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QUALITY RISK MANAGEMENT
RASHID MAHMOOD MSc. Analytical Chemistry
MS in Total Quality Management
Senior Manager Quality Assurance
Nabiqasim Group of Industries Pakistan
What is Quality Risk Management?
Quality
Risk
Management
QRM
Definitions
Degree to which a set of inherent properties of a product, system or process fulfills requirements.
Combination of the probability of occurrence of harm and the severity of that harm
Systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle." (ICH Q9)
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.
Typical QRM process
• What might go wrong or has gone wrong?
• What is likelihood or probability?
• What are the consequences (severity)?
• What is the level of risk? Any mitigating factors?
Risk Review
Ris
k C
om
mu
nic
atio
n
Risk Assessment
Risk Evaluationunacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
InitiateQuality Risk Management Process
Output / Result of theQuality Risk Management Process
Risk
Ma
na
ge
men
t t oo
ls
Integrate QRM during product life cycle
Say, what you do
Do, what you say
Gain experience
Improve it
Approval
Manufacture for market
Analyse root cause:Continuous improvement
Update documentation
Quality Risk Management
(QRM)
(Risk of) Failure ?
ICH Q9 Link back to patient risk
Process
Materials
Design
Manufacturing
Distribution
Patient
Facilities
Opportunities to impact risk using quality risk
management
Implementing QRM Means
The weakest chain will no longer be a problem.
Risk Assessment
Risk Identification What might go wrong?Risk Analysis What is the likelihood (probability) it will go wrong?Risk Evaluation What are the consequences (severity)?
Note
3 fundamental questions
Parameters for “calculating” Risks
A picture of the life cycle
Probability Detectability Severity
past today future
Refers to
Time
Refers to
Refers to
= Risk Priority Number
x x
What is RPN? RPN = (Severity) x (Probability) x (Detection)
The RPN is used to prioritize action based upon the risk.
For example the Risk Priority Number (RPN ) is categorized as below.
Risk Levels ( SOPs Production)
1-125 -Low
126-343-Medium
344-1000-High
Severity and Probability are simple concepts?
Which consequence is more severe?300 lives lost in single plane crash.300 lives lost on US roads over a weekend.300 lives potentially lost from cancer within the next 20 yearsWhich probability is most 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.
Risk Management Methods and Tools
• 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
• 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 filteringCompare and prioritize risks with factors for each risk
Basic Quality Risk Management Facilitation Methods
Some of the simple techniques that are commonly used to structure risk management by organizing data and facilitate decision-making are:FlowchartsCheck SheetsProcess MappingCause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram)
“Risk management is the future of quality
management.”
14
Failure Mode & Effect Analysis (with Criticality)
10987654321
Sev
erit
y of
Eff
ect
10987654321O
ccur
renc
e P
roba
bili
ty
S
CriticalityS x P
123456789
10Det
ecti
on*
“SPD” or “Risk
Priority Number (RPN)”
P S x P x D
*Higher detection ability lowers risk score.
Benefits of Quality Risk Management
Create baseline for more science-based decisions Create awareness to maintain product quality throughout product life cycle. No sudden surprises in operations Better process and product understanding Better monitoring and control strategy Better utilization of resources Reduced risks to patient Regulatory compliance all the time
