Information & Training. | Quality Assurance. Quality Management.
Change Management Risk Assessment
All change involves risk, for some change the risk will be minimal, for example changing the cosmetic color of a product, other change may carry significant risks, for example changing the materials used in implantable medical devices, or changing an ingredients supplier for pharmaceutical products.Good practice for all change management processes, is that a risk assessment should be performed. The risk assessment should be commenced as early as possible in the change process. When a problem or an opportunity for improvement can be addressed via a change, then as a proposed solution is being developed, the risk associated with the proposed solution should be considered.
At the early stages of a change proposal, there may be various approaches to achieving objectives. The potential risks associated with the approach to potential solutions should be considered as early as possible.
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 >>>
The risk assessment may be continually developed as the change is progressed through design development, prototyping. etc.. The level of supporting documentation, the intensity of qualification and any validation, the range of approvals required, will all be driven by the potential risk associated with the change.
A risk assessment should be performed in accordance with pre-defined risk operating procedures. Standard practice is that the potential for a risk to arise is estimated, then the potential severity associated for each risk is again estimated. These two estimates of “risk probability” and “risk severity” can then be combined to determine an overall risk rating. In many organizations the “risk detectability” is also estimated to help extract the higher level risks.
From the “risk probability” (P), “risk severity” (S) and “risk detectability” (D) estimates the risk priority number (RPN) can be determined.
P * S = RPN or P * S* D = RPN
The risk level for each potential risk identified is often shown on a matrix where the probability or likelihood of a risk arising is graphed versus the potential severity or impact associated with the risk.
A risk assessment should be considered from the initial stages of any change process. The earlier the potential risk impacts associated with a change are considered, the better the potential change choices and the greater the opportunity to design out inherent risks within a product or process.
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 >>>