By Grant Mordue
It’s always best to avoid having to investigate a non-compliance, but if you do experience a non-compliance, it is necessary to investigate it quickly and efficiently. The investigation should be described in an investigation report, which should also be clearly understandable to anyone reviewing the report, even if the examiner was not part of the organization at the time and the review is taking place. years after the event.
Writing a clearly understandable report is often a challenge, especially in a second language and by someone who was close to the investigation at the time, who might therefore not include the key information required by external reviewers seeking to understand the situation. .
This article provides advice on how to write a proper investigation report. Throughout these steps, focus on simplicity; less is more. A complex investigation often becomes a complex (and potentially confusing) report. Therefore, it is important to follow a simple structure for the content of the report. If the investigation expands and becomes complex, it is important to restructure the report accordingly to avoid lengthy and potentially confusing content.
- What happened?
- When did it happen?
- Where did this happen?
- Who was there when it happened?
- Who was contacted when this happened?
- What was directly impacted?
- What immediate action has been taken? Who did what, when and how?
- What was the immediate impact of the action taken?
The initial data can be reported on an unexpected event or a deviation recording template, and this information and data should be used to compose the introductory section of the report.
The person reading the report now knows the problem (by reading the information described above); however, they don’t know anything about how this compares to the normal (conforming) situation that experienced the unexpected event. This part of the report should briefly help the reader to understand the unexpected (problem or nonconformity) versus the routine (expected) conformance situation involved.
Briefly describe the routine (compliant) operation, process, equipment, etc. involved.
Link and directly compare the unexpected event (nonconformity) to the compliant situation to help the reader understand the potential impact of the nonconformity.
Describe the immediate actions taken and explain how this impacted the unexpected situation, for example, quickly restored compliance and allowed routine operations to continue or shut down operations in a safe manner to support the start of the process. ‘investigation.
The reader should now understand why the initial action taken was the most correct and appropriate, based on their understanding from the previous parts of the report, and the impact of the issue or non-compliance on the business. operational operations concerned.
Describe how the investigation was structured and completed to determine the root cause. Make sure that the relevant procedure has been followed throughout and that the evidence and data used and recorded demonstrate compliance with this procedure. Remember that during an inspection, the content of the report will be compared to the content of the relevant procedure (s), such as, for example, gap management and investigation, CAPA management and, potentially, escalation. critical non-conformities to management. .
Describe the structure used for the survey. This could be a fishbone diagram, with structural titles completed, for example ,. Product, process, paperwork / procedures, people, premises, equipment and / or the “5 whys” or other structure chosen from the relevant procedures.
The reader should be able to follow the content of the investigation and come to the same conclusion as the author, i.e. at least the most probable root cause (s) based on the evidence and data reviewed during the investigation and presented in the report, or the actual root cause, again based only on the evidence and data available and presented in the report.
The description should present the evidence obtained to exclude or include potential definitions of the root cause. Be careful to avoid conclusions that are not supported by evidence and instead are based on guesswork, hasty conclusions, or gut feeling.
This can potentially be the most complex part of the report; therefore, the ‘less is more’ principle mentioned above should be applied to include only key facts and data rather than just reporting everything that has been done, without focusing on what is important to help the company. reader to reach the same conclusion as the author (based on only the evidence, facts and data reported).
At this point, the evidence might support the conclusion that the true root cause has been proven; however, if not, the most likely root cause should be
checked in. Be careful not to stop the investigation too early, based on the first potential or actual root cause identified. The investigation should continue until all potential root cause elements have been assessed using the required evidence and data.
If the actual root cause has not been proven, the action plan should include the introduction of additional monitoring and checks to gain additional information and data that could be used to support further investigation and determine the actual root cause if the problem recurs.
If the actual root cause has not been confirmed and proven, consider using and reporting hypotheses. The hypothesis-based investigation identifies sequences and events which, if they were to occur, would be the source of the problem encountered. The action plan should then include monitoring and data collection to determine or rule out each assumption, leading to the identification of the most likely root cause, which should be avoided during future operational activity.
This is an important part of the investigation and reporting, as the impact of the nonconformity should be assessed for the potential to affect other lots, manufacturing activities, equipment and operations, etc.
This requires understanding exactly when the problem first occurred. Based on the evidence and data, the date of the first occurrence may be much earlier than when the problem was first identified. The problem can also be much more widespread than just affecting the specific operation that encountered the problem first.
In the report, clearly indicate when the problem first occurred and when it last occurred (based on the impact assessment and supporting evidence required) and list all operational activities impacted by this date range.
The required actions should also take into account the outcome of this impact assessment and this date range.
Describe the actions (listed below) that have been taken at the time of writing the report and any actions that still need to be taken.
Corrective actions – the actions carried out immediately, subsequently, and planned to directly correct the non-conformity specifically experienced. Actions should relate to both the direct activity that alerted staff to the problem and triggered the investigation and the outcome of the broader impact assessment described above.
Preventive actions – actions carried out immediately, subsequently and planned to avoid the recurrence of similar non-conformities, for example on all the elements involved associated with the first cause.
Efficiency check – the actions, data collection and review that are necessary to verify whether the CAPAs have been effective in both correcting and preventing non-compliance. The effectiveness check may not be completed by the time the investigation report is released; however, this verification must have been formally integrated into the CAPA monitoring system to ensure that it is completed and that evidence is available to demonstrate that the actions were effective.
Avoid root cause assignment and categorization of “human error”. The investigation must continue beyond a link with a human cause to be evaluated, for example:
- The effectiveness of the training received
- The clarity of the instructions provided, e.g. registration form, procedure, system display, etc.
- The complexity of the operation, depending on the design of the installation and the equipment used
- The working conditions experienced at the time of the non-compliance, such as overtime or the night shift, the absence of key personnel (supervisors and managers), the ambient temperature and humidity experienced by the personnel, restrictions operational experience (wearing of restrictive protective clothing, poor lighting conditions, time constraints, reduced visibility, etc.), the level of stress felt by the staff at the time, etc.
- Where there is a clear human connection to the issue, it is important that the same personnel directly affected be involved in the investigation initiated to determine whether the above factors may have influenced or caused the event being experienced.
- The CAPA should include taking the appropriate actions agreed upon with the staff involved and the effectiveness check should include staff feedback to determine if the actions taken were successful in correcting and preventing the problem.
If you follow the eight steps outlined above, you will be able to clearly communicate the non-compliance situation – and I hope that by doing these exercises you will also learn enough to take action to ensure that the non-compliance will only recur.
About the Author:
Grant Mordue is the Director of Pro-Active GMP Consulting Ltd., a UK-based consulting firm founded in April 2020 to help companies successfully implement a proactive level of cGMP quality management and compliance. Mordue has over 30 years of experience managing cGMP compliance of manufacturing and supply operations locally (nationally) and globally, including managing regulatory inspections. He holds a BSc (Hons) in Applied Chemistry and is a Chartered Chemist and Fellow of the Royal Society of Chemistry in the UK. You can contact him on LinkedIn.