Potential failure
- Thread starter NuRiZ
- Start date
Enghabashy
Quite Involved in Discussions
* potential field failure is one of risk assessment requirement - Quality M sys. ISO 9001
** regarding M review, one of input as follow :
- e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
*** the output of risk assessment actions taken or FMEA are the clear evidences
** regarding M review, one of input as follow :
- e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
*** the output of risk assessment actions taken or FMEA are the clear evidences
Enghabashy
Quite Involved in Discussions
*the severity , occurrence; detection are 3 basic parameters ; therefore the risk assessment / FMEA could be more effective as annually reviewing ; specially if there's relevant finding ; NCs, complaint , audit results --etc. -- it should be reviewed accordingly for any effect /threats / occurrence rating / any detection or action taken could be added
John Predmore
Trusted Information Resource
post: 698376 said:
@NuRiZ, What makes you say updating your established format was ineffective? What criticisms were given? Were there risks you did not foresee? Was your assessment of identified risks inaccurate? Help us understand what about your current format is ineffective so we can offer helpful ideas. Once you make 5 postings on the Cove, you will be allowed to attach a file. Then we will understand better.
Your response didn't answer my questions...
I would also add that a potential failure should have no record of occurring if it has occurred it is no longer a potential failure but an actual failure. I have no idea how to track a potential failure except to say that it still hasn't happened...hence why I am asking for clarification of what concerns you about this potential failure and what you expect management to do about it?
I would also add that a potential failure should have no record of occurring if it has occurred it is no longer a potential failure but an actual failure. I have no idea how to track a potential failure except to say that it still hasn't happened...hence why I am asking for clarification of what concerns you about this potential failure and what you expect management to do about it?
My auditor state that my potential field failure was not clearly evidence in management review.
I already add in minute that the review done based on PFMEA, since the requirement is updated back 2010 during TS 16949.
Due to auditor now put this under NC, i have difficulty to answer the Y-Y as this is potential, how to evidence it?
I already add in minute that the review done based on PFMEA, since the requirement is updated back 2010 during TS 16949.
Due to auditor now put this under NC, i have difficulty to answer the Y-Y as this is potential, how to evidence it?
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