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Transform variable data into attribute data

K

Kid006

Starting to get Involved
#21
#21
Thanks for the following up

Bev D said:
This is a 'special process' clause that has nothing to do with a Cpk value, normal distribution, etc. 'special process' examples are those like welding. the only way to test for the integrity of the weld is through a destruct test - which can't be done on 100% o fall welds on all product. a die cut process that creates a feature or dimension can be verified on 100% of the parts, so this clause doesn't seem to apply to your situation at all. What does you quality manager say about this?
What do your procedures say about qualifying 'special processes'?
Click to expand...
Our procedures doest not have a section for special processes, the manager attitude its "fix it"

Jim Wynne said:
The (a) section of 21 CFR 820.75 says:
Why is validation considered necessary?
Click to expand...
since our machine is running in a parameter window validation was required
 
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Jim Wynne

Jim Wynne

Staff member
Admin
#25
#25
Kid006 said:
Hydraulic pressure (100-500) and time (1-3 segs)
Click to expand...
Let's summarize:
  1. You originally wanted to transform variable data into attributes data because of an auditor who suggested that your data didn't make sense and the process wasn't properly validated.
  2. It was determined that the transformation you wanted to do wouldn't make sense.
  3. We then learned that you are under the impression that you need to validate the process in accordance with 21 CFR 820.75, which describes requirements for validation of "special" processes.
  4. It doesn't appear at this point that you have a "special" process, because the product in question can be measured/verified (without destruction) after production.
I think you need to discuss all of this with the auditor, and find out why she thinks you have a special process. If the answers aren't satisfactory, you should escalate the issue with the CB/NB to get clarification.
 
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