sslean validation 20070622
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© Cordis Corporation 2004 155-2862-1 1
Six Sigma and Lean Tools for Validation
Jan C. Crielaard, Principal, WW Validation Cordis Corporation, a Johnson and Johnson Company
Pharmaceutical Technology’s Annual ConferenceJuly 23-25, 2007 - Park Hyatt at the Bellevue - Philadelphia, PA
© Cordis Corporation 2004 155-2862-1 2
Agenda
• Validation life cycle and Six Sigma methodologies – Concepts and Definitions– Basis for Process Validation
• Utilize Lean tools to assess validation system efficacy and efficiency – RACI analysis– Group Technology and Job Standardization– Value Stream Map– Gauge RnR
© Cordis Corporation 2004 155-2862-1 3
Agenda
• Control plans and validation metrics– Purpose of control plans– Metrics / Quality Indicators– Dashboards
• Interactive Exercise: – Facilitating a transactional Kaizen initiative.
© Cordis Corporation 2004 155-2862-1 4
Learning Objectives
• Provide common terminology• Understand GMP evolution and how it relates to
Six Sigma• Introduce selected Six Sigma tools and present
how they can be applied to validation• Introduce selected LEAN tools and apply these
tools to assess and improve validation systems
© Cordis Corporation 2004 155-2862-1 5
Validation life cycle and Six Sigma methodologies
© Cordis Corporation 2004 155-2862-1 6
Minimize risk to the public health associated with pharmaceutical products by:– Encourage implementation of risk-based
approaches for industry and FDA– Encourage continuous improvement
FDA’s Initiative GMPs for the 21st Century
© Cordis Corporation 2004 155-2862-1 7
– Focus on variability reduction through process understanding
– Focus on detect, analyze, correct and prevent problems
FDA’s Initiative GMPs for the 21st Century
© Cordis Corporation 2004 155-2862-1 8
• To improve efficiency by optimizing a process and eliminating wasted efforts in production
• Focus lays on reducing variability in process and product quality characteristics and are not for changing the fundamental design of a manufacturing process (FDA, page 20)
• Achieving and maintaining a state of control for process begins at the process development phase and continuous in entire product life cycle
• Quality should be built into the product
Continuous Improvement FDA
© Cordis Corporation 2004 155-2862-1 9
Six Sigma
• A systematic approach for continuous sustainable Improvements
• Define phase: Clear problem understanding • Measure phase: Establish Baseline• Analyze phase : Identify key drivers• Improve phase : Manipulate key drivers for optimal solutions• Control phase : Strategy to maintain gains
Measure
AnalyzeImprove
Control
Define
© Cordis Corporation 2004 155-2862-1 10
DMAIC tool overview
· Benchmark· Baseline· Voice of the
Customer· Process Flow
Map· Project
Management
Define Measure Analyze Improve Control
· Defect Metrics· Data
Collection, Plan, Logistics
· Sampling Techniques
· Cause & Effect Diagrams
· FMEA· Risk Analysis· Control Charts· Capability· Reliability· Root Cause
· Design of Experiments
· Modelling· Tolerancing· Robust Design
· Statistical Control
· Preventative Activities
· Verification· Effectiveness
© Cordis Corporation 2004 155-2862-1 11
Causal thinking y = f(x1, x2,…, xn)
Cause-and-Effect Diagram
Process output
Machine
MenMaterialsMother Nature
MeasureMethodMachine
MenMaterialsMother Nature
MeasureMethod
© Cordis Corporation 2004 155-2862-1 12
Risk Based approach
• Is a paradigm focused on testing those aspects that can affect the product quality
• Requirements:– A proper and true understanding of the system– The ability to identify and asses product risk inherent to the manufacturing
process, Risk Management
Traditional
• Inputs/outputs determined at time of validation
• Validation used to catch issues
• All facility, utility and process equipment and components are validated
Risk-Based
• Inputs/outputs transferred from design to validation
• Validation used to confirm requirements
• Validate equipment and components that have potential impact to product quality
© Cordis Corporation 2004 155-2862-1 13
Risk Management
•The process of measuring or assessing risk and developing strategies to manage it
•Guides the setting of specification and process parameters for manufacturing, assess and mitigate the risk of changing a process or specification, and determine the extent of discrepancy investigation and corrective actions
•Risk management is an iterative process, it should be repeated when new data becomes available
•Controls commensurate with level of risk
© Cordis Corporation 2004 155-2862-1 14
Risk Management
Production
monitoring
Risk Estimation
Risk Evaluation
Risk Control
© Cordis Corporation 2004 155-2862-1 15
Risk Estimation
•Risk estimation is a way to quantify the risk associated with each cause of each hazard identified
Tools:
•Fault Tree Analysis (FTA)
•Failure Mode Effects Analysis (FMEA)
•Hazard Analysis and Critical Control Points (HACCP)
•Failure Mode Criticality and Effects Analysis (FMCEA)
•Hazard Operability Analysis (HAZOP)
•Control HAZOP (CHAZOP)
© Cordis Corporation 2004 155-2862-1 16
FTA
• Top down approach:
Given a potential Hazard,
determine the possible drivers
of failure
• Each failure mode may have its own failure mode
• Continue till individual sources are identified
Identify Hazards
Identify all potential failure modes
Diagram the fault tree
TEAM
EFFORT
© Cordis Corporation 2004 155-2862-1 17
FTA
Inadequate control body
temperature
Machine
MenMaterialsMother Nature
MeasureMethod
Inaccurate Temp reading
Cooling mech ineff.
Inadequate control body
temperature
Machine
MenMaterialsMother Nature
MeasureMethod
Inaccurate Temp reading
Cooling mech ineff.
© Cordis Corporation 2004 155-2862-1 18
FMEA• Bottom-up-approach:
Given a system,determine potential
hazards by asking what can go
Wrong
• Focus on how and under which circumstances system will fail
• Focus not if system will fail
Identify component or process steps
Identify what can go wrong
Determine Effect for user
Score•Severity
•Occurrence•(Detectability)
Evaluate the risk &identify controls and mitigation
actions
T
E
A
M
E
F
F
O
R
T
Functional Component Failure Mode
User Harm S
ev
Occ
Det Control
Temp sensor Drifts low
Body temp too low 9 2 2
Accuracy Testing
Cooling Mech
Underpowered coolant
Body cools to slow 5 6 6 Test loop
© Cordis Corporation 2004 155-2862-1 19
Impact Assessment *
Impact assessment characteristics:• Bottom-up-approach• Specific criteria build around families of potential failure
modes• Criteria are common to Pharmaceutical systems• Assessment on system and component level
* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
© Cordis Corporation 2004 155-2862-1 20
System Impact Assessment*Criteria indicating “Direct Impact “
1. The system has direct contact with the product
2. The system provides an excipient, or produces an ingredient or solvent
3. The system is used in cleaning or sterilization
4. The system preserves product quality
5. The system produces data which is used to accept or reject product
6. The system is a process control system that may affect product quality and there is no system for independent verification of control system performance in place
* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
© Cordis Corporation 2004 155-2862-1 21
Component Criticality Assessment*
Criteria indicating “Criticality “
1. The component is used to demonstrate compliance with the registered process
2. The normal operation or control of the component has a direct effect on product quality
3. Failure or alarm of the component will have a direct effect on product quality or efficacy
4. Information from this component is recorded as part of the batch record, lot release data, or other GMP-related documentation
* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
© Cordis Corporation 2004 155-2862-1 22
Component Criticality Assessment*
Criteria indicating “Criticality “
5. The component has direct contact with product or product components
6. The component controls critical process elements that may affect product quality, without independent verification of the control systems performance
7. The component is used to create or preserve a critical status of a system
* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
© Cordis Corporation 2004 155-2862-1 23
Impact Assessment
Systems and Components
ImpactAssessment
CommissionSystem
Intended Use
Change Control
Change ControlEvaluation
DesignDocuments
Requirements
Indirect Direct
System Boundaries
Industry Guides
Hazard Analysis
FMEA
No Impact
Good Engineering Practice
Commission and Qualify system
© Cordis Corporation 2004 155-2862-1 24
Risk knowledge
• Drives Design - e.g.”Design for impact”
• Establishes qualification requirements• Drives Acceptance Criteria• Establishes baseline for (Change Based)
revalidation
© Cordis Corporation 2004 155-2862-1 25
Utilize Lean tools to assess validation system efficacy and efficiency
© Cordis Corporation 2004 155-2862-1 26
Overall approach
Principle: Map current state (data and facts)
Purpose:
Analyze - Identify improvement opportunities based on current performance:– Compliance– Efficiency
Outcome: Map future state (new process, targets)
© Cordis Corporation 2004 155-2862-1 27
Tools
• RACI analysis• Group Technology and Job Standardization• Value Stream Map (VSM) • Gauge RnR (Attribute)
© Cordis Corporation 2004 155-2862-1 28
RACI Analysis
Purpose: Identify and optimize:• Responsibility• Accountability• Consult• Information
1 Map current stateDepartment
Role
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Verification of build prerequisites A R IPreparation for Execution A R C I IComponents and Raw Material on warehouse A R C IComponents and Raw Material Released A R I I ITools and Equipment Calibrated I I I A RTesting Equipment Identified A RConsumables as required per SOP's I A RVerify Certification of personnel involvedValidation procedure A R I CCalibration Procedure A R I CPM Procedure A R IDocuments Released Before Units ManufacturingBill of Material released C ASOP Released or Draft A RAnalytical and Test Method Validations A RSpecifications / Acceptance criteria A RPreparation of the Equipment Set-up the Equipment Parameters according to SOP R/AVerification of Tools availability according to SOP R/Aetc….
CalibrationOperationsWarehouse Training Engineering Quality
© Cordis Corporation 2004 155-2862-1 29
RACI Analysis
2 Analyze / Improve• R and A defined for each task• Consistent approach• Minimize duplicate roles• Combine C and R role where possible• Align A and R to organizational structure• Etc.
3 Map future state• Integrate in procedures
Typical improvement opportunities• Responsibilities not defined• More than 1 person responsible• Approvers that only need to be informed
© Cordis Corporation 2004 155-2862-1 30
Group Technology Analysis
• Identify similar tasks• Identify common groups• Optimize the validation process based on largest
common groups
© Cordis Corporation 2004 155-2862-1 31
Group Technology Analysis
• Identify common elements based on completed validations
Grouping property 1Grouping property 2Grouping property 3Grouping property 4Grouping property 5
Document numberCommon element 1 2 3 4 5 6 7 8 9 0 11 12
Approval (to Execute)
Approval Statement x x x x x x x x x x x xpersons x x x x x x x x x x x xtitles x x x x x x x x x x x xPurpose
Reason for the validation x x x x x xExpected outcome x x x x x x x xresults and conclusion x xStatement : applicable IOQ's have been completed xStatement: report contains the results of…. x
Scope
Process in scope x x x x x xProduct/part in scope x x x x x x x x x xSystem Identification x x x xProduct matrix of all catalog numbers in scope x x x x x x x x x xLocation x x x x x x xStrategy Reference x x x x x x x xListing of processing elements x
© Cordis Corporation 2004 155-2862-1 32
Group Technology Analysis
• Analyze data to identify groups (patterns, %)
All%
Allprotocols
%
Allreports
%Facility Equipment Utility
Common elementApproval (to Execute)
Approval Statement 100 100 100 100 100 100persons 100 100 100 100 100 100titles 100 100 100 100 100 100Purpose
0 0 0 0 0 0
Reason for the validation 54 90 46 25 33 100Expected outcome 69 100 33 100 33 100results and conclusion 23 0 0 0 100 0Statement : applicable IOQ's have been completed 8 14 0 25 0 0Statement: report contains the results of…. 8 0 33 0 0 0Scope
0 0 0 0 0 0
Process in scope 8 14 0 25 0 0Product/part in scope 54 57 33 75 67 33System Identification 85 86 67 75 100 100Product matrix of all catalog numbers in scope 31 29 33 25 33 33Location 77 100 100 100 0 100Strategy Reference 62 71 67 50 33 100Listing of processing elements 62 86 33 100 33 67
GROUP TECHNOLOGY ANALYSIS
© Cordis Corporation 2004 155-2862-1 33
Job Standardization
• Develop standard process for common groups.• Focus improvement initiative on occurrence:
System Type
EQUIPMENT87%
UTILITIES11%
FACILITIES2%
© Cordis Corporation 2004 155-2862-1 34
Job Standardization
Change Type
MOVE EQUIPMENT33%
UPGRADE EQUIPMENT13%
UPGRADE SOFTWARE13%
NEW EQUIPMENT11%
EXISTING EQUIPMENT6%
MINOR TOOL MODIFICATION6%
UPGRADE ROOM2%
NEW UTILITIES2%
REPAIR EQUIPMENT3%
NEW TOOL 5%
MOVE LINE DIFFERENT BUILDING
6%
Same Type of Validation
• Develop standard process for common groups.• Combine groups with similar common elements:
© Cordis Corporation 2004 155-2862-1 35
Group Technology Analysis (Compliance)
• Identify common elements based on internal and external requirements
pro
toco
lfo
rma
t
rep
ort
form
at Internal procedure
#1
Internal procedure
#2
Internal procedure
#3
Internal procedure
#4
1987 FDA Guidance
GHTF.SG3 N99-10(2004)
Common elementApproval (to Execute)
X X
Approval Statement X Xpersons x xtitles x x x xPurpose
X X
Reason for the validation x xExpected outcome x x xresults and conclusion
Statement : applicable IOQ's have been completed
Statement: report contains the results of….
ScopeX X
Process in scope
Product/part in scope x xSystem Identification x xProduct matrix of all catalog numbers in scope xLocation
Strategy Reference xListing of processing elements x
© Cordis Corporation 2004 155-2862-1 36
Group Technology Analysis (Compliance)
• Improve alignment to regulatory requirements• Remove non value added elements /
requirements from existing procedures
© Cordis Corporation 2004 155-2862-1 37
Value Stream Map (VSM)
• ‘Walk the actual process’ (not the procedure)• Map the process• Identify and collect critical metrics
© Cordis Corporation 2004 155-2862-1 38
Current state VSM
176 hrs
I dle Time = 288 hrs(36 days)
Processing Time = 386 hrs(48 days)
Product Development Team
Tact Time = 1.7 Days(includes PQ Protocol &
Report)
1 hr 160 hrs 1 hr80 hrs
PQ Report Approval
9
Generate PQ Report
1
20 daysC/T
Y ield N/A
Protocol Execution
27
10 daysC/T
Y ield 30%
PQ ProtocolApproval
8
1 hour (est)C/T
Y ield 27%
Generate PQProtocol
1
18 daysC/T
Y ield N/A
DesignCharacterizationSummary Report
Released
1 min (est)C/T
Y ield N/A
1 hour (est)C/T
Y ield 28%
56 hrs
144 hrs0
PQ Current StateValue Stream Map
IProtocol in Sign-
Off(7 days)
IDelay f or product
build(22 days)
IReport in Sign-
Off(7 days)
148 PQ’s per YearDemand
Available Time
Days per Week
Weeks per Year
250 Days per Year
50
5
0(cPDM)
56 hrs
© Cordis Corporation 2004 155-2862-1 39
Brainstorm improvement opportunities
‘Kaizen bursts’• Green: Implement now• Yellow: Get more data• Red: Implement later
© Cordis Corporation 2004 155-2862-1 40
VSM – Kaizen Bursts
176 hrs
I dle Time = 288 hrs(36 days)
Processing Time = 386 hrs(48 days)
Product Development Team
Tact Time = 1.7 Days(includes PQ Protocol &
Report)
1 hr 160 hrs 1 hr80 hrs
PQ Report Approval
9
Generate PQ Report
1
20 daysC/ T
Y ield N/ A
Protocol Execution
27
10 daysC/ T
Y ield 30%
PQ ProtocolApproval
8
1 hour (est)C/ T
Y ield 27%
Generate PQProtocol
1
18 daysC/ T
Y ield N/ A
DesignCharacterizationSummary Report
Released
1 min (est)C/ T
Y ield N/ A
1 hour (est)C/ T
Y ield 28%
56 hrs
144 hrs0
PQ Current StateValue Stream Map
xxxx
Sign-Off meetings?Other methods f ormanaging approvalprocess; Perf orm
VOC with eff ectiveteams
IProtocol in Sign-
Off(7 days)
IDelay f or product
build(22 days)
IReport in Sign-
Off(7 days)
I mprove yieldthrough standardprocess outputs
148 PQ’s per YearDemand
Available Time
Days per Week
Weeks per Year
250 Days per Year
50
5
Simplif y deviation process;defi ne what is a deviation;
mistake-proof documentXxxx system to prevent
certain types of deviations;electronic f orm routing
0(cPDM)
56 hrs
PQ ReportGenerator (xxxor xxx f ormat)
I mprove yieldthrough standardprocess outputs
Ensure that all inf ois available and
prerequisites aremet prior to
initiating protocol -Checklist
Clarif y inf orequired – use
more tables!
Expertise ofdocument authors –
xxx training;dedicatedresources?
Train project leaderson validation projectmanagement; provide
skeleton planReview
approvalmatrix
Checklist f orreviewer
responsibility
Pareto of rejectreasons – what
are primaryopportunities?
Establish pre andpost-sterile
correlation incharacterization sothat PQ testing canoccur pre-sterile
Projectplanning f or
lab resources
Establishbasic testing
capabilities ateach site
Write procedurewith appropriate
detail f orexecution – xxx
concept?
Eliminateredundantinf ormation
f rom protocol
Pareto of rejectreasons – what
are primaryopportunities?
© Cordis Corporation 2004 155-2862-1 41
Future State VSM
• New process design / lay-out• Targets
© Cordis Corporation 2004 155-2862-1 42
Future state VSM
176 hrs
I dle Time = 288 hrs(36 days)
Processing Time = 386 hrs(48 days)
Product Development Team
Tact Time = 1.7 Days(includes PQ Protocol &
Report)
1 hr 160 hrs 1 hr80 hrs
PQ Report Approval
9
Generate PQ Report
1
2 daysC/ T
Y ield N/ A
Protocol Execution
6
10 daysC/ T
Y ield 90%
PQ ProtocolApproval
4
1 hour (est)C/ T
Y ield 90%
Generate PQProtocol
1
2 daysC/ T
Y ield N/ A
DesignCharacterizationSummary Report
Released
1 min (est)C/ T
Y ield N/ A
1 hour (est)C/ T
Y ield 95%
56 hrs
144 hrs0
PQ Current StateValue Stream Map
IProtocol in Sign-
Off(2 days)
IDelay f or product
build(10 days)
IReport in Sign-
Off(2 days)
148 PQ’s per YearDemand
Available Time
Days per Week
Weeks per Year
250 Days per Year
50
5
0(cPDM)
56 hrs
© Cordis Corporation 2004 155-2862-1 43
Gauge RnR (Attribute)
Can be applied to the transactional process.
Basic steps:• Map the process and Identify all possible outcomes of the
process• Design gauge RnR• Develop different scenarios• Develop repeats (alternative description of scenarios)• Have different users evaluate the different scenario’s
(blind)
• Analyze the variation
© Cordis Corporation 2004 155-2862-1 44
Gauge RnR
Identify all possible
outcomes of the
transactional process
© Cordis Corporation 2004 155-2862-1 45
Gauge RnR
Design gauge RnR
2 people 5 scenarios 4 repeats
Joe Sally
Scenarios 1 2 3 4 5 1 2 3 4 5
repeats 1234 5678 .… .… .… …. 1234 5678 .… .… .… ….
© Cordis Corporation 2004 155-2862-1 46
Gauge RnR
Few examples of different scenarios
(Process for handling deviations):• You are analyzing the data from a PQ, and you realize that the
statistical method prescribed in the protocol is not appropriate. You can use the existing data, but you decide to use a different statistical method for the analysis.
• You are conducting a PQ test, and you accidentally drop one of the test units on the floor and damage the unit. You decide to replace the test unit with an extra unit from the same lot.
Repeat:• You accidentally scratched the surface of a test unit. Since there are
sufficient units in the lot, you decide to take a new unit from the lot and use this for testing.
© Cordis Corporation 2004 155-2862-1 47
Gauge RnR
Analyze the variation in the study results to determine:• Do appraisers classify the same scenario in the same way
each time? (% Matched Within Appraiser)
• Did each appraiser correctly classify the scenario as compared to the standard? (% Matched Appraiser vs. Standard)
• Do the appraisers’ classification agree with each other? (% Matched Between Appraisers)
© Cordis Corporation 2004 155-2862-1 48
Analyze data
What about:
• Scenario number 1?
• Scenario 2?
• Scenario number 5?
2 people 5 scenarios 4 repeats
Minitab: Stat>Quality Tools>Attribute Agreement Analysis
Scenario Appraiser Repeat Measurement Standard Scenario Appraiser Repeat Measurement Standard1 Joe 1 1 1 4 Joe 1 3 3
Joe 2 1 1 Joe 2 3 3Joe 3 1 1 Joe 3 3 3Joe 4 1 1 Joe 4 3 3Sally 1 1 1 Sally 1 3 3Sally 2 3 1 Sally 2 3 3Sally 3 1 1 Sally 3 3 3Sally 4 1 1 Sally 4 3 3
2 Joe 1 1 2 5 Joe 1 5 5Joe 2 1 2 Joe 2 5 5Joe 3 1 2 Joe 3 5 5Joe 4 1 2 Joe 4 5 5Sally 1 2 2 Sally 1 5 5Sally 2 2 2 Sally 2 3 5Sally 3 2 2 Sally 3 5 5Sally 4 2 2 Sally 4 5 5
3 Joe 1 4 4Joe 2 4 4Joe 3 4 4Joe 4 4 4Sally 1 4 4Sally 2 4 4Sally 3 4 4Sally 4 4 4
© Cordis Corporation 2004 155-2862-1 49
Considerations for an Attribute Gage R&R Study
– Clear and concise operational definitions are critical
– Each person makes a decision (pass/fail, 1,2,3,4.., etc.) for each scenario repeatedly
– The scenarios should represent the range of variation in the process
– People should make random and “blind” decisions; they should not know which scenario they are reviewing when they record their results
– Data must be balanced for Minitab—each person must decide each scenario the same number of times
© Cordis Corporation 2004 155-2862-1 50
Control Plans and Validation Metrics
© Cordis Corporation 2004 155-2862-1 51
Control Plan - Purpose
Classical: Maintain the validated state– Change Control– APR / Periodic Review – Time based re-validation
SixSigma: Enable effective decision making“what gets measured gets managed”– Maintain performance level (set targets)– Identify improvement opportunities– Sustain gain
© Cordis Corporation 2004 155-2862-1 52
Metrics
Classical: Reported as part of the Quality System – Metrics rolled up in Quality Management Review
SixSigma:– Based on causal thinking
Process output
Machine
MenMaterialsMother Nature
MeasureMethodMachine
MenMaterialsMother Nature
MeasureMethod
© Cordis Corporation 2004 155-2862-1 53
Causal thinking y = f(x1, x2,…, xn)
Causal Driver Hierarchy
Process output
Drivers (x’s)Dirver of Drivers (x’s)
xxxxx …xxxx … x
xxxx … x
x
...
Process output
Drivers (x’s)Dirver of Drivers (x’s)
xxxxx … xxxx …xxxx … xxxx … x
xxxx … xxxxx … xxxx … x
x
......
© Cordis Corporation 2004 155-2862-1 54
Useful Metrics
A metric is:• A standard or unit which can be measured• The dimension, capacity or amount of something• A means to assess performance
Specific/Systematic (linked to business needs)Measurable/MeaningfulAgreed-upon/ActionRelevant/ Rooted in factsTangible/Thoughtful
© Cordis Corporation 2004 155-2862-1 55
Balanced Metrics
Leading vs.. Lagging• Causal Effect drivers are leading and may be used for
a proactive approach e.g analysis, decision making and corrective actions
• Indicators measured near or at the end of process are lagging, they are useful for overall analysis but they lag the Causal effect link
Effectiveness vs.. Efficiency• Effectiveness is a metric for the result of a process• Efficiency expresses the capability of that process• Both are required to express the success of a process
(optimizing one often adversely affects the other)
© Cordis Corporation 2004 155-2862-1 56
Balanced Metrics
Leading
Lagging
Effectiveness
Efficiency
Supplier
Input Metrics
CustomerOutputProcessInput
Output MetricsProcess Metrics
X X
X
X XX
X
Examples:
•Leading: % engineer trained against validation procedures
•Lagging: % reject protocols
•Effectiveness: Validation related audit observations
•Efficiency: % of validation first time right
© Cordis Corporation 2004 155-2862-1 57
Dashboard Causal driver Hierarchy
Tactical
Strategic
More frequent
Less frequent
Linkage / Focus
Frequency of review
Mission: Compliant validations in an efficient manner
Key Outcome Measures (y's)
Strategic Objectives
# ObservationsValidation throughput
time/ Yield
Compliancy Efficiency
Key Drivers Measure (x's)
Approvaltime
Executiontime
# Reviewiterations
#Deviations
Responsetime
% trainedengineers
# Audits
# Fieldcomplaints
# NCR
# Test cases% trainedengineers
© Cordis Corporation 2004 155-2862-1 58
Features of a Well-Dressed Dashboard
# of Reviews
LCL and UCL
Average
Benchmark
Review
iterations
TimeF M A J J A
2
4
6
8
10G
oodQuick reference legend
i.e. “Trend down=Good”
Clean Data Display:Average and control limitsTrend and goal
Title X and Y axis
Chart legend andupdate frequency
DescriptionThis dashboard shows the number of iterations average per month.
The benchmark of 2 iterations is the goal.
ExplanationMore then 1 review means rework. Rework is waste. Waste needs to be minimalized.
Action planDescending trend is good.
Ascending is bad, requires root cause analysis and preventive action.
Description, Explanation and action plan
© Cordis Corporation 2004 155-2862-1 59
Interactive Exercise: Facilitating a transactional Kaizen initiative
改善
© Cordis Corporation 2004 155-2862-1 60
What is Kaizen
What is Kaizen ? ( 改善 - ky’zen)
• “Kai” means “change”
• “zen” means “good (for the better)”
• Gradual, orderly, and continuous improvement
• Ongoing improvement involving everyone
Kaizen is the lean manufacturing term for continuous improvement and was originally used to describe a key element of the Toyota Production System.
© Cordis Corporation 2004 155-2862-1 61
What is Kaizen
• Kaizen describes an environment where functional areas and individuals proactively work together to improve processes.
• Kaizen events focus resources and employees on a specific area to achieve real process improvements in a short period of time.
© Cordis Corporation 2004 155-2862-1 62
What is Kaizen
Most Kaizens have these common features:• Focus on making improvements by detecting and
eliminating waste• Use a problem solving approach that observes how the
process operates, uncovers waste, generates ideas for how to eliminate waste, and makes improvements
• Use measurements to describe the size of the problem and the effects of the improvement
Tools: Six Sigma and Lean Tools: Six Sigma and Lean
© Cordis Corporation 2004 155-2862-1 63
The benefits to applying Kaizen
• Solutions emphasize commonsense low-cost approaches,
Thus,• Continual adjustment and improvement becomes
possible and further desirable.
Creativity before capital!Creativity before capital!
© Cordis Corporation 2004 155-2862-1 64
Transactional Kaizen
• Improvement opportunities in transactional processes:
• Simplify/streamline processes• Reduce lead times• Eliminate mistakes/rework
All these alternatives can be combined in a broad improvement plan.All these alternatives can be combined in a broad improvement plan.
© Cordis Corporation 2004 155-2862-1 65
Scope of transactional Kaizen
• Goals must be 100% achievable during the Kaizen Event
• Results must be quantifiable• Must meet the business objectives of the
organization
© Cordis Corporation 2004 155-2862-1 66
Event Format
• Clear expectations• Start times & end times• Dedicated participation• There are no bad ideas• Transparent roles & responsibilities
© Cordis Corporation 2004 155-2862-1 67
Activity Flow
Review Base
Condition
Identify
Waste
Problem
SolveCommunicat
e
Coordinate
Verify
Measure
Update
Job Standardizati
on
Present
Out-Brief
Implement
Solutions
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1 week Kaizen using DMAIC approach
Day 1: Define• Training• Why are we here• Walk the process• Review existing data• Define goals and scope
Day 2-3-4: Measure and Analyze phases:• Investigate identified problems• Collect additional data• Solve identified problems• Identify waste• Develop Performance Metrics• Perform Risk Assessment• Pilot solution (if possible)• Identify Validation/Regulatory Requirements.
Measure
AnalyzeImprove
Control
Define
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1 week Kaizen using DMAIC approach
Day 5 Improve phase:• Implement improvements• Eliminate waste• Implement Performance Metrics
Ongoing: Control phase :• Verify and Measure improvements
Measure
AnalyzeImprove
Control
Define
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Conclusion
Kaizen events enable resources and employees to be focused on process improvements.
Questions?Questions?
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Contact information
Jan C. Crielaard
Cordis Corporation, a Johnson and Johnson Company
E-mail: Jcrielaa@crdnl.jnj.com
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References
• A.I.A.G. Measurement Systems Analysis: Reference Manual. A.I.A.G., 1990 (Available from A.I.A.G. (313)358-3570)
• Wheeler, Donald J. and Lyday, Richard W. Evaluating the Measurement Process, Second Edition. Knoxville, TN: SPC Press Inc. 1989.
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References
• ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities, Volume 5 Commissioning and Qualifications, first edition March 2001 www.ISPE.org
• IVT, Technical Guide, Six Sigma and Process Validation Strategies www.ivthome.com
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References
• Siegfried Schmitt, The Manager’s Validation Handbook, Strategic Tool for Applying Six Sigma to Validation Compliance, PDA, DHI Publishing, ISBN 1-930114-84-2
• Don Tapping and Tom Shuker, Value Stream Management for the Lean Office Productivity Press, ISBN 1-56327-246-6
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References
• Mike Rother, John Shook, Learning to See, value –stream mapping to create value and eliminate muda, version 3 The Lean Enterprise Institute, www.lean.org, ISBN 0-9667843-0-8
• Shigeo Shingo, Zero Quality Control: Source Inspection and the Poka-yoke System Productivity Press, ISBN 0-915299-07-0
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