When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were effective or ineffective? My assumptions were as follows:

It’s no secret to anyone, anywhere, that we’re experiencing a global business challenge, especially in manufacturing.

One could argue that for too long, manufacturers in the United States have been complacent and indifferent to signs of market change, steadily losing market share to offshore businesses that were more productive and efficient.

Geoff Bilau, senior writer for the International Association for Plumbing and Mechanical Officials (IAPMO) Group, was awarded first place for his paper by the American National Standards Institute (ANSI) for describing the importants of quality standards and accreditation.
--Editor

I've been auditing to ISO 9001 since 1992. A part of my auditing philosophy has been to add value to the audited organizations by suggesting opportunities for improvement. Following, I will describe the most effective “value adds.”

The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.

Off the record, current, and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

Internal auditing, when effectively implemented, can arguably be considered the most important tool in the quality system tool box. It’s the primary method for continuously monitoring a company's quality management system (QMS). In fact, the feedback from internal auditing is critical to the growth of the QMS.

Liquid delivery is a common laboratory process and this critical function is often overlooked. As a result, routine research and test results can be in error based on a simple misunderstanding or misapplication of liquid delivery instruments. This article focuses on defining and exploring accuracy and precision, which are fundamental elements of regulatory compliance.

When regulatory compliance and risk management come to mind, they usually evoke feelings of fear, uncertainty, and doubt as to how well an organization is prepared for government scrutiny or any worst-case business scenario. Questions arise, such as: Have we developed the proper procedures to ensure product compliance? How can we measure and actually know if we are within the regulatory guidelines?  Do we have “proof of absence” or are we at risk from “absence of proof” by market and regulation? Do our systems help or hinder us?

From an antacid to a new cancer treatment, every drug must be proven safe and effective in controlled clinical trials before the U.S. Food and Drug Administration (FDA) allows it to be sold in the United States.