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Literature Review

Technical analysis of proposed sampling plans, their statistical equivalence, and comparison with sampling plans covered by existing requirements of 42 CFR Part 84, Subpart E, 84.41
By:- Written under NIOSH contract The purpose of this analysis of the proposed sampling plans is twofold: To explain the changed philosophy and new sampling plans and to help users in selecting or designing the new sampling plans. The previous QC requirements involved AQL sampling schemes that were first developed by the U. S. Army in 1942. The proposed rule allows the producer to use more recent developments in the application of statistical methodology to quality assurance. It shifts one's focus of attention more to protecting the consumer and addresses the relationship between the sampling inspection plan and statistical process control and capability. The proposed rule does not require conformance to an AQL -- AQL is to protect the producer. Instead, it allows the use of ANSI/ASQC standard Q3 and/or Mil-Std-1916. These standards focus on the consumers need that off-grade product lots be recognized and rejected.

Valid Sampling Plans: A case study


By: Lynn D Torbeck, Statistician This case presents the prevailing thinking on the sampling plans related to FDA requirement and current industry practices. Sampling plans provide immediate protection against major failures. The case says that population size does not matter as long as it is at least 10 times greater than the sample size. It also discusses about MIL STD 105E standard.

The sampling Plan was developed for only the critical materials and hence it can be taken foreward for other materials as well. The plan is tested on the automated plant as it was most important to implement it here due to the above mentioned facts. So it should be tested at the other conventional plants as well in future. The sampling plan is made for only the paint industry but the framework can be used by other industries as well to construct their sampling standards.

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