Quality events elevated to CAPA will require an investigation and root cause analysis. The process to identify root cause should start with outputs of the investigation. Analysis of the root cause is critical to identify the corrective action and/or preventive action that can be taken to prevent recurrence or prevent ocurrence.
When conducting a root cause analysis, the following should be considered:
- Systematic generation of cause and effect conclusions supported by documented evidence.
- Evaluate significant or underlying causes and their relationship to the problem.
- Ensure that causes are identified, not the symptoms.
- Check for more than one root cause (above processes if necessary).
Our Root Cause Analysis training course teaches the following three tools:
Fishbone Diagram - A cause-and-effect analysis is a Fishbone or tree diagram that shows the possible and likely causes. This has then to be verified and tested empirically before recommendations can be made.
5 Whys Method - The 5 Whys is a questions-asking method used to drill down using the cause/effect relationships underlying a particular problem.
Is/Is Not Tool - The Is/Is Not analysis tool to is used determine root cause. It is a comparative analysis method of comparing what has occured to the expected state.
Root Cause Analysis is a one day course appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Examples include investigators, laboratory, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers. We also have a one day course specifically designed for Root Cause Analysis.
PathWise not only provides an outside perspective to these issues, we bring proven best-practices, tools, and processes. We’ve studied the best of the best in the life sciences field, and bring an intimate knowledge of regulations.
Interested in Investigation Faciliation? Check out our solutions for facilitating investigations. Using multiple root cause analysis tools, we work with investigation teams to solve high visibility, real-world problems in a timely manner.
* Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010 November 4, 2010