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The Practical Application of Quality Risk Management Tools
B. Chatterjee ASQ Eastbay SectionNovember 13, 2014
November 14, 2014
ObjectiveQuality Risk Management (QRM) differs from traditional Risk Assessment approaches in that QRM activities are built into the business process and the toolkits are predefined.
There are many tools which can be applied to evaluate risk. Many have been used for decades as part of an organization’s quality and/or business systems.
This presentation will discuss the considerations in applying risk assessment tools, their strengths and weaknesses and strategies to implementation of an effective QRM program.
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Agenda• What is Risk Management• RM Tools• Possible Application Model• Driving Risk Communication• Driving Knowledge Management• Conclusion• Q & A
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Our Definition of Risk• Risk can be defined as the combination of the probability
of occurrence of harm and the severity of that harm to allstakeholders
• Stake holders are: the company and its shareholders (the business), its employees, country/state/local-specific regulatory bodies, the business community, and most importantly…the public
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Risk Reduction Guidance• Food: Pathogen Reduction and Hazard Analysis and
Critical Control Points (HACCP) • Commerce: Sarbanes Oxley: Section 404- Management
Assessment of Internal Controls• Medical Device: ISO 14971- Applying Risk Management
Analysis to Medical Devices• GAMP5: Risk Analysis Model• ISO 3100: Risk Management• Many, many more…
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Why Embrace Risk?• “The rule is significant in that plants are responsible for
developing and adopting a HACCP program to ensure they have in place science-based controls to prevent and reduce food safety hazards.”
-Thomas J. Billy, Administrator, Food Safety and Inspection Service
• “To protect investors by improving the accuracy and reliability of corporate disclosures made pursuant to the securities laws, and for other purposes.”
- Sarbanes-Oxley Act
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Governance, Risk, and Compliance Model
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Risk Assessments (RA) and Risk Based Decision Making (RBDM)
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Key Message From Guidance• QRM used by an organization can provide regulators
with greater assurance of a company’s product and process understanding and the ability to assure the quality of manufactured products
• QRM should be used by regulators (both assessors and inspectors) to guide regulatory activities independent of the industry of QRM
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The Goals of Risk Management• Objective: Risk Management provides a tool that
systematically quantifies the necessary action to be taken as opposed to more subjective methods, which could differ depending on perceptions, human factors, and similar constraints
• Repeatable: Risk Management processes enable an organization to use the same methodology for categorizing all adverse events within the system, regardless of how and when they occurred
• Consistent: Much like having a repeatable process, ensuring the outcome is consistent is also key to Risk Management. Risk tools are formulaic in nature and are designed to produce an objective and consistent result every time
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“Good Risk Management Practices”• Risk Management should:
– Create value– Be an integral part of organizational processes– Be part of decision making– Explicitly address uncertainty– Be systematic and structured– Be based on the best available information– Be tailored– Take into account human factors– Be transparent and inclusive– Be dynamic, iterative, and responsive to change– Be capable of continual improvement and enhancement
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ISO 3100‐Risk Management
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Top View: Compliance Heat MapContextual, Enterprise View of All Compliance Topics
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Providing Structure
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Roles for Standards and Standardization• Standards allow for efficiency gains by applying prior
lessons learned• Examples of standards include:
– Workflows– Taxonomy– Models– Materials– Platform processing technologies– Equipment– Testing
Lower Risks, Lower Costs, and Higher Quality?
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Return on Standardization and Risk Management
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Phase Gate Concept• Formally integrates RA and RM pre-requisites as part of
the product development lifecycle• Establishment of success metrics for each Phase Gate• Designed to identify those activities with an
unacceptable risk of failure• Moves decision making away from the subjective to the
objective• Often requires timeline and resource commitment before
proceeding to next Phase Gate
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Where Can Risk Management Tools be Used?
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QRM Integrated Into Workflows
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Facility Project Initiation and Operational Startup
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Risk Assessment Tools
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Risk Assessment (RA) Tools• Deploying QRM can employ a variety of RA tools. The most
commonly used tools include:– Pugh Matrix– Decision Tree Analysis– Ishikawa (Fishbone)– Input/Output Diagrams– Heat Map (Severity Analysis)– Cause and Effect Analysis (C&E)– Correlation Map– Pre-Hazard Analysis (PHA)– Failure Mode and Effects Analysis (FMEA)– Fault Tree Analysis (FTA)– Hazard and Critical Control Plan (HACCP)– Hazard and Operability Plan (HAZOP)
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Pugh Matrix/Heat Map Approach
• Pugh Matrix– Scoring, weighting & ranking approach– “Kepner-Tregoe like” decision analysis
• Can include multiple SMEs to help design and complete assessment
• Answers many questions in parallel
• Allows for multiple ‘correct’ answers
• Allows different scenarios to be evaluated objectively
• Permits the reasons for decisions to be understood and documented
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Site Selection Matrix
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Decision Tree Analysis• Can be used as visual aids to structure and solve sequential
decision problems• Especially beneficial when the complexity of the problem
grows• Three types of “nodes”
– Decision nodes - represented by squares (□)– Chance nodes - represented by circles (Ο)– Terminal nodes - represented by triangles (optional)
• Solving the tree involves pruning all but the best decisions at decision nodes, and finding expected values of all possible states of nature at chance nodes
• Create the tree from left to right • Solve the tree from right to left
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Example – Decision Tree
• Can calculate expected value of each decision option
• Can address uncertain decisions as well as high certainty decisions
• Can calculate the value of decision nodes to identify which decision has the maximum benefit
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Ishikawa Diagram
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Input-Process-Output Diagram
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vessel fill volume
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Homogen
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excipien
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process tem
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homogen
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Ambien
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Ambien
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Uncontrolled Parameters (Noise)
Controlled Parameters
Buffer concentration Suspension FoamSurfactant level Suspension pH
API Loading Suspension ViscosityBuffer pH Suspension Assay
API Wettability Suspension physical stabilitySurfactant specification Suspension Chemical stability
API Particle Size Distribution Suspension HomogeneityHPMC Viscosity (grade) Suspension Particle Size Distribution
IPO Diagram for Spray Granulation Suspension Preparation
Inputs Outputs
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Cause & Effect Analysis
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Correlation Map
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Pre-Hazard Analysis
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Fault Tree Analysis• Composed of Events and
Gates• Event: a cause or an
effect • Gate: Defines the
conditional relationship between causes and effects, between x’s and y’s (what must happen for the effect to occur)
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Fault Tree Analysis• Uses:
– New facility or equipment– When multiple causes of a failure mode are suspected– When an interaction of causes is suspected– Input to Failure Modes and Effects Analysis– Input to an experimental design to characterize a process or to
determine variables and levels that will create a failure mode• Limitations:
– Time and resource consuming– Requires expert knowledge of system under study– Can lead to paralysis by analysis (infinite chains of cause and
effect)– Requires Microsoft Visio or other specialized software to document– More useful as a problem solving than a problem prevention tool
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FMEA
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Hazard and Critical Control Plan Analysis (HACCP)
• A method of identifying and controlling sources of variation at critical process steps that could lead to a hazardous condition
• Similar to a control plan• Cannot be used effectively without manual or automated process
control methods, including statistical process control• Uses:
– New manufacturing process or equipment• Limitations:
– Requires excellent process knowledge– FMEA should precede HAACP to identify critical hazards/failure
modes – a HAACP could be an action to reduce risk in an FMEA– Requires use of more complex statistical tools to be effective
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HACCP
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Hazard and Operability Method (HAZOP)• A team-based risk management tool designed to identify hazards
and deviations from normal operations, determine the hazard level and brainstorm actions and recommendations to prevent the hazard from occurring, or to minimize its impact
• Uses:– New or current manufacturing process or equipment– Excellent tool for maintenance groups
• Limitations:– Risk level more subjective than FMEA– Typically these is no reassessment of risk after risk controls are
applied
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HAZOP
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HAZOP
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HAZOP
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Analytic Hierarchy Process (AHP)
1. Develop a hierarchy or tree of criteria, in clusters from high level categories at the top level to more specific sub-criteria, down to ratings and measures that will be used to differentiate the strategic value of options against these criteria.
2. Establish the relative priorities of the criteria for use in assessing options by comparing the criteria against each other using a pairwise comparative judgment approach.
3. Rate the options against quantitative or qualitative scales that are derived to measure how well the options or alternatives reflect the priorities expressed in the criteria, resulting in a relative prioritization of the various options.
4. Perform sensitivity analysis on the option prioritization to determine the robustness and key drivers of the decision, and optimize the allocation of resources
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Pairwise Comparison Matrix: Alternative Sites vs. Program Goal
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AHP – Final Analysis
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Connect Them…• Combines the benefits of Fault Tree Analysis and Event
Tree Analysis• Powerful RA tool for identifying and communicating risk
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Bow Tie Risk Concepts
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Promotion
• Multiple Threat Lines• Some Threats appear
in Multiple Bowtie diagrams
• Focus at this stage is on the Control Framework (left side of diagram)
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Novel Risk Assessment Tools• As organizations realize the benefits of an integrated
QRM philosophy the willingness to explore new RA tools increases
• These tools build upon the basic capabilities of more conventional RA tools but provide greater efficiency in some cases and facilitate the communication component of RM which is so critical to realizing the full value of QRM
• Some effective tools that are being used in our industry include:– Analytical Hierarchy Process (AHP)– Bowtie Analysis
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Business Processes That Enable QRM
Systematic Approach to Build Knowledge
Who: Co-Development Team When: Iterative approach to Risk Assessment
How:• Risk Assessments:
• Process, Materials, Stability
• Structured Technical Knowledge
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Project Plan Embedded in RA Tool
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Risk Communication
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Driving QRM Knowledge Management
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Capturing Knowledge on a Single RA and Related Output
• Well documented risk assessments– Capture justifications not just rankings– Support justifications with data whenever possible– Document who attended RA sessions
• All QRM documents are inherently living documents– Maintain good versioning practices– Dates of RA, decisions and outputs
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Knowledge Flow Between Projects – Standard Practices• Phase Gate approach coupled can drive standard for each
risk assessment– Standard practices for risk identification– Standard definitions for risk analysis ratings– Standard thresholds for risk evaluation criteria
• Management reinforces consistency through standard milestone reporting– Ensure that all high risk elements are addressed– Ensure proposed development activities are aligned with high risk
elements– Ensure appropriate risk review/updates of QRM documents are
occurring
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Knowledge Flow Between Projects – Libraries of Failure Modes
• Subject Matter Experts can compile common failure modes into libraries, organized by unit operation, raw material type, product platform
• The libraries can promote sharing of best practices and learnings between projects– Failure modes libraries are intended to promote critical thinking
and knowledge sharing– Teams are trained to critically evaluate the content of libraries
and provide feedback/learnings to experts
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Well Developed QRM Program Summary
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Contact Information
Bikash [email protected]
Pharmatech Associates, Inc.22320 Foothill Blvd. #330Hayward, California 94541Telephone: 510-732-0177
Visit our website at:www.pharmatechassociates.com
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