1. Quality risk management involves identifying potential risks, analyzing their likelihood and consequences, and taking actions to address unacceptable risks. 2. Various tools can be used for quality risk management including Failure Mode and Effects Analysis, Hazard Analysis and Critical Control Points, and Fault Tree Analysis. 3. These tools help identify hazards, evaluate risks, and prioritize risks so that appropriate actions can be taken to control risks and improve quality.

1. PES
MODERN COLLEGE OF PHARMACY (Ladies)
MOSHI, PUNE
Savitribai Phule Pune University
B.PHARM
Semester- VII
By
Mrs. Sneha Patil
Assistant Professor
Dept. of Pharmaceutics
Quality risk management -
Technology development and
transfer

2. Quality risk management
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 Quality - the degree of excellence of something
 Risk – The combination of the probability of occurrence of harm
and the severity of that them
 Definition of Risk management as per WHO – a strategic safety
program designed to decrease product risk by using one or
more interventions tools
 ICH Q 9 guideline, quality risk management provides a
structure to initiate and follow a risk management process

3. Quality risk management
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Scope
Aspects
1.Development
2.Manufacturing
3.Distribution
4.Inspection
5.Submission/review processes throughout the lifecycle of drug
substances, medicinal products, biological and biotechnological
products

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General quality risk management

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General quality risk management
Responsibilities
 When QRM team is formed, they should include experts from
the appropriate areas and persons having knowledge about the
quality risk management process
 Decision makers must take responsibility for co-ordinating QRM
across various functions and departments of their organization

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General quality risk management
Initiating a QRM process
QRM should include systematic processes designed to co-
ordinate, facilitate and improve science based decision making
with respect to risk
Possible steps used to initiate and plan a QRM
1.Define the problem and/or risk question
2.Assemble background information and/or data on the potential
hazard, harm or human health impact relevant to risk assessment
3.Identify a leader and necessary resources
4.Specify a timeline, deliverables and appropriate level of decision
making for the risk management process

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General quality risk management
Risk assessment
It consist of identification of hazards and the analysis and
evaluation of risks associated with exposure to those hazards
Fundamental questions are helpful for defining risks for risk
assessment purposes
1.What might go wrong?
2.What is the likelihood (probability) it will go wrong?
3.What are the consequences (severity)?

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General quality risk management
Risk identification
 It is a systematic use of information to identify hazards
referring to the risk question/problem description
 Information includes historical data, theoretical analysis,
informed opinions and concern stakeholders
 Risk analysis
 Qualitative and quantitative process associated with estimation
of the risk associated with identified hazards

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Quality risk management methods and tools
1. Basic risk management facilitation methods (flowcharts, check
sheets etc.)
2. Failure Mode Effects Analysis (FMEA)
3. Failure Mode, Effects and Criticality Analysis (FMECA)
4. Fault Tree Analysis (FTA)
5. Hazard Analysis and Critical Control Points (HACCP)
6. Hazard Operability Analysis (HAZOP)
7. Preliminary Hazard Analysis (PHA)
8. Risk ranking and filtering
9. Supporting statistical tools

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Quality risk management methods and tools
1.Basic risk management facilitation methods (flowcharts, check
sheets etc.)
Simple techniques that are commonly used to structure risk
management by organizing data and facilitating decision-making
are :
a.Flowcharts
b.Check Sheets
c.Process Mapping
d.Cause and Effect Diagrams (also called an Ishikawa diagram or
fish bone diagram)

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Quality risk management methods and tools
2. Failure Mode Effects Analysis (FMEA)
 FMEA (see IEC 60812) provides for an evaluation of potential
failure modes for processes and their likely effect on outcomes
and/or product performance
 Once failure modes are established, risk reduction can be used
to eliminate, contain, reduce or control the potential failures.
FMEA relies on product and process understanding
 FMEA methodically breaks down the analysis of complex
processes into manageable steps
 It is a powerful tool for summarizing the important modes of
failure, factors causing these failures and the likely effects of
these failures

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Quality risk management methods and tools
2. Failure Mode Effects Analysis (FMEA)
 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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Quality risk management methods and tools
3. Failure Mode, Effects and Criticality Analysis (FMECA)
 Each failure mode of the product is identified and then
evaluated for critically or severity
 Critically is then translated into a risk and if this level of risk is
not acceptable, corrective action must be taken
 It is utilized for failure and risk associated with manufacturing
process

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Quality risk management methods and tools
4. Fault Tree Analysis (FTA)
 This tool assumes failure of the functionality of a product or
process
 FTA can be used 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)
 Fault Tree Analysis is an effective tool for evaluating how
multiple factors affect a given issue
 FTA relies on the experts’ process understanding to identify
causal factors

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Quality risk management methods and tools
5. Hazard Analysis and Critical Control Points (HACCP)
 HACCP is a systematic, proactive, and preventive tool for
assuring product quality, reliability, and safety
 It involves hazard analysis, determining critical control point,
establishing critical limit, establishing a system to monitor
critical control point and establishing a record keeping system
 It might be used to identify and manage risks associated with
physical, chemical and biological hazards (including
microbiological contamination)

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Quality risk management methods and tools
6. Hazard Operability Analysis (HAZOP)
 It is a systematic brainstorming technique for identifying
hazards using so-called “guide-words”
 “Guidewords” (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
 HAZOP 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
 It has also been used primarily in the pharmaceutical industry
for evaluating process safety hazards

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Quality risk management methods and tools
7. Preliminary Hazard Analysis (PHA)
 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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Quality risk management methods and tools
7. Preliminary Hazard Analysis (PHA)
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 and
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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Quality risk management methods and tools
8. Risk ranking and filtering
 This tool for comparing and ranking risks
 Risk ranking of complex systems typically requires evaluation of
multiple diverse quantitative and 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
 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
 Used to prioritize manufacturing sites for inspection/audit by
regulators or industry

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Quality risk management methods and tools
9. Supporting statistical tools
 Output of a risk assessment may be combination of quantitative
and qualitative estimation of risk
 Risk prioritization number (RPN) may be assigned to the
deviation/ stage of the process that is affected
 This helps to categorize the deviation
RPN = Severity  Occurrence  Detection
 RPN methodology is a technique for analyzing the risk
associated with potential problems identified during FMEA

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Quality risk management methods and tools
9. Supporting statistical tools
 Revised RPNs and percent reduction in RPN provides an
indication of the effectiveness of corrective actions and used to
evaluate the value to the organization of performing the FMEA
Percent reduction in RPN = (RPNi - RPNr) / RPNi
Where,
RPNi = Initial RPN
RPNr = Revised RPN

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Quality risk management methods and tools
9. Supporting statistical tools
Principal statistical tools commonly used in the pharmaceutical
industry are:
a.Control Charts: e.g. Acceptance Control Charts, Control Charts
with Arithmetic Average and Warning Limits, Cumulative Sum
Charts, Shewhart Control Charts, Weighted Moving Average
b. Design of Experiments (DOE)
c. Histograms
d. Pareto Charts
e. Process Capability Analysis

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Quality risk management methods and tools
9. Supporting statistical tools
Principal statistical tools commonly used in the pharmaceutical
industry are:
a.Control Charts: e.g. Acceptance Control Charts, Control Charts
with Arithmetic Average and Warning Limits, Cumulative Sum
Charts, Shewhart Control Charts, Weighted Moving Average
b. Design of Experiments (DOE)
c. Histograms
d. Pareto Charts
e. Process Capability Analysis

24. References
1. Kalyani Veena, Ali Younus Mohammed. Industrial Pharmacy –
II. First edition: Nirali Prakashan , Pune; 2020, Pg.no. 2.8-
2.12
2. Kataria Mahesh, Bilandi Ajay. Industrial Pharmacy –II. First
edition: Nirali Prakashan , Pune; 2021, Pg.no. 2.4-2.8
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