Deviation investigations are critical activities for pharmaceutical companies to ensure product quality and GMP compliance. However, regulatory inspections and warning letters reveal that many companies have deficiencies in their deviation investigations. This article summarizes eight common mistakes and provides corresponding improvement suggestions.
1. Not Leveraging Historical Data for Continuous Improvement
Many companies fail to effectively utilize historical deviation data for trend analysis, missing opportunities to identify potential problems and improvements. A robust data tracking and analysis system should be established to regularly analyze deviation data (e.g., root cause, involved department, involved process) to proactively identify issues and implement corrective actions.
2. Using “Human Error” as a Root Cause
Simply attributing deviations to “human error” is insufficient. The true root cause is often hidden in procedures, training, environment, or equipment. In-depth analysis should be conducted to determine the underlying causes of human error, such as:
- Unclear procedures: Revise SOPs to improve the clarity of operating instructions.
- Inadequate training: Enhance employee training to ensure proficiency in operating procedures.
- Environmental distractions: Improve the work environment to reduce distractions.
- Equipment defects: Improve equipment design or conduct maintenance.
3. Failing to Find the “Probable” Root Cause
Some investigations fail to identify a clear root cause, even when all necessary information is available. This may be due to insufficient investigator skills or a misunderstanding of “definitive” conclusions. Regulatory agencies do not require “absolute” certainty in all investigation conclusions; a “most probable” root cause based on thorough investigation and available data is sufficient.
4. Failing to Find the “True” Root Cause
Identifying the true root cause is critical. Using the “5 Whys” analysis or other root cause analysis tools (e.g., fishbone diagram, KT analysis) can help us delve into the essence of the problem. For example, “backup power supply failure” is not a true root cause; we need to further ask “why did the backup power supply fail” until we find an actionable root cause, such as “inadequate backup power supply maintenance procedures.”
5. Preparing an Unclear or Difficult-to-Follow Investigation Report
Investigation reports are read not only by internal employees but also by regulatory inspectors. Therefore, reports should be clear, concise, and easy to understand, containing all necessary supporting facts and rationale. Training on effective report writing should be provided.
6. Ignoring Contributing Factors and Associated CAPAs
Contributing factors are elements that, in addition to the root cause, contributed to the occurrence or impact of the event. Contributing factors should also be subject to root cause analysis and corresponding CAPAs should be developed.
7. Inadequate CAPA Measures
Investigations should link root causes to effective CAPA measures to prevent recurrence. The need for interim control measures during CAPA implementation should also be assessed.
8. Not Performing Interviews
Interviews with relevant personnel should be conducted as soon as possible to obtain firsthand information. Adequate preparation should be done before interviews, with targeted questions designed.
Conclusion:
Conducting thorough deviation investigations requires time and effort, but the returns are significant: improved operational efficiency, reduced costs, enhanced product quality, and improved compliance. Avoiding the above eight common mistakes will help companies establish more effective deviation management systems, reduce regulatory risks, and achieve continuous improvement.
