Tag Archives: steven walfish

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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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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