Quality risk management q9 & haccp

QUALITY
MANAGEMENT
SYSTEM
1FACULTY OF PHARMACY,SRIHER

Basic terms
Decision Maker(s):
Person(s) with the competence and authority to make appropriate and timely quality risk
management decisions.
Detectability:
The ability to discover or determine the existence, presence, or fact of a hazard.
Harm:
Damage to health, including the damage that can occur from loss of product quality or
availability.
Hazard:
The potential source of harm (ISO/IEC Guide 51).
Product Lifecycle:
All phases in the life of the product from the initial development through marketing until
the product’s discontinuation.

Basic terms
Quality Risk Management:
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 policy and ensures that quality
objectives are met.
Risk:
The combination of the probability of occurrence of harm and the severity of that harm
(ISO/IEC Guide 51).
Risk Acceptance:
The decision to accept risk (ISO Guide 73).
Risk Analysis:
The estimation of the risk associated with the identified hazards.

Basic terms
Risk Assessment:
A systematic process of organizing information to support a risk decision to be made within
a risk management process. It consists of the identification of hazards and the analysis and
evaluation of risks associated with exposure to those hazards.
Risk Communication:
The sharing of information about risk and risk management between the decision maker and
other stakeholders.
Risk Control:
Actions implementing risk management decisions (ISO Guide 73).
Risk Evaluation:
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative
scale to determine the significance of the risk.
Risk Identification:
The systematic use of information to identify potential sources of harm (hazards) referring
to the risk question or problem description.

Basic terms
Risk Management:
The systematic application of quality management policies, procedures, and practices to the tasks of
assessing, controlling, communicating and reviewing risk.
Risk Reduction:
Actions taken to lessen the probability of occurrence of harm and the severity of that harm.
Risk Review:
Review or monitoring of output/results of the risk management process considering (if appropriate)
new knowledge and experience about the risk.
Severity:
A measure of the possible consequences of a hazard.
Stakeholder:
Any individual, group or organization that can affect, be affected by, or perceive itself to be affected
by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the
primary stakeholders are the patient, healthcare professional, regulatory authority, and industry.
Trend:
A statistical term referring to the direction or rate of change of a variable(s).

CONTENTS:
Introduction
Scope
Principles of quality risk management
General quality risk management process
Integration of QRM into industrial and regulatory operations
References

INTRODUCTION:

SCOPE:
This guideline provides Principles & examples of tools for quality
risk management that can be applied to 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

SCOPE:
biological and biotechnological products :-
 raw materials,
solvents,
Excipients
packaging
Labeling materials in drug (medicinal) products
 biological and biotechnological products

PRINCIPLES OF QUALITY RISK
MANAGEMENT:
Two primary principles:
The evaluation of the risk
to quality should be based
on scientific knowledge
and ultimately link to the
protection of the patient.
The level of effort, formality
and documentation of the
quality risk management
process should be
commensurate with the level
of risk.

GENERAL QUALITY RISK MANAGEMENT
PROCESS:
It is a systematic process for
the assessment, control,
communication and review
of risks to the quality of the
drug product across the
product lifestyle.

GENERAL QUALITY RISK MANAGEMENT PROCESS:
Overview of a typical QRM process:

GENERAL QUALITY RISK MANAGEMENT PROCESS:
Decision makers:
Persons with competence and authority to make a decision.
MANAGEMENT RESPONSIBILITY:
• ENSURE THAT:
ongoing QRM processes operate
• COORDINATING:
Quality risk management process across various functions and departments
• SUPPORTING:
the team approach

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
Development
Engineering/statistics
Regulatory affairs
Production operations
Business, sales and operations
&….individuals knowledgeable of the QRM process

When to initiate and plan a QRM process
• First define the question which should be answered
Including pertinent assumptions identifying 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, deliverable
and appropriate level of decision making
for the QRM process

Risk Assessment
Risk identification:
What might go wrong?
Risk Analysis
What is likelihood (probability) it will go wrong?
Risk Evaluation
What are the consequences(severity)?
3 fundamental
question

Risk Assessment: Risk identification
“what might go wrong?”
A systematic use of information to identify hazards referring to the risk
question or problems
• Historical data
• Theoretical data
• Informed opinions
• Concerns of stakeholders

‘what is likelihood it will go wrong?”
• 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

• Start with 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 Assessment: Risk Evaluation
“what is the Risk?”
• Compare the identified and analysed risk against given risk criteria
• Consider the strength of evidence for all three of the fundamental
questions
What might go wrong?
What is likelihood (probability)it will go wrong?
What are the consequences(severity)?

Risk Control: Decision making Activity
• 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 identified risks being
controlled?

Risk Control: Residual Risk
• The residual risk consists of e.g., ---
 hazards that have been assessed & risks that have been accepted
Hazards which have been identified but the risk 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 & techniques.

Risk Control: Risk Reduction
• Mitigation or avoidance of quality risk
• Elimination of risks, where appropriate focus on 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.

Risk control: Risk acceptance
• Decision to-
-Accept the residual risk
-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
• 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/competentauthorities

what is an “acceptable risk”?
Risk control: Risk Acceptance
who has to accept risk?
• Decision maker(s)
-Person with the competence and authority to make appropriate and
timely QRM 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 professionals,
regulatory authority and industry.
-The secondary stakeholders are patient associations, public opinions,
politicians.

Risk communication
• Bi-directional sharing of information about risk and risk management
between the decision makers and others.
• 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, guidelines and SOPs
• Exchange or sharing of information as appropriate
• Sometimes formal, sometimes informal
-improve ways of thinking and communicating
• Increase transparency

Risk Review: Review Events
• Review the output /results of the QRM process
• Take into the 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.

RISK MANAGEMENT METHODOLOGY:
One method
“all inclusive”?

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.
• Specific risks do not always require the same tool
• Using a tool the level of details 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 experience.

Contributing Items To Manage Quality Tools:
• 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, documentation,
regulatory compliance.
• Process Risk:
e.g., process operations and quality parameters
• Product Risk (safety & efficacy):
-e.g., quality attributes:
measured data according to specifications.

Risk Management Methodology
• Supports a scientific and practical approach to decision-making
• Accomplishing steps of the QRM process
-Provides documented, transparent and reproducible methods.
-Assessing current knowledge
-Assessing probability, severity and sometimes detectability
• Adapt the tools for use in specific areas.
• Combined use of tools may provide flexibility
• Informal ways-
-empirical methods and/or internal procedures.

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
• No one tool for 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

Overview: Some Tools And Their Key Words:
• Failure Mode Effects Analysis (FMEA);
-Breakdown 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.
• 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 prioritise risks with factors for each risk.

Failure Mode Effects Analysis (FMEA)
• FMEA 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.

FMEA
Potential Areas of Uses:
• 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. It identifies
elements/operations within the system that render it vulnerable. The output/results
of FMEA can be used as a basis for design or further analysis or to guide resource
deployment

Failure Mode, Effects and Criticality Analysis
(FMECA)
• FMEA might be extended to incorporate an investigation of the degree of severity
of the consequences, their respective probabilities of occurrence, and their
detectability, thereby becoming a Failure Mode, Effects, and Criticality Analysis.
• In order for such an analysis to be performed, the product or process
specifications should be established.
• FMECA can identify places where additional preventive actions might be
appropriate to minimize risks.

FMECA
• FMECA application in the pharmaceutical industry should mostly be
utilized for failures and 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

Fault Tree Analysis:
• The FTA tool is an approach that assumes failure of the functionality of a product
or process.
• This tool evaluates system (or subsystem) failures one at a time but can combine
multiple causes of failure by identifying causal chains.
• The results are represented pictorially in the form of a tree of fault modes. At each
level in the tree, combinations of fault modes are described with logical operators
(AND, OR, etc.).
• FTA relies on the experts’ process understanding to identify causal factors.

FTA
• FTA can be used to establish the pathway to the root cause of the failure.
• 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.
• The output of an FTA includes a visual representation of failure modes.
• It is useful both for risk assessment and in developing monitoring programs.

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.
• It is a systematic brainstorming technique for identifying hazards using so-called
guide words.
• Guide words (e.g., No, More, Other Than, Part of) are applied to relevant
parameters (e.g., contamination, temperature) to help identify potential deviations
from normal use or design intentions.
• HAZOP often uses a team of people with expertise covering the design of the
process or product and its application.

HAZOP
• 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 products.
• It has also been used primarily in the pharmaceutical industry for evaluating
process safety hazards.
• As is the case with HACCP, the output of a HAZOP analysis is a list of critical
operations for risk management.
• This facilitates regular monitoring of critical points in the manufacturing process.

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.
• 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

PHA
• PHA might be 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.
• Typically, hazards identified in the PHA are further assessed with other risk
management tools such as those in this section.

Risk Ranking And Filtering:
• Risk ranking and filtering is a tool for comparing and ranking risks. Risk ranking
of complex systems typically involves 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.

Risk ranking and filtering:
• Risk ranking and filtering can be used to prioritize manufacturing sites
for inspection/audit by regulators or industry.
• Risk ranking methods are particularly helpful in situations in which
the portfolio of risks and the underlying consequences to be managed
are diverse and difficult to compare using a single tool.
• Risk ranking is useful for management to evaluate both quantitatively-
assessed and qualitatively-assessed risks within the same
organizational framework.

Supporting Statistical Tool:
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), and facilitate more reliable decision making. 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

Introduction
• HACCP is a systematic method for the identification, assessment and control of safety
hazards.
• Such hazards are defined as biological, chemical, or physical agents or operations that are
reasonably likely to cause illness or injury if not controlled.
• In the manufacture of pharmaceuticals, these may include the manufacture of certain
antibiotics, hormones, cytotoxic substances or other highly active pharmaceuticals,
together with operations such as fluidbed drying, granulation is an example of hazard unit
operations.
• The use of inflammable solvents (solutions) and certain laboratory operations may also
constitute hazards.
• The following elements of the HACCP methodology are integral parts of the validation
master file:
— development of a flow diagram of the process.
— verification of the flow diagram on site.

Introduction
• In addition, HACCP will extend this concept to include an analysis of the critical quality
variables as well as the assessment of hazards affecting the safety of workers and
environmental pollution hazards directly related to the process (in particular in open
systems) concerned.
• GMP for pharmaceutical products require the validation of critical processes as well as of
changes in the manufacturing process which may affect the quality of the final product.
• Experience shows that most manufacturing processes contain steps that are “critical” from
the point of view of variations in final product quality.
• All HACCP systems are capable of accommodating changes, such as advances in
equipment design and processing procedures or technological developments.
• HACCP should not replace GMP; however, its application may be used as a first step
towards GMP.

Links With Other Programmes
• In each stage of the manufacture and supply of pharmaceuticals, the necessary conditions
should be provided and met to protect the pharmaceuticals concerned.
• This has traditionally been accomplished through the application of Good Clinical
Practice (GCP), Good Laboratory Practice (GLP), GMP and other guidelines, which are
considered to be essential to the development and implementation of effective HACCP
plans.
• HACCP plans are focused on hazards, the overall objective being to ensure that
pharmaceuticals are safe for use. The existence and effectiveness of GCP, GLP and GMP
should be assessed when drawing up HACCP plans.

Principles:
• The HACCP system is based on seven principles. Some stages are linked to speciﬁc
principles while others serve as an introduction to the concept.
• The seven principles are:
1.Conduct a hazard analysis.
2. Determine the critical control points (CCPs).
3. Establish target levels and critical limit(s).
4. Establish a system to monitor the CCPs.
5. Establish the corrective action to be taken when monitoring indicates that a
particular CCP is not under control.
6. Establish procedures to verify that the HACCP system is working effectively.
7. Establish documentation concerning all procedures and keep records appropriate to
these principles and their application.

Guidelines for the application of the HACCP
system:
The following guidelines will be found useful in applying the HACCP system:
• Before HACCP is applied to any sector, that sector should be operating in
accordance with the principles of good practices and the relevant legislation.
• Management commitment is necessary if an effective HACCP system is to be
implemented.
• HACCP should be applied to each specific operation separately.
• CCPs identified in any given example in any reference document (including GMP
guidelines) may not be the only ones identified for a specific application or may be
of a different nature.

Cont.…..
• The HACCP application should be reviewed and necessary changes made when
any modiﬁcation is made in the product or process, or in any step.
• It is important, when applying HACCP, to take into account the nature and size of
the operation.
• There should be a HACCP plan. The format of such plans may vary, but they
should preferably be speciﬁc to a particular product, process or operation. Generic
HACCP plans can serve as useful guides in the development of product and process
HACCP plans; however, it is essential that the unique conditions within each facility
are considered during the development of all components of the HACCP plan.

Application:
1. Assemble a HACCP team
2. Describe the product and process
3. Identify the intended use
4. Construct a flow diagram
5. On-site confirmation of flow diagram
6. Principle-1
7. Principle-2
8. Principle-3
9. Principle-4
10. Principle-5
11. Principle-6
12. Principle-7

1.Assemble a HACCP team:
• Team members should therefore represent all the relevant disciplines, such as research and
development, production, quality control, quality assurance, microbiology, engineering and
distribution or others as applicable.
• Team members should have speciﬁc knowledge and expertise regarding the product and process
Where such expertise is not available on site, expert advice should be obtained from other sources.
• Team members should be able to:
(a)conduct a hazard analysis
(b) identify potential hazards;
(c) identify hazards which should be controlled;
(d) recommend controls and critical limits;
(e) devise procedures for monitoring and veriﬁcation;
(f) recommend appropriate corrective action where deviations occur;
(g) verify the HACCP plan.

2.Describe The Product And Process:
A full description of the product and the process should be drawn up, including relevant
quality information such as the composition, physical/chemical properties, structure, pH,
temperatures, method of cleaning, bactericidal/bacteriostatic treatments (e.g. heat-
treatment), drying, screening, mixing, blending, packaging, and the storage conditions. The
method of distribution and transport should also be described, especially where products are
thermolabile.
61
3. Identify The Intended Use:
• The intended use should be based on the expected uses of the product by the end
user or consumer. In speciﬁc cases, vulnerable population groups, e.g. geriatric
patients, infants and immunocompromised patients, may have to be considered.
FACULTY OF PHARMACY,SRIHER

4.Construct a flow diagram:
• The flow diagram should be constructed by the HACCP team, and should cover
all operations and decisions in a process.
• When applying HACCP to a given operation, the steps preceding and following
that operation should also be considered.
• A block-type diagram may be sufficiently descriptive.
5.On-site confirmation of flow diagram:
• The HACCP team should confirm the processing operation against the flow
diagram during all stages and hours of operation.
• Amendments to the flow diagram may be made where appropriate, and should be
documented.

6.List all potential hazards associated with each step, conduct a hazard analysis, and consider
any measures to control identiﬁed hazards (Principle 1):
In the hazard analysis, the following should be included wherever possible:
— the probable occurrence of hazards and the severity of their adverse health
effects;
— the qualitative and/or quantitative evaluation of the presence of hazards;
— the survival or multiplication of microorganisms of concern;
— the production or persistence in drugs of toxins, chemicals or physical agents;
— the conditions leading to the above.

Cont.…
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;
— risk of explosions; and mix-ups.

7.Determine critical control points (Principle 2):
• A CCP in the HACCP system can be more easily 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, and
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.

8.Establish critical limits for each CCP (Principle 3):
• Critical limits must be specified and verified, if possible, for each critical
control point. More than one critical limit may sometimes be elaborated at a
particular step.
• The criteria used often include measurements of temperature, time, moisture
level, pH, and sensory parameters, such as visual appearance and texture.
Critical limits should be scientifically based.

9.Establish a monitoring system for each CCP (Principle 4):
• Monitoring is the scheduled measurement or observation of a CCP relative to its
critical limits. Monitoring should be recorded.
• The monitoring procedures used must be able to detect loss of control at the CCP,
and this information should ideally be available in time to make adjustments to
ensure control of the process and prevent violations of the critical limits. Where
possible, process adjustments should be made when monitoring results indicate a
trend towards loss of control at a CCP.
• These adjustments should be made before a deviation occurs. Data derived from
monitoring must be evaluated by a designated person with the knowledge and
authority to carry out corrective actions when indicated.
• If monitoring is not continuous, the amount or frequency of monitoring must be
sufﬁcient to guarantee that the CCP is under control.

Cont.…..
• Most monitoring procedures for CCPs will need to be done rapidly because they relate to
on-line processes and there will not be time for lengthy analytical testing.
• For this reason, physical and chemical measurements are often preferred to
microbiological tests because they can be done rapidly and can often indicate the
microbiological control of the product.
• The personnel conducting the monitoring of CCPs and control measures should be
engaged in production (e.g. line supervisors, maintenance staff) and, where appropriate,
staff from quality control.
• They should be trained in monitoring procedures. Where continuous monitoring is
possible, a reliable monitoring procedure and frequency should be identiﬁed.
• Statistically designed data collection or sampling systems should then be used.
• All records and documents associated with monitoring CCPs must be signed and dated by
the person(s) carrying out the monitoring and by a responsible reviewing ofﬁcial(s) of the
company.

10.Establish corrective actions (Principle 5):
• 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. 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.
• Individuals who have a thorough understanding of the process, product and HACCP plan
should be assigned the responsibility for the oversight of corrective actions.
• As appropriate, experts may be consulted to review the information available and to assist in
determining the disposition of noncompliant product.
• Actions taken must also include the proper disposition of the affected product. Deviation and
product disposition procedures must be documented in the HACCP records.

11.Establish verification procedures (Principle 6):
• Procedures should be established for verification.
• Verification and auditing methods, procedures and tests, including random sampling and
analysis, can be used to determine whether the HACCP system is working correctly.
• The frequency of verification should be sufficient to confirm the proper functioning of the
HACCP system.
• 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.
• Initial verification of the HACCP plan is necessary to determine whether it is scientifically and
technically sound, that all hazards have been identified, and that, if the HACCP plan is properly
implemented, these hazards will be effectively controlled.

12.Establish documentation and record keeping (Principle 7):
• Efficient and accurate documentation and record keeping are essential to the application of a
HACCP system and should be appropriate to the nature and size of the operation.
• Examples of activities for which documentation is required include:
— hazard analysis;
— CCP determination;
— HACCP plan;
— critical limit determination.
• 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.

Risk Management Methodology:
• Supporting statistical tool
-Acceptance control charts
-control charts
 control charts with arithmetic average and warning limits
Cumulative sum charts;”cuSum”
Weighted moving average
-Design of experiments(DOE)
-Histograms

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 of direct regulatory oversight
• Degree of rigor and formality commensurate with complexity and/or
criticality of the issue
• Implement QRM principles when updating existing gfuidelines

Potential Applications of 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.
• 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.

Quality Risk Management as Part of Integrated Quality Management –
-Documentation
-Training & education
-Quality defects
-Auditing/Inspection
-Periodic review
-Change management/change control
-Continual Improvement

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Quality risk management as part of
• Regulatory operations
-Inspection and assessment activities
• Industry operations
-Development
-Facilities. Equipment and utilities
-Material management
-Production
-Laboratory control and stability testing
-Packaging and labelling
FACULTY OF PHARMACY,SRIHER

Quality risk management q9 & haccp

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