Information & Training. | Quality Assurance. Quality Management.
Change Control | Managing and Controlling Change
In every organization change is inevitable, change can arise due to external factors outside the control of the organization or can arise from internal factors. Externally driven change can come from revisions to regulatory requirements, new technology, customer expectations, government policy, consolidation of the supply base, raw material availability, etc., …etc.. Change from within an organization can arise from a revision to the organizational strategy, process improvement, test and inspection outcomes, employee expectations, …etc…etc.. Regardless of the reason for change, the critical consideration is that change needs to be managed in order to ensure there is effective control over the preparation, approval, implementation stages of all change.A change management process, can be a component of a Quality Management System or can be a stand alone process. Which ever approach is taken, the essential elements in a change management process will be the same, these elements are:

The Principles of Quality Management
The Quality Manual
Quality Standards and Specifications
The Quality Management System
Revised requirements of ISO 9001: 2015
Design Quality – Products & Processes
Good Manufacturing Practice (GMP)
Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
Information & Training presentation >>>
i) The reason for a proposed change needs to be understood.
ii) The benefits associated with the proposed change should be detailed.
iii) The proposed change needs to be assessed by appropriate stakeholders.
iv) The impacts of the change needs to be understood.
v) The proposed change needs to be approved.
vi) The implementation of the change needs to be planned.
vii) The implementation needs to be monitored.
viii) The change should be fully documented, with “before” and “after” change records maintained.
ix) The effectiveness of the change should be assessed after a suitable period of time.
The above can be consolidated into the Planning, Performance, Implementation and Confirmation stages of a change management process.
When implementing a change process the first requirement is a knowledge of approaches to change, equally, the change process itself needs to be fully documented and approved (via procedures) within the Quality Management System. Those involved in any aspect of change, need to understand the approved methodology for implementing change within the organization and must adhere to the approved operating procedure requirements. Training will be an ongoing process. Monitoring of the performance and level of adherence to the approved change management procedure will need to be performed. Adherence will normally be assessed during routine internal audits, or can be based on feedback from product and process tests and inspections, from customer feedback or as part of an annual (or bi-annual) Management Review.
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>