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level: Level 2

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level questions: Level 2

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The purpose of this is to provide a general overview of and references for some of the primary tools that might be used in quality risk management by industry and regulatorsANNEX I : RISK MANAGEMENT METHODS AND TOOLS
Basic Risk Management Facilitation Methods: Simple techniques that are commonly used to STRUCTURE RISK MANAGEMENT by organizing data and facilitating decision-making are1 Flowcharts 2 Check Sheets 3 Process Mapping 4 Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram)
It provides for an evaluation of POTENTIAL FAILURE MODES for processes and their likely effect on outcomes and/or product performance. Once established, risk reduction can be used to eliminate, contain, reduce or control the potential failures and a powerful tool for summarizing the important modes of failure,FAILURE MODE EFFECTS ANALYSIS (FMEA)
FAILURE MODE EFFECTS ANALYSIS (FMEA) USES:1 to PRIORITIZE risks and MONITOR the effectiveness of risk control activities. 2 to ANALYZE a manufacturing operation and its effect on product or process.
FMEA might be extended to incorporate an investigation of the degree of severity of the consequences, their respective probabilities of occurrence, and their detectability, thereby becoming a __ It can identify places where additional preventive actions might be appropriate to minimize risks.FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS (FMECA)
FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS (FMECA) USES:1 Utilized for failures and risks associated with manufacturing processes; 2 Relative risk “score” for each failure mode, which is used to rank the modes on a relative risk basis.
An approach that assumes failure of the functionality of a product or process. This tool evaluates system (or sub-system) failures one at a time but can combine multiple causes of failure by identifying CAUSAL CHAINS.FAULT TREE ANALYSIS (FTA)
FAULT TREE ANALYSIS (FTA): USES:1 ESTABLISH the PATHWAY to the ROOT cause of the failure 2 INVESTIGATE COMPLAINTS or deviations in order to fully understand their root cause and to ensure that intended improvements will fully resolve 3 EVALUATES how multiple factors affect a given issue. 4 Useful both for risk assessment and in developing monitoring program
A systematic, proactive, and preventive tool for assuring product quality, reliability, and safety. It is a STRUCTURED APPROACH that applies technical and scientific principles to analyze, evaluate, prevent, and control the risk or adverse consequence(s)HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)
7 STEPS OF HACCP1 Conduct a HAZARD ANALYSIS AND IDENTIFY PREVENTIVE MEASURE for each process 2 determine the CRITICAL CONTROL POINTS 3 establish CRITICAL LIMITS 4 establish a system to MONITOR THE CRITICAL CONTROL POINTS 5 establish the CORRECTIVE ACTION to be taken when monitoring 6 establish system to verify that the HACCP system is WORKING EFFECTIVELY 7 establish a RECORD-KEEPING SYSTEM
HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP): USES:1 to identify and manage risks associated with physical, chemical and biological hazards (including microbiological contamination) 2 most useful when product and process understanding is sufficiently comprehensive to support identification of critical control points
It is a systematic brainstorming technique for identifying hazards using so-called “Guide-words” (e.g., No, More, Other Than, Part of, etc.) are applied to relevant parameters (e.g., contamination, temperature) to help identify potential deviations from normal use or design intentions.HAZARD OPERABILITY ANALYSIS (HAZOP)
HAZARD OPERABILITY ANALYSIS (HAZOP): USES:1 can be applied to manufacturing processes, including outsourced production and formulation as well as the upstream suppliers, equipment and facilities for drug substances and drug (medicinal) products. 2 Used primarily in the pharmaceutical industry for evaluating process safety hazards and regular monitoring of critical points in the manufacturing process.
A tool of analysis based on applying prior experience or knowledge of a hazard to identify future hazards that may cause harm. The tool consists of: - the identification of the possibilities that the risk event happens - the qualitative evaluation of the extent of possible injury - a relative ranking of the hazard using a combination of severity - the identification of possible remedial measuresPRELIMINARY HAZARD ANALYSIS (PHA)
PRELIMINARY HAZARD ANALYSIS (PHA): USES:1 useful when analyzing existing systems or prioritizing hazards where circumstances prevent a more extensive technique from being used. 2 used to evaluate the types of hazards for the general product type 3 used early in the development of a project when there is little information on design details or operating procedures.
a tool for comparing and ranking risks. The tool involves breaking down a basic risk question into as many components as needed to capture factors involved in the risk. These factors are combined into a single relative risk score that can then be used for ranking risks. “Filters,” in the form of weighting factors or cut-offs for risk scores, can be used to scale or fit the risk ranking to management or policy objectives.RISK RANKING AND FILTERING