Key learnings from NSF International’s training program
The Deviation and Corrective and Preventive Action (CAPA) Management training by NSF has further developed my understanding of dealing with deviations – from the discovery of the non-conformance to CAPA effectiveness check.
Inspectors study how companies react when a problem arises and are under pressure, which exemplifies the robustness of scientific and organisational integrity of the company’s operations. A case in point – was appropriate support and sufficient resources provided for quality investigations? And are companies committed to improving their Pharmaceutical Quality System?
I have learnt that applying the Five to Thrive method is one of the best ways to manage a deviation. First, to record the engagement immediately. Second, head to the site to GEMBA and recreate the problem to support resolution followed by triaging the problem using risk assessment. The personnel involved should also be interviewed to address the root cause – though it is important to note that we are focusing on the problem instead of the person. Throughout the process, all information obtained should be documented in real time using a standardised template.
A company’s culture and management are crucial parameters when it comes to Deviation and CAPA Management, in my opinion. Creating an open and blame-free culture encourages personnel to raise a deviation confidently. Mistakes made are essential for growth, wherein we learn from them to improve on the process, systems or products which ultimately benefits the patients. Management should also provide adequate resources for investigations to avoid the personnel worrying about excessive tasks after raising a deviation, be it minor or major. The investigation should be conducted in proportion to the risk. Trending of minor deviations is also essential to ensure that minor deviations do not escalate to major or critical ones. Deviations cannot be planned. Take, for example, a temporary change; it is an unexpected non-conformance that must be investigated.
Usually, there exists not one single root cause for a deviation, but multiple root causes that have to be addressed by CAPAs. Mere “human error” alone is no longer acceptable for non-conformances as there is usually an underlying issue stemming from the process, procedures or systems. The more common root cause analysis tools used in the industry are the Fishbone Analysis and 5-Whys. I personally feel that Process Mapping is a simple yet powerful tool that is extensive in identifying gaps in the investigation, finding root causes, understanding the process flow and finding ways to improve the process.
The deviation report should be factual, detailing the entire story and linking the root cause analysis to CAPAs. It should be simple enough such that anyone from outside the organisation is able to understand what has occurred and how it was resolved.
There should be an effectiveness check of the corrective action in place after a specified period to observe if the problem is still occurring. If the deviation recurs, the root cause may not have been adequately determined, or the corrective action is incorrect or ineffective. Preventive actions should also be put in place to prevent the occurrence of similar problems with other processes, procedures or systems. CAPAs should be specific, measurable, achievable, realistic and timed.
Overall, this training has guided me on how to achieve the above and is useful in dealing with any non-conformances that I may face. It has also proved that deviation and CAPA management is applicable to all personnel in the pharmaceutical industry.
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Alyaa is a Compliance Engineer with No deviation. She has successfully completed multiple qualification projects, whilst ensuring that her team had engineering compliance support with good communication. She was also involved in a mock audit as a scriber on the auditor team. Alyaa believes that the safety, quality and efficacy of products is of utmost importance, to benefit patients at the end of the line.