5 Tips for Rock Solid Supplier Controls

5 Tips for Rock Solid Supplier Controls

April 30th, 2013 // 3:02 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Are you in control of your medical device chain of supply to ensure quality? Here are five simple tips to help you to obtain better supplier control for the benefit of your patients, practitioners and employees:

#1 Set Up Product/Service Quality Requirements During Design of Product

Remember that 21 CFR Part 820.30 has 10 sections on design controls for medical devices. So, it is very important for you to have a strong definition for quality right from the start.

  • Set up clear specs for the product.
  • Evaluate and prioritize all risks and ID any outsourced service that you will need.
  • Qualify any tier 1 suppliers that are key to quality during your design verification or your design validation.

#2 Outline Strong Procedures for the Supplier Relationship

You want to make sure that you have good procedures set up for monitoring, qualifying, maintaining and leaving the supplier relationship. Managing any purchased or received product is going to mandate various SOPs for your partners with various degrees of responsibility. You should track them with a tiered system.

  • Define your suppliers in tiers. The top tier should be the ones that are most critical to quality. You want to make sure to have contractors and consultants in their own tier.
  • You should have a definition for qualification and requalification for every supplier tier. You should be careful of having only a paper reviewing process for the higher risk to quality tiers.
  • You should have standard monitoring metrics that are used for any inspection, test or collection of metrics.
  • Set up action limits for the metrics and set up actions based upon those results.
  • Set up a system for disengaging from a supplier, and have a process set up for switching to a new supplier.

#3 Set Up an Approved Audit Schedule for Suppliers

cGMP guidelines state that a quality audit is an examination that is systematic and independent of the quality system for a manufacturer.

  • The schedule should have slots to qualify any new suppliers, and requalification of current suppliers.
  • Make sure that all audits of suppliers are done according to schedule. Any changes in the schedule should have a reason for the change and this should be approved by management.

#4 Have Internal Controls for Each Supplier

After supplier qualification, be ready to monitor the performance of every supplier and take quick action when any performance is seen as marginal.

  • Look at the ability of each supplier to meet product and service requirements.
  • Set up inspection criteria based on results of the qualification process for each supplier.
  • Set up goals for each supplier according to the metrics that you collect.
  • Collect/document/act on performance of each supplier based upon controls you established.

 #5 Feed Your Data and Metrics to Other Parts of Quality System for Constant Improvement

Did you know that poor CAPA procedures are the big reason many companies get cGMP violation observations on 483s? You should always be ready to implement a supplier CAPA.

Updated Daily – Read our latest FDA, cGMP Compliance News


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