Solutions for Performance Driven Companies
Microsoft Enterprise Open Source


                                            ...
Featured Speaker

                                        Angelo Scangas                                              Ange...
Aras Overview

Business:                               Product Development & Quality Compliance
                          ...
New Era Ohio, LLC




                     Recent Downloads




Copyright © 2007 Aras Corporation   All Rights Reserved   ...
FMEA
Failure Mode and Effects Analysis
        Risk Management

     Angelo G. Scangas
               President
      Qual...
FMEA


       Agenda
       • Introduction
       • FMEA as a Risk Management Tool
       • Failure Mode and Effects Analy...
FMEA

  Course Objective
       Participants will understand and
       be able to effectively apply and
       sustain th...
FMEA
                   WHAT IS A FMEA?
   The Failure Mode and Effect Analysis (FMEA) is a
   Prevention Technique used t...
FMEA
   So, is this something new?
       No!!!
         Origins in Safety (Part of the Dupont Safety Process)
         St...
FMEA



               Criticisms of FMEA
         FMEA often misses key failures

         FMEA performed too late does n...
FMEA
 Life Cycle
                                         PDP Overview
    Plan
Approved &            Phase 0             ...
FMEA
  OVERVIEW OF THE FMEA PROCESS
        Define the scope of the study.
           Scope Definition Worksheet
        S...
FMEA
  OVERVIEW OF THE FMEA PROCESS
        Identify all failure modes & the corresponding effects.
        Rate the relat...
FMEA

Item /                                     C                  O                    D                                ...
FMEA
                           Timing
        One of the most important factors for the
        successful implementation...
Slide 15

AS1        qsg, 2/17/2007
FMEA



  DFMEA Scope Worksheet
        Product:                             Date:
        Scope Defined by:

        Part...
FMEA

  PFMEA Scope Worksheet

        Part 1: What process components are to be included in the
        investigation?
  ...
FMEA                 Design FMEA

        •Led by Design Responsible Engineer

        •Customer includes End User, Other ...
FMEA


                 Process FMEA

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

Item /                                     C                  O                    D                                ...
FMEA

  Design Intent and Process Function


       Defines the function of the product or the
       process
        1.  ...
FMEA

Item /                                     C                  O                    D                                ...
FMEA
   Potential Failures
       (D) Manner in which a component, subsystem or
           system could fail to meet desig...
FMEA

  Types of Questions to ask


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

   Regardles...
FMEA

Item /                                     C                  O                    D                                ...
FMEA



                       Potential Effects

               Determine the effects of potential failures.


       Eff...
FMEA



  Severity Ranking
        Rating of 1 to 10 with 10 being the most
        severe impact.
          Use a scale.
...
FMEA

   Hazardous         Very high severity ranking when a potential failure mode
                                      ...
FMEA
   Process Severity Evaluation Criteria

   Effect                      Severity of effect                           ...
Classification
FMEA




        This column may be used to classify
        any special product characteristics (e.g.,
   ...
FMEA

Item /                                     C                  O                    D                                ...
FMEA
                      Potential Causes
   Determine the potential causes of each of the failure types.
   What are th...
FMEA

Item /                                     C                  O                    D                                ...
FMEA



  Occurrence Ranking
        How often will each cause occur?
               Ignore the severity of the effect and...
FMEA

   Occurrence Evaluation Criteria

 Probability of         Possible Failure           Cpk       Rankings
 Failure   ...
FMEA

Item /                                     C                  O                    D                                ...
FMEA
   Current Controls


   What are the current design or process controls to prevent
   or detect the potential failur...
FMEA

Item /                                     C                  O                    D                                ...
Detection / Prevention Rating
FMEA



   The assessment of the ability of
   the “design/process controls” to identify a
 ...
FMEA                         DETECTION (D) Evaluation Criteria
        Detection          Criteria: Likelihood of DETECTIO...
FMEA

   Process Detection Evaluation Criteria

       Qualitative probability                  Quantitative probability R...
FMEA

  6. Risk Assessment

       Severity
       The impact(s) of failure


       Occurrence
       The likelihood of a...
FMEA

Item /                                     C                  O                    D                                ...
FMEA


   7. Risk Priority Number (RPN)
               Severity        1                                      10
         ...
FMEA

                                         So, why do we need to
                                         calculate th...
FMEA



   REDUCING THE POTENTIAL RISK:

       First line of defense -
            Eliminate causes of failure so that it...
FMEA



  Priority for Action
         Involve Management to assign resources
        (human/financial) for action items t...
FMEA



  Disagreements on Ratings?
        Use data where possible.
        Try to come to consensus.
        If consensu...
FMEA



  FMEA – Reduce Future Liability

        FMEA can be a legal document
        Courts can take a favorable view of...
FMEA

 FMEA Pitfalls – A review
       Cross-functionality of the Team
       Leadership of the Team
       Scope Definiti...
FMEA

 In Conclusion

       FMEA does take time and effort
       It does reduce the risk to your customer
       It does...
Case Study


FMEA Risk Management
   Leading Approaches
         Delphi
Overview



 Business Profile
  Company:
  Thermal Division – Troy, MI
  Markets:                                         ...
FMEA




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confidential   Slide 54   7/18/2007   aras.com
FMEA Libraries




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confidential   Slide 55   7/18/2007   ar...
Process Flow Diagram




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confidential   Slide 56   7/18/200...
Control Plan




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confidential   Slide 57   7/18/2007   aras...
FMEA + PFD + CP
   Connectivity




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confidential   Slide 58...
FMEA Action Item
   Notification and Sign Off




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confident...
FMEA Analysis




Copyright © 2007 Aras Corporation   All Rights Reserved   Aras Confidential   Slide 60   7/18/2007   ara...
Integration of Solutions
Coordinate & Collaborate on
New Product Programs                                                 ...
Angelo G. Scangas
                                                                                               President...
Solutions for Performance Driven Companies
Microsoft Enterprise Open Source


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FMEA

  1. 1. Solutions for Performance Driven Companies Microsoft Enterprise Open Source FMEA Risk Management Risk Management for Today’s Business Environment for Today’s Business Environment July 2007 Featured Speaker Angelo Scangas President, QSG Aras Corporation www.QualitySupportGroup.com Heritage Place Angelo@QualitySupportGroup.com 439 South Union Street Lawrence, MA 01843 [978] 691-8900 www.aras.com Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential aras.com
  2. 2. Featured Speaker Angelo Scangas Angelo@QualitySupportGroup.com President, QSG www.QualitySupportGroup.com Specializes in consulting & training for: FMEA & risk management Quality process improvement Angelo Scangas President, QSG Lean six sigma ISO/TS certification webcast 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. Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 2 7/18/2007 aras.com
  3. 3. 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: Microsoft Enterprise Open Source Most Advanced [i.e. No Charge / FREE Software] Technology Companies 2006 2006 2006 Established in: 2000 2005 2005 2005 Offices: Massachusetts (HQ), Michigan, California “Proven Solutions used by Leading Companies” Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 3 7/18/2007 aras.com
  4. 4. New Era Ohio, LLC Recent Downloads Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 4 7/18/2007 aras.com
  5. 5. 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
  6. 6. 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. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 7
  8. 8. 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 Safety Regulatory Customer Satisfaction Program • Coordinated/Documented team effort • A method to determine the need and priority of actions Quality Support Group, Inc. 7/18/2007 All rights reserved 8
  9. 9. 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 Industry Medical Devices Industry (ISO 13485) Electronics Industry Petroleum refineries Military Logistics Support to name a few…. Quality Support Group, Inc. 7/18/2007 All rights reserved 9
  10. 10. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 10
  11. 11. FMEA Life Cycle PDP Overview Plan Approved & Phase 0 Phase 1 Phase 2 Phase 3 Phase 4 Project Started PPAP/IPPAP, Equipment, Tooling Definition Complete & Design, Development, and Processes Ready, Project Close Concept Developed / Design Feasibility Vehicle Integration and FPE Vehicles Built, Out and Make Business Rationale Demonstrated Parts Authorized Approved to Launch Good Business Business Rationale Business Project Plan Business Case Business Case After Action Developed Case Complete Confirmation Confirmation Reviews Developed Resources Initial Motorcycle Assigned Systems, Sub- Service Life Make vs. Buy Support systems, and Cycle Costs decisions & Information Components are Make Good sources Qualified Regulatory Req’s Reports selected Base E.O. Complete & Assigned Design Risk Documented Assessment Product (FMEAs) Validation Research of System, Sub- Design System, & Vehicle PPAP/IPPAP Make Good existing knowledge Reports Specs. Developed Full Vehicle Process Risk Plant Training Requirements Defined Styling Inputs Assessment (PFMEA) Operation After Action Visual or Physical Instructions Reviews Process Rep. of Concept Manufacturing Control Plan Process Definition FPE Vehicles Built Training Plans Containers, Crating, Prelim. Mfg Material Handling Process Production Process Assessment Verification System Validation Reqmnts. Project Records / Documentation Collected Quality Support Group, Inc. Project Reviews / Technical Reviews Ongoing 7/18/2007 All rights reserved 11
  12. 12. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 12
  13. 13. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 13
  14. 14. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Quality Support Group, Inc. 7/18/2007 All rights reserved 14
  15. 15. FMEA Timing One of the most important factors for the successful implementation of an FMEA AS1 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 15
  16. 16. Slide 15 AS1 qsg, 2/17/2007
  17. 17. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 16
  18. 18. 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? Quality Support Group, Inc. 7/18/2007 All rights reserved 17
  19. 19. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 18
  20. 20. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 19
  21. 21. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Critical Quality Support Group, Inc. 7/18/2007 All rights reserved 20
  22. 22. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 21
  23. 23. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Quality Support Group, Inc. 7/18/2007 All rights reserved 22
  24. 24. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 23
  25. 25. 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? Quality Support Group, Inc. 7/18/2007 All rights reserved 24
  26. 26. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect VOC Quality Support Group, Inc. 7/18/2007 All rights reserved 25
  27. 27. FMEA Potential Effects Determine the effects of potential failures. Effects of the failure mode on the customer (internal or external) Quality Support Group, Inc. 7/18/2007 All rights reserved 26
  28. 28. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 27
  29. 29. FMEA Hazardous Very high severity ranking when a potential failure mode 10 without warning effects safe system operation without warning Severity Hazardous with Very high severity ranking when a potential failure mode 9 warning affects safe system operation with warning System inoperable with destructive failure without Very High 8 compromising safety High System inoperable with equipment damage 7 Moderate System inoperable with minor damage 6 Low System inoperable without damage 5 Very Low System operable with significant degradation of performance 4 Minor System operable with some degradation of performance 3 Very Minor System operable with minimal interference 2 None No effect 1 Quality Support Group, Inc. 7/18/2007 All rights reserved 28
  30. 30. FMEA Process Severity Evaluation Criteria Effect Severity of effect Ranking Hazardous, without warning May endanger personnel. Involves non-compliance 10 with gov’t. regulation without warning. Hazardous, with warning Same as above only with warning 9 Very High Major disruption to production line; 100% of 8 product scrapped High Minor disruption to production line; customer 7 dissatisfied Moderate Product operable; not cosmetically satisfactory 6 Low 100% of product may have to be reworked; some 5 customer dissatisfaction Very Low Fit/finish defects noticed by most customers 4 Minor Same as above, but, defect noticed by average 3 customer Very Minor Same as above, but, defect noticed only by the 2 discriminating customer None No effect 1 Quality Support Group, Inc. 7/18/2007 All rights reserved 29
  31. 31. Classification FMEA 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 30
  32. 32. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Root Cause Analysis Data Quality Support Group, Inc. 7/18/2007 All rights reserved 31
  33. 33. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 32
  34. 34. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Quality Support Group, Inc. 7/18/2007 All rights reserved 33
  35. 35. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 34
  36. 36. FMEA Occurrence Evaluation Criteria Probability of Possible Failure Cpk Rankings Failure Rates > 1 in 2 < 0.33 10 Very high, failure is 1 in 3 > 0.33 9 almost inevitable > 8 High, repeated 1 in 8 > 0.51 1 in 20 0.67 7 failures > 1 in 80 > 0.83 6 Moderate, occasional 1 in 400 > 1.00 5 failures 1 in 2000 > 1.17 4 > 3 Low, relatively few 1 in 15,000 1.33 1 in 150,000 1.50 2 failures > < 1 in 1,500,000 1.67 1 Remote, unlikely Quality Support Group, Inc. 7/18/2007 All rights reserved 35
  37. 37. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Think Prevention Quality Support Group, Inc. 7/18/2007 All rights reserved 36
  38. 38. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 37
  39. 39. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Quality Support Group, Inc. 7/18/2007 All rights reserved 38
  40. 40. Detection / Prevention Rating FMEA 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). Quality Support Group, Inc. 7/18/2007 All rights reserved 39
  41. 41. FMEA DETECTION (D) Evaluation Criteria Detection Criteria: Likelihood of DETECTION by Design Control Ranking Absolute Design Control will not and/or can not detect a potential cause/mechanism 10 Uncertainty and subsequent failure mode; or there is no Design Control. Very Remote Very remote chance the Design Control will detect a potential 9 cause/mechanism and subsequent failure mode. Remote Remote chance the Design Control will detect a potential cause/mechanism 8 and subsequent failure mode. Very Low Very low chance the Design Control will detect a potential 7 cause/mechanism and subsequent failure mode. Low Low chance the Design Control will detect a potential cause/mechanism 6 and subsequent failure mode. Moderate Moderate chance the Design Control will detect a potential 5 cause/mechanism and subsequent failure mode. Moderately High Moderately high chance the Design Control will detect a potential 4 cause/mechanism and subsequent failure mode. High High chance the Design Control will detect a potential cause/mechanism 3 and subsequent failure mode. Very High Very high chance the Design Control will detect a potential 2 cause/mechanism and subsequent failure mode. Almost Certain Design Control will almost certainly detect a potential cause/mechanism 1 and subsequent failure mode. Quality Support Group, Inc. 7/18/2007 All rights reserved 40
  42. 42. FMEA Process Detection Evaluation Criteria Qualitative probability Quantitative probability Ranking of not detecting Remote likelihood that product would be shipped containing this defect • detection reliability at least 99.99% 1/10,000 1 • detection reliability at least 99.80% 1/5,000 2 Low likelihood that product would be shipped containing this defect • detection reliability at least 99.5% 1/2,000 3 • detection reliability at least 99% 1/1,000 4 Moderate likelihood of detection • detection reliability at least 98% 1/500 5 • detection reliability at least 95% 1/200 6 • detection reliability at least 90% 1/100 7 High likelihood that product would be shipped containing this defect • detection reliability at least 85% 1/50 8 • detection reliability at least 80% 1/20 9 Extreme likelihood that product would be shipped containing this defect 1/10 + 10 Quality Support Group, Inc. 7/18/2007 All rights reserved 41
  43. 43. 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? Quality Support Group, Inc. 7/18/2007 All rights reserved 42
  44. 44. FMEA Item / C O D Action Results Process Potential Current Response & Potential Potential S l c Process e R Step Cause(s)/ Recommended Traget S O D R Failure Effect(s) of e a c Controls t P Action Mechanism(s) Actions Complete E C E P Mode Failure v s u e N Taken Of Failure Date V C T N s r c Function Prevent Detect Quality Support Group, Inc. 7/18/2007 All rights reserved 43
  45. 45. FMEA 7. Risk Priority Number (RPN) Severity 1 10 none hazardous Occurrence 1 10 remote very high frequency Detection 1 10 very detectable 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 44
  46. 46. FMEA So, why do we need to calculate the RPN’s? 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 45
  47. 47. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 46
  48. 48. 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!!! Quality Support Group, Inc. 7/18/2007 All rights reserved 47
  49. 49. 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. Quality Support Group, Inc. 7/18/2007 All rights reserved 48
  50. 50. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 49
  51. 51. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 50
  52. 52. 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 Quality Support Group, Inc. 7/18/2007 All rights reserved 51
  53. 53. Case Study FMEA Risk Management Leading Approaches Delphi
  54. 54. Overview Business Profile Company: Thermal Division – Troy, MI Markets: Aras Innovator Automotive Supplier Solution: Customers: Aras Quality Planning GM, Ford, DCX, Renault/Nissan Approach: Products: Process-oriented approach with data- Designs & manufactures advanced driven quality documents cooling systems • DFMEA, PFMEA Challenge: • Process Flow, Control Plans Quality Planning deliverables • Part Submission Warrants, PPAP coordination during All tie together and feed each other Product Development creating customer deliverables Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 53 7/18/2007 aras.com
  55. 55. FMEA Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 54 7/18/2007 aras.com
  56. 56. FMEA Libraries Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 55 7/18/2007 aras.com
  57. 57. Process Flow Diagram Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 56 7/18/2007 aras.com
  58. 58. Control Plan Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 57 7/18/2007 aras.com
  59. 59. FMEA + PFD + CP Connectivity Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 58 7/18/2007 aras.com
  60. 60. FMEA Action Item Notification and Sign Off Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 59 7/18/2007 aras.com
  61. 61. FMEA Analysis Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 60 7/18/2007 aras.com
  62. 62. Integration of Solutions Coordinate & Collaborate on New Product Programs Assign, Manage and Track APQP Activities Program 8D Activities PPAP Deliverables Management 5 Phase CAPA DFMEA, PFMEA, PFD, Control Plan all related to Parts within a Program Quality Events can Result in Modification of ISO Quality Quality Quality documents, FMEA libraries or templates Systems Planning Quality Planning documents can be used in analysis of Quality Events Quality Events including Customer Complaints, Nonconforming Material, Product and Audits can initiate CAPA Quality Planning documents Engineering related to the appropriate Part CAPA can trigger in a Product Structure Engineering Changes Closed Loop Processes for Quality Products Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 61 7/18/2007 aras.com
  63. 63. 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 Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential Slide 62 7/18/2007 aras.com
  64. 64. Solutions for Performance Driven Companies Microsoft Enterprise Open Source FMEA Risk Management Risk Management for Today’s Business Environment for Today’s Business Environment July 2007 Featured Speaker Angelo Scangas President, QSG Aras Corporation www.QualitySupportGroup.com Heritage Place Angelo@QualitySupportGroup.com 439 South Union Street Lawrence, MA 01843 [978] 691-8900 www.aras.com Copyright © 2007 Aras Corporation All Rights Reserved Aras Confidential aras.com
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