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Problem Statement - Coggle Diagram

- - - - Does not comply with therapeutic effect
      - Will not meet the patient's need
      - Has an adverse reaction
- - - - A method in maintaining the quality of the product, minimizing the risk of failure in the blending unit operation and product’s scale-up
    - - Failure Mode, Effects and Criticality Analysis (FMECA)
        
        Uses
        
        utilized for failures and risks
        associated with manufacturing processes
        
        a relative risk “score” for each failure mode
        
        to rank the modes on a relative
        risk basis
        
        Limitation
        
        extensive labor required
        
        large number of trivial cases considered
        
        inability to deal with multiple-failure scenarios or unplanned cross-system effects s
        
        Qualitative and quantitative information
        
        extended to incorporate an investigation of the degree of severity of the consequences, their respective probabilities of occurrence, and their detectability
      - Fault Tree Analysis (FTA)
        
        Uses
        
        to establish the pathway to the root cause of the failure
        
        to investigate complaints or deviations in order to fully understand their root cause
        
        to ensure that
        intended improvements will fully resolve the issue
        
        for evaluating how multiple
        factors affect a given issue
        
        Limitation
        
        the uncertainties in covering all failure modes
        
        inaccuracy in human error in investigation of complex man-made systems
        
        inefficiency of the tool in case of scarce or insufficient data
      - Failure Mode Effects Analysis (FMEA)
        
        Uses
        
        To prioritize risks and monitor the effectiveness of risk control activities
        
        Applied to equipment and facilities
        
        To analyze a manufacturing
        operation
        
        Effect on product or process
        
        Identifies elements/operations within the system
        
        Render vulnerable
        
        As a basis for design or further analysis
        or to guide resource deployment
        
        Limitation
        
        Time consuming
        
        Detection Controls Are Not Tested Adequately
        
        FMEA Is an Assessment Tool, it doesn’t eliminate problems
        
        Qualitative information
      - Basic risk management facilitation methods
        
        Simple techniques that are commonly used to structure risk management by organizing
        data and facilitating decision-making
        
        Example:
        
        Flowcharts;
        
        Check Sheets;
        
        Process Mapping;
        
        Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram)
        
        Limitation
        
        Oversimplifying
        
        Requires an attention to detail
        
        Repetition
      - Hazard Analysis and Critical Control Points (HACCP)
        
        Uses
        
        to identify and manage risks associated with physical, chemical and biological hazards
        
        to support identification of critical control points
        
        facilitates monitoring of critical points
        not only in the manufacturing process but also in other life cycle phases
        
        Limitation
        
        Lack of expertise
        
        Single HACCP Plan is not appropriate
        
        High cost
        
        risk management information
      - Hazard Operability Analysis (HAZOP)
        
        Uses
        
        applied to manufacturing processes
        
        used primarily in the pharmaceutical industry
        
        evaluating process safety
        hazards
        
        monitoring of critical points in the manufacturing process
        
        Limitation
        
        only focusses on single failure conditions rather than on combinations of possible events leading to resultant failure.
        
        time consuming,
        
        overly detailed and complex
        
        requires some form of expert facilitation
      - Preliminary Hazard Analysis (PHA)
        
        Uses
        
        analyzing existing systems
        
        Evaluate type of hazard
        
        General product typew
        
        Product class
        
        Specific product
        
        used early in the development of a project
        
        Limitation
        
        Hazards must be foreseen by the analysts
        
        The effects of interactions between hazards are not easily recognize
      - Risk ranking and filtering
        
        Uses
        
        For comparing and ranking risks
        
        To prioritize manufacturing sites for inspection/audit
        
        by regulators or industry
        
        helpful in situations in which the portfolio
        of risks
        
        to evaluate both quantitatively-assessed
        and qualitatively-assessed risks within the same organizational framework
        
        Limitation
        
        May require significant effort in establishing risk factors and evaluation criteria
        
        May require significant effort in breaking down risk into many components
        
        Results may be difficult to correlated irectly with absolute risks
      - Supporting statistical tools
        
        Tools in pharmaceutical industry
        
        Control Charts, for example:
        
        Acceptance Control Charts (see ISO 7966);
        
        Control Charts with Arithmetic Average and Warning Limits (see ISO 7873);
        
        Cumulative Sum Charts (see ISO 7871);
        
        Shewhart Control Charts (see ISO 8258);
        
        Weighted Moving Average.
        
        Design of Experiments (DOE);
        
        Histograms;
        
        Pareto Charts;
        
        Process Capability Analysis.
        
        Uses
        
        can support and facilitate quality risk management
        
        enable effective data
        assessment
        
        aid in determining the significance of the data set
        
        facilitate more reliable decision
        making
    - - Friday 13th Risk Framework
        
        a new quantitative risk assessment method
        
        Uses
        
        To identify the sensitivity of the process parameters to the blend homogeneity in a blending unit operation
        
        To understand better the vulnerability or sensitivity of the critical process parameters to unexpected failures in a blending unit operation
        
        Describes the unexpected failures as not achieving the targeted blend uniformity caused by the fluctuation of the critical process parameter
      - Suitable mathematical model
        
        Refers to the data that can be measured and numerically expressed by mathematical model
        
        Uses
        
        minimize the risk of failure that may occur comprehensively
        
        To ensure that the prediction of observed data is accurate for V-blender unit operation in pharmaceutical industry
        
        To account for a few critical process parameters and limited state capabilities in their studies
      - Bayesian Network
        
        To identify the critical process parameter (CPP) that has direct effect on the appearance, impurity, yield of the finished product and process’s maximum performance
        
        To illustrate the probabilistic relationship among a set of process parameters that may affect the performance of blending unit operation