OQ - is it required?


We have a gluing process which requires LED light source to cure the adhesive. After the successfull IQ of the LED light source is it neccessary to perform OQ for the equipment if I have a quality inline inspection which verify the quality of the gluing process?

I’m really appreciate the answers,



What does your Master Validation Plan say?

Ok, that was a trick question. :slight_smile: But seriously, that SHOULD be your guidance in the decision making process.

There is really not enough information to say one way or the other. If the glued piece falls off and is sealed up inside a patient, I would think considerable effort would be warranted to ensure that process is sufficient and repeatable. If the glued piece would be a minor nuisance if it fell off then maybe not a big deal. However, I would assert that there’s no way to know (by inspection) if the gluing process is satisfactory. To do so would require destructive testing (which, obviously, you can’t do on 100% of the results). What’s the risk if the gluing process fails? How do you know that the cure time is sufficient? How do you control the amount of adhesive applied (and if it is unevenly spread, does that cause a failure)?

Assess the risk, look at failure modes and likely failures, then determine if the risk warrants validation. Document all this and be ready to defend it.