FAT, SAT & Commissioning Activities, Oh My!

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Factory Acceptance Testing, Site Acceptance Testing& Commissioning Activities, Oh My!

Execution of factory acceptance testing (FAT) and siteacceptance testing (SAT) is a business-critical activity when it comes tocommissioning of a new system or equipment. The International Society forPharmaceutical Engineering (ISPE) defines FAT and SAT as the inspection andstatic and/or dynamic testing of manufacturing systems performed to approve thesystems for delivery and to support qualification of the systems.1FAT is conducted at the equipment manufacturer’s site and SAT at the final siteof installation.

FAT Is Key To Minimizing Downstream Issues

New biopharmaceutical equipment is customized anddesigned to fit the manufacturing operations model and product types beingproduced.  The complex nature of the systems, the technology, and theintricacies associated with meeting business and regulatory expectationspresent constant challenges during the commissioning phase. Eliminating issuesand errors up front allows you to minimize the number of business compromisesthat need to be made downstream. Unique requirements, such as accommodating theequipment’s dimensions for existing site drainage, piping, or room dimensions,need to be identified and addressed prior to shipment. In addition, new issues,such as position of the handle for accessibility, etc., can be identified whenFAT is performed. The costs of addressing such issues, whether simple orcomplex, grow once shipped from the equipment manufacturing site. Given theintricacies of advanced technology, FAT is also the right place to verifysoftware design specification, interface, and device integration.

A thorough assessment of the new unit post design andfabrication certainly reduces commissioning issues, which adds a definitivebusiness value. However, to effectively measure the return on investment,businesses should entrust the same team with all commissioning activities, i.e.,FAT, SAT, and commissioning. The metric should consider the number of issuesobserved post FAT in relation to the man-hours invested in the FAT and SATactivities. Addressing the issues at the equipment manufacturer’s site has aplethora of advantages, such as ease of sourcing components, quality ofequipment/instrument used to test and correct, cost, etc. A FAT includes checksfor safe access, interlocks, flow chart machine functions, orientation of dooropening, equipment dimension, utility fittings, piping lengths, closeness,sensors, testing tamper resistance/seals, electrical requirements, anddocumentation such as hardware design specifications, drawings, andcertificates. These aspects primarily relate to functionality, safety, fitnessto user requirements, compliance of the system to GMPs, and data integrity. Itis common to find inconsistencies post fabrication since there arepossibilities of misses during translation of all the user requirementspecifications (URS) and purchase order commitments into design/fabrication. Anexample is the use of a typical coated surface instead of a stainless-steelfinish for environmental chambers. The product impact could be minimal since itis strictly used for storage of the unit’s post-secondary packaging. However,there could be an impact on the cleaning procedure that might be appliedon-site. Making such changes at the installation site is impractical; hence,FAT is a must-do step versus nice to do, for critical systems.

FAT provides the opportunity for the equipment owner’srepresentatives to meet the equipment manufacturer’s expert teams, and theknowledge shared during the FAT sessions is critical to the long-term successof the commissioning process, i.e., through training. Identifying and involvingthe FAT team thus becomes critical. The test runs during FAT also providefirst-hand experience observing the unit running. Identifying and resolving thepunch list items during performance of the FAT allows for authorizing shipmentof the equipment to site. This is a critical milestone prior to SAT; hence, itshould only be completed by an authorized, trained, and approved subject matterexpert.

Figure 1: FAT and SAT

Upon receipt at the site and successful installationverification, critical aspects of the FAT are typically verified in the siteenvironment through a SAT, including the interfaces and monitoring devices[Figure 1]. Utility capacity, automation, interface, and control issues/gapsusually are highlighted during this stage. Therefore, additional test cases toverify the potential failure modes need to be integrated into the SAT protocol.

Use A Responsibility Matrix For Optimal Efficiency

The off-site FAT, on-site SAT, and commissioningactivities need careful planning for flawless execution. The commissioning2and qualification plan (CQV plan) needs to be adjusted based on the extent ofreliance on third parties for equipment expertise, test execution,commissioning project management, regulatory expertise, quality, automation,lab testing, etc. Table 1 provides guidance on the checks and balances requiredwhen utilizing external services for commissioning. A responsibility matrixprovides clarity and ensures ownership of activities, along with optimalutilization of internal and external subject matter experts.

Table 1: Example - Balanced Responsibility Matrix

FAT/SAT Activity	Execution Responsibility Matrix
	Equipment Manufacturer (Vendor)	Approved External SME (Contractor)	Customer Organization
Scoping, identifying codes and regulatory references	Provide supporting evidence	Draft and/or review, provide SME inputs.	Drafted and/or approved by regulatory compliance
User requirement specification (URS)	Provide consultation.	Draft and/or review, provide SME inputs.	Drafted and/or approved by user department
Data sheet	Provide per client URS requirement.	Review, provide SME inputs for revisions where  needed.	Review and approval by internal engineering and  stakeholder departments.
Drawings	Provide per client design requirements.	Review support.	Review and approval by internal engineering.
FAT inspection/test plan/protocol	Draft and review.	Collaborate with vendor to finalize the plan.  Provide SME inputs.	Collaborate, review, and approve by internal  engineering and stakeholder departments.
Operating Procedures	Provide operating manual.	Draft and/or provide SME inputs.	Internal user department and stakeholders draft  and/or approve.
Calibration records	Perform calibration and provide records.	Perform on-site calibration where required and  provide records.	Perform on-site calibration and/or approve  calibration reports.
Calibration schedule	NA	Provide calibration frequency justification.	Develop calibration schedule and maintain.
Certificates, material of construction, finish etc.	Provide certificates	Verify and provide SME input.	Verification and acceptance.
Raw data review	Vendor’s internal QA.	On-site verification support.	Reviewers and QA.
Participation	Vendor PM, technologists, SME	On-site or virtual execution support.	Engineering, qualification, and user departments.
Inspection: Ex. weld, name plate, drain, dimensions,  documents	Vendor technologists, SME.	On-site or virtual execution support.	Engineering, qualification, and user departments.
Tests: Ex. pressure, vacuum, component  functionality, controls.	Vendor technologists, SME.	On-site or virtual execution support.	Engineering, qualification, and user departments.
Data integrity review	Vendor QA.	On-site verification.
Punch list resolution	Vendor PM, technologists, SME.	Verify and provide SME input.	Internal user department, engineering, and  stakeholder approval.

Defining The Goals In A CQV Plan & LeveragingCheckpoints

In addition to the responsibility matrix (includingresponsibilities of approved contractors), a CQV plan must have other criticalcomponents for transparency throughout the project and for robustness. The CQVplan should define the approach for the URS, system impact assessment (SIA),design specification (DS), hardware/software specification (HDS/SDS),functional risk assessment (FRA), FAT, SAT, commissioning, and qualification(IQ/OQ/PQ) documentation, traceability matrix, and stage gate requirements foreach equipment. In addition, the approach to deviation and change managementduring commissioning and qualification must be defined in the plan. The siteengineering team should be responsible for commissioning and validation of thequalification activities. They can rely on project managers and consultants todrive the project and to provide status updates. Where required, the samplingplan needs to be statistically justified by a trained statistician, asstipulated by guidance.3 Different approaches can be taken whenqualifying direct and indirect impact systems. It must be verified that alltest methods/procedures used are qualified prior to use.

To apply a risk-based approach,4 thereneeds to be documented justification at each stage that would withstand anyregulatory scrutiny. It has been found that 45% of the data integrity issues inwarning letters were associated with operations related data.5 Newproduction equipment, with a substantial amount of automation, monitoring,parameters, and attributes, generates critical data. Data governance, control,and assurance of traceability and integrity need to be considered during earlycommissioning.  The controls become even more critical when risk-basedleveraging is applied. Though the CQV plan can potentially identify leveragingopportunities, the outcome of the test cases and the integrity assurance of thevendor-provided data need to be considered prior to officially accepting thetest to be leveraged. Adequate stage gate documented decision steps need to beintegrated into a concise CQV plan.

Conclusion

Developing your FAT and SATplans executing them, and maintaining integrity throughout the process requirescareful, meticulous planning and continual re-evaluation of the plan. This iseven more critical during the pandemic, when teams work across the globevirtually and activities are fast tracked. The development of a fit-for-purposeCQV plan with a clear definition of vendor and contractor roles andresponsibilities,6 continual reconfirmation against the plan afterevery critical execution, providing justification of any changes to the plan,and incorporating enough stage gate points for the assessment are key aspectsto be considered. The goal is to assure traceability and maintain integritythroughout the project, where multiple external parties are involved, bothvirtually and on-site. Where enough supporting evidence is not available, thestrategy on leveraging needs to be reconsidered. It is also ideal to have the teamgoals and responsibilities established. Maintaining the team until the CQVplanned activities are complete is critical since much knowledge may remaintacit in a fast-paced commissioning scenario. Adequate mechanisms need to be inplace within the CQV plan to document and convert the tacit knowledge intointernal explicit knowledge at the earliest opportunity. Applying the insightsdiscussed in this article can add value and greatly reduce potential downstreamissues during a critical CQV project.

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