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Overview of PFMEA
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Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
1
QUALITY
PFMEA’sA
1 Hour Overview
Revised By: Lawrence Brozowski 09-2004
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
THE REAL VALUE OF FMEA PROCESSTHE REAL VALUE OF FMEA PROCESS
• FOCUS PRODUCT ON CUSTOMER CONCERNSAND ERROR PROFFING
• CAPTURE LESSONS LEARNED
• TRAIN NEW PERSONNEL
• COMMUNICATE REQUIREMENTS
• SAVE RESOURCES
RETAIN TECHNICAL MEMORY
• DRIVES TO ZERO DEFECTS
• REDUCE THE COST OF QUALITY
• IMPROVE PRODUCTIVITY AND RELIABILITY
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
JOB DESCRIPTION
FIRST TIME QUALITYQUALITY AT RATE
QUALITY POLICY
QUALITY CREATES CUSTOMER ENTHUSIASM
EXPECTION IS ZERO MANUFACTURING DEFECTS
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY THE PROBLEM WITH VERBALLY EXPRESSED
TECHNICAL DATAA major problem with verbally expressed technical data is that various company functions use local vocabularies that are not understood by other functions.
Example: what is your definition of the word quality?
If you are thinking variation reduction, you will probably expect / accept higher costs for tools, gages, materials, equipment and tighter tolerances on designs.
If you think in terms of customer satisfaction, you are looking for lower costs, $0 tooling, less expensive processes andtechnical innovation.
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
INFORMATION ACCOUNTABILITY
Information we have plenty of, but what’s really necessaryto your work, and what form should it take? Don’t expect aninformation manager to tell you. The big thing to learn is not howto use the computer, or even how to organize information, but how to take responsibility for the information you have.
Information accountability means making information a tool, which in turn is the basis for common actions. This notion is something that we are just beginning to grasp.
Only now can the question be asked:What does this information mean, both for my job function and for the function of other people’s work.
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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RETENTION OF OF TECHNICAL MEMORYTECHNICAL MEMORY
•FMEA’S ARE MORE IMPORTANT THEN FINANCIALS
•Financials only tell you IF you made money.
•FMEA’s tell you HOW to make products that make money
•Problem recognition and knowledge retention should be
considered the most important aspect of the QUALITY process.
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
Manufacturing System Manufacturing System Fundamental ValueFundamental Value
ISO 9000
Global Manufacturing System
PPAPAPQP R@R
MRP
FMEA
Financial
QS 9000
Control Plan
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
WHAT IS A QUALITY SYSTEM
• “The organizational structure, responsibilities, procedures, processes, and resources for implementing
quality management”
• Quality Management: “That aspect of the overall management function that determines and implements the quality policy”
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
Quality System Requirements
• Purpose
– Define the quality system expectations
for internal and external suppliers
production and service parts & materials.
– Ensure customer satisfaction
beginning with conformance to requirements
continuing with reduction of variation and waste
to benefit the final customer, suppliers, and OEM’s.
– RETENTION OF TECHNICAL MEMORY
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
93% OF OUR PROBLEMS ARE
WHERE THE REQUIREMENTS
ARE:
Missing Misunderstood Wrong Ignored
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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USE STANDARD BASIC QUALITY TOOLS
TO ACHIEVE THE REQUIRED RESULTS
DRIVE DISCIPLINEDRIVE DISCIPLINE
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
OEMOEMResponsibilityResponsibility
SupplierSupplierResponsibilityResponsibility
DFMEADFMEA PickingPicking KPC’sKPC’s
GD&T To add printGD&T To add printSourcingSourcingFinal PrintFinal Print
PFMEAPFMEAControl PlanControl Plan
PPAPPPAP
RFQRFQ
APQPAPQP
SSTSSSTS
FMEA Process OverviewKnowledge Transfer
APQPAPQP
PREVENTION
HINDSIGHT
Knowledge Base
3210
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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VIEW POINT’S VIEW POINT’S forforFMEA IMPLEMENTATIONFMEA IMPLEMENTATION
•The MINAMALIST VIEW (very short lacking critical information
•A VERBOST VIEW (very knowledge intensive)
REALITY IS our documentation isCLOSER TO THE MINAMALEST’S VIEW
Keep in mind that most design testing is done with the parts built to nominal
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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OEMOEMResponsibilityResponsibility
SupplierSupplierResponsibilityResponsibility
DFMEADFMEAPickingPicking KPC’sKPC’s
GD&T To add printGD&T To add printSourcingSourcing Final PrintFinal Print
PFMEAPFMEAControl PlanControl Plan
PPAPPPAP
RFQRFQ
APQPAPQP
SSTSSSTS
FMEA Process OverviewKnowledge Transfer
APQPAPQP
PREVENTION
HINDSIGHT
Knowledge Base
Feedback Loop
3210
Re-Learning Adding NewInformation
Execute Design
CurrentDesign
LessonsLearned
DesignTweak
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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DO AS YOU SAYDO AS YOU SAY
SAY AS YOUSAY AS YOU DODO
YES THIS MEANS EVERYTHING YOU DO
THE FMEA PROCESS CAN NOT HELP IMPROVE ISSUES (CANNOT BE A PROACTIVE TOOL) IF ALL THE FAILURE MODES ARE NOT RECORDED IN THE DOCUMENTATION
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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KEY DEFINITIONS
A FMEA is an analytical tool that uses a disciplined technique to identify and help eliminate product and process potential failure modes.
FAILURE: When equipment is not able to perform the actions as Required per specifications.
FAILURE MODE: The omission of required actionor incorrect action that precedes the failure.
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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IMPORTANCE OF PFMEA's
• Systematic Method to Analyze a Process
• The Process Potential FMEA:– Identifies potential product related process failure modes
– Assesses the potential customer effects of the failures
– Identifies the potential manufacturing or assembly process causes and identifies process variables on which to focus controls for occurrence reduction or detection of the failure conditions
– Develops a ranked list of potential failure modes, thus establishing a priority system for corrective action considerations
– Documents the results of the manufacturing or assembly process
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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FAILURE MODES AND EFFECTS ANALYSIS
HISTORY
• Initially developed in the 1940’s
• Used extensively in NASA Apollo Program in 1960’s
• Carried to other industries by displaced Apollo engineers
• Adopted by Ford engineering in the 1980’s
• Adopted by Automotive Industries Action Group (AIAG)
• Incorporated into GM GVDP and PPAP
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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UNDERSTANDING FAILURE MODE RELATIONS
• Every problem is preceded by the error and the source of the error (cause).
• The cause is that which produces an incorrect action (something done poorly) or an omission of a required action (something not done).
All problems have three components:1. Frequency of occurrence of the cause.2. The ability to detect (the problem / effect or error).3. Severity (how the problem / effect affects the customer).
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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POTENTIAL FMEA NumberFAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
Item Process Responsibility Prepared By
Model Year(s)/Vehicle(s) Key Date FMEA Date (Orig.)
Core Team
SC O DR. Action ResultsProcess Function Potential Failure Potential Effect(s) EL Potential Cause(s)/ C E P. Recommended Responsibility Actions S ODR.Requirements Mode of Failure VA Mechanism(s) of C Current Process Control T N. Action(s) & Target Taken E COP.
S Failure U E Completion Date V CT N.S R C
1
2 3
5 6
8
9 10 11 12
1314
15
16
17
18 1920
21
22
4
7
CONTROL
PLAN
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1
2
3
4
5
6
7
FLOW DIAGRAM
PFMEA’s
• LISTS EACH OPERATION
• CURRENT CONTROLS
• ENHANCED CONTROLS FROM RECOMMENDEDACTIONS
• KPC's, KCC'sPER OPERATION:
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS FOR NON-CONFORMING PRODUCT
JOB
JOBINSTRUCTIONS
PER OPERATION:
• INSPECTION FREQUENCY
• GAGE & CHECKING DEVICES
• REACTION PLANS OF NON- CONFORMING PRODUCT
• “PICTURE” OF PROCESS
• SHOWS FLOW OF PROCESS
• FOUNDATION FOR PFMEA, CONTROL PLANS, TOOL LAYOUTS, WORK STATION LAYOUTS, ET.
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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FMEA FORM DETAILFMEA FORM DETAIL
POTENTIALFAILURE MODE
POTENTIALEFFECTS
POTENTIALCAUSES
CURRENTCONTROLS
RECOMMENDATIONS
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS(PROCESS FMEA) FMEA Number: 1
Item: 2 Process Responsibility:3 Prepared by: 4
Model Year(s)/Vehicle(s) 5 Key Date 6 Date (Orig.) 7
Core Team: 8 Date (Rev.) 7
Process C Potential O D
Function/ Potential Potential S l Cause(s)/ c Current Current e R. Recommended Responsibility Action Results
Failure Effect(s) of e a Mechanism(s) c Process Process t P. Actions & Target Actions S O D R.
Mode Failure v s of Failure u Controls Controls e N. Date Taken e c e P.
Requirements s r Prevention Detection c v c t N.
9 10 11 12 13 14 15 16 16 17 18 19 20 21 22
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POTENTIAL CAUSE IS DIRECT RELATIONSHIP TO PROCESS CAPABILITY
CURRENT CONTROL = DETECTION CAPABILITY
THE OUTCOME HERE IS PRIMARILY CONTROLLED BY
PRODUCT OR PROCESS ENGINEERING
SQE SHOULD CONCENTRATE ON THESE AREAS. THE SQE HAS ABILITY & AUTHORITY TO EFFECT CHANGES IN THESE AREAS WORKING WITH THE
SUPPLIER
POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS(PROCESS FMEA) FMEA Number: 1
Item: 2 Process Responsibility:3 Prepared by: 4
Model Year(s)/Vehicle(s) 5 Key Date 6 Date (Orig.) 7
Core Team: 8 Date (Rev.) 7
Process C Potential O D
Function/ Potential Potential S l Cause(s)/ c Current Current e R. Recommended Responsibility Action Results
Failure Effect(s) of e a Mechanism(s) c Process Process t P. Actions & Target Actions S O D R.
Mode Failure v s of Failure u Controls Controls e N. Date Taken e c e P.
Requirements s r Prevention Detection c v c t N.
9 10 11 12 13 14 15 16 16 17 18 19 20 21 22
{
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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ERROR PROOFING TYPES OF INSPECTION
SuccessiveSource Self
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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Location of check• Occurs before the processing station• Cannot proceed with further processing
Human inspection• Source inspection through product or process design • PFMEA Detection code = 1• PFMEA Occurrence code = 1
Technology/Equipment/Tooling Checks (free of human intervention)• Error Proofing** per AIAG FMEA Reference Manual• Accomplished through product or process design• PFMEA Detection code = 1 & Occurrence code = 1
** Other definitions offered by various authors, e.g., mistake proofing, mistake detection, Poka-Yoke, etc.
Source
SOURCE INSPECTIONMistake CANNOT Be Created
“Cannot Make”PREVENTION
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY
Self
Location of Check• Occurs within the processing station – or - immediately after
processing• Part still remains in the processing station
Human Inspection• Visual or manual inspection• PFMEA Detection code = 5 through 9
Technology/Equipment/Tooling Checks• Error Detection** per AIAG FMEA Reference Manual• PFMEA Detection code = 2 with auto stop• PFMEA Detection code = 3 with warning only ** Other definitions offered by various authors, e.g., mistake proofing, mistake detection, Poka-Yoke, etc..
SELF INSPECTIONMistake CAN Be Created
“Cannot Pass”DETECTION
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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Location of Check• Occurs in next processing station OR in downstream processing station(s)
Human Inspection• Visual or manual inspection• PFMEA Detection code = 5 through 9
Technology/Equipment/Tooling Checks• Error Detection** per AIAG FMEA Reference Manual• PFMEA Detection code = 4• PFMEA Detection code = 3 with redundant checks** Other definitions offered by various authors, e.g., mistake proofing, mistake detection, Poka-Yoke, etc.
Successive
SUCCESSIVE INSPECTION
Mistake CAN Be Created“Cannot Accept”
DETECTION
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY RISK PRIORITY NUMBER (RPN)
S C O D R. Action ResultsProcess Function Potential Failure Potential Effect(s) E L Potential Cause(s)/ C E P. Recommended Responsibility Actions S O D R.
Requirements Mode of Failure V A Mechanism(s) of C Current Process Control T N. Action(s) & Target Taken E C O P.S Failure U E Completion Date V C T N.S R C109 11 12
13
14
15
16 18 1920
21
22
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18. RISK PRIORITY NUMBER (RPN)– This Is Simple Multiplication
– Multiply the Ranking Given to the Three Evaluations: SEVERITY X OCCURRENCE X DETECTION = RPN
S O D R
E X C X E = P
V C T N
R E
C
– There Is a Specific RPN for Each Potential Cause
– The Process Is Assigning Risk to Each Cause
– This Is Root Cause Focused
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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HOW TO MAKE THE PFMEA & HOW TO MAKE THE PFMEA & CONTROL PLAN DYNAMICCONTROL PLAN DYNAMIC
WAS ISSUE ON
FMEA?
• ADD CONDITION TO FMEA
• DEVELOP PROPER CONTROL FROM LEARNING
• IMPLEMENT CORRECTIVE ACTION
REVISEPFMEA TO REFLECT CURRENT PROCESS
REVISE CONTROLPLAN TO REFLECT CURRENT PROCESS
MACHINES GAGES TOOLS
IMPOSE DISCIPLINE ON MANAGEMENT
WASCONTROL
PLANFOLLOWED?
SUPPLIER’SPROCESS
CUSTOMERCOMPLAINTS
* STARTFAILURE ANALYSIS
YES
NO
NO
YES
•SCRAP
•AUDITS
•WARRANTYPR/R'sPPM
REVIEW DETECTION FORACCURACY & ROBUSTNESS• UPDATE RPN BASED ON
CAUSE• DEVELOP ACTIONS TO
LOWER RPN
NOTE: IF MANAGEMENT IS AT FAULT THEY ARE NOT FULFILLING THEIR JOB OR AGREEMENT
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Operations
Transport Inspection Delay Storage
PROCESS FLOW
SYMBOLProc
NumberProc Name
Pieces per Shift
Work Centr/ Trans Mode
PFMEA
Prod/Proc/Char
Description
Special Char. Class
Potential Failure Mode
Potential Effects of Failure Mode
SEV
Potential Cause(s) /
Mechanism(s) of
OCC
Current Process Controls
DET
RPN Recommended Actions
Responsibility & Target
Date
ACTIONS TAKEN
SEV
OCC
DET
Gauge
R&R
& Date
CONTROL PLAN
Gauge Descriptio
n
Customer Specs
Reaction PlanFrequency SIZE
Control MethodSAMPLING Tool &
Mach. Number
Also refer to APQP page 96 to 101 (DCP Journey)
Dynamic Operational Control Plan
Informational Content not the form is the KEY issue
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KEY POINTS ON PFMEA DEVELOPMENT
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KEY POINTSKEY POINTS
Flow Diagram
Should Provide A General Sequential Picture Of The Process.
• Shows Progression Of The Manufacturing Process
• Organizes the ProcessKeeps the Group FocusedPhysical Appearance Of The Flow Document
• Should Have Legend(s) Explaining Symbolism used.
• Operations Should Be Numbered.• Label or Title Of Operation Or Manufacturing
Process Should Appear On Paperwork.
OP
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PFMEA
Accurate PFMEA development is very time consuming work, Requires A Team
Approach.When done properly the PFMEA can become basis for multiple applications.It is a repository of all our collective experience.Needs to be a dynamic process - CONSTANTLY reflecting lessons learnedIt is a main enabler for prevention.It is proactive.Provides CLARITY OF FOCUS through high RPN identification.Key To Prediction and Prevention Of Problems.Creates Organizational Memory.Facilitates Lessons Learned Solutions For Like or Similar Processes.Accurate & Detailed Development. Facilitates Duplication of Best Practices. Should Follow The Sequence of the Flow Diagram for the
Corresponding Manufacturing Or Assembly Process.
POTENTIAL FMEA NumberFAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
Item Process Responsibility Prepared By
Model Year(s)/Vehicle(s) Key Date FMEA Date (Orig.)
Core Team
SC O DR. Action ResultsProcess Function Potential Failure Potential Effect(s) EL Potential Cause(s)/ C EP. Recommended Responsibility Actions SODR.Requirements Mode of Failure VA Mechanism(s) of C Current Process Control T N. Action(s) & Target Taken ECOP.
S Failure U E Completion Date VCT N.S R C
1
2 3
5 6
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9 10 11 12
1314
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18 1920
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PFMEA’s
KEY POINTS ON PFMEA DEVELOPMENT
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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KEY POINTSKEY POINTS
PFMEA (continued)
All Material Or Sub-assemblies Entering Each Operation Are Considered Good Parts.
• Sub-assemblies, if manufactured at same location require separate PFMEA.
• Purchased parts are considered good; incoming inspection should address characteristics or operation addresses through error proofing.
Do Not Set Target Goals For RPNs• Use common sense when determining if further
process improvements are not feasible.
POTENTIAL FMEA NumberFAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA) Page of
Item Process Responsibility Prepared By
Model Year(s)/Vehicle(s) Key Date FMEA Date (Orig.)
Core Team
SC O DR. Action ResultsProcess Function Potential Failure Potential Effect(s) EL Potential Cause(s)/ C EP. Recommended Responsibility Actions SODR.Requirements Mode of Failure VA Mechanism(s) of C Current Process Control T N. Action(s) & Target Taken ECOP.
S Failure U E Completion Date VCT N.S R C
1
2 3
5 6
8
9 10 11 12
1314
15
16
17
18 1920
21
22
4
7
PFMEA's
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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FMEA IMPLEMENTATION KEYS
MAJOR INPUTS TO FMEA Development
4 WALL OPERATIONAL SEQUENCE
TO MUCH, TO LITTLE, MISSING, WRONG
LANGUAGE IS CRITICIAL
RPN REDUCTION STRATEGY
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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MAJOR INPUTS TO FMEADEVELOPMENT
•DFMEA CUSTOMER CONCERNS•BOM•PRINT SPEC’S KPC's / KCC's•EQUIPMENT LIST•MAINTANCE PLANS•INSPECTION POINTS / GAGES•MOVE ACTIONS•STORAGE POINTS / KANBAN QUANTITIES•REWORK LOOPS OUT POINTS IN POINTS•SCRAP OUT POINTS•DATA INPUT POINTS
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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4 4 WALL OPERATIONAL SEQUENCE
• Starts at receiving inspection• Directs the documentation / data requirements of the Tier 2
suppliers• Follows everything that is done within the plant
• Documents ALL data collection points
• Through getting the product to the assembly plant
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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OPERATIONAL SEQUENCE
• The operational sequence numbering must be the same in the FLOW CHART, PFMEA and the CONTROL PLAN
• The numbers should not be repeated within the documentation for a single part number. OP 10 in Receiving , OP 10 in Sub Assembly, OP 10 in Assembly, OP 10 in Shipping, not allowed
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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CommentsX X X - X X X Field length 7 digits
1 0 -Work Center # by Plant Location, 4 wall flow
A - Alpha Field / Task Code
- 0 0 1 Process step number
Operational Sequence Matrix
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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FAILURE MODES
THERE ARE 6 MAIN CAUSES OF FAILURE RELATING TO PROCESS FAILURE MODES
•TOO MUCH•TOO LITTLE•INCOMPLETE•MISSING•WRONG•CYCLE TIME
It is rare for a failure modeto have more then five (5)important causes and threeimportant effects.
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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LANGUAGE IS CRITICIAL
• WEIGHT MEASUREMENT 1 OZ. = 28.34 GRAMS
• VOLUME MEASUREMENT 1 OZ. = .125 CUPS
BE SPECIFIC USE COMMON LANGUAGE
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY KEY KEY POINTSPOINTS
KPC's & KCC's
• Identified Early in Design Development• Identified by Engineering Through Voice of
the Customer in the Design Stage• The initial identification in the Process
occurs in the Flow Diagram•Details of How Processing Affects KPC's
Identified in PFMEA•Detail of Process and Product Control
Identified in Control Plans
Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004
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QUALITY RPN Reduction RPN Reduction StrategyStrategy
The Advanced Product Quality Plan (APQP)
for each product should include the strategy
for reducing the risk identified through the PFMEA process;
RPN numbers.
•This is referred to as your RPN Reduction Strategy.
•This is an organized method for prioritizing and using the
PFMEA to gain maximum benefit.
RPN Reduction Strategy Example –Identify Top 5-10 RPNs
–Follow through on recommended actions for each
–As each RPN is reduced work on the next highest RPN
–Continues working through this process
RPN
RPN
RPN
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KEY KEY POINTSPOINTS
REACTION PLANS•Often a weakness in the system•They need to be clear•The Reaction Plan provides the direction to
Drive Appropriate Action•We Spend Time and Energy Developing
Them; If Not Followed We Waste Time and We Lose an Obvious Opportunity for Success
•They Are the Final Detour Sign That Leads Us Back to the Correct Route.
ALTO
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QUALITY PFMEA’s ARE A LIVING PFMEA’s ARE A LIVING DOCUMENTDOCUMENT
The PFMEA is referred to as a living document because the intent is to use the document throughout the life of the product
– Once the product enters the “normal” production cycle any revisions to the design or manufacturing process should be reflected
– When a step in the process is revised or changed due to process or design improvements, you must revise the PFMEA and re-evaluate the effect of the change on severity, occurrence and detection
– This is the part in the process that normally fails to occur
• Be aware of this when you review any PFMEA's
• Develop a disciplined review process to ensure design and associated process revisions are updated to FMEA File