In Canada, acceptance sampling has been used in legal metrology applications for nearly four decades. One of its principal uses has been in the quality control of utility meters that measure electricity or natural gas supplied to consumers. By law, such meters must be inspected for conformance to specification requirements prior to use and be periodically inspected while huse. With few exceptions, due to the numerous utility companies in the country and their varied practices, the meters exist in the form of isolated lots for inspection purposes. The proportion of nonconforming meters in a lot has traditionally defined lot quality for utility meter sampling inspection purposes. Another principal application of acceptance sampling has been in the quality control of the net contents of packaged products sold in the marketplace. Such products include those sold on the basis of such measures as weight, volume, length, and area. In this particular application, products are also usually inspected on an isolated-lot basis for regulatory purposes. However, lot quality is usually measured on the basis of two criteria for such products: the proportion of nonc- forming packages in the lot and the lot mean quantity. This section reviews Canadian quality control practices in these two areas of application, highlighting some of the deficiencies and issues. Three-class s- pling plans are proposed as a possible solution to some of these deficiencies and issues.Specification Setting for Drugs in the Pharmaceutical Industry JAcrgen Iwersen and Henrik Melgaard Novo Nordisk A/S, ... To ensure compliance in practice we need manufacturing processes to be robust and in control, measurements systems to be in control and the measurements must be traceable. ... The final guidelines are adopted by the regulatory bodies of the European Union, Japan and USA.
|Title||:||Frontiers in Statistical Quality Control 8|
|Author||:||Hans-Joachim Lenz, Peter-Th. Wilrich|
|Publisher||:||Springer Science & Business Media - 2006-08-08|