Sampling Plans for (FDA) Quality Audits
Why Should You Attend:
Quality audits typically involve sampling of records and other documents. When the auditor samples, this may raise questions 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 time (once for each error) or one time 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 webinar 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 non-conformances and the proper technique for a quality audit. An