Within the Life Science industry, patient Safety and Product Quality are vital considerations. FDA approval is dependent on these two values when new products are being brought to market. As a result, this approach filters down to the design and build phases of projects, buildings, and the systems and equipment installed.
With over 10 years of experience in the Life Science sector, David Wheeler, MEP Systems and Equipment Turnover Coordinator is involved in equipment setting and installation, start-up and turnover. In brief, David takes delivery of the packaged equipment sets, gets them in place, hooked up, then coordinates the system start-up and handover documentation for commissioning to commence. His role is essential for production efficiency and quality in the Life Science sector.
David is currently working onsite with a leading manufacturer in North Carolina, USA on Life Science projects in the areas of Biotech, Pharma, and Gene Therapy. David shares his 8 top tips for efficient handover & turnover of equipment & systems.
Defining systems will identify where the boundary or piece of equipment starts and stops and where the breakpoints are situated. Defined boundaries will form the scope of the Turnover Package (TOP) for each system. It is essential to get CQV (Commissioning, Qualification, Validation) and owner reviews and approvals. It is important to keep the approved boundaries up to date on the latest revision P&IDs if there are reissued drawings due to design bulletins.
Fig.1 – Typical boundary break indication
Having this document or index in place will define the material that needs to be included in the TOP. The CQV group can review and approve this index, defining the TOP content and structure ahead of time.
Fig.2 – Sample section detail
Once the system boundaries have been defined and there is agreement on the TOP Table of Contents, draft a sample TOP for review. It is easier for all relevant parties to get on board if they can see this in the flesh’ as opposed to trying to visualise it based on a generic Table of Contents.
Fig.3 – Sample cover page detail
Assess if the intent is to produce physical hard binders for turnover or to maximize the use of electronic material for quicker and easier review and sign-off. If actual binders are required to contain original documents with ‘wet’ signatures, these can often be produced at the end of the project if electronic versions have been made available earlier. Electronic documents can be bookmarked, hyperlinked, and can include an OCR (Optical Character Recognition) function which will make reviewing much more efficient. The process of formatting these files electronically may also serve as a checks and balances exercise for the group building the packages.
Fig.4 – Typical bookmarking function in .pdf
Arming the trade partners with the information and guidelines will greatly increase the quality of the TOP content most likely received from installing contractors and as a result, will also produce a better TOP product for delivery to the client. Setting regular meetings in the early phases of construction ensures successful project delivery.
Co-ordination with equipment vendors, requesting a sample of their TOP for assessment against the project goals will help to align that portion of the TOP with the field-installed systems. CQV personnel look at the complete system and do not differentiate between factory-built and tested equipment and field installed services hooked up to equipment. The overall system, including the equipment components, needs to function and meet the design intent.
Fig.5 – Sample equipment vendor content
The boundary P&IDs, defined Table of Contents, and draft sample packages will form the structure of the overall process. To enhance these and maximize efficiency, it is advisable to generate a system dependency matrix identifying which utility systems support certain manufacturing components. This should include energization paths and airflow paths highlighting what power line-ups and HVAC units are needed first to support critical rooms. This allows the overall team and commissioning groups, to agree on the priority systems, the sequence of build-out, and start-up resulting in a smooth transition and handover. It also allows the resource curve needed to commission and release for production to be flattened out.
Once TOPs start to become available and the associated systems are built, tested, flushed, or passivated, typically the CQV group is walking these systems down. Punchlist items are being generated and addressed. Mechanical, electrical, and controls checklists are being executed. To successfully manage these activities, it is important to hold regular meetings with all parties to drive the priority systems, schedule the formal walk-downs, manage punch lists, achieve sign-off and transfer care, custody, and control of the equipment & systems to the client.
Fig.6 – BIM360 punch list tool screenshot
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