This course strives to bring caring people together to re-write the book on how to manage laboratory quality. It is the public preview of what members are working on in the Mini Risk Evaluation Course
About AWEsome-U, AWEsome Numbers, Zoe Brooks
Getting around, finding stuff, making the most of the site.
This 'course' is a central hub for all members with references, resources, discussion forums and spin-offs to project groups.
Fast-track to what you really need to know to meet requirements for IQCP (Risk Management) requirements and implement verified QC Processes.
Members can self enroll. No password required.
A fresh new approach to quality management!
- Welcome to the wonderful world beyond sigma!
- Mathematically-OptimiZed Risk Evaluation™
- Risk Management - Glossaries & Regulations
- You can do M.O.R.E!
- Narrated Mini-Course
- Mechanics of IQCP Verification, Webinar Sept 15, 2015
This webinar series was presented in June/July 2015.
Notice how much the concepts and metrics have been refined and simplified between then and early 2016. It's broken into 1-10 minute videos for your convenience.
- Regulations and Acceptable Risk (5 Minutes)
- The DIMS Test - Does It Make Sense? (1 Minute)
- A number is a thing OF AWE (3 Minutes)
- From SQC to Risk Management (1.5 Minutes)
- IQCP Flow Chart (2 Minutes)
- Risk-Based Quality Grades (2 Minutes)
- Beware Grade D methods (1.5 Minutes)
See how factual risk drivers are converted to clear risk metrics.
Examine the impact of QC processes in three distinct groups of laboratories.
Has quality improved since 2000? Has QC practice improved? It is fascinating to see the measured data!
- Risk Drivers - Current Risk 11:36 Minutes
- Examples with Margin for Error 5:32 Minutes
- Current Risk Y2K 3:36 Minutes
- Managing Risk For Each QC Sample 1:20 Minutes
Acceptable risk is "a state achieved in a measuring system where all known potential events have a degree of likelihood for or a level of severity of an adverse outcome small enough such that, when balanced against all known benefits—perceived or real—patients, physicians, institutions, and society are willing to risk the consequences."
Videos from the webinar series. Segments may be from different dates.
- Setting Acceptable Risk (6 Minutes)
- Setting Medical Goals (3 Minutes)
- Table to select risk level for groups of laboratories (1 Minutes)
- References x7
Risk Evaluation is the "process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk." (ISO 14971). Can you judge acceptability of risk with sigma?
Sigma = #SD from current mean to TEa limit.
- Margin for Error is the #SD shift to unacceptable risk.
Sigma of zero = 50% of results fail TEa limit.
- ME of zero = the more than the approved acceptable risk level fail TEa limit.
Mini-Videos (may be from different dates)
- Margin For Error vs Sigma (1 Minute)
- Sigma Polls - what is acceptable? (2.5 Minutes)
- Sigma Shift - DIMS? (12.5 Minutes)
- References x7
"At the least, the ability of the QC procedures to detect medically allowable error should be evaluated.” CLSI EP 23-A
- QC Process Design (4 Minutes)
- QC Design Examples (11.5 Minutes)
- QC Frequency (5.5 Minutes)
- References x 17