Through the many different iterations of the CQV model, from the traditional V-model to the hybrid approach to the risk-based approach, a significant amount of time and effort has been spent demonstrating to regulatory inspectors that facility, equipment and utilities are rigorously and robustly commissioned, qualified and validated to their intended use. Can the amount of time and efforts be streamlined, yet regulatory expectations be met?
Enter TIMWOOD, a mnemonic for the seven wastes of manufacturing – Transport, Inventory, Motion, Waiting, Overproduction, Overprocessing and Defects. In order to streamline the time and efforts expended on the CQV process, the contributors to these wastes must be identified before appropriate mitigations can be taken to improve the effectiveness of the CQV process – regardless of the model chosen.
This article aims to provide high-level ideas that can be further explored by respective organizations during the setting up of the CQV Execution Plan (CQEP).
Transport
By default, equipment testing shall be executed in the intended installation position as per design. As far as possible, this should be the default decision to prevent unnecessary equipment relocations that bear the potential of equipment damage and retesting. However, subject to project scheduling and nature of the equipment, equipment CQ could be performed out of place with the technical justification of validity of the test results after moving into place to avoid retesting. With meticulous planning, the overall CQV schedule could be optimised/shortened while ensuring the integrity of the test results.
Inventory
It is very common for CQV projects to generate all test protocols (Commissioning Protocols, Commissioning & Qualification Protocols, Installation Qualification Protocols, Operations Qualification Protocols, etc.) to have them ready for execution either for progress reporting or for assurance of readiness. There are different views as to whether this is the best practice. Should a First of Kind (FoK) approach be taken for a facility, equipment or utility so that deficiencies/issues/problems identified in the FoK document could be incorporated in the subsequent iteration of the FoK? This would eliminate the time and effort required to remediate errors in all of the documents that were based on the same template.
Movement/motion
Sufficient thought should be given to the document storage location for review/approvals. Shall the documents be centrally located, where the reviewers/approvers go to the documents to work on them rather than the other way around? Implementing the former has a greater advantage in that the risk of documents being misplaced will be minimised. This will also help save the document executor’s time in “chasing” the reviewer/approvers. The document executor shall be kept busy with what the document executor does best – to execute.
Book an informative introductory 15-minute call with JoonLeong to clarify your CQV / Kneat / Paperless validation requirements and to understand how we can support you.
Waiting and delays
Waiting is often an easy waste to overlook. In the case of executed document review, it is the norm that the document shall be 100% completed before it is routed for review. This could result in a “lull” period for the reviewers, which is not the best for the project execution. One of the ideas that has effectively kept the reviewers engaged fully is “review by test scripts” instead of “review by document”. By the time the last test script is reviewed, the entire document has been reviewed and readied for execution post approval. Tracking of test scripts, reviewing personnel effectiveness and utilization of paperless solutions are among the areas that contribute to the success of this approach.
Overproduction
During the initial scoping of the CQV project, the ratio of personnel between the document author, executors, reviewers, and approvers including the agreed turnaround time shall be considered. If poorly planned, it could result in the CQV executors “overproducing”, with a bottleneck at the review or approval stages which hinders the completion of the single-piece flow. Therefore, a holistic view is required during the management planning of resources to ensure that sufficient hours/resources are planned.
Overprocessing
“Are the tests in the CQV protocol sufficient to demonstrate that the facility, equipment or utility meets its intended use?” This is usually the question at the back of the mind of authors, reviewers, SMEs and approvers. More often than not – unnecessary tests with minimum to no value are added to the test script simply because “these tests are always included”. One has to be clear on the nature of the system being tested, the objective of the test and the approach that is taken for the CQV. For e.g. alarm testing for a Commercial Off the Shelf (COTS) Fridge/Freezer used in a training lab versus a customized Purified Water Generation & Distribution System used for cleaning/generating water for injection.
Defects
Exceptions, incidents, deviations, and non-compliances are the common definition of defects in the CQV realm. Every one of those defects calls for lengthy discussions on reporting and remediation, including, but not limited to the design documents’ revision through Change Management through to partial or full re-execution. In addition to having suitably qualified personnel executing tests, the time and effort could be streamlined through utilizing the First of Kind (FoK) approach to eliminate duplicated efforts on duplicated defects.
As the adage goes, “there’s more than one way to skin a cat”. The same applies to the lean CQV approach. The seven wastes identified in manufacturing shall be viewed as concepts that are applicable and adaptable to CQV – thus lean CQV. Organizations shall examine closely during project setup to identify potential pitfalls and subsequently devise suitable countermeasures. At the end of the day, the objective remains the same – to bring the product faster, with the same testing robustness and quality, to the patients.
Please read my guide to IQ, OQ, and PQ in the pharmaceutical industry and the article on Commissioning and Qualification in the pharma industry: debunking the 5 myths for a more comprehensive understanding of the CQV process.
At No deviation, we partner with you to help you with executing your CQV process, troubleshooting or your CAPA, or implementing new digital solutions. Our team will come with an open mind and follow the simple steps that are Understand, Observe, Define, and Implement.
Reach out to us to know more about Paperless CQV, Web-based EMS, or simply like-minded resources support. You can also visit our website for more information on our services.
