Section 1.3 Root Cause Analysis
Undertake Root Cause Analysis
- Root cause analysis (RCA) is a thorough assessment of the possible cause(s) of the deviation.
- It helps to determine appropriate and effective corrective and preventative actions (CAPA). It may be conducted as part of the CAPA plan, or as a standalone assessment.
- Involve key members of the study team, as well as your unit’s Quality Assurance or Regulatory Team (where possible).
- There are tools which may be used to help determine the root cause – for example, ‘the five whys’ and the ‘fishbone diagram’.
- Examples of things to consider as part of the RCA include:
- Procedure
- Was there a procedure in place? Where is it documented? Is it clearly documented and easily accessible?
- Training
- Was training provided? How were training and procedures communicated? Was communication clear?
- People/Organisational
- Was human error an issue, and is there a reason for this? Were they adequately trained. How is information communicated?
- Systems/Equipment
- Any issues with systems or equipment?
- Environment/Nature
- Any external or internal factors that may contribute e.g. train strikes, pandemic, redundancies?
- Procedure
