Throughout the course of the cleanroom construction phases and process equipment installation there are milestones noted that require validation of the construction phases and installation of process equipment. Cleanroom equipment and process equipment components may require inspections and validation with the drawings and specifications as not to impede or affect future progress of the cleanroom construction and final validation of the cleanroom environment.
Attempting to validate any cleanroom construction during the final stages of construction only can prove frustrating and fruitless unless a strict validation process has been integrated into the cleanroom construction project at the design stages and followed to specification throughout the phases of the cleanroom construction.
DQ - Design Qualification, review of all design and specifications to assure compliance with client requirements and ability to achieve cleanroom operational parameters.
IQ - Installation Qualification, inspection and qualification of all installation processes and components to assure compliance with specifications and ability to achieve and maintain operational parameters per design.
OQ - Operational Qualification, correct installation of equipment has been assured, it has to be demonstrated that, it can deliver the operating ranges specified in design drawings and written specifications
PQ - Performance Qualification, verification and documentation that the cleanroom equipment and systems are working reproducibly within the entire specified working range and limits. The cleanroom equipment and systems are always inspected individually and are always a part of the overall or partial process. A detailed test plan should be created based on a comprehensive process description before this final validation process.
Failure to insure these milestones are accomplished can result in improper operating parameters upon final validation and certification that can be costly to correct at the final stage.