Information & Training. | Quality Assurance. Quality Management.
CAPA. Corrective Action Process | Preventative Action Process
Corrective Action seeks to identify the cause(s) of a problem, to understand the circumstances which allowed the cause(s) to arise, to identify what needs to be performed to ensure the problem cause(s) cannot arise again and to implement permanent “fixes” to prevent any repetition of the problem going forward.Preventative Action (or Preventive Action) seeks to identify problems before they arise, to identify the potential cause(s) of a problem, to understand the circumstances which could allow the cause(s) to arise, to identify what needs to be performed to ensure the problem cause(s) cannot arise and to implement permanent “fixes” to prevent any possibility of the problem actually arising into the future.
As can be seen from the above, both Corrective and Preventative Action (CAPA) have broad similarities,
– with Corrective Action the problem has already arisen so damage has already been done, whereas
– with Preventative Action, the focus is on “not allowing” the problem to arise in the first instance.
Corrective action is clearly an essential requirement in any organization. For example, consider a manufacturer of pharmaceutical products, where a customer complaint is received due to products causing injury, clearly action must be taken to understand and correct, otherwise the organization could not continue in business. However, considering this example again, the industry tends to be highly regulated and therefore the regulatory bodies do not want customers (patients using pharmaceutical products) to get to the stage where complaints are being made, so they insist on organizations having effective and comprehensive preventative action processes in place.
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 >>>
Problem identification.
There needs to be a clear understanding of what problem needs to be addressed or what opportunity for improvement exists. This will usually necessitate the writing of a problem statement or CAPA objective.Understanding the problem (root cause identification).
Gather up a team to investigate, or responsibility may rest on a single individual if the task is quite limited in scope. The problem investigation team should seek to utilize fact based analytical tools (e.g. fault tree analysis, failure mode effects analysis, cause and effect, etc., ..). The objective must be to identify the root cause. Without root cause identification, the problem will re-appear as the solutions which will be implemented to address the problem will not be effective.Identification and agreement on solutions to correct the problem.
With the root cause identified, solutions will be needed to correct. There may be a number of options available, each with their own particular resource demands, costs and approval requirements. The team tasked with responsibility for addressing the problem, needs to determine the optimum solution and obtain whatever agreements are necessary to allow them to implement.Implement the proposed solution.
This will often necessitate implementing change through a controlled documentation and change management process.Verification of effectiveness.
This is often the most critical stage. Has the problem been addressed? It is only now that an understanding can begin to develop, if the root cause was successfully identified and the appropriate solutions effectively implemented. If the problem is not adequately addressed, then the team need to go back to the 2nd stage of understanding the problem.Monitoring.
Initial results indicate that the problem has been addressed. However, only over time, will the team be able to fully state that an effective and permanent “fix” has been implemented. Therefore, there needs to be some form on on-going monitoring available, so that if the problem re-appears, it immediately becomes visible.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 >>>