- August 8, 2023
- Posted by: Bruce Klopfenstein
- Category: CQV
The final stage of CQV is one of the most critical; the Handover. This is where all of the hard work and efforts that were put in by the team, could be not fully realized if the Handover is not handled smoothly and successfully. Below are the key steps required to ensure a smooth handover:
Define and formalize the process
As early in the project as possible, prior to writing the Validation Plan, decide how the handover will be done. Who accepts and signs off for which systems, how documentation is formatted and transmitted, what are the expectations for a completed system, what are the forms to be used, etc. This should be discussed and agreed upon by all affected parties and, for contractual and practical reasons, be a formal documented procedure.
Decide the order and grouping of systems
Obviously, utilities are the first systems handed over but how are they prioritized and grouped? For example, does the client want WFI generation as soon as it’s tested or do they prefer to have it grouped with WFI Distribution and Storage before taking ownership? (assuming WFI is segmented into these three systems). This can be a substantial effort in the planning phase to work through on a large project but better here than in the chaos of when handover is happening and systems are being handed off in mass. This should be included in the CQV schedule, not just when testing is done and documents are completed, but how the system handover is managed.
Work closely and early with the client’s Doc controller
This is a key consideration that surprisingly is often assumed – “We always format and transmit our documents this way, we thought you knew that.” The client should be able to have the documents prepared as they require. If there is no client document controller, then that is an issue that should be raised early. You do not want this role to arrive at the 11th hour and declare that the format and process is all wrong and needs to be changed. As with the handover process, this should be a formal, documented procedure.
Coordinate with the OR Team
Operational Readiness (OR) used to be a novel concept used by a few clients. Now it is considered a key project success component with a lead role such as OR Manager/Director that often evolves into an operational role later. If you have such a person on your project, engage them early on so that the appropriate onboarding, training, testing involvement, etc. are included in the CQV planning. Some clients want tight coordination with this final contractual phase of the project, up to and including active involvement in testing. Others just want to know key CQV milestones to include in their schedule. The point is to make sure you are aligned with this aspect of the client’s approach.
Be sure the client is prepared to take ownership
Typically called, TCCC – Transfer of Care, Custody, and Control. This is another key element that is often assumed by both parties. We had one client who said, “Yes, the system is complete but we’re not ready to sign the acceptance because we’re having trouble getting our staff onboard. We have no one to maintain it so you’ll just have to keep it until we get our people hired and trained.” This has contractual (payment was based on acceptance) and labor (keeping equipment maintained and in some cases running) implications. This scenario can be acceptable if it is thought out ahead of time with payment terms. Be sure to discuss this with the client early on to avoid unprepared ownership.
Lastly, but most importantly, don’t forget the safety implications of TCCC. In one instance, the client assumed that once they took ownership, then the safety procedures for that system shifted to the client’s safety program. Although awkward, this might have been possible if developed with a plan that everyone was aware of. In this case, it was just assumed and caused a great deal of confusion and potential risk. An emergency meeting was called and luckily no one was hurt but this shouldn’t have happened. Include safety in the planning for handover so everyone knows what to do. Again, the best approach is a formal, documented procedure.
To summarize, successfully managing the handover from Commissioning, Qualification, and Validation to a client requires several crucial considerations. Firstly, a well-defined, formalized handover process should be established early in the project, detailing all necessary procedures and expectations. Secondly, strategic decisions should be made on the order and grouping of systems to be handed over, which should be incorporated into the CQV schedule. Thirdly, it is critical to collaborate closely with the client’s Document Controller to ensure all documents are correctly prepared and formatted. Operational readiness is another key area of consideration, requiring effective coordination with the OR team for seamless onboarding and testing. Ensuring the client is fully prepared to assume ownership, or Transfer of Care, Custody, and Control (TCCC), is another essential step that prevents any operational or maintenance issues. Lastly, safety considerations must be integrated into the handover process to mitigate any potential risks. Each of these considerations requires thoughtful planning and documentation, ensuring the project’s success and client satisfaction.