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Bruce Wold
By Bruce Wold
Tuesday, September 22, 2015 - 11:24

During project planning it is very important to ensure that each of the parts will be produced consistently. To do this, the manufacturing process must be qualified to ensure that it is repeatable and stable, both dimensionally and cosmetically.  At Elite Plastics, this qualification process is broken down into four sections including design qualification, installation qualification, operational qualification and performance qualification. We will explain them in further detail below:


Design qualification (DQ)

During this initial stage, Elite Plastics receives the design print and goes through a tolerance review to determine whether the tool can be built as the customer has requested.


Installation qualification (IQ)

The Elite Plastics team then begins qualifying how to install the tool so that the process can be repeated in the same way during future production runs.


Operational qualification (OQ)

At this point, design experiments are conducted and variables are tested to identify where the part is best suited to run. To do this, parts are taken from multiple conditions and are submitted to metrology for measurements. Based on the measurement results, the next step is performance qualification.


Performance qualification (PQ)

Finally, features, dimensions and cosmetics are evaluated. The production process is run and a predetermined number of parts are randomly selected and inspected by metrology to measure whether the process is deemed to be both repeatable and reliable.


One strength of Elite Plastics is the high quality standards that are adhered to. To uphold these standards, our team goes through this series of qualification steps for every project to ensure that parts meet our customer’s needs. 

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.