Every deviation is meaningful to improve your existing process, practice and system in some extent.
➡️ If any deviation is repeated a significant number of times, it could turn into a major deviation and must be treated as such. The investigation of the deviation should also determine the reason why the implemented corrective actions were not successful.
➡️ Your repeated deviation revealed that your manufactured product, process and environment where you manufacture should become risky and all come under question mark??? Some times, companies was not affording repeated deviations, and soon will be getting regulatory action.
➡️ If you want to save your company from repeated deviation and regulatory actions, you should adopt following easy steps.
1. Change your Attitude:
➡️ Whenever any deviation generates, don’t blame inter or intra department personnel, machine, process, system, etc. Because every deviation is a pill to cure your deficiency about existing systems, process and practice, etc. It will act as to rebuild your process, practice and system by implementing effective proper CAPA.
➡️ So, if you want to reduce deviations then you must be working together and don’t balm each other and investigate in a proper way with the conclusion of assignable or probable root cause and its other impacted factors.
➡️ Reported deviation immediately after generation without fail and close within timeline based on criticality. Now onwards change your attitude when any new or repeated deviation observed.
2. Focus on multiple contributing factors instead of root cause:
➡️ Mainly generation of repeated deviation is only happening due to prioritize single root cause.
➡️ If you want to prevent the incident happening again, you must need to remove as many of the contributing factors as possible, not just single root cause.
➡️ There is number of contributing factors in queue before the deviation happens. So, start digging and don’t stop at the first and most visible contributing factor.
➡️ Focus on those contributing factors which have the critical impact, not on those factors which have easiest to solve.
➡️ Hence, remove the term ‘root cause’ from your procedure and mindset.
3. Know your process and product:
➡️ You can’t be investigating of deviation without an understanding of your product and process in deeply.
➡️ Problem solving is dependent to your knowledge about products and process. You must know your product key critical process parameters, critical quality attributes, product quality, safety and efficacy parameters.
➡️ If you don’t know your product and process then inadequate CAPA will be initiated based on investigation of deviation. Which will be recurring repeated deviation over the time.
4. Don’t treat every deviation in the same way:
➡️ If you treat every deviation the same, you are likely to suffer from deviation blindness, which are familiar symptoms too many peoples now a days.
➡️ If you don’t segregate deviation based on its risk. It will become dangerous to your product as well as process.
➡️ Whenever any deviation log, you must need to prioritize the risk and take your time to investigate based on criticality.
➡️ Don’t be follow the traditional techniques that you have to close every deviation within the timeline like 30 days.
5. Go to the scene instead of Desks:
➡️ If you want to fix deviation properly, you must go to the place at where deviation occur as soon as possible.
➡️ As discuss earlier that every deviation is not the same. Hence, stand up your convenient place and go to the scene where problem arise. Otherwise generating CAPAs are same or usually based on assumptions with past experience of the same type of deviation.
6. Don’t encourage people to reduce deviation numbers are good:
➡️ We all know that we need accurate performance measures to make the right decision.
➡️ What most people don't know is there before selecting any performance measure, you must first decide on what behaviors you wish to increase then select the most appropriate measure.
➡️ When encouraged to reduce deviations, people usually enforce and deviation appeared to decrease in number an overnight. Such a measure may encourage number reporting of deviation, particularly if blame culture is alive and kicking. You need to change your attitude.
➡️ Deviation are good news not a bad one. It provides you that learn from the experience.
Summary:
When investigating deviations, please make sure you don’t focus on finding only root cause. Look into relevant contributing factors and take an appropriate CAPA. Never treat every incident the same. If your policy allows 30 days to ‘close out’ of all critical and minor investigations then it’s too dangerous to your firm. You have to create a culture where people report the incident on time and you clearly do understand their importance. If you routinely complete investigations from behind a desk one thing is guaranteed that your diagnosis of the problem and prescribe for those CAPAs are probably wrong. Ask yourself that have you expert and knowledge of your product and process before starting of investigation.
About the Author:
Dhansukh Viradiya is a highly accomplished expert in the pharmaceutical and biopharmaceutical industries. With over 10 years of experience in the field, he has gained comprehensive knowledge and expertise in various areas, including Process Validation, Cleaning Validation, Quality Management System, In-process quality assurance, Qualification etc.
Mr. Dhansukh holds a Master's degree in Pharmacy from a renowned University, where he specialized in Quality Assurance.
As a thought leader, Mr. Dhansukh has published numerous articles and white papers on various topics related to pharmaceutical and biopharmaceutical industries. His research work focuses on emerging trends, current regulatory expectations, advancements in technology, personalized medicine, and the intersection of healthcare and technology.
With his passion for improving patient care and dedication to advancing the field, Dhansukh Viradiya continues to make significant contributions to the pharmaceutical and biopharmaceutical industries. His insights and expertise make him a valuable resource in understanding the dynamic landscape of these sectors and their impact on global healthcare.
Disclaimer:
The author's biography is provided for informational purposes only and does not imply any endorsement or affiliation with the article or its content.
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