Application of Critical Analysis in Deviation Management- 9 reasons why
The Medicines & Healthcare Products Regulatory Agency (GMDP Symposium 2016) stated the common deficiencies found in deviation management systems and CAPAs as listed below:
- Deviations were not adequately documented and investigated, consequently the appropriate CAPAs were not implemented.
- The investigations lacked the appropriate level of root cause analysis and did not capture the relevant details of information.
- The nature of the deviation was described erroneously, consequently the quality impact of the deviations and CAPAs implemented were not appropriately evaluated.
- As deviations were not fully investigated, the appropriate measures were not established to prevent reoccurrence.
- The root cause was not adequately considered for example in one of investigations reviewed by an inspector, it concluded that “Human error” was the root cause without taking into consideration that the underlying error was due to lack of a defined procedure to control the activity.
- There was no process to assess the effectiveness of the implemented CAPA actions to ensure these are managed and assessed in line the principles of Quality Risk Management.
Based on these findings by the inspectorate, it is not surprising that critical analysis is strongly required in performing proper investigation actions hence the nine (9) reasons for the application of critical analysis in deviation management.
- Provides an analytical thinking and problem solving strategy to investigate the occurrence of a deviation.
- Evaluates the strength of evidence to support the root cause of the deviation and determine the actual root cause.
- Enables the deviation investigator to be attentive to details, observing the relevant evidence that will assist in elucidating the overall deviation issue.
- Enables the development of appropriate Corrective/ Preventative (CAPA) plan that can be implemented to resolve the deviation issue.
- Eliminates the reoccurrence of the same deviation.
- Eliminates “Human Error” as always stated as the generic root cause of a deviation.
- Assists in the identification of contributing factors beyond the root cause.
- Instils confidence in the Quality Management system as deviations are being manged in a compliant and an effective manner.
- Indicator that the relevant deviation investigator possesses the adequate training and skills to perform this activity.
In conclusion, adequate training and full comprehension of the deviation management process is required for the appropriate investigation of deviations to GMP compliance.
Are there more reasons that can be included, please include these
What have been your own experiences when dealing with deviations.
For information and training on this topic, please contact Ibelemaemeh@setaxtrainingconsultancy.com.