The medical device industry is in a perpetual state of change as technology continues to evolve, while standards and regulations are in constant state of rescript to ensure the ongoing safety and efficacy of medical devices. This dynamic industry demands an equally dynamic approach to quality. Antediluvian approaches to quality that were premised on inspection, inspection, and more inspection, are just not viable options today.

In the coming months, I would like to enlist my colleagues and ask that you read my ranting, even if these views and concepts appear obverse to your own. It is my intent to grow a dynamic forum using my column Devine Guidance as a medium for providing relevant and practical information influencing the medical device industry today; and share in open and honest discourse on how we, as quality and regulatory professionals, can make our industry better.

Finally, I would like to kick off 2010, by breaking down the components of an effective supplier-management system through a series of papers that capture and reflect current industry practices. My intention is to highlight key areas where regulatory bodies are beginning to exhibit a keen interest.

Increased FDA focus
The first area of opportunity that demands some serious attention is the renewed focus on the importance of supplier management in the medical device industry. In recent years, the FDA has increased its vigilance in regards to the prevention of medical device manufacturers inadvertently procuring nonconforming materials from their suppliers and subsequently employing these materials into finished medical devices.

According to Kimberly Trautman, the FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing nonconforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk¹. The Code of Federal Regulations, Title 21 Part 820 – also known as the Quality System Regulation – requires all medical device manufacturers and medical device distributors to establish a certain level of control over their supplier base, under Subpart E: Purchasing Controls².

The Code of Federal Regulations³, under Title 21 Part 820 – Section 820.50, regulates purchased-material controls to ensure that the evaluation of suppliers, components, and raw materials occurs prior to the incorporation of procured materials into the manufacturing of medical devices⁴.

Several key attributes are associated with an effective supplier-management system, and because the QSR is not overly prescriptive when it comes to the details of a system, organizations are free to develop supplier-management systems tailored to their manufacturing and operational environment. A vast majority of medical device manufacturers distribute product both inside and outside of the United States, and hence, compliance with regulations, such as the Medical Device Directive⁵ (93/42/EEC of 14 June 1993 – soon to be 2009) become additional mandated requirements. Standards such as EN ISO 13485:2003⁶ must also be considered during the development and implementation of an effective supplier-management system.

Additionally, risk is playing an increasingly prevalent role in identifying critical factors associated with supplier selection, defensive-receiving inspection activities pursued, ongoing supplier maintenance, supplier corrective action, etc. Furthermore, business risk and risk of device failure, premised on supplier performance issues, need to be adequately identified and incorporated into an effective supplier-management system.

I hope this introductory column has provided sufficient granularity to garner some interest and bring you back for my first discussion topic, Devine Guidance–For an Effective Supplier-Selection Process.” Future Devine Guidance columns will cover topics such as supplier selection, evaluation checklists, the importance of a specification, defensive receiving inspection, supplier scorecards and metrics, yields, supplier corrective action, supplier maintenance, the value of measurement data, source inspection, and other relevant topics.

References:

1. Poor Supplier control causing recalls, FDA says; contract is key to success. (2007, May), The Sheet – Medical Device Quality Control, 11(6). Danvers, MA.
2. Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ. 
3. Code of Federal Regulation. (2008, April). Title 21 Part 820: Quality system regulation, Washington, D.C.: U. S. Government Printing Office.
4. Devine. C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ. 
5. Medical Device Directive (1993). Council Directive 93/42/EEC. Medical Device Safety Service.
6. Medical devices – quality management systems – requirements for regulatory purposes. (2007). EN ISO 13485:2003/AC:2007.