IMM's Plant Tour: Making the impossible look easyIMM's Plant Tour: Making the impossible look easy

It sounds like a contradiction, but in fact, it is the goal that custom molders in the medical industry (and others) are now targeting: Increase quality while taking cost out of process and product. At Classic Industries, a privately held custom molder established in 1972, this seeming disparity becomes reality for 400 million parts produced every year because both quality and cost are considered at every step of the art-to-part cycle.

According to president Jay Policastro, this dual focus is a common thread throughout product design, development, manufacturing, and project management stages. "Our customers are major medical device OEMs, and theirs is a world where cost and quality rule. We need to focus on these issues up front," he says.

At the same time, Policastro realizes the paradox these two goals create. "It's a fact of life that quality and the systems required to maintain it cost money, so we have to be creative in cost cutting."

To learn more about the specifics of Classic's creativity, IMM's recent tour of its East Pointe facility in Latrobe, PA focused on following parts through their life cycle, from concept through production. The journey begins with a visit to the plant, where white floors and cleanroom molding mimic a hospital operating environment. East Pointe, which opened its doors late in 1999, is an exact copy of another Classic facility in El Paso, TX.

"One of the recurring comments from potential customers after visiting our plants is that they probably won't be able to afford us. When we give them a quote, however, they're surprised at how competitive we are," Policastro says. Our tour will uncover the ways in which Classic maintains its competitive edge in the face of stringent regulatory and economic demands.

Design Dynamics
Beginning in engineering, it becomes clear that producing the lowest-cost parts depends on Classic's designers being involved in the project from the start. But even when an OEM wants to control the entire design, project engineers can complement customers' efforts to varying degrees.

For example, at its concept stage, a design can be fine-tuned for functionality, cycle time, and automation of both process and value-added operations such as assembly or decoration. These added engineering perspectives help improve quality while taking out cost. Even when a design is optimized, however, Classic designers can and do take an out-of-the-box approach that may include automating the process, changing the material, or tweaking the tool design. In addition, tool designs go through moldfilling simulation to help reduce molded-in stress, find the best process window, determine optimum cavitation, and reduce costs by minimizing runner size and wall thickness.

When a consensus is reached on design details, project engineers manage the toolmaking process. According to David Smith, business unit manager, no two customers have the same tooling needs, so Classic works with toolmakers around the world to source the best mold for the job. Because all tools are equipped with cavity pressure transducers, they are fully integrated into Classic's process monitoring system when production begins.

Once tools are built, designers work with the metrology department to validate the tool. Key dimensions are measured as part of the first article inspection, while critical factors are identified and coded into the process monitoring system. Metrology workers also perform a capabilities study, FMEA, and a DOE verification study as a means of ensuring an optimum process.

Manufacturing Marvels
All molding at Classic's East Pointe facility is done in a Class 100,000 cleanroom, with some areas at Class 10,000. A powerful ventilation system complete with Hepa filters maintains the stringent air quality requirements.

After a production design review in which the customer approves initial parts and future production, project engineers turn the tool over to operations. At this point, a process has already been established and automation, if indicated, has been built and added to the appropriate press.

Each of the 17 presses is equipped with Ranger robotics for part removal and degating, and runners are automatically sent to a grinder in the lower level, where all auxiliaries are located. Machines are also fitted with a one-shot hopper fed pneumatically by a dryer-hopper (AEC Whitlock) also located in the lower level.

A device called the Smart Chute, designed in-house, automatically shuttles parts that do not meet specifications to a diversion chute on each machine. If a shot is out of tolerance, for example, those parts will be diverted. If barrel temperature strays by 3F (and tolerances are set to +/-2F), again the part diversion system is activated. Process monitoring indication lights are standard on each molding machine as well.

"During the validation process for each tool," says Policastro, "we develop upper and lower control limits. Using our production and process monitoring system, which is installed on each machine, we can track up to 32 of these factors. The system monitors each shot and each parameter, and when any one of them varies outside of preset limits, the part is diverted. When our customer assembles parts we have molded, it has less scrap because parts are consistent, and thus a lower total cost. This is one of the ways we are able to control quality economically, because we have the systems in place to do so."

Bringing Six Sigma methods to the shop floor is yet another creative approach aimed at process improvement to meet both quality and cost targets. Six Sigma "black belts," people specially trained in this system, work with cross-functional teams to reduce variation in both parts and processes.

Classic chose Netstal Synergy machines for thin-wall, high-speed molding, and Ferromatik Fanuc Roboshot all-electrics for general purpose molding. Classic makes a point of replacing a machine after 60,000 hours of use.

"Within five years, we will have converted to electric machines only," Policastro says. "The reason is that we get precision and high speed with energy savings."

Tooling Techniques
Believing that quality doesn't stop when the tool goes into storage, Classic has designed a temperature- (70 to 72F) and humidity-controlled (50 percent) room for its 400-plus active molds. After a production run, each mold gets an immediate inspection, maintenance, and cleaning in the tooling department, where four toolmakers are on staff seven days a week.

Each mold has a job packet associated with it, containing a blueprint, any required forms, a revision history, and inspection requirements. A tagging system identifies the tool's status: red for work needed, blue when fixed, yellow for preventive maintenance needed, and green for production-ready.

A mold maintenance database contains maintenance history logs. It is also used as a training tool because it contains a mold-specific checklist of what needs to be done, whether it's a fix, PM, or periodic maintenance requirement for the tool.

Business Blueprint
Even though the journey of a part through a molding facility usually ends at the shipping dock, our tour continues on to the president's office for more specifics on the business of medical molding. Policastro explains that while Classic has a large support department, there are only five key executives along with Joe Policastro, Jay's father and ceo of the company. Keeping the hierarchy to a minimum has helped Classic work with each customer in a one-on-one relationship.

In 1992, Classic began to specialize in medical device molding, and in 1995, a new management team came up with a long-term plan to succeed in this market. Part of the current five-year business plan includes a strategy to evolve into a contract manufacturer for several medical customers. At present, Classic does this type of work for one customer for whom it designs, builds tooling, molds, assembles, and packages an eyewear component.

"Contract manufacturing is becoming more attractive to our customers," Policastro says, "because it helps them to achieve a higher earnings-per-share figure. Instead of investing capital in depreciable equipment, these OEMs turn to contract manufacturers for a better return on their dollar."