QA- Lec 7 Flashcards

1
Q

Risk

A
  • The combination of the probability of occurence of harm and the severity of that harm
  • ICH Harmonised Tripartite Guidelines
  • Quality Risk Management Q9
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2
Q

General Quality risk management process

A
  • The Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle
    *
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3
Q

What is a risk management

A
  • The process of identifying, analysing and responding to risk
    • It includes maximising the probability and consequences of positive events (oppertunities) and minimising the probability and consequences of adverse events (Threats)
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4
Q

Principles of quality risk management

A
  • Scientific
    • The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient
    • Needs to be done by a specialist with in-depth knowledge of the field
  • Commensurate with the level of risk
    • The level of effort, formality and documentation of the risk management process should be commensurate with the level of risk
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5
Q

Why bother

A
  • Improve understanding of your operations
    • Protect assets and enhance the reputation of the company
  • Protects assets and enhances the image of the organisation
  • Optimises operational efficiency
  • Contributes to a more effective allocation of resources
  • Improves decision making, planning and prioritisation
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6
Q

Risk management process

A
  • Risk assessment
    • Identification, analysis, evalution
  • Risk control
    • Reduction, acceptance
  • Risk review
    • Acceptance, or review events
  • Communication
    • Output results of the risk management
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7
Q

Risk management process- ICHQ9

A
  1. Initiate- Quality Risk Management Process
  2. Risk assessment
    • Risk identification
    • Risk analysis
    • Risk evaluation
  3. Risk control
    • Risk reduction
    • Risk acceptance
  4. OUtput/ result of the quality risk
  5. Risk review
    • Review events
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8
Q

Risk assessment

What is it

A
  1. Identification
    • What can go wrong
  2. Analysis
    • What is the likelihood of it going wrong
  3. Evaluation
    • What are the consequences/severity
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9
Q

Risk assessment- Identification

A
  • Risk identification from
    • Historic data
    • Theoretical analysis
    • Informed opinions
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10
Q

Risk assessment- analysis

A
  • Estimate risk associated with identified hazards
  • Links
    • Likelihood of occurrence
    • Severity of harm
    • Detectability
  • Order the risks and investigate the highest score first (most extreme risk first)
    • Failure mode effect analysis (FMEA- provides overall scoring of risk assessment)
  • Establish the root cause of the risk
    • 5 Why?
    • Ishikawa, fishbone diagram
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11
Q

Risk Assessment- Evaluation

A
  • Compares the identified and analysed risk against given risk criteria
  • Output of risk analysis
    • Quantitative- numerical probality- easy to translate into other outputs (graphs/stats). To much specificity- small number of changes can result it large effects on graphs/stats
    • Qualitative- high, medium or low (Traffic lights, red, amber, green)
      • Easy to visualise
      • Lack ranking detail
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12
Q

Risk control

A
  • Reduce or accept risks
  • Consider
    • Is the risk above an acceptable level
    • What can be done to reduce or eliminate risks
    • What is the appropriate balance among benefits, risks and resources
    • Are new risks introduced as a result of the identified risks being controlled
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13
Q

Risk control- reduction

A
  • Risk mitigation (FMEA)
    • Reduce severity of outcome
    • Reduce probability/chance of harm
    • Increase detectability
  • Review risk
    • Have you introduced new risks into the system
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14
Q

Risk communication

A
  • Sharing information about risk and risk management between decision makers and stake holders
    • Occurs at any stage in the process
    • Among all intrestedpartie- management, staff, regulators and patients
  • Communication can include
    • Training programmes
    • Use colour
    • Use psychology
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15
Q

Risk review

A
  • A mechanism to review or monitor events should be implemented
  • Frequency based on risk
  • Events that impact on quality
    • Planned
      • Product review
      • Audit
    • Unplanned
      • Equipment failure
      • Out of specification results
      • Product recall
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16
Q

Summary

A
  • Risk management is a simple process
  • Risk management is useful
  • Risk management is a regulatory hot topic