Tag Archives: steven walfish

ANSI Z1.4 Reduced Inspection

Question If you have Ac=0 and Re=2 what do you do for 1? I have not used the reduced sampling before, so am curious what should be done in this instance. Answer If you review the footnotes for Table II-C … Continue reading

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AQL Clarifications

Question I am confused about the values used for AQLs. For example in Table II-A the AQL values range from 0.010 to 1000. Where do these values come from and what do they mean? The table states, “AQLs, in Percent … Continue reading

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DPMO

Question My question concerns the process performance metric DPMO (defects per million opportunities). I want to use this to quantify a particular supplier’s performance. My question is, is the number of defects referred to in the calculation the number of … Continue reading

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Z1.4 Sample Size

Question I am trying to determine the sampling size using my ANSI/ASQ Z1.4 table and I wanted to get some clarification. If I am using Table II A and my Sample Size Code letter is D, what would be my … Continue reading

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Six Sigma Statistical Meaning

Question I need to understand the statement, “Adding a 1.5 sigma shift in the mean results …….” I’m used to the bell curve and + /- three sigma. How does the extra +/- three sigma fit in, and what is … Continue reading

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Switch from ANSI/ASQ Z1.9 to ANSI/ASQ Z1.4?

Question Hi, We are using ANSI z1.9 for a dimension test of packaging components. As dimension is under variable, can we switch to ANSI z1.4? The reason for this is to align with our supplier who is using ANSI z1.4. … Continue reading

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Z1.4: Selecting the Sample Size

Q: I work for a pharmaceutical company that manufactures soft gel capsules. What is the proper way to select a sample size when using ANSI/ASQ Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes? I’ll further illustrate my question with … Continue reading

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Z1.4:2008 inspection levels

Q: I am reading ANSI/ASQ Z1.4-2008: Sampling procedures and tables for inspection by attributes, and there is a small section regarding inspection level (clause 9.2). Can I get further explanation of how one would justify that less discrimination is needed? … Continue reading

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Sampling Plan for Pharmaceuticals

Q: We are a U.S. dietary supplements manufacturer operating under c-GMP conditions set by the U.S. Food & Drug Administration (FDA). As such, we perform analyses of incoming raw materials (finished product ingredients), intermediate products (during manufacturing), and finished products. Analyses include … Continue reading

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ANOVA for Tailgate Samples

Q: I have a question that is related to comparison studies done on incoming inspections. My organization has a process for which it receives a “tailgate” sample from a supplier and then compares that data with three samples of the next three shipments to “qualify” them. The reason behind … Continue reading

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