Punc List Items from Previous qualification phase

Hello All,

I’m sure we’ve all been there.

You complete your IQ and had a (deviation, non-conformance) in one of the tests, i.e the supplier material certificate is missing.

The certicate will be available in say 4 months and you are asked to push on with the qualification eg the the OQ with a rationale that this does not impact the functionality.

Now this company has proceduralised that previous qualification phase must be approved before going onto the next phase. So the IQ is approved the missing cert goes onto a punch list.

My question is how can you go back to the IQ which was approved and insert the missing cert?

The procedures should allow for (risk-based) conditional acceptance instead of a hard line of pass for the gating criteria.

What should be done (but it needs to align with the procedures) is that the test is failed and a deviation report written. Analysis is done on the failure and the risk determined. If the risk is deemed (and documented as) sufficiently low, then the IQ can be conditionally accepted (with the documented deviation). Once the deviation is resolved, an amendment to the IQ report can be written to show the deviation was properly resolved.

Without procedural backing, though, you’re just a process NC waiting to happen!