Change Management Procedure
1. DEFINITIONS
1.1. “Process Output” – the result of any process; these are typically defined in the Process Definition Document for each top-level process.
2. CHANGES TO PROCESSES
2.1. Management system processes will undergo changes, typically when:
2.1.1. Improvement opportunities have been identified, typically to improve process effectiveness
2.1.2. Nonconformities within a process are identified and require corrective action
2.1.3. Conditions in the industry or company change, requiring a process to be updated
2.1.4. New processes are added which impact on existing processes, requiring changes
2.1.5. Customer requirements result in a need to change processes
2.1.6. Any other reason determined by management
2.2. In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
2.3. At a minimum, process changes shall include the steps herein:
2.3.1. The request for a process change shall be documented, typically in a CAR Form per the procedure Corrective Action Procedure. The justification for the change shall be recorded.
2.3.2. The change shall be reviewed by appropriate management, including the senior most manager(s) responsible for the process. Changes must be approved prior to implementation.
2.3.3. The appropriate Process Definition Document(Process flowchart) will be updated to reflect the change. This document will undergo review and approval per the procedure Control of Documents Procedure.
2.3.4. The revision indicator of the Process Definition Document will be incremented, and the nature of the change recorded.
2.3.5. The follow-up verification step of the CAR process shall seek to ensure the change has had the intended effect, and/or has improved the process. If not, the change may be rolled back or a new change made to correct any new issues that arise as a result of the change.
3. CHANGES TO PROCESS OUTPUTS
3.1. The methods for changing process outputs are typically defined in the Process Definition Document. Where a process output is a document, the rules for changing documents above shall apply.
3.2. Formal changes to process outputs will be used when the change is significant. Minor changes may be made without formal control, however the decision on what constitutes significant vs minor change must be agreed upon by those involved in the change. If a customer indicates a change is significant, this will trump any internal decision.
4. CHANGES TO DOCUMENTATION
4.1. Management system documents undergo changes when there is a need to revise them.
4.2. Changes to documentation are done in accordance with Control of Documents Procedure.
Note:
Optionally following records are maintained online at www.companycertification.com/lyra
- Process Description (Quality Plan)
- Document Change Request Form
- Corrective Action Request Form