BioPro Spotlight: CP Medical
by Seamus Kennedy
Modern business life has come to mean a sharp understanding of paperwork. In fact, a prime challenge in the biomedical field is working with detailed and lengthy FDA paperwork. Success here can actually assist the profitability of an enterprise.
Complexity of FDA paperwork combined with English as a second language offers challenges
A key to this success is how we communicate—not only with our public, our industry, and our prospective and regular customers, but also within, to everyone who works for the company. CP Medical, an OBA member, has gained substantially, from its recent venture with internal communication, to streamline and improve its FDA paperwork.
As a manufacturer of sutures and medical needles, CP Medical works diligently with FDA regulations. One of its chief challenges for FDA paperwork is careful conformity to each and all details.
As Glenda Grace of CP Medical notes, past audits had shown that employees needed to learn why FDA requires a sign-off, and how to fill out paperwork fully and in correct order. It was clear that many simply didn't understand FDA paperwork. Coupling this with the fact that a majority of folks at CP Medical have English as their second language, Glenda saw both the problem and solution. “Empower our people, and they will feel confident and valued,” she explained.
OBA facilitates flexible training to meet member needs
In parallel, one of the foundations of the Oregon Bioscience Association training program is to provide for the needs of members. This commitment has flexibility for not just technical issues, but training that helps companies and individuals with many key business needs.
So Glenda teamed with Dan Hill, OBA’s director of member services and BioPro Workforce Training. Together with Nick Campbell, an instructor of OBA classes, they worked to bridge this language barrier. In March and April of last year, FDA overview classes, with translators for both Vietnamese and Korean, were held at CP Medical. Glenda, Dan and Nick had focused on each detail, and pooled resources. Even the PowerPoint presentations had been translated into these two other languages.
Results are immediate – and dramatic
So how did they do? Auditing showed that, immediately and dramatically, the classes resulted in close to 60% reduction of errors. This in turn created a huge change in the workload in auditing, as well as less paper-process rejections in the audit, and some increases in production. Log in, sign off, dating and correct order started standardizing. “A light went on for each employee as they got it, by learning in their native language,” said Glenda.
The reception from the employees was positive, and they became participatory in the resolve of FDA paperwork issues. Each employee could embrace the processes involved with knowledge and understanding. Teamwork can be defined here as bridging the gap by building the bridge. The industry has workers who now understand, and industry is strengthened as well. This training became everyone’s success.
FDA paperwork has been a huge part of work process for CP Medical, from the inception of the company in 1992. Glenda is pleased with the results of the classes. She commented: “OBA is wonderful for both higher level training, plus entry-level training such as this. OBA is there to provide specific training for our needs. And good training empowers.”
About the author:
Seamus Kennedy is a business communicator, who deals with effective packaging of verbal, nonverbal, written and visual communication. What we say and how we say it can add strength to even our clearest message, and Seamus helps individuals and organizations to bolster their ability to get their message across. His public speaking and presentation classes, for example, have garnered the attention of local press. skennedy@imagina.com