IATF versus SPC

[ScottK]

Have you received the audit report and non-conformance yet? It would be helpful to see exactly how it was worded and what requirements were cited.

I've had this situation in some ISO13485 audits and stopped arguing with the auditor, let them write up what they wanted to write up, then I disputed the finding in the audit response and stated I would take no action on it. When it was reviewed by the auditor's organization my argument stood.

 

[Golfman25]

I will crunch the numbers and see. The argument currently being put forth is "according to the data we are shipping parts out of tolerance" I am arguing that we are not because of the control limits being put into place and tooling changed before the product hits that point.

This has been one of the hardest most pointless arguments I have dealt with in a long time.

I appreciate you confirming what i am thinking.

Really. You stated above that you're testing the products down the line. The monitoring is simply for tool wear and when to change out the tool. Your final product test results would be what you check capability on. Maybe you can just use the actual product testing as your control?

 

[Golfman25]

Have you received the audit report and non-conformance yet? It would be helpful to see exactly how it was worded and what requirements were cited.

I've had this situation in some ISO13485 audits and stopped arguing with the auditor, let them write up what they wanted to write up, then I disputed the finding in the audit response and stated I would take no action on it. When it was reviewed by the auditor's organization my argument stood.

This will depend on the Registrar. Some are better than other. My last one, I couldn't win an appeal no matter what. The people reviewing the appeals where worse than the auditors. I had one tell me I "should have" done something based totally on their opinion.