as of 2019 - 12 - 10
19 Quality Risk Management
19.A Principles and requirements
Summary:
19.A.1 Introduction
19.A.2 Implementation of QRM
19.A.2.1 Training
19.A.3 Organisational maturity and efficiency of QRM
19.A.4 Relationship between the QRM principles
19.A.5 Effort, rigour and formality of QRM
19.A.6 Definitions
19.B Potential applications and uses of quality risk management
Summary:
19.B.1 Proactive and reactive application of QRM
19.B.2 Integrated application of QRM
19.B.2.1 QRM in the product life cycle
19.B.2.2 Embedding of QRM in the pharmaceutical quality management system
19.B.3 Benefits and advantages of integrated quality risk management
19.C The quality risk management process
Summary:
19.C.1 Initiation of a QRM process
19.C.2 Risk assessment
19.C.2.1 Risk identification
19.C.2.2 Risk analysis
19.C.2.3 Risk evaluation
19.C.3 Risk control
19.C.3.1 Risk reduction
19.C.3.2 Risk acceptance
19.C.4 Insights from the QRM process
19.C.5 Risk communication
19.C.6 Risk review
19.D Methods and tools of quality risk management
Summary:
19.D.1 Selection and applicability of methods
19.D.2 Basic procedures for the facilitation of quality risk management (enabler)
19.D.3 Informal methods and tools
19.D.4 Stepwise use of QRM methods and tools
19.D.5 Mind map (MM)
19.D.5.1 Concept & areas of application
19.D.5.2 Strengths, weaknesses & limitations
19.D.6 Fault tree analysis, FTA
19.D.6.1 Concept & areas of application
19.D.6.2 Strengths, weaknesses & limitations
19.D.7 Cause and Effects Diagram (CED)
19.D.7.1 Concept & application areas
19.D.7.2 Strengths, weaknesses & limitations
19.D.8 Failure Mode Effects Analysis (FMEA)
19.D.8.1 Concept & application areas
19.D.8.2 Strengths, weaknesses & limitations
19.D.9 Hazard Analysis and Critical Control Points (HACCP)
19.D.9.1 Concept and application areas
19.D.9.2 Strengths, weaknesses and limitations
19.D.10 Hazard Operability Analysis (HAZOP)
19.D.10.1 Concept and application areas
19.D.10.2 Strengths, weaknesses & limitations
19.D.11 Risk ranking and filtering
19.D.12 Supporting statistical methods
19.D.12.1 Control charts
19.D.12.2 Weighted moving average
19.D.12.3 Design of Experiments (DOE)
19.D.12.4 Histograms
19.D.12.5 Pareto charts
19.D.12.6 Process capability analysis/studies
19.E References
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