Sampling Plan for Quality Audits

Duration: 90 Minutes
Quality audits provide assurance to management that the quality system operates effectively. Part of the audit evidence is the records examined. There is a balance, since too few records may mean missing an issue, but too many may not be a good use of resources. This presentation provides the information you need to use in sampling for quality audits.
Sampling for Quality Audits
Instructor: Daniel O'Leary
Product ID: 501619
Objectives of the Presentation
  • The concepts of sampling when conducting quality audits
  • The difference between a nonconformance and nonconformities
  • The use of (non-statistical) convenience samples
  • Using standard sampling plans in an audit
  • Using the binomial distribution to understand audit sampling
  • An examination of the FDA's QSIT sampling plans
Why Should you Attend
Quality audits typically involve sampling of records and other documents. Sampling raises many questions for the auditor such as the number of records to sample and the limit on nonconforming records. 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 one time as a nonconforming record. Some auditors determine the sample size without using statistical techniques. 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 presentation 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 technique 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. Participants learn some standard sampling plans as well as the reason they work. As an example, the presentation explains the FDA sampling plans in the Quality System Inspection Technique (QSIT).

Who will Benefit
  • Quality Managers
  • Audit Managers
  • Lead Quality Auditors
  • Quality Auditors
  • Regulatory Affairs Managers
Bonus Material
An explanation of how to calculate the exact binomial confidence intervals using an Excel spreadsheet.
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Instructor Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; 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.
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