Unexpected Benefits

Medical Device Companies are required to comply with various regulations, based on where products are marketed. As start-up businesses or established companies enter the medical device arena, sometimes quality systems and regulations are viewed as a painful part of doing business. Cultures, procedures, workflow and management style may be changed when implementing a Quality System – and change is always difficult. However, there may be some unexpected benefits realized by a company that embraces a Quality Management System.

As part of a Quality System, process controls are put into place to ensure product repeatability and reproducibility. If a process is left to its mysterious and magical tendencies, producing acceptable product by chance, there is a likelihood of high waste and higher cost. Identifying key equipment characteristics and understanding the effect on a product or service will ensure that each product produced will be made to specification and satisfy the customer. Waste, rework, labor costs and material costs are reduced in an understood process. If inspection or customer complaints are depended upon to find a lack of quality, it will be too late. In this economy, what company can afford to not control processes?

Corrective and preventive action systems capture, investigate, solve and remediate problems once and for all. How many times have you thought, “We’ve had this problem before, what worked last time?” Solving a problem by putting a system in place will ensure that the problem will not be a recurring issue. This will provide understanding about process flow, process interactions and build confidence in the product or service. Looking for trends and relationships between problems could lead to preventing difficulties in the future. Improvements in environment, training, equipment, test methods or materials will increase productivity and product or service reliability.

Perhaps a little known benefit of implementing a Quality System is the way that all staff members are affected. After changes are complete, walls between “management and workers” are torn down and fear is removed, staff members are free to participate in problem solving, improvement teams and communicate day to day knowledge about the best way to serve the customer. This empowerment at all levels of the organization makes for an atmosphere of teamwork and value of staff members. People do their best each day knowing that they are important to the success of the company. Communicating to employees the goals for the company and the importance of participation are un-measurable assets. People are encouraged to learn new skills to prepare for future challenges. Pride in workmanship and staff members willing to go the extra mile to serve the customer is priceless.

Dr. W. Edwards Deming, credited with starting the movement of Total Quality Management, had this message: by improving quality, companies will decrease expenses as well as increase productivity and market share. At Regulatory and Quality Solutions, LLC, we’ve seen evidence of this as it’s practically applied to our clients. So, get through the painful, confusing and difficult challenges that are presented by implementing a Quality System. Customers, employees and the bottom line will benefit.

“Profit in business comes from repeat customers, customers that boast about your project or service, and that bring friends with them.” – Dr. W. Edwards Deming

-Beth Freed