In our company engineering or manufacturing fills out an IQ OQ form or procedure, signs it, and then hands it off to QA for approval and filing in the equipment file. The use of equipment without required IQ OQ approval is an SOP violation.

Much to my dismay I have discovered that key equipment IQ OQs have not been signed off by QA over the last two years, after eng/mfg gave the IQ OQ to QA, QA filed it in the equipment file, but never signed off on it, and therefore never approving it. No problems with the documentation were noted or brought up, they were just never signed off. This was discovered when we moved some equipment and redid the IQ OQs and I wanted to reference the previous IQ OQs.

Fortunately the line was only used to build test units, but the test units were used in various V&V testing, the results of which were submitted to various agencies, and so on.

I am at a loss about what to do about it, I can come up with ways so the problem doesn't happen in the future and will do a corrective action, but I'm having a difficult time figuring out what my argument is for or against the validity of the tests performed. Just as an example, the sterile pouch was validated, but the heat sealer IQ OQ was never approved, meaning the work instructions were not followed since it has rules about equipment use, along with the equipment SOP mentioned above. Multiply that by many times and that is what I'm looking at.

Thanks for any help.

In our company engineering or manufacturing fills out an IQ OQ form or procedure, signs it, and then hands it off to QA for approval and filing in the equipment file. The use of equipment without required IQ OQ approval is an SOP violation.

Much to my dismay I have discovered that key equipment IQ OQs have not been signed off by QA over the last two years, after eng/mfg gave the IQ OQ to QA, QA filed it in the equipment file, but never signed off on it, and therefore never approving it. No problems with the documentation were noted or brought up, they were just never signed off. This was discovered when we moved some equipment and redid the IQ OQs and I wanted to reference the previous IQ OQs.

Fortunately the line was only used to build test units, but the test units were used in various V&V testing, the results of which were submitted to various agencies, and so on.

I am at a loss about what to do about it, I can come up with ways so the problem doesn't happen in the future and will do a corrective action, but I'm having a difficult time figuring out what my argument is for or against the validity of the tests performed. Just as an example, the sterile pouch was validated, but the heat sealer IQ OQ was never approved, meaning the work instructions were not followed since it has rules about equipment use, along with the equipment SOP mentioned above. Multiply that by many times and that is what I'm looking at.

Thanks for any help.

This is quite serious and is a sure 483.

I would suggest that you quickly do a requalification covering all IQs, OQs and PQs. With this, all your future batches produced on these equipment will be held valid.

You will have to do a Risk analysis for the batches that were produced on the unqualified equipment and an assurance that though the equipment was not qualified, the product met the specifications and that the safety, quality and efficacy of the device is satisfactory. If you can not demonstrate these factors, it would be a serious issue.

Also, the CAPA should be robuts to prevent any similar issue happening in future. Revisit your SOP - I am quite surprised why Quality Department is not involved in the equipment qualification exercise :confused:

P.S. - I have changed the thread title to reflect the correct situation. Let me or any moderator know if its not ok.

This is quite serious and is a sure 483.

I would suggest that you quickly do a requalification covering all IQs, OQs and PQs. With this, all your future batches produced on these equipment will be held valid.


Ajit,

I agree with everything you said; except maybe for the part about requalifying. If the only value the QA department adds (in this case) is a signature, is re-executing really necessary?

Certainly serious, certainly needs corrective action, a risk analysis is certainly warranted, and certainly something needs to be done as a corrective measure. I wonder if QA could just approve the reports and attach a cover memo explaining the situation (and referencing the risk analysis)?

Without being more intimate with the full details, I'm not necessarily ready to advocate this position, but I wanted to float it out as much for discussion as anything.

Yodon, I agree with your agreement of Ajit's agreement.:tg:

Nice job, Ajit; I concur with your writeup. I do agree with Yodon as to the extent of requalification is necessary. If the OP has just completed them and everything was OK, the amount of additional qualification work may be avoided. Saying, requalifying the efforts here are the least of the concerns.

1. Complete the current requalifications and assure they are signed off and accepted.

2. If the current requalification has assessment against changes/deviation since last qualification, then that should cover any possible changes and the like.

3. As to the non-signed IQ OQ reports.... as Yodon alluded to, the severity can vary depending on the significance of the signature. If all it is would be a "yes, everything looks good", then that is a lesser evil than QA signing that the validation effort was acceptable, accomplished goals, etc.

That will need to be addressed ASAP; assessing what was done at that time and if it is acceptable.

4. More importantly, to me, is the CAPA process of QA not signing the documents, and the process moving forward without a check in place. You need fairly robust assurance that does not happen again.

there are two issues: QA's lack of signature and the acceptability of the IQ/OQ.

If the IQ/OQ wasn't acceptable then the lack of signatures and the subsequent use of the equipment is very, very serious and would in all liklihood require re-qualification. (I can envision how the miss could be trivial)


However, if the validation was acceptable and the only noncompliance was the lack of a signature, requalification woudl only serve as a punitive action.