Mil Std 105E  Sampling Plans Not Dead Yet

Mil Std 105 E was officially cancelled in 1995 and replaced by ANSI/ASQ Z 1.4 for sampling by attributes.  At that time I purchased a copy of Z 1.4 (for a fee ~$199.00, and copyrighted; whereas the Mil Std stated that its "distribution was unlimited" - no fees and no copyright worries), and started to switch my clients over to Z 1.4. But in checking I found that the Z 1.4  sampling plan was identical to the 105E's, so I went back to 105E with those of my clients who hadn't updated / wanted that type of plan, using the105E's plans copied in the SOP's I wrote for them, without having to purchase Z 1.4 / updates for every client and worrying about the associated copyright issues. 

However, one of my clients had an FDA CGMP compliance inspection, and was called out for using 105E, an "obsoleted standard" for acceptance sampling, and the FDA inspector was adamant in the need to change to an alternative. I couldn't convince the inspector that the plans were identical, so, rather than argue, we changed (in a couple of instances, to Nicholas Segura's C=0, also for a fee and copyrighted, and derived from Z 1.4).  

Recently, while updating an QC inspection SOP, I stumbled upon some older Quality Digest articles arguing for the advantages of the old Mil Std105E, and which referenced ASTM E2234, which "carries forward" that standard (e.g., see Wikipedia reference below).  So now I once again have Mil Std 105 E as an option for clients for its sampling plans for QC sampling in CGMP applications in medical device manufacturing, because they have always been and are still valid, but I now had a valid, easy to understand rationale for their continued use.       

"MIL-STD-105 was a United States defense standard that provided procedures and tables for sampling by attributes based on Walter A. Shewhart, Harry Romig, and Harold F. Dodge sampling inspection theories and mathematical formulas. Widely adopted outside of military procurement applications.

The last revision was MIL-STD-105E; it has been carried over in ASTM E2234 - "This practice establishes lot or batch sampling plans and procedures for inspection by attributes using MIL-STD-105E as a basis for sampling a steady stream of lots indexed by acceptance quality limit (AQL). It provides the sampling plans of MIL-STD-105E in ASTM format for use by ASTM committees and others and recognizes the continuing usage of MIL-STD-105E in industries supported by ASTM. This practice also establishes lot or batch sampling plans and procedures for inspection by attributes."

It was officially cancelled in February 1995 by a Notice of Cancellation. This Notice was updated in March 2001 and again in February 2008. The current Notice of Cancellation (Notice 3) recommends that future acquisitions refer to: MIL-STD-1916, "DoD Preferred Methods for Acceptance of Product", or ANSI/ASQ Z1.4, "Sampling Procedures and Tables for Inspection by Attributes"."

-- Wikipedia and ASTM E2234 description (Color added by JEL)

The above information is presented FYI only.

-- jel@jelincoln.com

12/25/2023 - Added additional to ASTM E2234. - JEL