Trepanning is the process of drilling a hole in the skull. It was practiced as far back as 10,000 years ago. Archaeological artifacts lend credence to the lore that the process was used by some cultures to expel evil spirits.

Finally, the long and arduous process that appears to be a requisite phase in the development of an international quality management system standard appears to be nearing an end.

In Part I and Part II

The status of nuclear power in the United States is finally changing. As of last month, there were 18 proposals under review by the Nuclear Regulatory Commission (NRC) for 28 new units in 14 states.

Industrial organizations face numerous compliance regulations such as management system certification, information security, corporate social responsibility compliance, and limiting the content of hazardous substances in products.

As the universe of quality management systems expands, it’s interesting to observe the increasing variables that constitute the concept of applicability. Let’s take maintenance of records as an example.

In Part I, “Savvy Compliance Strategy Can Improve GMP,” we took a high-level look at a process for automating regulatory compliance managem

The Bre-X gold scandal that rocked the Toronto Stock Exchange (TSX) during the late 1990s forever changed the Canadian mining sector. When millions in pension dollars were lost due to fraudulent and falsified test data, investors around the world were outraged.

There is no shortage of standards. There are standards that define how something should be made vs. those related to processes, such as ISO 9001.

Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S.