Saturday, August 14, 2010

Quality Assurance: To Count the Cost—or Not?

One of the regulatory responsibilities of the Quality Control Unit is the release decision for drug batches into the market. When I was first given that responsibility early in my 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 in order to put the financial arms 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 Phil Crosby, the ghost of gurus past, whose apparition onto the quality scene said that the Price of Nonconformance (PONC) is the measurement of quality, not indexes.1 With Genzyme's manufacturing write off of $21.9 million dollars in July and an additional write off of $6.5 million dollars in August 2, along with an expected consent decree disgorgement fine of $175 million dollars3—and costs associated with third-party control and quality system and facility upgrades—we're talking real money. Real PONC.

In the grand, cosmic, economic scheme of "pay now, or pay later," an upfront investment in quality by design through qualified personnel, training, facility design, product development, technical transfer, process validation, supplier qualification, environmental monitoring, etc., for any pharmaceutical company has got to be the best dollar spent.

When things go wrong, it always happens at the worst possible time and when the solution is at the highest possible cost. The most painful cost is the effect of the loss of patient and consumer confidence, and perhaps, the loss of a brand.

So, here is an admonition to the quality assurance professional:

Do not count the cost of the batch when making the batch release decision. Regardless of the lost standard and opportunity costs, to reject a batch when it is the right decision is not only the ethical, moral decision, but also it is the best financial decision for the company the long run.

However, do count the cost of PONC. Picture yourself at the edge of the landfill tallying the cost of everything going into the pit.


Because behind every rejected raw material, component, bulk, finished product; behind every stale item on "hold" taking up space in the “morgue” section of the warehouse; behind every inefficiency and "do over" is lurking a frank or potential quality system failure and regulatory compliance problem. Counting the PONC is an effective measure of the health and welfare of the quality management system, which is a QA responsibility.

So, in these economically difficult times, before your profit improvement committees launch suggestion boxes or start unscrewing half the light bulbs in order to save the company money, zero in on PONC, and begin to systematically reduce the budgeted line item known as “standard waste,” the planned product write offs. It will be an effective, bottom line and quality improvement strategy.

So, the question is: Should QA count the cost, or not?

The answer is: yes, they should and shouldn’t.

1 Crosby, Philip. (1984) Quality without Tears, McGraw-Hill, p. 86.

2 Genzyme Reports Financial Results for Second Quarter of 2010, 21 July 2010,

3  Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits, FDA Press Release, 24 May 2010,

The QA Pharm

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