Valid Statistical Techniques Made Easy Part 2

In the previous session we asked: How do you know you have quality if you cannot reliably measure what you are doing? This second session 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 session 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 part on Variable TMV. Thus, attending the first part on Variable TMV is NOT a requirement to attend this one.

Attribute measurements typically end up with a Pass/Fail or Accept/Reject decision. This session 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 session 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.

The training 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

Content

• Fundamentals of TMV/MSA/GR&R
• Definitions and Terminology
• Quality System Regulation and Guidance Documents
• Significant Trends and FDA Warning Letters
• Variable TMV Introduction
• Quality Metrics
• Cost of a Poor Measurement System
• Sample Size Considerations
• Set Up and Data Collection
• Reviewing Metrics and Graphics
• Examples from Industry
• Validation of Analytical Procedures (VAP)
• FDA Regulations and Guidance and ICH Guideline (ICH Q2(R1))
• Definitions, Terminology and Mapping to TMV Concepts
• Example from Industry
• User´s Manual for Variable TMV

Duration: 2 hours

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