is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC and airs on Thursday, April 19th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.
This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)
