This module will explain the engineering documentation (P&IDs, piping isometrics, etc.) used to specify and design equipment or systems in a manufacturing facility and will also walk you through how to develop a 100-page plus validation test (IQ, OQ, PQ) protocol for a clean in place (CIP) system. You will learn:
- How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
- How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
- How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
- The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications).
- How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
- How to qualify equipment, instruments and piping systems, and automation controls.
- How to document all of these steps in a 100 page plus equipment validation protocol which you will develop as your end of module assignment.