Trending of Quality Data (1 day)
Instructor
Course Description
This course teaches how to trend complaint, service, inspection and other quality data to detect issues that should be investigated. This is a key element of you Corrective Action – Preventive Action (CAPA) program. It teaches how to put together an effective trending program that also reduces the incidents of false detections. The course covers selecting the right tool, normalizing data, grouping data, and preliminary investigations of signals. It covers STAT-10, Statistical Techniques for Trending Data, of the book Statistical Procedures for the Medical Device Industry.
What You Will Learn
- How to determine which characteristics should be trended.
- How to set up a trending plan for each characteristic including the trending tool, normalizing data, grouping data, frequency to update, etc.
- How to react to out-of-trend points.
Primary Audience
This course is designed for those individuals responsible for trending of quality data and managing the CAPA system.
Course Outline
- Introduction
- Pareto Chart
- Change-Point Analysis
- Average – Standard Deviation Control Chart
- Individuals Control Chart
- Attribute Control Chart
- Lognormal Control Chart
- Normalized Individual Chart
- Selecting the Right Trending Tool
- Trending Plan
Software
Prerequisites
None.