"Each manufacturer must establish and maintain procedures to guarantee that all purchased or otherwise received products and services meet the specified requirements." This is stated in Part 820, Subpart E Section 820.50 of the Code of Federal Regulation.
For medical device or diagnostics manufacturers, this seemingly simple sentence in the Federal Code can result in a significant investment of time and money. Its meaning is straightforward - you are accountable not only for the quality, efficacy, and safety of your own manufactured products but also for the raw materials, components, and services provided by the contract manufacturer.
The FDA has noted that suppliers who provide materials or services that don't comply with regulations are a direct cause of the increase in medical device recalls. Consequently, the agency has been enhancing its surveillance of medical manufacturers and making them responsible for supplier non - compliance. The FDA now requires subcontractors to be registered. In some cases, subcontractors are audited not because they have made mistakes but because their customers have encountered problems directly related to the supplier.
Part 820 Subpart E Purchasing Controls obliges medical device manufacturers to establish and maintain procedures to ensure that all products and services purchased from third - party suppliers adhere to FDA regulations. Briefly, Section 820.50 requires you to:
Enhance supplier performance through an audit program.
Every medical manufacturer should think about developing and implementing a supplier performance audit program to assist in reducing risk and monitoring and maintaining supplier compliance. A supplier audit program can significantly reduce the Cost of Poor Quality (COPQ) risks that can delay or disrupt a new product launch and harm current product sales. A properly designed and managed supplier performance audit process will help you to establish:
Our auditors conduct more than 100 audits per year for their clients. Many companies lack the internal resources to carry out all the supplier quality audits required by their procedures. Often, these companies either modify their procedures to decrease the required audit frequency or simply become non - compliant. Both options expose the company to FDA scrutiny and the possibility of unacceptable products. We can provide additional support to your staff. For some companies, we conduct all their supplier audits because it is more beneficial than taking their staff out of the office. At other clients, we help to simplify the supplier qualification and monitoring process, reducing the number of on - site audits by increasing the amount of statistical trending.
The current FDA focus on supplier performance and compliance, combined with the advantages of reducing COPQ and supplier risk, strongly advocates for the implementation of a supplier performance audit program. If you want more information or want to begin with supplier auditing, visit our website at www.bbotek.cn or contact us at service@bbotek.cn.
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标签: supplier audit