In recent years, ASTM E2500 and various ISPE Baseline Guides focusing on risk-based commissioning, qualification, and verification have made the days of executing identical C&Q protocols and repeat testing a distant memory. Now we must ask ourselves how can an integrated C&Q approach be implemented in an organized and efficient manner? Two major pieces to solving this puzzle are identifying and approving critical user requirement specifications (URSs) early in the project and the effective use of Requirements Traceability Matrices (RTMs).
User Requirement Specifications (URSs)
The URS (sometimes called a Process or Product Requirements Specification) will be the basis for all equipment & system testing. The URS needs to be focused on quality-critical requirements that affect the product’s quality and/or patient safety. It is imperative that the approved requirements are able to be tested and focus on what the system needs to do, not how the requirement is achieved. Avoid including general features just because they appear in equipment/system documentation. Keeping these guidelines in mind will ensure that the URS does not become ambiguous and will also prevent non-value added testing later in the process.
For example, a recently reviewed cleanroom URS included the following requirement: “Computational Flow Dynamics (CFD) analysis must be completed for classified spaces to minimize the risk of airborne contaminants coming in contact with the process stream.” In lieu of including this engineering tool as a requirement, the user requirements associated with airborne contaminants and air flow should include the level/classification of airborne particulates and pressurization actually required in the cleanroom spaces. This will then be verified/tested by performing smoke studies, measuring differential pressures, and obtaining actual particulate counts in test protocols.
Requirements Traceability Matrices (RTMs)
RTMs provide a roadmap to document where each user requirement is tested in the validation life cycle. Usually in a table format, user requirements are listed in the first column and then subsequent columns are added for each test document executed throughout the CQV process for that equipment or system. This allows for documentation of where each user requirement was successfully tested. This can include FAT, SAT, vendor startups, commissioning, vendor qualifications, and final company qualification documents.
A question that normally comes up during projects is, “How are we verifying each user requirement was actually tested in the document(s) specified by the RTM?” A great way to satisfy this issue is to incorporate the RTM into the final company qualification protocol. A “Verified By” column can be added as the last column and then the RTM can be executed as part of the company’s qualification protocol. This provides a mechanism to go back and review the previous testing documents and sign off that each user requirement was actually tested successfully as per the RTM by the “Right Person at the Right Time.” Procedural verbiage in the protocol can indicate that a protocol deviation and/or addendum be generated if it’s determined that a requirement was not properly tested during review.
While URSs and RTMs are only part of the overall validation life cycle, the timing and strategy in which they are implemented can go a long way in simplifying the integrated testing approach for any C&Q project.