The document discusses the history and concepts of lean manufacturing. It originated from Henry Ford's mass production system and was further developed by Japanese engineers like Ohno at Toyota. Lean aims to reduce waste and non-value added activities in production. It identifies seven types of waste like overproduction, waiting, defects. The document also outlines various lean tools used in manufacturing like just-in-time, 5S, standardized work, visual management and value stream mapping to reduce waste and optimize flow. It discusses how lean principles align with FDA's process analytical technology initiative to build quality into pharmaceutical manufacturing processes.

1. LEAN
MANUFACTURING
AND VALUE STREAM
MANAGEMENT
Prepared By,
Mythili Srinivasan,
Poona College of pharmacy,
BVDU.

2. LEAN MANUFACTURING AND VALUE
STREAM MANAGEMENT
History
 Henry Ford and his right-hand-man Charles E. Sorensen
first integrated lean manufacturing in 1913 and they created
the flow of production, also known as mass production.
 Japanese engineers from Toyota, Taiichi Ohno and Shigeo
Shingo, reviewed Ford's concept and invented the "Toyota
Production System" in 1930.
 They also introduced right-sizing machines to ensure the
quantity needed, self-monitoring machines to ensure the best
quality and they pioneered quick changeovers.
 The "pull system" was then established whereby each step
will notify the following step with materials needed to keep
the work continuous and the work performed faster and
easier with less costs and inventory.
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3. LEAN MANUFACTURING AND VALUE STREAM
MANAGEMENT
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 Lean means – Slim+ Strong
 Lean manufacturing is a strategy that aims to reduce the different types of wastes
encountered in the production cycle thus generating higher profits, better quality and
customer value.
 Lean wastes
 Lean wastes have been developed by lots of authors who studied lean manufacturing and who
tried to identify the reasons behind the high costs of production.
 Tinoco (2004), Vu (2007) and Miller, Pawloski, & Standridge (2009) described 7 types of
lean waste as follows:
1. Waiting consists of the time needed between steps due to quality inspection and testing,
space between stages, which can delay the process and add non-value added activities.
2. Overproduction is linked to non-required items leading to high cost and bigger inventory.
3. Excess inventory consumes a lot of time and needs a bigger storage thus increasing the cost.
4. Over Processing is when industries purchase more sophisticated equipment than needed.
5. Defects lead to a rework operation or a destruction of the units produced; consequently to a
waste of products and time.
6. Transportation waste occurs when operators do not move the products with care and focus
causing defects.
7. Motion includes movement of the employees in addition to health and safety issues.

4. LEAN MANUFACTURING AND VALUE STREAM
MANAGEMENT
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5. LEAN MANUFACTURING AND VALUE STREAM MANAGEMENT
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6. LEAN TOOLS
The lean tools are discussed as follows:
 Just in time - By using the quantity needed, the time frame required and assuring the best quality of
product for the customer and this to operate in a faster way.
 5S Visual Workplace: This tool assures the continuous improvement by ameliorating the cleaning
performance. 5S steps are sorting (to eliminate useless items), shining (to keep workplace clean),
setting in order (to keep everything in place), standardizing and sustaining (to assure continuity).
 Standardized Work in order - To eliminate unnecessary inventory by the first line supervisors.
 Total Productive Maintenance (TPM) - Ensures a better performance of the equipment by maintaining
them in a good condition thus reducing the risk of troubleshoot and failure.
 Load Balancing - Aims to reduce the batch size to meet customer’s demand on time.
 Pull & Kanban Systems: It states all the information of the current stage and which parts are needed for
the next stage in order to respond quickly to the changes in the process for a better coordination.
 Work Cells: Each step needs to be completed before the next one is initiated in order to better organize
the work, to reduce the in-process inventory and to reduce the labour costs as different machines work
simultaneously.
 Rapid Changeover (SMED): It aims to fasten the way the changeover is performed in order to reduce
non-value added activities and the high costs generated from the waiting.
 Mistake-Proofing: It aims to reduce or prevent errors.
 Kaizen or “Continuous improvement” - Aims to involve all employees in the operation process and
this training them and coaching them on their tasks.
 Value Stream Mapping (VSM) - It is a visual representation of the whole production process in order to
eliminate all non-value added activities, emphasis on the value-added activities in the process and identify
waste.
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7. LEAN TOOLS
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8. LEAN TOOLS
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9. LEAN SIGMA PRINCIPLES
1. Specify value in the eyes of customer.
2. Identify the value stream and eliminate waste and variation.
3. Make value flow at the pull of the customer.
4. Involve, align and empower employees.
5. Continuously improve knowledge in pursuit of excellence.
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10. LEAN PROCESS
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11. LEAN VALIDATION
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12. APPLICATIONS OF LEAN SIGMA
1. Robust process design and development.
2. Robust technology/Process transfer.
3. Design of experiments
4. Control charting – OOC symptoms before they become OOS.
5. Understand source of variation- Process Vs measurement system.
6. Measurement system analysis – Prospective Vs retrospective.
7. Error proofing.
8. Standard work.
9. DMAIC
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13. LEAN TOOLS – EXAMPLES
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14. PROCESS FLOW MAPPING
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15. USE OF 5S IMPLEMENTATION
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16. HEIJUNKA SYSTEM
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17. HEIJUNKA SYSTEM IN MICROBIOLOGY &
CHEMISTRY LABS
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18. LEAN AND cGMP
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19. LEAN AND SIX SIGMA
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20. FDA’S PAT INITIATIVE
What is PAT?
PAT is a system for designing, analyzing and controlling manufacturing.
1. Timely measurements
2. Critical quality and performance attributes.
3. Raw and in process materials
4. Processes
The goal of PAT is to understand and control manufacturing processes.
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21. FDA’S PAT INITIATIVE
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22. CONCLUSION
 In a lean pharma manufacturing environment, cGMP and
lean must be equal partners. The cGMP standards together
with lean principles must be embedded into the culture of an
organization and the business strategy must reflect this.
 This challenge is less problematic because of recent changes
in regulatory thinking.
 The principles of FDA's PAT initiative appear to be
extremely well aligned with lean manufacturing .
 Companies are eliminating unwanted work and
incorporating efficient and cost effective work flow using
lean tools.
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23. REFERENCES
1. Lean Manufacturing practice in cGMP environment, Oct 1, 2006, Anne Greene, Dermot O
Rourke, Pharmaceutical Technology Europe, Vol 18, Issue 10.
2. An Introduction to Lean, Deborah Blecker-Shelly and Joel E. Mortensen, Continuing
Education Topics & Issues, August 2008.
3. www.ngpharma.com ,Design for Six Sigma and Lean Six Sigma for the Pharmaceutical and
Medical Industries, Tania Pinilla, Six Sigma Master Black Belt, Motorola University.
4. International journal for quality research, UDK 615:005.6 – Lean and six sigma concepts
application in pharmaceutical industry. Katarina Palovic, Vojislav Bosanic – Faculty of
Organizational sciences, Belgrade. Vol.6, NO.1, 2012.
5. www.pharmafocusasia.com, Pharmaceutical Manufacturers, Embracing Lean Six Sigma,
John E. Danese, Dennis Constantinou, Life Sciences.
6. S. Spear and H. K. Bowen, Decoding the DNA of the Toyota Production System (Harvard
Business Review, Boston, MA, USA, 1999)
7. H. Thomas, Transforming the Pharma Industry: Lean Thinking Applied to the
Pharmaceutical Manufacturing, Section 2, World Congress of Chemical Engineering
(WCCE7), Glasgow, UK, July 2005.
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