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Lean manufacturing Lean manufacturing Document Transcript

  • Lean Manufacturing in the Pharmaceutical IndustryWhat is Lean Manufacturing?Introduction: Lean Manufacturing is determining an efficient manufacturing process through the removal ofwaste, and implementing a flow, as opposed to batch and queue. It is not a stand alone orsingular process rather a philosophy that applies techniques to improve areas of the business.Some of the world’s most successful companies, including Toyota, are pioneers of leanmanufacturing. Their approach to lean manufacture is the reduction of waste human errors.Lean manufacturing elements can be implemented into any business stream frommanufacturing to laboratory operations, from warehouse to distribution centers. Leanmanufacturing is very powerful in that it can be designed and utilized to meet thePharmaceutical regulator’s requirements and reduce overall business costs. Leanmanufacturing and regulatory compliance are not mutually exclusive but can be combined todeliver simple but excellent performance improvements.Tools and Techniques:There are many tools in the lean manufacturing kit that can harness your best results and makethe best results the standard. These include:• Value stream mapping (VSM)• poke yoke• Standard work• Kaizen• The seven wastes• 5S.These elements can also form the basis for ‘visual factories’. How many times have you walkedinto your factory and not known whether the work place was in or out of control? Do you knowwhere that urgent certificate of analysis is or where the testing is up to? Lean manufacturingcan overcome all of these questions very simply.Value Stream Mapping (VSM)Value stream maps are used to ‘map’ your current operations from procurement of materials todelivered goods, and identifying the non-value adding steps.What is a non-value added step? Ask yourself, at any part of any process, would my customersbe willing to pay for this step to be completed?For example, would my customers pay for the labeling of product? The answer is yes becauseeach customer wants to know what they are consuming. Would my customers pay for 14 daysdelivery lead time that is part of the current process? The answer is no as value is not beingadded to the product at the delivery step.VSMs can be applied to even the smallest part of your process. When a process is mapped youcan then decide how to navigate your map and improve the journey from one end to the other. Page 1 of 5
  • Lean Manufacturing in the Pharmaceutical IndustryPoke yokePoke yoke is to ‘mistake proof’ or ‘fail safe’ your process. Poke yoke is a process that preventserrors from happening and allows easy detection of errors if they happen. Poke yoke must bebuilt into a process so the costs of re-work are minimized, if not eliminated.Standard workThe real value in standard work is that a process is monitored, measured and then rebuilt sothat all operators perform the task correctly, in the most efficient way, and in the same way.KaizenKai means ‘change’ and zen means ‘good’. Kaizen is similar to standard work in that a process istaken apart and re built - both techniques focus their energy on the factory floor where theprocesses actually happen.A kaizen activity, or ‘blitz’, takes a nominal 3-4 days and involves a number of key personnel.The process is dissected and all actions to improve the process must be realized andimplemented within those days of activity. All other interested parties must be kept informedof progress by using tools such as kaizen newspapers.The Seven WastesThe identification and value stream mapping of processes is generally used to eliminate theseven wastes. The reduction of the seven wastes in any organization will reduce process costsand help to develop a strong culture where processes are continuously improved. • What are the seven wastes? Overproduction; a customer will only pay for what they want • Transportation; adds no value to the customer’s product • Waiting; a customer will not pay for your waiting time • Motion; adds no value to the customer’s product • Processing; a customer will not pay for your administration time • Inventory; a customer will not pay for you to store product, but will be dissatisfied if they cannot obtain what they want when they want it. • Defects; no customer will pay for defective products, and the potential risk to customer’s well being must be mitigated.5SThe 5S process has a range of applications. Chemical industries use 5S to reduce the number ofworkplace accidents while other industries use 5S as a visual factory tool. With an implemented5S system you can recognize whether a work place is in control or out of control with a glance.It can be a very powerful tool in any office area.What are the 5Ss? • Sort; an aggressive process that uses a tag and release mechanism to discard unused items in a workplace • Set in order; where does equipment belong so that is accessible to operators and is conducive to smart work flow Page 2 of 5
  • Lean Manufacturing in the Pharmaceutical Industry • Shine; a clean workplace will instill pride and assist in creating a strong workplace culture • Standardize; so that what you have achieved is ‘standard procedure’ • Sustain; so that what you have achieved is maintained always.PRINCIPLES OF LEANThe five-step thought process for guiding the implementation of lean techniques is easy toremember, but not always easy to achieve: 1. Specify value from the standpoint of the end customer by product family. 2. Identify all the steps in the value stream for each product family, eliminating whenever possible those steps that do not create value. 3. Make the value-creating steps occur in tight sequence so the product will flow smoothly toward the customer. 4. As flow is introduced, let customers pull value from the next upstream activity. 5. As value is specified, value streams are identified, wasted steps are removed, and flow and pull are introduced, begin the process again and continue it until a state of perfection is reached in which perfect value is created with no waste.Methodoly: 1. Synchronization of manufacturing • Driven by demand rather than forecast • Continuous flow of work and people • Logical rhythm through the supply chain • Moving forward via downstream signals Page 3 of 5
  • Lean Manufacturing in the Pharmaceutical Industry 2. Elimination of waste • Non-value adding steps removed • Value adding steps broken down and linked • Problems solved at root cause (eliminate “rocks in water”)The methodology which should be adopted to reduce the waste & scrap and increase theproductivity in short, for implementing lean manufacturing in a pharmaceutical company,firstly, to monitor the production cycle and supply chain than, analyze the throughput time andyield, value chain and productivity and then apply work-study to reduce the unnecessary laborand material movements and reduce the time taken by each activity in its completion, improvethe throughput time and yield, the value added time and efficiency and implementautonomous maintenance, give trainings to the employees, introduce team formation andother success strategies like continuous innovation, brain storming and idea generation and lastbut not the least monitoring and reviewing activities and control the mishandling to happen inthe overall process.For the successful implementation of lean it is necessary to remove the elements of productionthat are unnecessary and add time, effort, cost but no value. These elements may be; • Any failure to fully utilize the time and talents of people. • Any motion that does not add value. • Any rework. • Over-processing. • Process Variability. • Waiting on parts, waiting for a machine to finish cycle. • Any inventory more than the minimum to get the job done. • Any nonessential transport is waste. • Producing too much, or producing too soon.After the implementation of lean in pharmaceutical industry the cellular flow concept will be; • End to end operations. • Continuous material movement, no inprocess storage. • Full visibility of all operations, preferably on same floor. • Each process should be pull system instead of conventional produce and push system. • In short only when one batch is completely produced next batch can be taken. • No inprocess quarantine. • Inspection and QC are non Value added activities (so time taken for inspection and quality control activities to be minimized). • Any process is in trouble, rest of the resources pours in to solve it immediately.Result: Page 4 of 5
  • Lean Manufacturing in the Pharmaceutical Industry Parameters Old Facility New Cellular Flow FacilityManufacturing Volume 10 – 20 Million 100 MillionValue added time ( % total 15% 40%time)Cycle Time ( Dispensing to 600Hrs 80HrsPacking)Distance Travelled by Batch 220 m 73 m(Dispensing to Packing)Distance travelled by QC 600 – 800 m 0mSampleyield 97.5% 99.6% Elements Gain Time Reduction in non value added time Motion Batch & QC sample movement reduced Inventory Max one batch inventory at each stage Waiting Reduction in waiting due to cellular flow Loss Reduction in yield lossOther lean benefits are; • Cycle time reduced from original 30 to 35 days to just 15 days. • Intermittent handling totally eliminated leading to substantial productivity improvement. • Bottleneck operations highlighted and addressed. • Risk of storing unlabelled products eliminated.References: • www.pharmout.net/.../white_paper_lean_pharma_m... - United Kingdom • es.kaizen.com/.../Kaizen%20Institute%20-... • www.smartconsultinggroup.com/.../lean-manufacturing-what-it-mean... • http://www.lean.org/whatslean/principles.cfm • http://www.leaningforward.co.uk/principles.htm Page 5 of 5