Competency information
Details
Re-evaluate the process previously audited.
Considerations
- Purpose of change management to manage change to prevent unintended consequences.
- Effective change control activities:
- quality planning and control of revisions to specifications
- process parameters
- procedures.
- Responsibilities of the quality control unit.
- Regulatory approval processes.
- Local governance.
- Standard operating procedures.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 5 | Outcome Use a change control system to document a change to a product, facility, or controlled documentation. |