The first plan is exact, and the second plan is approximate, but close enough for government work. An equivalent variables sampling plan would be n = 19, and k1 = 2.3883 for a one-sided tolerance, and n=19, and k2 = 2.784 for a two-sided tolerance. With the values above you can sketch out a rough O-C Curve and connect the dots to view its shape. The key points on the O-C Curve are as follows: A side point, the O-C Curve for this plan is fairly steep providing a reasonable chance of rejecting the inspection/test (not sure which) at a defect level less than 5%. Your plan above is n=59 and a=0, an accept on zero plan. Okay, let’s look closer at your sampling plan to find an equivalent variables plan. I’m not trying to give you a hard time here, but I’ve lived in your shoes and don’t want you to be caught with your pants down, if you know what I mean.
In either case, the FDA would not consider the Internet an acceptable source for referencing sampling plans during an possible audit review, and if known you could receive a finding from them. Am I correct in this assumption? If instead you are selecting samples, and performing a pass/fail test, then perhaps you might want to reference the ANSI/ASQ Z1.4 Standard on Sampling by Attributes. So, I assume you are subjecting medical devices to some accelerated testing or other, and noting the number of failures after the test duration completes. The application for the use of the above equation is as follows: select n units, subject all of them to the same test at the same time, note the number of units that fail after the test. N = ln(1-confidence level) / ln reliability
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For anyone looking in, the sample size for failure free testing is easily determined from the following equation: I was curious about your use of a reliability sampling plan supporting failure free testing for evaluating measures of attributes. But, I reviewed my reliability reference materials to verify the binomial distribution is correctly used in this application as it is in attributes inspection. I spotted your posting and thought, while it’s not a Six Sigma question per se, that I might be able to help anyway. I’ve spent a few years working in the med device industry supporting among others the quality management area.
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