Quality Mindset at Crescent Industries

by Dianna Brodine

Plastics Business

Crescent Industries is the largest employer in New Freedom, Pennsylvania, a town with a population of 4,500. As the company approaches its 70th year, Eric Paules has a deep appreciation for the legacy created by his grandfather, father and uncle, and an excitement for the possibilities of what the next generations will bring.

Medical molder begins as machine shop

Crescent Industries was founded as Summit Machine Works by Frank and Mary Paules in 1946. Frank had been a foreman at the American Insulator Corporation in New Freedom, but the post-war boom meant opportunities for those with machining experience. Frank's garage shop quickly grew and was incorporated as Crescent Industries, Inc. in 1954. Frank passed away unexpectedly in 1959, but his wife and sons carried on to build the business into a community staple.

In the early 1960s, the company added its first injection molding machines to aid with sampling the molds produced in the shop, and in the mid-1970s, Crescent Industries molded its first medical product – a diagnostic tray. "We had a reputation as a tool builder, and that reputation carried us well into the 1980s," said Eric Paules, vice president and COO. "We grew into a medical molder because of our customers, and we entered the medical market with a single tool. We picked it up from our customer and loaded it into my dad's Chevy on the way to hunting camp when I was eight years old. That tool still is running today." In the 1990s, Crescent Industries implemented an active marketing program, attending tradeshows and advertising its medical molding services to potential customers.

Growth in production volume led to significant growth in the employee base, building from around 90 employees in the 1990s to 140 employees today. The Paules family retains a majority ownership, but in 2001, Crescent Industries allocated one-third of the company shares through an Employee Stock Ownership Plan. This provides a long-term retirement benefit for the company's employees, ensuring the success of the company is shared by the people who make it successful.

Evolution necessary for growth

"Crescent Industries began injection molding plastic parts as a way to sample the molds we were building back in the 1960s," said Paules, "but growing that part of the business was a very conscious choice." Now comprising 90 percent of the company's annual revenue, the company offers injection molding for the medical, pharmaceutical, dental, defense, small arms and industrial/OEM markets. Annual sales are approximately $18 million, and the company processes over one million pounds of resin annually in moderate- to high-volume production runs.

"In terms of revenue, the molding eclipses everything else," Paules explained, "but we look very closely at the integration of the whole project. Mold design and mold construction definitely are emphasized." To provide its customers with an integrated single-source solution for injection molded components, Crescent Industries offers five core services: design and development, manufacture of new injection molds, custom injection molding, production machining and contract assembly and packaging services.

Secondary services have been strategically added to aid the company in its drive to become a single-source solution. "Customers want to work with one vendor to project completion," he explained. "We do partner with vendors for certain services, but most of the secondary services are done in-house." These services include device assembly, production packaging, ultrasonic welding, vacuum/pressure testing, annealing, cap lining, pad printing, CNC milling, drilling or tapping, EMI or RFI shielding, laser engraving, sterilization, ultrasonic parts cleaning and custom operations. "Around 60 percent of the projects we manufacture require some type of secondary or value-added process," said Paules.

The company makes annual capital investments in equipment to keep molding machines, machine tools and screw machines up to date, with the goal of maintaining an average machine age of less than 10 years. In recent years, purchases have replaced hydraulic injection molding machines with electric, and the company has moved toward high-speed mills for its machine tool equipment. "We continuously make investments in automation and robotics by adding automated work cells, most recently by adding two Baxter robots," Paules explained. An Objet 3D printer also has been purchased to serve low-volume and prototyping needs, but more may be on the horizon.

"Additive manufacturing holds great promise," he said. "At present, we use it to help our customers develop their products for manufacturability, but in the near future, there will be opportunity to satisfy larger lots sizes. Also, metal additive manufacturing will continue to evolve in terms of capability, durability and speed, which will open new options for design and development of tooling and components." Having noted limitations due to available material options for the Objet machine, Crescent Industries is looking to expand its capabilities with another equipment investment in the near future.

Three facilities provide flexibility, risk management

As the company has grown over the past seven decades, its facility needs have grown, too. Today, the company has three separate locations for its tool building, general injection molding and cleanroom molding operations.

"If I stand on the roof of my largest building, I can see the other two facilities," laughed Paules. The 12 North Front Street facility that houses the mold building operation today was the original location of Crescent Industries. "That was our primary and only facility until the mid-'90s," he said. "A room was added for four new injection molding machines in the 1980s, but we outgrew that space quickly. By the early '90s, we were renting space at a nearby industrial park."

There were challenges in running two facilities with molding operations at both locations. "We had material storage at both locations, and our production staff wasn't able to communicate effectively," Paules said. When Crescent Industries was able to buy a building in the industrial park, the company consolidated all of its molding operations to that location.

In 2009, when construction costs were down, the original tooling facility was renovated to bring it up to more modern building standards, and the company gained 7,000 square feet in usable space. In the same year, Crescent Medical Plastics (CMP) was established as a cleanroom molding operation located across the street from the general molding facility and in the same industrial park. There currently are four injection molding machines, plus a cleanroom facility, at CMP. The general molding facility has another 22 injection molding machines, and the mold building facility houses its own injection molding machines for production sampling.

"There has been debate over the years about the advantages of being under one roof," said Paules. "In the end, the logic was simple. Operating in three separate buildings provides flexibility we wouldn't have otherwise, and it also provides an immediate solution to any disaster recovery situation." He acknowledged there are tradeoffs, which include some duplicate equipment that had to be purchased for each facility, but Crescent Industries has developed a seamless operation, with material and people resources that are appropriately allocated and working together. "It also has allowed us to build a world-class cleanroom facility cost-effectively, while keeping the operational costs of a cleanroom isolated from customers who do not require such services," said Paules.

The medical molding facility is unique in its setup. The facility's employees are self-directed and cross-trained in multiple job functions. "We have a team leader and 20 employees who are dedicated to CMP," he explained. "Almost all know how to do each other's job, including material handling, mold setups and quality checks." The facility runs in two shifts, with the employees setting their own work schedules. Paules acknowledged a higher training level is required for the staff at CMP, but believes the employees have a higher level of investment in the facility as a result.

"When I first looked at setting it up, I wanted it to feel like a Silicon Valley start-up," Paules said. "I wanted the people who would be operating the equipment to be involved in the decision-making from the very beginning."

Quality woven into the fabric of the culture

A company the size of Crescent Industries operating in three separate facilities in highly regulated markets has a unique need for quality control. The tools and procedures must ensure consistency of product, while communication becomes critical to ensure everyone involved – from product design to tool build to molding – is documenting the course of a project as it moves throughout the company. "Our quality system has been woven into the fabric of our company culture," Paules said. "ISO-registered since 1998, ours is a mature and tested quality system." The company utilizes an integrated ERP system from IQMS at all facilities to ensure everyone is using the same procedures and information to make decisions, regardless of their physical location.

"Quality systems add value to the company," he explained. "They provide discipline and structure for doing the things you do every day. Initially, it was a struggle to get everyone to see past the procedure and the documentation. Now, I see people thinking and talking in the language, without necessarily referring to the standard. You know it's become part of the culture when you hear the quality system being discussed in every situation by your employees."

Paules explained that extending the quality system to the tool building operation was a challenge simply because of the personality traits required to do the job well. "By its nature, tool building tends to be a more creative process," he said. "There's a great deal of personal pride in the craftsmanship of the job. Getting those employees to realize they can be creative and innovative while still being in compliance with procedure meant we first had to help them understand that the quality measures weren't going to tie their hands, but rather guide their hands."

Rather than throwing every nuance of regulation and procedure at the employees at once, quality procedures were implemented in stages at Crescent Industries. First, employees were asked to log, initial and date changes in paper form. Then, a central computer system was implemented. Also, since tool building is a visual, creative process, quality standards and controls were introduced in ways that were compatible. "We wanted everything to be geared toward the way they think, and our people responded to that," Paules said.

While quality is everyone's responsibility, 10 percent of the workforce directly is involved with quality activities at Crescent Industries. A quality manager and three quality engineers lead the team, with inspectors on each shift reviewing overall project quality and lab techs who review all quality measures. "We have a large number of people involved, from ensuring quality at the product development stage in our R&D department to reviewing client requirements and our documentation to make sure all of the paperwork is correct when a job leaves the facility," said Paules.

According to the company's website, its quality engineering tools include PFMEA (Product/Process Failure Mode and Effect Analysis), Control Plans and Process Validation (including IQ, OQ and PQ). "These are an upfront agreed upon requirement between Crescent and our customers, with our SOP validation process outlining the minimum requirements," the site explains.

The company has what Paules calls "standard equipment for any modern lab" – coordinate measuring machines, video scopes, optical comparators, microscopes, gauges, etc. With the quality mindset always at the forefront, Crescent Industries is looking for new opportunities to improve its processes. "Our biggest opportunity going forward is in process monitoring," he explained. "We're looking at a new system to monitor characteristics of the injection molding process, which will give us quality assurance rather than quality control."

Crescent Industries has seen a market increase of 12 percent in the medical, pharmaceutical and dental industries, which drove its recent decision to become an FDA-registered manufacturing facility. The company has been 13485-certified for several years, so it wasn't much of an extension, according to Paules. "We needed to develop a master validation protocol and looked more carefully at how we validate our processes. It's made us a better molder because of the detail required to meet the standard," he said. "It's the mentality we've often had in building this company. We create the value we perceive our customers want, and then we promote and advertise it to gain more customers."

First-generation values, third-generation possibilities

Crescent Industries is a very personal enterprise for Eric Paules. "I'm the third generation, and although I never met my grandfather, I think he would be proud of the way in which we conduct business," he said. "We chose to run this company with integrity, and that value runs through the fabric of the company in the way we deal with employees and in the way they, in turn, deal with customers. It honors my grandfather's vision and his intent when he started the company."

With the seventh decade of family ownership coming to a close, Paules is confident in the company's future. "I'm convinced each generation is uniquely prepared to do what they need to do," he said. "My grandfather was a mold maker and machinist with the courage to take a risk by leaving a secure job and starting something on his own. I'm not sure my father or I have that adventurous spirit, but my dad was able to persevere through a very difficult transition when he had to pick the reins up to run the company right out of college and through difficult economic conditions. Then, along comes the next generation geared toward technology and computer science. I've been able to bring that into the company, and who knows what the next generation might achieve?"

Paules continued, "One-third of the company is owned by employees, and that's the biggest endorsement of how we value the people who work at Crescent. It will be interesting to see where they will help us go. We have a lot of talented people within these walls."