ich q9 quality risk management
TRANSCRIPT
ICH Q9:QUALITY RISK MANAGEMENTQUALITY RISK MANAGEMENT
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Seetharam Kandarpa Seetharam Kandarpa Seetharam Kandarpa Seetharam Kandarpa
ASQASQASQASQ----CPGP & ASQCPGP & ASQCPGP & ASQCPGP & ASQ----CQACQACQACQA
Objective
• Introduction to ICH Q9: Quality RiskManagement
• Guiding through the content of the ICH• Guiding through the content of the ICHQ9 document
• Providing some considerations, possibleinterpretations and where appropriateexamples
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Introduction to
ICH Q9: Quality Risk Management (QRM)
• Document is available on the ICH Webpage
www.ich.org
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Introduction to
ICH Q9: Quality Risk Management (QRM)
ICH Q9ICH Q9
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Basic Terms
• Harm:
– Damage to health, including the damage that can occur fromloss of product quality or availability.
• Hazard:
– The potential source of harm (ISO/IEC Guide 51).
• Risk:• Risk:
– The combination of the probability of occurrence of harm and theseverity of that harm (ISO/IEC Guide 51).
• Severity:
– A measure of the possible consequences of a hazard.
• Detectability:
– The ability to discover or determine the existence, presence, orfact of a hazard.
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Basic Terms
• Quality:
– The degree to which a set of inherent properties of a product,system or process fulfills requirements (see ICH Q6A definitionspecifically for "quality" of drug substance and drug (medicinal)products.)
• Quality Risk Management:
– A systematic process for the assessment, control,– A systematic process for the assessment, control,communication and review of risks to the quality of the drug(medicinal) product across the product lifecycle.
• Quality System:
– The sum of all aspects of a system that implements quality policyand ensures that quality objectives are met.
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Basic Terms
• Risk Assessment:
– A systematic process of organizing information to support a riskdecision to be made within a risk management process. Itconsists of the identification of hazards and the analysis andevaluation of risks associated with exposure to those hazards.
• Risk Identification:
– The systematic use of information to identify potential sources of– The systematic use of information to identify potential sources ofharm (hazards) referring to the risk question or problemdescription.
• Risk Analysis:
– The estimation of the risk associated with the identified hazards.
• Risk Evaluation:
– The comparison of the estimated risk to given risk criteria usinga quantitative or qualitative scale to determine the significance ofthe risk. 7
Basic Terms
• Risk Control:
– Actions implementing risk management decisions (ISO Guide73).
• Risk Reduction:
– Actions taken to lessen the probability of occurrence of harm andthe severity of that harm.
Risk Acceptance:• Risk Acceptance:
– The decision to accept risk (ISO Guide 73).
• Risk Management:
– The systematic application of quality management policies,procedures, and practices to the tasks of assessing, controlling,communicating and reviewing risk.
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Basic Terms
• Risk Communication:
– The sharing of information about risk and risk managementbetween the decision maker and other stakeholders.
• Risk Review:
– Review or monitoring of output/results of the risk managementprocess considering (if appropriate) new knowledge andexperience about the risk.experience about the risk.
• Requirements:
– The explicit or implicit needs or expectations of the patients ortheir surrogates (e.g., health care professionals, regulators andlegislators). In this document, “requirements” refers not only tostatutory, legislative, or regulatory requirements, but also to suchneeds and expectations.
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Basic Terms
• Decision Maker(s):
– Person(s) with the competence and authority to makeappropriate and timely quality risk management decisions.
• Product Lifecycle:
– All phases in the life of the product from the initial developmentthrough marketing until the product’s discontinuation.
Trend:• Trend:
– A statistical term referring to the direction or rate of change of avariable(s).
• Stakeholder:
– Any individual, group or organization that can affect, be affectedby, or perceive itself to be affected by a risk. Decision makersmight also be stakeholders. For the purposes of this guideline,the primary stakeholders are the patient, healthcareprofessional, regulatory authority, and industry. 10
Table of contents
1. Introduction
2. Scope
3. Principles of Quality Risk Management
4. General Quality Risk Management Process
5. Risk Management Methodology5. Risk Management MethodologyAnnex I: Risk Management Methods and Tools
6. Integration of QRM process into Industry and Regulatory operationsAnnex II: Potential Applications for QRM
7. Definitions
8. References
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1. Introduction
Risk ManagementQuality Risk Management
Quality Systems
Harm
SeveritySeverity
Stakeholder
Product Life Cycle
GMP Compliance
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This guideline provides
principles & examples of tools
of quality risk management that can be applied to
different aspects of pharmaceutical quality.
2. Scope
different aspects of pharmaceutical quality.
These aspects include development, manufacturing,
distribution, and the inspection and submission/review
processes throughout the lifecycle
of drug substances, drug (medicinal) products,
biological and biotechnological products
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2. Scope
• Drug substances,
• Drug (medicinal) products,
• Biological and biotechnological products
Including the selection and use of Including the selection and use of
– Raw materials
– Solvents
– Excipients
– Packaging and labelling materials
– Components
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3. Principles of Quality Risk Management
Two primary principles:
The evaluation of the risk to quality
The level of effort, formality and the risk to quality
should be based on scientific knowledgeand ultimately link to the protection of the patient
formality and documentation of the quality risk management process should be commensurate with the level of risk
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4. General Quality Risk Management Process
Systematic processes designed to designed to
coordinate, facilitate and improve sciencescience--based decision makingbased decision making
with respect to risk to quality
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on
Risk Assessment
Risk Evaluation
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Risk Analysis
Risk Identification
Initiate
Quality Risk Management Process
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4. General Quality Risk Management Process
Team approach
Risk Review
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Risk Control
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Risk Acceptance
Output / Result of the
Quality Risk Management Process
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Decision makers:Person(s)
with competence and authority to make a decision
4. General Quality Risk Management Process
• Ensuring that
ongoing Quality Risk Management processes operate
• Coordinating
quality risk management process
across various functions and departments
• Supporting
the team approach
Ma
na
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me
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po
ns
ibility
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4. General Quality Risk Management Process
Team approach
• Usually, but not always, undertaken by interdisciplinary
teams from areas appropriate to the risk being considered
e.g.– Quality unit– Quality unit
– Development
– Engineering / Statistics
– Regulatory affairs
– Production operations
– Business, Sales and Marketing
– Legal
– Medical / Clinical
– &… Individuals knowledgeable of the QRM processes
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4. General Quality Risk Management Process
When to initiate and plan a QRM Process
• First define the question which should be answered (e.g.
a problem and/or risk question)
– including pertinent assumptions identifying the potential for risk
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the potential for risk
• Then assemble background information and/ or data on
the potential hazard, harm or human health impact
relevant to the risk
– Identify a leader and necessary resources
– Specify a timeline, deliverables and appropriate level of decision making for the QRM process
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Should risks
be assessed?
Are there clear rules
for decision making?e.g. regulations
When to apply Quality Risk Management?
1. What might go wrong?2. What is the likelihood (probability)
it will go wrong?3. What are the consequences (severity)?No or
justification needed
Can you answerthe risk assessment
questions? No
Yes
“no RM“
Risk assessment not required(No flexibility)
Follow procedures(e.g. Standard Operating Procedures)
Document results,
decisions and actions
questions?
Yes“informal RM“
Initiate Risk assessment(risk identification, analysis & evaluation)
Run risk control(select appropriate measures)
Agree on a team(small project)
Select a Risk Management tool(if appropriate e.g. see ICH Q9 Annex I)
No
“formal RM“
Carry out the
quality risk management process
Document the steps
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4. General Quality Risk Management Process
• Risk Identification
What might go wrong?
• Risk Analysis
Risk Assessment
3 fundamental questions
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What is the likelihood (probability) it will go wrong?
• Risk Evaluation
What are the consequences (severity)?
Note: People often use terms
“Risk analysis”, “Risk assessment” and
“Risk management” interchangeably
which is incorrect!
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4. General Quality Risk Management Process
“What might go wrong?”
• A systematic use of information
Risk Assessment: Risk Identification
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• A systematic use of information
to identify hazards
referring to the risk question or problem
– historical data
– theoretical analysis
– informed opinions
– concerns of stakeholders
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4. General Quality Risk Management Process
“What is the likelihood it will go wrong?”
• The estimation of the risk
Risk Assessment: Risk Analysis
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• The estimation of the risk
associated with the identified hazards.
• A qualitative or quantitative process of linking the
likelihood of occurrence and severity of harm
• Consider detectability if applicable
(used in some tools)
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4. General Quality Risk Management Process
Risk Assessment: Risk Analysis
Often data driven
Keep in mind: Statistical approach may or may not be usedused
• Maintain a robust data set!
• Start with the more extensive data set and reduce it
• Trend and use statistics (e.g. extrapolation)
• Comparing between different sets requires compatible
data
• Data must be reliable
• Data must be accessible Risk Review
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4. General Quality Risk Management Process
“What is the risk?”
• Compare the identified and analysed risk
against given risk criteria
Risk Assessment: Risk Evaluation
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against given risk criteria
• Consider the strength of evidence
for all three of the fundamental questions
– What might go wrong?
– What is the likelihood (probability) it will go wrong?
– What are the consequences (severity)?
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4. General Quality Risk Management Process
Risk Assessment: Risk Evaluation
A picture of the life cycle
Probability Detectability Severity
= Risk Priority Number
x x
past today future
Data
refe
rs to
time
Impact
Can y
ou fin
d it?
• Frequency of
“occurences”
driven by
the number
of trials
• Degree
of belief
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4. General Quality Risk Management Process
Risk Control: Decision-making activity
• Is the risk above an acceptable level?
• What can be done to reduce or eliminate risks?
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• What can be done to reduce or eliminate risks?
• What is the appropriate balancebetween benefits, risks and resources?
• Are new risks introduced as a result of the identified risks being controlled?
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4. General Quality Risk Management Process
Risk Control: Residual Risk
• The residual risk consists of e.g.
– Hazards that have been assessed and
risks that have been accepted
– Hazards which have been identified but
the risks have not been correctly assessed
– Hazards that have not yet been identified
– Hazards which are not yet linked to the patient risk
• Is the risk reduced to an acceptable level?
– Fulfil all legal and internal obligations
– Consider current scientific knowledge & techniquesRisk Review
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4. General Quality Risk Management Process
Risk Control: Risk Reduction
• Mitigation or avoidance of quality risk
• Elimination of risks, where appropriate
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• Focus actions on severity and/or probability of harm; don’t forget detectability
• It might be appropriate to revisit the risk assessment during the life cycle for new risks or increased significance of existing risks
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4. General Quality Risk Management Process
Risk Control: Risk Acceptance
• Decision to
> Accept the residual risk
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> Passively accept non specified residual risks
• May require support by (senior) management
> Applies to both industry and competent authorities
• Will always be made on a case-by-case basis
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4. General Quality Risk Management Process
Risk Control: Risk Acceptance
• Discuss the appropriate balance between
benefits, risks, and resources
• Focus on the patients’ interests and
good science/data
• Risk acceptance is not
– Inappropriately interpreting data and information
– Hiding risks from management / competent authorities
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What is an “acceptable risk”?
Risk Control: Risk Acceptance
Who has to accept risk?
• Decision Maker(s)– Person(s) with the competence and authority
to make appropriate and timely quality risk management decisions
• Stakeholder– Any individual, group or organization
that can …be affected by a risk
– Decision makers might also be stakeholders
– The primary stakeholders are the patient, healthcare professional, regulatory authority, and industry
– The secondary stakeholders are patient associations, public opinions, politicians
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4. General Quality Risk Management Process
A Risk
Acceptance process
1/3 Finish baseline for
risk acceptance decisionrisk identification, risk analysis,risks evaluation, risks reduction
Risk reduction step
finished
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Yes
Stakeholders
involved as appropiate?
Revisit
risk assessment step
All identified
risks assessed?No
Yes
No
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4. General Quality Risk Management Process
A Risk
Evaluate measureson severity, probability, detectability
Check needed resourcese.g. employee, money
Measures/
actions needed?
Yes
A Risk
Acceptance
process
2/3
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Measures / Actions
appropriate?No
Yes
Revisit
risk reduction step
Other hazards
caused?Yes
Is a risk
reducible?
No
No
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4. General Quality Risk Management Process
A Risk Acceptance process 3/3
Is a risk
reducible?
Yes
No
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Accept theresidual risk?
Ready for communication
Accept risk
Sign off documentation
Advantageoutweighs risk?
Yes No
Yes
Risk not acceptable
Sign off documentation
Revisitrisk assessment step
No
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4. General Quality Risk Management Process
• Bi-directional sharing of information about risk and risk
management
between the decision makers and others
Risk Communication
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• Communicate at any stage of the QRM process
• Communicate and document
the output/result of the QRM process appropriately
• Communication need not be carried out
for each and every individual risk acceptance
• Use existing channels as specified in
regulations, guidance and SOP’s
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4. General Quality Risk Management Process
• Exchange or sharing of information, as appropriate
Risk Communication
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• Sometimes formal sometimes informal
– Improve ways of thinking and communicating
• Increase transparency
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Quality risk management
Communicationfacilitates trust
and understanding
Industryoperation- Submissions
- Manufacturing
Regulatorsoperation
- Reviews- Inspections
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4. General Quality Risk Management Process
Risk review: Review Events
• Review the output / results of the QRM process
• Take into account new knowledge and experience
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• Take into account new knowledge and experience
• Utilise for planned or unplanned events
• Implement a mechanism to review or monitor events
• Reconsideration of risk acceptance decisions,
as appropriate
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5. Risk Management Methodology
One method
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One method “all inclusive”?
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Expectations on methods and tools
• Supports science-based decisions
• A great variety are listed but other existing or
new ones might also be used
• No single tool is appropriate for all cases• No single tool is appropriate for all cases
• Specific risks do not always require the same tool
• Using a tool the level of detail of an investigation will vary
according to the risk from case to case
• Different companies, consultancies and competent
authorities may promote use of different tools based on
their culture and experiences
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Contributing items to manage quality risks
• System Risk (facility & people)– e.g. interfaces, operators risk, environment,
components such as equipment, IT, design elements
• System Risk (organisation)– e.g. Quality systems, controls, measurements, – e.g. Quality systems, controls, measurements,
documentation, regulatory compliance
• Process Risk
– e.g. process operations and quality parameters
• Product Risk (safety & efficacy)– e.g. quality attributes:
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5. Risk Management Methodology
• Supports a scientific and practical approach to
decision-making
• Accomplishing steps of the QRM process
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– Provides documented, transparent and reproducible methods
– Assessing current knowledge
– Assessing probability, severity and sometimes detectability
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5. Risk Management Methodology
• Adapt the tools for use in specific areas
• Combined use of tools may provide flexibility
• The degree of rigor and formality of QRM
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• The degree of rigor and formality of QRM
– Should be commensurate with the complexity and / or criticality of the issue to be addressed and reflect available knowledge
• Informal ways
– empirical methods and / or internal procedures
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Annex I: Risk Management Methods and Tools
• Provides a general overview of
and references for some of the primary tools
• Might be used in QRM by industry and regulators
• This is not an exhaustive list
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• This is not an exhaustive list
• No one tool or set of tools is applicable to every situation
in which a QRM procedure is used
• For each of the tools
– Short description & reference
– Strength and weaknesses
– Purely illustrative examples
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Overview: Some tools and their key words
• Failure Mode Effects Analysis (FMEA)
– Break down large complex processes into manageable steps
• Failure Mode, Effects and Criticality Analysis (FMECA)
– FMEA & links severity, probability & detectability to criticality
• Fault Tree Analysis (FTA)– Tree of failure modes combinations with logical operators
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– Tree of failure modes combinations with logical operators
• Hazard Analysis and Critical Control Points (HACCP)
– Systematic, proactive, and preventive method on criticality
• Hazard Operability Analysis (HAZOP)
– Brainstorming technique
• Preliminary Hazard Analysis (PHA)
– Possibilities that the risk event happens
• Risk ranking and filtering
– Compare and prioritize risks with factors for each risk47
5. Risk Management Methodology
• Supporting statistical tools
– Acceptance Control Charts (see ISO 7966)
– Control Charts (for example)
� Control Charts with Arithmetic Average andWarning Limits (see ISO 7873)
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� Cumulative Sum Charts; “CuSum” (see ISO 7871)
� Shewhart Control Charts (see ISO 8258)
� Weighted Moving Average
– Design of Experiments (DOE)
� Pareto Charts
– Process Capability Analysis
– Histograms
– Use others that you are familiar with….48
5. Risk Management Methodology
Q9 does not provide “drivers licences”
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6. Integration into Industry and Regulatory Operations
• Foundation for “science-based” decisions
• Does not obviate industry’s obligation
to comply with regulatory requirements
• May affect the extent and level • May affect the extent and level
of direct regulatory oversight
• Degree of rigor and formality commensurate with the
complexity and/or criticality of the issue
• Implement QRM principles when updating
existing guidelines
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Annex II: Potential Applications for QRM
This Annex is intended to identify potential uses of quality risk
management principles and tools by industry and regulators.
However, the selection of particular risk management tools is
completely dependent upon specific facts and circumstances. completely dependent upon specific facts and circumstances.
These examples are provided for illustrative purposes and
only suggest potential uses of quality risk management.
This Annex is not intended to create any new expectations
beyond the current regulatory requirements.
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Annex II: Potential Applications for QRM
Quality risk management as part of
• Integrated quality management
– Documentation
– Training and educationCompetent authorities– Training and education
– Quality defects
– Auditing / Inspection
– Periodic review
– Change management / change control
– Continual improvement
authorities
Industry
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Annex II: Potential opportunities
for conducting quality risk management
Competent authorities
Quality risk management as part of
• Regulatory operations
> Inspection and assessment activities
• Industry operations
– Development
– Facilities, equipment and utilities
– Materials management
– Production
– Laboratory control and stability testing
– Packaging and labelling
Competent authorities
Industry
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COMMUNICATION
Failure Mode, Effects & Criticality Analysis FMECA
FTA
Preliminary Hazard Analysis
Fault Tree Analysis
QUALITY SYSTEM
ICH Q9Quality Risk Management
TOOLS
FMEA
Hazard Analysis & Critical Control Points
Failure Mode Effect Analysis
Hazard Operatibility Analysis
MATERIALS
PRODUCTION
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Use the right “risk” expressionUse the right “risk” expressionplease!
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Thanks
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