by Phil Smart

As you know, the topic of supplier management gets covered during most notified body audits, regardless of whether they are certification or surveillance audits. This is because of the specific importance of supplier quality assurance in a medical device manufacturer's quality system. If your suppliers fail to meet your needs, you have a BIG problem. And of all audited elements, this one ranks in the top five in terms of nonconformity reports or "major" observations written.

Why? Simply because many manufacturers are not taking this element seriously enough. A sound program for ensuring quality from suppliers must contain the necessary depth of structure for 1) supplier selection and evaluation, 2) on-going supplier performance evaluation and 3) mechanisms for relating quality and delivery deficiencies back to the suppliers for timely and effective corrective/preventive action.And of course, with the coming ofISO 13485:2003 and current ISO 9001:2000, this subject gets even more attention. Remember, one of the eight quality principals is "mutually beneficial supplier relationships".

What are some typical observations?

System not functioning for evaluating the quality management systems of ALL suppliers, including OEM partners and key service providers such as sterilization facilities, test and calibration laboratories, cleaning and pest control subcontractors, etc. In particular, international suppliers in Europe, the Far East and Central & South America tend to be left behind...

Lack of good follow-through on less-than-adequate results of supplier surveys and supplier audits

Lack of adequate technical expertise when assessing the capabilities of particular suppliers such as sterilization and biocompatibility test labs.

Interesting enough, another finding has been lack of adequate quality management expertise when assessing the capabilities of particular suppliers such as sterilization and biocompatibility test labs. (sometimes only a microbiologist is sent, but without the necessary skills to assess the overall quality system.

Inadequate consideration of regulatory requirements when evaluating and qualifying certain suppliers. This is especially true for vendors of raw materials or subassemblies, which are used in a terminally sterilized product. In many cases, there is not adequate consideration of ISO 13485/ISO 14644 with respect to environmental controls, minimization of bioburden, etc.

In general much of the difficulty lies with inadequate resources. The Purchasing/
Materials Department is too busy or is not comfortable making regulatory decisions. As usual QA is "maxed out". Executive management is not willing to commit new resources. Yet, supplier issues persist, and Notified Body findings continue, costing the company unnecessary time and money.


Solution:

On-site and off-site training and certification of your people who are making the key decisions on supplier management.

Off-site supplier assessments with the specified aim of ensuring regulatory compliance AND nurturing mutually beneficial supplier relationships (this can really pay off. Send your key Buyers or QA Engineers along for training as well)

Conduct joint supplier strategy conferences, bringing your key vendors together to implement a strategy of business excellence through ISO 13485 and ISO 9001.