Deaths and serious injuries that may have been caused by adulterated heparin or by faulty capacitors in implantable defibrillators have made supply-chain issues a hot topic in the mainstream media. In fact, about 15% of all medical device recalls are caused by supplier-related incidents. Recent high-profile cases have prompted FDA to scrutinize the device industry's complex network of supply chains. Agency investigators are paying more attention than ever to a firm's ability to effectively control its own purchasing process. Based on the similarities between ISO 13485 Section 7.4.1 and 21 CFR Part 820.50, it is clear that device manufacturers around the world must establish and implement purchasing procedures that cover the following three areas: the supplier evaluation process, the tracking of purchasing data and information that clearly describe specified requirements, and the verification of purchased products. Even with compliant purchasing control procedures in place, firms still find themselves facing numerous product issues, especially when manufacturers improperly evaluate and inadequately control their suppliers.
Effectively evaluating suppliers and their ability to meet quality requirements still presents a challenge for many device firms. Manufacturers can evaluate their suppliers either by issuing a survey or performing an on-site audit. Supplier surveys typically are quick and easy but not always reliable. In a rare published purchasing study, 1000 surveys were distributed to suppliers and were followed with on-site audits conducted by the survey authors. The authors concluded that only about half of the suppliers actually provided accurate information on the surveys.
On-site audits provide an accurate assessment and general overview of the supplier's quality systems, operations, and documentation, but the audits often are limited in scope and, therefore, insufficiently thorough. Supplier audits require significant planning, resources, and follow up. It should be noted that lack of follow-up to audit observations is the most common deficiency of an external auditing program.
To effectively control supply chains, firms must perform a risk assessment of their suppliers and classify them as high- or low-risk partners.
High-risk suppliers typically are providers of critical components, assemblies, and raw materials, as well as single-source vendors. They always require the most stringent oversight and controls. High-risk suppliers must be properly qualified and formally bound to a mutually approved supplier agreement. Each agreement must contain a clearly understood notification policy requiring them to alert manufacturers of any supplier-induced changes before they are implemented. This notification allows the manufacturer to determine if the proposed change may affect product quality, since the quality of finished devices often is negatively affected by unauthorized supplier changes.
Low-risk suppliers do not need the same stringent oversight as high-risk suppliers and can be periodically surveyed with limited consequences.
In summary, firms can effectively control their supply chain, if they can properly evaluate, segregate, and manage suppliers based on risk.
Glen Feye is president and founder of Accurate Consultants Inc., a full-service consulting firm that specializes in regulatory affairs, quality systems, and compliance consulting for FDA regulated industry. A senior regulatory affairs and quality assurance consultant, Feye is experienced in quality and regulatory assurance for both the medical device and pharmaceutical industries. His areas of expertise include document control systems, corrective and preventive action (CAPA) programs, validation programs, and third-party assessment of suppliers. For more information about Accurate Consultants Inc., visit the company's listing in the online directory or go directly to its site at www.accuratefdaconsulting.com.