Module 2 - Process FMEA Training Rev 1

National Quality Department Business Excellence Program (BEX) Business Process Management System Training

Failure Mode & Effect Analysis FMEAApril 2011 Rev 1.0

National Quality Department

BPMS - FMEA Rev 1.0

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About This ModuleAn FMEA is a systematic method for identifying, analyzing, prioritizing and documenting potential failure modes, their effects on system, product, process performance and the possible causes of failure.


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What We Will Learn1. As a Team, how to construct an FMEA and associated Action Plan 2. How the FMEA process ties to process mapping 3. The relationship between Failure Mode, Cause and Effect 4. The different types of FMEAs


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Sample FMEAS Failure E Effects V Causes Must redo copy 6 Paper Jam Must redo copy Must redo copy O D R C E P C Controls T N Action Recommended Resp. Schedule Person Date Periodic Maint. 7 294 Periodic preventive maintence Place sign over copier outlining Existing standard size enlarge/reduce or User notes on reliable mach to clearly indicate 6 misset size 6 copier 5 180 standard reduce/enlarge User Existing misset notes on Place sign to encourage user to 6 control 5 copier 4 120 utilize auto settings Used landscape instead of portrait or Tray Place note on ruler re tray 6 vice versa 7 Selection 2 84 selection 7 align marking not clear Doc moved when lid closed Key Opr 3/1 Action Taken PM Schedule created and implemented Actual Compl. p p p Date S O D p r p n R i Risk s X k prpn 2/15 6 3 7 126 3 378

Key Opr

2/20

Place sign over mach Place sign over mach

2/15

6 3 2

36 1

36

Key Opr

2/20

2/15

6 2 2

24 1

24

Must redo copy Must redo copy Must redo copy Must redo copy Must redo copy

Key Opr

1/20

Placed Note

1/15

6 2 1

12 1

12

6

Use Auto Feeder / Enlarge marks for 8.5 " paper on 4 align ruler 3 72 ruler Key Opr Use Auto Place sign over copier re Feeder / "Ensure align prior to copying or 5 align ruler 2 60 use auto Feeder" Key Opr Place sign over copier to encourage user to use auto tray select Place cleaning material near copier

1/15

Enlarged marks

1/14

6 2 1

12 1

12

6

1/15

Displayed Sign

1/14

6 1 1

6

1

6

Auto select 6 function 3 54 Periodic Cleaning 6 Dirty Glass 6 SOP 1 36

User selected wrong tray 3

Key Opr

2/25

Place sign over mach Placed Cleaning Matl

2/20

6 2 3

36 1

36

Maint.

1/15

1/15

6 1 1

6

1

6


BPMS - FMEA Rev 1.0 Datafile/CopyFMEA.xls

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Why Use FMEAs?Identify critical product characteristics and process variables Prioritize product and process deficiencies in support of downstream improvement actions Help focus on prevention of product and process problems


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Benefits of FMEAs

Improves the quality, reliability and safety of processes. Helps increase customer satisfaction. Reduces process development timing and cost. Reduces the amount of rework, repair and waste. Documents and tracks actions taken. Prioritizes deficiencies to focus improvement efforts.


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Process and FMEA HierarchiesProcess - Level #1Step #1 Step #2 Step #3

FMEA - Level #1

Process - Level #2Step #1 Step #2 Step #3

FMEA - Level #2

Process - Level #3Step #1 Step #2 Step #3

FMEA - Level #37


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Process FMEA Steps

Steps Completed Prior to FMEA: Charter Team Develop and Characterize Process Map Identify Heavy Hitter Process Step Identify Associated ys (Product Parameters) Identify Failure Mode Identify Failure Effects/Rate Severity Identify Causes/Rate Occurrence Identify Controls (if any)/Rate Detection Calculate RPN Prioritize by RPN Order Determine Actions/Plan Recalculate RPN Based on Plan Take ActionBPMS - FMEA Rev 1.0 8

FMEA Steps:1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1.


FMEA Form

Header Accessible from View Header/Footer in Excel

Workbook in Excel


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\DataFile\FMEAForm.xls

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Cause -Failure Mode -Effect ContinuumEffect (ys) Cause (xs) Failure Mode


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The Cause and Effect Diagram Example Admin/Service ExampleMeasurements Materials Manpower

Failure Mode (Defect)

First produced in 1950 by Professor Kaoru Ishikawa Also called the: Ishikawa Diagram Fish Bone Diagram Developed to represent the relationship between some effect and all possible causes influencing it. Create using Igrafx:

Failure Effect Mother Nature Methods Machines


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The Cause and Effect Diagram Example (cont.)Measurement ManpowerInadequate training Lack of experience Distractions

MaterialLate Wrong quantity Defective

Reproducibility

Repeatability Linearity Stability Calibration

DefectsToo hot Too humid Not maintained Too cold Inadequate capability Vague Out of date Complex

Mother nature Machines

Methods

Datafile/Causeeffecte.igx


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Copy Machine Example Our process is copying documents on a Xerox model XC1045 copy machine. First we will construct a process map Then we will construct a cause and effect diagram Finally we will complete an FMEA


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Process: Making A CopyPlace Document in CopierN Hinges N Glass clean

Set number of copiesC Copies required Cr Number button

Enter size requiredC Size desired Cr Size button

Set light/dark settingsC Darkness desired

Select paper sourceC Size desired x Paper

Press button

Retrieve copies

Cr Button

Make Copies

Document set correctly Glass clean

Number of copies selected correctly

Size selected correctly

Darkness set directly

Correct paper tray selected

Copies

Copies Right number Right contrast Right orientation Right size Right paper

Legend C Controllable Cr Critical N Noise P Procedure x Input National Quality Department BPMS - FMEA Rev 1.0 14

Step 1: Identify Heavy Hitter Process Step

From the Process Map, identify the process step with the most likelihood of having failure modes with significant effects Use defect data and/or team knowledge about failure modes when selecting process steps Significant impact to the business? (COPQ, cycle time, fill rate, ...) Use a Cause and Effect Diagram to capture brainstorming results. After completing FMEA Steps #2-7 for all failure modes associated with this process step, return to this step and select the next most likely Heavy Hitter process step Not all process steps will need to be analyzed by the FMEABPMS - FMEA Rev 1.0


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Step 2: Identify Associated ys

From the Process Map, identify the ys that are associated with the process step being investigated As the ys are the indications of a successful completion of the process step, they are crucial as a basis for determining failure modes


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Step 3: Identify Failure Mode Brainstorm failure modes for the selected process step : Identify the ways in which the process could fail to generate each of the expected ys Eliminate duplicates from brainstorm list Are the failure modes from the same level of the process? Are the failure modes specific? Are the failure modes the most likely? Do the failure modes provide good coverage of the process step? Have all ys been considered?


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Step 4: Identify Failure Effects/Rate Severity

Pick the most likely failure mode and brainstorm the most important Effects: FAILURE EFFECTS are the outcome of the occurrence of the failure mode on the process. The impact on the customer --What does the customer experience as a result of the Failure Mode?

Identify each effect as being Attribute or Variable Severity doesnt change unless the design changes.


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Step 5: Identify Causes/Rate Occurrence

Identify the most likely causes for each failure mode using a Cause and Effect Diagram: CAUSES are the conditions that bring about the Failure Mode

Transfer the resulting information to the FMEA form Assign an occurrence value (1-10) to the likelihood that each particular cause will happen and result in the failure mode The occurrence score for each cause should be related to the likelihood of that cause resulting in the failure mode and producing the specific associated effect


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Organize Brainstorming IdeasMeasurementWrong Size Selected

MaterialsWrong Paper Size

ManpowerSelected wrong orientation

Copy MisalignedToo Humid Document Moved When Lid was Closed Alignment Marking Unclear

Mother Nature

Method

Machine

What would you add?National Quality Department BPMS - FMEA Rev 1.0 20

Step 6: Identify Controls (if any)/Rate Detection

Identify the current mechanisms in place which prevent the cause from occurring, or detect it before the product reaches the customer. Some examples of controls are SPC, training, maintenance, inspection/review, SOP etc. Assign a detection value (1-10) based on an assessment of the likelihood that the current control mechanisms will detect the cause of the failure mode before it reaches the customer. Dont agonize over detectability.


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Step 7: Calculate Risk Priority Number (RPN)The product of the estimates of severity

occurrence and detection.The RPN provides a relative priority for taking action the bigger the RPN, the more important to address.

RPN = SEVERITY x OCCURRENCE x DETECTIONNational Quality Department BPMS - FMEA Rev 1.0 22

Steps 8 and 98: Prioritize by RPN Order Use the Sort command in Excel to order the spreadsheet in descending order of Risk Priority Number (RPN). 9: Determine Actions/Plan Based on the causes found, determine actions that will minimize the effect of each cause, in priority order.


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Steps 10 and 1110: Recalculate RPN Based on Plan Assuming the actions are carried out successfully, reassign severity, occurrence and detectability.

Place these new ratings in the predicted columns (ps, po & pd). Assign a rating from 1 to 5 for each action that will show the risk associated with each action (5 being the greatest risk). Place the rating in the risk column.

11: Take Action Based on the risk mitigation column (Risk * prpn), take the actions indicated or reassign actions. Then.

Complete the actions indicated by the times stated!


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Step 1 ID Process StepsS Failure E Effects V Causes Must redo copy 6 Paper Jam Must redo copy Must redo copy

Step 2 ID ys Step 4O D R C E P C Controls T N Periodic Maint. 7 294

Steps 1-11Step 6 Step 9 Step 11Actual Compl. p p p Date S O D p r p n R i Risk s X k prpn

FMEAAction Recommended

Resp. Person

Schedule Date

Must redo copy Must redo copy

Periodic preventive maintence Place sign over copier outlining Existing standard size enlarge/reduce or User notes on reliable mach to clearly indicate 6 misset size 6 copier 5 180 standard reduce/enlarge User Existing misset notes on Place sign to encourage user to 6 control 5 copier 4 120 utilize auto settings Used landscape instead of portrait or Tray Place note on ruler re tray 6 vice versa 7 Selection 2 84 selection

7

Key Opr

3/1

Action Taken PM Schedule created and implemented

2/15

6 3 7 126 3 378

Key Opr

2/20

Place sign over mach Place sign over mach

2/15

6 3 2

36 1

36

Key Opr

2/20

2/15

6 2 2

24 1

24

Key Opr

1/20

Placed Note

1/15

6 2 1

12 1

12

align marking 6 not clear 4 Doc Must moved 3 redo Stepwhen lid copy 6 closed ID Failure Modes 5

Use Auto Feeder / Enlarge marks for 8.5 " paper on align ruler 3 72 ruler Key Opr Use Auto Place sign over copier re Feeder / "Ensure align prior to copying or Step 5 align ruler 2 60 use auto & 8 Step 7Feeder"

1/15

Enlarged marks

1/14

6 2 1

12 1

12

Step 10Key Opr 1/15 Displayed Sign 1/14 6 1 1 6 1 6


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Types of FMEA

Process FMEA

Helps analyze manufacturing and assembly processes to reduce the occurrence and improve detection of defects. Assists in the development of process control plans. Establishes a priority for improvement activities. Documents the rationale behind process changes and helps guide future process improvement plans. IS PROACTIVE! Should be started when new processes are designed or when old processes are changed.


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Process FMEA Scoring DefinitionScore 10 9 8 7 6 5 4 3 2 1 SEVERITY CRITERIA Hazardous Without Warning Hazardous With Warning Very High High Moderate Low Very Low Minor Very Minor None OCCURRENCE 1 in 2 Very High 1 in 3 Very High 1 in 8 High 1 in 20 High 1 in 80 Moderate 1 in 400 Moderate 1 in 2,000 Moderate 1 in 15,000 Low 1 in 150,000 Low 1 in 1,500,00 Remote DETECTION Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain

Note: When completing a Process FMEA, first assume the material is good and the process is bad. Then assume that the process is good and the material is bad. Lastly, review the process for safety considerations.


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Design FMEA Helps to identify potential process failure modes early in the process development cycle. Increases the likelihood that all potential failure modes and their effects on assemblies will be considered. Assists in evaluating process design requirements and test methods. Establishes a priority for design improvement. Documents the rationale behind design changes and helps guide future development projects. IS PROACTIVE! Should be done when new processes are designed or existing processes are changed.


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Defect FMEAHelps identify the root causes of defects. Establishes a priority for improvement activities. Documents plan of action. Provides methodology to battle initial ground swell of defects. Focuses effort on defects with highest $ impact. IS NOT PROACTIVE!


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Scoring CriteriaUse actual defect quantities

Score 10 9 8 7 6 5 4 3 2 1

SEVERITY CRITERIAHazardous Without Warning Hazardous With Warning Very High High Moderate Low Very Low Minor Very Minor None

OCCURRENCEVery High Very High High High Moderate Moderate Moderate Low Low Remote

DETECTIONAbsolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain

Note: To change header information, click on "View" then "Header".RISK: Optional field used to reflect the probability of completing actions.


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The CatapultAnalyze the Catapult process using the FMEA tool.(Remember we want to get the most bang for the buck.)Break into the Catapult teams We have already constructed a process map First, we will construct a cause and effect diagram Then we will complete at least two failure modes for the most critical step(s) of our process Appoint a spokesman for your team to debrief the class on your progress, questions, etc. Complete the FMEA (FMEAform.xls) for the Catapult process before the third session (We will use this information for our DOE competition)

25 minutes!


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Catapult Process MapStart Assemble Catapult Pins (2) Arm Rubber Band Ball Arm moves smoothly Secure to table Select Catapult Settings Plan or Prediction equation Computer Feasible settings Set Catapult Pins Positions Designated Clamp Tape Measure Tape

Aligned with tape 3 inches

Correct settings

Pull Arm to Proper Angle

Shoot

Measure distance

Record distance

Stop

Operator Consistency No Parallax

Operator Lateral movement Correct angle

Tape Measure Observers positioned properly

Recorder Computer

Ball flys straight

Accurate measurement 2 inches

Correct distance recorded


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FMEA Exercise

Complete the Diagram BelowMen Method Material Release consistency Rubber Band Ball Angle measurement

Calculation procedure

Distance Air Conditioner Mother nature Machine Arm moves freely Repeatability Reproducibility Measure

Datafile/CatapultC&E.IGX


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FMEA Summary

When To Update an FMEA?design application environment material operation

An FMEA should be updated whenever a change is being considered to a processs:


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Summary of Product/Process FMEAs

What is the tool? Spreadsheet

When do you apply this tool? When evaluating product for robustness (functionality, produceability, reliability) During early stages of defect reduction efforts to identify causes When identifying key process/product parameters and evaluating methods for controlling them

What will the tool identify/show? All product/process failure modes, related effects, causes, & methods of controlling them Risk Priority Number (RPN) for action based on failure severity, probability of occurrence and detection capability Actions/plans to reduce elements of RPN

What results can you expect? Learn to identify critical product/ process parameters Achieve consensus on solutions and methods of implementation Detailed product/process understanding


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Keys to Success

Identify purpose...BE SPECIFIC! Understand effects...INVOLVE CUSTOMERS & SUPPLIERS! Link to the process map. Use to prioritize efforts, allocate resources. Use as a risk assessment/prioritization tool based on predicted impact. Use to build consensus on prioritization. Encourage creativity...TEAMWORK! PLAN! ASK QUESTIONS!BPMS - FMEA Rev 1.0 36


Process FMEA Steps

Steps Completed Prior to FMEA: Charter Team Develop and Characterize Process Map Identify Heavy Hitter Process Step Identify Associated ys (Product Parameters) Identify Failure Mode Identify Failure Effects/Rate Severity Identify Causes/Rate Occurrence Identify Controls (if any)/Rate Detection Calculate RPN Prioritize by RPN Order Determine Actions/Plan Recalculate RPN Based on Plan Take ActionBPMS - FMEA Rev 1.0 37

FMEA Steps:1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1.


What We Have Learned1. As a Team, how to construct an FMEA and associated Action Plan 2. How the FMEA process ties to process mapping 3. The relationship between Failure Mode, Cause and Effect 4. The different types of FMEAs


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FMEA AppendixFMEA Scoring Criteria, Terminology and Spreadsheet


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FMEA AppendixKey Definitions for FMEASeverity is an assessment of how serious the effect of the potential failure mode is on the customer.The customer in this case could be the next operation, subsequent operations, or the end user.

Occurrence is an assessment of the likelihood that a particular cause will happen and result in thefailure mode.

Detectionis an assessment of the likelihood that the current controls (design and process) will detectthe cause of the failure mode, should it occur, thus preventing it from reaching your customer. The customer in this case could be the next operation, subsequent operations, or the end user.

Current Controls (for both design and process) are the mechanisms which prevent the cause of thefailure mode from occurring, or detect the failure mode, should it occur, before the product reaches your customer. For example, current controls include SPC, inspections, written procedures, training, preventive maintenance and all other activities that ensure a smooth running process.

Critical Characteristics are those items which affect customer safety and/or could result in non-

compliance to regulations and thus require controls to ensure 100% compliance. These are usually processsettings such as temperature, time, speed, etc. acceptable levels of capability.

Significant Characteristics are those items which require SPC and quality planning to ensureNational Quality Department BPMS - FMEA Rev 1.0 40

A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T.


Process or Product Name Description of Process or Product being analyzed. Responsible Name of Process Owner. Prepared By - Name of Agent coordinating FMEA study. FMEA Date Dates of Initial and subsequent FMEA Revisions. Process Step/Part Number Description of individual item being analyzed. Potential Failure Mode Description of how the process could potentially fail to meet the process requirements and/or design intent, i.e. a description of a non-conformance at that Potential Failure Effects Description of the effects of the Failure Mode upon the customer, i.e. what the next user of the process or product would experience or notice. SEV (Severity) An assessment of the seriousness of the effect of the potential failure mode Potential Causes Description of how the failure could occur, described in terms of something OCC (Occurrence) Description of how frequently the specific failure cause is expected to Current Controls Description of process controls that either prevent, to the extent possible, DET (Detection) An assessment of the probability that the current controls will detect the potential cause, or the subsequent failure mode. RPN (Risk Priority Number) The product of the Severity, Occurrence, and Detection Rankings i.e., RPN = SEV * OCC * DET. Actions Recommended Actions to reduce any or all of the Occurrence, Severity or Detection rankings. Responsibility Person or group responsible for the Recommended Action. Actions Taken Brief description of actual action and effective date. New SEVERITY Rating after corrective action. New OCCURENCE Rating after corrective action. New DETECTION Rating after corrective action. Resulting new RPN after corrective action.

Terminology

FMEA Appendix

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Suggested PFMEA Severity Evaluation CriteriaCriteria : 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 function) inoperable (loss of primary 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) Ranking Or may endanger operator (machine or assembly) without warning 10

FMEA Appendix

Effect

Hazardous Without warning Hazardous With warning Very High

Or may endanger operator (machine or assembly) without warning

9

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 repair time between a half hour and an hour. Or a portion (less than 100%) of the product may have to scrapped with no sorting, or vehicle/item repaired in repair department with a repair time less than a half-hour

8

High

Vehicle/item operable but at a reduced level of performance. Customer very dissatisfied.

7

Moderate

Vehicle/item operable but comfort/convenience item(s) inoperable. Customer dissatisfied

6


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FMEA Appendix

Suggested PFMEA Severity Evaluation CriteriaLow Vehicle/item operable but comfort/convenience item(s) operable at a reduced level of performance. Fit and finish/squeak and rattle item does not confirm. Defect noticed by most customers (greater than 75%) Fit and finish/squeak and rattle item does not confirm. Defect noticed by 50% of customers Fit and finish/squeak and rattle item does not confirm. Defect noticed by discriminating customers (less than 25%) No discernible effect Or 100% of product may have to be reworked, or vehicle/item repaired offline 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, online but out-of-station 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 5

Very Low

4

Minor

3

Very Minor

2

None

1


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FMEA Appendix

Suggested PFMEA Occurrence Evaluation CriteriaProbability Very High Failure : Persistent Likely Failure Rates * 100 per thousand pieces 50 per thousand pieces 20 per thousand pieces 10 per thousand pieces Moderate Failures : Occasional 5 per thousand pieces 2 per thousand pieces 1 per thousand pieces Low : Failures Relatively Few 0.5 per thousand pieces 0.1 per thousand pieces 0.01 per thousand piecesBPMS - FMEA Rev 1.0

Ranking 10 9 8 7 6 5 4 3 2 144

High : Frequent Failures

Remote: Failure is UnlikelyNational Quality Department

FMEA Appendix

Suggested PFMEA Detection Evaluation CriteriaDetection Criteria Inspection Types A Almost Impossible Very Remote Remote Very Low Low Absolute certainty of nondetection Controls will probably not detect Controls have poor chance of detection Controls have poor chance of detection Controls may detect B X C X X X X X Cannot detect checked or is not 10 9 8 7 6 Suggested Range Detection Methods of Ranking

Control is 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 {Statistical Process Control} is based on variable Control gauging after parts have left the station, or Go/No Go gauging performed on 100% of the parts after parts have Error detection in subsequent left the station operations, OR gauging performed on setup and firstpiece check(for set up causes only)

Moderate

Controls may detect

X

5

Moderately High

Controls have good chance to detect

X

X

4


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FMEA Appendix

Suggested PFMEA Detection Evaluation CriteriaHigh Controls have good chance to detect X X Error detection instation, or error detection in subsequent operations by multiple layers of acceptance: supply, select, install, verify. Cannot accept discrepant part. Error detection instation, (automatic gauging with automatic stop feature). Cannot accept discrepant part. Discrepant parts cannot be made because item has been error-proofed by process/product design. 3

Very High

Controls almost certain to detect

X

X

2

Very High

Controls detect

certain

to

X

1

Inspection Types: A: Error-proofed B: Gauging National Quality Department C: Manual Inspection

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Questions ?


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