What is Equipment Qualification?

Document ID

Document ID TE9329

Published Date

Published Date 04/03/2019
Question
What is Equipment Qualification?
Summary
A description of what Equipment Qualification (EQ) is and its parts including IQ/OQ.
Answer
Equipment Qualification (EQ) demonstrates that the instrument does what the user needs it to do. EQ is frequently referred to as simply IQ/OQ as these sections comprise the bulk of the effort on the part of the instrument manufacturer. DQ and PQ are primarily the responsibility of the customer. EQ gives the end user and their regulator(s) confidence in the results that are obtained with the equipment. EQ will often be used as evidence of regulatory compliance during regulatory Audits.

EQ is comprised of four parts:
1. Design qualification (DQ) - Verify that the instrument is designed to do what the user needs it to do.
  • This section documents the manufacturer's specifications and any other additional specifications that the user may have.
  • The goal is to make sure that the customer got the right instrument.
2. Installation qualification (IQ) - Verify that the instrument is installed in such a fashion that it can do what the user needs it to do.
  • This section documents that the instrument has been installed according to manufacturer's recommendation.
  • The goal is to make sure that all the parts are there and that they are all set up correctly
3. Operational qualification (OQ) - Verify that the instrument can meet the analytical specification required for it to do what the user needs it to do.
  • This section is where it is demonstrated through a process/procedure/SOP that the instrument can do what the manufacture claims that it can do.
  • This process generally involves running a series of standards to demonstrate that the instrument meets the specifications from the DQ section.
  • The goal is to make sure that the instrument works properly.
4. Performance qualification (PQ) - verify that the instrument continues to do what the user needs it to do.
  • This section is where the customer designates the steps they will take to ensure continued performance of the instrument after the initial service from Hach.
  • This section is to be created by the customer, with assistance from Hach, according to their internal quality procedures.
  • The goal is to make sure that the instrument still works after Hach Service has left the building.