Statistical Quality Control and Method Validation/Verification (QCMV2) e-Learning

Purpose

Only when the system is known to be stable can data be collected to calculate the observed mean and SD of a new lot number of QC material. % CV is introduced and used in the SD computation of short shelf-life control materials.

Key Message

• New lot numbers of control material should be tested in parallel with the currently in-use control material.
• Parallel testing is only performed when the instrument is operationally stable.
• Package inserts serve as a guideline only and should not be used when creating the L-J chart for the new control.  %CV tells us WHERE WE ARE in terms of precision.

Self Assessment

Can you: 

• Understand the importance of parallel testing?
• Identify the steps to perform parallel testing at their site?
• Calculate the %CV?