As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
The control of nonconforming product should never be an onerous task. Keep it simple by never allowing non-conforming product to make its way into your organization’s supply chain. While UAI is convenient, eventually the use of such concessions is going to break your heart.
In this edition of Devine Guidance (DG), the doctor will provide guidance for 21 CFR, Part 820 – Subpart – I, Nonconforming Product, specifically (820.90). The key takeaways for this week are: sticking to procedures; understanding the importance and elements of effective control of nonconforming product; refraining from the UAI disposition; reworking to approved specifications; and maintaining and updating accurate DHRs.
In a perfect world, there would never be a need to handle non-conformances from your supplier base. However, the world of medical device manufacturing is far from perfect (please do not tell the regulators). You may call it fate, destiny, or bad luck, but Dr. D. calls it problem suppliers. Rest assured some of your suppliers will eventually deliver nonconforming product and at some point in the not-so-distant future, I will address managing nonconforming products as a whole. Warning letter violation Vio…