“At the end of a wrench, is a patient.”
The tragic events that happened twelve years ago aboard the Deep Water Horizon (yes, the one that the movie was based on) reinforced a sacred rule – accountability cannot be outsourced. For those who are not aware, of the approximately 126 personnel on board, only 7 were from the sponsor, British Petroleum (in a cruel twist of fate, several BP employees happened to be visitors to the drilling rig on that fateful day). But rarely does the news coverage mention the ~119 outsourced employees affected that day.
The GxP regulatory environment has rules and guidance around these outsourcing arrangements. The 21 CFR 211s states that the manufacturer’s Quality Unit is responsible for approving or rejecting products or services provided under a contract (§ 211.22(a)). The Quality Systems Approach to Pharmaceutical CGMP Regulations assigns accountability to Senior Management as well as specifying that “[i]t is critical in a quality system to ensure that the management of the contractor be familiar with the specific requirements of the contract.”
An outsourced facilities management (FM) relationship is unique since the contracted third party often works both side-by-side and on site with the contracting company. According to FDA guidance (here), the quality and compliance oversight of this arrangement must ensure that “the contract firm’s and contracting manufacturer’s quality standards should not conflict.” This concept can sometimes be forgotten or overlooked in the race for cost savings. Many FM contracts are put in place by a company’s procurement department rather than the Quality Unit; thus, the ability to test for basic qualifications can be overlooked or not considered. Even when the Quality Unit is involved, there can be a perception of pressure to approve the third party where red flags may exist or the correct technical skills were not present in the contracting company at the onset of the engagement, and this gap may not be evident until it is too late.
As Data Integrity citations increase, companies should identify data integrity risks with their outsourced third parties. Performance is measured with data and metrics within organizations as well as regulators seeking metrics for quality. Even though the service is outsourced, the FM data will inevitably affect GMP decisions, either directly or indirectly. Whether looking at calibration, maintenance, lab services, GMP cleaning, or logistics, the output and associated data must be defined and monitored. In this respect, the importance of Data Governance becomes critically important and needs to ensure inclusion in the third-party governance of the service.
Aligned objectives and mutual risk management principles must balance the perception of a difference in incentivization for the outsourced service provider vs the contracting company. Many publicly traded companies recognize their reliance on third parties as disclosed risks in their annual reports. Regardless of the cost vs quality equation, the GMP decision affecting product quality is always the common denominator.
Lachman Consultants can help your firm assess the suppliers of Facilities Management services and assure that the Supplier Agreements cover critical areas, including data governance. Please reach out to P.Day@LachmanConsultants.com for an evaluation today.
