Function:

Function of the item being analyzed to meet the Design intent. Includes information regarding the environment in which this system operates. Failure Mode: A Failure Mode is the manner in which a component, assembly or system could potentially fail to meet the design intent. Typical failure mode may include, not limited to:
Yield; Fatigue; Material Instability; creep; wear; corrosion; Cracked Deformed; Leaking

What is FMEA? FMEA is a systemised group of activities to: Recognise and evaluate the potential failure of a product / process and its effects Identify actions which could eliminate or reduce the chance of potential failure occurring Document the process

Why FMEA? For a company policy where continuous improvement is emphasized for its product, process FMEA is a living document

Who should do FMEA? Cross Functional Team Effort with a leader Team of knowledgeable individuals Ex. Expertise in Design, Mfg., Assly, Quality. Etc. Team should include representatives of sub-contractors and/or customers

QS-9000 requirements FMEA shall consider special characteristics Aiming defect prevention rather than defect detection Use FMEA manual & CFT approach

When FMEA should be done? Essence is timeliness Pro-Active rather than reactive Before process failure mode occurs Advantages of FMEA Avoids late change crisis Reduces or eliminates chance of implementing corrective change excellent technique for preventive action interactive process which is never ending

Process Function/ Requirements

Potential Failure Mode

Potential Effect(s) of Failure

Specify the description and Function of the process List out Outputs of the Process

Example Process function / description Manual application of wax inside door Machining of outer diameter To cover inner door at minimum thickness to retard corrosion Outer diameter, run-out, free from tool mark

Requirements

Potential Failure Mode

Two Assumptions are

Potential Effect(s) of Failure

Sev

1. 2.

Consider all inputs are acceptable Consider the Design is acceptable List the failure modes those are possible to occur against the requirements specified in the previous column. Apart from Engg. Specification, what would a customer consider objectionable CUSTOMER is Next opn. Subsequent Opn. End user Example
Bent, Diameter oversize, Diameter undersize, Cracked, Deformed, Open Circuited, Burred

OD not clear Is it a failure mode in machining of casting / forging?

Potential Effect(s) of Failure List the effects of failure in Next operation Subsequent operations Customer End user/ Environment Describe the effects using the terminology specified in Severity rating table For each failure mode, more than one effect can be listed

Sev

Class

Severity

C l a s s

Potential Cause(s) / Mechanis m (s) of Failure

Assess the seriousness of the effect in a 1-10 scale This rating applies to EFFECT only (i.e. previous column) Consider the Design FMEA Consult subsequent Mfg./ Assembly plant Safety related effects should be rated in Nos.9 or 10 While giving ranking consider only the required criteria (i.e. next opn. / vehicle)

Classification

Potential Cause(s) / Mechanism (s) of Failure

O cc ur

Classify special product characteristics (e.g. critical, key, major)

Potential Cause(s) / Mechanism (s) of Failure

Occ ur

Current Process Control prevention

Current Process Control detection

List the first level potential causes such as man machine tool process parameter Fixture etc. List the root causes under the first level causes using WHY? WHY? analysis Describe the causes in such a way that can be eliminated or controlled Dont use ambiguous statements such as operator mal-functioning Fixture problem etc. Use the cause and effect diagram, if required consider input materials in last iteration of cause analysis Contd..

Occurrence

Current Process Controls

Current Process Controls

prevention

Detection

Estimate the probability of occurrence on a 110 scale Rate against each causes Use past data as a basis (cpk/rejection %) for ranking Document the basis of occurrence ranking For a new process, if there is no previous experience, use team judgement Dont consider failure-detecting measures while giving ranking (100% inspection.)

Current Process Control Prevention Type of Controls Level P-Prevention Type Prevention of causes Detection of causes & leading to corrective actions Detection of defect

Current Process Control Detection

D et ec t

RP N

Examples Mistake proofing SPC, Visual control etc. 100% inspection, patrol inspection

D- Detection

List the existing controls, which can detect the causes or failure mode While listing, specify the frequency of detection measures

Examples Visual Check, one per shift for film thickness SPC chart five pieces in an hour On-line monitoring of crimping force Auto-control of temperature 100% on-line inspection Visual monitoring of Ammeter

Detection Assess the probability of controls listed in the previous column, which will detect the cause or failure mode While giving ranking, assume the failure is occurred Dont assume ranking is low because the occurrence is low Random controls should not influence detection ranking One detection ranking can be assigned to multiple controls

RPN

Recommended Action

Responsibility Recommended Action & Target Completion Date Action Results

Policy for RPN to take action Define a target RPN and anything above that can be considered for action. For Ex. It can be 50. Considering 95% of the failures are attended consider only high priority no. for take action and review periodically As a first priority, take action on causes to reduce occurrence ranking The next priority is to consider action on controls to reduce detection ranking severity ranking can be reduced by elimination of failure mode by change in processes or design

Responsibility & Target Completion Date

Actions Taken

Sev

Oc c

De t

RP N

Specify the responsibility and target completion date for every actions identified During APQP, the FMEA completion dates should be prior to Production run

PROCESS FMEA QUALITY OBJECTIVES PROCESS IMPROVEMENTS: The FMEA drives process improvement as primary objective. With an emphasis on Error / Mistake proofing solutions HIGH RISK FAILURE MODES: The FMEA address all high-risk failure modes as identified by FMEA team, with executable action plans. All other failure modes are considered. CONTROL PLANS: The pre launch and production Control Plan consider the failure modes from the process FMEA. INTEGRATION: The FMEA is integrated and consistent with process flow diagram and the process control plan. The process FMEA considers the design FMEA, if available as part of its analysis. LESSONS LEARNED: The FMEA considered all major lessons learned as input to failure mode identification SPECIAL OR KEY CHARACTERISTICS: The FMEA identifies appropriate key characteristics candidates as input to the key characteristics selection process, if applicable due to company policy. TIMING: The FMEA is completed during the Window of opportunity where it could most efficiently impact the product design of product or process. TEAM: The right people participate as part of the FMEA team throughout the analysis and are adequately trained in FMEA methods DOCUMENTATION: The FMEA is completely filled out by the book including action plan and new RPN values. TIME USAGE: Time spent by FMEA team as early as possible is an effective & efficient use of time, with a value added result. This assumes recommended actions are identified as required and the actions are implemented.

Action Results

Actions Taken

Sev

Occ

Det

RPN

Describe the verification results Where effectiveness measure is required, specify the target date accordingly After the assessment of the actions taken, reassess the values of severity, occurrence, detection and RPN