Q: I work at a cosmetics manufacturing company that produces sunscreen in bulk amounts. When we make 3,000 kg of sunscreen, we will use that in 10,000 units of final sunscreen products which will weigh 300 g each.
How many samples do I need to collect from the 10,000 units to pass the qualification?
The products need to pass both attribute and variable sampling tests such as container damage, coding error, micro testing, and Active Pharmaceutical Ingredients (API) failure. Almost 100 percent of final products were inspected for appearance error, but a small number of them should be measured for micro testing and API chemical analysis.
For Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes, we have to collect a sample of 200 (lot size of 3,201-10,000; general inspection level II; acceptable quality level 4.0 L), and more than 179 should pass for qualification.
For Z1.9-2008: Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming, we have to collect a sample of 25 (lot size of 3,201-10,000; general inspection level II; acceptable quality level 4.0, L), to meet the requirement of 1.12 percent of nonconformance.
Which sampling plan should we follow for micro testing and API chemical analysis?
A: If the micro test is pass/fail, then you should use Z1.4. The API chemical test probably yields a numerical result for which you can calculate the average and standard deviation. Then, the proper standard to use is Z1.9. If the micro test gives you a numerical result, then you can use Z1.9 for it as well.
One thing to consider is the fact that the materials are from a
batch. If the batch can be assumed to be completely mixed without settling or separation prior to loading into final packaging, then the API chemical test may only need to be done on the batch, not on the final product. Micro testing, which can be affected by the cleanliness of the packaging equipment, probably needs to be done on the final product.
U.S. Liaison to TC 69/WG3
ASQ CQE, CQA, CMQ/OE, CRE, SSBB, CQIA
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