case study

Making the Case for Quality

Mega Pack Line Blow-Up: DMAIC Roadmap Leads Boston Scientific Heredia to Reengineer Packaging Lines

• Corporate rates of improvement at Boston Scientific represent a yearly challenge and opportunity to improve and exceed different operation indicators such as service and efficiency, safety, quality, and cost within the company.

• A DMAIC roadmap provides a standardized and recognized set of tools to be used as methodology during part of the project implementation, based on a lean manufacturing point of view.

• Core team members and product builders within the Amplatz Super Stiff™ Guidewires area worked together to improve efficiency, increase safety, and save money using a DMAIC roadmap.

At a Glance . . .

The Mega Pack Line Blow-Up Project at Boston Scientific, Heredia (Costa Rica) was intended to implement 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, and boxing areas, plus the installation and validation of an automated pouch sealer. Using a DMAIC roadmap 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, Heredia

Boston Scientific is one of the largest recognized global companies dedicated to the design, manu- facturing, and distribution of less invasive medical devices. Its products are used to treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain. Installed in 2004, the Boston Scientific site in Heredia, Costa Rica, manu- factures guidewires used for vascular and urological procedures, and ablation catheters to treat heart arrhythmias. There are more than 700 employees at the site.

Why Quality?

The value improvement initiatives constitute a key element in the endless journey of process improvement required by Boston Scientific’s corporate improvement rates, which can be achieved following set company standards guidelines. Mega Pack Line Blow-Up for Amplatz Super Stiff Guidewire is an example of a high-performance initiative implemented at the Heredia site. The guidewire represents the second highest value of production manufactured at Boston Scientific Heredia site, and provided a great opportunity for improving efficiency, space reduction, and quality—resulting in a cost saving and cost avoidance.

In the fourth quarter of 2012, during routine metrics review, core team members within the hoop- ing, packaging, sealing, and boxing of Amplatz Super Stiff Guidewires production areas detected multiple opportunities for improvement due to waste in nonvalue-added activities, replication of inspections, space utilization, idle times, an operator-dependent sealing process, and lack of one-piece flow due to manufacturability of the cell design. This improvement opportunity was strate- gically planned to be executed for the following year.

The major changes incurred and tools used as part of this project were the implementation of an automated band sealer in replacement of the old manual sealers, and the application of process simu- lation software to estimate future production outputs. The second major change was the rebalance of the line to obtain a one-piece flow, applying lean manufacturing tools.

by Daniel Calvo Camacho

January 2015

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Reengineering the Guidewire Packaging Production Process

An Amplatz Super Stiff is a guidewire constructed of a flat wire that produces a larger inner core, increased stiff- ness, 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 proce- dures. 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 follow- ing a best-practice methodology for improvement projects according to company standards.

Define

The hooping, packaging, and boxing areas of Amplatz Super Stiff Guidewires were found subject to improve- ment in the following areas (see Figure 1):

• Efficiency

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• Reducing transportation of materials (by 285 feet) • Headcount reduction (direct labor) to eliminate nonvalue-added

activities • Optimization of inspections and process flow by eliminating

repeated activities • Integrating current cell station in a one-piece flow manufacturing

line, reducing cycle time, improving quality inspections, and reducing scrap of components

Measure

According 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 hoop- ing and boxing. In terms of head count, the state of direct labor needed for the operations of these areas is 29 operators. Finally, inspection activities repeated by multiple individuals, such as cos- metic defects, were found in the packaging and boxing areas, leading to inefficiency and delay of operations.

Analyze

A process simulation was completed considering the potential integration of the hooping, packaging, and boxing areas, while also assuming the standard cycle time of an automated band sealer and the potential reduction of nine product builders (seven operators

Final station configuration once the Mega Pack Line was implemented with the automated band sealer and hoops transportation carousel.

Cross-section of an Amplatz Super Stiff Guidewire

Figure 1: Product transportation before the project implementation

285 ft of material transportation.

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in the packaging area and two in boxing). Based on this model, a potential target of 4,100 units per shift was identified considering the elimination of one shift, which could increase the site’s efficiency under the assumption of a one-piece flow process and the change of takt time (pace of manufacturing unit by unit) from 12 seconds per unit to 7.6 seconds per unit.

Improve

This phase was divided into two main activities:

• Kaizen Event: With participation from product builders, quality technicians, and engineers this event demonstrated integration of manufacturing areas—specifically the hooping and packaging work stations—by implementing a mechanical carousel that constantly moves the inserted guidewire in the hoop (see photo below). The main benefit was eliminating product transportation long distances, which contributes as a poka-yoke item (mistake-proofing device) that provides a takt time to the line. In addition, the boxing area layout was redesigned to be more ergonomical, reduce space, and balance with the packaging work stations to achieve a one-piece flow. Participation of the product builders and other functional areas promoted engagement and participation during the execution of this project.

• Automated Band Sealer: Since a new piece of equipment must be installed as part of the production line integration, this piece of equipment was designed to Boston Scientific’s policies, and then a full process characterization was executed to guarantee the sealing process was capable and met specifications. Preliminary results obtained from the factory acceptance test (once equipment was built) were analyzed, and then a design of experiments (DoE) and confirmation run were executed to release the process for

validation (see Figure 2). One of the main goals of this activity was to confirm a single operational process range for the two types of pouches currently used, and avoid resetting of the equipment during production order changes. Seal strength and seal width were fully analyzed as main outputs to be controlled.

Control

This final activity was performed in two main steps.

• Process Validation of the Automated Band Sealer: Respective operational qualification/process qualification activities were summarized and successful results of the process validation were properly documented through respective reports. This confirmed the results obtained as part of the process characterization previously

Proposed hoop transportation carousel

Figure 2: Output graphs of the design of experiments

Rear T*Front T

120

110

100 120 125 140 135 140

Speed*Front T 348

342

336

330

324 120 125 140 135 140

Speed*Front T 348

342

336

330

324 120 125 140 135 140

Average pull < 0.3 0.3 – 0.6 0.6 – 0.9 0.9 – 1.2 1.2 – 1.5 1.5 – 1.8 > 1.8

Hold values Front T 120 Rear T 100 Speed 324 UPN 90554937

Factor Name A Front T B Rear T C Speed D UPN

Contour Plot – Average Seal Strength Low Settings

Pareto Chart of the Standardized Effects (response is Average Tensile Strength (Lb), Alpha = 0.05)

D

A

AD

B

AC

C

AB

0 1 2 3 4 5 6 7

Te rm

Standardized effect

2.776

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0.255 0.270 0.285 0.300 0.315 0.330 0.345 0.360

LSL

Within Overall

Process data

Potential (Within) Capability

LSL 0.25 Target * USL * Sample mean 0.3547 Sample N 30 StDev (Within) 0.00372952 StDev (Overall) 0.00433232

Observed Performance PPM < LSL 0.00 PPM > USL * PPM Total 0.00

Exp. Within Performance PPM < LSL 0.00 PPM > USL * PPM Total 0.00

Exp. Overall Performance PPM < LSL 0.00 PPM > USL * PPM Total 0.00

Cp * CPL 9.36 CPU * CpK 9.36

Overall Capability Pp * PPL 8.06 PPU * PpK 8.06 Cpm *

Process Capability of Seal Width – OQ Hogh Settings

Figure 3: An illustration of the respective capability analysis performed during process validation

documented, and at the same time, falls within the requirements of Boston Scientific’s quality system for release of manufacturing changes similar to this case (see Figure 3).

• Dry Run: Once the process validation activities were completed, the dry run was performed with the main intention to document any potential gap of facility installations, sealer performance, understanding of the new process flow by the operators, and challenge of the target outputs defined as part of the simulation model explained in the measure phase.

Final implementation of this project occurred in late March 2013. More than one year after completion, its main benefits in several business metrics provide sufficient evidence to summarize its results in the following section.

Results

Main results obtained due to the Mega Pack Blow-Up were tracked through several different indicators, including:

Efficiency and Service

The improvement project reduced product transportation by 51 percent (moving from 258 feet to 120 feet in materials transportation). The reduction then increased the idle space in the manufacturing floor by 711 square feet, which allowed

for the introduction of new manufacturing lines. Finally, the efficiency of the line was improved by about 15 percent, with a base line output improvement of 3,600 units (two shifts) to 4,100 units (one single shift). The final design of the line pro- vided an increase in production capacity of 63 percent.

Thanks to the process characterization activities performed in the band sealer, the project identified a single process parameter range for the two types of pouches used for Amplatz Super Stiff, eliminating potential downtimes caused by setting parameters.

Safety

New working stations were designed and implemented, including the implementation of a mechanical carousel that transports the product; the implementation of an automated band sealer machine eliminating operator dependency dur- ing the sealing operation; and finally, the boxing station was improved with a new design and better ergonomic conditions for the operators.

Quality

Quality at the source was implemented due to the integra- tion of the hooping, packaging, and boxing areas. This meant redundant inspections were eliminated and appropriate con- trols were relocated to guarantee the quality of critical outputs

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(avoidance of quality incidents—five based on baseline of 2012) and provide a leaner manufacturing process. This represented an overhead reduction of about $33,000 by the relocation of idle indirect personnel.

Finally, the process characterization (executed by a DOE) and validation of the sealing process provided sufficient objective evidence that critical outputs such as seal strength and seal width, which define the sterile barrier, comply and exceed with the acceptance criteria defined by the Boston Scientific Quality System.

Cost

The Mega Pack Blow-Up project was documented and it is traceable 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 the cost of labor.

Boston Scientific’s Continuing Commitment to Quality

Value improvement initiatives constitute a key element in the endless journey of process improvement required as per the corporate improvement rates at Boston Scientific. This can be achieved following the set of standards required by the company.

Integration of different manufacturing areas, core teams with different academic backgrounds, research and development resources, plus the documentation required to satisfy the qual- ity system standards was one of the main challenges during the execution of the project. A clear understanding of proj- ect goals, impact on indicators, and the aggressive timeline requested by management were always topics of discussion.

More than quality, it’s imperative to note that a single ini- tiative can have a tremendous impact on different business

indicators. Efficiency, service, safety, and cost constitute a benchmark for later initiatives to be implemented.

For More Information

• To learn more about Boston Scientific, please visit www.bostonscientific.com/en-US/home.html.

• For industrial-related topics about Costa Rica, please visit www.cinde.org.

• To read more examples of success in quality, please visit the ASQ Case Studies landing page at asq.org/knowledge- center/case-studies.

Acknowledgments

Special thanks to the core team involved in this project: Jairo Barrantes, project engineer who coordinated meetings and integration of different business areas; Henry Araya, quality engineer; Marco Lopez and Tatiana Soto, production super- visors; Marco Bonilla, equipment engineer; Pablo Viquez and Carlos Arce, industrial engineers; and the product build- ers who participated in the kaizen event. A special recognition goes to Inguiboor Streber, project sponsor, for her deep commitment and collaboration during the execution of this project. All of them demonstrated innovative thinking, global collaboration, and high performance as main values during the execution of this project.

About the Author

Daniel Calvo Camacho has worked as a manufacturing engi- neer at Boston Scientific, Heredia Facility since 2008. He earned a bachelor’s and licentiate degree in industrial produc- tion engineering from the Instituto Tecnológico de Costa Rica, and is currently pursuing a master’s degree in innovation man- agement at Eindhoven University of Technology – Netherlands.