This procedure package includes 4 documents:
1. Change Control Procedure
Purpose – The purpose of this (5) page procedure is to ensure that changes to any product or process within the scope of your company’s quality management system are planned, approved and implemented in a controlled manner; maintaining the safety and efficacy of product and effectiveness of the quality management system.
Scope – This procedure applies to any changes to product that has been released for manufacture, and to any changes to process that will result in a change to product or process documentation, or that otherwise may potentially have an impact on product characteristics or safety. This procedure incorporates a procedure for deviations from planned arrangements or specifications within any part of your company’s quality management system…
2. Deviation Report Form
3. Change Note Form
4. Change Register Form
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