Pfmea Overview

Worldwide PurchasingPFMEA 14799 Revised L Brozowski 6-2004

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QUALITY

PFMEA’sA

1 Hour Overview

Revised By: Lawrence Brozowski 09-2004


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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


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JOB DESCRIPTION

FIRST TIME QUALITYQUALITY AT RATE

QUALITY POLICY

QUALITY CREATES CUSTOMER ENTHUSIASM

EXPECTION IS ZERO MANUFACTURING DEFECTS


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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.


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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.


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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.


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Manufacturing System Manufacturing System Fundamental ValueFundamental Value

ISO 9000

Global Manufacturing System

PPAPAPQP R@R

MRP

FMEA

Financial

QS 9000

Control Plan


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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”


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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


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93% OF OUR PROBLEMS ARE

WHERE THE REQUIREMENTS

ARE:

Missing Misunderstood Wrong Ignored


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USE STANDARD BASIC QUALITY TOOLS

TO ACHIEVE THE REQUIRED RESULTS

DRIVE DISCIPLINEDRIVE DISCIPLINE


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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


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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


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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


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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


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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.


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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


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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


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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).


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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

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18 1920

21

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CONTROL

PLAN

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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.


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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

{


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ERROR PROOFING TYPES OF INSPECTION

SuccessiveSource Self


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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


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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


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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


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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

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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


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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.





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

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PFMEA’s

KEY POINTS ON PFMEA DEVELOPMENT


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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.





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

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5 6

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PFMEA's


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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


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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


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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


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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


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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


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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.


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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


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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


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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