process audit to assure compliance for key
and critical suppliers .
Quality Data used for sourcing decisions
Example: Supplier base bid list
GM 113
Supplier Management
Effective problem solving process
For any delivery of parts with deviation, tier 1 validates the formal deviation
request of the tier X complaint (refer to Control of Nonconforming Product
CNC6).
Tired suppliers shall demonstrate a systematic and disciplined approach to
problem solving.
Example:
GM 114
Supplier Management
Tired suppliers monthly performance tracking
Example:
6 panel