Anaheim, Calif. — Technical seminars on standards' changes, scientific molding and part design highlighted the Aug. 11 program for the Southern California section of the Society of Plastics Engineers. The program was held in conjunction with the group's annual Western Plastics Trade Fair in Anaheim.
Revisions in standard ISO 13485:2016 for medical device makers and standard ISO 9001:2015 for their suppliers mention “risk” more often than earlier versions, said Bob Mehta, principal consultant and recruiter for GMP ISO Expert Services Inc. of Mission Viejo, Calif.
Across the board, “the inclusion of risk management and risk-based decisions” permeate the requirements for quality management systems, Mehta said. The changes “raise the bar for suppliers,” result in “more explicit requirements for software verification” and tend to align more closely with U.S. Food and Drug Administration requirements.
Regarding the “loosely used term” scientific molding, Vishu Shah, president of the consulting group Consultek LLC of Chino, Calif., credited industry guru John Bozzelli of Midland, Mich., for setting the concept in motion.
Shah guided attendees through multiple comparisons about “what is” and “what is not” scientific molding.
“Molding is a science, not an art,” Shah said. “We base decisions only on facts” and not on old practices and myths about sometimes magical solutions to processing issues.
”The basics are not there in many molding shops,” Shah said. A processor needs to focus initially on quality equipment and tooling and sufficient maintenance practices.
Shah presented the optimum part design seminar in the absence of Tuan Dao, principal of the Polymer Engineering Group of Yorba Linda, Calif., and president of the SPE section.
A designer must minimize components, thoroughly test polymer materials and avoid trying to replace plastics for metal on a one-to-one basis. Walls must measure up, ribs are critical for rigidity and gate type and location needs deft handling.
A family emergency prevented Dao from making the presentation in person. Shah participated in preparing the presentation.