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

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



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