Embedding Risk-Based Approaches to Quality Management in Life Sciences Organisations

Transcription

1 Embedding Risk-Based Approaches to Quality Management in Life Sciences Organisations Kinapse Consulting, 2012 Advise Build Operate

2 In recent years, there has been much discussion about the adoption of risk-based approaches in quality and compliance. The MHRA began to introduce a level of risk assessment into its inspection programmes in 2009 and the US FDA has published a number of discussion papers acknowledging the value of pursuing alternative, risk-based approaches (e.g. to the monitoring of clinical trials). In the present day, leading life sciences organisations are evolving to adopt risk-based approaches to quality and compliance. Indeed, it is our belief that effective quality assurance (QA) is only sustainable through establishing risk-based approaches which align management focus and effort in order to optimise process and outcome quality from all GxP-governed activities. But how should one establish a risk-based quality and compliance capability and how far-reaching should that capability be? This paper outlines some of the benefits of risk-based methods alongside our approach for establishing riskbased quality and compliance, advocating a wide-reaching scope in order to realise the greatest benefits. The Opportunity- Why Do it? At first glance, there are a number of obvious benefits to risk-based quality and compliance approaches. They enable: Alignment of leadership focus and time to areas of greatest risk thus improving assurance of risk Better resource allocation through alignment of allocation of scarce QA resources to areas of highest risk Effective agency interactions through the improved ability to clearly demonstrate and discuss the basis for decision making and QA focus However, in our experience, the adoption of risk-based approaches can have a much more profound impact. Firstly, within QA organisations, a clear understanding of the risk profile of activities across the portfolio and lifecycle can have a significant impact on how QA organisations build skills and discharge their responsibilities. For example, in the past, given limited headcount numbers, leaders of QA organisations may have been tempted to resource well defined workload first (e.g. GLP related work where requirements tend to be very clearly defined) and then work out how to resource the rest of the more nebulous work (typically GCP and PV related activities) with remaining headcount numbers. Where organisations have adopted risk-based approaches, they typically find that the greatest risks lie within the clinical arena which has led to a significant change to focus regarding skills building and resourcing. In addition, a pan-organisation understanding of risk is leading to a significant change in the relationship between Business Leadership and QA & Compliance Leadership. Audit strategies and plans are now based on a commonly understood and supported assessment of organisational risk. As a result, there is greater Business support for QA activities thus enabling a far more collaborative and constructive relationship between leaders of the different functions than was historically the case. In the broader organisation, however, a common understanding of risk can have a fundamental impact on the way that the organisations themselves are run. The different units within life sciences organisations tend to be run discretely, each with their own, distinct ways of working and language. For example, within the QA arena, it is not uncommon to find Audit Committees who struggle to identify which findings have the greatest significance when presented with a multitude of audit reports from multiple functions each with supposedly the same finding rating but with seemingly disparate potential impacts. At Kinapse, we believe that a clear understanding of risk built across the organisation can provide both a common language for discussions between groups/functions as well as helping Business Leaders and leadership teams to clarify or confirm where they should focus their effort. Furthermore, a clear understanding of risk coupled with an understanding of the potential commercial benefit can validate strategic direction and improve the effectiveness of overall decision making. A common risk language and an understanding of the profile of risk within an organisation can also support more effective and efficient due diligence through the provision of an established mechanism for assessing potential partners. In these circumstances, organisations are able to understand the impact of any acquisition/ alliance on their risk profile relatively rapidly as well as understanding the associated implications for their operations. Embedding Risk-Based Approaches to Quality Management in Life Sciences Organisations Page 3

3 How do Leading Companies Embed Risk-based Approaches? It is commonly understood that risk assessment should incorporate both an understanding of: Impact (a measure of the severity of harm should a risk not be managed effectively) and Vulnerability (a measure of the likelihood of that harm coming to pass) In our experience, the key to developing and maintaining the optimal risk assessment is the identification of the right risk parameters (and their associated impact and vulnerability) against which to measure the organisations activities. The right risk parameters will vary significantly from organisation to organisation depending upon its strategy and portfolio as well as external environmental factors/trends. For example, where an organisation works with extremely volatile materials, one of the risk parameters that we would typically select would describe whether those materials are being employed in a particular indication (which would in turn, increase the risk profile of all activities relating to that indication). Similarly, where a company changes strategy to externalise much of their Development activity, they might choose to identify a risk parameter describing whether multiple, new external partners are being employed for any one programme (which would again potentially increase risk) until such a time that they have confidence that their change in strategy is successful. Each risk parameter is then assigned an impact and vulnerability rating. Illustrative Impact Rating Illustrative Vulnerability Rating Embedding Risk-Based Approaches to Quality Management in Life Sciences Organisations Page 4

4 In parallel, we collate all existing programme (principally Discovery and Development programme) plan data. It is necessary to collect programme data relating to each of the risk parameters included in the assessment. This can be a resource intensive effort, especially where the data are not available in existing systems. As a result, some organisations may choose to start with a small number of key parameters in the initial development of the assessment and then subsequently incorporate more parameters and more sophistication into their assessment as they get more experienced with the tool and the process of evaluating risk. All ongoing and planned programmes are evaluated against the risk parameters in order to enable the development of heat maps which provide a summary of the risk associated with all programmes and/or activities that are underway or planned. Whilst this heat map is useful in itself in clearly describing risk, organisations can derive many more benefits from the risk assessment. For example, we work with leading QA organisations to use the risk data alongside industry benchmarks to develop associated audit plans and resourcing algorithms in order to ensure that the QA organisations priorities and resources are aligned to risk. The following table provides an illustrative description of how study level risk assessments can support the determination of the optimal audit plan for a sample set of clinical programmes. Embedding Risk-Based Approaches to Quality Management in Life Sciences Organisations Page 5

5 Furthermore, an understanding of the risk profile coupled with industry benchmarks can enable the modelling of QA resource requirements to enable optimal audit coverage and additional QA organisational support (e.g. in the form of consultation and advice). The table below provides an illustrative example of sample resource requirements for an R&D QA organisation, including scenario planning for varying levels of audit coverage for studies of varying levels of risk. Critical Success Factors In our experience the critical success factors which need to be in place to fully embed risk base approaches are: Cross GxP scope: whilst there are many benefits to be gained from a clear understanding of risk within a particular GxP, we believe that risk-based approaches are at their most effective when applied consistently across GxPs to enable a cross organisational understanding of risk and enable better cross functional prioritisation and decision making. Indeed as stated in ICH Q9, Achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. At Kinapse, we have found that a simple methodology which is consistently applied combined with cross functional input at key stages in the risk assessment process enables the development of a pan-organisational risk assessment. Business input to risk analysis as well as QA expert input: a combination of Business and QA expert input is essential for the successful assessment of organisational risk and associated decision making. As the owners of risk, the Business leadership need to provide extensive input and feel ownership for the outcome of the integrated risk assessment. The internal QA group has a key role to play in providing their experience of effective risk criteria as well and ensuring that agency trends and intelligence are incorporated into the tool design and maintenance. Balance between risk criteria and accuracy: as in the development of any analytical tool, there is a tension between the urge to include as many risk criteria as possible in order to improve the accuracy of the output and the need to ensure that the tool is not so large and unwieldy that it becomes difficult to populate and maintain. Regular review and revision: we recommend that risk assessments should be reviewed annually or whenever there are significant changes internally or externally which are likely to impact the risk profile of the organisation and its activities such as changes to organisational strategy or external policy changes Interaction with agencies: frequent and regular discussions with agencies can enable organisations to refine their risk assessments and associated tools. Embedding Risk-Based Approaches to Quality Management in Life Sciences Organisations Page 6

6 Conclusions Whilst a number of the major agencies have signalled support for risk-based approaches, their full adoption across the life sciences industry is still in its infancy thus it remains to be seen how far this agency support will extend. Interestingly, ICH Q9 states that, Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. This would appear to signal that companies should feel confident in initiating programmes to embed risk management. Indeed, in a world of increasingly stringent requirements and increasingly limited resource, we believe that risk-based approaches are the only viable option for companies who want to protect patient safety and improve data quality whilst enabling commercial success. Authors Suzanne Budsworth and Bruce Seymour-Taylor. Suzanne is a Senior Vice President at Kinapse with over 15 years of experience of working in Clinical Development and Medical Affairs. She has extensive experience of working in quality and compliance organisations. Bruce is a Kinapse Consulting Partner with 30 years of clinical development and quality assurance most recentlyhaving held the post of Director of Global Quality Assurance for Europe and Asia-Pacific with Johnson & Johnson. For more information, please contact Suzanne Budsworth at: suzanne.budsworth@kinapse.com About Kinapse Kinapse provides consulting and outsourcing services to life sciences organisations. Our mission statement is: Collaborating with our clients to innovate for exceptional results. Kinapse clients include many of the world s leading pharmaceutical, biotechnology, medical device and specialty pharmaceutical companies, government organisations and life sciences service providers. Our key advantages are: Focus on the life sciences industries Deep industry experience and technical acumen Successful history of project delivery and repeat business Kinapse Ltd. Tuition House St George s Road Wimbledon, London SW19 4EU Phone: Website: Follow us on Follow us on LinkedIn