We believe the right thing to do is include failure analysis activities, test/evaluation in the audits as part of corrective action . Customer returns, and product failures are analysed for failure modes to determine root cause & subsequent corrective action. What is the forum opinion ? Should a failure analysis be included in the audit, even if this is an off-site remote support location? Should test / insp. equipment . etc. be included in the lab scope for the failure analysis?

The TS spec & rules seem to point in that direction clearly , but there seems to be a debate in the real world. Seems like it is the right thing to do regardless of the requirments/ rules. Thanks

The TS spec & rules seem to point in that direction clearly , but there seems to be a debate in the real world. Seems like it is the right thing to do regardless of the requirments/ rules. ThanksWhen a standard or procedure says XYZ shall be done, then XYZ needs to be audited. Whether or not the "real world" think's XYZ is the right thing to do is beside the point.

What should be the point is the question, "How do we know that our failure analysis process is effective and adds to customer satisfaction?" That question is the basis of a good process audit on the failure analysis process.

If the "real world" (I'm fairly familiar with that place) does not find value in understanding and learning from failures, that is the basis for difficulty in achieving functionality and value in failure analysis.

Arguably that "real world" appears to be a very heavily populated place. :rolleyes:

We believe the right thing to do is include failure analysis activities, test/evaluation in the audits as part of corrective action . Customer returns, and product failures are analysed for failure modes to determine root cause & subsequent corrective action. What is the forum opinion ? Should a failure analysis be included in the audit, even if this is an off-site remote support location? Should test / insp. equipment . etc. be included in the lab scope for the failure analysis?

The TS spec & rules seem to point in that direction clearly , but there seems to be a debate in the real world. Seems like it is the right thing to do regardless of the requirments/ rules. Thanks


Hello rjkozak,

Before I respond to your post, can you help me understand your interpretation of "failure analysis." Do you do this as part of corrective action (reactive) or as part of FMEA (proactive)?

Stijloor.

We believe the right thing to do is include failure analysis activities, test/evaluation in the audits as part of corrective action . Customer returns, and product failures are analysed for failure modes to determine root cause & subsequent corrective action. What is the forum opinion ? Should a failure analysis be included in the audit, even if this is an off-site remote support location? Should test / insp. equipment . etc. be included in the lab scope for the failure analysis?

The TS spec & rules seem to point in that direction clearly , but there seems to be a debate in the real world. Seems like it is the right thing to do regardless of the requirments/ rules. ThanksI agree. Those sub-processes are part of the QMS and should be subject to internal audits. If those processes are not being carried out effectively, the results of the failure analysis could be questioned, potentially inducing to "bogus" corrective actions. Failure analysis, when effectively performed, can provide an organization early warnings about product performance. Because of the tremendous financial and legal impacts product failures can bring to a company, having an effective failure analysis process is key to organizations. IM&TE equipment in the lab should be calibrated. Otherwise, you run the risk of making critical decisions based on faulty data. In my mind, there is no justification NOT to consider failure analysis as part of the QMS. And if you agree it is part of the QMS, then they must be internally audited.

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