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The deviation management process flow has 5 main phases:
1. Identification:
*** Your first step should be to get a clear picture of what happened.
*** Before packaging, deviations can occur during the sampling and testing of raw materials and/or the finished product. When your products fail to meet industry standards, you may receive customer complaints or notifications.
*** All deviations will be issued and handled by the people in charge of Quality Risk Management in your organization.
*** Collect all relevant information and categorize the deviation. As previously stated, the incident can be classified as a minor, major, or critical deviation.
2. Reporting:
*** Your organization must keep track of all deviations and have a policy in place for reporting them.
*** The deviation report is usually filed by the department where the deviation occurred. After identifying the problem, the maximum time frame allowed is one day.
*** During this phase, the concerned personnel must provide all relevant information to aid the investigation.
*** You can use QMS software, built-in best-practice forms and procedures to guide you through the process of documenting all relevant deviation data points. This assists in reducing the margin of human error and making the correct decision.
3. Investigation:
*** After you’ve identified and reported the deviation, you must determine what caused it. The concerned department, in collaboration with the QA department, will conduct a root-cause analysis.
*** When the deviation is significant or critical, root-cause analyses are required. This means that the deviation will have a significant impact on your product’s or cGMP’s overall quality. If the deviation is labeled as an incident or minor, no root-cause analysis is required.
*** After completing the root-cause analysis, the next step in this phase is to determine whether a CAPA is required.
*** When the root-cause analysis reveals that the problem is recurring and systemic, a CAPA is typically initiated. If the deviation has no impact on the overall quality of your product or cGMP, CAPA is not initiated.
*** While the QA department approves the CAPA, the responsible department is responsible for implementing and closing the CAPA.
*** Similarly, when a deviation occurs, you can use a system like QMS software to determine whether or not a CAPA is required.
4. Documentation:
*** When the investigation into the deviation is finished, you must document the root cause and the resulting CAPA plan for tracking purposes.
*** It is also critical for your company to keep an audit trail, which is a regulatory requirement.
*** Audit trails are chronological records of all actions, events, and changes, including deviation management, root-cause analysis, and CAPA activities.
5. Implementation:
*** Finally, you will have a deadline to meet as well as a CAPA to complete.
*** You will ensure that this particular deviation does not occur again during this phase.
*** You will first describe the problem in CAPA. The scope should be addressed next. Once the problem and its scope are identified, you will implement immediate fixes while investigating the root cause of the problem. Following the completion of the root cause analysis, your company will plan and implement actionable steps (i.e. corrective and preventive actions).
