Enhancing Quality of CAPA and Deviation Reports: 7 Points to consider.

Enhancing Quality of CAPA and Deviation Reports: 7 Points to consider.

Here are some key topics to focus on improving the quality of your deviation/ investigation reports

1.?The investigation/deviation report should be easily accessible and effectively perceived by all parties well; after the event and the investigation. Deviation report must provide scientific proof and a systematic methodology that takes in to account the incident findings.

?2.?A well researched deviation investigation should be completed within stipulated time period. (In most organizations typically within 30 days)?

Contents in the deviation investigation should include the following components:

Event summary

3. Chronology of the deviation: Include the who, where, what, when details in this section. Be explicit information such as exact date and accurate data. Give exact information and facts in chronological order, which include data or observations prior to, during and or after the event. Provide appropriate data as to how the incident was controlled and additionally at the situation ?time..

4. Provide documentary evidence for Batches affected and criteria of selection: Organisation should have well defined SOP for selection of Batches, SOP must be very clear how if any potential risk was addressed immediately and that the criteria for identification and control of the affected material.

5. Root-Cause Investigation: This is the part to exhibit that a deliberate methodology was taken to explore the most appropriate true root cause of the issue. Often Root Cause Investigation is investigated by various Tools: 5Why’s, Fish-Bone Analysis and all tools should be scientifically applied

6. CAPA Efficiency measurement: Efficiency of deviation and CAPA should be investigated in timely manner. The assessment and resulting conclusions must be objective and scientific based. Identification of appropriate corrective and preventative actions should be completed based on the root cause investigation section and should address all root causes identified.

7. Historical Analysis: Appropriate documentary evidence should be provided to record deviations and CAPA’s. Yearly data is curate and statistical analysis is done. Any re-occurrence quality issues should be investigated and efficiency CAPS or deviation should be measured.?