Medical Device Manufacturing

#1
Question(s)-If we have a manufacturing process to make a medical device, and we add a LVDT sensor for the first time in the initial manufacturing process where the material is fed into making the product, do we need and IQ, OQ, PQ, or just a IQ, PQ. The LVDT sensor will be rejecting material if it is not within the thickness parameters set. We have never had this and implementing for the first time.

The second question is the validations would just be needed at the process(equipment)where the LVDT sensors are added, and not at the other equipment within the process, correct?
 
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chris1price

Trusted Information Resource
#2
As always, difficult to provide an exact answer without lots of additional information. However my recommendation would be to do IQ, OQ and PQ
- IQ, to make sure it is installed correctly and you have all the necessary paperwork in place
- OQ, to make sure it operates correctly at the limits, rejecting and accepting what you think it should
- PQ, one or more production lots to make sure it works as you expect over a longer trial, and under usual operating conditions.

Look at your risk assessment, can it effect other down-stream equipment? If it can, include them in the validation. Maybe just the PQ, but it better to be safe than sorry.

You don't say where you are based, but arguing with an FDA inspector why you didn't do the validation, will cost more than a PQ report!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
An FDA talk about your IQ OQ PQ will be (I guarantee) shorter than a long discussion about why it wasn't done. FDA audits are very dry and clinical. They are trained by the FBI and have had their sense of humor removed surgically :)

If I had to choose between my boss is mad at me for forcing IQ OQ PQ vs an FDA warning letter Ill choose the first. Part of your job is to protect the company and your customers. The fact you asked this on a forum tells me you are unsure enough and should do it.
 
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