Unit 5 ICH Guidelines

ICH Q9 guidelines on risk
assessment and Risk

management methods and
Tools
Risk Management
The systemic application of quality management policies,
procedures and practices to the tasks of assessing,
controlling, communicating and reviewing risk.
Principles of Quality Risk
Management
1. The evaluation of the risk to quality should be based on

scientific knowledge and link to the protection of the
patient
2. The level of effort, formality and documentation of the

quality risk management process should be of the same
level/measure of risk
Quality Risk Management
Team
• Experts from the appropriate areas (e.g. quality unit,

business development, engineering, regulatory affairs,
production and sales)
• Individuals who are knowledgeable about the quality risk

management process
Overview of a typical quality risk management process
Initiating a Quality Risk
Management Process
• Define the problem and/or risk
• Assemble background information

on the potential hazard, harm or
human health impact
• Identify a leader and necessary

resources
• Specify a timeline and appropriate

level of decision making
Risk Assessment
A systemic process of
organizing information to
support a risk decision to
be made within a risk
management process
Risk Assessment
Three fundamental questions for

clearly defining the risk(s)
1. What might go wrong?
2. What is the probability it will go

wrong?
3. What are the consequences?

Risk Identification
The systemic use of

information to identify
potential sources of harm
referring to the risk or
problem
Risk Analysis
The estimation of the risk
associated with the
identified hazards. It is
the qualitative or
quantitative process of
linking the probability of
occurrence and severity
of harm
Risk Evaluation
The comparison of the

estimated risk to given
risk criteria using a
qualitative or
quantitative scale to
determine the
significance of the risk
Risk Control
• Actions implementing risk

management decisions
• The purpose is to reduce the risk

to an acceptable level
• The amount of effort used in risk

control should be proportional to
the significance of risk
Risk Control
• Is the risk above an acceptable
level?
• What can be done to reduce or

eliminate risks?
• What is the appropriate balance

between benefits, risks and
resources?
• Are new risks introduced as a

result of the idetified risks being
controlled?
Risk Reduction
• Actions taken to lessen the
probability of occurence severity
of the harm
• Risk reduction measures might

introduce new risks into the
system or increase the
significance of other risks
• Revisit risk assessment to identify

and evaluate any possible change
Risk Acceptance
• The decision to accept the risk
• The best quality risk management

might not entirely eliminate risk
• The quality risk is reduced to a

specified acceptable level which
will decided on a case-by-case
basis
Risk Communication
• The sharing of information about
risk and risk management
between the decision maker and
other stakeholders
• Parties could coomunicate at any

stage of the process
• The output/result should be

appropriately communicated and
documented
Risk Review
• Review or monitoring of
output/results of the risk
management
• The process should be utilized for

events (planned or unplanned
events)
• The frequence of any review

should be based on the level of
risk
• Risk review might include

reconsideration of risk acceptance
decisions
List of recognized risk
management tools
• Basic risk management facilitation methods
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects and Criticality Analysis (FMECA)
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk ranking and filtering
• Supporting statistical tools

Basic Risk Management
Facilitation Methods
Commonly used to structure risk management by
organizing data and facilitating decision making
• Flowcharts
• Check sheets
• Process Mapping
• Cause and effect diagram (Ishikawa diagram)

Failure Mode Effect Analysis
(FMEA)
• An evaluation of potential failure modes and 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 effect of these failures
• Potential Areas of Use(s)
1. To prioritize risks and monitor effectiveness of risk control activities
2. To analyze manufacturing operation and its effect on product or

processes
Failure Mode Effects Analysis (FMEA)
Failure Mode, Effects and
Critically Analysis (FMECA)
• FMEA extended to incorporate an investigation of the degree of severity
of the consequences, their probabilities of occurrence and their
detectability
1. For failures and risks associated with manufacturing processes
2. The output of FMECA is a relative risk score for each failure mode and is
used to rank the modes of failure
Failure Mode, Effects, and Critically Analysis
(FMECA)
Fault Tree Analysis (FTA)
• It is an approach that assumes failures of the
functionality of a product or process
• This tool can combine multiple causes of failure

by identifying casual chains
1. To establish the pathway to the root cause of

the failure
2. To investigate complaints and deviations in

order to fully understand their root cause
3. For evaluating how multiple factors affect a

given issue
4. Useful for risk assessment and in developing

monitoring programs
Hazard Analysis and Critical
Control Points (HACCP)
• Its is a structured approach that applies technical and scientific
principles to analyze, evaluate, prevent and control the risk due to the
design, development, production, and use of the products
1. To identify and manage risks associated with physical, chemical and

biological hazards (including microbiological contamination)
2. Useful when product and process understanding is sufficiently

comprehensive to support identification of critical control points
Hazard Analysis and Critical Control Points
(HACCP)
Hazard Operability Analysis
(HAZOP)
• HAZOP is based on a theory that assumes that risk events are
caused by deviations from the design or operating intentions.
1. Applied to manufacturing processes
2. The output of a HAZOP analysis is a list of critical operations

for risk management which facilitates regular monitoring of
critical points in manufacturing process
Preliminary Hazard Analysis
(PHA)
• It is a tool of analysis based on applying prior experience
or knowledge of hazard or failure to identify future
hazards that might cause harm
• Potential Area of Use(s)
1. Analyzing existing system or prioritizing hazards
2. Used early in the development of a project where there

is little information on design, details or operating
procedures
Preliminary Hazard Analysis (PHA)
Risk Ranking and Filtering
• It is a tool for comparing and ranking risks which requires the evaluation of
multiple quantitative and qualitative factors for each risks
• This tool involves in breaking down a basic risk question into as many
component as needed to capture factors involved in the risk
• Potential Areas of Use(s):
1. Used to prioritize manufacturing sites for inspection/audits by regulators

or industry
2. Useful when management needs to evaluate both quantitatively-assessed

risks and qualitatively-assessed risks within the same organizational
framework
Supporting Statistical Tools
• Statistical tools can enable effective data assessment, aid in determining the
significance of the data set(s) and facilitate more reliable decision making
• List of some of the principal statistical tools used in the pharmaceutical industry:
1. Control Charts
2. Control Charts with Arithmetic Average and Warning Limits
3. Histograms
4. Pareto Charts
5. Process Capability Analysis

Conclusion
• Quality Risk Management is a process that supports
science-based and practical decisions when integrated
into quality systems
• It provides documented and reproducible methods to

accomplish steps to the quality risk management process
• Appropriate use of quality risk management does not

eliminate industry's obligation to comply with regulatory
requirements.
References
• http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4
/Q9_Guideline.pdf
• http://eurogtps.com/PROJECTOUTCOMES/EuroGTPHOTTOPICS/4RISKMANAGEMENT/44Rel
evantdefinitionsintheriskmanagementpr/tabid/246/Default.aspx
• http://www.fmea-fmeca.com/fmea-examples.html
• http://www.emeraldinsight.com/journals.htm?articleid=1463554
• http://www.qualitytrainingportal.com/resources/problem_solving/problem-solving_tools-
fault_tree.htm
• http://www.beverageonline.com/doc/gary-ades-on-food-safety-haccp-haccp-haccp-pa-
0004
• http://www.oshatrain.org/notes/2bnotes18.html
Questions?
Thank You

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ICH Q9 guidelines on risk

assessment and Risk

1. The evaluation of the risk to quality should be based on

2. The level of effort, formality and documentation of the

• Experts from the appropriate areas (e.g. quality unit,

• Individuals who are knowledgeable about the quality risk

• Assemble background information

• Identify a leader and necessary

• Specify a timeline and appropriate

Three fundamental questions for

1. What might go wrong?

2. What is the probability it will go

3. What are the consequences?

The systemic use of

The comparison of the

• Actions implementing risk

• The purpose is to reduce the risk

• The amount of effort used in risk

• What can be done to reduce or

• What is the appropriate balance

• Are new risks introduced as a

• Risk reduction measures might

• Revisit risk assessment to identify

• The decision to accept the risk

• The best quality risk management

• The quality risk is reduced to a

• Parties could coomunicate at any

• The output/result should be

• The process should be utilized for

• The frequence of any review

• Risk review might include

• Failure Mode Effects Analysis (FMEA)

• Failure Mode, Effects and Criticality Analysis (FMECA)

• Fault Tree Analysis (FTA)

• Hazard Analysis and Critical Control Points (HACCP)

• Hazard Operability Analysis (HAZOP)

• Preliminary Hazard Analysis (PHA)

• Risk ranking and filtering

• Supporting statistical tools

• Cause and effect diagram (Ishikawa diagram)

• It is a powerful tool for summarizing the important modes of failure,

• Potential Areas of Use(s)

1. To prioritize risks and monitor effectiveness of risk control activities

2. To analyze manufacturing operation and its effect on product or

• Potential Areas of Use(s)

1. For failures and risks associated with manufacturing processes

• This tool can combine multiple causes of failure

• Potential Areas of Use(s)

1. To establish the pathway to the root cause of

2. To investigate complaints and deviations in

3. For evaluating how multiple factors affect a

4. Useful for risk assessment and in developing

• Potential Areas of Use(s)

1. To identify and manage risks associated with physical, chemical and

2. Useful when product and process understanding is sufficiently

• Potential Areas of Use(s)

1. Applied to manufacturing processes

2. The output of a HAZOP analysis is a list of critical operations

• Potential Area of Use(s)