March - 20238In My OpinionRolando E. Ardon, MB, Director, Quality and Regulatory Compliance,UFP Technologies, Inc. [NASDAQ:UFPT]ByWhen I first joined a Medical Device Assembling plant, little I knew that I was entering a vast world that was more than manufacturing. I already had experience in the food and beverage industry, so I had some knowledge about the regulations and technical requirements for basic quality systems, the typical textbook approach in many cases. However, in the medical device manufacturing realm, the story would eventually turn out to be different. We needed to get more hands on with the US regulations which were the main ones to follow. It was a time when ISO 9002 standard had 20 chapters and 13485 was not a stand-alone standard which would require the 9000 to support on.We had a basic quality management system (QMS) to support the operation, all paper-based since technology for this was in its infancy, Windows version was 2.0. Certifications were not mandated, they were optional. Then came this customer that required us to get certified so they could sell in Europe, and everything changed from there. The biggest challenge was not creating the many procedures and document we required, but changing the whole mindset in the organization to adopt this discipline. I started to envision the implementation of an electronic system to support the QMS since the amount of paper was growing exponentially, creating some issues in the record retention control and proper document handling. FDA did not inspect foreign facilities then, but we needed to meet the ISO standard requirements. It was hard not to get excited creating quality systems to meet what was being asked for. It was helpful to have worked on creating quality systems for an automotive environment before, since in that industry systems are more prescribed, and more tools are offered. There was a clearer picture when using the QS 9000 standard with the AIAG guidance. When attending a course in Washington D.C. about Process Validation, the instructor started talking about Failure Mode and Effects Analysis. I was perfectly familiar with it and spoke to it easily. Most attendants looked back at me in despair as if I was speaking something magical, a breakthrough technique. This just showed me how laxed were the standards back then. Of course, it was more important to follow the Good Manufacturing Practices (GMPs), but differences were significant between the regulation and the standards.As time passed, the ISO standards evolved to be more specific and in alignment with the US regulations, the spirit of ISO 13485. Several transitions were required to adopt the updated standards. As systems evolved, customers, especially the larger ones, got stricter and more demanding. This is what the whole industry was facing. Creativity was at an all-time high. The complexity of the Medical Devices was generating a higher potential for failures and prompt for recalls, fines, and in worse cases, deaths or human injuries. ADOPTING eQMS­THE GENERATION OF QUALITYIn My Opinion
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