China
Africa
Explore chapters and articles related to this topic
Visual Inspection
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Currently, the USP contains two chapters that focus on visible particles and visual inspection, USP <790> Visible Particles in Injections and USP <1790> Visual Inspection of Injections (10,11). USP <790> provides guidance on the processes needed for an appropriate quality management system including the need for 100% inspection and an appropriate sampling plan/Acceptable Quality Limit (AQL) level at batch release. USP <1790> provides detailed information on preventing defects, inspection processes, sources of contamination, and the need for a particle identification program. The identification/composition of particulate matter is very important when considering the medical significance when performing a risk assessment for the presence of the particulate(s) (2).
Administration of Acceptance Sampling
Published in Edward G. Schilling, Dean V. Neubauer, Acceptance Sampling in Quality Control, 2017
Edward G. Schilling, Dean V. Neubauer
Before a sampling plan can be derived, one or more nominal quality levels must be set to define the protection to be afforded by the plan. These includeAcceptable quality limit (AQL): Maximum fraction defective that, for purposes of acceptance sampling, can be considered satisfactory as a process averageAverage outgoing quality limit (AOQL): Maximum average outgoing quality to the consumer under rectificationIndifference quality (IQ): Level of quality with equal chance of being accepted or rejectedLot tolerance percent defective (LTPD): Objectionable level of quality that should be rejected at least 90% of the time (also 10% limiting quality [LQ])Producer’s quality level (PQL): Level of quality that should be passed most of the timeConsumer’s quality level (CQL): Level of quality that should be rejected most of the timeThe AQL, AOQL, IQ, and LTPD are used to index many existing acceptance sampling plans and schemes. Furthermore, the PQL and CQL with associated risks are used in the derivation of two-point plans. Risks must also be associated with the AQL, IQ, and LTPD; the latter two are fixed at .50 and .10, respectively, while the former sometimes varies over a range in the order of 0.5%–13% as with MIL-STD-105E. These nominal quality levels are necessarily fixed by the consumer to meet the consumer’s needs with due consideration to protecting the reasonable PQLs from rejection. Sometimes, this is done unilaterally, but more often by negotiation between the consumer and the producer. The consumer should be as much interested as the producer in good lots being accepted from the point of view of scheduling and price.
Generalized one-tailed hypergeometric test with applications in statistical quality control
Published in Journal of Quality Technology, 2020
Nataliya Chukhrova, Arne Johannssen
Suppose we are responsible for purchasing bearings for the maintenance department of a large airline. The bearings are under contract from a local supplier and we must devise an appropriate acceptance sampling plan for them. Management has stated in the contract in relation to the magnitude of fraction defective that the acceptable quality limit is 2 percent and the rejectable quality limit is 6 percent, the producer’s risk is 5 percent, and the consumer’s risk is 10 percent. Assuming a lot size of 2,000 bearings, we use Table 10 to specify an appropriate acceptance sampling plan that meets all these criteria because we have precise, that is, crisp, noncomplementary formulation of underlying hypotheses (with ). It can be easily found that the sampling plan with the smallest possible sample size satisfying the constraints [1] and [2] (compare page 8) is n = 169 and c = 6 (with actual risks 0.0466 and 0.0989, respectively). Thus, if seven or more defective bearings were encountered, the lot would be rejected, otherwise accepted.