Risk management tools

Topic:- RISK MANAGEMENT TOOLS
Subject Name :- Quality Management System
Subject Code:- MQA102T
Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
1st sem M.Pharm.

CONTENTS
1. Introduction
2. Basic Risk Management Facilitation Methods
3. Failure Mode Effects Analysis (FMEA)
4. Failure Mode, Effects & Criticality Analysis (FMECA)
5. Fault Tree Analysis (FTA)
6. Hazard Analysis and Critical Control Points (HACCP)
7. Hazard Operability Analysis (HAZOP)
8. Preliminary Hazards Analysis (PHA)
9. Risk Ranking and Filtering
10.Supporting Statistical Tools
11. Questions
12.Reference
4/6/2022 2
Smt. BNB SPC, Salvav-Vapi

INTRODUCTION [1]
Annex I: Risk Management Methods & Tools
• The purpose of this annex is to provide a general overview of & references for some
of the primary tools that might be used in quality risk management by industry &
regulators.
• It is important to note that no one tool or set of tools is applicable to every situation
in which a quality risk management procedure is used.
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BASIC RISK MANAGEMENT FACILITATION METHODS[1]
Some of the simple techniques that are commonly used to structure risk management
by organizing data and facilitating decision-making are:
• Flowcharts
• Check Sheets
• Process Mapping
• Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone
diagram).
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1. FAILURE MODE EFFECTS ANALYSIS (FMEA) [1][3]
• FMEA provides for an evaluation of potential failure modes for processes &
their likely effect on outcomes and/or product performance.
• It is a powerful tool for summarizing the important modes of failure, factors
causing these failures and the likely effects of these failures.
Potential Areas of Use(s) :-
• FMEA can be used to prioritize risks and monitor the effectiveness of risk
control activities.
• FMEA can be applied to equipment and facilities and might be used to
analyze a manufacturing operation and its effect on product or process.
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2.FAILURE MODE, EFFECTS & CRITICALITY
ANALYSIS (FMECA) [1][3]
• FMEA might be extended to incorporate an investigation of the degree of severity of
the consequences, their respective probabilities of occurrence, & their detectability,
thereby becoming a Failure Mode Effect and Criticality Analysis .
• mostly be utilized for failures & risks associated with manufacturing processes;
however, it is not limited to this application.
• The output of an FMECA is a relative risk “score” for each failure mode, which is
used to rank the modes on a relative risk basis.
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3. FAULT TREE ANALYSIS (FTA) [1][3]
• The FTA is an approach that assumes failure of the functionality of a product
or process.
• This tool evaluates system failures one at a time but can combine multiple
causes of failure by identifying causal chains.
FTA can be used ;
• to establish the pathway to the root cause of the failure.
• to investigate complaints or deviations in order to fully understand their root
cause and to ensure that intended improvements will fully resolve the issue
and not lead to other issues (i.e. solve one problem yet cause a different
problem).
• It is an effective tool for evaluating how multiple factors affect a given issue.
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4. HAZARD ANALYSIS & CRITICAL CONTROL POINTS
(HACCP) [1][2][3]
• HACCP is 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) of hazard(s) due to the design, development, production,
and use of products.
• HACCP might be used to identify and manage risks associated with
physical, chemical and biological hazards (including microbiological
contamination).
• It is Most useful when product and process understanding is sufficiently
comprehensive to support identification of critical control points.
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HACCP consists of the following seven steps: [2]
(1) conduct a hazard analysis and identify preventive measures for each step of
the process;
(2) determine the critical control points;
(3) establish critical limits;
(4) establish a monitoring system to monitor the critical control points;
(5) establish the corrective action to be taken when monitoring indicates that the
critical control points are not in a state of control;
(6) establish system to verify that the HACCP system is working effectively;
(7) establish a record-keeping system.
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SEVEN PRINCIPLES OF HACCP [3]
7. Establish record keeping & documentation procedures
6. Establish verification procedures
5. Establish corrective actions
4. Establish monitoring procedures
3. Establish critical limits
2. Determine the critical control points (CCPs)
1. Conduct a hazard analysis
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Principle 1
List all potential hazards associated with each step, conduct a hazard
analysis, and consider any measures to control identified hazards
• It involves listing of the steps in the process & identify that where significant hazards
are likely to occur.
• HACCP will focus on hazards that can be prevented, eliminated or controlled.
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A two-stage hazard analysis is recommended.
• During the first stage, the team should review the materials, activities, equipment,
storage, distribution and intended use of the product.
• A list of the potential hazards (biological, chemical and physical) which may be
introduced, increased or controlled in each step should be drawn up.
• During the second stage, a hazard evaluation should be conducted, i.e. the severity of
the potential hazards and the probability of their occurrence should be estimated.
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Potential hazards in relation to at least the following should be
considered:
— materials and ingredients;
— physical characteristics and composition of the product;
— processing procedures;
— microbial limits, where applicable;
— premises;
— equipment;
— packaging;
— sanitation and hygiene;
— personnel
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Principle 2
Determine critical control points (CCPs)
• A CCP is a step at which control can be applied and is essential to prevent or eliminate
a pharmaceutical quality hazard or reduce it to an acceptable level.
• It is determined by the use of a decision-tree, which facilitates a logical approach. The
way that a decision-tree is used will depend on the operation concerned, e.g.
production, packing, reprocessing, storage, distribution. Training in the use of decision-
trees should be given.
• If a hazard has been identified at a step where control is necessary for safety & no
control measure exists at that step, or any other, the product or process should be
modified at that step, or at an earlier or later stage, to include such a control measure.
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Principle 3
Establish critical limits for each Critical Control Points (CCP)
• Critical limits must be specified and verified, if possible, for each critical control point.
• A Critical Control Limit (CCL) is a maximum or minimum value to which a biological,
chemical, physical parameters must be controlled at a Critical Control Point to prevent,
eliminate or reduce to an acceptable level.
• This criteria include measurements of temperature, time, moisture level, pH, and
sensory parameters, such as visual appearance and texture.
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Principle 4
Establish a monitoring system for each Critical Control Points (CCP)
• Monitoring is the scheduled measurement or observation of a CCP relative to its
critical limits.
It should describe;
- How measurements will be taken
- When measurements will be taken
- Who is responsible for the measurements taken
- How frequently the measurements are taken
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Principle 5
Establish corrective actions
• Specific corrective actions should be developed for each CCP in the HACCP
system in order to deal with deviations when they occur.
• These actions should ensure that the CCP is brought under control.
• It includes identification of the problem & taken to assure that the problem will not
occur again .
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• Corrective actions should include at least the following:
(a) determination and correction of the cause of non-compliance
(b) determination of the disposition of the non-compliant product
(c) recording of the corrective actions that have been taken
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Principle 6
Establish verification procedures
• Procedures should be established for verification.
• Verification and auditing of methods, procedures and tests, including random
sampling & analysis, can be used to determine whether the HACCP system is
working correctly.
• Examples of verification activities include:
— review of the HACCP system and its records
— review of deviations and product dispositions
— confirmation that CCPs are kept under control
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Principle 7
Establish documentation and record keeping
• Efficient & accurate documentation & record keeping are essential to the application
of a HACCP system.
• Examples of activities for which documentation is required include:
— hazard analysis
— CCP determination
— HACCP plan
— critical limit determination
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• Examples of activities for which records are required include:
— CCP monitoring activities
— process steps
— associated hazards
— critical limits
— verification procedures and schedule
— deviations
— associated corrective actions
— modifications to the HACCP system
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5. HAZARD OPERABILITY ANALYSIS (HAZOP) [1][3]
• HAZOP is based on a theory that assumes that risk events are caused by
deviations from the design or operating intentions.
• It is a systematic brainstorming technique for identifying hazards using so-
called “guide-words”.
• “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.
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Potential Areas of Use(s):-
• applied to manufacturing processes, including outsourced production &
formulation, as well as the upstream suppliers, equipment and facilities for
drug substances & drug (medicinal) products.
• also been used primarily in the pharmaceutical industry for evaluating process
safety hazards.
• The output of a HAZOP analysis is a list of critical operations for risk
management.
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6. PRELIMINARY HAZARDS ANALYSIS (PHA) [1][3]
• PHA is a tool of analysis based on applying prior experience or knowledge of a
hazard or failure to identify future hazards, hazardous situations and events that
might cause harm, as well as to estimate their probability of occurrence for a given
activity, facility, product or system.
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• The tool consists of:
1) the identification of the possibilities that the risk event happens,
2) the qualitative evaluation of the extent of possible injury or damage to health
that could result &
3) a relative ranking of the hazard using a combination of severity and
likelihood of occurrence, and
4) the identification of possible remedial measures.
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Potential Areas of Use(s)
• useful when analyzing existing systems or prioritizing hazards where
circumstances prevent a more extensive technique from being used.
• It can be used for product, process and facility design as well as to evaluate
the types of hazards for the general product type, then the product class, and
finally the specific product.
• PHA is most commonly used early in the development of a project when there
is little information on design details or operating procedures; thus, it will
often be a precursor to further studies.
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7. RISK RANKING & FILTERING [1]
• Risk ranking and filtering is a tool for comparing and ranking risks.
• Risk ranking of complex systems typically requires evaluation of multiple
diverse quantitative & qualitative factors for each risk.
• The tool involves breaking down a basic risk question into as many
components as needed to capture factors involved in the risk.
Potential Areas of Use(s):-
• used to prioritize manufacturing sites for inspection/audit by regulators or
industry.
• Risk ranking is useful when management needs to evaluate both
quantitatively-assessed and qualitatively-assessed risks within the same
organizational framework.
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8. SUPPORTING STATISTICAL TOOLS [1]
• Statistical tools can support and facilitate quality risk management.
• They can enable effective data assessment
• aid in determining the significance of the data set(s), &
• facilitate more reliable decision making.
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A listing of some of the principal statistical tools commonly used in the
pharmaceutical industry is provided:
• Control Charts,
for example:
- Acceptance Control Charts
- Control Charts with Arithmetic Average and Warning Limits
- Cumulative Sum Charts
- Shewhart Control Charts
- Weighted Moving Average
• Design of Experiments (DOE)
• Histograms
• Pareto Charts
• Process Capability Analysis
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QUESTIONS
1. Write a note on Risk assessment within the HACCP system. (summer 2018)
2. Write a note on Hazard Analysis & Critical Control Points. (winter 2019)
3. Enumerate different QRM tools. Describe seven steps to implement Hazard Analysis
& Critical Control Point(HACCP). (summer 2019)
4. Explain in detail Critical Control Points & Hazard Analysis. (summer 2020)
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REFERENCES
1. ICH Q9 guideline (pp 11-14)
2. WHO Technical Report Series No 908, 2003, Annex 7 Application of Hazard
Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals, pp
99-110
3. Mollah, Hamid, Harold Baseman, and Mike Long, eds. Risk Management
Applications in Pharmaceutical and Biopharmaceutical Manufacturing. Vol.4, John
Wiley & Sons, 2013, pp 25-33
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Thank you
4/6/2022 32

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