Editor’s note: This is the third in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.

In part one of this series, we considered the management perception that current good manufacturing practices (cGMPs) aren’t relevant to the business, and laid out the defense that cGMPs enable a predictable quality outcome that serves the business and its patients very well. Part two explained how the quality function was in the best position to defend the relevance of cGMPs, but all too often it has problems of its own and should be the focus of serious organizational development. Here we make the case for a data-rich source of feedback to determine how effective the quality system is. Otherwise one is flying blind.

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