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 (B)

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 (B), Management (C), System (D)</p> Signup and view all the answers

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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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