Sampling Plan for Quality Audits

Instructor: Daniel O Leary
Product ID: 702581
  • Duration: 90 Min
This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2018

Training CD / USB Drive

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Read Frequently Asked Questions

Why Should You Attend:

Quality audits typically involve sampling records and other documents. Sampling raises questions for the auditor, such as the number of records to sample and the limit on nonconforming records. There is a 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. 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 provides the information you need to use sampling for quality audits. 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).

Areas Covered in the Webinar:

  • Concepts of sampling applied to quality audits
  • Difference between a nonconformance and nonconformities
  • Use of (non-statistical) convenience samples
  • Use of standard sampling plans in an audit
  • Role of the binomial distribution to understand audit sampling
  • FDA’s QSIT sampling plans

Bonus Material:

An explanation of how to calculate the exact binomial confidence intervals using an Excel spreadsheet.

Who Will Benefit:

  • Quality Managers
  • Audit Managers
  • Lead Quality Auditors
  • Quality Auditors
  • Regulatory Affairs Managers
Instructor Profile:
Daniel O Leary

Daniel O Leary
President, Ombu Enterprises, LLC

Daniel O'Leary, 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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