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Compliance Isn’t Accidental: A Case for Management’s Commitment to Quality

During my global travels, I’ve met a wide variety of people, including an assortment of executives who strategically drive their medical device companies toward success. Are they all successful? No. I say that tongue-in-cheek, because some managers with executive responsibilities make a decent profit for their companies every year, but fail miserably in directing and enabling the quality and regulatory requirements mandated by FDA and ISO Registrars. It’s true. They don’t know how to handle these requirements.

In this ongoing, quiet recession with which the world is struggling (and getting used to), there is a not-so-fine line drawn in the sand that separates business acuity and regulatory compliance. Purists say there is no line, and “the architecture of the Quality System Regulation and ISO 13485:2012” thrives on a seamless relationship between regulatory requirements and business systems excellence. Realists say there is no contest; business initiatives and monetary success are clear winners, while quality and regulatory are just a means to a predetermined end.

FDA investigators and ISO auditors like me also have a lot to say about the approach that should be taken. Mainly, it must document demands for management commitment and establish a policy for quality that is understood by all employees at all levels of the company. Business and quality must be equal under one roof.

Suggestion:
 W. Edwards Deming, father of the quality movement, famously laid out 14 points for management. Chief among them was the notion of “constancy of purpose.” Deming argued that a company’s commitment to quality had to come from the top, and it had to be reinforced over and over again. Unless a business views quality as its single, non-negotiable goal, workers will inevitably feel the need to make tradeoffs—and quality will slip.

This is not Smoke and Mirrors
Symptomatically, there are common indicators for medical device companies that succumb to the quality management “monster” that, frankly, was probably conceptualized and nurtured from business needs in the dark-paneled offices of top-level management. This is where strategic decisions to increase revenue become reality, and the quality and regulatory requirements are just an afterthought—a necessary evil. The architecture of both the Quality System Regulation and ISO 13485 depends upon management that is committed first to quality and regulatory requirements from a standpoint of earnest involvement, and second, to responsibility to assure that the quality policy is understood, implemented and maintained at all levels of the company.

Plan Appropriately
From my observations and discussions, large, multi-national companies are commonly predisposed to documenting strategic initiatives using detailed plans and deliverables. Smaller companies, not so much. These top-level plans should be linked to the goals and objectives of operating units and, of course, individual process owners. Planning is not just for larger companies. On the contrary, small companies that have an appropriately-sized planning platform commonly use goals and objectives as tools for compliance and improvement. The lack of planning at all levels usually puts an emphasis on quick-fix solutions, firefighting and extending employee responsibility without adequate training. In turn, these conditions have resulted in a lack of willingness by employees to participate in improvement initiatives, and more often, quality is seen as an added cost to be avoided. Plans give initiatives an action-based foundation for which responsibility is appropriated, outputs are expected and trends become a metric-driver for measured success.

The lack of documented plans and the inadequate understanding of the regulations in this respect is a common symptom of the eventual downturn of the Quality Management System (QMS). It catches up with you when you least expect it—for example, when an FDA inspection doesn’t go as planned, or when you’re in the middle of a recall of a profit-generating legacy product. As I said, this need for an efficient and effective QMS is considered as just a necessary evil by some senior managers and this, of course, leads to an inappropriate management style. Lack of plans and planning can result in a behavior that can affect the channels of communication among employees, spotlight a lack of understanding of the needs and requirements of customers and create a failure to understand the basics and key linkages between concepts like business process re-engineering and design. This lack of planned integration between the “soft” and “hard” issues of a QMS can result in unwillingness by employees to participate in improvement initiatives and, again, quality is seen as an added cost and something to be avoided.

Measure Employee Performance
You can’t pull off quality without competent people. I used to think that a strong process could steer the ship; however, people drive the QMS. Management must insist that the criteria for competency be developed based on appropriate education, skills, training and experience for activities, tasks, functions and processes. The level and detail of such qualifications, skills, training and experience will depend upon the complexity of product, process and, basically, your QMS. Manufacturing Class III medical devices demands a different and more complex set of ground rules than Class I devices. The demands on personnel are unalike and subjectively complicated.

Suggestion: Whether you give training duties to your employees, take them on personally or some combination of the two approaches, it’s important that management provide all levels of personnel with a history of the company through the lens of quality and improvement. Let them know what problems you have had in the past, how you corrected these problems and where your company stands with respect to its quality goals and objectives today.

It is up to your organization, with backing from management, to determine the necessary criteria for the various functions and activities affecting product and QMS based upon these factors. A skills matrix, for example, is a valuable tool used by medical device companies to determine and manage the competency levels required by different activities and functions to make safe and effective medical devices.

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