Change assessment

Step by step

1. Request QA Manager

   QA Manager records a change number, type, title, description, requester and target date.

   • Establishes the proposed work
   • Updates Change controls

2. Context QA Manager

   Supplier Manager or Admin confirms the affected supplier or product reference when one applies.

   • Identifies affected reference records
   • Updates Products, Suppliers, Change controls

3. Impact assessment QA Manager

   QA Manager records No Impact, Minor, Major or Regulatory and considers whether filing is required.

   • Records impact and filing relevance
   • Updates Change controls

4. Approval QA Manager

   QA Manager reviews the proposed change and approves or rejects it with a recorded status decision.

   • Captures approval or rejection
   • Updates Change controls
   ApprovalA person approves before the work moves on.

5. Implementation QA Manager

   The responsible team carries out approved work and changes the record to Implemented.

   • Distinguishes performed change from approval
   • Updates Change controls

6. Close QA Manager

   QA Manager checks the outcome and closes the change record.

   • Ends the controlled item
   • Updates Change controls

QA Manager

Assesses and approves the change.

Supplier Manager

Provides supplier context.

Admin

Maintains product reference data.

Qualified Person

Considers relevant changes during batch review.