| 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
regulators | ANNEX 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 are | 1 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 HACCP | 1 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 measures | PRELIMINARY 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 |
