OQ and reporting issues

[APIJ QE]

One of our CAPA's describes a validation case where our OQ1 and OQ2 run of a molding process was rejected because of Technical issues.
We solved the problems and OQ1 OQ2 and OQ3 where finalized.

The CAPA issue focused on that timelap; the report concerning the issues where reviewed 5 months later (ref. ALCOA).

Problem/forum question:
Our customer wants to see our solution that this (timelap between failure and reporting/review) will not happen in future.
Does the customer has a point and that we had to start the next OQ procedure not before the report was formal reveiwed and signed even it where technical) issues?
Hopefully someone has a suggestion to solve this in a correct way, for both parties. In our opinion, when it is a technical issue and not a validation issue, there is no need to review a report first (which takes days or longer...).
Thanks! Apij, regards from the Netherlands

 

[William55401]

Welcome to the Cove. I believe your customer is quite reasonable in their expectation to have contemporaneous validation reporting. If an OQ run failed, close it with a report real time before executing the next round of OQ. This is normal practice in all orgs I have been in and supported. A validation failure for whatever reason, including "technical", is a failure. This is probably not the answer you wanted. Another way to think about this. Orgs put in Quality Systems to deliver conforming product and ultimately customer satisfaction. Is your customer satisfied with the lag in reporting? Should your org consider a more real time approach?

One more to think about. Validation should not be executed unless you have confidence of first time success. Often, this means executing engineering studies before validation to confirm OQ limits deliver conforming product. You and your customer both want the validations to pass first time. Do the pre-work before executing your validation protocols. This minimizes the chances of failure and avoids the need to write reports regarding failed validation steps. Just a suggestion.

 

[APIJ QE]

Thanks for your fast and complete reply! Your comments and suggestion are very helpful and underlines the need to include some remarks in our VMP. Especially the real time approach you mentioend (ALCOA ... ) needs our attention in the organisation.