QSB Uj

FAST RESPONSE PROCESS
Standardized Rapid Reaction to Quality Issues: Problem Solving and Communication

This presentation was developed by General Motors Corporation Worldwide Purchasing. All rights reserved. No part of this material may be reproduced in any form, or by any method, for any purpose, without written permission of General Motors Worldwide Purchasing.
QSB WORKSHOP REV. 062705 1
General Motors Corporation. All rights reserved.
Problem Solving WHAT IS A PROBLEM?

A Problem is the GAP between the current situation and customer satisfaction.
In 2005 Problem Report and Resolution (PRR), now requires the use of the 8D deliverables.
QSB WORKSHOP REV. 062705
8D PROBLEM SOLVING LOGIC FLOW DIAGRAM

D1 Select Team D2
(Example)
Define The Problem
D3
Contain The Problem
D4
Identify The Root Cause Verify Effectiveness Of Actions
Implement Permanent D5 Corrective Action
D6
D7
Institutionalize Throughout The Organization

3
D8
Recognize & Formally Disengage The Team

8D PROBLEM SOLVING PROCESS
D1 D2
Select Team Use the team approach by forming a multidisciplinary problem solving team. Members should have the expertise and authority needed to solve the problem effectively. Define the Problem Part 1 represents what the customer actually said; Part 2 represents what the engineer or expert says relative to the problem. Containment Interim Actions (quick fix) that prevent the problem from getting to the customer. Identify the Root Cause Define all the events that produced the problem. Use a systematic procedure to identify and verify the root cause: DOE, Fishbone Chart, Drill Deep Analysis, 7 Diamonds (Include Blue Card).
4
D3
D4
PROBLEM SOLVING TOOLS

Flow Chart Fishbone Diagram
(Example)
Pareto Chart
Problem
Histogram
Problem
5 Whys
Why Why Why Why Why Root Cause
Run Chart
Scatter Plot
Control Chart
Pictograph
7 Diamond Process
Problem Identified
Begin Interrogation
(Example)
Responsibility
Responsibility
Production 1
Correct Process? Yes Correct Tool? Yes Correct Part? Yes
Is Engineering support required?
Will Process Change Resolve?
Vehicle Assembly Engineering 5
No
Production 2
Product Change Required?
Design Release 6
Uncertain
Production 3
Rel. Engineer/ SQA/Supplier 4
Parts Quality? No
Extremely Complex Problem
Statistical Engineering 7
Diamonds 1 - 4
Used to determine if production is running the manufacturing process to design intent.
Diamonds 1-4 evaluate the stability of the process. Once a problem has been identified, the automatic response must be to immediately perform diamonds 1-4.
Initial investigation is done where the defect was found.

If investigation determines the cause of the problem is upstream, then investigation should be conducted at the upstream source as well. Statistical Engineering occurs when the manufacturing process does meet design intent and the problem still exists.
1 - Correct Process
Can any of these cause the problem?
Manufacturing Corrects
(Example)
Correct Process?
Is the correct Standardized Work posted? Is Standardized Work being followed? Are build documents being adhered to (if applicable)?
Manufacturing
Correct Tool?
Manufacturing
Correct Part?
Quality Sys / SQ / Supplier 4
Parts Quality?
Are gaging requirements / frequencies being adhered to? Is the job being done the same on all shifts? Does the operator understand what the product standards are? Is it the regular operator? Has there been a lot of turnover on the job? Has the operator been properly trained? Are the visual aids current? Does the operator understand the quality outcomes of her/his job? Does the operator know how to communicate when he/she has a problem?
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2 - Correct Tool
Manufacturing
(Example)
Correct Process?
Correct Tool?
Manufacturing
Correct Part?
Parts Quality?
Can any of these cause the problem? Are the correct tools & fixtures being used? (all shifts) Are the tools set to the specified requirements? Are they properly calibrated? Are both shifts using the same tool? Are the tools worn? Do the tools & fixtures have mutilation protection? Has the workstation been error proofed? Have the tools or error proofing been bypassed? Does the workstation layout allow the operator to work effectively? Has the Preventive Maintenance been done? (check log) Are tools functioning correctly?
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3 - Correct Part
Manufacturing
(Example)
Can any of these cause the problem?

1 Correct Process?
Manufacturing
Correct Tool?
Is the parts routing current? Are the correct parts being used? Are parts stocked in the correct location? Do the part numbers on the boxes agree with their location? Is error proofing needed? Is existing error proofing device working correctly?
Correct Part?
Parts Quality?
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4 - Part Quality
Manufacturing
(Example)
Correct Process?
Quality Systems is responsible for determining if parts have changed and overall part quality: Supplier Data CMM Checks Fixture Checks Visual Part to Part Visual Lot to Lot If parts quality (out of specification) is determined to be the problems root cause, then Quality Systems will notify manufacturing and/or the supplier that there is a problem and work with manufacturing and/or the supplier to validate the corrections.
Manufacturing
Correct Tool?
Manufacturing
Correct Part?
Quality Sys / SQ / Supplier
Parts Quality?
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COUNTERMEASURE CARD
Card #
__________
Referred by Quality Systems Manager
Date: ______________ Initiated by: _________________ Dept: ______________ Phone: _____________________ Part Name __________________ Part # ________________ Model ______________________ Unit # ________________
Problem Description: ___________________________________________________ ___________________________________________________ ___________________________________________________
Return to the Quality Department
Referred to: ________________________ (SQA or SQE, 4) Referred to: ________________________ (Quality Engineer, 5A) Referred to: ________________________ (Red X, 5B) Referred to: _________________________ (Engineering, 6) Referred to: _________________________ (other)
(Example)
Assigned to ___________________
Date ______________
Yes No Additional Information: __________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________
Problem Analysis (where defect was found)
1 2 3
Standardized Work Followed? Correct Tools / Fixtures / Error Proofing? Correct Parts? Parts in spec?
Countermeasure ____________________________________ ___________________________________________________ ___________________________________________________ Completed by ___________________ Date ______________
Problem Analysis (upstream operation, if applicable)

Return to the Quality Department
Yes
No
1 2 3
Standardized Work Followed? Correct Tools / Fixtures / Error Proofing? Correct Parts? Parts in spec?
Countermeasure ______________________________________ _____________________________________________________ _____________________________________________________ Completed by _____________________ Date ______________
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Practical Problem Solving Report
Author: Problem in shift: A: __ B: ___
Phone No:
Date:
(Example)
Safety Report
Q uality
Responsiveness
P eople
C ost
O ther
Problem found by: SIP: ___ CARE: ___ Maintenance: ___
GCA: ___ OTHER: Production: ___
___
Problem Description:
Sketch:
Problem Definition (Real Problem):
Point Of Cause (where problem is first occurring):
Quality Standard: Deviation: Problem: How Often: Containment:
Breakdown Start Time: End Time: Duration: Direct Run Loss:
Others
Who
Date
Status
Process/Part Check (similar to "7 Diamond Process" Steps 1-4): Y N 1 Has the operator been trained ? Is the SOS being followed? 4 2 Do the parts support quality ? Is correct tool being used?
3
Diagnostic sheet available: Y N

Check to see if there are any Diagnostic Sheets available to support solving this problem. Yes: No: ______ Used?
Is correct part being used?

If Yes, w hich one?
Direct Cause Analysis: (see other side for 5 Why Analysis) 1) Indicate possible direct causes on diagram.
2) Circle most likely direct causes.
Man
Machine
PROBLEM
Method
Material
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Practical Problem Solving Report

Report No:
Root Cause Analysis:In the first WHY write down the Direct Causes from the front.
(If you found more than one Possible or Direct Cause, please utilize additional sheets for each Direct Cause)
Why?
(Example)
Why?
Why?
Why?
Why?
Root Cause:
Long-Term Countermeasures
WHO
DATE
STATUS
Any Similar Areas where this might apply:
1- Identified 4- Closed
2- Implemented 3- Feedback
Follow-Up and Evaluation: Verification: Measurements over past ____________ days have shown problem to be: circle one: (min. 20) Resolved Not Resolved Countermeasure Standardized? Further PPS Activity required: Yes: No: Date: Name:
Area:
Approval Signature:
If yes, how is the standard documented?
Date/ Signature:
Team Leader
Group Leader
Shift Leader
Area Manager
A - Shift B - Shift
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Drill Deep Analysis/Worksheet

Drill Deep Worksheet
Name: Supplier contact: GM SQE: Supplier Duns: Issue Title: ID Type: Failure Mode: Effects of Failure Mode: Cause of Failure Mode: PRR PRTS CDP Other ID Number: Supplier Name and Location: Phone: Revision Date:
(Example)
Prevent Why did the manufacturing process not prevent the defect?
5 Whys M1 Why did the manufacturing process not prevent this failure mode? M2
**************** **************** ** **************** **************** ** Manuf act uri ng process **************** prevent ion & **************** st andardi zed w ork ** **************** **************** **
Corrective Action
Owner
Due Date
M3
Prevent
M4
M5
M-RC
Q1 Why did the quality process not protect GM from this failure mode? Q2
**************** **************** ** **************** **************** ** Qualit y process **************** det ect ion & **************** cont ainment ** **************** **************** **
Q3
Protect Why did the Quality process not protect the customer (GM) from the defect? Predict Why did the planning process not predict the failure?
5 Whys Ask WHY until actual root cause is determined.
Prot ect
Q4
Q5
Q-RC
P1 Why did the planning process not predict this failure mode? P2
**************** **************** ** **************** **************** ** Planning process **************** informat ional cont ent **************** in FMEAs and CPs ** **************** **************** **
P3
Predict
P4
P5
P-RC
K1 What are the key findings based on this quality issue? K2

**************** **************** ** **************** **************** ** **************** **************** **
K3
K4
K5
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D5
D6 D7 D8
Permanent Corrective Action Identify and implement permanent corrective actions that will eliminate the problem. Remember that permanent means forever. The problem should never be able to occur again. Verify Effectiveness of Action Verification takes place in these four areas: Root Cause, Interim Actions, Permanent Actions, Prevention. Verify the implemented action does eliminate the problem (short term, long term and other similar processes) and does not cause any other problems. Prevent Recurrence (Institutionalize) Preventing recurrence means preventing changes to the part, process or system that allow a problem to occur. Prevention covers all similar and related processes, designs, systems, etc. Congratulate Your Team Recognize the contributions of all the team members as a group and individually.
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INSTITUTIONALIZE (READ ACROSS)

Identify similar products and processes which can potentially have or produce the same failure mode. Implement the solution across the organization.
Update the necessary documentation:

PFMEA Control Plan Error Proofing Verification* Standardized Work Instructions* Operator Instructions* Lessons Learned*
Implement Layered Process Audits* to verify the system is working consistently.
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Read Across Matrix

READ ACROSS MATRIX
SUPPLIER:
Name: Location: Duns: Contact Name: Contact Phone: E-mail: Eight Week Period:
(Example)
(Ref. GM 1927-69,PRR Read Across)
SYMBOL & STATUS KEY:

O Original Product line and location
PQE/SQE:
Name: Phone: GM location / Provider Contact Phone: E-mail:
X Product line and/or location with similar process R Repeat Issues N/A Not Applicable Completed & 3rd Party/GM verified Completed & Supplier verified only Not Completed
Due Date:
A.P.Q.P. Duns #1/ Location Duns #2/ Location
Part Name & Number
GM Assy. Plant
Customer Concern
Failure Mode
5 Why Analysis
N/C or CPV
CS Status
PRR Number / Issue

Containment Cause of Failure Mode Corrective Action Prevent Corrective Action Protect Corrective Action Predict Corrective Action Key Findings Corrective Action
Corporate Champion
Product / Process Classification
Symbols
Part Name & Number
GM Assy. Plant
Customer Concern
Failure Mode
5 Why Analysis
N/C or CPV
CS Status
Corrective Action
PRR Number / Issue

Corporate Champion
Symbols
Part Name & Number
GM Assy. Plant
Customer Concern
Failure Mode
5 Why Analysis
N/C or CPV
CS Status
Corrective Action
PRR Number / Issue

Corporate Champion
Symbols
Read Across - analysis of opportunities of system deficiencies and corrective actions that encompass all GM parts, manufacturing processes, and other plant locations.
Corrective Action
FAST RESPONSE PROCESS

Standardized Rapid Reaction to Quality Issues: Communication and Ownership of Significant Quality Concerns
FAST RESPONSE
Fast Response is a system that: - standardizes reaction to significant External/Internal Quality failures. - promotes communication and discipline through daily meetings. - utilizes a visual method of displaying important information. In preparation for the Fast Response meeting, at the start of the day, Quality shall identify significant Quality concerns from the last 24 hours which may include: Customer concerns Supplier concerns Line stops (Internal / Customer) Dock Audits / Audit issues Other internal Quality concerns
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The workshop team should discuss how to define a significant Quality concern.
The Fast Response meeting: - shall be held daily to review the significant Quality concerns gathered by Quality. Meetings are held daily at minimum, some organizations may hold meetings every shift.
- is a communications meeting, not a problem solving meeting. It can be a 10 - 20 minute stand up meeting held on the shop floor or in a production conference room.
- is a manufacturing review meeting owned by manufacturing and supported by Quality, Engineering, Maintenance, etc At the Fast Response meeting, leadership shall: - Designate a leader (owner) for each concern/issue. - Assign owner report out for next meeting Owners shall be responsible for assuring all problem solving and exit criteria are met in a timely manner.
Owner report out shall include updates on the following: - Standardized Worksheets and Operator Instructions - Problem Solving Results Root Cause with supporting data Permanent Corrective Action with verification data - PFMEA - Control Plan - Layered Process Audits* - Workforce Notification - Read Across Matrix - Other documentation as appropriate
Report out to Leadership is scheduled on the Fast Response Tracking Board as deemed necessary.
The Fast Response Tracking Board should be part of a visual management system. The format should be displayed as large as is practical in the meeting area.
FAST RESPONSE TRACKING BOARD (Example)

To optimize visual management, this form is displayed in the meeting area (ex.: 4 x 8 dry erase board, laminated poster, etc).
EXIT CRITERIA
Issue Number
1 2
Issue Description
Material Contam inated Burrs Parts m islocated on assem bly Mixed Parts
Date Opened Unit I.D. # Owner

1/10/2005 2/15/2005 333933 98002222 McGrath Adam s
Next Date (of Owner Report out to Staff)

4/29/2005 CLOSED
Root Cause Analysis Corrective Action Implemented Error Proof/Detection Corrective Action Verified PFMEA / CP Updated Standardized Work Operator Layered Process Audits Lessons Learned (Institutionalized)
G G G G G G G G G G R G G G R R G G R G Y G N/A G G G G Y Y G N/A G G G G G N/A N/A R R R R R R R R N/A R
Overall Status
Containment
Y G R
R
G G G G
Open 4/23/05 Open Open
3/21/2005 9950560607 McIntosh
4/29/2005
3/22/2005
34523339
McGrath
4/29/2005
Paint dots found on loose 3/28/2005 & m is-built parts Loose 7m m 3/28/2005 bolt on front cover
98002222
McGrath
5/11/2005
Open
98002222
McGrath
5/23/2005
Open
EXIT CRITERIA STATUS KEY R Required but not initiated Y Initiated but not com plete G Com plete N/A Not Applicable
Points to Review: Ownership Exit Criteria Overall Status

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Date Closed
Leadership shall display a visual Quality status. Any type of visual management can be used: calendar, chart, etc
Daily Quality Chart
Month
Year
January
2004
31 29 28 30
(Example)
22 21 13 12 2 1 3 14 4 5 23 15
24 25 17 16 6 7
26 27 19 18 8 9 20 10 11
LEGEND:
Green
No Quality Disruptions
Yellow
Internal Quality Disruption (defined locally) Customer Quality Disruption (eg. PRR, Pull, Spill)
Red
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FAST RESPONSE PROCESS KEY STEPS

Quality gathers significant issues from the past 24 hours. Daily Fast Response Meeting assigns owner to each issue. Outside the meeting the owner utilizes the Problem Solving process to correct and prevent recurrence.
Issues are tracked on the Fast Response Tracking Board. Owners are required to give periodic updates at Fast Response meeting.
Owner responsible for completion of all exit criteria. Results of Problem Solving process communicated. Fast Response Tracking Board indicates exit criteria is green.
FAST RESPONSE
BENEFITS:
Improves Quality metrics: reduces PPM and warranty costs. Reduces PRRs and increases customer satisfaction. Provides a systematic approach for Problem Solving* and communication of Quality issues. Reduces recurrence of Quality issues. Assures all issues are resolved. Supports continual improvement. Strengthens documented implementation of Lessons Learned** database.
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FAST RESPONSE SUMMARY

Organizations shall
have a defined process for Problem Solving leading to root cause identification and elimination. use the Problem Solving format prescribed by the customer. follow guidelines called out in GM GP5 (Problem Report & Resolution PRR) Process. hold a daily Fast Response meeting. utilizes a format, like the Fast Response Tracking Board to identify: overall status of the significant Quality concerns. ownership of each concern. exit criteria required to close a concern. display daily Quality status.
CONTROL OF NONCONFORMING PRODUCT

Identification, Containment and
Communication
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Establish a method to ensure product that does not conform to specified requirements is: Clearly identified using consistent identification (tagging). Prevented from unintended use or installation (containment). Establish a consistent identification process using a Visual Management method. (Example) STOP LIGHT METHOD preferred method Red = Scrap Yellow = Suspect Green = Good
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(Example) SCRAP TAG CONTENT IN THIS SECTION IS AT LOCAL DISCRETION

PLT001 REQUIRED FOR SCRAP PRODUCT/CONTAINERS
(SCRAP BINS PAINTED RED DO NOT REQUIRE A TAG)
SUSPEC T TAG CONTENT IN THIS SECTION IS AT LOCAL DISCRETION

PLT002 REQUIRED FOR REWORK, REINSPECT, SUSPECT PRODUCT/ CONTAINERS
TAG MUST SHOW LAST OPERATION.TO ASSURE PROPER REINTRODUCTION
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OK FOR USE TAG CONTENT IN THIS SECTION IS AT LOCAL DISCRETION

PLT003 ANY COLOR (except red or yellow) FOR CONFORMING PRODUCT IS ACCEPTABLE
DO NOT USE
(IF YELLOW IS NOT USED TO DISTINGUISH SCRAP FROM SUSPECT, THE RED TAG MUST HAVE DISPOSITION.)
Nonconforming product shall be prevented from unintended use or installation through containment. Leadership must develop, organize and maintain a system for control of nonconforming product.
All nonconforming and suspect product shall be segregated.
SEGREGATION AREAS:
Segregation areas shall be foot printed or otherwise identified. Example: Scrap bins Rework Tables Spill containment areas Nonconforming material hold areas
Containment shall verify breakpoint: - using 100% Inspection - for a duration specified by site leadership
For product containment issues, containers shall be identified: - Red = Nonconforming product - Yellow = Suspect product - Green = After breakpoint conforming product Containment activity and tasks must be customer approved with supporting documentation: - work instructions - referenced in control plan - operator training records Customer Engineering approval may be required. All Control Plan inspections and tests shall be performed; product removed from the approved process flow shall be reintroduced into the process stream at or prior to the point of removal.
NOTE: When it is not possible to reintroduce at or prior to removal: a customer approved rework procedure shall be used to assure conformance to all inspections and test requirements. Process & authority for releasing product out of rework, repair and containment areas shall be defined. Product containment issues shall be reviewed by Leadership.
Containment Worksheet shall be used and completed to: - Provide a systematic approach to containing all suspect product. - Identify all areas to be checked for nonconforming product.
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CONTAINMENT WORKSHEET
DEPARTMENT: DEPARTMENT CONTAINMENT OWNER:
(Example (Example) )
DATE:
Laboratory
PRODUCT NAME / NUMBER: PRODUCT NONCONFORMANCE:
G. Hall 10066044
1/6/2003
Burr on flange
PRODUCT CONTAINMENT SCOPE
IDENTIFY ALL AREAS WHERE SUSPECT PRODUCT COULD BE LOCATED LOCATION POTENTIAL QTY. AREA VERIFIED SUSPECT PROD. FOUND? QTY? VERIFICATION RESPONSIBILITY
Receiving Laboratory WIP Storage Areas Outside Processing - (Plating) Scrap Bins Rework Areas Shipping Dock Heat T reater At Customer In T ransit Service Parts Operations
500 6 1000 1000 42 0 0 0 0 0 0 2548
P.S. K.C. P.S. C.J. K.C. B.T. K.C. P.S. B.T. B.T. P.S.
500 6 1000 1000 42 0 0 0 0 0 0 2548
P. Smith T. Brown P. Smith C. Jones C. Jones C. Jones C. Jones C. Jones C. Jones C. Jones C. Jones C. Jones
TOTAL FOUND
SEGREGATE SUSPECT PRODUCT TO (location, as feasible): 2548 pcs to Containment Area SORT METHOD (eg. visual, gage, mating part): Visual for burrs SORT CRITERIA (clear pass / fail standards): Max Burr per standard I.D. METHOD CONFORMING (eg. mark, tag, sign): White paint dot near defect area I.D. METHOD NONCONFORMING (eg. mark, tag, sign): Mark defect with red paint.
What if potential quantity does not equal total found?

When do you call the customer?
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Do you call the customer?

For an internal issue:
all suspect product contained prior to shipment. No chance of escape.
36

No
Certify parts that will be shipped.
37

For a potential external issue: all suspect material
not contained or not confident all product contained.
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Yes!
Contact : Assembly Plants Service Parts (SPO), Tiered Suppliers as required.


No
Certify parts that will be shipped.
Yes!
Contact : Assembly Plants Service Parts (SPO), Tiered Suppliers as required.
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A nonconformance alert and containment procedure shall establish the timeline, tasks and communications necessary to meet customer requirements.
Quality issue notification Concern with certification or was suspect stock shipped?
(Example)
Begin shipping certified stock.
Initiate containment actions, determine suspect population, begin Fast Response*.
Y
Contact external customer.
Develop & implement external containment and certification plans. Continue Fast Response* & Close Issue.
Begin shipping certified stock.
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Quality issue notification
Quality issues can be: Supplier initiated. Issues found by external customer.
Initiate containment actions, determine suspect population, initiate Fast Response*.
Initiate containment actions immediately at all infected locations! Begin Fast Response* process problem solving efforts.
Concern with certification or was suspect stock shipped?
Is there a concern with the certification procedure or has suspect stock been shipped? If YES to either question, contact customer immediately! If NO, then begin to ship certified stock.
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Contact External Customer
Needs to be a live conversation no voice or email. A phone list for contacts is established. Establish conference calls when required by customer. A supplier executive acts as lead and single point for communication. All stakeholders including Tier suppliers participate in calls.
(Example)
GM Contacts
GM SQ Mgmt Team Name Initial contact must be made with at least one person at each affected facility. Responsibility E-mail Phone
GM EngineerTeam
Name
Responsibility
E-mail
Phone
GMT 560 (Flint) Department
Name
Responsibity & shift
E-mail
PHONE
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Develop & implement containment and certification plans
Initiate at customer locations with appropriate sort instructions. A Customer should be informed of the following items: Certification method. Description and picture(s) of the marked parts. Description and picture(s) of any marked or added labels. Identify parts/labels. Begin to ship certified stock. Notify customer of breakpoints.
CERTIFIED STOCK SHIPMENTS
Begin shipping certified stock
(Example)
Arrival Date Time Carrier Tracking number Quantity
Assembly Plant Arlington
Ship Date Time
Arrival Date Time
Carrier
Tracking number
Quantity
Assembly Plant Silao
Date
Ship Time
Flint 880
Toluca
Pontiac
Mishawaka
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Work through problem solving process. Continue Fast Response* & Close Issue Consider for Quality Gates*/C.A.R.E.* and Layered Process Audit*
Continue to follow customers notification process requirements. The organizations nonconformance alert notification and containment process includes communication and actions for all stakeholders: Customer(s) Tier-2s, etc. Internal stakeholders
The process should include closing the loop with permanent resolution and issue closure. Problem Solving* Lessons Learned*
All containment issues shall be reviewed by leadership.
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BENEFITS:
Assures all suspect and nonconforming product is contained. Increases customer satisfaction and communication. Reduces repetitive Quality spills. Assures all issues are resolved with all customer contacts: internal and external. Assures a systematic approach for all issues.
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CONTROL OF NONCONFORMING PRODUCT SUMMARY

Nonconforming product shall be:
clearly identified using consistent identification (tagging). contained through the use of a Containment Worksheet. segregated in well identified areas. released using a defined process and authority. reintroduced into the process stream at or prior to the
point of removal.
Organization shall have a nonconformance alert and

containment procedure that meets customers requirements (timeline, steps, communication, etc).
Product containment issues shall be reviewed by Leadership.

STANDARDIZED OPERATIONS
WORKPLACE ORGANIZATION
A clean, well-organized work environment.
STANDARDIZED WORK INSTRUCTIONS

What work are we to do and how long should it take?
OPERATOR INSTRUCTIONS
How are we to perform the work?
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WORKPLACE ORGANIZATION
Workplace Organization encompasses a systematic approach to ensure:
work areas are organized for safety, quality, ergonomics and optimal use. only required and regularly used equipment, tools and materials are present in the work area. work areas are controlled using visual management. product and information flow is easily understood. housekeeping is defined by work area instructions. regular management reviews (Layered Process Audits*) are performed. waste elimination and continual improvement. a clean, bright workplace.
5S is a Best Practice system utilizing five steps

to achieve neatness and order in the workplace.
ENGLISH TERMS (JAPANESE)
Sort (Seiri) - Sorting out what is needed from what is not needed. Set in order (Seiton) - A place for everything and everything in its place. Shine (Seiso) - Clean the area, tools, equipment and remove scrap. Standardize (Seiketsu) - Set standards and follow them. Sustain (Shitsuke) - Ongoing compliance promotes pride and ownership so that it becomes a way of life.
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S-1: SORT Divide the needed and unneeded items at

the job site, removing any unneeded items. Four areas of focus:
Before
- Equipment
- Tools - Inventory/Storage - Personal items
Sort and Tag:
- Place a green tag on any item in regular use.

- Place a red tag on any item which isnt used or is not in working condition. - Place a yellow tag on any item that use or condition isnt known for sure.
S-2: SET IN ORDER A place for everything and

everything in its place.
Categorize: - How often do I use this item? Determine a location: There is a best place for every item. - If used frequently keep near If not place at the rear. - Use Shadow Boards. Set limits for material levels: - Standard packs. - Work in process. - Container size and identification.
After
S-3: SHINE - Eliminate the source of dirt and leaks (oil, air, water, etc).
Clean machines, tools, floors, cabinets. Develop instructions for cleaning methods and frequency. Organize for cleaning (correct materials, rags, brooms, etc.). Find ways to reduce the time required for cleaning.
(Examples)
Before
After
Out-of-standard conditions can be easily identified and corrected.

S-4: STANDARDIZE - Standardize the area visually and

mark location of each item. Color coding for designated areas. Designate area shapes. Consistent label height and color throughout facility. Storage containers and storage areas practices.
(Example)
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S-4: STANDARDIZE
(CONTINUED)
Determine cleaning schedule and methods. Standardize cabinet organization. Define a simple method to identify problems using visual controls.
(Example)
All items are properly identified
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S-5: SUSTAIN Ongoing compliance and continual improvement.

Leadership commitment and involvement (top down). Drive 5S throughout the organization. Incorporate housekeeping into Operator Instructions. Training is the key to continual improvement. Establish formal housekeeping audit/checklists. Incorporate 5S compliance into a formal Layered Process Audit * program. Keep trying to find a better way.
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Create a checklist:
5S Evaluation
Date: Name : Area:
(Example)
Item Notes for Next Score Level of (0-5) Improvement
Item No.
1 2 3 4 5
Description
Removing Unnecessary Items Storage of cleaning
5S Evaluation & Scoring Criteria Rating Scale: 0-5 (Poor = 0, Excellent = 5)
All items not necessary to performing work are removed from the workplace; only tools & products are present at work All cleaning equipment is stored in a neat matter ; handy & easily available when needed. All floors are clean and free of debris, oil & dirt. Cleaning of Floor cleaning floors is done routinely - - daily at a minimum. No outdated, torn or soiled announcements are displayed. All Bulletin boards bulletins are arranged ina straight and neat manner. Fire hoses and emergency equipment are unobstructed & Emergency Access stored in a prominent easy-to-locatemanner. Stop switches & breakers are marked or color-coded for easy visibility. Work-in-process, tools & any other material are not left to sit directly on the floor. Large items such as tote bins are Items on floor positioned on the glance; lines are straight and at right angles with no chipped or soiled paint. Aisles & walkways are clearly delineated and can be Aislewys - marking identified at a glance; lines are staight and at right angles with no chipped or soiled paint. Aisles are always free of material & obstructions: nothing is Aislewys ever placed on the lines & objects are always placed at right maintenance angles to the aisle lines. Storage of boxed, containers & material is always neat at Storage & right angles. When items are stacked, they are never crooked arrangement or in danger of toppling over.
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A well organized workplace is the best place to visualize your Standardized Work work flow, operator movement, time, etc.
FLOOR LAYOUT
Before
Insp
(Example)
FIRE EXT.
LATHE
Back up CNC Back up Broach
Dept. 816
LATHE
After
R000987654 F1234567890
RAW
Insp
FIN
BROACH
SCRAP
4 3
BROACH
CNC
CNC
Dept. 816
FIRE EXT.
58

STANDARDIZED WORK PROVIDES A FOUNDATION FOR: ensuring operators are consistently performing the same tasks and procedures. an efficient production sequence. reduced variation within a process. waste reduction, problem solving and quality control. identifying value added tasks. continual improvement. a lean organization. auditing operator conformance to work instructions (Layered Process Audit*).
(Example)
OPERATION: FROM:___________________________ TO: _____________________________ STEP NO. ELEMENT TIME STANDARD INWALK
QUANTITY PER SHIFT:______________ SHIFT:________
CUSTOMER CYCLE TIME:________________ OPERATOR CYCLE TIME:_______________
WORK ELEMENT
HAND WORK
MACHINE
PROCESS STOCK
QUALITY CHECK
CRITICAL OPERATION SAFETY
Standardized Work Instructions shall Include: - Work Elements - Operator Movement - Operation Cycle Time
WORKSTATION AREA DRAWN TO SCALE
TOTAL
60
Implementation of Standardized Work Instructions

Multi-disciplinary team(s) shall identify and list all operations to implement Standardized Work Instructions. Examples of how to prioritize: Customer Quality Concerns Necessity for a Defined sequence or method of work Off-line Rework High RPN Employee Flow-through
Multi-disciplinary teams shall develop Standardized Work Instructions.
Impacted and new employees shall be trained in the use of Standardized Work (Standard Operator Training*).
Multi-disciplinary team(s) shall continuously develop and improve Standardized Work Instructions.
STANDARDIZED WORK INSTRUCTIONS OPERATOR MOVEMENT
(Example)
WORK ELEMENTS
OPERATION CYCLE TIME

Display of Standardized Work Instructions

Standardized Work Instructions shall be displayed at each operation.
Operations performed same way every time. Reduces the risk of omitting components. Quality checks and frequency are indicated. Process improvements easily identified.
WORK ELEMENTS
OPERATOR MOVEMENT
Training is simplified and consistent. Reminds operator of correct sequence. Alerts operator to safety concerns. Assures operator is following approved process (Layered Process Audits)*. OPERATION CYCLE TIME
Assures leadership operation is running as approved. Operator knows if equipment is showing signs of wear. Machine and operator hand work and walk time separated. Time allocated for quality checks are included.
(Example)
GROUP / TEAM OPERATION NAME / #
Torque Converter Blank Op. 10
PROCESS NAME:
TC Cover Line
ELEMENT TIME
WORK ELEMENTS
Load Coil (Time to load each coil)
HAND
MACHINE
WALK
DIAGRAM
QUALITY CHECK
SAFETY
ERGO
IN PROCESS STOCK
NO.
OPERATOR
1 3
2.0
Manual index press to set travel Adjust travel Run first piece Quality checks per operator instructions Run press in manual mode Check first 5 pieces per operator instructions Set press to auto Run press Gage 2pieces/press/hour from hold bin Place finished product from hold station into gondola Tag full gondola with internal move tag Notify fork lift driver to move full gondola to shipping dept. Move empty gondola into position (remove all tags/labels) Repeat all steps in set-up, gage, inspect and run on all 3 presses
6.0 2.0 16.0 6.0 3.0 3.0 12.0 2.0 40.0 2.0 2.0 6.0 5.0 2.0 22.0 15.0 2.0 4.0 2.0
6
5 6 4
50 pc Hold
2
`1
A
5
2 1
50 pc Hold
16.0
6
5 3 4 2
TAKT TIME CYCLE TIME
26.4 18
TOTAL HANDWORK MACHINE CYCLE TIME WALK TIME
119.0 18.0 33.0
50 pc Hold
OTHER ACTIVITIES CONTROL BLOCK J.E.S. LOCATION: Posted on press control panel (Each press)
SAFETY AUDIT
Verify light curtains at beginning of shift Perform gaging as stated in the control plan. Perform audit at beginning of shift Notify fork lift operator when gondola is full (400/container) Tag material with OK to move tag. Record downtime, post performance data to team board at end of shift, record scrap data.
ASSIGNED OPERATORS 1ST SHIFT FRED JONES

SAFETY REQUIREMENTS
QUALITY AUDIT
W.P.O.
MATERIAL HANDLING
2ND SHIFT
AL SMITH SUPPLEMENTAL OPERATORS
Safety shoes (steel toe)

DATA RECORDING
Safety glasses with side shields Hearing protection Kevlar gloves
1ST SHIFT 2ND SHIFT
Kathy Barnes Larry Walker
64

Best People Practices Chart Address: AA-007
Operation Name:
Head ABCDE/RUNNER/ABCDE Line: 1 Shift: ALL Area: L6 Head Assembly
(Example)
Contact your coach or coordinator with any changes, questions, or quality concerns.
Work Flow Diagram Total Current Cycle Time: 65.5 sec
Part Production Procedure Item # 1 2 3 4 5 6 7 8 9 10 11 12
Elements Unload 'ABCDE/Runner/ABCDE' Place cluster on rack Tape runner with blue tape and masking tape Transfer 'ABCDE/Runner' to 'ABCDE/Runner/ABCDE' fixture on assembly machine Load 'Runner' onto assembly machine Start machine cycle for 'ABCDE/Runner' and 'Runner' Get 'ABCDE' from WIP table Load 'ABCDE' onto assembly machine Get 'ABCDE' from WIP table Load 'ABCDE' onto assembly machine Start machine cycle for 'ABCDE/Runner/ABCDE' and 'ABCDE/Runner' Get 'Runner' from cart
Target Cycle Time: 55 sec
11 12
10
6 7 9
TOTAL MANUAL TIME: 45.78 sec Standard Daily Routine ( Minutes per Shift) Shift Second 389 5 9
2 Rack
3 Tape
Item A B C
Elements Load/Unload machine AA-007 Record production downtime/scrap Cart handling for 'Runners'
First 389 5 9
Third N/A N/A N/A
Required Personal Protective Equipment

Total Minutes Used: Total Utilization: 403 79% 403 79% 0 0%
Remember Safety 1st!
Note: Operator will be relieved during two 23-minute breaks and one 30-minute lunch. Effective Date:________________________________ Manufacturing General Supervisor Approval:________________________________
65

(Example)
QUALITY CHECK
TORQUE CONVERTER OP. A PUMP VANE SETTER
PROCESS NAME:
PUMP-A & TURBINE-A

SAFETY ERGO IN PROCESS STOCK NO. OPERATOR
ELEMENT TIME
WORK ELEMENTS
HANDWORK MACHINE WALKING
DIAGRAM
24
1 LOAD VANES 2 SET VANES 3 SET INNER RING AND LOAD TAB ROLLER 4 LOAD / UNLOAD WASHER 5 SET PUMP TO SHIPPING RACK
2.8 7.1
34.0 0.6 0.7
8.3 2.9 3.5 2.9 1.2 5.6
PIERCE FINISHED PUMP STOCK
Can you Improve this work cell ?

WASHER VANER
5
A
41 Sec. 34 Sec.
22.9 34.0
12.7 4.9
J.E.S. LOCATION:
POSTED AT OPERATOR WORK STATION SAFETY AUDIT QUALITY AUDIT W.P.O. MATERIAL HANDLING DATA
OTHER ACTIVITIES
VERIFY LIGHT CURTAINS AT BEGINNING OF SHIFT PERFORM GAGING AS STATED IN THE CONTROL PLAN PERFORM AUDIT AT BEGINNING OF SHIFT PUSH FINISHED PRODUCT TO NEXT OPERATION EVERY 64 PARTS
CONTROL BLOCK
ASSIGNED OPERATORS 1ST SHIFT 2ND SHIFT ROBERT ADAMS SAM BATES TRAINING DATE 1/12/04
SAFETY REQUIREMENTS
SAFETY GLASSES
SUPPLEMENTAL EMPLOYEES 1ST SHIFT 2ND SHIFT Tom Smith Patricia Knoles
TRAINING DATE 6/05/03 1/12/04
KEVLAR GLOVES STEEL TOE SHOES
RECORDING
RECORD DOWNTIME, POST PERFORMANCE DATA TO TEAMBOARD AT END OF SHIFT, RECORD SCRAP DATA
OTHER
LOAD VANES TO VANER EVERY 40 CYCLES
66
(Example)
TORQUE CONVERTER OP. A PUMP VANE SETTER
PROCESS NAME:
PUMP-A & TURBINE-A

QUALITY CHECK
ELEMENT TIME
SAFETY
ERGO
WORK ELEMENTS
HANDWORK MACHINE WALKING
DIAGRAM
IN PROCESS STOCK
NO.
OPERATOR
24
1 LOAD VANES 2 SET VANES 3 SET INNER RING AND LOAD TAB ROLLER 4 LOAD / UNLOAD WASHER 5 SET PUMP TO SHIPPING RACK
2.8 7.1
34.0 0.6 0.7
8.3 0.9 3.5 0.9 1.2 1.8
FINISHED PUMP STOCK
WASHER
4
A
3 1 2
PIERCE
VANER
41 Sec. 34 Sec.
22.9 34.0 4.9 4.9
OTHER ACTIVITIES J.E.S. LOCATION:

POSTED AT OPERATOR WORK STATION SAFETY AUDIT QUALITY AUDIT W.P.O. MATERIAL HANDLING DATA RECORDING
VERIFY LIGHT CURTAINS AT BEGINNING OF SHIFT PERFORM GAGING AS STATED IN THE CONTROL PLAN PERFORM AUDIT AT BEGINNING OF SHIFT PUSH FINISHED PRODUCT TO NEXT OPERATION EVERY 64 PARTS
CONTROL BLOCK
ASSIGNED OPERATORS 1ST SHIFT 2ND SHIFT ROBERT ADAMS SAM BATES TRAINING DATE 1/12/04 1/12/04
SAFETY REQUIREMENTS
SAFETY GLASSES
RECORD DOWNTIME, POST PERFORMANCE DATA TO TEAMBOARD AT END OF SHIFT, RECORD SCRAP DATA
SUPPLEMENTAL EMPLOYEES 1ST SHIFT 2ND SHIFT Tom Smith Patricia Knoles
TRAINING DATE 6/05/03 1/12/04
KEVLAR GLOVES STEEL TOE SHOES
OTHER
LOAD VANES TO VANER EVERY 40 CYCLES
Standardized Work provides a basis for effective Operator Instructions.

OPERATOR INSTRUCTIONS
Where to use operator instructions? Operator instructions are commonly available for: manufacturing and assembly inspection and data collection pack out laboratory
Often overlooked activities include: offline rework and containment set-up and change-over events prototype and engineering activities process labeling points material handling shipping and receiving maintenance/repair office
68
Best Practices Operator Instruction Format:

Short descriptions of how to perform EVERY step necessary to complete the required work (bullet format). Instructions for individual stations: minimal in length, specific and concise. Photos or graphics which enhance and explain work requirements to indicate: part orientation/nesting - critical characteristics cosmetic features - assembly detail inspection points on the part - gages all applicable labels - packaging machine settings and/or messages any required safety equipment
Translations for any prominent language spoken by the operators .

Best Practices Operator Instructions Content :

operator safety issues and required safety equipment. work elements and sequence of events performed by operator. start-up procedures. change-over procedures. shutdown procedures. quality checks and data collection points (SPC, etc.). inspection frequencies. standard work-in-process quantities (standard packs). reaction plans for common and special cause events. machine/equipment settings and messages.
Note: Where appropriate operator instructions can be linked to other operator instructions such as labeling, inspection, gaging and packaging.
Best Practices Operator Instructions:

Operator Instructions shall, when appropriate, be updated as a process or product change occurs. Operator Instructions should be: developed by multi-disciplinary teams. developed from Standardized Work Instructions*. used for Standardized Operator Training*. used as a template for new programs.
Operator Instructions are an indicator of a world class organization.
71
Rev. Date: mm-dd-yy
JOB ELEMENT SHEET

Area/Cell/Department: Operation Number: Process/Part Name:
Page:
# of ##
Control Block
(Example)
Label boxes for the pictures. Use to reference appropriate key point or step.
Space to add photographs, drawings or sketches.
SEQ
- STEP (What) THE " WHAT"IN THIS SECTION IS THE LIST OF ALL THE MAJOR STEPS OF THE OPERATION SEQUENTIALLY IN THE LEFT HAND COLUMN. EACH STEP SHOULD BE AN ACTION NECESSARY FOR ADVANCING THE ELEMENT TO ITS SUCCESSFUL COMPLETION.
SYM
- KEY POINT (How) THE "HOW" PART OF THE DOCUMENT. IS ASSOCIATED WITH THE STEPS AND IF THERE IS SOMETHING THAT NEEDS TO BE EXPLAINED REGARDING SAFETY/ERGONOMICS, QUALITY/KNACKS, THEY ARE EXPLAINED AND IDENTIFIED BY THE APPROPRIATE SYMBOL IN THE COLUMN. KNACKS ARE KEY POINTS WHICH MAKE A JOB PERFORMANCE EASIER (TRICKS, PERCEPTIONS, SPECIAL KNOWLEDGE, ETC). CRITICAL OPERATIONS SHALL BE IDENTIFIED.
REF
- REASON (Why) IN THIS AREA WE EXPLAIN WHY A KEYPOINT OR STEP IS IMPORTANT AND WHAT HAPPENS IF THIS POINT IS IGNORED. IT ALSO MAKES THE JOB MORE MEANINGFUL.
Symbol Legend (SYM):
Safety
Ergonomics
Quality
K Knack
C Critical
File/Ref:
72
Rev. Date: 5/15/03 Shift Control Block Team Leader
JOB ELEMENT SHEET

Supervisor/Group Leader Date Area/Cell/Department: Operation Number: Process/Part Name: NO. 2A
Page: 1of 1 FINAL DRIVE N/A HEAVY DUTY/VOLVO UNLOAD
1 2 3
(Example)
SEQ
- STEP (What) -
SYM
- KEY POINT (How) 1A USE BLUE VINYL GLOVES 1B REMOVE ALL TAGS, STICKERS AND DEBRIS 1C SET ASIDE DAMAGED OR DIRTY DUNNAGE
REF
- REASON (Why) 1A CUSTOMER DEMAND 1B PROPERLY IDENTIFIED ASSEMBLIES TO CUSTOMER 1C REDUCE SEDIMENT LEVELS 2A PROPERLY IDENTIFIED ASSEMBLIES TO CUSTOMER NUMBERS 3 THROUGH 9 ARE THE ONLY ONES ACCEPTED BY OUR CUSTOMER. OTHERS ARE TO BE PUT INTO REJECT BUGGY 3A OBTAINS "PARK" STATUS IN AUTOMOBILE 4A ALLOWS FINAL DRIVE ASSEMBLY TO BE INSTALLED INTO TRANSMISSION CASE AT ASSEMBLY PLANTS 5A REDUCES BODY STRAIN
1 VISUALLY INSPECT DUNNAGE
2 VISUALLY INSPECT ASSEMBLY AND WRITE

CORRESPONDING STACK HEIGHT NUMBER ON INTERNAL GEAR. ONLY #'s 3 THROUGH 9 ARE TO BE USED
2A ENSURE CORRESPONDING INKJET INFORMATION IS CORRECT WITH STACK HEIGHT NUMBERS WRITTEN IN WHITE ON HEAVY DUTY, PINK ON VOLVO AND A YELLOW DOT ON VOLVO INTERNAL 3A ACKNOWLEDGE SPRING TENSION AND WINDOW CLEARANCE
3 DEPRESS PARK LOCK PAWL INTO PARKING

GEAR
4 INSERT SHORT END OF SHIPPING PIN INTO

INTERNAL GEAR PIN HOLE, LONG END LOCKING PARK LOCK PAWL IN POSITION
K 4A TURN INTERNAL GEAR WHILE DEPRESSING

PARK LOCK PAWL UNTIL PARK LOCK PAWL ADVANCES INTO FULL DEPTH 5A INSERT UNLOAD ASSIST DEVICE INTO THE SUN GEAR SHAFT AND LIFT FINAL DRIVE ASSEMBLY INTO THE BASKET USING THE "UP" AND "DOWN" CONTROL LEVERS 5B LOWER ASSEMBLY CAREFULLY INTO DUNNAGE,
5 REMOVE ASSEMBLY FROM LINE AND LOAD

INTO CORRESPONDING DUNNAGE
5B PREVENT BEARING FRACTURE
Symbol Legend (SYM):
Safety
Ergonomics
Quality
K Knack
C Critical
File/Ref:ES-705-FAHDVU
73
BENEFITS OF STANDARDIZED OPERATIONS

Workplace Organization: clean machines perform better. supports part cleanliness and improves quality. optimizes workspace flow and reclaims wasted floor space. improves employee's performance, attitude and focus on quality. reinforces organization's commitment to customer satisfaction. Standardized Work: process improvements are easily identified. safety, quality and labeling points are included. operator training simplified and consistent. assures operator is following approved process (Layered Process Audits)*.
BENEFITS OF STANDARDIZED OPERATIONS

Operator Instructions: promotes safety and quality consciousness. minimizes missed steps in the process. - operations - omitted or incorrect components - quality checks - labeling increases the operator's level of understanding.
standardizes operator training process.
75
STANDARDIZED OPERATIONS SUMMARY

Organizations shall
utilize a systematic approach to implement and maintain Workplace

Organization.
develop and implement Standardized Work Instructions using multidisciplinary teams.
include work elements, operator movements and operation cycle time

in Standardized Work Instructions.
train impacted and new employees in the use of Standardized Work

Instructions (Standardized Operator Training)*.
post Standardized Work Instructions at all operations. utilize a systematic approach to develop Operator Instructions for all
work.
verify, (Layered Process Audits)* maintain and update operator

instructions as processes/parts change.
STANDARDIZED OPERATOR TRAINING

Was Operator training verified and documented?
77

Standardized Operator Training shall be used to: define the minimum training content for each operation. identify who in the organization will conduct training. establish required documentation and tracking methods.
Trainers shall monitor new operators activities and retrain if
necessary to assure Standardized Work Instructions are being followed. Trainers shall instruct operators using the standard operation training record.
The trainer shall notify downstream operations of potential defects.
78
Operation Name and # ___________________
Standardized Operation - Training Record Review

Safety/ Equipment Operation
Review operator job instructions/ Discuss critical points Explain and demonstrate Standardized Work Instructions Quality records to be filled out (eg. Check sheets) Part (product) function Demonstrate the operation and answer questions
(Example) Complete
Application: The following shall be completed with any new operator (for any given operation).
Demonstrate gaging and answer questions

Have new employee run operation and answer questions Teach past problems (eg. FMEA, Top Problems List) Verify first units produced, coach as needed Return within the shift, verify std work & product quality again Return in approx. 1 day, verify std work & product quality again Notify downstream operations of potential defects
Employee Signature _______________

Trainer Signature _______________

Standardized Operation - Training Record

Training Sign - Off Sheet
(Example)
Mold / Station # Associate Name:
Workcell Shift: Date:
Training Criteria SAFETY

Fire Exits / Extinguisher Location Safety Glass Policy Personal Protective Equipment MSDS Location
Associate Initials
Trainer Initials
Comments
QUALITY
Gate trimming Technique Visual Defects Scrap Procedure
PAPERWORK
Production reporting Scrap Reporting Bar Code Scanning / Label Verification
OPERATIONS
Operator 1 Work Instructions - Min. 16 Hrs. Operator 3 Work Instructions - Min. 16 Hrs. Packaging Requirements (Regular / Service)
WORKCELL ORGANIZATION
5S Responsibilities Supply Cabinet Location / Contents Work Cell Board Review
Employee Signature Date: Form Ref: Rev.#
Trainer Signature Date: Date:
80
REQUIREMENTS (continued): The trainer shall verify quality at a frequency determined necessary to assure all standards are met. At a minimum the trainer shall return within the shift and again within approximately one day. Operator training shall be tracked on Trained Operator Tracking Sheets. Operator Tracking Sheets shall be posted at each operation and verified through Layered Process Audits. Scheduling of refresher training for assigned operators is at local site discretion. Supplemental employees shall not perform the job unless they have been trained within the last three months.
81
(Example)
LATEST Job Instructions Rev. Date
TRAINED OPERATOR TRACKING

Operation Name/# CNC OPERATORS
SOP- 3510 QAL-23 SOP- 3510
1/1/2004 9/23/2004 10/13/2004
LATEST TRAINING DATE AND TRAINER INITIALS

SOP-3510 QAL-23 SOP-3510
DEPT. ASSIGNED EMPLOYEE Burns, J. Smith, K. Underwood, L. Whithers, A.
1/02/04 J.M. 9/23/04 K.T. 10/14/04 J.M 1/02/04 J.M. 9/23/04 K.T. 1/02/04 J.M. 9/23/04 K.T. 10/14/04 J.M 1/02/04 J.M. 9/23/04 K.T. 10/14/04 J.M
SUPPLEMENTAL EMPLOYEE Brown, L 1/02/04 J.M. 9/23/04 K.T. Troy, P. 1/02/04 J.M. 9/23/04 K.T. 10/14/04 J.M
82
TRAINING / FLEXIBILITY CHART

Author: Group: Job Number
(Example)
Issue Date Team #
Name (Write Position if not T/M)
% of group that # of 3/4 reached circle jobs Check jobs / per person here if person to meet target is target rotation plan met (% of boxes Req'd Actual checked)
Job Name
# of people at 3/4 circle per job to meet coverage requirements Check here if target is met
Plan Actual
Know s Steps - In Training Can perform w ithout supervision Can teach
% of group that reached coverage target (% of boxes checked)
Can teach and do repairs
83

BENEFITS: Assures all operators have adequate and similar training.
Assures unqualified operators receive training prior to operating equipment.

Reduces sort, rework and containment activities. Communicates operator status to all stakeholders.
84
STANDARDIZED OPERATOR TRAINING SUMMARY

Organizations shall
ensure operator training is being tracked on Trained Operator Tracking Sheets. post operator Tracking Sheets at each operation.
notify downstream operations of new operators.

train Supplemental employees who have not performed the job within the last three months.
85
RISK REDUCTION PROCESS

PROACTIVE
RPN REDUCTION PROCESS: Reducing the risk of a POTENTIAL QUALITY FAILURE
REACTIVE
ERROR PROOFING PAST QUALITY FAILURES
86
PROCESS FAILURE MODE & EFFECTS ANALYSIS (PFMEA)

DEFINITION
An analytical technique for each process step that identifies: ways a process may fail to meet requirements. consequences to the internal / external customer (severity). frequency the failure will/could happen (occurrence). effectiveness of current controls (prevention & detection). ranking of causes and effects (risk priority number). A structured procedure for identifying and eliminating process related failure modes.
87
PROCESS FAILURE MODE & EFFECTS ANALYSIS

(Example)
What can go wrong?
15xxxxx
How does it affect customer?
PO T E POTENTIAL N T IAL F AILURE FAILURE M O DE MODE AN D AND E F FEFFECTS E CT S ANANALYSIS ALYSIS (PRO (PROCESS CE SS F M E FMEA) A)
REV'D DATE : FMEA DATE : FMEA CONDUCTED BY :
How likely are we to notice if this happens?

B/P Level: 001, 7-NOV-02
MODEL YEAR / CARLINE : PRODUCTION PLANT :

C L A S S
PROCES S NAME/ NUMBER
PROCESS FUNCTION
POTENTIAL POTENTIAL EFFECT(S) OF FAILURE MODE FAILURE
S E V
POTENTIAL CAUSE(S)/ MECHANISM(S) OF FAILURE
O C C
CURRENT CONTROLS
PREVENTION
DETECTION
D E T
R P N
ACTION RESULTS RESPONSIBILI RECOMMENDED TY & TARGET S O D ACTION(S) COMPLETION ACTIONS E C E DATE TAKEN V C T
R P N
10
Install Incorrect pilot part bearing installed
Misbuild: 7 part does not function. 7
Manual: incorrect part selected Machine Vision ID Incorrect
7 No
No 10 490 Sensor to prevention detection detect
Shad, B. 3/1/02 7 7 4 146
bearing type 3 No In-line prevention Audits 6 126 New Laser NA Station.

7 3 2 42
20
Correct Incorrect unable to subor install assy reversed subassembly
How often does this cause happen? (AIAG PFMEA Third Edition)
How high is the risk?
SEVERITY RANKINGS
Effect Hazardous without warning Hazardous with warning Very High Criteria: Severity of Effect This ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. The final customer should always be considered first. If both occur, use the higher of the two severities. (Customer Effect) Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation without warning. Very high severity ranking when a potential failure mode affects safe vehicle operation and/or involves noncompliance with government regulation with warning. Vehicle/item inoperable (loss of primary function). Criteria: Severity of Effect This ranking results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. The final customer should always be considered first. If both occur, use the higher of the two severities. (Manufacturing/Assembly Effect) Or may endanger operator (machine or assembly) without warning. Or may endanger operator (machine or assembly) with warning. Or 100% of product may have to be scrapped, or vehicle/item repaired in repair department with a repair time greater than one hour. Or product may have to be sorted and a portion (less than 100%) scrapped, or vehicle/item repaired in repair department with a repair time between a halfhour and an hour. Or a portion (less than 100%) of the product may have to be scrapped with no sorting, or a vehicle/item repaired in repair department with a repair time less than a half-hour. Or 100% of product may have to be reworked, or vehicle/item repaired off-line but does not go to repair department. Or the product may have to be sorted, with no scrap, and a portion (less than 100%) reworked. Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on-line but out-ofstation. Or a portion (less than 100%) of the product may have to be reworked with no scrap, on-line but in-station. Or slight inconvenience to operation or operator, or no effect. Ranking 10
High
Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied.
Moderate
Vehicle/item operable but Comfort/Convenience inoperable. Customer Dissatisfied.
item(s)
Low
Vehicle/Item operable but Comfort/Convenience item(s) operable but at a reduced level of performance. Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by most customers (greater than 75%). Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by 50% of customers. Fit and Finish/Squeak and Rattle item does not conform. Defect noticed by discriminating customers (less than 25%. No discernible effect.
Very Low Minor
4 3
Very Minor None
2 1
(AIAG PFMEA Third Edition)

OCCURRENCE RANKING
Probability Likely Failure Rates PpK Ranking
< 0.55 > 0.55 > 0.78 > 0.86 > 0.94 > 1.00 > 1.10 > 1.20 > 1.30 > 1.67 10 9 8 7 6 5 4 3 2 1
Very High: Persistent Failures > 100 per Thousand Pieces 50 per Thousand Pieces High: Frequent Failures 20 per Thousand Pieces 10 per Thousand Pieces Moderate: Occasional Failures 5 per Thousand Pieces 2 per Thousand Pieces 1 per Thousand Pieces Low: Relatively Few Failures 0.5 per Thousand Pieces 0.1 per Thousand Pieces < 0.01 per Thousand Pieces Remote: Failure is Unlikely
Detection
Criteria
Manual Inspection
Error Proofed
Gauged
Rating
DETECTION RANKINGS
X X X X X X
Suggested range of detection methods
10
Almost Impossible Very 9 Remote 8 7 6 5 Remote Very Low Low Moderate
Absolute certainty of non-detection. Controls will probably not detect. Controls have poor chance of detection. Controls have poor chance of detection. Controls may detect. Controls may detect. X
Cannot detect or is not checked. Control achieved with Indirect or random checks only. Control is achieved with visual inspection only. Control is achieved with double visual inspection only. Control is achieved with charting methods, such as SPC. Control is based on variable gauging after parts have left the station, or go/no-go gauging performed on 100% of the parts after parts have left the station. Error detection in subsequent operations, OR gauging performed on set-up and first piece check (for set-up causes only). Error detection in station, OR error detection in subsequent operations by multiple layers of acceptance: Supply, select, install, verify. Cannot accept discrepant part. Error detection in-station (automatic gauging with automatic stop feature). Cannot pass discrepant part. Discrepant parts cannot be made because item has been error proofed by process/product design.
Controls have a Moderately 4 good chance to High detect. Controls have a 3 High good chance to detect. 2 1 Very High Certain Controls almost certain to detect. Controls certain to detect.
X X X

RISK PRIORITY NUMBER (RPN)

Risk Priority Number (RPN) is the result of Severity, Occurrence and Detection rankings.
PO T E N T IAL Severity x Occurrence x Detection = RPN F AILURE M O DE AN D E F F E CT S AN ALYSIS (PRO CE SS F M E A)
REV'D DATE :
15xxxxx
MODEL YEAR / CARLINE : PRODUCTION PLANT :

C L A S S
FMEA DATE :
(Example)
D E T R P N
FMEA CONDUCTED BY :
PROCESS NAME/ NUMBER
PROCESS FUNCTION
POTENTIAL POTENTIAL EFFECT(S) OF FAILURE MODE FAILURE
S E V
POTENTIAL CAUSE(S)/ MECHANISM(S) OF FAILURE
O C C
CURRENT CONTROLS
PREVENTION
DETECTION
10
Install Incorrect pilot part bearing installed
Misbuilt, part doesn't function Loss of Engine Power; Engine
Manual: incorrect part selected Machine Vision ID Incorrect
7 No
No 10 490 prevention detection
20
Correct Incorrect Assy - Piston or piston reversed QSB WORKSHOP REV. 062705 and rod piston
3 No
In-line prevention Audits
6 126
92
PFMEAs shall be completed for all manufacturing processes and support functions as required by the Quality Management System. Support functions include: (receiving inspection, material handling, labeling, shipping, repair, rework, etc). PFMEAs shall: conform to current AIAG guidelines and customer requirements. be updated on a regular basis (living documents). exist for all product lines / part numbers. include all processes and process steps. be utilized for Continual Improvement. have accurate Severity/Occurrence/Detection ratings.
93
Multi-disciplinary teams shall perform periodic PFMEA Reviews. The frequency and/or number of PFMEA reviews shall be determined by supplier leadership based on: customer expectations (PR/Rs, DDW, Launch activities, etc) process capability (FTQ, SPC, etc)
changes to the process (Error proofing, Tier 2 changes, etc)

Criteria to prioritize which PFMEA to review include:
product from an acquisition, tool move or change in supplier.

PFMEA developed without adequate cross-functional involvement. PFMEA for part(s) with history of PR/R, Customer complaints, Warranty or FTQ issues.
Occurrence ratings (FTQ, scrap, etc) have changed significantly.

PFMEA with oldest revision dates.
PFMEA Review shall include the following at a minimum: verification that all operations/processes are included and accurate (paint, heat treat, material handling, labeling, etc). all process controls are included. Detection ratings are accurate. Occurrence ratings are analyzed using data (SPC, FTQ, Quality Gate, C.A.R.E.*, Scrap, Layered Process Audits* results, etc). verification that the PFMEA meets customer requirements and expectations (AIAG, PPAP, Launch, DDW, etc). Upon completion of the review, a list of the highest (RPN) Risk Reduction opportunities is established or revised based on the new data.
An action plan or equivalent shall be utilized by the multi-disciplinary team to track progress in reducing the RPN ratings.
RPN TRACKING CHART

(Proactive)
No. OP No. Function & Failure Mode RPN Value Who Recommended Actions SENSOR TO DETECT BEARING TYPE
(Example)
Completion Revised Date RPN
10
INCORRECT BEARING INSTALLED INCORRECT OR REVERSED SUBASSEMBLY
490
B. SHAD
12/1/2004
112
20
126
N. ADAMS
INSTALL LASER STATION
12/31/2004
42
50
HOLE MISSING
168
INSTALL POST ON ASSEMBLY S. BROWN FIXTURE 12/23/2004
42
60
INCORRECT LABEL
112
V. WAGNER
IMPLEMENT SCANNER
1/30/2005
21
The number of RPN reduction opportunities on the list is dependent on complexity of parts and process, size of plant, customer feedback, etc
96
(Example: GM form1927-21)
(This is for reference only; check for latest revision)

REACTIVE RISK REDUCTION: ERROR PROOFING PAST QUALITY FAILURES

Multi-disciplinary team(s) shall be utilized to develop a list of the past internal and external quality failures.
Team(s) identify true PFMEA Severity, Occurrence and Detection rating for each RPN using AIAG guidelines.
Team(s) shall develop an action plan to Error Proof the failures. Recommended Actions are improvements that will prevent or reduce the Failure Mode. When Error Proofing is not feasible, a plan to improve detection shall be established.
A team member shall be assigned responsibility for implementing the recommended action.
Reasonable target completion dates shall be established.
REACTIVE RISK REDUCTION: TOP FAILURES LIST

(Example)
QUALITY FAILURES
# of Issue # Proplem Discription Occurances ICA-04-01 WRONG FITTINGS INSTALLED 21 CA-04-12 NUT LOOSE / UNDER TORQUED 10 CA-04-04 O'RING SEAL CUT/DAMAGED 8 ICA-04-09 SPRING OMITTED 8 ICA-04-15 ASSEMBLY DAMAGED BY IMPROPER HANDLING 5 CA-04-02 SEAL MISLOCATED, OMITTED OR EXTRA 5 CA-04-05 SENSOR DAMAGED / BROKEN 4 CA (EXTERNAL) ICA (INTERNAL) Last Cost Per Occurance Occurance 9/23/2004 $940 11/4/2004 $950 11/11/2004 $1,165 10/30/2004 $457 12/31/2004 $1,500 12/4/2004 $864 11/11/2004 $453
99
REACTIVE RISK REDUCTION: ERROR PROOFING PAST QUALITY FAILURES

Error proofing shall be verified per the Error Proofing Verification* process.
When corrective actions have been implemented, teams shall
validate the new Occurrence and Detection rankings and resultant RPN.
Teams shall update PFMEAs with all corrective action measures.
100
RISK REDUCTION
SITE LEADERSHIP:
should review the need for PFMEA training at least once per year. shall support RPN reduction activities and provide necessary resources. shall review the RPN reduction tracking charts. shall ensure that formal multi-disciplinary teams are utilized in the preparation and ongoing review of PFMEAs.
101
Risk Reduction
BENEFITS:
Supports continual improvement as expected by TS16949. Allows leadership to allocate limited resources to critical areas. Provides a basis for effective error-proofing and problem solving. Core tool for APQP and PPAP requirements. Provides a Lessons Learned* archive. Promotes cross-functional teamwork. Meets customer expectations for living documents.
102
RISK REDUCTION SUMMARY

PROACTIVE Leadership shall support RPN reduction activities and provide necessary resources. PFMEAs shall undergo a complete review. A list of the highest (RPN) Risk Reduction opportunities shall be established. An action plan or equivalent shall be utilized by the multi-disciplinary team to track progress in reducing the RPN ratings. REACTIVE A list of the past internal and external quality failures shall be established. Team(s) shall develop an action plan to Error Proof the failures.
ERROR PROOFING VERIFICATION

Was error proofing verified?
104
ERROR PROOFING / DETECTION DEVICE FUNCTIONING

Failure mode: Burr Cause: dull tool
Severity: Occurrence: Detection:
Defect caught at GM Assembly Line (scrap): Supplier process PpK > 1.10 Error detection device in process
5 4 3
RPN = 5 x 4 x 3 = 60 ERROR PROOFING / DETECTION DEVICE FAILS

Failure mode: Burr Cause: dull tool
Severity: Defect caught at GM Assembly Line (scrap): 5 Occurrence: Supplier process PpK > 1.10 4 Detection: Error detection device not functioning 10
RPN = 5 x 4 x 10 = 200

All error proofing/detection devices with the potential to fail, wear, misalign, or otherwise become out-of-adjustment shall be verified at a minimum of once per day. Note: This is not mastering a gage, (e.g. Setting gage to zero) It is sending known good & bad parts through to confirm the device is operating correctly. .
DEFINITIONS:
Error Proofing Device (CAN NOT MAKE) - Devices which prevent the manufacture or assembly of nonconforming product. Error Detection Device (CAN NOT PASS or CAN NOT ACCEPT) Devices which prevent the transfer of nonconforming product (e.g. 100% in-line inspection equipment).

ERROR PROOFING DEVICES SHALL BE VERIFIED AND THEIR RESPECTIVE LOCATIONS DOCUMENTED
Master Document of Error Proofing devices, with identification number and location Verification frequency Identify masters (Good/Bad) and defect being checked
REACTION PLANS SHALL BE DEVELOPED TO FOLLOW WHEN THE ERROR PROOFING DEVICES FAIL VERIFICATION
Clearly defined reaction plan if device fails to detect When/if shut down when device fails to detect bad part? Containment plan? (100% Inspection, etc.) Are suspect parts rerun thru Error Proofing device? How/when is Error Proofing device repaired? Lot size of parts run between Error Proofing verification History of process to determine verification frequency How robust is the process? How easy is it to contain suspect product?
ERROR PROOFING DEVICES SHALL BE VERIFIED ONCE per DAY
VERIFICATION RESULTS SHALL BE RECORDED WITH IMMEDIATE RESPONSES TO FAILURES
Develop Log of Error Proof Verification failures with reaction plan to nonconformities Develop form to notify of nonconformities and escalate reaction to nonconformities Document as Lessons Learned Method for getting information to management Determine how information is to be displayed
VERIFICATION RESULTS SHALL BE REVIEWED BY SITE LEADERSHIP
107
(Example)
ERROR PROOFING VERIFICATION CHECKLIST
SNAP RING PRESENCE op# OP 30 OP 30 OP 30 OP 30 OP 40
SHIFT: DATE:
YES NO
THESE ITEMS ARE TO BE CHECKED DAILY 4 5 6 7 8 9

OPERATE L&R SNAP RING INSTALLATION TOOL WITHOUT SNAP RING - IS PART REJECTED ? DID RED LIGHT ON LIGHT TREE TURN ON ? (L&R) DID REJECTED PART STAY IN STATION ? (L&R) DID ANDON ALARM SOUND? (L&R) OPERATE SMALL SNAP RING INSTALLATION TOOL WITHOUT SNAP RING - DID GAGE REJECT PART ? DID RED LIGHT ON LIGHT TREE TURN ON ? (SMALL SNAP RING)?
Code
4 5 6 7 8 9 10 11 182 15 12 13 14 YES NO
10 DID REJECTED PART STAY IN STATION? (SMALL SNAP RING) 11 DID ANDON ALARM SOUND ? (SMALL SNAP RING)? 12 DOES PART STILL STAY IN STATION WHEN HAND VERIFICATION TOOL DISPLAYS A RED REJECT LIGHT? 13 IS SMALL SNAP RING VISUAL IN PLACE ? 14 IF SMALL SNAP RING TOOL IS DOWN, IS THE BACK-UP GAGE USED? 15 DOES BACK-UP GAGE REJECT PART IF NO SNAP RING IS PRESENT? 16 DOES THE LIGHT TURN RED? (SMALL SNAP RING BACK-UP)?
SUPERVISOR:
TOTAL # OF X'S IN EACH COLUMN

AUDITOR:
ANY ITEM SHADED NOT WORKING PROPERLY, THE SUPERVISOR MUST BE NOTIFIED IMMEDIATELY. ANY ITEM OUT OF COMPLIANCE SHOULD BE REVIEWED WITH SUPERVISOR OR A COPY OF THE AUDIT GIVEN TO SUPERVISOR.
(Example)
DEPT.____________
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
ERROR PROOFING VERIFICATION RESULTS
JAN % IN COMPLIANCE: # OF ITEMS ON CHECKLIST: # OF VERIFICATIONS TOTAL # OF ITEMS VERIFIED: # OF ITEMS IN COMPLIANCE:
FEB
MAR
APR
MAY
JUNE
JUL
AUG
SEP
OCT
NOV
DEC
ITEMS NOT IN COMPLIANCE
NUMBER OF ITEMS NOT IN COMPLIANCE
109

BENEFITS:
Assures error proof/detection devices are working as intended. Prevents nonconforming product from being made or transferred. Establishes a history for each device; indicates when preventative maintenance or repair is needed. Instills discipline within the process.
110
ERROR PROOFING VERIFICATION SUMMARY

Error proofing devices shall be verified at least once per day.
Error Proofing device locations shall be documented.

Reaction Plans to failures shall be developed. Verification results shall be recorded. Leadership shall review verification results.
111
LAYERED PROCESS AUDITS

Were Leadership Layered Audits Performed?
112

Layered Process Audits provide a system to: - verify compliance to the documented process. - instill discipline. - improve communication. - improve overall quality. Layered Process Audits are becoming an industry standard. Layered Process Audits must be owned by manufacturing leadership. Quality and other functions will participate and support the Layered Process Audits system.
113

At a minimum of once per shift, Layered Process Audits shall be conducted on high risk items throughout the manufacturing, assembly,and associated processes.
Frequency of Layered Process Audits is based on production volume and the level of risk of the process and associated procedures. Layered Process Audits supplement ongoing control plan and job instruction checks.
114

Develop a checklist:
A list of high risk items to be verified during Layered Process Audits shall be established. Possible elements to consider include: Gages functioning and calibration confirmation Stacking/packing techniques Visual aids presence and content Process parameters Work instructions Product identification Torque monitoring (if applicable) Documentation / record completion Customer feedback
Layered Process Audits shall verify appropriate Quality documentation.


Develop a Checklist with Reaction Plan:
Include repetitive nonconformance items from internal audits (process, safety, housekeeping, management walk through, etc) on the Layered Process Audits checklist.
Questions should be direct and simple in nature.

Phrase questions so yes indicates conformance. Layered Process Audits results shall be recorded.
Nonconformities shall be addressed immediately.

Reaction plan(s) for nonconformities detected during Layered Process Audits shall be documented and available for use. Corrective actions shall be documented.
116
LAYERED PROCESS AUDIT CHECKLIST

(Example)
DATE SHIFT
LAYERED AUDIT REACTION PLAN

OPERATION
LAYERED AUDIT CHECKLIST

REACTION CODE
op# ITEM #
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 26 27 28 29 30
ITEMS TO BE CHECKED DAILY
REACT CODE YES NO
Reaction Step
01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
TOTAL NUMBER IN EACH COLUMN
29 30
117
LAYERED PROCESS AUDITS CHECKLIST

(Example)
LAYERED PROCESS AUDIT CHECKLIST
SHIFT: WEEK ENDING:
1st
FRI SAT N/C
Op # 30 Assembly Are the builders checking rotation and marking parts (touch point)? Have the parts been inspected for presence of 8 holes and identified with orange marker? Systemic Are the operator verification sheets completed daily by all shifts ? Are the tagging procedures being followed? Are the posted Temporary Alert Notices current?
CODE
MON TUES WED THUR
3 3
Y N
N N
N Y
Y Y
Y Y
Y Y
2 2
CODE
MON TUES WED THUR
FRI
SAT
N/C
1 1 2
TOTAL NONCONFORMING
N Y Y
N Y Y
N Y Y
N Y Y
Y Y Y
FRI
Y Y Y
SAT
4 0 0
WK TOT
MON TUES WED THUR
RECORD ACTIONS TAKEN ON BACK OF SHEET
LIST ANY QUALITY OR MANUFACTURING CONCERNS ON ALL OPERATIONS.

AREA IS CONGESTED. HOUSEKEEPING INSTRUCTIONS ARE TOO GENERAL.
118
LAYERED PROCESS AUDITS FREQUENCY

Layered Process Audits frequency:
- High risk items shall be verified a minimum of once per shift.

- The manufacturing supervisor shall verify & audit (daily) Quality documentation to ensure that it is being completed by the operators. - The manufacturing area manager shall verify & audit (weekly) that supervisor verification is being completed. - Leadership shall conduct Process Layered Audits assessments periodically (monthly/quarterly).
Operator Supervisor
Manager Site Leader

LAYERED PROCESS AUDITS STRUCTURE

(Example)
LAYERED AUDIT MATRIX FREQUENCY
SHIFT DAILY WEEKLY MONTHLY QUARTERLY
SUPERVISOR
OPERATIONS MANAGER
CORPORATE MANAGER
INSPECTOR
PART/PRODUCT ERROR PROOF VERIFICATION FIRST PIECE APPROVAL STANDARDIZED WORK INSTR. OPERATOR TRAINING POSTED SAFETY LIST COMPLETE PROCESS SET-UP SHEET COMPLETED SPC COMPLIANCE TOOL APPROVAL QUALITY GATE DATA COMPLETE SYSTEM PREVENTATIVE MAINTENANCE CALIBRATION COMPLIANCE LOT TRACEABILITY HOUSEKEEPING VOICE OF THE CUSTOMER 6 PANEL POSTED ACTION PLAN UP TO DATE PRRs POSTED C.A.R.E. DATA POSTED QUALITY GATE BOARD CURRENT
120
PRESIDENT
EXECUTIVE MANAGER
OPERATOR
PLANT MANAGER
QUALITY MANAGER
When appropriate, the Layered Process Audit nonconformance shall be added to the Fast Response* system and/or the C.A.R.E.* checklist.
Layered Process Audit results shall be added to the Lessons Learned* database when appropriate.
Audit results shall be summarized and reviewed by the manufacturing site leadership.
121

(Example)
DEPT._________________
100% 90% 80% 70% 60% 50% 20 40% 30% 20% 10% 0%
JAN FEB MAR APR MAY JUNE JUL AUG SEP OCT NOV DEC
LAYERED PROCESS AUDIT RESULTS

50
47 43 43
45 40 35
27 23 16 16 24 19 22
30 25 20 15 10 5 0
JAN 88% 20 20 400 353 47 FEB 68% 15 9 135 92 43 MAR 95% 20 28 560 533 27 APR 96% 30 15 450 434 16 MAY 97% 20 20 400 386 14 JUNE 84% 10 10 100 84 16 JUL 95% 20 20 400 380 20 AUG 95% 25 20 500 477 23 SEP 94% 20 20 400 376 24 OCT 95% 20 20 400 381 19 NOV 95% 20 20 400 378 22 DEC 89% 20 20 400 357 43
14
% IN COMPLIANCE: # OF ITEMS ON ASSESSMENT: # OF ASSESSMENTS TOTAL # OF ITEMS ASSESSED: # OF ITEMS IN COMPLIANCE: NON CONFORMANCES NON CONFORMANCES Safety Missed Audits 5S Related Product Voice of Customer Systemic Gage Calibration Poke Yoke
10 10 2 10 6 9
8 8 7 4 4 7 5
5 3 7 3 2 1 6
2 2 3 2 2 2 3
NUMBER OF ITEMS NOT IN COMPLIANCE 1 1 1 1 1 3 4 5 2 1 2 2 2 2 2 1 1 1 1 1 3 4 4 4 3 2 2 2 2 2 2 2 5 6 7 5 7
1 1 2 1 2 2 2 8
1 1 3 1 2 2 2 10
1 10 2 10 10 2 2 6
122
LAYERED PROCESS AUDIT SUMMARY

Organizations shall
Designate manufacturing to own and conduct Layered Audits. Develop a check list of high risk items to be verified during audit process. Establish frequency of audits. (High risk items to be audited at a minimum of once per shift). Verify appropriate Quality documentation. Track and review the results of Layered Process Audits.
123
Quality Verification
QUALITY GATES
Data Driven Process Improvement Stations
C.A.R.E.
CUSTOMER ACCEPTANCE REVIEW & EVALUATION
PROTECTING THE CUSTOMER

WHAT ARE QUALITY GATES?

A Quality Gate is a distinct station in the process: where 100% inspection is conducted. an accept/reject decision is made. data collected is utilized for continual improvement. Quality Gates require immediate escalation when gate alarm is reached.
Operator (s) are assigned to Quality Gate stations and are responsible for performing all quality functions as called out in the Operator Instructions* and control plan. NOTE: Operator Training Records Boundary Samples, Safety Bulletins, and Run Rules should also available to the operator at the Quality Gate. Quality Gates use production process metrics in order to signal when special causes occur. First Time Quality (FTQ) Parts per Hour
Why Do We Need Quality Gates?

To provide a systemic approach to reduce process variation. To improve first time quality (FTQ) and process capability by: - promptly identifying special cause variation. - making decisions based on data. - systematically reducing common cause variation. To alert operators of abnormalities.
Where to Place the Quality Gate?

Points in the process or operation where there exists: high risk PRR high RPN low capability (Ppk, Cpk, FTQ) Any operation with a Cpk or Ppk below 1.0 requires 100% inspection Between departments or distinct processes.
QUALITY GATE ROLES & RESPONSIBILITIES

Operator
Performs quality checks. Reacts to nonconformance. Initiates escalation when alarm limits are reached. Reacts to identified discrepancies at the Quality Gate.
Engineer, Supervisor, and Maintenance
Quality Manager
Facilitates the daily Quality Gate meeting. Manages the Quality Gate Problem Solving and follow-up.
Plant Manager (Director of Operations)

Owns the Quality Gate. Develops and promotes problem solving and Error Proofing. Attends Quality Gate review 1 per day.
SIX COMPONENTS OF AN EFFECTIVE QUALITY GATE

Tally Sheet with Alarm Limits
Immediate Action Response Sheet

Overall Defect Chart Top Defect Chart(s)
Problem Solving Sheets

Management Walk-Through/Daily Meeting (Layered Process Audit)*
128
QUALITY GATE BOARD SETUP

(recommended display)
Overall Gate Performance Top Defect Chart
Appropriate Chart For Each Defect
Run Chart p or np Chart u or c Chart Track by shift if appropriate Pareto Analysis Overall Pass Rate, by Shift Individuals or Run Chart (%)
Feedback
C.A.R.E. Functional Test,
Historical Information
Charts, Tally Sheets, Review Sheets, Lessons Learned

Cause and Effect Diagram, Solution Tree, or Common Problem Solving Document Run Rules
PPM, Warranty
Pareto Analysis
Review Response Sheet Sheet
129
Tally Sheet with Action Limits

The Tally Sheet:
records the number of each type of problem by the hour. addresses special cause variation. alerts operator when alarm limit is reached. is located at or near the point of inspection.
1st Hour 2nd Hour 7:00-8:00 5:00-6:00 3rd Hour 8:00-9:00 6:00-7:00 4th Hour 9:00-10:00 7:00-8:00 5th Hour 8:00-9:00 6th Hour 7th Hour 1:00-2:00
(Example)
8th Hour 2:00-3:00 1:00-2:00
#
0 1 2 3
Defectives Gate Alarm 6:00-7:00

4:00-5:00 Misc. Bolt Reject Lash Reject Crank Torque 4 3 3 5
10:00-11:00 12:00-1:00
Total 5 4 3 6
11:00-12:00 12:00-1:00
ll l
ll lll ll l ll lll l Do not call an Alarm
Call an Alarm!
# Defects Per Hour # of Assemblies Off Line
18
130
Immediate Action Response Sheet

Documents response when Alarm Limit is reached. Records immediate actions taken by responders.
NOTE: This sheet is for communication and is not intended to track the problem solving process. (Example)
System Who Called When
3/7/05 8:45 AM
Immediate Action
New Lot of Bolts to Assembly
Break Point Who Answered When

RJ123456 M. Smith 3/7/05 9:00 AM
1 Bolts Breaking J. Smith 2 3 4 5 6
131
Overall Defect Chart

Typically a First Time Quality Chart of percentage good vs. time. Is a report card for the process that is being measured. Should be of greatest interest to the manager. (Example)
First Time Quality - Assembly Process
95 90 85
Implementation of Corrective Action
FTQ%
80 75 70 65 60
Implementation of Quality Gate
May
May
Aug
Sep
Aug
Sep
Nov
Dec
Month
132
Nov
Mar
Mar
Feb
Feb
Jun
Jan
Jun
Oct
Oct
Apr
Jul
Jul
Top Defect Chart (s)

Tracks progress of eliminating common cause variation. Perform a Pareto analysis and develop a control chart for the top 1-5 defects.
Top Defect Chart
7
(Example)
6 5
Number of Defects
Crank Torque
Misc.
Defect Type
Bolt Reject
Lash Reject
133

Communicates the activities of the problem solving process. 8D form Internal corrective action request Drill Deep Analysis/ Worksheet Cause and Effect diagram
Solution Tree
Fast Response Tracking Board PRR Response
134
Management Walk-Through/Daily Meeting

Management shall regularly review the data and the action items. Perform the daily meeting when the gate or process is new. Once the Quality Gate process is institutionalized (verified by Layered Process Audits)*, the meeting can be held on a weekly basis. Management Walk Through shall be done daily. Sign off indicating presence at Management Walk-Through/Daily Meeting
Quality Gate Review For

Title Plant Manager Quality Manager Engineering Manager Maintenance Manager Area Supervisor
3/8/2005
Signature
John Smith Mary Jones Anne Miller Marty Morris Ray Roberts
1. Review the First Time Quality Chart

Is it getting worse, better or staying the same?
FTQ Chart is staying steady.
2. Review Alarms from Previous Day(s)

Was the Immediate Action Response Sheet utilized?
Yes
What were the problem(s)?
Bolts were breaking

Was the response timely?
Immediate Action completed within 15 minutes of the problem discovery

Was the root cause identified?
Root Cause Analysis needs to be performed. - Mary Jones 3/10/05
3. Review the Pareto Chart of Top Defects

What is the Top Defect?
Crank Torque defects
4. Review the Control Charts of Top Defects

Are they getting worse, better or staying the same?
All are staying the same.
5. Review the Problem Solving Documentation and Action Plans

Are there any road blocks that need to be removed?
No
Are there any resources that need to be re-assigned?
No
Quality Gate Information Board
136
ALARM LIMITS
Alarm limits perform two very important functions:
reveal special causes.

provide concrete evidence that a process is stable/unstable. Alarm limits are: Absolute and real numbers, that give us a true reflection of the process. Taken directly from measuring the process daily. Calculated from the actual variation in the process. A statistically valid number that triggers a reaction when reached. When the number of defects found reaches the alarm limit; escalation to initiate the problem solving process begins.
REACTION PLAN
When the Alarm Limit is reached:
Operator immediately initiates escalation.

Engineering, Maintenance and Supervisor immediately responds to identified discrepancies. Initiate containment or immediate action if possible. Establish breakpoint. Note: Immediate Action Notify C.A.R.E.* if necessary.
Response Sheet is the documentation of the above escalation process.
Quality Manager initiates: Verification of Control of Non-Conforming Product. Problem Solving process as required. C.A.R.E.* if necessary. Follow-up activities such as report out at the Fast Response Meeting.
COLLECT DATA:
Samples Defects 1 1 2 0 3 1 4 2 5 0 6 1 7 0 8 0 9 0 10 1 11 2 12 1 13 0 Totals Samples 14 15 16 17 18 19 20 21 22 23 24 25 25 Defects 0 0 1 0 2 0 0 0 1 0 0 1 14
Calculation of Limit Total Defects Total Number of Samples Average Number of Defects Sq. Root of Avg. Defects 3 Times Square Root Adding Avg. Defects + 3 times Sq. Root Alarm Limit
(Example)
14.00 25.00 0.56 0.75 2.24 2.80 3
SCOPE OF CHANGING ALARM LIMITS

Alarm limits are changed only if there is:
an intentional, permanent change in the actual process. or a special cause variation, where despite our best efforts to discover the cause we are unable to make the correction.
QUALITY GATE MAINTENANCE

After implementation is institutionalized (Layered Process Audits)* discontinue daily Quality Gate Meetings and start weekly meetings. After Corrective Actions are in place recalculate alarm limits and change if necessary. When defect rate at Quality Gate decreases, place another gate upstream to further improve the process. Note: If Quality Gates are called out in the control plan, prior customer approval is required for removal or relocation.
140
TYPES OF QUALITY GATES
141
QUALITY GATE DIAGRAM
OP 10 OP 40 CARE
OP 20
QG GP12
QG
OP 30
142
C.A.R.E.
CUSTOMER ACCEPTANCE REVIEW & EVALUATION
Protects your customer from non-conforming product, discrepancies and labeling errors. Verifies that process controls are effective. Provides information for rapid corrective action.
Supplements the approved control plan.

Applies to customer satisfaction items that are part related. The Plant Manager & Quality Manager should facilitate activities.
143
Customer Satisfaction items shall be identified.

Customer Satisfaction Items can include:
Pass-through items Customer/Assembly Plant Feedback Warranty Issues Customer used features Past PR/R issues High RPN Failure modes Labeling Supplier Management Concerns (such as Tier II changes, tool moves)
When practical, Customer satisfaction items, part(s) and/or lot will be marked, touched, gauged or scanned.
144
When a nonconforming part is found:

The alarm limit for C.A.R.E. items is 1. Therefore, the Quality Gate escalation process is initiated as soon as a nonconformance is found. Rework and inspect in the normal process flow (when practical) rather than off-line to ensure specified requirements are met. Offline rework should be approved and included in the part control plan. Rework requires standardized work instructions and inspection. Reworked material must be sent back through C.A.R.E.* Report nonconforming data to Fast Response* Meeting. Add the root cause corrective action to the Layered Process Audit*.
145
GP-12
A process of documenting the organizations efforts to verify control of its processes during start-up, acceleration, and process/part changes.
Assures any quality issues that may arise are quickly identified, contained and corrected at the organizations location and not at the customers receiving location.
Identifies high risk operations providing opportunities for continual improvement. A Quality Gate with an alarm limit of 1. Note: Use GP-12 data and other information to determine placement of other Quality Gates.
QUALITY GATES
BENEFITS:
Protects internal/external customers from defects. Helps decrease common cause and special cause variation. Standardizes reaction to process variation. Verifies process controls are effective. Drives continual improvement. Focuses on customer satisfaction items.
147
QUALITY GATE SUMMARY

Organizations shall:
Implement at least one Quality Gate. Note: GMPT suppliers shall implement C.A.R.E.
Institute 100% inspection.
Take immediate action when alarm limit is reached.

Place Information Board at point of Quality Gate. Implement corrective actions based on Quality Gate data. Conduct regular management walk-through/meetings at the
Quality Gate(s).
148
LESSONS LEARNED
Capitalize on success minimize mistakes
149
LESSONS LEARNED
A Lessons Learned system: establishes a process for capturing information that will support continual improvement to all operations/processes. prevents repeated mistakes allowing an organization to capitalize on its successes. applies to all functions and responsibilities, therefore, everyone in the organization should participate. All documentation that will support continuous improvement shall be entered into a Lessons Learned database. A disciplined approach to problem prevention using Lessons Learned shall be established.
Lessons Learned may be identified by anyone. Most activities within an organization result in prevention of future problems or improving performance. These activities build Lessons Learned.
Examples of activities to Identify Lessons Learned: GM Read Across Matrix Monthly Q-Charts Layered Process Audits Error Proofing Verification Internal Quality Issues Quality Gates (C.A.R.E.) APQP Process Continuous Improvement Teams Problem Solving (PR/Rs, Risk Reduction) Management Reviews Suggestion Programs
151
(example)
READ ACROSS MATRIX
SUPPLIER:
Name: Location: Duns: Contact Name: Contact Phone: E-mail: Eight Week Period:
(Ref. GM 1927-69,PRR Read Across)
SYMBOL & STATUS KEY:

O Original Product line and location
PQE/SQE:
Name: Phone: GM location / Provider Contact Phone: E-mail:
X Product line and/or location with similar process R Repeat Issues N/A Not Applicable Completed & 3rd Party/GM verified Completed & Supplier verified only Not Completed
Due Date:
A.P.Q.P.
Product / Process Classification
Duns #1/ Location
Duns #2/ Location
Part Name & Number
GM Assy. Plant
Customer Concern
Defect on Part
5 Why Analysis
N/C or CS CPV Status
1
Corrective Action
PRR Number / Issue

Containment Technical Root Cause Identified Predict Corrective Action Prevent Corrective Action Protect Corrective Action Key Findings Corrective Action
Corporate Champion
Symbols
Part Name & Number
GM Assy. Plant
Customer Concern
Defect on Part
5 Why Analysis
N/C or CS CPV Status
2
Corrective Action
PRR Number / Issue

Containment Technical Root Cause Identified Predict Corrective Action Prevent Corrective Action Protect Corrective Action Key Findings Corrective Action
Corporate Champion
Symbols
(This is for reference only; check for latest revision)

Lessons Learned shall be documented. Documentation may include: Lessons Learned Form APQP Checklist PFMEA Computer Form or Website, etc
Lessons Learned must be communicated and kept available to all current and potential users. Communication can be performed by: posting the lessons learned form including on a lessons learned website utilizing a company newspaper or closed circuit tv distribution of pocket cards, etc Leadership should review the Lessons Learned process to assure Implementation.
153
LESSONS LEARNED
BENEFITS:
Prevents repetitive mistakes and reduces waste of resources.
Transfers knowledge to all stakeholders in an organization.

Provides a history of activities.
154
LESSONS LEARNED SUMMARY

Organizations shall
empower everyone in the organization to participate in Lessons Learned process. establish a process for capturing Lessons Learned.
establish and institutionalize a system to document Lessons Learned.

establish a disciplined approach to problem prevention using Lessons Learned. review the Lessons Learned process to assure implementation.
KEY STRATEGIES
Fast Response
Control of Non-Conforming Product (Identification) Workplace Organization Standard Operator Training
No Major Disruptions
No PRRS + 0 PPMS = World Class Quality
Risk (RPN) Reduction

Error Proofing Verification Layered Process Audits Quality Gates (C.A.R.E.) Lessons Learned
156
Now that we have discussed QSB
Educators Tell Us We Learn & Understand

10% of what we hear 15% of what we see 20% of what we both see & hear 40% of what we discuss with others 80% of what we experience directly or practice 90% of what we attempt to teach others
157
WORKSHOP
158
WORKSHOP AGENDA NOTES

Workshop time is valuable. Please refrain from spending group time to work on other issues. If the group needs outside resources (HR, IE, etc,), contact those who can help. Contact the Workshop Trainer or Supplier Champion. Results will be delivered to the Top Management of the company during the second day of training. Use this as an opportunity to enhance the procedures already in place and meet all the requirements for each strategy by presenting each teams ideas. The presentations are starting points and will need more development by employees and management as they are implemented. Results that cannot be achieved by the closing meeting, must be included in the QSB Action Plan.
DIVIDING INTO WORKSHOP TEAMS

Form teams of three to five people when possible. If there are not enough people to form nine teams, assign two or three strategies to each team. The following are suggestions on how to pair strategies and assign personnel:
RISK REDUCTION ERROR PROOFING VERIFICATION LESSONS LEARNED OPERATOR TRAINING STANDARDIZED OPERATIONS NONCONFORMING PRODUCT Manufacturing Engineers, Maintenance, Operators, Supervisors, Auditors
Supervisors, Operators, Training or Human Resources, Manufacturing Engineering, Quality Engineer Operations Manager, Quality Manager, Operators
Layered Process Audits Quality Gates (C.A.R.E.) FAST RESPONSE

WORKSHOP TEAM DELIVERABLES

Review the presentation and determine if all SHALLS are presently being met by your systems. Is there a form? How is the requirement being documented? How is the requirement being tracked and analyzed? Is management reviewing the results? How are results communicated to the workforce? Are results posted? Are results discussed in employee team meetings? Has the requirement been included in a QS 9000 procedure? Develop suggestions for forms, tracking methods, management review timing and communication responsibilities. Develop a To-do List or use the Action Plan form to begin listing actions required to implement strategy. As a group decide how and who will present the teams ideas.
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WORKSHOP PRESENTATION AGENDA

Introduce each team member. State the strategy to be presented. BRIEFLY describe the requirements and their status: being met in all cases, partially met in some areas, not being met, etc... Present your suggestions: forms, tracking methods, etc Present your To-do List or Action Items.
Ask for questions and comments.

NOTE: The presentation for each strategy should take approximately 10 minutes.
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FAST RESPONSE PROCESS

Standardized Rapid Reaction to Quality Issues: Problem Solving and Communication

Problem Solving WHAT IS A PROBLEM?

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

8D PROBLEM SOLVING LOGIC FLOW DIAGRAM

Define The Problem

Contain The Problem

Identify The Root Cause Verify Effectiveness Of Actions

Implement Permanent D5 Corrective Action

Institutionalize Throughout The Organization

Recognize & Formally Disengage The Team

QSB WORKSHOP REV. 062705

8D PROBLEM SOLVING PROCESS

QSB WORKSHOP REV. 062705

PROBLEM SOLVING TOOLS

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

Correct Process? Yes Correct Tool? Yes Correct Part? Yes

Is Engineering support required?

Will Process Change Resolve?

Vehicle Assembly Engineering 5

Product Change Required?

Rel. Engineer/ SQA/Supplier 4

Extremely Complex Problem

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

Initial investigation is done where the defect was found.

Quality Sys / SQ / Supplier 4

QSB WORKSHOP REV. 062705

Quality Sys / SQ / Supplier 4

QSB WORKSHOP REV. 062705

Can any of these cause the problem?

Quality Sys / SQ / Supplier 4

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

Quality Sys / SQ / Supplier

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

Referred by Quality Systems Manager

Problem Analysis (where defect was found)

Countermeasure ____________________________________ ___________________________________________________ ___________________________________________________ Completed by ___________________ Date ______________

Problem Analysis (upstream operation, if applicable)

Countermeasure ______________________________________ _____________________________________________________ _____________________________________________________ Completed by _____________________ Date ______________

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

Practical Problem Solving Report

Author: Problem in shift: A: __ B: ___

Problem found by: SIP: ___ CARE: ___ Maintenance: ___

GCA: ___ OTHER: Production: ___

Problem Definition (Real Problem):

Point Of Cause (where problem is first occurring):

Quality Standard: Deviation: Problem: How Often: Containment:

Breakdown Start Time: End Time: Duration: Direct Run Loss:

Diagnostic sheet available: Y N

Is correct part being used?

2) Circle most likely direct causes.

QSB WORKSHOP REV. 062705

General Motors Corporation. All rights reserved.

Practical Problem Solving Report

Any Similar Areas where this might apply:

If yes, how is the standard documented?

Countermeasure __________ _ _________________ Completed by _ Date ______

Countermeasure ____________ _ _________________ Completed by _ Date ____

Author: Problem in shift: A: B: _

Problem found by: SIP: _ CARE: _ Maintenance: ___

GCA: _ OTHER: Production: _