Where does Failure Mode and Effects Analysis (FMEA) come from?

Developed by the Aerospace industry in the1960s

Spread to the Automotive industry

Now used extensively across all industry sectorsRoot Cause Analysis: Documenting, implementing and closing non-

conformances

Different Types of FMEA

DesignAn analytical technique used primarily by DesignResponsible Engineer/Team as a means to assurepotential failure modes, causes and effects have beenaddressed for design related characteristicsProcessAn analytical technique used primarily by a ManufacturingEngineer/Team as a means to assure potential failuremodes, causes and effects have been addressed for process related characteristics

Root Cause Analysis: Documenting, implementing and closing non-conformances

Process FMEA

A structured approach to:•Identifying the way in which a process can fail to meet critical customer requirements

•Estimating the risk of specific causes with regard to these failures

•Evaluating the current control plan for preventing these failures from occurring

•Prioritizing the actions that should be taken to improve the process

Root Cause Analysis: Documenting, implementing and closing non-conformances

Our Focus is on Process FMEA

Concept:To identify ways the product or process can fail and then plan to prevent those failures, utilizing mistake proofing toolsand techniques.

Refer to sample sheet 2 – FMEA template

Root Cause Analysis: Documenting, implementing and closing non-conformances

Why we use FMEA?

Prevention rather than cure.Increase probability of DETECTIONIdentify biggest contributor to failures and eliminate themReduce probability of failure occurringBuild quality into the product & process.

Root Cause Analysis: Documenting, implementing and closing non-conformances

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When to use FMEA?

FMEA is most beneficial as a “before the-event” actionDesign FMEA should be done during initial design of productProcess FMEA should be done during design of manufacturing process Root Cause Analysis: Documenting, implementing and closing non-

conformances

Potential Applications for PFMEA

Outsourcing / Resourcing of productDevelop Suppliers to achieve Quality Renaissance / Scorecard TargetsMajor Process / Equipment / Technology ChangesCost ReductionsNew Product / Design Analysis

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Root Cause Analysis: Documenting, implementing and closing non-conformances

Guide to Process FMEA?

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Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 1 Scope the project

Step 2

Step 3

Brainstorm all potential failure modes

Identify potential effects of failure

Determine severity rankingsStep 4

Identify causes of failureStep 5

Guide to Process FMEA?

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Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 6 Determine occurrence ranking

Step 7

Step 8

Define current control methods

Determine Detection rankings

Calculate Risk Priority RankingsStep 9

Prioritize actionsStep 10

Step 1 - Scope Process

•Formulate cross functional team•Understand customer/process requirements•Define start and end of process•All team members walk and observe the process•Get the ‘process worker’ to explain the operation/process under review.•Make notes/observations. Root Cause Analysis: Documenting, implementing and closing non-

conformances

Definition of a failure mode

The way in which a specific process input fails - if not detected and either corrected or removed, will cause an

effect to occur.

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 2 –Brainstorm all potential failure modes

•Utilize process flow chart - break down each step•Use knowledge of previous and existing parts/processes•Review all quality information -complaints, scrap, rework, turn backs, etc.•Talk to internal and external customers.

Refer to handout Root Cause Analysis: Documenting, implementing and closing non-

conformances

Definition -Effects of failure

Effect - impact on customer requirements.Generally focused on impact on external customer, but can also include downstream processes.Does not fit/Cannot load or fastenIntermittent operation/Unscheduled DowntimePoor performance of productLost sales

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 3 – Identify potential effects of failures

For each failure mode, identify the effect(s) on the current or next process or customer downstream in the manufacturing/assembly process.

Describe the effects of the failure in terms of what the customer might notice or experience

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 4 –Determine severity ranking

Refer to handout

Root Cause Analysis: Documenting, implementing and closing non-conformances

Definition - Causes

Sources of process variation that causes the failure mode to occur. E.g. Part not in fixture properly Incorrect toolInaccurate GaugeInaccurate quote/invoicing

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 5 – Identify all potential causes off failure

How the failure could occur, described in terms of something that can be corrected orcontrolled• Experiments may have to be conducted to determine causes - use Technical Problem Solving• There could be more than one cause for each failureRoot Cause Analysis: Documenting, implementing and closing non-

conformances

Step 6 –Determine occurrence ranking

Refer to handout

Root Cause Analysis: Documenting, implementing and closing non-conformances

Definition –Current Controls

Systematic methods/devices in place to prevent or detect failure modes or causes (before causing effects)Prevention consists of mistake proofing,Automated control and set up verificationsControls consists of audits, inspection, training, etc.

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 8 -Determine detection ranking

Refer to handout

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 9 -Calculate the Risk Priority Number

RPN = Risk Priority Number

Multiply severity, occurrence and detection rankings together

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 10 - Prioritize corrective actions

Tackle highest RPN’s first• How can we reduce the occurrence?• How can we improve the detection?• Use process improvement skills• Where possible apply mistake proofingtechniques.

Root Cause Analysis: Documenting, implementing and closing non-conformances

Step 10 - Prioritize corrective actions

Standardization across all products or processesIntroduce any change in a controlled manner. Note :- Mistake proofing process will result in either lower occurrence or detection rankings

Root Cause Analysis: Documenting, implementing and closing non-conformances

Reassess rankings when action completed

FMEA must be a live documentReview regularlyReassess rankings whenever changes made to product and/or processAdd any new defects or potential problems when found

Root Cause Analysis: Documenting, implementing and closing non-conformances