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
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)
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
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
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
7
Q
Risk management process- ICHQ9
A
- Initiate- Quality Risk Management Process
- Risk assessment
- Risk identification
- Risk analysis
- Risk evaluation
- Risk control
- Risk reduction
- Risk acceptance
- OUtput/ result of the quality risk
- Risk review
- Review events
8
Q
Risk assessment
What is it
A
- Identification
- What can go wrong
- Analysis
- What is the likelihood of it going wrong
- Evaluation
- What are the consequences/severity
9
Q
Risk assessment- Identification
A
- Risk identification from
- Historic data
- Theoretical analysis
- Informed opinions
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
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
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
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
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
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
- Planned