ControlofDesignProcessChanges.docVIP

Procedure: Control of Design and Process Changes Document information, authorship and approvals Author signs to confirm technical content Prepared by: Job title: Signature: Date: Subject matter expert reviewer signs to confirm technical content Reviewed by: Job title: Signature: Date: Quality representative signs to confirm document complies with quality management system Authorised by: Job title: Signature: Date: Document review date Table of Contents 1. Purpose 3 2. Application 3 3. Responsibilities 3 4. Procedure 3 4.1. General 3 4.2. Engineering change request 4 4.3. Corrective action request 5 5. Heading 1 6 5.1. Heading 2 6 5.1.1. Heading 3 6 Heading 4 6 This procedure applies to both product design changes and manufacturing process design changes. Form FM704-1 Engineering Change Request is suitable for both of these. To separate the two types, this procedure and FM704-1 may both be split into two. Control of product design changes is required by ISO?13485 and CFR?820 (sections 7.3 and 820.30 respectively). Control of the manufacturing process changes is explicitly required only in CFR?820.70(b). ISO?13485 is not explicit. Purpose This procedure describes the system, provides instructions and identifies responsibilities for initiating, processing and controlling: device design changes manufacturing process design changes. Application The procedure applies to device and manufacturing process design changes after completion and approval of the design. Specifically, it applies once the design is: released to regulators for pre-market approval undergoing clinical trials released to production. During the device and the manufacturing process design phase, and before any of the preceding events take place, design changes are controlled in accordance with Procedure QP703 Design Control. Responsibilities Role Responsibility Engineering Manager Area Manager Quality Manager Amend roles and responsibilities according to your company processes a