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.

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.