Zero Acceptance Number Sampling Plans and the FDA


Question

There has been some debate over using the MIL-STD-1916 acceptance sampling plan over the ANSI/ASQ Z1.4-2003 (R2013) sampling plans.  The opinion is that the ANSI/ASQ Z1.4-2003 (R2013) is outdated and no longer an acceptable method of determining a qualification sample plan and the MIL-STD-1916 should be used in place of ANSI/ASQ Z1.4-2003 (R2013). Do you have information around this debate over which sampling plans are acceptable by the FDA?

Answer

FDA does not (and can not) tell you what sampling plan is to be used.  The FDA requirement is that the plan be statistically valid.  As long as you follow the regulation, you are meeting FDA requirements.

In medical device manufacturing the key point is to have the plan accept on zero defectives.  This point is not FDA but legalese.  It is based on past lawsuits.  The plan “Zero Acceptance Number Sampling Plans” by Nicholas L. Squeglia (available from ASQ) has been widely adopted for this reason.

ANSI/ASQ Z1.4 in not outdated and continues to be widely used.  It is the American National Standard Institute (ANSI) version of MIL-STD-105 which the government discontinued maintaining, allowing ANSI to maintain it along with many, many other MIL-STD’s as a government cost reduction.

MIL-STD-1916 can be used but it is not widely used because of its difficulty and practical use.

James Werner

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