How information systems augment manufacturing efficiencies

SEISA Medical, manufacturer of medical devices, says information management augments product quality. Here's how.
November 18, 2009
Contract manufacturer, SEISA Medical, has more than 2,000 employees worldwide.

Contract manufacturer, SEISA Medical, has more than 2,000 employees worldwide.

SEISA Medical is a vertically integrated, full-service provider of medical devices.

SEISA Medical is a vertically integrated, full-service provider of medical devices.

Integration of information systems across the supply chain helps to tightly manage processes and quality assurance, especially for medial device manufacturing. Production of medical devices involves a commitment to tightly manage all processes relating to manufacturing and quality assurance because of intense government regulations and the drive to fully implement lean processes.

SEISA Medical is an ISO 13485-2003 certified contract manufacturer of complex medical devices and components (95% of which are FDA Class 2 and 3), with 1,200 production personnel divided between facilities in Mexico and Slovakia. (SEISA stands for Servicios Internacionales de Ensamble Sociedad Anonima, in English, International Assembly Services Inc.) The company produces more than 1,000 SKUs for 15 discrete U.S.-based medical device manufacturers, and uses source components and materials from more than 1,000 suppliers in North America, Europe and Asia. Data collection and data management systems deliver consistent quality and product performance.

Tips for a lean enterprise

Essential advice for making manufacturing lean includes the following.

– Put a focus on providing value for customers;

– Ensure management philosophy drives the company to exceed quality and regulatory standards for customers;

Seisa Medical product experience includes Class I, II, III devices.

Seisa Medical product experience includes Class I, II, III devices for endoscopy, cardiology, endovascular, respiratory, electro surgery, urological, general surgical, surgical kits, and mother/baby care products.

– Use industry benchmarks, aiming data collection efforts at key performance indicators for fixed and variable processes, and for data points that are correlative and independent;

– Seamlessly integrate disciplines including supply chain, production, quality assurance, industrial engineering, environmental health and safety practices, among others;

– Manage information effectively, especially for highly regulated, high-mix, high-volume production operations, separating customer information appropriately;

– Track and meet U.S. FDA-requirements;

– Coordinate manufacturing and distribute work orders cost-effectively among available facilities;

4 questions for continuous improvement

Supply chain management, however, will only be successful over the long term with a commitment to continuous adaptation and improvement. Questions to ask, and answers to monitor, include:

– Are enterprise resource planning (ERP) and material requirements planning (MRP) platforms are properly managed?

– Does the supplier base have appropriate response time, especially since first in / first out (FIFO) is often a requirement, and suppliers and customers all seek to minimize inventories?

– Does current knowledge of import / export regulations match source and ship-to countries?

– Are information systems adapting and coordinating as needed among IT departments in the supply chain?

Seisa Medical does outsourced medical device manufacturing.

Seisa Medical does outsourced medical device manufacturing.

– Adapt the information system as needed to meet customer requirements from supply chain to final distribution;

– Consider an interoperable "system of systems" concept;

– Analyze production volumes with ability to correlate to material and distribution costs, looking at data ranges from the mundane (cost per manufactured unit and revenue per unit sold) to very complex, such as sales per unit for multiple countries adjusting for fluctuating currency exchange rates;

– Use the information system to drive continuous improvement and integrate it with Six Sigma initiatives;

– Interpret data for fixed and bottom line performance indicators, routinely developing action plans using the data;

– Adopt a flexible business model that allows quickly implemented actions to respond to customer needs;

– Review and assess production floor practices against key performance indicators for the previous day, current week, and monthly "going rates;"

– Pay particular attention to data that may indicate less-than-expected performance, especially quality and service level measurements;

– Collaborate with customers on proposed changes supporting recommendations with reliable data from the information management system;

– Train individuals to manage and interpret data;

– Adapt the supply chain model to fit varied customer inventory needs, allowing production of devices and components on predictable production schedules or with quick response "pull" type production, as needed; and

– Use IT systems to help manage this complex and diverse set of disciplines to deliver component parts and materials on the shop floor at the right time. Integrate real-time tracking of shipments to the distribution centers and point of sale destinations into information management systems.

Plant operations – production tips

Like most every industry, the medical device sector is significantly cost-driven, but quality always must come first. About half of SEISA production is FDA Class III compliant-which essentially means that those products are "life sustaining." If quality is the first priority, then the remainder of manufacturing activities is simplified.

A significant amount of information is pushed directly to the production line; shop-floor operations rely on current, accurate information obtained from the information technology system. Moreover, the engineering group can take action when data may point to a real (or potential) concern relating to production volume or quality.

Information can result in corrective actions, such as modifying supplier integration, conducting additional training of a line operator, or pausing a work order that may require analysis of a secondary operation, such as product sterilization.

El Paso / Juarez: 4th largest North American manufacturing center

El Paso, Texas, and Ciudad Juarez, Mexico is the fourth largest manufacturing center in North America. Recent challenges include the recession, swine flu outbreak, and Mexican cartel violence. Even so, the region’s manufacturing sector remains afloat, and global corporations continue to seek it out when looking at opening up shop along the U.S./Mexico border.

Cd. Juarez has more than 380 "maquiladora" operations (or twin plants) that employ nearly 230,000 people and manufacture a wide range of products including automotive parts, medical devices and consumer electronics. Of these operations, 85% are owned by U.S. corporations. In recent months, some facilities have scaled down to 4-day work weeks to adjust to a weakened U.S. market. Workforce is retained to ensure that they can handle the projected uptick in Mexico’s production when the recession lifts.

Also Mexican cartel violence has not directly impacted legitimate manufacturing and distribution in the El Paso/Juarez region. Cd. Juarez saw 51 maquila permits issued in 2008 as compared to 27 in 2007, an 88% increase. The city also had nearly 4.2 million square feet of industrial space absorbed in 2008, ranking among the top three since 2000.

Cd. Juarez also outperforms other Mexican cities in job growth, having created approximately 60,000 net new jobs over the past three years.

When it’s working correctly, information management systems result in higher productivity and faster resolutions. At SEISA that means higher efficiencies with fewer management personnel, inspectors, and production workers. While subjective conclusions have been minimized, they have certainly not been eliminated. More importantly, the interoperable "system of systems" developed in concert with suppliers and customers, has enhanced the ability to quickly and efficiently resolve manufacturing issues by generating almost immediate feedback, internal and external to the organization.

Manufacturers can exceed quality and regulatory standards with continuous improvement to manufacturing and quality assurance processes with a robust system of data collection and data management. Involving customers, through a transparent and interactive model, enables them to join in an audit and review of the finished product. Such collaboration leads to repeat business and referrals.

– Author: Julio Chiu is CEO of SEISA Medical LP, a contract manufacturer of Class 2 and 3 medical devices, headquartered in Cd. Juarez Mexico.

Also read from MBT : Supply chain complexity hampers medical device company operations, compliance .

– Edited by Mark T. Hoske, electronic products editor, Manufacturing Business Technology, MBT