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Need Help with Case Study Questions



I'm near the final stages of a new opportunity in the medical field and my background is ISO based. So I'm a little lost with regards to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). I am genuinely confused by the last case study example.

Can someone answer these questions? I would get a better idea of what I need to focus on when replying. I would greatly appreciate it.:thanx:


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Steve Prevette

Deming Disciple
Staff member
Super Moderator
It would help to know the context for this exercise. Is this a college course? What textbook(s) and background material were provided?

Also, if you "google" search on "performance qualification" there are a lot of references out there. To me, this is a fundamental quality engineering question of how to approach problem - solving.


This is a case study given to me by a potential employer. Since I have been working primarily in manufacturing that's NON-Medical. So, I need some guidance on how I can answer these questions. Particularly, The last two examples are two areas I'm not too familiar with and I have "googled" various references but, they do not give specific examples on how to solve the "dilemma" exhibited on the case study. Can someone guide me? I'm all ears! Thanks guys!


Steve Prevette

Deming Disciple
Staff member
Super Moderator
Throw out the IQ, PQ, and OQ issue for the moment. If you were faced with a situation that a vendor supplied defective product to you and this resulted in defective product out the door, what would you do? And if you were told the existing monitoring did not catch this internally, but you had to be told by a customer complaint that you had an issue, what would you do? The problem does state there are time and cost constraints for running DOE on all of the combination of tools and combinations. What else could be done. I'd start looking at past data and were they doing some form of statistical analysis of data on hand, and what was it about the vendor's product that caused the problem. And what are the implications for a recall?


Thanks so much for this guidance. I really appreciate it. I think the first thing I would do is apologize to the customer. Then, I would ask for the non-conforming material to be returned for analysis. Check the date code and all quality records for that date. Also, I would check the previous and post error records to see if any established control limits have been lower or higher then normal. I am supposed to be hypothetical for all responses, problems that occurred etc. Am I on the right path? :cfingers:

Steve Prevette

Deming Disciple
Staff member
Super Moderator
Yes, I'd say now you are on the right path. Work through what you would do, and then go back and read again about the Qualifications and see what fits in what context. Keep in mind since this is an operating process, the IQ should have been completed long ago (though a good discussion is - should it have caught this problem, or do we get to assume the problem started after installation).


I think the assumption here would be that a defect slipped through the cracks even after control limits, procedures and inspection points are established throughout the process. Am I left to assume human error? What are the steps?

Bev D

Heretical Statistician
Staff member
Super Moderator
puttign the IQ, OQ, PQ question back on the table, the case study is incorrect in stating that PQ requires DoEs. PQ is typically the production of 3 sequential lots at nominal process settings. the requirement for PQ acceptance is that the material meets all specified tolerances. if from a special process, a sample is taken for the destruct testing. this is when Cpk calculations are made.

DoE is used in the OQ step to validate the special process. typically a fractional factorial is used for the final validation material which is supposed to be acceptable at all combinations of the input tolerances.

yes it can appear cost prohibitive, but if one uses effective DoE, sample plans, adn leverages past knowledge of common materials and equipment, we can devise effective validation plans. (not having effective validation plans can lead to failures that can have substantial cost effect from recall/scrap to regulatory sanctions.)


Thanks for your input! I agree with you that DoE is needed. But, in this particular case study it's not in play. What are the steps taken to go around it? That is the true question......Unless it's a "trick question"? Thoughts anyone?
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