Q&A WITH JOHN TAUPIER, GENERAL MANAGEMENT PROFESSIONAL REGARDING THE USE OF ISO 13485 IN MANAGING SUPPLIERS
John Taupier is a 30+ year veteran of the aerospace and medical industries whose career includes operational management positions at Raytheon, Smith & Nephew, Instrumentation Laboratories, NP Medical and, most recently, as Business Unit Manager for Nypro Inc., a Jabil Company. John has as wealth of experience in managing manufacturing operations, including supplier selection and supplier management. Moreover, he has the experience and judgement shaped by many compliance audits from customers, notified bodies and regulators.
John shares his senior management perspective on management systems and how they are applied to supplier relationships.
Q: When you learn a supplier is ISO 13485 certified what does that say to you about 1) the supplier company, 2) your level of risk mitigation, and 3) any burden that removes from you as the party ultimately responsible for that supplier?
A: Having spent most of my career managing highly-regulated operations and businesses and knowing the rigor required for an organization to become ISO 13485 certified, many of my fundamental questions are answered immediately with this certification. In having these questions answered, I can shift my focus towards understanding the capabilities and value-add propositions a potential supplier can provide. Business risk in critical areas of regulatory compliance, quality and continuity of supply are reduced and transferred to the supplier to the extent possible, allowing greater internal focus on other critical factors and the ability to seize opportunities to grow and expand our business.
Q: As a manager of multiple different contractors, how does your involvement differ from provider to provider? Is ISO 13485 certification a factor in that?
A: There are a multitude of suppliers and business partners you rely on to successfully meet the goals and objectives of the organization. In regulated business environments, this truth is of great significance since you are responsible to ensure your suppliers are maintaining regulatory compliance while delivering the expected value of a product or service. Typically, with medical device manufacturing, suppliers are classified as critical, major or minor; these ratings are based on the product(s) or service(s) risk to product quality and reliability, as well as the degree of influence they have towards the successful ongoing operation of your business. In the “critical” and “major” tier classifications, I do not often find suppliers that do not hold an ISO 13485 certification.
Q: When you think about significant service relationships, like on-site staffing or workforce managed service providers, does ISO 13485 certification provide you any sense of risk mitigation? Would it apply to any service provider or does it depend on scope of work?
A: There is no question for me that knowing that our on-site staffing service provider possess an ISO 13485 certification mitigates risk. It is very rare, in my experience with staffing firms, to find one with an ISO 13485 certification. I believe this to be a differentiator from other service providers competing in the MedTech space. When you consider that most of the contract staffing provided to NYPRO is working directly on medical device components and products within a regulated manufacturing environment, it makes sense they are provided by a firm that holds this certification. In addition, there are strong synergies created between the organizations when they both possess an ISO 13485 certification.
Q: As a healthcare products manufacturer who has managed supplier relationships, what advice would you give to other MedTech companies in their potential use of ISO 13485 as a supplier selection criteria or management tool?
A: For me it is a clear preference to select suppliers who possess the ISO 13485 certification. I like to know a supplier has undertook this level of effort and rigor. Considering the future and managing risk and service levels, the supplier must undergo third party regulatory audits on a set frequency to maintain this certification. This provides an additional level of confidence.
Q: Of the issues and challenges you face in the workplace, what keeps you up at night?
A: As a manager, there are situational challenges that arise that can keep you up at night. For me, continuity of supply is probably the number one from an ongoing operational perspective. Continuity of supply includes the supply to our customers as well as from the hundreds of suppliers we depend on to meet our objectives. It includes the correct quality in the right quantity when needed. When you consider the pure number and complexity of influences that can erode or stop supply, it is clear why this can keep you awake at night. Therefore, it is important that during the supplier selection process, we choose partners who reduce adverse influences to help assure supply, regardless whether a product or service.
Q: Where do you see MedTech manufacturing going in the next 5-10 years as it relates to the buyer/supplier relationship and risk management? How do you see that applying to the staffing provider?
A: I believe that over the next 5-10 years, a continued effort will be made to consolidate organizational supply base to help reduce overall supply portfolio risk and better leverage scale to remain competitive in the MedTech manufacturing sector. This belief is supported by the consolidation seen over the past few years with the large MedTech OEMs buying each other up. Those staffing firms who already have an ISO 13485 certification are well positioned to provide the desired regulatory risk mitigation for this changing sector. Additionally, I believe the potential for these same staffing organizations to scale in support of growth is well supported because of this certification.