STRATEGY |
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Risk management delivering value for
pharmaceutical facilities:
DNV’s experiences
Mark Boult, DNV
Working with all types of healthcare organisations on risk management, DNV has knowledge of the range of different risks which such organisations, including pharmaceutical companies, have to manage and the systems they use to achieve this. In the July issue of World Pharma Network the DNV article explored some of these risks and the abilities of pharmaceutical companies to mitigate them. In this article DNV discusses the management of risks from pharmaceutical facilities, drawing upon their experiences of working with pharmaceutical organisations around the world. The article’s aim is to provide ideas for pharmaceutical organisation’s risk management systems that will enable readers to identify opportunities to improve their management of major hazard and biological risks. It presents developments DNV is leading in the areas of Process Safety Management and Biorisk Management.
Managing Major Hazard Risks
– Process Safety
Management
Major hazards are an issue for pharmaceutical facilities, as well as for others (eg chemical process and energy companies). DNV ’s support in this area for pharmaceutical organisations draws on their experience working across the full range of these industries. For these industries there is evidence showing improved occupational safety performance over the last 20 years. However, the evidence we have does not indicate any associated reduction in the financial impact of major hazard events. When a major hazard incident occurs it often gains a high profile in the media, resulting in major costs, and potentially harm to people and the environment.
Accordingly it is clear that performance in managing major (process) hazards may not be directly linked to good occupational health and safety performance, hence we need to give it special focus. DNV sees that safety improvements have come through the application of:
- Risk assessment;
- Formal safety management systems;
- Behaviour based safety programmes.
Furthermore, improvements in major hazard safety can be realised from actions aimed at the prevention of major hazard incidents which are based on the thinking behind the above proven approaches. DNV is applying and continuing to develop existing and new approaches where process safety management (sometimes referred to as major hazard management) is delivered efficiently and effectively by making it an integral part of HSE (Health Safety and Environmental) management.
The process safety system model (which should be integrated with an organisation’s HSE system) aims to assure that the facility is:
- Designed right;
- Built right;
- Operated right;
- Maintained right.
This approach recognises the importance of developing and maintaining knowledge whilst also having competent and motivated people. It is depicted in the figure below. Each aspect is explained in table 2 .DNV has worked with clients and has helped them deliver real benefits following the philosophy described to deliver real benefits for improved process safety. We are continuing to make developments to aid others in their assessment of their process safety management system and also assisting in the development of these systems to be more effective and efficient.
One major development is a comprehensive process safety management system structured on the above model to deliver the “Design, Build, Operate and Maintain RIGHT” goal.
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Laboratory Biorisk Management
Biological containment laboratories are critical for vaccine development and diagnostic work, as well as basic research into human, animal and plant pathogens. Laboratories wishing to operate safely and responsibly must implement management systems that ensure appropriate biorisk controls are identified and implemented. The potential severity of such risks can be seen by the response to biorisk incidents by organisations, governments and the media. In addition to the potential harm to people and other organisms, these responses have major costs and significant impact on those in the affected location(s) and beyond.
Biorisk in laboratories encompasses both biosafety and biosecurity, where biosafety involves harm to people and other organisms whereas biosecurity covers the deliberate unauthorised removal of materials. In DNV we see biosafety and biosecurity as being closely interlinked, and believe that common systems are required to manage both effectively. These systems include the more traditional technically orientated areas such as facility design or personal protective equipment, but also include areas such as “Management and Organisation”, “Project Management” and “Human Factors”, which we believe can provide significant contributions towards delivering the effective management of your biorisks.
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Case Study – Biomedical Research Facility
A biotechnology organisation recognised the importance of safety and of creating a strong safety culture to the success of their business through the prevention of all accidents. The accident prevention goal was set as a top level goal by the organisation’s senior management. This organisation turned to DNV for a range of biorisk management services to support their drive to enhance their systems and culture by taking a proactive approach to managing these risks.
DNV’s support covered both biosafety and biosecurity (collectively referred to as biorisk). The work included conducting safety management system assessments, reviewing containment laboratory facilities, and providing specialist biorisk training. The study drew on DNV’s experience of managing risk in a wide variety of industries together with their people’s knowledge of laboratories and biorisks. Core risk management principles were successfully applied. A major emphasis of the work was on people and their safety attitudes – “safety culture”. The study helped the organisation to gain a better understanding of the risks associated with the diverse range of activities they undertake involving biological organisms, and to successfully enhance their management of these risks.
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Developing Biorisk Management – A DNV Research Focus
As an Independent Foundation DNV invests profits in research to support the successful delivery of its purpose: “To safeguard life, property and the environment”. One of its research programmes is on laboratory biorisk management. This programme includes the following major projects:
Laboratory Biorisk Management Standard Development
There is currently no international standard for practices in containment laboratories, hence DNV initiated a project in 2005 to address this issue, and discovered there was great interest from operators all over the world for such a standard. The development of a standard was therefore initiated by DNV, together with the European and American Biosafety Associations, and WHO.
The standard is being developed using the CEN Workshop Agreement process, which is an internationally recognised consensusbased standards-development approach. The peer-designed Standard will complement the current WHO guidelines and enhance existing national regulations. The intention is that it will promote good practice in the containment laboratories, and provide organisations with a tool for internal audit and third-party certification of facilities and management systems. This will therefore assure regulators, funding bodies and the community that adequate measures are in place to responsibly manage biorisk.
Laboratory Task Risk Assessment
Biological containment laboratories are necessary for diagnostic and detection work, and are also critical for research and development. There are many different types of micro-organisms that are handled in these laboratories, and each activity that is performed on the micro-organism has the potential to pose a risk. Therefore, the risks should be evaluated, so that measures can be put in place to protect both the workers and the environment from infection. According to the WHO’s laboratory Biosafety Manual, risk assessments provide the backbone to any laboratory safety programme. Some countries also have a legal requirement that the activities carried out in containment laboratories should be covered by a risk assessment. However, risk assessments can prove difficult to complete without the correct knowledge and tools. DNV is currently developing a tool which will help workers carry out their risk assessments more easily and constructively.
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Biosafety-Europe
Biosafety-Europe is a co-ordination action funded through the European Commission’s sixth framework and which started April 1 2006. The project has 20 partners from 11 European countries and has an overall aim of promoting European harmonisation and the exchange of practices relating to biosafety and biosecurity management of biological containment.
Laboratories must take into account regional and national regulatory requirements, as well as international biosafety guidelines, when developing biosecurity and biosafety management systems. The different requirements may treat some issues differently, and some issues can even be conflicting. The differences in legislative frameworks and differing ways they are interpreted is one of the major reasons that various approaches, different controls and alternate best practices have developed within the fields of biosecurity and biosafety.
Against this background, our project aims to ask three broad questions:
- Who is working within BSL3 and 4 facilities in Europe and under which regulatory and operational frameworks?
- How are facilities implementing biosecurity and biosafety controls and are they effective?
- How can biosecurity and biosafety be improved, and how can this be harmonised at the European level?
DNV is acting as one of four work package managers and the project is co-ordinated by the Institute for Immunology and Immunoprophylaxis in Switzerland. In summary, we hope that the ideas presented will support you in the ongoing development of risk management throughout your organisations, with or without the support of companies like DNV. Risk management in pharmaceutical organisations can have positive impact on the performance of the organisation itself, and on the performance of others.
Mark Boult
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Mark was the risk advisor in the National Patient Safety Agency from 2002 to 2006 where his work included involvement in medication safety projects. Currently he is leading the risk management work for the NHS Litigation Authority, which is provided on their behalf by DNV to health providers in England.
Mark Boult, Healthcare Market Sector Leader, DNV
E-mail: Mark.boult@dnv.com
Website: www.dnv.com
Contact:
DNV, Palace House, 3 Cathedral Street, London SE1 9DE, UK
Tel: +44 20 7357 6080 (W-Switchboard)
+44 20 7716 6536 (W-Direct)
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