FMECA (Critical Analysis) Format and Ranking Table

kuyakut

Involved In Discussions
#1
Our QMS is mature, we have TS 16949 , ISO 9001 and ISO 13485 . The another segment that we will trying out is AS9100C. We hire a trainor for this specific Quality system. During the training he emphasize that we need a FMECA on top of our PFMEA. Does any one of you has a FMECA format and ranking table.
Thanks in advance.
 
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dsanabria

Quite Involved in Discussions
#2
FYI - AS9100 is for Quality Management systems process - not for product or usage of FMECA.... maybe you might want to find a competent trainer in Quality Management System. :2cents: :nope:
 

John Broomfield

Leader
Super Moderator
#4
Here is a FMECA procedure from Sydney Water:

http://www.sydneywater.com.au/web/g...ments/document/zgrf/mdq2/~edisp/dd_046414.pdf

"Sydney Water?s maintenance objective is to ensure that assets achieve their design service requirements within acceptable risk at lowest life cycle costs. The purpose of this procedure is to document the procedure for undertaking Failure Mode Effects and Criticality Analysis for Sydney Water?s facility assets. The objective is to identify the items where modification to the design or the operating, inspection, or maintenance strategies may be required to reduce the severity of the effect of specific failure modes. It can be performed to meet a variety of different objectives, for example, to identify weak areas in the design, the safety-critical components, or critical maintenance and test procedures."

SW may appreciate being updated on any improvements you make to their procedure.
 

dsanabria

Quite Involved in Discussions
#5
Our QMS is mature, we have TS 16949 , ISO 9001 and ISO 13485 . The another segment that we will trying out is AS9100C. We hire a trainor for this specific Quality system. During the training he emphasize that we need a FMECA on top of our PFMEA. Does any one of you has a FMECA format and ranking table.
Thanks in advance.
Here is a link for the Supply Chain Management Handbook - Chapter 2 and the chart on Special Requirements and Critical Items Control


http://www.sae.org/servlets/registr...AGE=getSCMHBOOK&vgenNum=469&scmhs=1&REF=login


In addition, check out the attachment Technical Manual.
 

Attachments

Q

QABJH

#7
thank you for this great thread! I have 15 years in Product Development and am now developing an ISO 13485:2016 compliant QMS. Our product is new, no predicate, but the technology inside the device has existed for years. It's just the intended use that would be different. As such, the FMECA may be strongly suggested. We'll do the FMEA first.

I'm just wondering whether we would want to identify certain FMEA items to reduce severity of the effect of failure (so choosing those that have high severity numbers?) or those whose RPN number would be the highest??

if we perform the FMECA, we are likely to hire consultants to perform this.

Thanks,
QABJH
 
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