Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions
Supply chain management is tougher than it used to be. In just about every industry, it seems OEMs (Original Equipment Manufacturers) are increasingly outsourcing once-traditional in-house functions, adding geographical distance and other external variables to the supply chain. This, of course, adds complexity to the process stream and requires manufacturers to have a pretty high “chain” tolerance as the likelihood that something will go wrong and quality will be compromised grows greater.
These OEMs aren’t the only ones noticing the pain potential. With so much room for error – and potential public harm, the FDA is increasingly targeting supply chains in the Life Sciences. As a result, OEMs are holding their outsourcing partners to the same level of scrutiny and expectations for integrity, and pushing their suppliers hard to meet the same FDA requirements they themselves face.
In the eyes of regulators, the finished product quality of medical devices, pharmaceuticals and biologics is only as strong as the links between manufacturer and supplier. So, to reinforce the links, it’s the responsibility of the OEM to establish proper quality controls and to provide proper evidence for products and services obtained from its suppliers. Manufacturers must prove that they are extending their CAPA and quality systems to their supplier network.
So how do manufacturers prove that? To a degree, in writing. The FDA requires third-party suppliers to Life Sciences manufacturers abide by a formal Supplier Quality Agreement (SQA) to ensure these suppliers are manufacturing according to GMP and reporting quality issues. While those agreements are mandatory, there is always a possibility that a supplier will choose to make an exception or take a short-cut to build its component at a lower cost for a higher profit.
Bring in the Reinforcements
Because of that possibility, particularly as supply chain scrutiny continues to grow, the written contract isn’t quite enough anymore. A holistic, automated enterprise quality management system (EQMS) will enable companies to obtain a global view of all quality issues and supplier information across the product continuum. Within the EQMS, an integrated supplier management process will help manufacturers track their product components effectively in order to deliver safe, reliable, and high-quality finished product to end users.
Suppliers are always going to be evaluated on three major issues when dealing with a customer (OEM) that is providing FDA-regulated product: quality, productivity and delivery.
Suppliers who want to prove they can consistently sustain these factors at a high level must:
- Maintain operations under a strong over-arching quality system.
- Provide proper documentation of standard operating procedures (SOPs) in which employees are trained.
- Make sure all systems are validated.
- Have quality systems in place for Complaint Handling, Nonconformance, Root Cause Analysis and CAPAs.
Prevent Chain Reactions
There have been plenty of recent headlines about suppliers letting their customers down, and the majority of the time the failure crept downstream and eventually into the marketplace because of a breakdown in one or more of those quality systems.
Take air bag maker Takata Corp. One of the auto industry’s largest-ever recalls was launched due to faulty parts that directly resulted in injury and death. Years into the recall, Takata’s senior VP of global quality assurance outright admitted in front of a U.S. Congressional subcommittee, that Takata, after several years of investigation, still did not know the root cause of the problems. What was apparent was that something broke down in the CAPA process. In response, industry regulators pointed out: “If you don’t find out the root cause, who knows? We may have this same discussion again in four, five, six, seven, 10 years.” This was a glaring case of supplier error.
Other recent high-profile quality process failures have included the 2010 BP Deepwater rig explosion, the 2009 Toyota rapid-acceleration recall, and the tragic 1986 Challenger shuttle explosion. In each case, somewhere along the chain, the manufacturer failed to adhere to the quality principles of having a mutually beneficial supplier relationship and ensuring that their suppliers could deliver optimal results. These were all caused by OEM and supplier error.
Looking at the Life Sciences industry, St. Jude found itself in the news over certain faulty defibrillator leads. In 2012, an FDA inspection report indicated the manufacturer failed to adequately test design changes made to its leads in the wake of a recall issued the previous year for older versions of that same product which had had third-party component problems. The inspection report found that the newer lead design elements were tested only once, when even the company’s own protocols called for five tests.
These chain reactions demonstrate that product defects/deviations can be discovered at various points in the product lifecycle:
- If it happens during the manufacturing process
- If an issue is discovered during an audit or testing
- From customer complaints – after the product has already been released to the market
All of these breakdowns may be tracked in separate systems and managed differently by different departments, making reviews difficult for management. While SOPs are helpful, they may not necessarily compare apples to apples. Additionally, manually handling CAPA and quality information from suppliers is highly risky – think of the potential for human error.
Link Quality Processes across the Continuum
An alternative is to use technology to monitor the QMS of a supplier continuum. It’s better to implement quality systems on a single platform – EQMS provides for fact-based decision making – and extend that platform to the supplier network.
For instance, a robust EQMS helps efficiently identify supplier quality red flags through a repeatable, compliant, and closed-loop CAPA/SCAR process that logs and manages quality issues originating from any source. When all suppliers are monitored in the same system, CAPAs/SCARs can be enacted, completed, and recorded more quickly, upholding quality without slowing down the manufacturing process. EQMS is the system of record and the single source of truth.
Remember: Prevention is the Best Medicine
Unfortunately, in too many Life Sciences companies today, monitoring supplier quality is still thought of as a necessary evil. Implementation of a quality system is seen as unnecessary expense. If an OEM is on the fence about whether to implement an automated quality system, they need only survey the leaders in their industry, or check in with the FDA. It’s certain they’ll tell you, EQMS is actually an easy pill to swallow.
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