Sampling Plans for Quality Audits - Webinar Recording/Transcript

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Sampling Plans for Quality Audits

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Sampling raises questions for the auditor, such as the number of records to sample, counting nonconforming records and limits on acceptance. If a record has three errors does the auditor count it three times — one time for each error — or one time as a nonconforming record?

Some auditors determine the sample size without using statistical techniques.  Sampling the records in an audit is not the same as sampling at incoming inspection — the purpose is different, so the method changes. An audit may need to determine the error rate in a process, or least show that it is not too great.

Dan O’Leary, one of FDAnews’s most popular presenters, will examine the issues in audit sampling and provide the answers you need for planning. Over the course of 90-minutes you’ll:

  • Learn the concepts of sampling applied to quality audits
  • Understand the difference between a nonconformance and nonconformities
  • Learn about the use of (non-statistical) convenience samples
  • Understand the use of standard sampling plans in an audit
  • Understand the role of the binomial distribution to understand audit sampling
  • Understand FDA’s QSIT sampling plans

Bonus Material: Participants receive an explanation of how to calculate exact binomial confidence intervals using an Excel worksheet.

Quality audits provide assurance to management that the quality system operates effectively.  This presentation provides the information you need to use sampling for quality audits.

  • Quality Managers
  • Audit Managers
  • Lead Quality Auditors
  • Quality Auditors
  • Regulatory Affairs Managers

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices and clinical labs. He is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.