Supplier oversight and quality is imperative in maintaining the integrity of your product as well as your brand. When done correctly by knowledgeable and experienced consultants, supplier audits have proven to mitigate risks to medical device firms while improving the performance of their suppliers.
Dissecting Parts of 21 CFR 820
21 CFR Section 820.180(c) requires that ‘upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed and that any required corrective action has been undertaken.’
In addition to being required by the FDA, employing audits to enforce supplier control may be critical to a device manufacturer’s well-being as a company of repute. According to the FDA, 21 CFR 820.50 continues to be of significant concern to the agency, whereby suppliers supplying nonconforming materials may be directly linked to the increase of medical device recalls.
The question here is "how can device manufacturers better position themselves in order to deal with the agency’s increased vigilance over their business practices?"
The answer lies in the establishment of a solid and rigorous method by which medical device manufacturers audit their suppliers. 21 CFR 820.50 requires that manufactures evaluate suppliers, contractors and consultants and they must establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services.
Establishment of a Supplier Audit Program
In order to achieve and maintain compliance with 21 CFR 820 in general, and especially 820.50 with respect to purchasing controls, it is prudent to include the services of an already audited consulting company. Qualified consultants can help your company establish a supplier audit program whereby you may achieve the following goals:
- A well written supplier quality agreement, which outlines responsibilities and tasks of both the supplier and the device manufacturer
- Establishment of postal audits which focus on your technical requirements and the ability of the supplier to fulfill them
- Establishment and provision of scorecards in order to monitor the performance of a supplier
- Establishment and execution of a risk-based analysis of suppliers linked to their record of nonconformance
- Creation of supplier audit check lists for on-site auditing
- Review of your supplier’s capability to provide services in accordance with ISO 9001: 2008 and ISO 13485: 2003
The ability to conform with the requirements of 21 CFR 820.50 Purchasing Controls will also allow you to reduce the probability of receiving a 483 or even a Warning Letter.
GxP-CC is comprised of experts who provide compliance consulting to medical device, dental lab and pharmaceutical industry firms. Employing their services can result in your company’s increased performance through your ability to provide supplier oversight for your company. Contact them today to discuss your compliance needs.
Posted in 21 CFR 820.50 Purchasing Controls, Compliance Consulting, FDA 21 CFR Section 820.180(c), FDA Form 483, FDA Warning Letter, GxP CC, ISO 13485: 2003, ISO 9001: 2008, Medical Device Supplier Audits