Standards: Are They Really Standard?

In the absence of clearly defined standards we will continue to see “spin” relative to the frequency issue, and we will continue to see flourishing debates. In viewing the pharmaceutical supply chain security matter, the guiding question is what will the pharmaceutical community decree? Will Six Sigma (with 99.9997 percent efficacy) be an absolute requirement? Or, will 94-99.65 percent functionality be acceptable? One need only do the math to understand what seemingly innocuous failure rates can really equate to in terms of larger volume. In a case of 48, 4.2 Sigma has a failure rate of 17 percent, or one failure every six cases. Six Sigma, on the otherhand, has a failure rate of less than or equal to two percent, or one failure for every 6,127 cases.