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Quality speaks
Professional Development Meeting: Sampling Plans for Quality Audits
Speaker: Dan O’Leary
Tuesday, May 27 2025
Presentation: 7:00pm
Location: Webinar (zoom link sent via email to members)
Register in advance for this meeting:
https://us06web.zoom.us/meeting/register/fy9wHBJzT1aVoBMI9skDKw
After registering, you will receive a confirmation email containing information about joining the meeting.
Speaker: Dan O’Leary
Tuesday, May 27 2025
Presentation: 7:00pm
Location: Webinar (zoom link sent via email to members)
Register in advance for this meeting:
https://us06web.zoom.us/meeting/register/fy9wHBJzT1aVoBMI9skDKw
After registering, you will receive a confirmation email containing information about joining the meeting.
Quality audits typically involve sampling of records and other documents. Sampling raises questions for the auditor, such as the number of records in the sample, counting nonconforming records, and limits on acceptance. For example, if one record has three errors does the auditor count it three times (once for each error) or one time as a nonconforming record.
Audit sampling methods are in two broad categories – convenience sampling and statistical sampling. Convenience sampling uses the auditor’s judgement to determine the sample size which is often small (3 or 5) and doesn’t provide any statistical analysis. An experienced auditor can get a sense of a process from a convenience sample.
Statistical sampling uses larger sample sizes and draws statistical conclusions about the process. Statistical sampling can provide information about whether the process meets the maximum tolerable error rate, MTER. Sampling the records in an audit is different from sampling at incoming inspection; the purpose is different, so the method changes. This presentation examines the issues in audit planning and in audit sampling.
Participants learn the difference between counting nonconformities and counting nonconformances and which technique to apply in a quality audit. Participants learn some standard sampling plans as well as why they work. As an example, the presentation explains the sampling plans in the FDA’s Quality System Inspection Technique (QSIT) used during the Inspection of medical device manufacturers.
About the speaker:
Dan O’Leary 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. His professional experience relates to quality, reliability, and operations management. Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. He is an ASQ Certified Medical Device Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt. He is also the Chair of the Granite State section of ASQ.
Audit sampling methods are in two broad categories – convenience sampling and statistical sampling. Convenience sampling uses the auditor’s judgement to determine the sample size which is often small (3 or 5) and doesn’t provide any statistical analysis. An experienced auditor can get a sense of a process from a convenience sample.
Statistical sampling uses larger sample sizes and draws statistical conclusions about the process. Statistical sampling can provide information about whether the process meets the maximum tolerable error rate, MTER. Sampling the records in an audit is different from sampling at incoming inspection; the purpose is different, so the method changes. This presentation examines the issues in audit planning and in audit sampling.
Participants learn the difference between counting nonconformities and counting nonconformances and which technique to apply in a quality audit. Participants learn some standard sampling plans as well as why they work. As an example, the presentation explains the sampling plans in the FDA’s Quality System Inspection Technique (QSIT) used during the Inspection of medical device manufacturers.
About the speaker:
Dan O’Leary 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. His professional experience relates to quality, reliability, and operations management. Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. He is an ASQ Certified Medical Device Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt. He is also the Chair of the Granite State section of ASQ.
Look out for upcoming event
Meeting is open to all
There is no cost for this event and preregistration is not required Obtain ASQ re-certification credit
Please post and invite your colleagues and friends to attend this interesting and informative meeting
If you have any suggestions for future speakers or topics, please contact the ASQTZ Section Chair:
Emile Najm at [email protected]
There is no cost for this event and preregistration is not required Obtain ASQ re-certification credit
Please post and invite your colleagues and friends to attend this interesting and informative meeting
If you have any suggestions for future speakers or topics, please contact the ASQTZ Section Chair:
Emile Najm at [email protected]
