QS-9000 Element 4.10.5

J

jcricehf

#1
:confused: If a procedure states that a sign-off on a job operation is the quality record that identifies whether product passed or failed. Can we cease collecting in-process inspection results, provided the control plan does not state that we are recording results?

My interpretation of 4.10.5 is that we must record the results of these individual in-process inspections. The QS-9000 Revision 3 states that (paraphrase) " the supplier must show clearly whether the product passed or failed the inspection or test". A single sign-off on an operation does not "clearly show" whether any particular sample in any individual periodic inspection "passed or failed the inspection or test". :frust:

Maybe I need to clarify my point. If our control plans state that 5 samples are to be taken every hour, are we not required by the QS-9000 standard to provide documentation of the results of the inspection of those 5 samples for each hourly inspection? The standard (QS-9000) supersedes any procedure, work instruction, or control plan specified documentation of inspection results. If this is not the case, where does one acquire the data to establish process cycles for preventive adjustment of the process?:bonk:
 
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D

D.Scott

#2
Hi jcricehf

Welcome to the Cove.

If your procedure states that it is the quality record that identifies pass/fail, then why would it not be clear?

You need to show that all of the inspections/tests required in your process are done and that they pass (or fail). If you state that is how you will verify and document it, why would it be challenged?

I may be missing something but it sounds like you are doing fine.

An afterthought would be that if your sign-off documents a pass/fail, it may be argued that you would have to state which it was (pass or fail) when you sign-off. To fix that I would state that the sign-off was to identify pass only. Failures would require some other action than the sign-off (we would use a nonconformance report form and isolate the parts for disposition).

Dave
 
J

jcricehf

#3
Maybe I need to clarify my point. If our control plans state that 5 samples are to be taken every hour, are we not required by the QS-9000 standard to provide documentation of the results of the inspection of those 5 samples for each hourly inspection? The standard (QS-9000) supersedes any procedure, work instruction, or control plan specified documentation of inspection results. If this is not the case, where does one acquire the data to establish process cycles for preventive adjustment of the process?
 
D

D.Scott

#4
I think I see what you are doing. 5 samples every hour - tested - not recorded. Your sign off is at the end of the job and includes all the processing and tests/inspections.

In that case, I think you will need to have a sign-off for each set of samples (the individual results would seem redundant if the sign-off was for "pass") showing that it was done and the result. QS-9000 does require you to clearly show the result (pass/fail, not to be confused with a numerical result).

Next point is where would you get your data? The best case for me would be to chart the hourly samples and use the collected data for process analysis. If your hourly tests require any kind of computer input, it may be possible to save the data for analysis and it would double as documentation of the result.

Am I getting any closer to making sense for you? If not, keep posting - we will get there eventually and I'm sure others will jump in once we paint a clear picture.

Dave
 
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