March 09 1

QA for batch review
Lean
Muda
Kaizen
GSK Case study and approach
Findings & action plan & solutions
Results
Conclusion
March 09 2

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Extent of the process:
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Review of production batch records
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QC results
Deviation resolution
Previously released in-process batches
Environmental monitoring results
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Cleaning results etc.
The process requires :
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Input from several departments (production, QC, etc.)
Communication with departments/teams (production, QC and QC environmental monitoring team, etc.)
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Internal communication with QA deviation handling team
March 09 3

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Quality issues that don’t get resolved quickly can lead to: increased costs increased waste increased inefficiencies
March 09 4

Lean…the relentless pursuit of the perfect process through waste elimination
The more focus is placed on eliminating waste from systems the faster the lead times will be and the cost of production will be reduced
March 09 5

. . . any process or value stream
Lead Time / Cycle Time
Before
After
Work . . .
Value Add Time
Wait / Waste . . .
Non Value Add Time
Higher satisfaction
• Reduced cycles
• Better delivery
• More capacity
• Better quality
• Productivity
• Reduced waste
Lean attacks waste
March 09 6

Japanese word for waste but with deeper connotation:
Any non-value activity = Muda
Searching around to retrieve tools = Muda
Muda œ Direct loss of money or at least failure to increase efficiency
March 09 7

Motion
Unnecessary movement and energy used to perform tasks
Rework
Transport, poor timing too frequent or infrequent movement of documents
Inventory
Items not being actively processed to add value is waste
Waiting
Refers to time spent by QA waiting for batch/document to arrive, queue for their products to empty (backlog)
March 09 8

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Reducing waste brings closer to perfection
Continuously find ways to improve the process
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Keep the customer in focus…are we adding value?
cycle time
March 09 9

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Japanese term
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“Kai” means “Change”
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“Zen” means “for the better”
Kaizen:
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Continuous Improvement
Eliminating non-value adding time and steps
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Breaking barriers
Concept
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Small incremental improvements
Improvements add up over time
Kaizen does not necessarily mean an event or “Blitz”
March 09 10

Change process to apply the Lean principles, targeting waste
Not traditional meetings… intense, focus on action and speed
Key concept: try-storm instead of brainstorm
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New ideas are tried quickly, observe results
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Quick iterations: try-observe-improve and repeat
No money…it’s about creativity, not $ solutions
March 09 11

Activities performed by the team :
Batch record issuance
5 sequential batch record reviews by the team for each batch of product
Deviations investigation and resolution
OOS follow-up
Specification sheet management
Answer to questions from all departments: RA, other QA team, compliance, manufacturing, QC, maintenance, etc.
March 09 12

Situation :
Request from higher QA management to optimize the QA team activities
QA team with several past issues in team management
Team not efficiently organized
Constant race for batch release
Knowledge of significant time wasted
Internal Kaizen just started batch release optimization
Solutions identified in-process of implementation
Microsoft Excel
Worksheet
March 09 13

Mandate :
Maintain department activities
Do not slow down activities
Lean the activities of the team
Rebuilt team confidence
Implement and improve on-going Kaizen to focus on the team field of activities
Means :
Team of two persons to manage the project and supervise the team: one internal GSK Project Manager one QA/Compliance Specialist (SLP) familiar with the GSK QA team
March 09 14

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Goal :
Improve performance
Simplify flow
Improve quality
Minimize delays
Optimize productivity
Improve work conditions
Maintain work
Reduce
Waste
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Means : Activities analysis to improve efficiency (time Ö cost)
March 09 15

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One tool : established and logical analysis process
Process : c Observe and document internal processes d Identify strengths e Evaluate gaps and opportunities for improvement f Apply our experience and knowledge of other industries and clients g Propose practical solutions (personnel, methods, documentation…)
March 09 16

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Activities of greatest value
Major cost areas or consuming large portion of resources
Activities where need for improvement is already known
Activities considered important in achieving organization's goals & priorities
Analyse process to determine specific issues / items to optimize / flow of documents and information
March 09 17

Movement of documents and information down the value stream
Objective is continuous flow as product, documents and information is transformed by continuously adding value
Flow is created by eliminating queues and stops, and improving process flexibility and reliability
March 09 18

How long (total elapsed time) does each batch review process take?
What is the efficiency of the process (active time vs. total time)?
What departments are involved? In what way? Who, how and when?
What is the flow of documents?
What is the flow of information?
How is the coordination done with the production department? With the QC department?
What are the communication processes?
Who coordinates the batch review process?
Where are the documents?
March 09 19

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Identify process batch review boundaries
Turn clouded, confused situation (who does what, when) Â logical sequence of events (process steps)
Identify all actions, decision points, feedback loops
Understand departments and functions involved in process and their role
Understand interdependencies of the batch review process with other processes (manufacturing schedules, regulatory release expectations, etc.)
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Understand critical factors affecting performance
Recognize "disconnects" (things that should be happening but are not)
C Identify illogical work flow
March 09 20

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Loss of QC/EM results
Information filed in various locations
Working in silos
Communication with production and QC not easy
Time lost to search for information (QC, EM, deviation)
Little team internal coordination
Multiple reviews to finalize batch records
March 09 21

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Based on process mapping and information gathered:
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Analyze how work
"currently" gets done
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Cycle time involved
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Identify bottlenecks, waste, duplication and rework
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Propose optimization:
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Personnel (qualification, location)
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Documentation flow
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Sequence of activities
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Communication methods
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Computerized system needs
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KPI identification
March 09 22

Reorganization of the team by :
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Relocation of the team
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Document control implementation
Centralize information
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Addition of targeted personnel
Constant involvement of the team
Implementation of solutions one step at a time
March 09 23

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Implemented Tools
Batch status board
Guidance documents
Informative tools
Implementation of Document Logs
On-going practical training
Documentation flow improvement
March 09 24

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Means:
Continuous involvement of the team
Participation of the QA team to implement the document control
Availability and involvement of the team supervisors
March 09 25

Built a true team spirit
Team took back ownership
Centralization of the information at the document control resulting in:
No more loss of documents
Improvement of traceability
Back log resolved
Time saving results during batch review process: 20%
Improvement of relationship with other departments (mostly production and QC)
Improvement process continued by the QA team after the project … lean approach thinking acquired
March 09 26

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“Easy wins” to build confidence
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Implement selected solutions
(including continuous on-work training)
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Implement KPI and start recording data for baseline
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Follow implementation
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Ensure internal transfer of knowledge
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Periodic review of results and improvement
March 09 27

Learn …
Communication, awareness, training
Experience …
Kaizen events in physical process areas, workflow analysis in spatial planning
Apply …
Strategic departmental areas, critical / high waste processes Æ develop pilot tests
Adopt …
Lean as a part of the toolkit, part of the culture
March 09 28

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Solutions:
Compliance (design and layout review)
Quality Assurance (quality system, audit, training, SOP, deviation, CAPA, annual review, etc.)
Regulatory Affairs (establishment licence, drug licence application, medical device licence application, PSN, clinical trial)
Field of expertise:
Animal facility, API, Biotech (vaccines), Blood & Tissue Products (cell culture, gene therapy), High Potency Compounds, Laboratories, Medical Devices,
Natural Health Products, Sterile Products (injectable)
Julie-Léa Lipszyc
Senior Compliance Specialist / Project Manager
Quality Manager
Tel : 514 735 5651
Cell: 514 299 9938
Julie.lipszyc@snclavalin.com
March 09 29