Statistics in ASTM Standard Test Method Development, Application, and Quality Assurance - eLearning Course

About the Course

This course provides detailed methodology on how to set up Statistical Control Charts relevant to test method performance monitoring over time as per ASTM D6299. The course begins with an overview of the importance of data trustworthiness as a key business driver, followed by understanding common cause variation between test results using Statistical Thinking. Precision fundamentals, Industry standard test method precision performance metrics such as repeatability, reproducibility, site precision, and associated business applications will be presented in detail as the first topic, to serve as a foundation upon which the Statistical Control Charts methodology are based on. Bias fundamentals, along with use of Statistical Control Charts and other statistical techniques for assessing and monitoring laboratory bias over time versus industry, will be covered in detail, followed by an overview of relative bias between test methods as the final topic.

The course consists of three modules and includes instructor led videos, web-based exercises, and assessments.

Learning Outcomes

By the end of this course you should be able to:

• Articulate the core principles and concepts associated with statistical 'thinking'
• Explain the concepts and differences for test method repeatability, reproducibility, site precision
• Explain the concepts and differences between absolute and relative bias for test methods
• Assess single lab bias relative to CRM and ILCP Performance
• Apply D6708 principles to assess relative bias between two test methods
• Apply ASTM repeatability, reproducibility, site precision, and bias to make product quality compliance decisions
• List the implicit assumptions when using these quality metrics to judge the trustworthiness of test results
• Articulate the concepts and differences between false alarms and missed signals
• Quantify the statistical confidence and risks associated with the decisions based on measurement data
• Explain the primary purpose of a control chart
• Articulate the basic premise, statistical bases and limitations of a control chart
• Outline the steps associated with setting up and regular use of control charts
• Construct I / MR / EWMA control charts as per ASTM D6299
• Set decision limits based on concepts of false alarms and missed signals
• Examine control charts and decide on the in-control status of a test method
• Statistically combine the cumulated control chart data to obtain long term test method performance baselines
• Design a quality control program for test method performance surveillance for precision and bias monitoring
• Avoid the common errors and misconceptions associated with statistical control chart set up & operation

Audience

• Lab technicians
• Lab QA/QC personnel
• Lab managers
• Personnel involved with product quality assurance and regulatory compliance testing
• Process Analyzer and Control engineers involved with production planning and optimization

ASTM Standards Referenced

• ASTM D6299-18 - Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
• ASTM D6708-18 - Standard Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purport to Measure the Same Property of a Material
• ASTM D3764-15 - Standard Practice for Validation of the Performance of Process Stream Analyzer Systems

Certificate and CEUs

CEUs: 2.1

Certificate: A certificate is available upon successful completion of the course and an 80% or higher score on the exam.

Access

1 year online subscription for a Single-User Only via username/password. Requires internet access.

For pricing for Multi-User access or for more information, please contact sales here or call 1-877-909-ASTM.

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