Valid Statistical Techniques Made Easy Part 2

Valid Statistical Techniques Made Easy Part 2

English | Intermediate Level | Presentation | 1 hour and 56 minutes

Corresponds to 1 day of teacher-directed learning

Description

In the previous webinar we asked: How do you know you have quality if you cannot reliably measure what you are doing? This second webinar will focus on Attribute Measurement Systems - that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the gauges, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it made easy? This webinar will provide simple metrics to evaluate the human performance and industry best practices to reduce variation. It's as simple as that!

Test Method Validation (TMV), also known as: Measurement System Analysis (MSA) and Gauge R&R (GR&R). The name is not important, the application of this very valuable statistical methodology is essential for a quality system. The material covered in this webinar is completely independent of the first webinar on Variable TMV. Thus, attending the first webinar on Variable TMV is NOT a requirement to attend this webinar.

Attribute measurements typically end up with a Pass/Fail or Accept/Reject decision. This webinar provides a very practical approach to conducting Attribute TMVs. Participants will gain a working knowledge of how to organize an Attribute TMV, collect data, analyze the results and improve the measurement system.

The presenter's keep it simple approach will avoid statistical complexity - participants do NOT need to have a background in statistics.

This webinar is targeted to professionals concerned with the application of valid statistical methods and tools to satisfy the requirements of the FDA:s Quality System Regulation and ISO 13485:2016. In particular, the Attribute TMV methodology is important for Design Control and Process Validation.

This webinar will provide a working knowledge of the principles and application of Attribute TMV/MSA/GR&R. As such, participants will:

Learn the quality metrics and industry standards used to evaluate the effectiveness of a measurement system

Understand how to quickly analyze results, diagnose problems, and improve a measurement system

Understand how to apply this valuable methodology in Design Control and Process Validation

Learn some techniques to deal with destructive testing

 

This webinar is targeted to professionals concerned with the application of valid statistical tools and methods to meet the requirements of the FDA's Quality System Regulation. As such, the content should have great value to individuals in industry who are involved with: research and development; new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; and regulatory compliance. In addition, managers and members of the leadership team will see how value is added to a product or process by applying this valuable methodology.

There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our keep it simple approach.

Content

  • Review of Questions from Part 1 Webinar on Variable TMV
  • Destructive Testing - Four Techniques from Industry
  • Address Emailed Questions
  • Fundamentals of Attribute TMV/MSA/GR&R
  • Definitions and Terminology
  • Quality System Regulation and Guidance Documents
  • Significant Trends and FDA Warning Letters
  • How to Run an Attribute TMV
  • Organizing an TMV
  • Conducting an TMV
  • Improving an Attribute Measurement System
  • Industry Best Practices
  • Technical Details
  • Attribute TMV Metrics
  • Sample Size

Course module

1. Valid Statistical Techniques Made Easy Part 2

This is dr. Peter Kneppel's lecture Valid Statistical Techniques Made Easy Part 2.

Trainer: Peter Kneppel
Duration: 1 hour and 56 minutes (Total duration of the course: 1 hour and 56 minutes)

Additional material

There is no additional material for this course.

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