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Transcript of FMEA Risk Management
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
for Today’s Business Environment
July 2007
Featured Speaker
Angelo ScangasPresident, QSG
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
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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
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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.
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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
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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….
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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
7/18/2007Quality Support Group, Inc.
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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
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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
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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.
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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
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
Function
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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
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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.
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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?
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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
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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
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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
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
Function
Critical
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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
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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
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
Function
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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
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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?
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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
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
Function
VOC
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FMEA
Determine the effects of potential failures.
Potential EffectsPotential Effects
Effects of the failure mode on the customer(internal or external)
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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.
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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
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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
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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.
7/18/2007Quality Support Group, Inc.
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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
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
Function
Root Cause AnalysisData
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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
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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
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
Function
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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.
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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
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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
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
Function
Think Prevention
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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
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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
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
Function
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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).
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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
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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
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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?
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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
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
Function
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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
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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?
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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
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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!!!
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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.
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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
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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
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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
Slide 53 7/18/2007 aras.comCopyright © 2007 Aras Corporation All Rights Reserved Aras Confidential
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
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FMEA
Slide 55 7/18/2007 aras.comCopyright © 2007 Aras Corporation All Rights Reserved Aras Confidential
FMEA Libraries
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Process Flow Diagram
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Control Plan
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FMEA + PFD + CP Connectivity
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FMEA Action Item Notification and Sign Off
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FMEA Analysis
Slide 61 7/18/2007 aras.comCopyright © 2007 Aras Corporation All Rights Reserved Aras Confidential
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
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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
for Today’s Business Environment
FMEARisk Management
for Today’s Business Environment
July 2007
Featured Speaker
Angelo ScangasPresident, QSG