One of the regulatory responsibilities of the quality control department is the release decision for drug batches into the market. When I was first given that responsibility early in my quality assurance (QA) career, it was impressed upon me to not count the cost of the batch when making that decision.

That was good advice. But looking back, I would have modified that admonition slightly to put the financial arm’s length of the QA role in a broader perspective.

For sure, QA must not allow the cost of the batch to influence its release decision. One needs to be objective and independent—no apples to polish, no axes to grind. Patients deserve no less. But QA needs to do more than call balls and strikes.

It was Philip Crosby, the ghost of gurus past, who said in his Quality Without Tears: The Art of Hassle-Free Management (McGraw-Hill, 1995) that the price of nonconformance (PONC) is the measurement of quality, not indexes.

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