Organising IQ, OQ and PQ content in a "smart" way

Hi all,

I've been encountering several different ways of interpreting the purpose of "operational qualification" (OQ) of manufacturing equipment as per 21 CFR 820.80

There's probably some room for interpretation here, I can understand that, but I would just like to tap in to the great knowledge of this community to hear your thoughts on this since I'm quite new to the medical device manufacturing practices.

I'm basically looking for an stringent way of defining and arranging the content to reduce confusion.

Would you include all of these three things in an operational qualification (OQ) for a piece of automatic manufacturing equipment?
1. Capability of the machine according to specs?
2. Finding "Challenge settings" and control limits for the machine when manufacturing the specific part?
3. Software (part-specific program) you made to manufacture the part?

I'm leaning towards IQ on 1
OQ for 2 and 3.

Last edited:


Staff member
Super Moderator
Your 1. does not relate to the IQ/ or anywhere. Capability of the machine according to machine spec is determined and then evaluated before it is coming to installation. In IQ, you ensure that the machine is installed per recommendation and all inputs to machine well and securely provided.
Your 2. and 3. are OQ elements.
PQ is a confirmation that the OQ outputs that are set, are providing stable and acceptable machine outputs (part) consistently in actual use environment.
Hi, 21CFR820.80 (or 820.70) does not mention IQ, OQ or PQ, just that, when required, validation should occur. What you define as going into IQ or OQ is largely up to you. Provided you have clear procedures and the necessary tasks are performed, it is unlikely someone will object to having a task in a different bucket.

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