When will Revision 5 of the AIAG FMEA Manual be released?

Elsmar Forum Sponsor
#73
I got in my newsletter following information if anyone is interested (numbering is a bit off, copy/paste doesn't work smoothly in this case - original is 1-10):

"On April 4th, AIAG and QM hosted a webinar on the latest updates to the new AIAG-VDA FMEA process. If you missed this webinar, the key highlights are summarized here.


  1. The "new" AIAG-VDA FMEA Handbook is now scheduled to be released in June 2019.

  1. The 6-Step process proposed in the "2016 Draft" version has been changed to a 7-Step process; Step 7 is titled "Results Documentation." (The other steps are the same except the title of Step 1 has been changed from "Scope Definition and Project Planning" to "Planning and Preparation.")
  2. An emphasis on COQ (Cost of Quality) has been added as a measure of the effectiveness of an FMEA; if the Cost of (Poor) Quality does not show a reduction, the FMEA has not been effective. We are big fans of COQ and offer a comprehensive online Cost of Quality course.


  1. The use of FMEA-MSRs (Monitoring and System Response) as a supplement to Design-FMEAs was further explained.

  • FMEA-MSRs will allow risk analysis of "Mechatronic Systems" to be addressed; mechatronic systems combine mechanics, electronics and computing.
  • The Action Priority (AP) Rating Tables for FMEA-MSRs will incorporate functional safety concepts from ISO 26262 (Road vehicles -- Functional safety). A goal of ISO 26262 is to ensure functional safety is considered throughout the full development process.

  1. The configuration of the PFMEA Rating Tables has been modified. (The DFMEA Rating Tables were not discussed.)

  • The Severity Tables will include columns to rate the impact of an effect on "Your Plant," the "Ship-to Plant," and the "End-User."
  • The Occurrence Tables include a column on the "Type of Control" to differentiate between control approaches such as behavioral, technical and best practice controls.
  • Columns have been added to the Detection Tables called "Detection Method Maturity" and "Opportunity for Detection" to be used to indicate the level of experience the organization has had with the detection method.

  1. In Step 4, Failure Analysis, for each Failure Mode, it is recommended that the "4M" categories (Man, Machine, Material, environMent), be considered as sources of Failure Causes.
  2. As further clarification of how the AP (Action Priority) Tables are designed, it was explained that the designation of High, Medium and Low gives the greatest weighting to the Severity Rating, then Occurrence and then Detection.
  3. In a change from the "2016 Draft" version, the use of integrated software is no longer recommended. FMEAs can be documented using either a spreadsheet (as most of the organizations now do according to a survey conducted by AAIG) or with integrated software.
  4. Use of the verb "shall" has been removed from the Handbook.
  5. OEMs will have the option to add CSRs (Customer Specific Requirements) to the FMEA guidelines in the Handbook.
 

Jimmy123

Involved In Discussions
#75
I got in my newsletter following information if anyone is interested (numbering is a bit off, copy/paste doesn't work smoothly in this case - original is 1-10):

"On April 4th, AIAG and QM hosted a webinar on the latest updates to the new AIAG-VDA FMEA process. If you missed this webinar, the key highlights are summarized here.


  1. The "new" AIAG-VDA FMEA Handbook is now scheduled to be released in June 2019.

  1. The 6-Step process proposed in the "2016 Draft" version has been changed to a 7-Step process; Step 7 is titled "Results Documentation." (The other steps are the same except the title of Step 1 has been changed from "Scope Definition and Project Planning" to "Planning and Preparation.")
  2. An emphasis on COQ (Cost of Quality) has been added as a measure of the effectiveness of an FMEA; if the Cost of (Poor) Quality does not show a reduction, the FMEA has not been effective. We are big fans of COQ and offer a comprehensive online Cost of Quality course.


  1. The use of FMEA-MSRs (Monitoring and System Response) as a supplement to Design-FMEAs was further explained.

  • FMEA-MSRs will allow risk analysis of "Mechatronic Systems" to be addressed; mechatronic systems combine mechanics, electronics and computing.
  • The Action Priority (AP) Rating Tables for FMEA-MSRs will incorporate functional safety concepts from ISO 26262 (Road vehicles -- Functional safety). A goal of ISO 26262 is to ensure functional safety is considered throughout the full development process.

  1. The configuration of the PFMEA Rating Tables has been modified. (The DFMEA Rating Tables were not discussed.)

  • The Severity Tables will include columns to rate the impact of an effect on "Your Plant," the "Ship-to Plant," and the "End-User."
  • The Occurrence Tables include a column on the "Type of Control" to differentiate between control approaches such as behavioral, technical and best practice controls.
  • Columns have been added to the Detection Tables called "Detection Method Maturity" and "Opportunity for Detection" to be used to indicate the level of experience the organization has had with the detection method.

  1. In Step 4, Failure Analysis, for each Failure Mode, it is recommended that the "4M" categories (Man, Machine, Material, environMent), be considered as sources of Failure Causes.
  2. As further clarification of how the AP (Action Priority) Tables are designed, it was explained that the designation of High, Medium and Low gives the greatest weighting to the Severity Rating, then Occurrence and then Detection.
  3. In a change from the "2016 Draft" version, the use of integrated software is no longer recommended. FMEAs can be documented using either a spreadsheet (as most of the organizations now do according to a survey conducted by AAIG) or with integrated software.
  4. Use of the verb "shall" has been removed from the Handbook.
  5. OEMs will have the option to add CSRs (Customer Specific Requirements) to the FMEA guidelines in the Handbook.
If customers need CRS, I think they don“t agree the content of the standard booklet.
 

SQ_Joe

Involved In Discussions
#78
The release of the AIAG-VDA FMEA Release/Version 1 will be June 3rd, 2019.

It is the result of poorly developed FMEA plans of the past. It is in a 3 layer approach; the focus level, the level above the focus level, and the level below the focus level for which the Focus Level Team is responsible.

No more, "This is our Ranking of Risk." They are defined for all.

RPN is finally eliminated. It is replaced with an Action Priority of High, Medium, or Low. This gives 1,000 possibilities instead of RPN's 127.
The need for excellent trainers and facilitators will be paramount during transition.

There is no expectation that old FMEAs need to be redone. This is for new FMEAs or supplier & customer desire to complete a new FMEAs in the new format.
 

brandieb1230

Involved In Discussions
#80
We are a supplier for Ford, GM and FCA. I am interested in reviewing this book and possibly implementing changes based on it but am nervous they won't meet our customer's requirements as the FMEA book hasn't changed. Any suggestions or advice?
 
Thread starter Similar threads Forum Replies Date
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
B What is the Latest Revision Of the AIAG PPAP Manual? APQP and PPAP 1
O AIAG Manual Master List with Current Revision Level IATF 16949 - Automotive Quality Systems Standard 2
S AIAG working on PPAP 4th Edition? Revision status of AIAG documents APQP and PPAP 8
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C SOP unification. Revision No, Revision history Document Control Systems, Procedures, Forms and Templates 4
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 14001 revision process ISO 14001:2015 Specific Discussions 1
B CQI-11 (Plating Audit) - New revision updates IATF 16949 - Automotive Quality Systems Standard 0
P Proposed revision of IEC 62304 - 2019 IEC 62304 - Medical Device Software Life Cycle Processes 6
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
A Domain of the component (EASA CM No.: CM-SWCEH-001 Issue 01 Revision 02) Point 9.3.3 (Usage domain aspects) EASA and JAA Aviation Standards and Requirements 0
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
M Revision of a Form which is a Procedure Attachment Document Control Systems, Procedures, Forms and Templates 1
S IMS Manual Review and Revision Prior to Audit ISO 14001:2015 Specific Discussions 4
2 First Article Requirements for Revision Changes of Engineering AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
ScottK Question for Auditors on 7.1.4 in the ISO9001:2015 revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
T ISO 9004:2018 Revision - Released April 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Brizilla Knowledge of the upcoming ISO 17025 Revision ISO 17025 related Discussions 5
Q Change revision number in document when only codification was changed Document Control Systems, Procedures, Forms and Templates 8
Sam Lazzara Preferred Location for Revision History Section in Documents Document Control Systems, Procedures, Forms and Templates 16
J Is there a specification that provides directions on Drawing Revision Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
L Supplier Revision Confirmation of Received Engineering Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO 14971 and ISO TR 24971 revision ISO 14971 - Medical Device Risk Management 32
Q AS9100 Re-certification Audit - Which Revision? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Proposed System: Revision = Modification Date; Approval = Access Permissions Document Control Systems, Procedures, Forms and Templates 1
Q Objective and Goals - ISO 9001:2008 Frequency Revision Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
N Transition Audits - AS9100 Revision D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 26
P Is the next revision of ISO 15378 following the High Level Structure? Other ISO and International Standards and European Regulations 5
M Future of ISO 14971 - Possible revision? ISO 14971 - Medical Device Risk Management 9
L The ink is dry(ing) on the revision of ISO 14001:2015. “Is the payoff worth the price Imported Legacy Blogs 0
A Post-market Clinical Studies of Orthopaedic (Revision) Implants EU Medical Device Regulations 1
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
I Document Control - Document Revision History Question Document Control Systems, Procedures, Forms and Templates 16
T Is there a requirement in TS16949 that PO's show a revision level? IATF 16949 - Automotive Quality Systems Standard 3
O Regulatory Notification for IVD IFU Instructions Revision ISO 13485:2016 - Medical Device Quality Management Systems 3
M Is explicit revision control needed if handled automatically by software? Document Control Systems, Procedures, Forms and Templates 6
Marc Interview with Marek Bidwell about the revision to ISO14001 ISO 14001:2015 Specific Discussions 0
M Automated Revision Updates - Notifications of new revisions for ISO's to subscribers Document Control Systems, Procedures, Forms and Templates 2
J Questionable Audit Finding about Revision Levels of Product Manual CD's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Similar threads


















































Top Bottom