Now viewing: installation qualifiaction

Bruce Wold
By Bruce Wold
Friday, September 28, 2012 - 15:18

 

I just posted a short video on IQ, OQ, PQ and I have been asked to elaborate on what it is.  IQ, OQ, PQ is a protocol used to validate instrument performance.  Essentially, it ensures that parts are made the same way, using the same process, every time.  This is  important in plastics manufacturing, especially when making items like medical devices, not only to ensure they pass regulatory requirements, but to ensure that they are made to specification and function properly.       

The steps in the process are usually shortened to IQ, OQ, PQ, which stands for:

  • IQ – installation qualification
  • OQ – operational qualification
  • PQ – performance qualification

Installation qualification is the first step and that means recording all steps that go into setting up the machinery.  This ensures that the project can be set-up the exact same way in the future.  This involves detailing each step and measurement and following these steps in every subsequent set-up. 

Operational qualification is the second step in the process and uses testing data to make certain that the product meets all specifications outlined by the customer.

Performance qualification is the last step in the process and it ensures that the actually product consistently meets requirements when manufactured under the conditions outlined in the IQ and PQ.  This is the last stop before full production and without success; the initial two steps are repeated. 

After the IQ, OQ, PQ process is completed, documentation is filed so it can be referenced at any time, and production can begin.