Failure Mode Effects Analysis

FMEA

A systematic group of activities intended to:

Recognize the potential failure(s) of a product or process and the severity of effect of that failure(s). Identify critical characteristics. Rank order potential design and process deficiencies. Identify actions that can eliminate or reduce the chance of the potential failure from occurring and reaching the customer. Document the process.

A living document.

Failure Mode Effects Analysis

Guided by Customer Requirements Customers are internal Customers are external Focus is on risk reduction with Design Manufacturing

Failure Mode Effects Analysis

Ideally used before a failure mode is unknowingly designed into a product or process. Is also very useful with existing processes and products. Intended to be an interactive process that never ends. (Living Document) Requires a cross functional, multi-level team approach. Supports Duracell Planning for Quality (DPQ) phases II and III.

Failure Mode Effects Analysis

FMEA Types System

Focus is on functions and interactions among systems. Focus is on potential failure modes of products due to design deficiencies and errors. Focus is on potential failure modes caused by process deficiencies.

Design

Process

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Team Selection

Cross Functional and Multilevel Operators, Mechanics, Engineers, Leaders Team Leader Designated Must be Empowered to implement actions

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Define Process

Develop a Process Flow diagram that is representative of the process as it truly is.

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process
Detail Failure Mode Causes Effects

Brainstorm failure modes. Select and define failure modes that impact critical characteristics. Identify root causes. Define effects of failure mode. Determine how often failure modes occur. Determine current controls ability to detect.

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Calculate Risk Numbers

Calculate Risk Priority Number (RPN) for each failure mode. RPN = Worst severity x most frequent occurrence x worst ability to detect.

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Build Paretos One for Severity One for Severity x Occurrence One for RPN
Identify Vital Few Failure Modes

Build Pareto Chart

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Develop Recommended Actions

Develop and implement actions on Vital Few Failure Modes

FMEA Process

Team Selection

Define Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

FMEA Process

Detail Failure Mode Causes Effects

Calculate Risk Numbers

Build Pareto Chart

Develop Recommended Actions

Evaluate effect of actions taken on process in terms of severity, occurrence and detection. Recalculate RPN and reassess risk number. Reprioritize and repeat.

FMEA Format
Process Process Cell Size Cell Size Cell Chemistry Cell Chemistry
Process Function Potential Failure Mode Potential Effect(s) of Failure S e v C l a s s

Process Responsibility FMEAProcess Responsibility Due Date FMEA Due Date FMEAFMEA Number Number
Potential cause(s) of Failure O c c Current Controls D e t S * O R P N

Page 1 of 1 Prepared by Page 1 of 1 Prepared by FMEA Date (Orig.) Date (Orig.)(Rev.) FMEA
Recommended Action(s) Area/Individual Responsible & Completion Date Actions Taken

(Rev.) Action Results s e v o c c d e t S * O R P N

Severity Rating

Severity Severity is a rating corresponding to the seriousness of an effect of a potential failure mode. No Effect Very Slight Effect Slight Effect Minor Effect Moderate Effect Significant Effect Major Effect Serious Effect 1 2 3 4 5 6 7 8 No effect on system or output performance or on subsequent processes. Customer will probably not notice the failure. Nuisance Fault noticed. Slight effect on output performance. Customer slightly annoyed. Nuisance fault obvious. Minor effect on output or process performance. Slight deterioration. Chronic nuisance fault. Moderate effect on performance. Customer dissatisfied. Nuisance repair required. Performance degraded but safe. Discomfort. Repair required. Non-vital part nonfunctional. Rework/Repairs necessary. Performance severely affected but safe. Dissatisfied customer. Subsystem inoperable. Equipment damaged. System inoperable but safe. Very dissatisfied customer. Potentially hazardous failure. Safety related but gradual failure.

Very Serious 9 Effect Hazardous Effect 10 Hazardous failure. Safety related sudden failure, Government regulation non-compliance.

Severity Rating
Severity Severity is a rating corresponding to the seriousness of an effect of a potential failure mode. No Effect Very Slight Effect Slight Effect Minor Effect Moderate Effect Significant Effect Major Effect Serious Effect 1 2 3 4 5 6 7 8 No effect on system or output performance or on subsequent processes. Customer will probably not notice the failure. Nuisance Fault noticed. Slight effect on output performance. Customer slightly annoyed. Nuisance fault obvious. Minor effect on output or process performance. Slight deterioration. Chronic nuisance fault. Moderate effect on performance. Customer dissatisfied. Nuisance repair required. Performance degraded but safe. Discomfort. Repair required. Non-vital part nonfunctional. Rework/Repairs necessary. Performance severely affected but safe. Dissatisfied customer. Subsystem inoperable. Equipment damaged. System inoperable but safe. Very dissatisfied customer. Potentially hazardous failure. Safety related but gradual failure.

Very Serious 9 Effect Hazardous Effect 10 Hazardous failure. Safety related sudden failure, Government regulation non-compliance.

Occurrence Rating
Occurrence Occurrence is a rating corresponding to the rate at which a failure mode occurs before any detecting measures are applied. Occurrence Rating Cpk Notes Failure Rate Almost 1 Failure unlikely. Similar processes or Cpk 1.67 5.0 1 in Impossible products show no failure. 1,500,000 Remote 2 Cpk 1.50 4.5 1 in 150,000 Remote number of failures likely. Very Slight 3 1 in 15,000 Very few failures likely. Cpk 1.33 4.0 Slight 4 1 in 2000 Few failures likely. Cpk 1.17 3.5 Low 5 1 in 400 Occasional failure. Cpk 1.00 3.0 Medium 6 1 in 80 Moderate number of failures likely. Cpk 0.83 2.5 Moderately 7 1 in 20 Frequent failures likely. Cpk 0.67 2.0 High High 8 1 in 7 High number of failures likely. Cpk 0.51 1.5 Very High 9 1 in 3 Very high number of failures likely. Cpk 0.33 1.0 Almost 10 Failures almost certain to occur. Cpk0.33 1 in 3 Certain Similar processes/products show 1.0 failures.

Detection Rating
Detection
Detection is a rating corresponding to the likelihood that the detection methods or current controls will detect the failure. Almost Certain 1 Reliable detection controls are known with similar processes or products. Controls are almost certain to detect the failure mode. Very High 2 History with similar processes available. Controls very likely to detect the failure mode High 3 Controls highly likely to detect the failure mode. Moderately High 4 Controls likely to detect the failure mode. Medium 5 Controls might detect the failure mode. Low 6 Low likelihood that controls will detect the failure mode. Slight 7 Slight likelihood that controls will detect the failure mode. Very Slight 8 Very slight likelihood that controls will detect the failure mode. Remote 9 Remote likelihood that controls will detect the failure mode. Almost 10 Almost certain that controls will not detect the failure mode. No Impossible known controls available to do so.

Example FMEA
Potential Failure Mode and Effects Analysis Process FMEA Process Responsibility - Sunil Dhage Key Date

System - 4/3A Li Ion Cell Subsystem - Laser Weld Pressure Plate to Interrupter Component - Pressure Plate/Thermal Interrupter Master Drawing # 364140 Core Team: Manufacturing Development

FMEA # 97-08-01 Page # 1 Prepared by: T. Pratt, Shawn Stone, Sunil Dhage FMEA Date Orig. 8/5/97 (Rev) FILE NAME - C:\data\fmea\ppintlsr.sam

Process Function / Reqs.

Potential Failure Mode

Potential Effect(s) of Failure

S C Potential Cause(s) / e l Mechanisms v a of Failure s s 8

O Current Process Controls c c u r

Laser Weld Pressure Plate to Thermal Interrupter

Completely fails to scrap weld. (presumes automated equipment in use)

Poor placement of 4 Vision system components in tooling Impedance check OCV check Contamination on parts Parts not sitting flat 3 Incoming Inspection Operator Inspection

D e t e c t 1

R Recommended Action P N

Responsibility and Action target complete date Taken

S O D R e c e P v c t N e c t

32

24

Burn Through

loss of hermeticity damage to device safety issues leakage

10

3 Height Check Operator Inspection Machine set up wrong 2 Operator Inspection SPC Components out of 4 Incoming Inspection tolerance Welder fails to cycle 2 Operator Inspection Impedance Check OCV Check Incorrect settings 3 Vision system Visual check after thermal treatment cycle non conforming parts 3 Incoming Inspection

1 1 1 1

24 16 32 16

4 120

4 120

Example FMEA contd

System - 4/3A Li Ion Cell Subsystem - Laser Weld Pressure Plate to Interrupter Component - Pressure Plate/Thermal Interrupter Master Drawing # 364140 Core Team: Manufacturing Development Potential Failure Mode and Effects Analysis Process FMEA Process Responsibility - Sunil Dhage Key Date FMEA # 97-08-01 Page # 2 Prepared by: T. Pratt, Shawn Stone, Sunil Dhage FMEA Date Orig. 8/5/97 (Rev) FILE NAME - C:\data\fmea\ppintlsr.sam

Process Function / Reqs.

Potential Failure Mode

Potential Effect(s) of Failure

S C Potential Cause(s) / e l Mechanisms v a of Failure s s 8

O Current Process Controls C C U R

Laser Weld Partial failure to Pressure Plate weld to Interrupter Detected prior to shipment

scrap

Poor placement of 4 Vision system components in tooling Pull Test Operator Inspection Contamination on parts Parts not sitting flat Machine set up wrong Non conforming components Damage on surface of parts Incorrect settings 3 Incoming Inspection Operator Inspection 3 Height Check Operator Inspection 2 Operator Inspection Pull Test 4 Incoming Inspection 3 Operator Inspection Incoming Inspection 2 Operator Checks Pull test 3 Incoming Inspection 3 Incoming Inspection 4 Visual Inspection Incoming Inspection 4 Incoming Inspection

D R Recommended Action E P T N E C T 4 128

Responsibility and target complete date

Action Taken

S O D R e c e P v c t N e c t

120

5 4 2 5 8

120 64 64 120 128

Partial failure to weld-Undetected prior to shipment

Cell failure in field

non conforming parts Contaminated parts Damaged parts

4 8 8 2 4

120 192 256 64 128

Non conforming components Poor placement of 4 Pull test components in tooling Vision System

Pareto by Severity

Severity Pareto
15

Score

10 5 0
Burn Through Score 10 Partial Fail to Weld Undetected 8 Partial Fail to Weld Detected 8

Fails to Weld 8

Failure Mode

Pareto by Severity x Occurrence

Severity * Occurrence
34

Score

32 30 28
Score Burn Through 30 Partial Fail to Weld 32 Partial Fail to Weld 32 Fails to Weld 32

Failure Mode

Pareto by Risk Priority Number

(Severity x Occurrence x Detection)

Pareto by Risk Priority Number

300

Score

200 100 0
Sco re B urn Thro ugh 120 P artial Fail to Weld - P artial Fail to Weld 256 128 Fails to Weld 32

Failure Mode

Pareto of Top Failure Mode

Pareto of Partial Fail to Weld Causes by RPN
300 250 200 150 100 50 0
Damaged Parts Score 256 Contaminated Parts 192 Incorrect Settings 128 Poor Part Location in 128 Non Conforming Parts 64

Score

Causes

FMEA Summary
Identify Potential Failure Mode

Effect

Cause

Determine Severity

Determine Occurrence

Identify Current Controls Determine Detectability

Calculate Risk Priority Number Actions leading to Continuous Improvement