Root cause analysis (RCA) is a structured method for identifying the main cause of a problem and implementing changes to the system.
- It’s an important part of CAPA (Corrective and Preventive Actions) management in the pharmaceutical industry.
- RCA is used to determine the underlying cause of a nonconformity or other undesirable situation.
- It is a key element of the pharmaceutical quality system, as defined by ICH Q10, which integrates Quality Management principles and Good Manufacturing Practice (GMP).
- RCA is so important for CAPA processes because it helps to identify the true cause of a problem, rather than just treating the symptoms.
- RCA can also help to prevent similar problems from happening again in the future, or from happening at all if they are potential problems.
- RCA can also help to improve customer satisfaction, reduce costs, enhance safety, and foster a culture of quality within the organization.
RCA tools and techniques that can be used in CAPA
The 5 Whys:
A simple technique that involves asking “why” five times to get to the root cause of a problem.
Fishbone Diagram:
A graphical tool that shows the possible causes of a problem in different categories, such as people, process, equipment, environment, etc.
Pareto Chart:
A bar chart that shows the frequency or impact of different causes of a problem, highlighting the most significant ones.
Fault Tree Analysis:
A logical diagram that shows the sequence of events that lead to a problem, identifying the root cause and possible failure modes.
Failure Mode and Effects Analysis (FMEA):
A systematic method that evaluates the potential failures of a product or process, their causes, effects, and risks, and suggests corrective actions.
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