In 21 CFR 820 Subpart B, the FDA states “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.”
A quality plan states the goals your company has to improve the quality of your products. It is a documented summary of your approach to meeting all manufacturing requirements (ISO, FDA, cGMP, etc). The quality plan can be written to address a specific project, or applied to a whole facility. Included in the plan is an outline of quality policies, procedures, practices, and guidelines used to define the quality expectations. It should specifically address where your company identifies quality checkpoints to satisfy all regulatory requirements – reference the SOPs, work instructions, forms and templates that are used to make it possible for you to manufacture a safe and effective product. The level of detail that you identify in your quality plan should follow this guideline – give enough information and references to be able to identify what needs to be achieved, but don’t necessarily go into the step-by-step details (leave that for the procedures and work instructions).
A Quality Plan can also be referred to as a Site Quality Plan or Control Plan. In the case of a control plan, it is recommended that there be one created for each product.
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