FMEA Risk Management

Solutions for Performance Driven Companies
Microsoft Enterprise Open Source
Risk Management Risk Management for Todays Business Environment for Todays Business Environment
FMEA
July 2007
Featured Speaker
Angelo Scangas
President, QSG
www.QualitySupportGroup.com
Aras Corporation
Heritage Place Lawrence, MA 01843 [978] 691-8900 www.aras.com
aras.com
Angelo@QualitySupportGroup.com 439 South Union Street
Copyright 2007 Aras Corporation
All Rights Reserved
Aras Confidential
Featured Speaker
Angelo Scangas President, QSG
Angelo@QualitySupportGroup.com
Specializes in consulting & training for:

FMEA & risk management Quality process improvement Lean six sigma ISO/TS certification Advanced product quality planning (APQP) CAPA & problem solving Internal auditing Project management SPC 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
All Rights Reserved
Aras Confidential
Slide 2
7/18/2007
aras.com
Aras Overview
Business: Product Development & Quality Compliance Open Source Enterprise Solutions for:
APQP, FMEA, CAPA, ISO Documents PLM New Product Introduction Project Program Management Configuration & Change Management
Technology:
[i.e. No Charge / FREE Software]

Established in: Offices: 2000 Massachusetts (HQ), Michigan, California
Most Advanced
Technology Companies
2006 2006 2006
2005 2005 2005
Proven Solutions used by Leading Companies

Copyright 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 3 7/18/2007
aras.com
New Era Ohio, LLC
Recent Downloads
All Rights Reserved
Aras Confidential
Slide 4
7/18/2007
aras.com
FMEA
Failure Mode and Effects Analysis Risk Management
Angelo G. Scangas
President Quality Support Group, Inc. Peabody, MA 01960 978-430-7611 Angelo@QualitySupportGroup.com
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
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.
7/18/2007
Quality Support Group, Inc. All rights reserved
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, subsystem, component or a process. Focus on Prevention An assessment of Risk Safety Regulatory Customer Satisfaction Program Coordinated/Documented team effort A method to determine the need and priority of actions
7/18/2007 Quality Support Group, Inc. All rights reserved 8
FMEA
So, is this something new?

No!!! Origins in Safety (Part of the Dupont Safety Process) Started in the Aerospace industry in the 1960s followed by: US Navy (AS9100) FDA (cGMP) Automotive Industry (TS 16949) Microelectronics Industry Medical Devices Industry (ISO 13485) Electronics Industry Petroleum refineries Military Logistics Support to name a few.
7/18/2007
FMEA
Criticisms of FMEA
FMEA 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
Life Cycle Plan Approved & Project Started
PDP Overview
Phase 0 Phase 1 Phase 2 Phase 3 PPAP/IPPAP, Equipment, Tooling and Processes Ready, FPE Vehicles Built, Approved to Launch Business Case Confirmation Motorcycle Support Information Regulatory Reqs Complete & Documented Phase 4 Concept Developed / Business Rationale Definition Complete & Design Feasibility Demonstrated Business Case Developed Resources Assigned Project Plan Complete Design, Development, Vehicle Integration and Parts Authorized Business Case Confirmation Project Close Out and Make Good After Action Reviews
Business
Business Rationale Developed Initial Service Life Cycle Costs Base E.O. Assigned
Make vs. Buy decisions & sources selected
Systems, Subsystems, and Components are Qualified Product Validation
Make Good Reports
Design Risk Assessment (FMEAs) System, SubSystem, & Vehicle Specs. Developed Styling Inputs
Design
Research of existing knowledge Full Vehicle Requirements Defined Visual or Physical Rep. of Concept
PPAP/IPPAP Process Risk Assessment (PFMEA) Process Control Plan Training Plans Process Verification Plant Training Operation Instructions FPE Vehicles Built Production System Validation
Make Good Reports
After Action Reviews
Manufacturing Process Definition Containers, Crating, Material Handling Reqmnts.
Process
Prelim. Mfg Assessment
7/18/2007
Quality Support Group, Inc. Project Reviews / Technical Reviews Ongoing All rights reserved
Project Records / Documentation Collected
11
FMEA
OVERVIEW OF THE FMEA PROCESS Define the scope of the study. Scope Definition Worksheet Select 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. MRD Process: Flowchart or Traveler Product: Blueprint or Schematic
FMEA
OVERVIEW OF THE FMEA PROCESS

Identify all failure modes & the corresponding effects. Rate the relative risk of each failure mode and effect. Severity Identify all potential causes Rate 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
Item / Process Step
Function
Potential Failure Mode
Potential Effect(s) of Failure
S e v
C l a s s
Potential Cause(s)/ Mechanism(s) Of Failure
O c c u r
Current Process Controls

Prevent Detect
D e t e c
Response & R Recommended Traget P Actions Complete N Date
Action Results Action Taken S O D R E C E P V C T N
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14
FMEA
Timing
One 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
7/18/2007
15
Slide 15 AS1
qsg, 2/17/2007
FMEA
DFMEA Scope Worksheet

Product: Scope Defined by: Date:
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 subassemblies? 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?
7/18/2007
17
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
7/18/2007
18
FMEA
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.
7/18/2007
19
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Critical
7/18/2007
20
FMEA
Design Intent and Process Function

Defines the function of the product or the process
1. 2.
Name of item or system Function of item per design intent
4.5.1 Business Case Review

7/18/2007
21
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
7/18/2007
22
FMEA
Potential Failures
(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.
7/18/2007
23
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?
7/18/2007
24
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
VOC
7/18/2007
25
FMEA
Potential Effects
Determine the effects of potential failures.
Effects of the failure mode on the customer (internal or external)
7/18/2007
26
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.
7/18/2007
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FMEA
Hazardous without warning Hazardous with warning Very High High Moderate Low Very Low Minor Very Minor None 7/18/2007 Very high severity ranking when a potential failure mode effects safe system operation without warning
Severity
10
Very high severity ranking when a potential failure mode affects safe system operation with warning System inoperable with destructive failure without compromising safety System inoperable with equipment damage System inoperable with minor damage System inoperable without damage System operable with significant degradation of performance System operable with some degradation of performance System operable with minimal interference No effect Quality Support Group, Inc. All rights reserved
8 7 6 5 4 3 2 1 28
FMEA
Process Severity Evaluation Criteria

Severity of effect Ranking
10 9 8 7 6 5 4 3 2 1 29
Effect
Hazardous, without warning May endanger personnel. Involves non-compliance with govt. regulation without warning. Hazardous, with warning Same as above only with warning Very High High Moderate Low Very Low Minor Very Minor None 7/18/2007 Major disruption to production line; 100% of product scrapped Minor disruption to production line; customer dissatisfied 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 customer Same as above, but, defect noticed only by the discriminating customer No effect Quality Support Group, Inc. All rights reserved
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.
7/18/2007
30
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Root Cause Analysis Data
7/18/2007
31
FMEA
Potential Causes
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.

(D) An indication of a design weakness resulting in the failure mode (P) How the failure could occur Typical failure causes: Improper torque, Inadequate gating, inadequate or no lubrication, part mis-located
7/18/2007
32
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
7/18/2007
33
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 mode Use data where possible
Customer complaints. Defect analysis.
FMEA
Occurrence Evaluation Criteria

Probability of Failure Very high, failure is almost inevitable High, repeated failures Moderate, occasional failures Low, relatively few failures Remote, unlikely Possible Failure Rates
> 1 in 2
Cpk < 0.33 > 0.33

> > 0.51
Rankings 10 9 8 7 6 5 4 3 2 1
1 in 3 1 in 8 1 in 20 1 in 80 1 in 400 1 in 2000 1 in 15,000 1 in 150,000 < 1 in 1,500,000
0.67
> > 0.83 > 1.00 > 1.17 >
1.33 1.50 > 1.67
7/18/2007
35
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
Think Prevention
7/18/2007
36
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
7/18/2007
37
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
7/18/2007
38
FMEA
Detection / Prevention Rating

The assessment of the ability of the design/process controls to identify a potential cause or design weakness before the component or system is released 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
Absolute Uncertainty Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
DETECTION (D) Evaluation Criteria

Criteria: Likelihood of DETECTION by Design Control
Design Control will not and/or can not detect a potential cause/mechanism and subsequent failure mode; or there is no Design Control. Very remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderate chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Moderately high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Very high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. Design Control will almost certainly detect a potential cause/mechanism and subsequent failure mode.
Ranking
10 9 8 7 6 5 4 3 2 1
7/18/2007
40
FMEA
Process Detection Evaluation Criteria

Qualitative probability Quantitative probability Ranking of not detecting
Remote likelihood that product would be shipped containing this defect 1/10,000 detection reliability at least 99.99% 1/5,000 detection reliability at least 99.80% Low likelihood that product would be shipped containing this defect 1/2,000 detection reliability at least 99.5% 1/1,000 detection reliability at least 99% Moderate likelihood of detection 1/500 detection reliability at least 98% 1/200 detection reliability at least 95% 1/100 detection reliability at least 90% High likelihood that product would be shipped containing this defect 1/50 detection reliability at least 85% 1/20 detection reliability at least 80% Extreme likelihood that product would be 1/10 + shipped containing this defect Quality Support Group, Inc. 7/18/2007 All rights reserved
1 2 3 4 5 6 7 8 9 10 41
FMEA
6. Risk Assessment
Severity The impact(s) of failure Occurrence The likelihood of a failure occurrence from an identified cause under current controls Detection How detectable is the failure at any point?
FMEA
Item / Process Step
Function
S e v
C l a s s
O c c u r

Prevent Detect
D e t e c
7/18/2007
43
FMEA
7. Risk Priority Number (RPN)

Severity Occurrence Detection 1
none
10
hazardous
1
remote
10
very high frequency
1
very detectable
10
extremely undetectable
S x O x D = RPN 1 x 1 x 1 = 1 5 x 5 x 5 = 125 10 x 10 x 10 = 1000

FMEA
So, why do we need to calculate the RPNs?
By giving every Failure Mode a RPN rating, we can now prioritize which failure modes to address now and which failure modes we address later.
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
7/18/2007
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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!!!

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.
7/18/2007
48
FMEA
FMEA Reduce Future Liability

FMEA can be a legal document Courts can take a favorable view of the liability if proper FMEA was conducted and risks were analyzed/acted upon Punitive damages can be eliminated and/or reduced
7/18/2007
49
FMEA
FMEA Pitfalls A review

Cross-functionality of the Team Leadership of the Team Scope Definition Data Availability NO Customer Involvement Meeting Management problems S,O,D criteria decisions (too long!) No supplier involvement Committed resources Management Commitment & Support
FMEA
In Conclusion
FMEA does take time and effort It does reduce the risk to your customer It does reduce the risk to you It does save time to product launch It does help with Continuous Improvement
7/18/2007
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Case Study
FMEA Risk Management

Leading Approaches Delphi
Overview
Business Profile
Company:
Thermal Division Troy, MI

Markets:
Aras Innovator
Solution:
Automotive Supplier
Customers:
Aras Quality Planning

Approach:
GM, Ford, DCX, Renault/Nissan

Products:
Designs & manufactures advanced cooling systems Challenge: Quality Planning deliverables coordination during Product Development
Copyright 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 53
Process-oriented approach with datadriven quality documents

DFMEA, PFMEA Process Flow, Control Plans Part Submission Warrants, PPAP
All tie together and feed each other creating customer deliverables
7/18/2007
aras.com
FMEA
All Rights Reserved
Aras Confidential
Slide 54
7/18/2007
aras.com
FMEA Libraries
All Rights Reserved
Aras Confidential
Slide 55
7/18/2007
aras.com
Process Flow Diagram
All Rights Reserved
Aras Confidential
Slide 56
7/18/2007
aras.com
Control Plan
All Rights Reserved
Aras Confidential
Slide 57
7/18/2007
aras.com
FMEA + PFD + CP Connectivity
All Rights Reserved
Aras Confidential
Slide 58
7/18/2007
aras.com
FMEA Action Item Notification and Sign Off
All Rights Reserved
Aras Confidential
Slide 59
7/18/2007
aras.com
FMEA Analysis
All Rights Reserved
Aras Confidential
Slide 60
7/18/2007
aras.com
Integration of Solutions
Coordinate & Collaborate on New Product Programs APQP Activities PPAP Deliverables DFMEA, PFMEA, PFD, Control Plan all related to Parts within a Program Quality Events can Result in Modification of ISO Quality documents, FMEA libraries or templates Quality Planning documents can be used in analysis of Quality Events Program Management Assign, Manage and Track 8D Activities 5 Phase CAPA
Quality Planning
Quality Systems
Quality Planning documents related to the appropriate Part in a Product Structure
Product Engineering
Quality Events including Customer Complaints, Nonconforming Material, and Audits can initiate CAPA CAPA can trigger Engineering Changes
Closed Loop Processes for Quality Products

Copyright 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 61 7/18/2007
aras.com
Angelo G. Scangas
President Quality Support Group, Inc. 978-430-7611 Angelo@QualitySupportGroup.com
Questions?
Aras Corporation
978-691-8900 info@aras.com www.aras.com
Recorded Presentation will be available at www.aras.com
All Rights Reserved
Aras Confidential
Slide 62
7/18/2007
aras.com
Solutions for Performance Driven Companies

Risk Management Risk Management for Todays Business Environment for Todays Business Environment
FMEA
July 2007
Featured Speaker
Angelo Scangas
President, QSG
Aras Corporation
Heritage Place Lawrence, MA 01843 [978] 691-8900 www.aras.com
aras.com
Angelo@QualitySupportGroup.com 439 South Union Street
All Rights Reserved
Aras Confidential

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Solutions for Performance Driven Companies

Microsoft Enterprise Open Source

Angelo@QualitySupportGroup.com 439 South Union Street

Copyright 2007 Aras Corporation

All Rights Reserved

Specializes in consulting & training for:

Copyright 2007 Aras Corporation

All Rights Reserved

Microsoft Enterprise Open Source

[i.e. No Charge / FREE Software]

2006 2006 2006

2005 2005 2005

Proven Solutions used by Leading Companies

New Era Ohio, LLC

Copyright 2007 Aras Corporation

All Rights Reserved

Quality Support Group, Inc. All rights reserved

So, is this something new?

Quality Support Group, Inc. All rights reserved

Make vs. Buy decisions & sources selected

Systems, Subsystems, and Components are Qualified Product Validation

Make Good Reports

Make Good Reports

After Action Reviews

Manufacturing Process Definition Containers, Crating, Material Handling Reqmnts.

Prelim. Mfg Assessment

Project Records / Documentation Collected

OVERVIEW OF THE FMEA PROCESS

Potential Failure Mode

Potential Effect(s) of Failure

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

Current Process Controls

Response & R Recommended Traget P Actions Complete N Date

Action Results Action Taken S O D R E C E P V C T N

Quality Support Group, Inc. All rights reserved

Quality Support Group, Inc. All rights reserved

DFMEA Scope Worksheet

PFMEA Scope Worksheet

potential weaknesses in the design

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

Quality Support Group, Inc. All rights reserved

Quality Support Group, Inc. All rights reserved

Potential Failure Mode

Potential Effect(s) of Failure

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

Current Process Controls

Response & R Recommended Traget P Actions Complete N Date

Action Results Action Taken S O D R E C E P V C T N

Quality Support Group, Inc. All rights reserved

Design Intent and Process Function

Name of item or system Function of item per design intent

4.5.1 Business Case Review

Potential Failure Mode

Potential Effect(s) of Failure

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

Current Process Controls

Response & R Recommended Traget P Actions Complete N Date

Action Results Action Taken S O D R E C E P V C T N