How does an organization identify and reduce it? Regulatory agencies worldwide are encouraging our industry to identify, assess, and manage the potential quality risks associated with pharmaceutical and biotech products. Pharmaceutical firms are also realizing that risk management is an important way to rationally set priorities for quality and compliance activities. This workshop presents the concepts of risk assessment and risk management to executives, managers, and technical personnel. Using examples and activities, participants learn about seven of the most frequently used tools and processes for identifying and quantifying risk. Integrated approaches to prevent risks from being expressed and protecting things of value are also presented.
Tools discussed include:
Small and large group activity: Why is risk management so important now?
From specifications to testing to process understanding
Changes in GMP requirements and expectations related to QRM
The six fundamental questions of risk assessment and risk management
Vulnerabilities and timing: What factors can make a product or organization more susceptible to hazards?
Small and large group activity: identifying vulnerabilities
Small and large group activity: What shapes risk perceptions?
The role of heuristics
The role of trust
Accident theory: the basis for many risk assessment tools
Turning accident theory on its head: tools for assessing risks
Defining each task, what is accomplished and how it is done
Preliminary tasks: Coming up with the “risk question”
Define the system or process
Identify the hazards – creating "risk scenarios"
Assess the risks
Evaluate the risks
Control and mitigate the significant risks
Monitor
Communicate to stakeholders
Small and large group activity: How can you apply the process?
The risks of too much and too little documentation of the QRM process
The risk assessment “toolset”: A look at some of the tools used in risk assessment and where they came from
Now that you know the process and some of the tools, you can apply them using several different scenarios.
Large group activity: A Warm-up to using some of the risk assessment tools
Small and large group activity: Practical example #1 – Risk and outsourcing. An overview of the outsourcing process and then a small group activity where learners can use one of the risk assessment tools. Ideas to control significant outsourcing risks will be identified. (This can apply to contract givers as well as contract receivers.)
Control and mitigation strategies: prevention or protection?
Small and large group activity: Practical example #2 – Risk and inspection readiness. Becoming “inspection ready” can be more focused on compliance priorities are identified. This large and small group activity first examines areas that regulatory age currently emphasizing. Participants will apply one of the risk assessment tools and use “risk rating” approaches described by regulatory agencies.
A closer look at the “risk library” – how much detail should you include in your formalized risk assessment
REAL WORLD CASE STUDIES: Working in small groups, participants apply a risk assessment and risk management tool to one of several case studies. The teams will share their conclusions in brief presentations to the large group. Case studies have been prepared that cover product development, handling of samples, distribution practices (cold and secure chain).
Setting up a QRM activity: Critical success factors to consider when you are setting up or evaluating a quality risk management program, including the importance of management support
Suggestions for early risk assessment projects: focus on what is important
Writing a procedure for risk assessment and risk management – key things to include
What can we learn from recent risk management failures in other industries? What can happen when you don’t understand the limitations of the risk model? What can happen when nobody thinks of “residual risk” or “unidentified risk?”
Discussion: Taking the next steps. What actions can you take? What will you be able to do with this information?
The evolution of "Quality Thinking" in the pharma industry
Key concepts and how they apply to risk-based thinking
How people think about risk
The QRM process: what it is all about
Applying Quality Risk Assessment Tools
Integrating QRM into your organization
Those in management, quality, development, compliance, laboratory, operations, and other technical areas like:-