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QuestionRead information below about Camacho, D.C. (2015). Mega Pack Line…Read information below about Camacho, D.C. (2015). Mega Pack Line Blow-up: DMAIC Roadmap Boston Scientific. Describe the tools used in each one of the DMAIC phases in this project. create a table with that information. What tools you think may have been redundant? What other tools you may have used to complement each of the DMAIC phases? Include costs, DPMO, sigma levels, and process capabilities if available. include a conclusions.Camacho, D.C.(2015)Making the Case for QualityMega Pack Line Blow-Up:DMAIC Roadmap Leads Boston Scientific Herediato Reengineer Packaging LinesAt a Glance . . .The Mega Pack Line Blow-Up Project at Boston Scientific, Heredia (Costa Rica) was intended toimplement an efficient continuous-flow packaging line in the Amplatz Super Stiff™ Guidewires area.The project focused on integrating the sub-assembly operation within the hooping, packaging, andboxing areas, plus the installation and validation of an automated pouch sealer. Using a DMAICroadmap to identify and achieve positive results, the project resulted in a savings of more than$100,000 and positively affected many other aspects of production.About Boston Scientific, HerediaBoston Scientific is one of the largest recognized global companies dedicated to the design, manufacturing,and distribution of less invasive medical devices. Its products are used to treat a widerange of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’shealth, and chronic pain. Installed in 2004, the Boston Scientific site in Heredia, Costa Rica, manufacturesguidewires used for vascular and urological procedures, and ablation catheters to treat heartarrhythmias. There are more than 700 employees at the site.Why Quality?The value improvement initiatives constitute a key element in the endless journey of processimprovement required by Boston Scientific’s corporate improvement rates, which can be achievedfollowing set company standards guidelines. Mega Pack Line Blow-Up for Amplatz Super StiffGuidewire is an example of a high-performance initiative implemented at the Heredia site. Theguidewire represents the second highest value of production manufactured at Boston ScientificHeredia site, and provided a great opportunity for improving efficiency, space reduction, andquality—resulting in a cost saving and cost avoidance.In the fourth quarter of 2012, during routine metrics review, core team members within the hooping,packaging, sealing, and boxing of Amplatz Super Stiff Guidewires production areas detectedmultiple opportunities for improvement due to waste in nonvalue-added activities, replicationof inspections, space utilization, idle times, an operator-dependent sealing process, and lack ofone-piece flow due to manufacturability of the cell design. This improvement opportunity was strategicallyplanned to be executed for the following year.The major changes incurred and tools used as part of this project were the implementation of anautomated band sealer in replacement of the old manual sealers, and the application of process simulationsoftware to estimate future production outputs. The second major change was the rebalance ofthe line to obtain a one-piece flow, applying lean manufacturing tools.by Daniel Calvo CamachoJanuary 2015ASQ www.asq.org Page 1 of 5Reengineering the Guidewire PackagingProduction ProcessAn Amplatz Super Stiff is a guidewire constructed of a flat wire that produces a larger inner core, increased stiffness, added strength for easier access, and better stability during catheter placement and exchange, which is ideal for use in severely obstructed tracts. It is used during the diagnosis of interventional or endoscopic biliary procedures. It is provided with polytetrafluoroethylene (PTFE) coating to reduce friction of the device during clinical procedures. It is offered in .035 in. and .038 in. diameters with either straight or J tip configurations. The product is inserted in a carrier tube (hoop) and then is packaged in a pouch. This particular device is shared among three different divisions in hospitals: peripheral interventions, urology, and endoscopy.The Mega Pack Blow-Up Project was executed following the steps of the define, measure, analyze, improve, and control (DMAIC) roadmap, a decision based on following a best-practice methodology for improvement projectsaccording to company standards.DefineThe hooping, packaging, and boxing areas of AmplatzSuper Stiff Guidewires were found subject to improvementin the following areas (see Figure 1):• EfficiencyASQ www.asq.org Page 2 of 5• Reducing transportation of materials (by 285 feet)• Headcount reduction (direct labor) to eliminate nonvalue-addedactivities• Optimization of inspections and process flow by eliminatingrepeated activities• Integrating current cell station in a one-piece flow manufacturingline, reducing cycle time, improving quality inspections, andreducing scrap of componentsMeasureAccording to the work content graph, the output of the hooping,packaging, and boxing areas was about 3,600 units from both shifts.The total amount of product transportation is 258 feet during hoopingand boxing. In terms of head count, the state of direct laborneeded for the operations of these areas is 29 operators. Finally,inspection activities repeated by multiple individuals, such as cosmeticdefects, were found in the packaging and boxing areas, leadingto inefficiency and delay of operations.AnalyzeA process simulation was completed considering the potentialintegration of the hooping, packaging, and boxing areas, while alsoassuming the standard cycle time of an automated band sealer andthe potential reduction of nine product builders (seven operatorsFinal station configuration once the Mega Pack Line was implementedwith the automated band sealer and hoops transportation carousel.Cross-section of an Amplatz Super Stiff Guidewirein the packaging area and two in boxing). Based onthis model, a potential target of 4,100 units per shiftwas identified considering the elimination of oneshift, which could increase the site’s efficiency underthe assumption of a one-piece flow process and thechange of takt time (pace of manufacturing unit byunit) from 12 seconds per unit to 7.6 seconds per unit.ImproveThis phase was divided into two main activities:• Kaizen Event: With participation from productbuilders, quality technicians, and engineers thisevent demonstrated integration of manufacturingareas—specifically the hooping and packagingwork stations—by implementing a mechanicalcarousel that constantly moves the insertedguidewire in the hoop (see photo below). The mainbenefit was eliminating product transportationlong distances, which contributes as a poka-yokeitem (mistake-proofing device) that provides atakt time to the line. In addition, the boxing arealayout was redesigned to be more ergonomical,reduce space, and balance with the packaging workstations to achieve a one-piece flow. Participationof the product builders and other functional areaspromoted engagement and participation during theexecution of this project.• Automated Band Sealer: Since a new pieceof equipment must be installed as part ofthe production line integration, this piece ofequipment was designed to Boston Scientific’spolicies, and then a full process characterizationwas executed to guarantee the sealing process wascapable and met specifications. Preliminary resultsobtained from the factory acceptance test (onceequipment was built) were analyzed, and then adesign of experiments (DoE) and confirmationrun were executed to release the process forvalidation (see Figure 2). One of the main goals of this activity wasto confirm a single operational process range for the two types ofpouches currently used, and avoid resetting of the equipment duringproduction order changes. Seal strength and seal width were fullyanalyzed as main outputs to be controlled.ControlThis final activity was performed in two main steps.• Process Validation of the Automated Band Sealer: Respectiveoperational qualification/process qualification activities weresummarized and successful results of the process validation wereproperly documented through respective reports. This confirmed theresults obtained as part of the process characterization previouslyProposed hoop transportation carousel documented, and at the same time, falls within therequirements of Boston Scientific’s quality system forrelease of manufacturing changes similar to this case(see Figure 3).• Dry Run: Once the process validation activities werecompleted, the dry run was performed with the main intentionto document any potential gap of facility installations, sealerperformance, understanding of the new process flow by theoperators, and challenge of the target outputs defined as partof the simulation model explained in the measure phase.Final implementation of this project occurred in lateMarch 2013. More than one year after completion, its mainbenefits in several business metrics provide sufficient evidenceto summarize its results in the following section.ResultsMain results obtained due to the Mega Pack Blow-Up weretracked through several different indicators, including:Efficiency and ServiceThe improvement project reduced product transportation by51 percent (moving from 258 feet to 120 feet in materialstransportation). The reduction then increased the idle spacein the manufacturing floor by 711 square feet, which allowedfor the introduction of new manufacturing lines. Finally, theefficiency of the line was improved by about 15 percent, witha base line output improvement of 3,600 units (two shifts) to4,100 units (one single shift). The final design of the line providedan increase in production capacity of 63 percent.Thanks to the process characterization activities performed inthe band sealer, the project identified a single process parameterrange for the two types of pouches used for Amplatz Super Stiff,eliminating potential downtimes caused by setting parameters.SafetyNew working stations were designed and implemented,including the implementation of a mechanical carousel thattransports the product; the implementation of an automatedband sealer machine eliminating operator dependency duringthe sealing operation; and finally, the boxing station wasimproved with a new design and better ergonomic conditionsfor the operators.QualityQuality at the source was implemented due to the integrationof the hooping, packaging, and boxing areas. This meantredundant inspections were eliminated and appropriate controlswere relocated to guarantee the quality of critical outputsASQ www.asq.org Page 5 of 5(avoidance of quality incidents—five based on baseline of2012) and provide a leaner manufacturing process. Thisrepresented an overhead reduction of about $33,000 by therelocation of idle indirect personnel.Finally, the process characterization (executed by a DOE)and validation of the sealing process provided sufficientobjective evidence that critical outputs such as seal strengthand seal width, which define the sterile barrier, comply andexceed with the acceptance criteria defined by the BostonScientific Quality System.CostThe Mega Pack Blow-Up project was documented and it istraceable by value improvement systems at Boston Scientific.It accounts for a total annual savings of up to $114,600 and$23,700 in cost avoidance, an amount directly related to thecost of labor.Boston Scientific’s Continuing Commitment to QualityValue improvement initiatives constitute a key element in theendless journey of process improvement required as per thecorporate improvement rates at Boston Scientific. This can beachieved following the set of standards required by the company.Integration of different manufacturing areas, core teams withdifferent academic backgrounds, research and developmentresources, plus the documentation required to satisfy the qualitysystem standards was one of the main challenges duringthe execution of the project. A clear understanding of projectgoals, impact on indicators, and the aggressive timelinerequested by management were always topics of discussion.More than quality, it’s imperative to note that a single initiativecan have a tremendous impact on different businessindicators. Efficiency, service, safety, and cost constitute abenchmark for later initiatives to be implemented.For More Information• To learn more about Boston Scientific, please visitwww.bostonscientific.com/en-US/home.html.• For industrial-related topics about Costa Rica, please visitwww.cinde.org.• To read more examples of success in quality, please visitthe ASQ Case Studies landing page at asq.org/knowledgecenter/case-studies.AcknowledgmentsSpecial thanks to the core team involved in this project: JairoBarrantes, project engineer who coordinated meetings andintegration of different business areas; Henry Araya, qualityengineer; Marco Lopez and Tatiana Soto, production supervisors;Marco Bonilla, equipment engineer; Pablo Viquezand Carlos Arce, industrial engineers; and the product builderswho participated in the kaizen event. A special recognitiongoes to Inguiboor Streber, project sponsor, for her deepcommitment and collaboration during the execution of thisproject. All of them demonstrated innovative thinking, globalcollaboration, and high performance as main values during theexecution of this project.About the AuthorDaniel Calvo Camacho has worked as a manufacturing engineerat Boston Scientific, Heredia Facility since 2008. Heearned a bachelor’s and licentiate degree in industrial productionengineering from the Instituto Tecnológico de Costa Rica,and is currently pursuing a master’s degree in innovation managementat Eindhoven University of Technology – Netherlands.BusinessShare Question