Continuous Flow Mfg Skip-Lot Sampling. Domenick Amato Frank Gomez Lynn Torbeck. 210.3(20) “Acceptance Criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level with an associated sampling plan …”
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How to define a “lot” or “batch” in a continuous flow process?
Assumption of homogeneity of product?
Assumptions about defects?Continuous Flow Mfg
“Consumer’s Risk” The probability that a bad lot is accepted by the customer. (Type II error or beta)
Levels not fixed but common values are 5% and 10%.Risk Management
Not inspecting all characteristics on the CoA or listed in the USP.
Can use reduced testing in Z1.4.
Use the switching rules in Z1.4.Reduced Testing
Faith and trust in an honest supplier. Good relations.
Proven history of quality with a stable and continuous process.
Clear criteria for action plan.Assumptions for Skip-Lot
ASQ (1996). ANSI/ASQ S1, “Attribute Skip-Lot Sampling Program.”
Schilling, E. (1982). Acceptance Sampling in Quality Control, New York, NY: Marcel Dekker, pp 443-451
Juran, J. and Godfrey, A. (1999). Juran’s Quality Handbook, Fifth Edition, pp 46-31, 46-32, New York: McGraw Hill.References