100% verification. Is validation necessary?


Good Day. I am setting up the QMS (ISO13485) for a start up medical device company: they manufacture laser devices and only manufacture 1 device at a time. There is 100% in process and at final inspection. Do I need to do process qualification? Do I need to do validate equipment and how extensively?


Starting to get Involved
It depends on the processes they have during manufacturing. For each step/process, you need to ask if you can 100% verify the output of that process. It is also called "special processes". If the output of the processes cannot be 100% verified, then you have to do process validation. Such as gluing, soldering, surface preparation, cleaning, sterilization, welding, sealing, cable crimping, curing, heating etc. Sometimes it can be the equipment itself. You can check the GHTF guidance: https://www.imdrf.org/sites/default...g3-n99-10-2004-qms-process-guidance-04010.pdf


Not out of the crisis
Super Moderator
To really answer your question we need more information, but the safest bet is to always do due diligence and properly validate the overall process. How that validation occurs is really up to the risk analysis of the process. You say that they are making laser devices... it really depends on how much they build themselves. if they are simply purchasing parts like PCBA, Lenses, etc. and assembling them, then their receiving inspection and lot control better be in control. But if they are building the PCBAs then that whole process will need to be validated. We really need more info to provide an accurate answer.

The Specialist

Personally, I would take the approach that 'validation' of each of the equipment, process and measurement methods ARE necessary. If you take a risk-based approach to the validation process then the output of your FMEA/ risk study (against URS/FDS/DS) further reported within a requirements traceability matrix may be all of the 'validation' effort required.

My point is that by documenting your (testing) decision-making processes using 'validation tools' you are essentially following good practice and can report on the validated status of equipment, process and measurement methods positively.

During your risk-based assessment, you will undoubtably uncover some activities that constitute 'validation', such as; Calibration and maintenance, GRR requirements, data management and procedure generation as a likely minimum.

Of course, this is only my opinion for discussion.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
We 100% inspect each unit operationally by turning it on and making it broadcast its temperature data (Its essential performance)

In any case, we validated the product as well. Its easier to just provide a report than to explain how 100% inspection fulfills the requirements. We use the 100% inspection statement to catch any auditor's "But what if" Scenarios.
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