"One response from FDA and industry is to better quantify the costs of quality failures: lost revenue, lost jobs, damaged reputations and, in some cases, loss of the company, Woodcock said. FDA also is looking closer at the root causes of failures, which may reflect management inattention, deliberate company decisions to defer investment in modern production facilities, or corporate disregard for the quality department. Companies take calculated risks with such approaches, she said, and should consider whether the savings are worth the cost to the firm. “We need the business side to become convinced that a commitment to quality can avoid costly failures.”"
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