FMEA

aras.com

Aras CorporationHeritage Place

439 South Union StreetLawrence, MA 01843

[978] 691-8900www.aras.com

Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential

Solutions for Performance Driven CompaniesMicrosoft Enterprise Open Source

FMEARisk Management

for Today’s Business Environment

FMEARisk Management


July 2007

Featured Speaker

Angelo ScangasPresident, QSG

[email protected]

Slide 2 7/18/2007 aras.comCopyright © 2007 Aras Corporation All Rights Reserved Aras Confidential

Featured Speaker

Angelo Scangas [email protected]

President, QSG www.QualitySupportGroup.com

Specializes in consulting & training for:FMEA & risk managementQuality process improvementLean six sigmaISO/TS certificationAdvanced product quality planning (APQP)CAPA & problem solvingInternal auditingProject managementSPC

Angelo is a member of the ASQ Quality Management and Automotive Divisions, as well as AIAG, serving as a Certified AIAG, IAOB and RAB-Lead Auditor.

Angelo Scangas

President, QSG

webcast


Business: Product Development & Quality ComplianceOpen Source Enterprise Solutions for:► APQP, FMEA, CAPA, ISO Documents► PLM New Product Introduction► Project Program Management► Configuration & Change Management

Technology: Microsoft Enterprise Open Source[i.e. No Charge / FREE Software]

Established in: 2000

Offices: Massachusetts (HQ), Michigan, California

“Proven Solutions used by Leading Companies”

200520052005

200620062006

Most AdvancedTechnology Companies

Aras Overview


New Era Ohio, LLC

Recent DownloadsRecent Downloads

FMEAFailure Mode and Effects Analysis

Risk Management

Angelo G. ScangasPresident

Quality Support Group, Inc.Peabody, MA 01960

978-430-7611 [email protected]

FMEA

Agenda• Introduction• FMEA as a Risk Management Tool• Failure Mode and Effects Analysis (FMEA)

Basic Concepts• Design & Process FMEA Methodology• FMEA Implementation Techniques• Dollarization of FMEAs

7/18/2007Quality Support Group, Inc.

All rights reserved 7

FMEA

Course Objective

Participants will understand and

be able to effectively apply and

sustain the FMEA Methodology as a

Risk Management and Preventive

Action tool.



FMEA WHAT IS A FMEA?The Failure Mode and Effect Analysis (FMEA) is a Prevention Technique used to define, identify and eliminate potential problems from a system, sub-system, component or a process.

• Focus on Prevention• An assessment of Risk

SafetyRegulatoryCustomer SatisfactionProgram

• Coordinated/Documented team effort

• A method to determine the need and priority of actions



FMEA

So, is this something new?

No!!!Origins in Safety (Part of the Dupont Safety Process)Started in the Aerospace industry in the 1960’s followed by:

US Navy (AS9100)FDA (cGMP)Automotive Industry (TS 16949)Microelectronics IndustryMedical Devices Industry (ISO 13485)Electronics IndustryPetroleum refineriesMilitary Logistics Supportto name a few….



FMEA

Criticisms of FMEAFMEA often misses key failures

FMEA performed too late does not affect key product/process decisions

The FMEA Process is tedious

The Risk Priority Number is not a good measure of Risk



FMEA

Process

PDP Overview

Business

Phase 0 Phase 4Phase 3Phase 2Phase 1

Concept Developed / Business Rationale

Definition Complete & Design Feasibility Demonstrated

Design, Development, Vehicle Integration and Parts Authorized

PPAP/IPPAP, Equipment, Tooling and Processes Ready, FPE Vehicles Built, Approved to Launch

Project Close Out and Make Good

Business Rationale Developed

Base E.O. Assigned

Initial Service Life Cycle Costs

Visual or Physical Rep. of Concept

Full Vehicle Requirements Defined

Research of existing knowledge

Business Case Confirmation

After Action Reviews

Business Case Developed

Resources Assigned

Project Plan Complete

Design Risk Assessment (FMEAs)

System, Sub-System, & Vehicle Specs. Developed

Make vs. Buy decisions & sources selected

Styling Inputs

Manufacturing Process Definition

Containers, Crating, Material Handling Reqmnts.

Process Risk Assessment (PFMEA)

Process Control Plan

Training Plans

Process Verification

Product Validation

Systems, Sub-systems, and Components are Qualified

After Action Reviews

Make Good Reports

Business Case Confirmation

Production System Validation

PPAP/IPPAP

Plant Training

FPE Vehicles Built

Motorcycle Support Information

Regulatory Req’s Complete & Documented

Project Records / Documentation Collected

Project Reviews / Technical Reviews Ongoing

Operation Instructions

Make Good Reports

Design

Prelim. Mfg Assessment

Life Cycle Plan

Approved & Project Started



FMEA

OVERVIEW OF THE FMEA PROCESSDefine the scope of the study.

Scope Definition WorksheetSelect the FMEA team.Team Start-Up.

Team Start-Up Worksheet.Review Design Intent / Process Function and the process (PFMEA) or product (DFMEA) to be studied.

MRDProcess: Flowchart or TravelerProduct: Blueprint or Schematic



FMEAOVERVIEW OF THE FMEA PROCESSIdentify all failure modes & the corresponding effects.Rate the relative risk of each failure mode and effect.

Severity

Identify all potential causesRate the relative risk of each cause.

Occurrence

Identify all current design/process controls to prevent/detect the failure mode. Rate the relative risk of all controls.

Detection/Prevention

Prioritize for action.Calculate the RPN (risk priority number).Use the Pareto Principle.

Take action.Calculate the resulting RPN.



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken

Action ResultsResponse &

TragetComplete

Date

RecommendedActions

RPN

Detec

CurrentProcessControls

Occur

PotentialCause(s)/

Mechanism(s)Of Failure

Class

Sev

PotentialEffect(s) of

Failure

Potential FailureMode

Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function



FMEA

TimingOne of the most important factors for the successful implementation of an FMEA program is timeliness.

It is meant to be a “before-the-event” action, not an “after-the-fact” exercise.

Actions resulting from an FMEA can reduce or eliminate the chance of implementing a change that would create an even larger concern.

AS1

Slide 15

AS1 qsg, 2/17/2007



FMEA

DFMEA Scope Worksheet

Product: Date:Scope Defined by:

Part 1: Who is the customer?Part 2: What are the product features and characteristics?Part 3: What are the product benefits?Part 4: Study the entire product or only components or sub-assemblies?Part 5: Include consideration of raw material failures?Part 6: Include packaging, storage, & transit?Part 7: What are the manufacturing process requirements & constraints.



FMEA

PFMEA Scope Worksheet

Part 1: What process components are to be included in the investigation? Part 2: Who is the customer?Part 3: What process support systems are to be included in the study?Part 4: To what extent should input materials be studied during the investigation?Part 5: What are the product/process requirements & constraints?Part 6: Should packaging, storage, and transit be considered part of this study?



FMEA Design FMEA

•Led by Design Responsible Engineer

•Customer includes End User, Other Design Teams and Manufacturing

•Does not rely on process controls to overcome potential weaknesses in the design

•Does take into account the technical/physical limits of a manufacturing/assembly process



FMEA

It is initiated by a member from the Operations or Engineering.

Representatives from Design, Assembly, Manufacturing, Materials, Quality, Service and the Area Responsible for the next assembly should be involved.

The Process FMEA assumes the product/process as designed will meet the design intent.

Process FMEA



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function

Critical



FMEA

Design Intent and Process Function

Defines the function of the product or the process

1. Name of item or system

2. Function of item per design intent

4.5.1 Business Case Review



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function



FMEA

(D) Manner in which a component, subsystem or system could fail to meet design intent

(P) Manner in which the process could fail to meet the process requirements and/or design intent

Using this definition a failure does not need to be readily detectable by a customer to still be considered a failure.

Potential Failures



FMEA

Types of Questions to ask

How can the process/part fail to meet specifications/requirements?

Regardless of the engineering/requirement specs., what would the customer consider objectionable?

When this operation is being done, what could go wrong? Or, what tends to go wrong?



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function

VOC



FMEA

Determine the effects of potential failures.

Potential EffectsPotential Effects

Effects of the failure mode on the customer(internal or external)



FMEA

Severity Ranking

Rating of 1 to 10 with 10 being the most severe impact.

Use a scale.Use the same scale throughout.

To assign this rating, must assume the failure mode has occurred.Assign severity rating for every possible effect.

May have to estimate rating.



FMEA

Severity

1No effectNone

2System operable with minimal interferenceVery Minor

3System operable with some degradation of performanceMinor

4System operable with significant degradation of performanceVery Low

5System inoperable without damageLow

6System inoperable with minor damageModerate

7System inoperable with equipment damageHigh

8System inoperable with destructive failure without compromising safetyVery High

9Very high severity ranking when a potential failure mode affects safe system operation with warning

Hazardous with warning

10Very high severity ranking when a potential failure mode effects safe system operation without warning

Hazardous without warning



FMEA

Process Severity Evaluation Criteria

Effect Severity of effect Ranking

Hazardous, without warning

Hazardous, with warning

Very High

High

Moderate

Low

Very Low

Minor

Very Minor

None

May endanger personnel. Involves non-compliancewith gov’t. regulation without warning.Same as above only with warning

Major disruption to production line; 100% of product scrappedMinor disruption to production line; customerdissatisfied

Product operable; not cosmetically satisfactory

100% of product may have to be reworked; some customer dissatisfaction

Fit/finish defects noticed by most customers

Same as above, but, defect noticed by average customerSame as above, but, defect noticed only by the discriminating customerNo effect

10

9

8

7

6

5

4

3

2

1



FMEA Classification

This column may be used to classify any special product characteristics (e.g., critical, key, major, significant) for components, subsystems, or systems that may require additional design or process controls.



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function

Root Cause AnalysisData



FMEA

Determine the potential causes of each of the failure types. What are the potential causes of the failure mode?

A cause and effect (fishbone) diagram may be helpful here.

Potential Causes

(D) An indication of a design weakness resulting in the failure mode

(P) How the failure could occurTypical failure causes: Improper torque, Inadequate gating, inadequate or no lubrication, part mis-located



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function



FMEA

Occurrence Ranking

How often will each cause occur?Ignore the severity of the effect and any possibility that it will be detected. Rating on a 1 to 10 scale with 10 being the most frequent.

Define root causes of each failure modeUse data where possible

Customer complaints.Defect analysis.



FMEA

Occurrence Evaluation Criteria

Probability of Possible Failure Cpk Rankings Failure Rates

Very high, failure isalmost inevitable

High, repeated failures

Moderate, occasional failures

Low, relatively fewfailuresRemote, unlikely

> 1 in 21 in 3

1 in 81 in 20

1 in 801 in 4001 in 20001 in 15,0001 in 150,000

< 1 in 1,500,000

< 0.330.33

0.510.67

0.831.001.171.331.501.67

>

>>

>>>>>

>

109

87

654321



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function

Think Prevention



FMEA

Current Controls

What are the current design or process controls to prevent or detect the potential failure mode?

Prevention of cause of failure mode or reduction in occurrence.Detection of cause of failure mode leading to Corrective Actions



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function



FMEADetection / Prevention RatingThe assessment of the ability ofthe “design/process controls” to identify apotential cause or design weaknessbefore the component or system isreleased for production/shipped to the customer.Rate the Detection from 1 to 10 with 10 being no chance of detecting the failure mode or its effect(s).



FMEA DETECTION (D) Evaluation Criteria

1Design Control will almost certainly detect a potential cause/mechanism and subsequent failure mode.

Almost Certain

2Very high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Very High

3High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

High

4Moderately high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Moderately High

5Moderate chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Moderate

6Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Low

7Very low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Very Low

8Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Remote

9Very remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode.

Very Remote

10Design Control will not and/or can not detect a potential cause/mechanism and subsequent failure mode; or there is no Design Control.

Absolute Uncertainty

RankingCriteria: Likelihood of DETECTION by Design ControlDetection



FMEA

Process Detection Evaluation Criteria

Qualitative probability Quantitative probability Rankingof not detecting

Remote likelihood that product would beshipped containing this defect

• detection reliability at least 99.99%• detection reliability at least 99.80%Low likelihood that product would be

shipped containing this defect• detection reliability at least 99.5%• detection reliability at least 99%Moderate likelihood of detection• detection reliability at least 98%• detection reliability at least 95%• detection reliability at least 90%High likelihood that product would be

shipped containing this defect• detection reliability at least 85%• detection reliability at least 80%Extreme likelihood that product would beshipped containing this defect

1/10,0001/5,000

1/2,0001/1,000

1/5001/2001/100

1/501/20

1/10 +

12

34

567

89

10



FMEA

6. Risk Assessment

SeverityThe impact(s) of failure

OccurrenceThe likelihood of a failure occurrence from an identifiedcause under current controls

DetectionHow detectable is the failure at any point?



FMEA

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

DetectPrevent

RPN

DET

OCC

SEV

ActionTaken


TragetComplete

Date

RecommendedActions

RPN

Detec


Occur

PotentialCause(s)/


Class

Sev


Failure


Item / Process Step

Function



FMEA

7. Risk Priority Number (RPN)

Severity 1 10none hazardous

Occurrence 1 10remote very high frequency

Detection 1 10very detectable extremely undetectable

S x O x D = RPN1 x 1 x 1 = 15 x 5 x 5 = 12510 x 10 x 10 = 1000



FMEA

By giving every Failure Mode a RPN rating, we can now prioritize which failure modes to address nowand which failure modes we address later.

So, why do we need tocalculate the RPN’s?



FMEA

REDUCING THE POTENTIAL RISK:

First line of defense -Eliminate causes of failure so that it does not OCCUR - Implement prevention techniques

Second line of defense -Reduce probability of OCCURRENCE

Third line of defense -Improve DETECTION of the failure



FMEA

Priority for Action

Involve Management to assign resources (human/financial) for action items to reduce the RPN.Create a What, Who, How and When Matrix in order to monitor action items.The FMEA Team Leader will check the status of the FMEA follow-up and schedule review meetings as necessary.Re-calculate the RPN as action items are completed and validated. Calculate savings ($$$) if possible based on the reduction of the potential risk.

FMEA IS A “LIVING” DOCUMENT!!!



FMEA

Disagreements on Ratings?

Use data where possible.Try to come to consensus.If consensus fails:

Team may elect to defer to one of its members.Average individual ratings.

Only average if ratings are close (spread of 2 or 3 points maximum).

Get the process expert involved.



FMEA

FMEA – Reduce Future Liability

FMEA can be a legal documentCourts can take a favorable view of the liability if proper FMEA was conducted and risks were analyzed/acted uponPunitive damages can be eliminated and/or reduced



FMEA

FMEA Pitfalls – A review

Cross-functionality of the TeamLeadership of the TeamScope DefinitionData AvailabilityNO Customer InvolvementMeeting Management problemsS,O,D criteria decisions (too long!) No supplier involvementCommitted resourcesManagement Commitment & Support



FMEA

In Conclusion

FMEA does take time and effortIt does reduce the risk to your customerIt does reduce the risk to youIt does save time to product launchIt does help with Continuous Improvement

Case Study

FMEA Risk ManagementLeading Approaches

Delphi


Overview

Solution:

Aras Quality PlanningApproach:

Process-oriented approach with data-driven quality documents• DFMEA, PFMEA• Process Flow, Control Plans• Part Submission Warrants, PPAPAll tie together and feed each other creating customer deliverables

Company:

Thermal Division – Troy, MIMarkets:

Automotive SupplierCustomers:

GM, Ford, DCX, Renault/NissanProducts:

Designs & manufactures advanced cooling systemsChallenge:Quality Planning deliverables coordination duringProduct Development

Business Profile

Aras Innovator


FMEA


FMEA Libraries


Process Flow Diagram


Control Plan


FMEA + PFD + CP Connectivity


FMEA Action Item Notification and Sign Off


FMEA Analysis


Closed Loop Processes for Quality Products

Quality Events includingCustomer Complaints,

Nonconforming Material,and Audits can initiate CAPA

CAPA can triggerEngineering Changes

Assign, Manage and Track8D Activities

5 Phase CAPA

Quality Planning documentsrelated to the appropriate Partin a Product Structure

Coordinate & Collaborate onNew Product ProgramsAPQP ActivitiesPPAP Deliverables

DFMEA, PFMEA, PFD, Control Planall related to Parts within a Program

Integration of Solutions

ProgramManagement

ProductEngineering

Quality Events can Result inModification of ISO Quality

documents, FMEA libraries or templates

Quality Planning documents can be used in analysis of Quality Events

QualityPlanning

QualitySystems


Questions?

Angelo G. ScangasPresidentQuality Support Group, Inc.978-430-7611 [email protected]

Aras [email protected]

Recorded Presentationwill be available at www.aras.com

aras.com

Aras CorporationHeritage Place

439 South Union StreetLawrence, MA 01843

[978] 691-8900www.aras.com

Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential

Solutions for Performance Driven CompaniesMicrosoft Enterprise Open Source

FMEARisk Management


FMEARisk Management


July 2007

Featured Speaker

Angelo ScangasPresident, QSG

[email protected]