Process and Equipment Validation is a method to establish evidence that a product is produced that meets the predetermined specifications. When a new machine or equipment is acquired, a master validation plan is designed to test the functional specifications and other user requirements. As a part of the validation process, qualification tests are carried out to prove that the equipment shows satisfactory performances that are widely known as DQ, IQ, OQ, PQ tests. A validation report is generated after the execution of the qualification tests.
Regulatory agencies around the world have strict requirements for quality, procedures, performance testing, safety checks and the like, for a wide range of products.
In precision instruments, lab equipment or specialized machinery, even minor inaccuracies can cause problems and lead to inaccurate or incomplete results.
Equipment validation ensures your product will consistently perform within a given range. Most consumers look for certification from quality management systems, like ISO, before they even consider buying a product; so an incorrect system of validating your equipment can threaten your adherence to industry norms, as well as your certifications and compliances.
Here are some of the protocols that need to be kept in mind for successful equipment validation:
* Documentation Availability – All the documentation that is required should be verified and made available. This includes electrical schematics, mechanical and instrument drawings, utility and supply ratings, spare parts lists, and such.
* Component and Design Verification – The design of the equipment and its components should be verified in accordance with specifications and verification norms.
* Electrical Connections and Supply – All the electrical connections and the power supply to the equipment needs to be checked thoroughly before you begin the validation process.
* Utility Supply – Hydraulic, pneumatic, and other input supplies, as well as the connections, should be verified for quality and checked for leaks.
* Safety Compliance – Safety checks should be tested and noise levels should be within applicable standards. Electrical connections and fail-safes need to be checked and tested, and the wiring needs to be checked for leaks. Radiation and interference levels should be within acceptable limits too.
* Critical Instrument Calibration – Any sensors or monitoring instruments need to be calibrated correctly. The accuracy of primary monitoring instruments and controls should be within the limits of traceable standards, and the resolution should be within the required range.
* Environmental Verification –Instruments need to be checked for operation in various environments. This includes testing within the required ranges of temperature, humidity, light, electrostatic discharge isolation, and other conditions.
* Standard Operating Procedures – SOPs for various procedures should be available, like cleaning, periodic maintenance, software configuration, disaster recovery, etc.
* Instrumentation for Validation – The instruments used to validate the installation qualification should be listed and should be within the due date for re-calibration
These are just a few things that almost every validation process should incorporate. Depending on the industry the instruments are built for and the individual requirements of the validation, other aspects might also need to be taken into account.