Lean Validation
Lorraine Patridge
Horizon
September 27th 2012
Agenda
1.0 Introduction
2.0 Presentation Outline and Objectives
3.0 Traditional Validation Process
3.1 Traditional Setup
3.2 Traditional System Map
3.3 21st Century Initiative Timeline
4.0 Lean Validation Process
4.1 Lean System
4.2 Lean Validation Overview
4.3 KPI’s and Deliverables
4.4 Case Study
5.0 Execution
6.0 Wrap up
6.1 Lean Validation Model
6.2 Key Takeaways and Q&A
1.0 Introduction
Lorraine Patridge – Process Excellence Manager
• Degree in Mechanical Engineering, CEng
• Diploma in Applied Project Management and qualified
as a ASQ Certified Quality Engineer.
• Engineering experience in Vistakon, Hewlett Packard,
Medtronic, Abbott, Boston Scientific and Horizon
• Lean Six Sigma training and achieved Green Belt
qualification.
1
2.0 Presentation Outline & Objectives
Scope
• To propose a Lean validation process suitable for use across a
manufacturing value chain creating:
• a ‘right first time’ approach
• reducing validation life cycle time
• providing an effective and efficient method to access changes and
results
Objectives
• Enable audience to review:
• a lean validation model
• a case study
• In conjunction with
• understanding a typical implementation plan
• having the opportunity to discuss validation systems
3.0 Traditional Setup & Challenges
Traditional System Setup
• System can be complex
• Ambiguous ownership
• Inconsistent information, assessment coordination
• Multi stage feedback to wide team
• Write, Review, Approve – multiple loops
• ‘They who shouts loudest wins’ - priority level differences
Challenges
• Long Lead times, cycle times
• Inconsistency
• High rework rates
• GDP challenges
• Uneven Resource load
• Can have risk gaps
• Training & Education requirements
3.1 Traditional System Map
2
3.2 21st Century Initiative Timeline
4.0 Lean System
Lean System Setup
• Simple understandable process/system
• Clear ownership
• Consistent direction
• Cross functional team input (VRB)
• Write, Review, Approve – streamlined process
Benefits
• Risk Based Validations
• Reduced Lifecycle Times
• Consistency/Standard approach
• ‘Right First Time’
• Resource Levelling
4.1 Lean Validation Overview
3
4.2 KPI’s and Deliverables
KPI’s
• Increased 1st time pass rate
• Validation Cycle Lead time
• Resource Levelling
• Reduce number of errors
• Increased Success Rate for validations
• Reduction of re-validation due to error
4.3 Case Study
Situation:
Validation Challenges:
• Monitoring of Validation
• Inefficient and
inconsistent
• Approval process
cumbersome
• No clear ownership
•Delivery: Over 50%
late, long, variable
lead times
•Quality: High rework
> 50%, high number
of GDP errors
Results:
End State:
• Dedicated Val team
• Efficient and consistent
approach to validation
• VRB Approval process
• Validation Lead owned
VMP
• Risk Based Streamlined
simple system
•Delivery: >90% on
time, consistent short
lead time with
predictable delivery
•Quality: Rework <
10%,
4.4 Case Study: VMP
VMP
Validation
Leader
•Dedicated Validation Team
Validation Admin
VCR
Equipment SME
EUF SME
Computer
Systems
Quality / Micro
Process/
Engineering SME
Calibration
Protocol
Standardised Documentation
Validation
System
Validation
Execution
Validation
Report
• Validation
Policy
• Validation
Procedure
• VMP
Validation
Change Control
• VCR
• Equipment
Control
Validation Tools
Special
Validation Tools
• EUF
Qualification
• Process
Validation
• Test Method
Validation
• Cleaning
Validation
• CSV
• Automated
Process
Controllers
4
4.4 Case Study: Control
VMP
Streamlined Approval Matrix
Systems
Quality
Manufacturing
Assurance
Engineering
Facilities
VCR
R&D
Xˢ
Xˢ
(X)
Xˢ
Xˢ
(X)*
Utilities
(X)
Process
Validation Review Board (VRB)
Protocol
Approved VCR
• Defined Validation
Deliverables
Validation
Execution
VRB + Admin
Validation
Report
Engineering
Quality
IT
R&D
Regulatory
Validation
Cross Functional Team acts as Validation Review Board (VRB)
4.4 Protocol / Execution / Report Before
Typical IQ (Duplicate Leak Tester) validation before changes:
FM-VCR to be
drafted
(5) QA,
Validation
, Ops/Mfg,
Eng, RA
(4) QA,
Validation
, Ops/Mfg,
Eng
FM-IQ Protocol to be
drafted
Senior Level
required (e.g. only 1
QA eng and only 1
ME and only 1 RA
person)
FM-X IQ/OQ Report to
be written, incl ~40
signatures for all
sections plus
signatures for raw
data
Senior Level
required (e.g. only
1 QA eng and only
1 ME)
(4) QA,
Validation
, Ops/Mfg,
Eng
Senior Level
required ( e.g. only 1
QA eng and only 1
ME)
Repeat
for OQ
Overall
Validation
System
Validation
Change Control
Basic Validation
Tools
•SOP Val Doc
Routing &
Approval
•SOP Validation
Change Control
•SOP Validation
Review Board
•FM-X1 VRB
•FM-X VCR
• SOP
Validation
13(*2)
Approval
signatures
•SOP 309
Design
Qualification
•SOP 148 EUF
Qualification
•FM IQ/OQ
Report
•FM IQ/OQ
Protocol
4.4 Protocol / Execution / Report After
•
Typical IQ/OQ (Duplicate Leak Tester) validation after changes
FM-VCR to
be drafted
(3) QA ,
Val,
Ops/Eng
Eng Level
required,
ratio versus
existing
system ~4:1
Overall Validation
System
• SOP Validation
(17)
FM-IQ/OQ Protocol
to be drafted
Combined
IQ/OQ
(2) QA,
Ops/Eng
FM- IQ/OQ Report
to be written, plus
signatures for raw
data
Eng Level
required,
ratio versus
existing
system ~4:1
(2) QA,
Ops/Eng
Eng Level
required,
ratio versus
existing
system ~4:1
7 Approval
signatures
Validation Change
Control
• SOP Validation
Change Control
(10)
• FM-X VCR
Basic Validation
Tools
Standarised
Documentation
• SOP EUF
Qualification (6)
• FM IQ/OQ
Protocol/Report
5
5.0 Execution
Evaluate
Current State
Review Cycles
Management reviews & Updates Monthly
Project Team Weekly
Phase 1
Stakeholder
input
Strategize
execution plan
Phase 2
Project
Resources
Primary
Site Champion
Lean Validation Expert
Doc Admin
Trainer
Secondary
Input from
• Engineering
• Quality
• Management
• Operations
Develop Tools
Train &
Educate
Rollout Pilot
Phase 3
Pilot Review
Go Live
6.0 Lean Validation Process Flow
6.1 Key Takeaways
•
•
•
•
Develop Lean Structure
Agree tools
Standardise approach
Simplify approach
•
Become effective, efficient and robust.
Thank you
Q&A
6