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I participated in my first Factory Acceptance Testing (FAT) recently, and I wanted to share my experience of what that looked like. FAT is performed during the initial stages of Commissioning, Qualification and Validation (CQV) for new customized equipment purchased for pharmaceutical processes. This is needed to confirm that the vendor has successfully met the design specifications for an equipment and fulfilled the purchase order correctly. The motivation for an FAT is to catch deviations or errors at the earliest possible time so that corrective action can be applied with minimum disruption and avoid costly and time-consuming turnaround that comes with late discovery of issues.
FATs generally take place at the vendor’s facility immediately after an equipment has been manufactured, fabricated and verified for quality. This is a part of Quality-by-Design (QbD) approach to mitigate risks at the initial stage, eliminate any departure from specifications thereby conforming to quality, safety and design standards.
Here are some of the most important aspects of an FAT –
1. Review of the Vendor Turn-Over Package
The vendor turn-over package (TOP) consists of documentation comprising of the design, manufacturing, welding and fabrication, automation and control documents, instruments specifications, spare parts, data sheets / cut sheets, engineering drawings, calculations, bill of materials, certificates, operational and maintenance manuals, reports etc. that confirm that the equipment meets the design requirements.
In short, this is a repository for the equipment that is listed in the purchase order or Vendor Documentation Requirements (VDR) document. A TOP package that meets the VDR is necessary for a smooth FAT execution. Incomplete TOPs indicate that the equipment does not fully meet specifications and the missing documentation must be supplied by the vendor or tests must be executed by the client at later stages before GMP release – Site Acceptance Tests (SATs) or generic C&Q activities. The final TOP package is normally delivered to the client along with the equipment.
2. Safety and Quality Measures
The FAT is performed by the client representative and/or consultants at the vendor’s facility or wherever the equipment is being fabricated. This could be of 2-day or 2-week long execution time frame, depending on the number, and the complexity of the equipment. While working on-site at the facility, it is important to adhere to their quality and safety standards. Vendors normally provide a tour of their facility, information on emergency exits and if required, train visitors on their specific safety procedures. Adequate Personnel Protective Equipment (PPE) must be worn while observing or executing operational tests.
3. FAT Protocol Execution
The FAT protocol is authored by the client representative or consultant prior to the facility visit. The protocol includes tests associated with TOP verification, equipment/vessel/skid installation, product contact and non-product contact (sanitary or non-sanitary) auxiliary component installation, P&IDs and drawings walk-down, power and control verification, cleaning and passivation verification, operational tests etc. The vendor supplies the TOP package on-site for review and supports the client representative with material and resources for operational tests. Most tests in the FAT are executed as visual inspections or as documentation verifications. This not only helps complete the qualification activity but also provides a working knowledge of the equipment which is useful during subsequent commissioning.
4. Generating Punch List Items
The FAT protocol does not have a discrepancy log since this is a verification activity prior to shipment, and is being executed to ensure the equipment meets the requirements and to remove any bottlenecks prior to the regular installation, operational and performance qualification (IQ/OQ/PQ) stages. Any unsuccessful test runs or missing/incomplete documentation identified during TOP review is recorded onto a punch list and distributed to both the vendor and client management. The punch list mainly indicates the progress of the qualification activity. The punch list items can be addressed either prior to the FAT closure, or during the SAT execution, depending on its criticality. The vendor is considered to have delivered the product successfully if the FAT and SAT protocols are executed with all pending deliverables in the punch list closed.
5. Building Vendor-Client Relationship
FATs are a great way for the system owners to establish good working relationships with their vendor and other subcontractors. Vendors have a wealth of information to share about the procured equipment and other products in their portfolio. In addition, due to their unique position of servicing needs across multiple clients, vendor interactions provide a lot of valuable practical insights to the clients.
FATs help in fostering bonds with vendors on human level, both at work, and outside (working lunches, business dinners etc.) and add a very personal element to the usually dry aspects of vendor relationship management that are handled over purchase orders, emails and memos.
These interactions also help vendors better understand the needs of their client and build a bedrock of mutual trust that becomes necessary to navigate any trickier situations that might arise down the road. Lastly, it also improves the likelihood of collaboration between both parties over long term.
FATs are fantastic source of experience for understanding the engineering lifecycle of a project. They serve as a bridge between the design and the final product thereby helping one understand how it ultimately affects the manufacturing process. When FATs are more thorough, they dramatically lower risks with the manufacturing equipment and hence pave the way for a very smooth final on-site qualification.
