Are production samples quality records?

Howard Atkins

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Staff member
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#1
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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Rea

$ Contributor
#2
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
 
#3
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.
 

Marc

Hunkered Down for the Duration
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#4
Let's say you do a first off and last off per setup comparison. Would that be defined in your control plan?
 
#5
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.
 

Marc

Hunkered Down for the Duration
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#6
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.
 

Howard Atkins

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#7
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.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
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:
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.
This was not a customer requirement, was it?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Does one have to with each approval of PPAP to define the time that you require samples retained?
As I understand it you have to state how long you're going to keep PPAP samples either by procedure or by contract.

Other interpretations welcomed!
 
#10
I concur, other than PPAP or additional customer requirements , I don,t know of a requirement to retain sample parts.
However, and I may be reaching here,what you appear to have is a visual aid for verifying and/or validating the quality of the product. Although not a record, it becomes a document (???) that falls under the procedures of Doc. & Data Cont.

Comments please. I have set up basically the same process at other plants and have had the auditor ask "How do you know that the sample part is at the same rev. as what you are making/checking?"
 
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