Laboratory Concepts: AQC

 

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Fundamental Concepts

 
              

 

Fundamental Concepts

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Laboratory Concept LabVantage Concept Example
Analytical Batch A QC Batch is a group of Samples, including quality control Samples, which are processed together using the same method, the same lot of Consumables, at the same time or in continuous, sequential time periods. I want to test a group of Samples using the same method at the same time.
Set up the Batch Analysis QC Method specifies the procedure that is used to process a batch of Samples including quality control Samples. It includes:
•Test Methods or the list of Test Methods for Batch testing
•QC Method Sample Types or quality control Samples you plan to include in the QC Batch (such as Blanks, Duplicates, Spikes or Controls). It also specifies the Position Type to determine placement of quality control Samples among the Samples to be tested.
•Position Type specifies the exact or relative positioning of QC Samples within the Unknown Samples. For example you might define a "Control" Sample Type with an "Every" Position Type as follows:
Between the "Start" and "End" positions, insert "1" Control Sample after each group of "2" Unknown Samples.
•Calculation Action to specify the action (calculation) that should be taken when data is entered for the QC Sample. For example, an action can be defined to calculate the percent difference between the recorded and actual value of a Control Sample
•QC Evaluation Rules and Control Limits to evaluate QC Batch based on the Western Electric Company (WECO) Rules and the Westgard Multi-Rules Procedure.
•Consumables used during testing.
 The QC Method, "BC100" details the following:
Method Description
Associated Test Method PT Test
QC Method Sample Types Normal Control
Parameter Value = 4

Abnormal Control
Parameter Value = 7

Position Insert Controls:

Every
For every 2 Unknown Samples insert 1 Normal and 1 Abnormal Control Sample

Test Method for Control PT Test
Evaluation Rule Rule "ER1"specifies that the rule fails when 3 consecutive points are outside the same side of the Control Limit.
Consumables Consumables will not be used.
Create a Batch QC Batch Creation is the process of creating a Batch instance in LabVantage database by choosing a QC Method and the Samples that require testing.

Creating the Batch adds all selected Samples and, according to the QC Method, adds and positions the QC Samples. You can rearrange the positioning and add QC or Unknown Samples during Batch Creation.

 I create my QC Batch, "QC-040115" referencing QC Method "BC100". I select 6 Unknown Samples (with the "PT Test"associated). According to Method "BC100", the Normal and Abnormal Controls are inserted in positions 3 and 4, then 7 and 8.
Assign Work An Analyst or a Department can be assigned to a QC Batch. Batch "QC-040115" is assigned to Mary.
Enter Results Results can be entered either manually or directly from the instrument. As results are entered, calculations are executed simultaneously for a live feedback. You can immediately see the calculation results for the entered data.

The system can be configured to require input of Preparation data into the system prior to running a test for obtaining Procedural data.

 Mary enters results for the Unknown and QC Samples:
Position Sample Type Entered Value % Difference is calculated
1 Unknown 4.2
2 Unknown 4.0
3 Normal Control 4.0 0.00
4 Abnormal Control 7.0 0.00
5 Unknown 3.8
6 Unknown 4.4
7 Normal Control 4.2 5.0
8 Abnormal
Control		 7.1 1.4
9 Unknown 4.2
10 Unknown 4.3

As Mary finishes entering results for all Samples in the Batch, it is automatically Evaluated.

Review Batch Automatic (or manual) QC Batch Evaluation checks whether the batch follows the Evaluation Rule for the quality control Samples, as defined by the QC Method. The evaluation process issues a "Pass" or "Fail" determination for the QC Batch based on the Evaluation Rule.

After Evaluation, the QC Batch can be Reviewed. If the QC Method specifies Automatic Review on Success, then the system will automatically perform the review process after it has been evaluated and all evaluation checks have passed.

If needed, Retestlets you test the entire QC Batch or selected Samples again.

 The Batch Passes and is automatically Reviewed. Sample Test Approval is not required.
Control Charts A Control Chart is a tool used to identify variations in a process. For each QC Sample Type, view control data derived from current and past QC Batches. Mary creates a Control Chart to view the control data.