Quality in Orthopedic Device Manufacturing: Perspectives From Bal Seal Engineering

The November/December issue of Orthopedic Design & Technology featured a story on quality in orthopedic device manufacturing. As is the case with feature stories, there is always extra information that does not make it into print. Here is the full interview with Jesse Flores, vice president of quality assurance for Bal Seal Engineering, Inc., a Foothill Ranch, Calif.-based component manufacturer.

ODT: What systems does your company have in place to ensure quality?

At Bal Seal Engineering, we’ve established, documented and implemented a Quality Management System (QMS) certified to ISO 9001:2008 as well as TS16949. The system is maintained through the use of a quality policy, quality objectives, internal audits, analysis of data, corrective and preventive actions and in-depth management reviews. It is also in a state of continuous improvement.

ODT: Can you discuss the difference between quality and mere compliance, and what a company should be striving for in terms of quality standards?

Because we develop sealing, connecting, conducting and Electromagnetic Interference (EMI) shielding components for so many different kinds of critical equipment—from orthopedic devices and surgical hand tools to active medical implantable devices, as well as drug-delivery systems—we consider compliance with ISO 9001 standards to be a baseline, entry-level criteria that our customers expect. We’re consistently looking for ways to enhance our quality system, and thus we are striving more for overall quality assurance (QA), rather than rely on quality control (QC) methods for product compliance.

QC is generally defined as the inspection of parts at various points within manufacturing process to determine compliance. Because we’ve found this to be a less reliable, more costly and less efficient method, we’ve adopted a QA approach. This means we focus our efforts on measuring the “capability” of processes against specification limits. The purpose of QA is to determine the capability and consistency of our manufacturing processes and to help make applicable processes capable. “Inspection” then becomes only a formality to confirm product compliance (predictable and reliable).

The QA approach makes manufacturing responsible for product quality and changes the general role of the quality department to assessing the effectiveness of various processes.It also means collecting, analyzing and acting on other data. For instance, what percentage of orders get rejected in each area and why? Which operations generate the most scrap, and for which reasons? How many orders get returned from customers? What type of complaints do we get from customers? What do our internal audits reveal about our quality system? How effective are our corrective actions. With a QA process, we have metrics and quality trends in place—a QA Dashboard that enables us to identify where and when our improvement activities should tale place.

ODT: What steps do you think industry and regulators can take to: improve quality of ortho devices; and facilitate compliance to quality standards?

From an industry standpoint, orthopedic device makers can take measures to ensure that their component manufacturers are plugged into the design process from the very beginning, and that product quality criteria, production validation expectations, quality system expectations (such as control plans, failure mode effects analysis, etc.) and other logistical details are communicated as soon as they become available. Just doing these things can greatly reduce the risk of encountering quality issues, and can eliminate the need to deal with engineering roadblocks while under pressure to make trial deadlines or launch dates.

Of course, OEMs can also invest time and effort in the vetting of suppliers, ensuring that quality systems are clearly described and documented, and that the proper certifications (i.e.,ISO 9001, ISO 13485 etc.) are in place to meet manufacturing and regulatory requirements.