Quality Auditor Quotes

There was little effort to conceal this method of doing business. It was common knowledge, from senior managers and heads of research and development to the people responsible for formulation and the clinical people. Essentially, Ranbaxy’s manufacturing standards boiled down to whatever the company could get away with. As Thakur knew from his years of training, a well-made drug is not one that passes its final test. Its quality must be assessed at each step of production and lies in all the data that accompanies it. Each of those test results, recorded along the way, helps to create an essential roadmap of quality. But because Ranbaxy was fixated on results, regulations and requirements were viewed with indifference. Good manufacturing practices were stop signs and inconvenient detours. So Ranbaxy was driving any way it chose to arrive at favorable results, then moving around road signs, rearranging traffic lights, and adjusting mileage after the fact. As the company’s head of analytical research would later tell an auditor: “It is not in Indian culture to record the data while we conduct our experiments.

The only way to reduce errors by 70 percent was to make every single employee, in effect, a quality assurance auditor. Everyone had to take responsibility for catching mistakes. But most factory workers didn’t know enough about the engines to identify every small defect as it occurred. The only solution, managers decided, was a massive retraining effort. Except

Increasingly, I have become concerned that the motivation to meet Wall Street earnings expectations may be overriding common sense business practices,” he said. “Too many corporate managers, auditors, and analysts are participants in a game of nods and winks. In the zeal to satisfy consensus earnings estimates and project a smooth earnings path, wishful thinking may be winning the day over faithful representation. As a result, I fear that we are witnessing an erosion in the quality of earnings, and therefore, the quality of financial reporting. Managing may be giving way to manipulation. Integrity may be losing out to illusion.” It was a remarkable speech.

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