Pharmaceutical manufacturing is frequently faced with changes. Risks have hence become an integral part of any manufacturing project. Some common situations that are a potential peril include addition of a new user to an existing and validated WFI system, addition of a production shift, renovation of an existing facility, substitution of a supplier of printed packaging material, etc. Risk is not only limited to probability of a harm, it extends to include severity, detection, prevention and elimination of the harm.
Managing risks
Risk management has acquired new dimensions as better tools for assessment, reassessment, control and monitoring are now available. ICH Q9 elaborates ‘Quality risk management’. The identification, analysis, evaluation, reduction, acceptance, communication and review are critical steps in risk management. Risk management is not devoid of risks! A huge possibility is that only the ‘knowns’ are assessed. There is a need to have a systematic approach that can help think beyond what is known. The first crucial step is to define the problem and the affiliated pertinent assumptions. Next assemble available data and identify the resources, timelines and deliverables. Choose the best tools to manage risks. No single tool or set of tools qualifies best for every situation.
Using tools and techniques to manage risks
Techniques like flowcharts, process mapping, check sheets and ishikawa (fish bone) diagrams are employed in managing risks. The latter are particularly useful in scrupulously planning drying, compression, granulation, etc. in tablet manufacturing.
Controlling risks
Risk control implies the introduction of controls in facility, equipment, process, and/or product design which reduce the risk. Risk should decrease as knowledge of product and process build up in advancing product lifecycles.
Accepting risks
Risks should be accepted with preparedness for action plan and rectification to achieve desired goals. Absolute risk eradication is more a hypothesis as residual risk is a consequence of even the best managed situations and risks.
Communicating risks
It is good to be vocal about risks. The project teams should be trained to anticipate, accept and attenuate risks. A clear communication is a must to mitigate risks. Above all, risks should be appropriately communicated to all stakeholders.
Reviewing risks
A vigilant team managing a risk will always want to reiterate and revisit the major events in the management plan. Lessons learned should be reviewed, documented and shared. This can help to assemble data, generate information and synthesize knowledge.
Clearly, risk management involves diverse and multifarious approaches.
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Upcoming Events on Project Management
Event Name : Project Management and Change Control – Get it Right The First Time
Speakers : Neil Grumbridge (former Head of Quality and Safety, Health Protection Agency, UK) and Mr. Pravin Manker
Date & Venue : 29-30 July 2010, Harris Hotel Tebet, Jakarta
More Info: http://www.pharmasupport.in/latest-pharma-events.html
Contact: Mr. Rony Rianto on + 62 81808610171 or rianto@inovamitra.com OR Mr. Rizwan Rustam on + 62 2198949630 or rizwan.rustam@inovamitra.com
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