1. LEAN and AGILE
approach to manufacturing
and process improvement
Raheel Shafiq
Industrial & Manufacturing Engineer

2. Introduction
Manufacturing companies run up against capacity problems today.
They immediately look to increase;
 Overtime
 Add shifts
 Purchase new equipment.

3. Introduction
Instead they should look to optimize the performance of
their existing machines to increase;
 Equipment reliability.
 Minimize changeover times.
 Improve operator performance.
 Lower overall downtime.
 Reducing Bottlenecks
 Improving Machine Reliability
 Maintenance
 Maximizing Optimal Run Rates and Capacity

4. Lean Manufacturing
Over the last decade lean management has become
the vital driver of;
Operational change
Eliminating ‘waste’
Improving processes.
What is Lean Manufacturing?
“A systematic approach to the identification and
elimination all forms of waste from the value stream.”

5. Lean Manufacturing
From the Toyota shop floor, where the Toyota Production System was
first introduced, Lean solutions have evolved, become more
experimental and have now been implemented in all kinds of
manufacturing industries including the pharmaceutical manufacturing
sector.
Lean Building Blocks
Quick Changeover
Standardized Work Batch Reduction Teams
Quality at Source
5S System OEE Plant Layout
Visual
Cellular/FlowPull/Kanban TPM
KAIZEN

6. Lean Manufacturing
Lean is heavily based on the principle that;
Continuous improvement can be found through the
power of respect for people.
The culture of the company is crucial in
designing the business system that motivates people
to want to improve.
Teaching them the tools of improvement and
motivates them to apply those tools every day.
Lean therefore, must go beyond just the manufacturing
process and business strategy – it needs to involve all
employees, at all levels and not just the decision-
makers in order to be successful.

7. Lean In Pharma
 Several large pharmaceutical organizations had shown
a willingness to simplify operations and processes, and
reduce costs via Lean.
 Lean and cGMP(Current Good Manufacturing Practices) go
hand in hand, as quality is sustained at a
higher level with lower costs due to the Lean principles that are
applied.
 The company set up a series of Kaizen events (the Japanese
word for continuous improvement based upon knowledge), a
series of lean events to transfer and share company lean
knowledge.

8. Lean In Pharma
The question is “How can a manufacturing company
optimize the performance of their existing equipment?”
The answer is Overall Equipment Effectiveness
(OEE). OEE is an effective tool to analyze and improve your
production process.

9. Key to Lean Manufacture is Measurement
Need clear, objective focus on value
Example: OEE (Overall Equipment Effectiveness)
 A composite measure of the ability of a process to carry out
value adding activity
 OEE = % availability x % output achieved x % perfect
output
 If change to a process increases OEE it is worthwhile
Actual Available Production Time
Theoretical time minus planned downtime and shutdowns
This is the realistic best available production time (100%)
Planned Downtime
PM, Shutdowns,
Holidays
Machine Running Time
Actual production hours minus downtimes
This is possible production if 100% performance
Unplanned Losses
Breakdowns, HR,
Set-up time
Availability
Net Operating Time
Machine speed against theoretical speed
This is the possible output if 100% quality
Speed losses
Idling, minor
stopages
performance
Performance
Useful Production Time
Material in minus product out
This is the real output
Quality Losses,
adjustments, Set-up
waste
Quality
OEE

10. OEE (Overall Equipment Effectiveness)
• Overall Equipment Effectiveness (OEE) is a way to monitor and
improve the efficiency of your manufacturing process.
• Developed in the mid 1990’s,OEE has become an accepted
management tool to measure and evaluate plant floor
productivity.
• OEE is broken down into three measuring metrics of
Availability, Performance, and Quality.
• OEE empowers manufacturing companies to improve their
processes and in turn ensure quality, consistency, and
productivity measured at the bottom line.
• OEE = Availability x Performance x Quality

11. OEE (Overall Equipment Effectiveness)
• Metric 1: Availability:
Availability = Run Time / Total Time
Simple OEE: The total run time of the machine subtracting all
unplanned downtime.
• Metric 2: Performance:
Performance = Total Count / Target Counter
Simple OEE: How well a machine is running when it is running.
• Metric 3: Quality
Quality = Good Count / Total Count
Simple OEE : How many good parts versus bad parts a machine
has produced.

12. OEE (Overall Equipment Effectiveness)
OEE begins with Planned Machine Run Time and with
reductions from the three metrics.
 Availability takes into consideration any Down Time Losses
 Performance takes into consideration any Speed Losses
 Quality takes into consideration any Quality Losses

13. Six Big Losses
One of the major goals of OEE programs is to reduce and/or
eliminate what are called the Six Big Losses – the most
common causes of efficiency loss in manufacturing. The
following table lists the Six Big Losses, and shows how they
relate to the OEE Loss categories.

14. Six Big Losses

15. Addressing & Improving the Loss
Events of OEE:
Breaking OEE data up into the three metrics helps monitor and analyze the
data. The overall goal of the OEE tool is to reduce or eliminate these Loss
Events.
(1)Machine Breakdowns (events reducing availability)
Must eliminate unplanned downtime.
Downtime is the most critical factor to improving OEE because when the
process is not running you cannot address other metrics.
 Supplying downtime reason codes will help you monitor and specify a
particular source for later evaluation using Root Cause Analysis.

16. Addressing & Improving the Loss
Events of OEE:
(2) Machine Adjustments/Setups (events reducing availability)
 Tracking machine setup time is important to improving OEE.
 This time could include warm up time to consistently produce quality parts
or reducing the time it takes to exchange tooling/dies.
(3) Machine Stops (events reducing performance)
 Minimizing machine stops such as product misfeeds and component jams
will help improve performance.
 These stops are typically under five minutes and don’t require
maintenance to be called to the process.
 Train your machine operators to handle these events that occur on the

17. Addressing & Improving the Loss
Events of OEE:
(4) Machine Reduced Speeds (events reducing performance)
 Machine’s Target Counter will help determine the
Theoretical maximum speed of the machine.
Understanding the machine’s Ideal Run Rate (Target Counter) then
categorizing the data will help with your analysis.
Monitoring the data will help understand events such as
• tooling wear
• design capacity,
• training level of the operator running the machine.

18. Addressing & Improving the Loss
Events of OEE:
5) Machine Startup – Bad Parts (events reducing quality)
 Machine may produce bad product during the initial startup of the
process.
 Tracking these rejects from the machine will help pinpoint potential causes
that can be monitored and reviewed.
 Machine tolerances and temperature adjustments can be made.
(6) Machine Production – Bad Parts (events reducing quality)
 Eliminating bad parts/rejects are essential for all manufacturing machines
after the initial start up of the process.
 Tracking these bad parts will help you monitor the data to
discover possible patterns or causes in the manufacturing process

19. Addressing & Improving the Loss
Events of OEE:
The whole plant to be involved in the process of improving OEE.
From the Machine Operator to the Production Manager to the
Plant Manager, this production monitoring solution visualizes information
that can help everyone recommend solutions.

20. Methodology
In order to achieve this, a number of things must be arranged properly
during implementation.
You can proceed through the eight steps described one at a time. Once
OEE has been implemented, you carry out a critical step by step
evaluation in order to determine if any improvements can be made to the
measuring system.
Step 1: Select a (pilot) machine
Step 2. Draw up OEE definitions
Step 3. Define and organize OEE data-collection
Step 4. Train the team
Step 5. Collecting OEE data
Step 6. Processing OEE data
Step 7. Give the operators feedback
Step 8. Inform your management

21. Methodology
 The design is naturalistic as observing and recording ongoing
behavior, was done in natural settings.
 Collected data were the durations of various cycle loss times
components.
 The primary source of data is a time and motion study conducted
over day shifts. The secondary source is existing data from the mine.
 Motion study is design, while time study is measurement.
 The techniques of time study start with the last motion study technique,
which shows the close relationship between motion study and time
study. The techniques of time study are:
1.Predetermined time standards system (PTSS)
2.Stopwatch time study
3.Standard data formula time standards
4.Work sampling time standards
5.Expert opinion and historical data time standards

22. OEE Example Calculation

23. OEE TERMINOLOGY
(1) RUN TIME (Availability Metric) - The total production time that
the machine has been running and producing parts.
(2) SETUP TIME (Availability Metric) - The period of time on the
machine required for an operator to perform all the necessary
tasks to produce the first good part.
(3) DOWN TIME (Availability Metric) - The period of time the
machine is not available for production due to maintenance or
breakdown
(4) TOTAL TIME (Availability Metric) - The total accumulated
machine time of Runtime + Down Time + Setup Time.
(5) TARGET COUNTER (Performance Metric) - the number of
parts or cycles that should be completed at a particular point
within the shift, day, or production run.

24. OEE TERMINOLOGY
(6) TOTAL COUNT (Performance & Quality Metric) - The total
number of parts, good and bad, that are produced on a
machine.
(7) GOOD COUNT (Quality Metric) - The input count for any part
produced to manufacturing specifications on the machine.
(8) AVAILABILITY = Run Time / Total Time
(9) PERFORMANCE = Total Count / Target Counter
(10) QUALITY = Good Count / Total Count