Interpreting 4.10.5 Inpection & Test Records

L

Linda Jurasin

#1
The company I work for tests our product 100%. Some of the tests/inspections are not documented i.e: tests via fixtures, go-no-go. Then we have other tests that are performed using a testing unit and software which automatically records the data. Can we continue doing both and still comply with 4.10.5 (QS9000 3rd edition & current TE Supplement)? How does this affect Quality Records 4.16.1 (QS9000 3rd edition & current TE Supplement)?
 
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Marc

Hunkered Down for the Duration
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Admin
#2
You can do both. The auditor question will be why do you do those other tests and why do you not take data if you're doing them?

I would want to look at the control plan and I would want to understand what you're doing and why.

But - to look at the requirements, it is a matter of defining appropriate tests and inspections during the design phase and documenting them. In a production type of scheme, you're looking at the process FMEA and the process control plan contents. For inspections and tests defined within the control plan you 'have' to take data.

If you have inspections and tests not on the control plan my 'auditor' question would be why? Please explain.

I would also look at this from 4.20: Have you evaluated the need for statistical techniques on data you could gather from those 'hidden' inspections and tests.

I do want to caution you I'm not a T&E expert so I can't say exactly how that plays in.

When I think of inspections and tests I think of two levels. The minimum is Customer Requirements (including print call-outs, etc) and I think of company 'requirements' (which often exceed customer requirements). Company requirements may or may not be on the (a) control plan.

I see an obligation to record the customer requirements (inspections and tests) - they are a must.

I typically would expect to see additional inspection and test results recorded because I figure if you're doing the test/inspection you have the time to take the data and the data might become a useful continuous improvement tool (I love data, in case you can't tell) but I do not see it as a requirement unless it is a Control Plan item.

The rule is that if it is on the control plan, it must be recorded

Well, that's my 10 cents worth. That's the way I read it
 
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