Quality Risk Management:
Applying the principles and tools

Detailed course outline:

» Back to course description

Course outline:

1. Workshop Introduction and Objectives:

   • Participant goals/topics of importance

    

2. Quality Risk Management (QRM) defined

   • The what and why behind QRM

   • The basic elements of quality risk management

   • Analysis of all available information

   • Determine the likelihood of a risk

   • Assess the risk using methods to determine potential impact and severity

   • Evaluate and decide which risks to control

   • Control and mitigate the significant risks

   • Monitor

   • Communicate with all stakeholders

   • Small and large group activity: Why is risk management so important now?

    

3. 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

• Where we see the need for risk-based thinking 

• The growing importance of product and process understanding

• What regulatory agencies and national authorities have been saying

4. Key concepts and how they apply to risk-based thinking

• 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

 

5. How people think about risk

• 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

6. The QRM process: what it is all about

• 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

  • Risk ranking

  • Preliminary risk assessment

  • Hazard and Operability Studies (HAZOP)

  • Hazard Analysis and Critical Control Points (HACCP)

  • Failure Mode Effects and Criticality Analysis (FMECA)

  • Fault Tree Analysis (FTA)

  • Event Tree Analysis (ETA)

   

7. Applying Quality Risk Assessment Tools

• 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 in 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).

 

8. Integrating QRM into your organization

• 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?

» Back to course description

Course facts

Do you want our newsletter?

» Make sure to get the latest information

» Tip a colleague