Quality Management Program Overview
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Questions and Answers

What is the formula for calculating risk?

R(E) = L(E) * S(E)

What is residual risk?

  • Risks involved in planning processes
  • Risks that have been assessed and accepted (correct)
  • Risks not yet identified or linked to stakeholders (correct)
  • Risks that can be completely eliminated
  • Zero risk is always possible in risk management.

    False

    What are the primary goals of risk management?

    <p>To avoid, reduce, shift, assure, and account for risks.</p> Signup and view all the answers

    Define risk management.

    <p>Coordinated activities to identify, direct, and manage risks.</p> Signup and view all the answers

    Which of the following options are considered terms related to risk management?

    <p>Organization</p> Signup and view all the answers

    Study Notes

    Course Overview

    • Conducted by Dr. Detlef Behrens, featuring 4 lectures and exercises.
    • Final assessment is a 90-minute open-book written exam.

    Schedule

    • 26 April: Introduction to Risk Management (90 minutes)
    • 17 May: Business Continuity Management, Lean Management, Pareto, HAZOP Exercises (2 sessions of 90 minutes with a 15-minute break)
    • 28 June: Quality Management Exercises (2 sessions of 90 minutes with a 15-minute break)
    • 5 July: Quality Management in GxP environments Exercises (2 sessions of 90 minutes with a 15-minute break)

    Risk Definition

    • Defined as peril or loss, measured through the probability and severity of an event:
      • Risk (R) = Likelihood (L) * Severity (S)

    Risk through Hazard-Damage-Causality

    • Components:
      • Cause: Hazardous situations involving humans, machines, or the environment.
      • Damage: Can be evaluated as zero or one depending on the presence of harm.
      • Threats: Impacts arising from human actions or environmental coincidences.

    Residual Risk

    • Defined as hazards that have been assessed, accepted risks that remain unidentified, and risks not linked to customer or societal impact.
    • Aim for risk to be within acceptable levels, considering legal and scientific standards.
    • Emphasizes that achieving zero risk is impossible.

    Key Terms in Risk Management

    • Management: Coordinated activities to guide and direct an organization.
    • Organization: A structured group of people and institutions with specified responsibilities and relationships.
    • System: A set of related or interactive elements.

    Meaning of Risk Management

    • Encompasses coordinated activities to identify, direct, and manage risks.
    • Goals include:
      • Avoiding risks
      • Reducing risks (preventive)
      • Shifting risks
      • Assuring risks (curative)
      • Accounting for risks

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    Description

    This quiz covers the key topics of the Quality Management program led by Dr. Detlef Behrens. It includes details about risk management, business continuity management, and practical exercises in quality management. Test your understanding of these concepts as you prepare for the written exam.

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