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Quality Risk Management as aManagement Tool:How to Create and Use a QRM Plan
Carl Johnson
ASQ Senior Member
Certified Six Sigma Black Belt
May 2007
1
Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
Background, Scope, Definition
QRM Process and Methodology
Case Example
Matrices, Templates, Diagrams
Wrap Up
2
Objectives
Define and explain QRM in practical terms
Show how it benefited one company
Explain how you can use it as a business tool to getmanagement focused on the right things and therefore to dothe right things
Show why risk-based planning is gaining credence in industry(especially pharmaceutical Good Manufacturing Practices)
Give you a framework that can help you think about problemsin a new/different way, and be more effective in your job
3
Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
Background, Scope, Definition
QRM Process and Methodology
Case Example
Matrices, Templates, Diagrams
Wrap Up
4
Background
Risk management is as old as civilization
Shipments split among several vessels
Crops planted in separated fields
Purpose is to reduce impact of loss
Lessen frequency
Lessen magnitude
Risk is defined as the combination of
Probability of harm
Severity of harm
Similar analysis is used in Failure Mode and Effects Analysis and othertechniques
5
Scope
People
Product users
Patients
Employees
Product
Product quality
Specifications
Processes
Scrap
Rework
6
Definition
QRM is the discipline ofsystematically evaluating the
probability and severity of events thatcould happen throughout the valuechain, and then creating plans to
reduce the frequency and/or lessenthe severity of those events.
Source: Charter Consulting
7
Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
Background, Scope, Definition
QRM Process and Methodology
Case Example
Matrices, Templates, Diagrams
Wrap Up
8
Process
Initiate Risk ManagementProcess
Risk Analysis
Risk Evaluation
Risk Reduction
Risk Acceptance
Output/Result of the RiskManagement Process
RiskCommunication
Risk Acceptance
Review Events
Ris
kM
anag
emen
tToo
lsRisk Identification
Risk Communication
Risk Control
Risk Assessment
Risk Reviewacceptable
Source: ICH
9
Risk Assessment
Risk identification
“What might go wrong?”
Identification can be based on experience, judgment, designknowledge or any number of inputs.
Risk analysis
“What is the probability the identified risk will occur?”
“What’s the severity if it does?”
“How detectable will it be?”
Ideally, the answers to these questions would be quantified, but atleast they can be given a relative ranking suitable for later analysis.
10
Risk Assessment (cont)
Risk evaluation
Decide, based on the quantitative or relative rankings, which of therisks warrant further action in terms of the QRM plan.
Output
The output of the Risk Assessment phase is a prioritized list of risksfor further review.
11
Risk Control, Communication, and Review
Control
Risk reduction is concerned with finding ways to avoid the risk(reduce its likelihood) or mitigate the risk (reduce its severity).
Risk acceptance is a decision to accept the risk. This decisionshould be made on a case-by-case basis in line with the commentsregarding economic considerations mentioned above.
Hint: It is important in doing QRM planning to keep reasonably
detailed notes about decisions that are made.
12
Risk Control, Communication, and Review
Communication
Don’t assume everyone knows or understands the issues
Have a communication plan
Review
Learn from the planning experience and institutionalize it
13
Methodology
Establish goals, objectives, and planning scope
Structure the team and ensure organizational support
Review available process documentation and outsideinformation
Create Process Flow Diagrams (PFDs)
Identify risks
Analyze and evaluate risks
Develop recommendations
Institutionalize the QRM process
14
Institutionalizing
15
Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
Background, Scope, Definition
QRM Process and Methodology
Case Example
Matrices, Templates, Diagrams
Wrap Up
16
Role Matrix
PFVerify Flow Diagram
SPDevelop Flow Diagram
PSIntended Use andCustomers
PSProduct Type andDistribution
SalesOpsQACharter
AREAREQUIREMENT
F=Facilitate P=Primary S=SharedOperations includes Receiving, Warehousing, Manufacturing,Packaging, Shipping, Distribution
17
Representative Frequency and Severity Categories
Risk Frequency Categories
Category Description ScoreHigh Frequency more than once per week 4
Medium Frequency of several times per month 3Low Frequency several times per year 2
Negligible Frequency less than once per year 1
Risk Severity Categories
Category Description ScoreHigh Requires 200% inspection, requires re-inspection of sealed cartons,
causes one or more batches to be rejected or aborted4
Medium Requires rework to part of a batch 3Low Requires minor adjustment to manufacturing equipment or process 2
Negligible No major action required 1
Note: Detectablity was not considered in this first-cut analysis as assumed critical risks were considered equallydetectable.
18
Scoring Matrix Showing Risk Priority Numbers
4 8 12 16
3 6 9 12
2 4 6 8
1 2 3 4
1 2 3 4
Risk Frequency
1
2
3
4R
isk
Seve
rity
High risk area
4 8 12 16
3 6 9 12
2 4 6 8
1 2 3 4
4 8 12 16
3 6 9 12
2 4 6 8
1 2 3 4
1 2 3 4
Risk Frequency
1
2
3
4R
isk
Seve
rity
High risk area
19
Alternative Approach to RPN Definition
RISK PRIORITY NUMBER MATRIX
SeverityRPN
Severe Major Minor Negligible
Frequent 25 20 10 8
Probable 18 15 10 5
Occasional 12 9 7 3
Fre
qu
en
cy
Remote 8 7 3 1
20
Process Flow Diagram
Receive incomingraw materials from
supplier
Created by: Date: Validated by: Date: Page:
of
MANUFACTURING PROCESS FLOW DIAGRAM (PFD)
Transport rawmaterial to storagearea/warehousefor quarantine
Wa
reho
use
Start
Inspection of rawmaterials by QA
Raw materialsapproved?
Reject rawmaterials and label
accordingly
NO
YES
End
1
Pro
ductio
n
Go toPage 3
Storage of rawmaterials incontrolled
atmosphere
Storage of rejectedraw materials in
separate location
Weigh, verify, andsecure raw
material batch
Release and labelapproved raw
materials
8Document Number: Revision:
Raw MaterialStorage Room
Transport toreleased work
storage area forstock
Raw MaterialSupply Complete
receiving report,either manually orin BPCS and label
Complete incident/non conformance
report
Check receiving reportSend samples to lab for QC testing: in/out of specComplete inspection records
Materials responsibility ends
Compounding responsibility begins
21
Risk Analysis Template
22
Completed Risk Analysis Template
23
Risks Plotted Into PFD
24
Summary Level RPN Analysis
Risk Frequency
7,8,9,20,22,28,30,41,45,50,51,55,57,58,59,60
1,10,12,13,14,21,
27,31,33,40,47,49,52,54,
56, 49
6, 23,25,32,35,36,
39,535,19,24,26
16,37,46 38 11 29,48
18 3,17,34 2,15
4
High
Medium
Low
Negligible
Negligible Low Medium High
Ris
kS
eve
rity
Note: Risks in bold have been identified by management as requiring additional action
Risk Frequency
7,8,9,20,22,28,30,41,45,50,51,55,57,58,59,60
1,10,12,13,14,21,
27,31,33,40,47,49,52,54,
56, 49
6, 23,25,32,35,36,
39,535,19,24,26
16,37,46 38 11 29,48
18 3,17,34 2,15
4
High
Medium
Low
Negligible
Negligible Low Medium High
Ris
kS
eve
rity
Note: Risks in bold have been identified by management as requiring additional action
25
Recommended Actions
12PM in bags of washed plungers.53
12Bulk solution temperature falls below allowable limit.48
12Variations in cartridge fill volume.25
12Plunger insertion deviations (formerly “plungers sticking together”)23
16Refrigerator temperature deviations.19
9pH adjustment of bulk solution.11
12Incoming components may be out of spec.6
16Creation of quarantine labels in raw materials receiving area5
Risk Score (Max
= 16)Risk DescriptionItem #
26
Summary Action Plan
# 53RiskScore
12 Identified Risk Particulate matter in bags of washed plungers
Risk Description Particulate matter (PM) has been found in bags of washed plungers
Recommendation
Establish a supplier cleaning program with vendor including review of the vendors proposedcleaning processes and site inspections to verify agreed-upon operations. Define the agreedupon PM/cleanliness criteria and incorporate the criteria into the IQA procedures. Establishpreventive maintenance procedures on plunger handling equipment and validate that noadditional particulate matter is introduced.
Assign a Project Manager to complete this task under the direction of the individuals listedbelow.
Action Plan
Person Responsible Due Date9/1/05 for detailed plan which will
include completion dates
Monitoring Plan
Who? Quality Assurance, Operations
What? Monitor plunger PM
How?Check PM criteria during IQA – QAObserve operations to ensure no PM is introduced - Operations
How often? Per IQA procedures
Critical Limits
Critical limit is no lot of incoming plunger contains PM and no PM is observed within operations
Validation
Validation of the new practices will result from final inspection finding no PM inside cartridges
Required Reporting
QA will report to the Material Review Board (MRB) on a monthly basis regarding PM findings
27
Key Points
A structured approach is important – PFDs, interviews,workshops, reporting
Involving internal customers in workshops will improve theanalysis (e.g. Receiving is a customer of Purchasing)
Risk analysis benefits when research, experience andbrainstorming interplay
Management pays attention to good analysis and problemsolving
28
Conclusion
QRM is common sense
QRM brings structure to risk analysis
QRM gives direction to quality programs
QRM should be tried, because . . .
