ISO 9001-2000-- Validation of Processes


Dave N

Hi everyone
In the ISO Q9001-2000 standard clause 7.5.2 exactly what (from an Auditors standpoint) are they looking for.
thanks for your help,
Dave n

Mike S.

Happy to be Alive
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Here's my take on it: Let's say you have a process - as a simple example we'll say plating a piece of metal with copper. Let's say the spec. says the copper thickness is to be .00005" - .00009" thick, but you do not have the capability to measure this metalization thickness of the plated part. How do you ensure your process is good and puts out in-spec. parts? Let's say you precisely control the 3 process parameters X, Y, and Z that determine the metalization thickness within a narrow range and plating thickness measurements done by a special measurement lab show that so long as you control X, Y, and Z within those ranges, your plating thickness is always okay. As an auditor I want to see that you actually did the experiments (DOE would work well here) and had the measurements done, and that you follow the resulting procedure. Make sense?

Craig H.

I agree, Mike.

I think the key here is that it applies when measurements "cannot be verified by subsequent monitoring or measurement." (from the text). If you can measure the important parameters of your final product, then 7.5.2 doesn't apply.
Another point to look out for: If you change the process you need to validate it again.

Example: Let's say you install new equipment or software... Is the process still ok?



Hi Dave,
Another point is that validation of the process is required in cases where the output of the process is measured through destructive testing.
Eg. Case hardening.
Here the process is set by fixing the right parameters to give the required depth of hardening which is measured by destructive testing. The experiment conducted to arrive at the parameters needs to be recorded and also the measurement details through destructive testing to be recorded to validate the process which needs to be approved by the concerned authorities.
Also in such cases the persons operating the machines need to have trainnig records.( 7.5.2.b)
Hope the explaination is clear.



Quite Involved in Discussions
My company manufactures electronic test equipment. We perform 100% test and inspection on the equipment. (Don't get me started on the accuracy of 100% test and inspection, that's another thread).

In our quality manual I stated that the validation clause is excluded from the scope of our registration due to the 100% test and inspection (monitoring and measurement). My registrar had no problem with that.

A happy story for a change!
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Dave N

To All that responded to this thread,

I want to thank everyone for your input and suggestions. It has given me some good ideas.

Thanks again,
Dave N:)

Paul Simpson

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Sounds like special processes!

This goes back to the old versionof BS 5750 when our Ministry of Defence wanted a clause in the standard about "special processes", the examples they were thinking of were welding, plating etc. Where the quality of the weld or the bond could not realistically be determined by looking at the parts. The way that most companies addressed it was through either personnel qualification (e.g. coded welders) or by managing the process inputs and demonstrating that these gave consistent results (e.g. controlling plating currents and voltages, immersion times and solution quality).

Many companies are going for exclusion against this requirement in 9001 as they say all processes may be inspected and / or measured.

P.S. sorry if it duplicates some earlier replies
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