QA- Lec 7

Question 1

Risk

Answer 1

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

Question 2

General Quality risk management process

Answer 2

• 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
  *

Question 3

What is a risk management

Answer 3

• 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)

Question 4

Principles of quality risk management

Answer 4

• 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

Question 5

Why bother

Answer 5

• 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

Question 6

Risk management process

Answer 6

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

Question 7

Risk management process- ICHQ9

Answer 7

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

Question 8

Risk assessment

What is it

Answer 8

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

Question 9

Risk assessment- Identification

Answer 9

• Risk identification from
  
  • Historic data
  • Theoretical analysis
  • Informed opinions

Question 10

Risk assessment- analysis

Answer 10

• 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

Question 11

Risk Assessment- Evaluation

Answer 11

• 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

Question 12

Risk control

Answer 12

• 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

Question 13

Risk control- reduction

Answer 13

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

Question 14

Risk communication

Answer 14

• 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

Question 15

Risk review

Answer 15

• 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

Question 16

Summary

Answer 16

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