Introduction to Risk-based thinking and Quality Risk Management

Course goal

Provide a working knowledge and skills of the concepts and tools used in managing risk with applications to pharma and biopharma activities.

Course description

What is risk? How does an organization identify and reduce it?

Regulatory agencies world-wide 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 rating risk. Integrated approaches to prevent risks from being expressed and protecting things of value are also presented.

Tools discussed include:

  • Holographic Hierarchical Modeling and Risk Filtering and Ranking
  • Hazard Identification Tool (HIT)
  • Preliminary Risk Analysis (PRA)
  • Risk Check Sheets
  • Failure Mode Effects Analysis (FMEA)
  • Hazard Analysis and Critical Control Points (HACCP)


  • Define terms and concepts important in risk management.
  • Describe the importance of risk assessment and risk management in the pharma/biopharma industry
  • Given a topic, write a correctly structured risk question.
  • Discuss how scales can be developed using “key words”
  • Describe the phases used in managing risks.
  • Describe techniques used in risk assessment, when they are used, and how they are performed.
  • Given a set of quality system elements, identify where risk assessment tools and risk management processes can be effectively used.
  • Given a case, apply an appropriate risk assessment tool.
  • Identify issues in implementing Risk Management in an organization.

Who should attend

Those in management, quality, development, compliance, laboratory, operations, and other technical areas. Also, those who will participate in QRM teams and prospective QRM facilitators.

Course outline

  • RBT/QRM – examples of where it has been used and the benefits
  • The evolution of “Quality Thinking” in the pharma industry
    • From specifications to testing to process understanding
    • Changes in GMP requirements and expectations related to QRM
    • The connections between risk-based thinking, the product life cycle and the quality system: ICH Q8, Q9, and Q10
    • Regulatory requirements and expectations for QRM
  • Key concepts and how they apply to risk-based thinking
    • Activity: Terms and Definitions
    • Activity: The ICH Q9 Model
    • The eight fundamental questions of risk assessment and risk management
    • Risk tolerance and risk appetite
    • Vulnerabilities and timing: What factors can make a product or organization more susceptible to hazards?
    • Small and large group activity: identifying vulnerabilities
  • Why we need a structured approach when considering risk
    • Small and large group activity: What shapes risk perceptions?
    • The role of heuristics
    • The role of trust
  • Additional principles of RBT and QRM
    • Formal and informal assessments
    • Living and one time assessments
  • The QRM process: the big picture
  • QRM initiation
    • Goal, scope, level of detail
    • Risk questions
    • ACTIVITY: Writing a risk question
  • Hazard identification
    • Tools to use
      • Brainstorming
      • Hierarchical holographic modeling (HHM)
      • Hazard identification tool (HIT)
    • ACTIVITY: Identifying risks
  • Risk assessment
    • Tools to use
      • PRA
      • Risk Check Sheets
      • FMEA
    • Scales
    • ACTIVITY: Assessing risks
  • Risk evaluation
    • Risk blocks
    • Risk appetite and risk tolerance
  • Risk treatment
    • Options available
    • Swiss Cheese model
    • ACTIVITY: Risk reduction
  • Risk communication and documentation
    • Options available
    • Reports, risk memos
  • Risk monitoring and review
    • What is done
    • When this is needed (for living risk assessments)
    • Timing
  • Custom tools
    • When to create and use
    • Examples
  • Selecting the optimal tools for risk assessment
  • Landmines when doing a risk assessment and ways to get around them
    • Risk blocks
    • Risk appetite and risk tolerance
  • Roles and responsibilities– the role of the facilitator
  • Case studies
    • Introducing case studies, assigning teams
    • Instructions
    • Case study execution
  • Case presentations
    • Teams present their work
  • RBT, QRM, and your Quality System
  • Wrap-up of the course – What are you taking back?



James L. Vesper




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