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1 4d - Qualiy Risk Management
1 4d - Qualiy Risk Management
Tony Gould
Introduction
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Introduction
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Introduction
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GMP requirement
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What is QRM
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Risk Assessment
Risk Identification
Risk Analysis
Risk Evaluation
Risk Communication
Risk Control
Risk Reduction
Risk Acceptance
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unacceptable
Risk assessment
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Risk identification
Use of information to identify hazards or potential risks
Historical data, theoretical analysis, informed opinions
Risk analysis
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Likely to occur
May occur
Unlikely to occur
Very unlikely to occur
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Risk evaluation
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Risk evaluation
Moderate
Critical
Unacceptable risk
Intolerable risk
Intolerable risk
Medium
Acceptable risk
Unacceptable risk
Intolerable risk
Low
Acceptable risk
Acceptable risk
Unacceptable risk
Remote
Acceptable risk
Acceptable risk
Acceptable risk
High
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Minor
Risk evaluation
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Risk evaluation
Risk definitions:
Intolerable work to eliminate the negative event or
introduce detection controls is required as a priority
Unacceptable work to reduce the risk or control the
risk to an acceptable level is required
Acceptable the risk is acceptable and no risk
reduction or detection controls are required
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Risk control
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Risk reduction
Actions taken to lessen the probability of occurrence
of harm and the severity of that harm
Typically CAPA and change control
Risk acceptance
The decision to accept risk
If risk reduction action taken, follows re-analysis and
evaluation
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Risk Review
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Potential applications
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