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15th September 1999, 12:08 AM
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Are production samples quality records?
I had a discussion with one of my suppliers as to the length of time it is neccessary to save production samples.
4.16.1 talks about retention of PPAP approvals and quality records. I do not know of any other place that there is a definition of saving samples. My case is that production samples are quality records.
Has anyone got any ideas about this question.
Thanks
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15th September 1999, 07:40 AM
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As long as you keep the PPAP samples as required then the length of time you keep any other samples would be your own decision. I agree with you they would then be a quality record unless they are from your laboratory and then they would be covered by your lab. scope etc. (4.10.6.3 retention of test samples)
Rea
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15th September 1999, 07:46 AM
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The PPAP manual defines the requirements for "Master Sample"retention on page 14 Para VI.
I do seem to recall reading something about "last off" part comparison, which would indicate that you would retain a part until the end of a production run.
Also your customer may have additional requiremnts.
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15th September 1999, 07:51 AM
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Let's say you do a first off and last off per setup comparison. Would that be defined in your control plan?
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15th September 1999, 11:21 AM
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Yes,I would define it in the control plan, if that method is part of the process.
However, IMO using last part comparison is like final inspection; we really don't trust our in-process controls.
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15th September 1999, 02:04 PM
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Howard:
Is this what you are referring to? A first off / last off? I haven't seen anything like that with a time defined. I assumed that any retention time for in-process samples was determined by the supplier.
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16th September 1999, 12:10 AM
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I am not referring to PPAP samples rather to samples of a series lot.
I save samples of each lot thus if I receive a non conformance I can check my samples as approved at set up against the non conformance.
Apart from customer requirement does anyone know of a clause that "demands" retention of samples. Does one have to with each approval of PPAP to define the time that you require samples retained?
Thanks.
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16th September 1999, 04:11 AM
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That's what I thought you meant, Howard. I cannot remember such a requirement anywhere. The only sample retention requirement I am aware of (other than a customer specific requirement) is the PPAP retention requirement.
You said:
Quote:
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I save samples of each lot thus if I receive a non conformance I can check my samples as approved at set up against the non conformance.
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This was not a customer requirement, was it?
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