Installation Qualification is a documented process that verifies that critical pieces of equipment, piping, software or instruments that directly impact product quality have been;
- Properly delivered
- Correctly installed
- Configured according to standards set by the manufacturer or by an approved installation checklist
Think of it as a process of checking and verifying the equipment installation against a prepared checklist to make sure that the components meet the design specifications and that they are installed correctly.
For example, if you have just installed a new pressure vessel, you want to make sure that the manufacturer shipped you the right piece of equipment, made from the right materials as per the design specifications, that it is installed in the correct location, and that the pipework, instrumentation or electrical wiring are connected up properly.
This process is carried out by Commissioning and Qualification (C&Q) or Validation Engineers or Technicians and includes the following activities:
- Verifying that the manufacturer’s technical specifications of the equipment match the design and operational requirements as determined in the facility design element of the qualification process
- Cross-checking of contents against the packing list and checking for damage
- Checking the correct piece of equipment is installed in its proper location
- Verifying (wiring or piping) connections with other units or equipment
- Checking the installation of secondary instruments and ancillary equipment
- Checking for proper energy or utilities supply
- Confirming that the environmental and operating conditions are within the manufacturer’s guidelines
- Verifying software installation
- Recording firmware versions and serial numbers
- Recording calibration and validation dates of equipment used for the qualification
- Gathering all documentation, manuals, calibration certificates and certificates of conformity
This entire process is documented on pre-approved checksheets and signed by the person performing the procedure and then approved and signed by a senior validation team member and quality assurance team.
Here are some examples of professional IQ Templates for equipment installation verification, instrument installation verification, piping instrumentation verification and a P&ID walkdown template.