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Quality Risk Management as a
Management Tool:
How to Create and Use a QRM Plan
Carl Johnson
ASQ Senior Member
Certified Six Sigma Black Belt
May 2007
Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
 Background, Scope, Definition
QRM Process and Methodology
Case Example
 Matrices, Templates, Diagrams
Wrap Up
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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 get
management focused on the right things and therefore to do
the 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 problems
in a new/different way, and be more effective in your job
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Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
 Background, Scope, Definition
QRM Process and Methodology
Case Example
 Matrices, Templates, Diagrams
Wrap Up
3
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 other
techniques
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Scope
People
 Product users
 Patients
 Employees
Product
 Product quality
 Specifications
Processes
 Scrap
 Rework
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Definition
QRM is the discipline of
systematically evaluating the
probability and severity of events that
could happen throughout the value
chain, and then creating plans to
reduce the frequency and/or lessen
the severity of those events.
Source: Charter Consulting
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Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
 Background, Scope, Definition
QRM Process and Methodology
Case Example
 Matrices, Templates, Diagrams
Wrap Up
7
Process
Initiate Risk Management
Process
Risk Assessment
Risk Identification
Risk Management Tools
Risk Analysis
Risk Evaluation
Risk Control
Risk Reduction
Risk Acceptance
Risk Communication
Risk
Communication
Risk Review
acceptable
Output/Result of the Risk
Management Process
Risk Acceptance
Review Events
Source: ICH
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Risk Assessment
Risk identification
 “What might go wrong?”
 Identification can be based on experience, judgment, design
knowledge 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 at
least they can be given a relative ranking suitable for later analysis.
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Risk Assessment (cont)
Risk evaluation
 Decide, based on the quantitative or relative rankings, which of the
risks warrant further action in terms of the QRM plan.
Output
 The output of the Risk Assessment phase is a prioritized list of risks
for further review.
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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 decision
should be made on a case-by-case basis in line with the comments
regarding economic considerations mentioned above.
 Hint: It is important in doing QRM planning to keep reasonably
detailed notes about decisions that are made.
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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
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Methodology
Establish goals, objectives, and planning scope
Structure the team and ensure organizational support
Review available process documentation and outside
information
Create Process Flow Diagrams (PFDs)
Identify risks
Analyze and evaluate risks
Develop recommendations
Institutionalize the QRM process
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Institutionalizing
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Overview of Presentation
Objectives
Quality Risk Management (QRM) Context
 Background, Scope, Definition
QRM Process and Methodology
Case Example
 Matrices, Templates, Diagrams
Wrap Up
15
Role Matrix
REQUIREMENT
AREA
Charter
QA
Ops
Sales
Product Type and
Distribution
S
P
Intended Use and
Customers
S
P
Develop Flow Diagram
Verify Flow Diagram
P
S
F
P
F=Facilitate P=Primary S=Shared
Operations includes Receiving, Warehousing, Manufacturing,
Packaging, Shipping, Distribution
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Representative Frequency and Severity Categories
Risk Frequency Categories
Category
High
Medium
Low
Negligible
Description
Frequency more than once per week
Frequency of several times per month
Frequency several times per year
Frequency less than once per year
Score
4
3
2
1
Risk Severity Categories
Category
High
Medium
Low
Negligible
Description
Requires 200% inspection, requires re-inspection of sealed cartons,
causes one or more batches to be rejected or aborted
Requires rework to part of a batch
Requires minor adjustment to manufacturing equipment or process
No major action required
Score
4
3
2
1
Note: Detectablity was not considered in this first-cut analysis as assumed critical risks were considered equally
detectable.
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Scoring Matrix Showing Risk Priority Numbers
High risk area
Risk Severity
4
3
2
1
4
8
12
16
3
6
9
12
2
4
6
8
1
2
3
4
1
2
3
Risk Frequency
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4
Alternative Approach to RPN Definition
RISK PRIORITY NUMBER MATRIX
Frequency
RPN
Severity
Severe
Major
Minor
Negligible
Frequent
25
20
10
8
Probable
18
15
10
5
Occasional
12
9
7
3
Remote
8
7
3
1
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Process Flow Diagram
MANUFACTURING PROCESS FLOW DIAGRAM (PFD)
Raw Material
Storage Room
Raw Material
Supply
Start
Receive incoming
raw materials from
supplier
Complete
receiving report,
either manually or
in BPCS and label
Transport raw
material to storage
area/warehouse
for quarantine
Storage of raw
materials in
controlled
atmosphere
Inspection of raw
materials by QA
Warehouse
Raw materials
approved?
Check receiving report
Send samples to lab for QC testing: in/out of spec
Complete inspection records
NO
Reject raw
materials and label
accordingly
Complete incident/
non conformance
report
Storage of rejected
raw materials in
separate location
End
YES
Release and label
approved raw
materials
Transport to
released work
storage area for
stock
Materials responsibility ends
Production
Compounding responsibility begins
Created by:
Document Number:
Weigh, verify, and
secure raw
material batch
Date:
Validated by:
Go to
Page 3
Date:
Revision:
Page:
1 of 8
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Risk Analysis Template
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Completed Risk Analysis Template
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Risks Plotted Into PFD
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Risk Severity
Summary Level RPN Analysis
High
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,
39,53
5,19,24,26
Medium
16,37,46
38
11
29,48
Low
18
3,17,34
2,15
Negligible
4
Low
Medium
Negligible
High
Risk Frequency
Note: Risks in bold have been identified by management as requiring additional action
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Recommended Actions
Item #
Risk Description
Risk Score (Max
= 16)
5
Creation of quarantine labels in raw materials receiving area
16
6
Incoming components may be out of spec.
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11
pH adjustment of bulk solution.
9
19
Refrigerator temperature deviations.
16
23
Plunger insertion deviations (formerly “plungers sticking together”)
12
25
Variations in cartridge fill volume.
12
48
Bulk solution temperature falls below allowable limit.
12
53
PM in bags of washed plungers.
12
25
Summary Action Plan
#
53
Risk
Score
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 proposed
cleaning processes and site inspections to verify agreed-upon operations. Define the agreed
upon PM/cleanliness criteria and incorporate the criteria into the IQA procedures. Establish
preventive maintenance procedures on plunger handling equipment and validate that no
additional particulate matter is introduced.
Assign a Project Manager to complete this task under the direction of the individuals listed
below.
Action Plan
Person Responsible
Due Date
9/1/05 for detailed plan which will
include completion dates
Monitoring Plan
Who?
Quality Assurance, Operations
What?
Monitor plunger PM
How?
Check PM criteria during IQA – QA
Observe 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
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Key Points
A structured approach is important – PFDs, interviews,
workshops, reporting
Involving internal customers in workshops will improve the
analysis (e.g. Receiving is a customer of Purchasing)
Risk analysis benefits when research, experience and
brainstorming interplay
Management pays attention to good analysis and problem
solving
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Conclusion
QRM is common sense
QRM brings structure to risk analysis
QRM gives direction to quality programs
QRM should be tried, because . . .
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Contact Information
Carl Johnson
Chicago, IL
USA
+1 312 399 9455
[email protected]
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