LEAN and AGILEapproach to manufacturingand process improvement

Raheel Shafiq Industrial & Manufacturing Engineer

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

IntroductionInstead 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

Lean Manufacturing

Over the last decade lean management has become the vital driver of;Operational changeEliminating ‘waste’Improving processes.

What is Lean Manufacturing?

“A systematic approach to the identification and elimination all forms of waste from the value stream.”

Lean ManufacturingFrom 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

Lean ManufacturingLean 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.

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.

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.

Key to Lean Manufacture is MeasurementNeed clear, objective focus on valueExample: 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 worthwhileActual Available Production TimeTheoretical time minus planned downtime and shutdownsThis is the realistic best available production time (100%)

Planned DowntimePM, Shutdowns, Holidays

Machine Running TimeActual production hours minus downtimesThis is possible production if 100% performance

Unplanned LossesBreakdowns, HR, Set-up time

Availability

Net Operating TimeMachine speed against theoretical speedThis is the possible output if 100% quality

Speed lossesIdling, minor stopages performance

Performance

Useful Production TimeMaterial in minus product outThis is the real output

Quality Losses, adjustments, Set-up waste

Quality

OEE

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

OEE (Overall Equipment Effectiveness)

• Metric 1: Availability:Availability = Run Time / Total TimeSimple OEE: The total run time of the machine subtracting all

unplanned downtime.

• Metric 2: Performance:Performance = Total Count / Target CounterSimple OEE: How well a machine is running when it is running.

• Metric 3: QualityQuality = Good Count / Total CountSimple OEE : How many good parts versus bad parts a machine

has produced.

OEE (Overall Equipment Effectiveness)OEE begins with Planned Machine Run Time and withreductions 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

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.

Six Big Losses

Addressing & Improving the Loss Events of OEE:

Breaking OEE data up into the three metrics helps monitor and analyze thedata. 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.

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 machine.

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.

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

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 thePlant Manager, this production monitoring solution visualizes information that can help everyone recommend solutions.

MethodologyIn 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) machineStep 2. Draw up OEE definitionsStep 3. Define and organize OEE data-collectionStep 4. Train the teamStep 5. Collecting OEE dataStep 6. Processing OEE dataStep 7. Give the operators feedbackStep 8. Inform your management

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 study3.Standard data formula time standards4.Work sampling time standards5.Expert opinion and historical data time standards

OEE Example Calculation

OEE TERMINOLOGY(1) RUN TIME (Availability Metric) - The total production time thatthe 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.

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