Suppliers are obviously a critical component of your business.  Thus, when things start to go poorly, it’s not just their problem – it’s your problem. There are a variety of reasons why medical device suppliers could get booted from your Approved Supplier List but, quite often, the manufacturer-supplier relationship goes south over issues involving product quality and missed delivery time frames. That’s why ongoing monitoring is so important as a tool to head off serious supply issues. Regardless of how […]

When purchased products arrive at your facility, you need to confirm that they meet the requirements established in your quality agreement. What’s the best way to go about that? First, consider the risk associated with the purchased product and then examine any actions the supplier has already taken to verify compliance. Choosing the right verification method is a risk-based decision and there are a variety of methods available. These include: 100% inspection Sampling inspection Skip-lot testing Assessment of pre-shipment samples […]

Spotty quality. Price increases. Poor reliability. There are myriad reasons why medical device suppliers go from “approved” to “disqualified” on your Approved Supplier List. Regardless of how many suppliers you have, it’s important (and required) that you monitor their performance and conduct regular evaluations. This will allow you to make informed business decisions, spot performance issues before they worsen, uncover waste, and facilitate supplier performance. The most effective supplier evaluation programs are risk-based, continuous, supplier supported, cross-functional, visible, and accountable.   […]