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Rolando Ardon

When 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. Because of this, Quality Systems were settling in common principles and areas.  Many different names were given to the same techniques and methods, all based on the scientific method. Also, because of aging of such systems, there was also a higher probability for errors and omissions.  Along with the emerging technology, the use of computers was getting more and more important.

"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"

Electronic Quality Management Systems (eQMS) were developed and proved to be beneficial to increase the effectiveness and efficiency of the QMS.  At this stage, the Quality function was now one of the most important of the organizations. As I say, the final approval is always from Quality, and in medical device manufacturing, even more.

Now, a new challenge was created.  How do I migrate to an electronic system since so much paperwork is driving the companies crazy?  And, are the solutions that I am offered good enough to meet regulatory requirements?  This is a question that many heads of Quality are asking these days.  It is very time-consuming to compare systems and companies that now are making a full business out of it.  In some cases, like mine, was it worth developing one internally, a so-called homegrown system using the available tools?  I answered my question myself without imagining what I was going to come to.  After over 27 years in medical devices, and not counting with the funds to buy one of the systems, I decided to create one.  I said it was going to be temporary.  It grew as required, only with what was needed, not more, not less. Simple, user friendly and of course, compliant.  Temporary turned permanent; 9 years later, it is still there and has gone through FDA inspections and customer audits.  It even turned into a sales tool to attract customers. The organization grew around it and it found its place in the business.  Highly regarded, it solved the need of sustaining a full mature quality system with the capability of supporting company growth.

I learned that the key to success in this world of regulations and standards comes down to one word: simplicity.  As I joke with engineers of any field (and I am one) when I find something too complex, I say: “who designed this, an engineer?”  We tend to overcomplicate things.  We overthink the situations we are involved in.  Systems lose their basic purpose because we want to embellish them, because we think is too cool to have this and that, and it can do this and do that.  Who doesn’t come across many computing systems where only about 10 percent of its potential is used? It is the same thing with the human brain.  This creates confusion, frustrations, and overwhelming feelings about what is this good for.

One of my former leaders always said, “Never lose sight of the rabbit”.  Chase what is important, just that.  The rest is just baggage that will drag the organization down.  Analyze what is really required. Why waste energy if it’s not needed? This will save it for what matters without adding unnecessary human and financial costs.  Do not forget to have fun as you go.