Sampling Plan for Quality Audits

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

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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