Composite QC Cascade
This section explains the cascade engine with respect to the cascading of composite QC status:
- From sample scheme analyte to sample scheme
- From sample scheme to sample
- From sample to job
- From sample scheme analyte to job scheme analyte
- From sample scheme to job scheme.
|
SSA.WFS → |
SS.WFS → |
S.WFS |
|
↓ |
↓ |
↓ |
|
JSA.WFS |
JS.WFS |
J.WFS |
QC Assessments
A SSA's Composite Specification Status and Composite QC Status are set to Not Tested upon creation or when the result is cleared.
The following statuses, or some thereof, can be set for a composite QC status at various levels in the job:
|
Composite QC Status |
Definition |
|---|---|
|
Not Tested |
No assessment is made as yet. |
|
Not Required |
No assessment is required for the result. |
|
Pass |
The result passes assessment limits. |
|
Ignore Warning |
An assessed warning is ignored. |
|
Ignore Failure |
An assessed failure is ignored. |
|
Ignore Lower Failure |
An assessed lower failure is ignored. |
|
Ignore Upper Failure |
An assessed upper failure is ignored. |
|
Ignore Trend Failure |
An assessed trend failure is ignored. |
|
Warning |
The result passes assessment limits with a warning. |
|
Lower Warning |
The result passes assessment limits with a lower warning. |
|
Upper Warning |
The result passes assessment limits with an upper warning. |
|
Trend Warning |
The result passes assessment limits with a trend warning. |
|
Failure |
The result fails assessment limits. |
|
Lower Failure |
The result fails assessment limits with a lower failure. |
|
Upper Failure |
The result fails assessment limits with an upper failure. |
|
Trend Failure |
The result fails assessment limits with a trend failure. |
When a SSA receives a result, the result is assessed against all QC-related assessments: scheme limit, standard, precision and product assessment), to set the SSA's Scheme Limit Status, Standard Status, Precision Status and Specification Status:
|
SSA's Scheme Limit Status |
SSA's Standard Status |
SSA's Precision Status |
SSA's Specification Status |
Primary Spec's SpecSVA Is Critical for Validation | Resulting SSA's Composite QC Status |
|---|---|---|---|---|---|
|
Not Tested |
Not Tested |
Not Tested |
Not Tested |
<any> |
Not Tested |
|
Upper Failure, Lower Failure, Trend Failure, Failure |
<any> |
<any> |
<any> |
<any> |
Failure |
|
<any>
|
Upper Failure, Lower Failure, Trend Failure, Failure |
<any> |
<any> |
<any> |
Failure |
|
<any> |
<any> |
Failure, Trend Failure |
<any> |
<any> |
Failure |
|
<any> |
<any>
|
<any> |
Upper Failure, Lower Failure, Trend Failure, Failure |
Yes |
Failure |
|
Upper Warning, Lower Warning, Trend Warning, Warning |
Any statuses except Upper Failure, Lower Failure, Trend Failure, Failure |
Any status except Failure, Trend Failure |
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
<any> |
Warning |
|
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
Upper Warning, Lower Warning, Trend Warning, Warning |
Any status except Failure, Trend Failure |
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
<any> |
Warning |
|
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
Warning, Trend Warning |
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
<any> |
Warning |
|
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
Any status except Upper Failure, Lower Failure, Trend Failure, Failure |
Any status except Failure, Trend Failure |
Upper Warning, Lower Warning, Trend Warning, Warning |
Yes |
Warning |
|
Not Required, Pass, Ignored Upper Failure, Ignored Lower Failure, Ignored Trend Failure, Ignored Failure, Ignored Upper Warning, Ignored Lower Warning, Ignored Trend Warning, Ignored Warning |
Not Required, Pass, Ignored Upper Failure, Ignored Lower Failure, Ignored Trend Failure, Ignored Failure, Ignored Upper Warning, Ignored Lower Warning, Ignored Trend Warning, Ignored Warning |
Not Required, Pass, Ignored Trend Failure, Ignored Failure, Ignored Trend Warning, Ignored Warning |
Not Required, Pass, Ignored Upper Failure, Ignored Lower Failure, Ignored Trend Failure, Ignored Failure, Ignored Upper Warning, Ignored Lower Warning, Ignored Trend Warning, Ignored Warning |
<any> |
Pass |
|
Not Required, Pass, Ignored Upper Failure, Ignored Lower Failure, Ignored Trend Failure, Ignored Failure, Ignored Upper Warning, Ignored Lower Warning, Ignored Trend Warning, Ignored Warning |
Not Required, Pass, Ignored Upper Failure, Ignored Lower Failure, Ignored Trend Failure, Ignored Failure, Ignored Upper Warning, Ignored Lower Warning, Ignored Trend Warning, Ignored Warning |
Not Required, Pass, Ignored Trend Failure, Ignored Failure, Ignored Trend Warning, Ignored Warning |
Upper Failure, Lower Failure, Trend Failure, Failure, Upper Warning, Lower Warning, Trend Warning, Warning |
No |
Pass |
Composite QC Status
After specification and QC assessment occurs, the cascade engine sets the SSA's Composite Specification Status and Composite QC Status:
|
Assessed against... |
...to set |
Cascades to... |
Cascades to... |
Cascades uses... |
|
|---|---|---|---|---|---|
|
Scheme limits |
SSA's Scheme Limit Status |
|
|
SSA's Scheme Limit Status |
SSA's Composite QC Status |
|
Standard lot specification limits |
SSA's Standard Status |
|
|
SSA's Standard Status |
|
|
SVA's precision limits |
SSA's Precision Status |
|
|
SSA's Precision Status |
|
|
Each SampleSpecification's specification limits |
SSASpecification's Specification Status |
SSA's Composite Specification Status |
SSA's Specification Status, by looking at the SSASpecification related to the sample's Primary Specification, and where the SpecificationSVA's Critical for Validation is selected, then sets it to the SSASpecification's Specification Status, and where this check box is not checked, then sets it to Not Required. |
SSA's Specification Status |
Cascading Composite QC Status up through the Job
A Composite QC Status is exactly that—a composite of the Composite QC Status flags at the level below.
When a result is entered in context of a non-laboratory-batch job, the cascade engine cascades to each level of SS, Sample, Job, JSA and JS within the production, proposal or template job.
When a result is entered in context of a laboratory-batch job, the cascade engine cascades to each level of SS, Sample, Job, JSSA and JS first within the laboratory batch job, and then within each related original job.
- Composite QC Cascade from SSA to SS
- Composite QC Cascade from SS to Sample
- Composite QC Cascade from Sample to Job
- Composite QC Cascade from SSA to JSA
- Composite QC Cascade from SS to JS
The following statuses are possible for a Composite QC Status at various levels in a job.
|
Composite QC Status |
Definition |
|---|---|
|
Not Tested |
The initial state of QC assessment. |
|
Not Required |
The QC assessment is not required for the sample due to its Primary Analytical Type or Secondary Analytical Type or assessment limits not being available. |
|
Pass |
The QC assessment has passed. This means no failure exists on the contributing scheme limit assessment, standard assessment, precision assessment nor specification assessment (for the primary specification). |
|
Ignore Failure |
Only relevant in context of QC history. If a result underwent QC assessment and achieved a Composite QC Status of Failure, if it is subsequently ignored, then in QC history the QC Status is recorded as Ignored Failure. |
|
Ignore Lower Failure |
Only relevant in context of QC history. If a result underwent QC assessment and achieved a Composite QC Status of Lower Failure, if it is subsequently ignored, then in QC history the QC Status is recorded as Ignored Lower Failure. |
|
Ignore Upper Failure |
Only relevant in context of QC history. If a result underwent QC assessment and achieved a Composite QC Status of Upper Failure, if it is subsequently ignored, then in QC history the QC Status is recorded as Ignored Upper Failure. |
|
Ignore Trend Failure |
Only relevant in context of QC history. If a result underwent QC assessment and achieved a Composite QC Status of Trend Failure, if it is subsequently ignored, then in QC history the QC Status is recorded as Ignored Trend Failure. |
|
Warning |
At least one result that underwent QC assessment returned a warning. |
|
Lower Warning |
The QC assessment of a result was below the lower warning limit. |
|
Upper Warning |
The QC assessment of a result was above the upper warning limit. |
|
Trend Warning |
The QC assessment of a result failed trend analysis for warning limits. |
|
Failure |
At least one result that underwent QC assessment returned a failure. |
|
Lower Failure |
The QC assessment of a result was below the lower failure limit. |
|
Upper Failure |
The QC assessment of a result was above the upper failure limit. |
|
Trend Failure |
The QC assessment of a result failed trend analysis for failure limits. |
The following table defines the meaning of Workflow Status and Composite QC Status at any level in a job. (Of course, SSA can be set to have a Workflow Status of Listed Not Received, Insufficient Sample, Not Analysed or No Result, but this table is to do with result entry.)
|
Point in analytical process |
Composite QC Status |
Workflow Status |
Impact |
|---|---|---|---|
|
No results are entered |
Not Tested |
Not Started |
|
|
Some results are entered |
Pass, Failure, Warning, Ignored Failure, Not Required |
Started (not applicable at sample scheme analyte level) |
|
|
A critical detection limit failure exists in the set of results which impacts workflow status, and a critical QC failure exists somewhere in the set of results |
Failure |
Check |
Results cannot be released nor validated. |
|
A critical detection limit failure exists in the set of results which impacts workflow status and no critical QC failures exist in the set of results |
Pass, Warning, Ignored Failure, Not Required |
Check |
Results cannot be released nor validated. |
|
No critical detection limit failures exist in the set of results, however a critical QC failure exists somewhere in the set of results |
Failure |
Analysed |
Results can be released but cannot be validated. |
|
No critical detection limit failures and no critical QC failures exist in the set of results. |
Pass, Warning, Ignored Failure, Not Required |
Analysed |
Results can be released and then validated. |
|
Results are released, however a critical QC failure exists somewhere in the set of results |
Failure |
Released |
Results cannot be validated. |
|
Results are released and no critical QC failures exist in the set of results |
Pass, Warning, Ignored Failure, Not Required |
Released |
Results can be validated. |
|
Results are validated |
Pass, Warning, Ignored Failure, Not Required |
Completed |
End state |
Example: If a replicate QC sample has all its results, then the Workflow Status is rolled up as Analysed at the sample scheme and sample levels. However, if a QC failure results in the Composite QC Status being rolled up as Failure, this prevents the Workflow Status moving to Completed. This means there is a QC issue that needs to be resolved, before the sample can be considered completed. An ignore QC process changes the Composite QC Status to Ignored Failure, which then allows the sample scheme and sample to move on to have a Workflow Status of Completed.
