Apr 17, 2008

The Medical Device Quality Plan

I got stuck with writing a quality plan for our products, here is what the FDA says in CFR 21 820.20 (part d):

Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

If you're trying to please the FDA, you should probably keep the quality plan separate from the quality policy (part a) for clarity. I'm not sure why, but our documentation requires one quality plan per product, this makes it easy for me anyway. MD&DI's take:

As formulated in the new regulation, the requirements for quality planning are intended to apply to activities that are conducted during the production phase of a product's life cycle, and should refer to the company's design and development plan. In practice, the content of a company's quality plan will most often be provided by the outline of quality system documentation (820.20(e)) and by the device master record, and the plan itself may refer to sections of those documents where key activities are detailed. Guidance for establishing a quality plan can be found in ISO 9004-5.7

Seems simple enough, the quality plan should reference quality system procedures (part e) and design and development plan or validation and verification (V&V) activities. My example quality plan:

PURPOSE - Establish a quality plan that meets CFR 21 820.20.
SCOPE - This plan applies to product X.
~INSPECTIONS - sampling requirements, component receiving, in-process and final assembly inspection references (DMR reference if it includes inspection points)
~PACKAGING V&V - sterility, packaging, and shelf life V&V references
~DESIGN V&V - design V&V references including biocompatibility
REFERENCES - includes all documents listed above

Sorry, but I can't master formatting in blogger. It'll be fun updating the quality plan every time someone comes up with a new V or V protocol. Let me know if I'm missing something.

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