FMEA Overview What is FMEA?

FMEA Concepts FMEA Overview • What is FMEA? • AIAG (Automotive Industry Action Group) Defines FMEA in the 3rd edition of their FMEA manual as: An FM...
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FMEA Concepts

FMEA Overview • What is FMEA? • AIAG (Automotive Industry Action Group) Defines FMEA in the 3rd edition of their FMEA manual as: An FMEA can be described as a systematic group of activities intended to: (a) Recognize and evaluate the potential failure of a product or process and the effects of that failure. (b) Identify actions that could eliminate or reduce the chance of the potential failure occuring. occuring (c) Document the entire process It is complementary p y to the p process of defining g what a design or process must do to satisfy the customer. Copyright © 2007 SigmaFlow. All rights reserved. CONFIDENTIAL content, not to be redistributed without express SigmaFlow permission.

FMEA Overview • How are we going to use FMEA? • We are going to doing what is called a Process FMEA – Focused on improving a process by identifying the Potential Failures, Causes and opportunities for detection/identification. – Done when we can “map” map the process and break each piece into the components of our FMEA.

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FMEA Components

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FMEA-Process Map Linkage

The Process Map we create will define the activities and variables That drive the Failure Modes Effects Analysis Copyright © 2007 SigmaFlow. All rights reserved. CONFIDENTIAL content, not to be redistributed without express SigmaFlow permission.

Failure Mode “Tree”- Each Activity will Expand

Activity

Failure Mode

Failure Mode 1 Activity Failure Mode 2

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Effect

Severity

Effect 1

Severity Score

Effect 2

Severity S it Score

Effect 1

Severity Score

FMEA- Logic Path to Improvement

Activity

What can go wrong? (Failure Mode)

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What are the Effects?

How Bad is it

What can be done? (Action Plan)

FMEA- Logic Path to Improvement

Activity

What can go wrong? (Failure Mode)

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What are the Causes?

How often does it happen?

What can be done? (Action Plan)

FMEA- Logic Path to Improvement

Activity

What can go wrong? (Failure Mode)

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How can this be prevented and detected?

How good is this method of detection?

What can be done? (Action Plan)

Getting Started- Scoping to Find Actions High Level Process Map (Scope)

The High Level •The Process Mapping will scope our Study. • We want to cast as wide a net as our resources will permit. • The fish this net will catch are the action items for improvement.

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Detailed Process Group

Activity

Failure Mode

Effect, Cause, Control

Action

FMEA and Scoping • How do we cover a wide enough area to be thorough, yet narrow enough to have the resources needed to prod produce ce actionable res results? lts? • P Prioritizei iti W should We h ld prioritize i iti th the activities ti iti or ffactors t that are most in need of attention first. • Pace- Study activities at an appropriate level of detail that allows us to complete the entire study and have time and d resources tto workk on action ti items. it

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FMEA-Process Map Linkage- Prioritize

Sometimes we will need to prioritize the activities or factors we study. A cause and effect matrix will help us do that. Copyright © 2007 SigmaFlow. All rights reserved. CONFIDENTIAL content, not to be redistributed without express SigmaFlow permission.

Pace Yourself- Identification vs. Action • Imagine you were going to run a marathon, would you sprint the first mile and walk the rest? • Th The energy and dd detail t il we apply l tto thi this analysis l i should h ld b be consistent throughout. • Using the High Level Process Map to divide the process process, we will evenly distribute the detail in the activities to make sure we can “finish” the race.

• Prioritizing the activities is insurance in case you do still start to fast!

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Bringing it Together- Risk Priority Number • To prioritize the Failures we should focus on first we use a Risk Priority Number (RPN). The highest RPN represents: represents • The Most severe Effect • That Occurs Most Often • That we can’t Detect RPN= Severity(S) x Occurrence (O) x Detection (D) Example: RPN (210)= S(6) x O(7) x D(5)

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Failure Modes and Effects Analysis (FMEA)

Quickly analyze your FMEA using included charts

FMEA Analysis

RPN prioritized in PARETO a a ys s analysis

Making Improvements- Action Items and PRPN • Actions Identified in each logic path should be reviewed. • Careful consideration given that Critical Factors have been addressed. • Other Oth Considerations; C id ti • Severity should be addressed first, then Occurrence and finally Detection Detection. • Design/Process changes to reduce Severity and Occurrence ratings. • Mistake Proofing with focus on prevention not detection for Detection Ratings.

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PRPN- Post Risk Priority Number • Following the identification of Action items the PRPN should be calculated. The PRPN is an assessment of the e expected pected impro improvement ement if the actions are taken. • The easiest improvements that produce the greatest change may be your first targets targets. • Critical Factors should always be addressed first since they represent potential safety issues.

Copyright © 2007 SigmaFlow. All rights reserved. CONFIDENTIAL content, not to be redistributed without express SigmaFlow permission.

Failure Modes and Effects Analysis (FMEA)

Quickly analyze your FMEA using included charts

FMEA Analysis RPN/PRPN Analysis