Organisation / Establishment
The culture of the organisation / establishment can have a huge impact on the success or otherwise of a Root Cause Analysis study. There are several questions that may need to be asked:
- Are resources and support available from management to implement the recommendations and outcomes of the study?
- Is there evidence of business pressures getting in the way now, in the past and in the future to prevent improvement?
- Does a blame culture exist, where fault is found within the organisation / establishment?
The investigator should look for examples where management have stopped, vetoed or modified genuine and viable continual improvement measures without good, documented reasons.
Process / Procedure
In terms of the process or procedure that is being analysed, the study will need to establish:
- Is the process that is under investigation valid and capable?
- Is a reliable system in place for verifying or checking the process?
- Does the process undergo regular reviews to assess its efficacy?
For each of these three questions, documentary evidence would be required to demonstrate that:
- A validation study had been performed that includes and factors in the worst case scenario
- The system is effectively monitored
- That it is updated as necessary
Are the staff receptive to continual improvement?
Are there any potential issues with:
- Established staff (reluctance to adopt new practices)
- New or temporary workers (system unfamiliarity)
Do the staff demonstrate openness and trust?
Is training and refresher training up to date and adequate for the needs of the organisation?