Sampling Plan Based on Operating Characteristic Curve
Science Journal of Analytical Chemistry
Volume 6, Issue 3, May 2018, Pages: 21-24
Received: Jul. 19, 2018;
Accepted: Aug. 2, 2018;
Published: Aug. 29, 2018
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Masato Kazusaki, Quality Assurance Office Health & Crop Sciences Sector, Sumitomo Chemical Co., Ltd., Osaka, Japan
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In the pharmaceutical industry, bulk raw materials are purchased to manufacture the bulk pharmaceutical active ingredients. Some of these bulk raw materials in the packaging is randomly picked up to determine the quality of them. So, the sampling plan is an essential means of testing in quality inspections to make disposition decision. So far, the square root of N plus one rule has been employed to provide a simple mathematical way to calculate the number of items to be inspected for quality of raw materials. However, this rule is apparently not devised on the statistical consideration. Now, another sampling plan based on the operating characteristic (OC) curve is established. The OC curve is defined with a sample size and the maximum acceptable number of defective items, describing how well sampling plan discriminates between good and bad lots. This sampling plan is associated with risks such as the producer’s risk of incorrected rejection by the consumers and the consumer’s risk of incorrect acceptance of the lots with unsatisfied quality. The sampling plan based on the OC curve is exploited to validate the reliability on two levels of quality, such as acceptable quality level (AQL) and lot tolerance percent defective (LTPD). This newly established sampling plan is compared with the principle of the square root of N plus one rule to demonstrate the effectiveness to distinguish the good lots from bad lots for the plants where the individual packaging of raw materials is usually purchased at the level of less than 50. In the case of the number of the individual packaging is less than or equal to16, the capability of the new sampling procedure based on the OC curve for discrimination of the quality of lots inspected is superior or comparable to the principle of square root of N plus one rule. This paper describes the reliability and efficacy of the single-sampling plan under the principles of the OC curve.
Sampling Plan, Operating Characteristic Curve, Acceptable Quality Level, Lot Tolerance Percent Defective, In-Coming Material
To cite this article
Sampling Plan Based on Operating Characteristic Curve, Science Journal of Analytical Chemistry.
Vol. 6, No. 3,
2018, pp. 21-24.
Copyright © 2018 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/
) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Morris H. Hansenn, Some History and Reminiscences on Survey Sampling, Statistic Sci, 2, 180 (1987).
D. R. Bellhouse, A Brief History of Survey Sampling Methods, Handbook of Statistics, 6, 1-14 (1998).
Alan Julian Izenman, Statistical and Legal Aspects of the Forensic Study of Illicit Drugs, Statistical Sci, 16, 35 (2001).
FDA, Investigations Operations Manual, Subchapter 4.3: Collection Technique, section 220.127.116.11 Random Sampling.
FDA, CBER. “Draft Points to Consider in the Manufacture of In Vitro Monoclonal Antibodies,” March. 1992.
F. W. Quackenbush and R. C. Rund, “The Continuing Problem of Sampling,” J. Assoc. Official Analytical Chemists 50, 997 (1967).
E. M. Foster, “The Control of Salmonellae in Processed Foods: Classification Systems and Sampling Plan,” J. Assoc. Official Analytical Chemists 54, 259 (1971).
Saranadasa, H. ‘The Square Root of N Plus One Sampling Rule: How Much Confidence Do We Have?’ Pharmaceutical Technology, 27, 50 (2003).
Torbeck L. D. ‘Square Root of (N) + 1 Sampling Plan Is the square root of (N) + 1 a statistically valid scheme?’ Pharmaceutical Technology, 33, 128 (2009).
Arianna Mussidaa, Ursula Gonzales-Barron, Francis Butler, Operating characteristic curves for single, double and multiple fraction defective sampling plans developed for Cronobacter in powder infant formula, Procedia Food Science 1, 979 (2011).
Food and Agriculture Organization of the United Nations, World Health Organization, GENERAL GUIDELINES ON SAMPLING CAC/GL 50-2004.