By the time I began work as a Quality Engineer for The Gillette Company, in the early 1980’s, I had worked for several other organizations. None of them had Quality Management Systems, or a ‘QMS’
One of the first things I learned about quality management was that quality, cost and schedule were interrelated.
Some of the most challenging situations I have had to confront during my career have involved achieving compliance with regulations.
There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
There are right and wrong approaches for using measures to achieve performance improvement. Knowing the difference requires some book-learning, but mostly the wisdom of broad and deep experience.
For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity. It is an open disclosure of how poorly your organization complied with specific regulatory requirements.
Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.
Yes! The U.S. Award for Quality Excellence is known as the Malcolm Baldridge National Quality Award (MBNQA). In fact, the award was established as Public Law 100-107 by an act of Congress under the Reagan administration in 1987.
Following are some popular views about the cars mentioned related to quality management systems, above. Substitute the descriptions of the cars for descriptions of a company’s QMS and you’ll realize what the CEO is actually asking for in the conversation.
No matter what our perspectives may be or how they may differ, time is the one thing money cannot buy. It matters how we spend it. Quality 5.0 is coming2 and, although formative, it speaks of massive integration between humans and machines, digital neural interfaces, levelling of the economic playing field, increased longevity, global quality of life, ecological healing, and prolonged existence of humankind off-planet. I want to be ready for that!
A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).