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Quality system
质量风险评估在质量保证体系中的应用
辉瑞制药有限公司
解馨
Agenda
Introduction to QRM
Case Studies
Final Points
Slide 2
QRM - What is it?
Slide 3
QRM – Why do it?
Slide 4
QRM and other Methodologies
Slide 5
Overview - Principles
Slide 6
Overview – Process
Risk Assessment
Risk Identification
Risk Analysis
Unacceptable
Risk Evaluation
Risk Control
Risk Reduction
Risk Acceptance
Risk Review
Review Events
Slide 7
The 10 step approach to QRM
Slide 9
Step 2 – Define Risk Question
Slide 10
Step 3 – Choose Tool
Slide 11
Step 3 – Choose Tool (cont.)
Preliminary
Failure Mode
Hazard
and Effect
Analysis?
Analysis?
Risk Ranking
& Filtering?
Failure Mode,
Effect &
Hazard Criticality
Operability Analysis?
Analysis?
Hazard Analysis
of Critical Control
Points?
Slide 12
Step 3 – Choose Tool (Summary)
Severity
What are the factors which must be considered
that will have an impact on the patient /
compliance / company (consequences)?
• Probably covered in your risk question
Probability
What is the likelihood that the impact on the
patient/compliance/company will occur?
Detection
Can you detect the risk?
Remember low detection high risk
Slide 14
Step 5 – Define Scales
Slide 15
Step 5 – Define Scales (cont.)
Slide 16
Step 6 – Define Matrix
High
Medium High High
Medium
Probability
Increasing
Low
Low Low Medium
Increasing Severity
Slide 17
Step 6 – Define Matrix (cont.)
Slide 18
Step 7 – Determine Threshold for Action
Action thresholds:
Slide 19
Step 8 – Apply Tool
Slide 20
Step 8 – Apply tool (cont.)
Slide 21
Step 9 – Define Risk Reduction Measures
Slide 22
Step 9 – Define Risk Reducing Measures
Slide 23
Step 10 – Document and Approve
Risk Question:
Assessment
Team:
Equipment
Slide 24
Ongoing Risk Review
At Pfizer
SQRT/AQRT
Site Validation Committee
Corporate Auditors
Outside Pfizer
Inspectors
Regulatory Authorities
Slide 25
QRM – What can we do with QRM?
Retro-actively:
Making decisions around product and quality risk
for deviations/issues/complaints
Pro-actively:
Qualification & Validation
Change Management - Impact assessments
PM Programs and Calibration
Audit Frequencies
Materials Management
Training Optimisation
…….
Slide 26
QRM used in quality system
Slide 27
Case 1: Supplier Auditing
Slide 28
Case 1: Supplier Auditing
Slide 29
Case 1: Supplier Auditing
Slide 30
Case 1: Supplier Auditing
Slide 31
Case 1: Supplier Auditing
6. Define Matrix
7. and Threshold
When RPN is at least 96 (6S x 4P x 4D) =
schedule audit
8. Apply the tool
Supplier Severity Probability Detectability Total Risk
Score Score Score Score
(S) (P) (D) (SxPxD)
Supplier A
Supplier B
Supplier C
Supplier D
Slide 33
Case 1: Supplier Auditing
Slide 34
Case 1: Supplier Auditing
Slide 35
Case 2: Using QRM to determine SOP review date
Slide 36
Case 2: Using QRM to determine SOP review date
Slide 37
Case 2 Using QRM to determine SOP review date
Slide 38
Case 2 Using QRM to determine SOP review date
Slide 39
Case 2 Using QRM to determine SOP review date
Slide 40
Case 2 Using QRM to determine SOP review date
Increasing Probability
High
Medium High High
Medium
Low Medium High
Low
Low Low Medium
Slide 41
Case 2 Using QRM to determine SOP review date
Slide 42
Case 2 Using QRM to determine SOP review date
Slide 43
Case 2 Using QRM to determine SOP review date
SOP
Subject Sub-group Probability Outcome score
Category
5.Plant Training /
Documentation low medium low
Administration
Validation (System,
medium high high
Cleaning & Process)
Slide 44
Case 2 Using QRM to determine SOP review date
2.Quality
Operat 1.QO Safety low low low
ion
Analytical Method
low high medium
Validation
5.QO Training /
Quality Assurance medium high high
Administration
Slide 45
Case 2 Using QRM to determine SOP review date
Slide 46
Case 2 Using QRM to determine SOP review date
PLANT TRAIING/ADMINISTRATION
Slide 47
Case 2 Using QRM to determine SOP review date
Slide 48
Key learning of case 2
Slide 49
Case 3 Change control system with QRM
Slide 50
Case 3 Change control system with QRM
1.Initiate QRM
1.applicayion
3.Development work
Risk communication
3.Risk control
3.approval
Slide 51
Case 3 Change control system with QRM
Slide 52
Case 3 Change control system with QRM
Slide 53
Case 3 Change control system with QRM
Slide 54
Case 3 Change control system with QRM
Slide 55
Case 3 Change control system with QRM
Severity :
Quality risk to product caused by the product quality property’s
incompliance with the accepted specification.
Possibility :
The possibility of the product quality property’s incompliance with
the accepted specification
Slide 56
Case 3 Change control system with QRM
Slide 57
Case 3 Change control system with QRM
Increasing Probability
High
Medium High High
Medium
Low Medium High
Low
Low Low Medium
Slide 58
Case 3 Change control system with QRM
Slide 59
Case 3 Change control system with QRM
Quality Risk
Possibility(P) Severity(S) Risk Score (P
x S)
Quality Risk
Compliance Risk
Slide 60
Case 3 Change control system with QRM
Step 9 Define risk reducing measures
Responsible Party
Rank Action
and Target Date
Quality
1. Improve process: Investigation demonstrates
drying process variation is the cause of particle
size difference. New API site is required to
optimize drying process parameter to make the
particle size distribution reaching the current
Specification( Impurity, Residual
High specification. 2007.12
Solvent, Particle Size Distribution)
2. Set up new specification: Update impurity,
residual solvent control specification to adapt to
the new process.
3.Complete 3 batches test result comparison.
Test Method Applicability High Evaluate the applicability of the method 2008.5
Dissolution Rate High Complete Dissolution comparative test. 2008.5
Process Validation High Complete 3 batches process validation 2008.5
Carry out accelerated and ongoing stability
Stability High 2008.8
study
Compliance
Registration High Complete Registration 2009.3
GMP(EIR) Medium Provide EIR 2008.8
Slide 61
Case 3 Change control system with QRM
Step 9 Apply tools again
Risk Evaluation Risk Analysis Risk Evaluation
Quality Risk
Specification( High Low Low Low
Impurity, Residual
Solvent, ,Particle Size
Distribution)
Compliance Risk
Registration High Low Low Low
Slide 62
Case 3 Change control system with QRM
Step 10 – Document and Approve
Slide 63
Case 3 Change control system with QRM
Slide 64
Final Points
Slide 66
Thank you
Slide 67