Change Management is a critical process within a Quality Management System (QMS) that ensures all modifications are systematically evaluated, implemented, and verified to maintain compliance, quality, and efficiency.
Following are the critical stages or steps as a part of the Change Management process are:
Raise a Change Request
- Categories: Product, Process, Supplier, etc.
- Key Elements:
- Current State: Detailed description of the existing condition.
- Proposed Change: Clear definition of the intended modification.
Rationale: Justification for the change, including potential benefits.
Supporting Documents: Include validation reports, data, and other evidence.
Cross Functional Team Review
- Approval: Conduct a multi-disciplinary review.
- Feasibility/Risk Analysis: Assess the impact on cost, quality, safety, and compliance.
- Risk Mitigation Plan: Develop strategies to address identified risks.
Document Impact Assessment
- Affected Documents: Identify changes needed in PFD, PFMEA, CP, work instructions, etc.
- Training Requirements: Ensure all affected personnel are trained on the updated documents.
- Document Control: Maintain version control and ensure all changes are tracked.
Production Part Approval Process Impact
- Internal/External PPAP: Determine if the change requires a Production Part Approval Process (PPAP) submission.
- Validation: Ensure that the change does not affect the PPAP outcome.
Action Item Documentation
- Comprehensive Documentation: List all action items, responsibilities, and deadlines.
- Impact Assessment: Record the effect of each action on the overall process.
- Review and Approval: Ensure each action is reviewed and signed off by relevant stakeholders
Implementation and Effectiveness Verification
- Execution: Implement the change according to the plan.
- Effectiveness Check: Conduct post-implementation reviews to verify the effectiveness.
- Continuous Improvement: Gather feedback and refine the process as needed.
Read also:
- SOP for Change Control in Pharmaceutical Industry
- Types of Change Control in Pharmaceutical Industry
Resource Person: Suryakant Bhavikatty