Process Capability Indices for Medical Device Manufacturers - Webinar Recording/Transcript

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Process Capability Indices for Medical Device Manufacturers

In device manufacture, QSR requires, where appropriate, procedures for valid statistical techniques to establish, control and verify process capability acceptability. Particularly tricky: calculating process capability indices using data from Statistical Process Control (SPC), predominantly x-bar and R charts. Master that and you’re well on your way to cleaner inspections.

FDAnews is here to help.

We’ve invited master presenter Dan O’Leary to guide you through a thicket of statistical techniques mandated under the Quality System Regulation (§820.250).

Over 90 minutes of thorough, detailed instruction, Mr. O’Leary breaks down the process step by step. You’ll gain an understanding of:

  • The difference between variables data and attributes data...
  • The concept of process variability and its common metrics...
  • How to estimate process parameters from common SPC charts such as x-bar & R...
  • How to apply definitions of common capability indices such as Cp, Cpk, Pp, and Ppk...
  • Valid statistical techniques in the context of FDA’s QSR...
  • How to apply this information to your manufacturing processes...
  • And much more!

Bonus: A summary of statistical process control methods and their related process control indices, including all necessary formulas and constants.

This intense chalk talk is ideal for engineers tasked with quality, process, production, reliability and validation responsibilities.

Why risk a Form 483 or warning letter? This presentation makes it convenient and easy to master important, if complex, quality techniques.

  • Quality Managers
  • Quality Engineers
  • Process Engineers
  • Production Managers
  • Production Supervisors
  • Reliability Engineers
  • Validation Engineers
  • Consultants

Dan O’Leary, President, Ombu Enterprises LLC, is an expert on analytic skills and systems approaches in operations management. A top-rated presenter, Mr. O’Leary boasts 30+ years’ experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He 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.