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North Eastern Company (NE Company)* recently completed their ISO 13485 certification. They have been working with several medical device companies and are confident they will win some new business in the near future. One of the potential customers has had issues with their current supplier providing product with counterfeit components. This is a significant concern for the potential customer and they want to know how NE Company can avoid using and providing counterfeit parts.
In their 26 years of business, NE Company has never had a significant issue with counterfeit components and management believes that over 93% of their part numbers are not at risk for counterfeiting. For this reason, they are comfortable with their current practices and procedures for the majority of their purchasing activities.
However, because of the demand and strict requirements for the components used in the potential customer's products, they estimate that nearly 32% of those components may be at risk for counterfeiting. This increased risk and concerns from the potential customer have prompted management to review their practices.
How can NE Company identify components at risk for counterfeiting? How can they reduce the risk of purchasing counterfeit components? What tools are available to increase communication between purchasing and receiving to ensure the parts ordered are in fact the parts going through receiving?
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