Sampling Plans for (FDA) Quality Audits

Instructor: Daniel O Leary
Product ID: 702581
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar examines the issues in quality audit sampling and provide answers you need to plan your audit. Attendees will learn the difference between counting nonconformities and counting non-conformances and the proper technique for a quality audit. The training includes an explanation of the sampling plans FDA Investigators use for device inspections.

Why Should You Attend:

Quality audits typically involve sampling of records and other documents. When the auditor samples, this may raise questions such as how many records to sample and how many nonconforming records are too many. In fact, there is a more 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. Is this ever acceptable? 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 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 non-conformances and the proper technique for 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 will learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT).

Areas Covered in the Webinar:

  • 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.

Who will Benefit:

This webinar is for personnel at medical device companies involved in internal quality audits, but the same issues come up in supplier audits.

People in the following roles can especially benefit from the knowledge in this webinar:

  • Quality Managers
  • Audit Managers
  • Lead Quality Auditors
  • Quality Auditors
  • Regulatory Affairs Managers
  • Suppliers to medical device companies

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 holds an APICS certification in Resource Management.

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