Case Studies

Case Study 1 – Supplier Qualification

Examining the quality and manufacturing systems of our client and identifying ways to help mature their CAPA and data management systems so they can provide a thorough response to their customer’s questionnaire and remain in good standing with them.

 

Client Problem

A large customer wants increased testing services from the clients R&D scale lab in addition to requesting information about their quality and management systems.

  • How do we add robustness to our R&D testing services in an increasing regulatory-focused environment?

  • What aspects of ISO 13485 and GMPs are best for us to follow?

  • How do we make sure our supplier questionnaire provides the key information our customer needs?


Our Approach

First, we get an understanding of the testing services currently being provided. Since there are significant differences between the level of control and risk analysis required for testing services meant for R&D purposes versus those meant for the medical device and biopharma markets, it’s important to understand what application the client’s customer is using the testing services in. The basic approach follows a path of (1) understanding the needs of the client (2) the needs and specifications of the client’s customers and (3) identifying solutions that satisfy both parties.


Our Solution

Following that model, we focused our client on improving select areas of their overall quality system while assuring them that others were currently on solid ground. We make sure to focus our clients on what really matters to them and their customers. Again, providing solutions that are individually focused, not too much and not too little but just right. Ultimately, we provided minor suggestions for improvement related to CAPA and data managment and helped out client file a questionnaire with their customer.

Client Outcome

Our client successfully submitted a supplier quality questionnaire to their customer and were exempted from requiring an on-site or remote quality audit. Our client remains in good standing with their custom and are increasing their business with them.