Surface quality and cleanliness are critical for medical devices. As people live longer and continue to be more active, higher and more reliable device performance is expected. More medical devices are available, often involving extensive supply chains.
An array of analytical methods can be used to detect surface contamination and to characterize attributes of processes. Many involve “sending a sample to the lab.” There are many quicker, even if less precise, methods of determining that the process is outside of control parameters.
The Peter Principle holds that “in a hierarchy, every employee tends to rise to his level of incompetence” and it is still quoted and blamed in many management situations today. Is it true? And if so, why does it persist?
International experts have made significant changes to ISO’s airborne cleanliness classification standard — and now is the time for industry to comment.
Is there such a thing as a contamination control mindset? A quick web scan for the definition of “mindset” came up with a couple I thought interesting. Simply put, “a way of thinking about things” or, possibly more ominously, “a set of beliefs of a person (or perhaps a company) that affects the outcome of all their endeavors.”
My company is planning to expand its manufacturing capacity. Any words of advice on how best to scope the budget for construction projects?
“We know our ultrasonic system is working properly, because it’s making plenty of noise. Why is the cleaning process ineffective?” This recurring question has vexed manufacturers for decades.
This column updates the May 2010 column, and January 2011 column in which I reported on a whipsaw (a lose-lose situation) faced by the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA).
Organizations experiencing contamination issues know that contamination may cause serious financial risks to their bottom line.
In their book, Management? It's Not What You Think!, authors Henry Mintzberg, Bruce Ahlstrand and, Joseph Lampel offer “leadership realities” that are often overlooked or undervalued in organizations.
Poisons sap strength—including product quality and profits. Stop AMC at the source. Where is it in your process flow? Could AMC arise from the outside environment or prior processing in your supply chain? Is it being generated inside your facility?
Your goal is to create a work environment in which people are empowered, productive, contributing, and happy. Don't hobble them by limiting their tools or information. Trust them to do the right thing, then get out of their way and watch them succeed.
Obtaining requirements-oriented cleanliness in a cost-optimized way.
Born without a right leg, Tony Robles is a champion college wrestler from Arizona State University. In 2011, his senior year, he may well win the NCAA collegiate championship.