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Quality risk management
1. GMP TRAINING – SYMED LABS
WELCOME TO GMP TRAINING
SESSION
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2. GMP TRAINING – SYMED LABS
QUALITY RISK MANAGEMENT
GMP TRAINING
BY:
V.J.V.PRASAD,
MANAGER-QA
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OBJECTIVES
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To provide information on the background
of the ICH Q9 document
Give an aid by providing some points of
discussions on the understanding of the quality
risk management concept
Illustrations of how Risk Management can be
applied Pharmaceutical Industry
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PREAMBLE
Risk: A situation involving exposure to danger
E.g.: Driving with out wearing helmet
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Accident: An unfortunate incident that
happens unexpectedly and unintentionally,
typically resulting in damage or injury
Risk Management: A systematic process for
the assessment, control, communication and
review of risks.
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Former methods for Quality Risk Management
Methods of risk management in earlier days:
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Trends review
Check lists
Maps
Flow Charts
Compilation of observations
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Potential areas for Risk Management application
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Documentation [SOPs, Batch records etc.]
Training [Schedules and effectiveness]
Quality defects [Complaints, deviations, OOS etc.]
Audits [Compliance]
Periodic reviews [Revalidation assessment]
Change controls [Impact assessment]
Facilities, Equipment and Utilities [Components, maintenance ]
Material management [Receipt, storage and distribution]
Packaging and labeling [Container closure system and labeling]
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Approaches to Quality Risk Management
In general we are using two approaches to manage the risks ...
Pro active: Identify the treat exposure areas to mitigate the
potential for loss, before the loss occurs.
Reactive: Investigate the treat exposure areas to identify
the potential source for loss and its control, after the loss
occurs.
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E.g.: Analysis before implementation.
E.g.: Failure investigations.
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Area of scope for Risk Management
Area for Opportunities to
manage the risk
Design
Process
Materials
Facilities
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Manufacturing
Distribution
Patient
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Risk Based Concepts by ‘ICH’
“risk-based”
concepts and
principles
Q8
9
Q9
Q10
Q11
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Risk Based Concepts by ‘ICH’
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ksi R
Q10 Pharm. Quality Systems
High
Low
Using Q9
Quality Risk
Management
Q8 Pharmaceutical Development
Low
High
principles
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METHODS FOR RISK ASSESSMENT
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Qualitative: The ‘What’ analysis
Quantitative: The ‘How much’ analysis
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Severity and Probability are simple concepts?
Which consequence is more severe?
300 lives lost in single, fiery plane crash.
300 lives lost on roads over a weekend.
300 lives potentially lost from cancer within the next 20 years
Which probability is probable?
What does a “30% chance of rain tomorrow” mean?
30% of the days like tomorrow will have at least a trace of rain.
30% of the area will have rain tomorrow.
30% of the time tomorrow, it will rain.
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de
te
ct
ab
i
lit
y
Parameters for evaluating the ‘Risk’…
probability
hig
h
me
d
ium
low
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severity
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Estimation of Risk through RPN..?
Risk Priority Number = P X D X S
Probability (P) x Detectability (D) x Severity (S)
Refers to
Refers to
Refers to
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past
today
future
time
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Calculation of Risk Priority Number….
Rating scale for Risk:
Low=1
Moderate=2
High=3
Risk Priority Number (RPN) = P X D X S
RPN Scale:
Low: 0 to 9
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Moderate: 10 to 18
High: 19 to 27
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Over view of typical QRM process…
Initiate
Quality Risk Management Process
Risk Assessment
Risk Identification
Risk Analysis
unacceptable
Risk Control
Risk Reduction
Risk Acceptance
Output / Result of the
Quality Risk Management Process
Risk Review
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Review Events
Risk Management tools
Risk Communication
Risk Evaluation
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Basic Risk Management Tools…
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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);
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Failure Mode Effect Analysis (FMEA) concept…
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.
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Failure Mode Effect Analysis (FMEA) Process….
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Identify an area where risk exists.
Describe the system and function
Create a block or process flow diagram indicating relationships
within the process
Create a worksheet containing information about the system
(related block diagram)
What is important is that you have a process to analyze
potential failure modes (i.e. problems that could happen) AND
the potential effects of that failure on your process.
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STEP #1: Selecting the High Risk Process
Examples of how you can do this:
Lengthy process with more stages.
High risk of failures in the process.
Top failed product in the history.
Processes that are heavily dependent on human
intervention.
Product manufacturing in the oldest facility.
Process/Facility with rapid changes.
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STEP #2: Forming the assessment team
The assessment team should be
Subject matter expert.
Cross functional.
To cover all levels.
Solid understanding to the process being assessed.
Well experienced on the process being assessed.
Well qualified with strong analytical skills.
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STEP #3: Diagram the process
Map the process with flow charting
Clearly define the process with simple steps.
Don’t skip the critical steps during mapping.
Determine how things intended to work Vs. how thing
actually working.
Consult the experts to determine the best practices for
the process.
Allow team to the work site to observe the process steps
before mapping of process diagram.
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STEP #4: Identify the potential failure modes
Process can have multiple failure modes and each
failure mode can have multiple effects.
Address the following questions during failure modes
identification.
What could fail with this step? (Failure modes)
Why would this failure occur? (Causes)
What could happen if failure occurs? (Effects)
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STEP #5: Assess the failure modes and Causes
Risk mitigation requires an understanding of the
Severity, probability and detestability of the exposure.
Use clear scale for rating of risk consistently.
Keep the scales simple and ensure they are appropriate
to the exposure and organizations risk tolerance.
Causes identification should be transparent to mitigate
the risk effectively.
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STEP #6: Assessment of critical failure modes
The highest RPN’s should be focused on first and
should be considered as critical.
Ask the following questions during assessment
What might cause the failure to occur?
When might the failure occur?
Where might the failure occur?
Why might the failure occur?
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STEP #7: Redesign the process
Considerations for the redesignation of the process.
If identified the critical failure mode.
If inadequate controls are exists.
If existing process not robust.
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Direct the redesignated process prior to its wide spread
implementation.
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Frame work for Failure Mode Effect Analysis
Assesses the steps of the process and identify where the
problems may occur.
Identify consequences of each failure mode should it
occur.
Scores the exposures quantifiably.
The highest RPN’s should be focused on first.
Assists with better understanding of the process.
Brain storming is the critical to the process.
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Concerns regarding QRM implementation
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Hiding risks
Writing half the truth (e.g. in an investigation report)
A means of removing industry’s obligation to comply
with regulatory requirements
Both Companies & Inspectors have to think and not
simply follow black and white rules
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Conclusions for ICH Q9
Over all: Positive Contribution to patient protection
Further develops Quality Risk Management awareness,
that is already part of industry and regulatory culture
Ongoing change in behaviour
Identifying risks can be positive
A long list of identified risks that are assessed and
controlled provides high quality capability
Awareness of quality risks
“Risk-based approach”
A potential of risks remains - No “Zero” risk!
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Change in behavior….
From tick-box approach for compliance
Towards systematic risk-based
thinking
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Conclusion
The weakest link
in the chain will
no longer.... be a
problem.
The use of Quality Risk Management is mandatory
is an expectation of EU & PICs GMP
However, if you don’t use it,
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you will not gain the benefits
