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.


Organizations undergo significant changes through growth or decline, acquisitions, new technology and new products and processes. It is management’s responsibility to give guidance and direction. Also, many organizations now outsource production labor to save on payroll costs and benefits. Labor-related nonconformities can easily arise in such cases. Planning for your HR process must ensure that contract and agency personnel who perform work affecting product quality have adequate competency and training. Appropriate records must be kept of such training.

Quality professionals recommend that businesses train workers at all levels to look for ways to improve quality and to reduce problems before they happen. Management must back this training 100 percent. Competency-based training is an approach that is more often used in concrete skills learning than abstract learning. In the medical device industry, it is the difference between training to work instructions versus training to policy level documents. It differs from other non-related approaches in that the unit of learning is extremely fine-grained. All employees work on one competency at a time, which is likely a small component of a larger learning goal.

Suggestion: Talent management is the science of using strategic human resource planning to improve business value and make it possible for companies and organizations to reach goals. A talent-management strategy needs to link to business strategy to succeed. Two major areas of measurement are imperative: performance and potential, i.e. to tee-up the proper development of skills and increased responsibility.

Having the Right Attitude comes from The Top
Too many people turn the quest to improve quality and to be compliant into something oppressive. The idea that the QMS has to be dreary and involve a lot of negativity is nonsense. On the other hand, this is serious business with a mindset that spells leadership, leadership and more leadership. 

The job of management is to frame the pursuit of quality and regulatory compliance as an interesting, noble and worthwhile goal. If you are to truly improve quality at your business, whether you manufacture products, distribute goods or perform a service for your customers, your first step (and also the toughest first move) is to resist the enticement to dwell on your company’s failings. Instead, demonstrate to your employees that correction and then corrective/preventive action is more than wordsmithing but is, in fact, a pursuit of real, honest-to-goodness improvement.

Demonstrate Commitment
Budgeting for corrective and preventive action, training, internal audits and improvement initiatives should be deliberate. Companies that throw pocket change at quality compliance commonly get frustrated and constantly complain about not having a decent return on investment. What investment? There’s no budget. Tracking the cost of quality as part of this budgeting process and actually reporting on your progress during staff meetings and management review sessions is imperative.

Top management must actively participate in management reviews on a regular basis. How else are we going to see that they are truly leaders “walking the talk.” Employees at all levels see right through “lip service” and false promises. Employees don’t want a speech as much as they want to see how top management is going to live the quality policy and tough regulatory demands. This goes both ways. Equally, quality management must be allowed to participate in regular management meetings, planning sessions and decision-making processes. I read about a medical device company that had an executive staff that met alone and quite frequently—probably in one of those dark-paneled offices. They never included process owners and especially anyone from the quality department in their planning sessions. The president of the company couldn’t understand why her “message” wasn’t being heard by everyone. What can you expect when you don’t talk with everyone and don’t ask for suggestions? The article went on to say that she changed her modus operandi, and now the company continues to measure-up to the challenges on their “quality dashboard.” It’s just about talking and listening.

Suggestion: Management must be committed to:

  • Increasing access to more markets worldwide with ISO certification
  • Outlining ways to review and improve processes across your organization
  • Increasing efficiency, cutting costs and monitoring supply chain performance
  • Demonstrating that you produce safer and more effective medical devices
  • Meeting regulatory requirements and customer expectations

The quality department must report directly to top management. Reporting to operations can be misconstrued as a smoke-and-mirrors attempt at compliance. Your intentions must preclude bias and should allow objectivity to lead the way with strategic as well as task-oriented initiatives. Top management must champion quality, communicate it and understand its impact concerning the production of safe and effective medical devices every day.

Lastly, management’s strategic plan should include quality milestones and not just financial goals and objectives. The financial part of this equation is very important, without a doubt but, unfortunately, doesn’t present the whole picture. Strategic planning can, for example, include quality drivers like indisputable compliance to the QS Regulation and ISO 13485, effective and efficient process controls, supplier excellence, timely closure of corrective actions, the pursuit of CE Marking, etc. Quality must be implemented as a strategic requirement to build competitive advantage and a compliant QMS. Last time I looked, medical device companies are part of a regulated industry that becomes more complex every day.

John Gagliardi has had success over the past 45 years in the medical device and pharmaceutical industries because of his practical approach to process orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. He can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC
www.midwestprocessinnovation.com