Today's markets are growing globally and moving faster. Supply chains are leaner. Quality interruptions have dramatic financial and brand loyalty impact. To be effective, quality management systems (QMS) must keep pace, but unfortunately, everything is relative.

The rising cost of healthcare in the United States coupled with the absence of return on investment for Americans’ health is an important concern for many leaders across the country.

Years of experience working with businesses—especially in areas related to quality, customers, and continuous improvement—have taught me some lessons. One of the most valuable is knowing the right question to ask.

I attended a very nice presentation recently by a person who has been leading the lean charge for several years at a major medical center. As he reflected on key elements of his organization’s success, however, he made a statement that set off my hooey detector.

One focus of the regulations implemented by the U.S. Food and Drug Administration (FDA) during the past several years has been on quality in batch-to-batch production in the pharmaceutical industry.

Editor’s note: This is part two of a two-part series. To read part one, “Making the Leap from Manufacturing Manager to Consultant,” click here.

The theme of the recent 2012 Wharton Management Conference, “Changing the Game: Leadership in Crisis,” is an apt one for the auto industry.

Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their