Composite Specification Cascade

This topic explains the cascade engine with respect to the cascading of composite specification 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

Specification Assessments

A SSA's Composite Specification Status is set to Not Tested upon creation or when a result is cleared.

The following statuses, or some thereof, can be set for a composite specification status at various levels in the job:

Composite Specification 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 specifications on the sample, to set the SSASpecification's Specification Status.

A SSASpecification's Specification Status is set to:

Composite Specification 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...

...to set

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

Sets the SSA's Specification Status by considering the SSA Specification's Specification Status for the sample's Primary Specification, such that, where the SpecificationSVA's Critical for Validation is selected, then sets it to the SSASpecification's Specification Status, otherwise sets it to Not Required.

SSA's Specification Status

Cascading Composite Specification Status up through the Job

A Composite Specification Status is exactly that—a composite of the Composite Specification 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 Specification Status at various levels in a job.

Composite Specification/QC Status

Definition

Not Tested

The initial state of specification assessment.

Not Required

The specification 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 specification assessment has passed. This means no failure exists on the contributing specifications on the sample (for the primary and non-primary specifications).

Warning

At least one result that underwent specification assessment returned a warning.

Lower Warning

The specification assessment of a result was below the lower warning limit.

Upper Warning

The specification assessment of a result was above the upper warning limit.

Trend Warning

The specification assessment of a result failed trend analysis for warning limits.

Failure

At least one result that underwent specification assessment returned a failure.

Lower Failure

The specification assessment of a result was below the lower failure limit.

Upper Failure

The specification assessment of a result was above the upper failure limit.

Trend Failure

The specification assessment of a result failed trend analysis for failure limits.

After this, the sample scheme analyte's Composite Specification Status is set to cascade as a composite of those on the sample scheme analyte specifications, to give an overview of all specifications linked to the sample scheme analyte.

All SSASpecs' Specification Statuses

SSA's Composite Specification Status

Not Tested in all

Not Tested

None contain Failure, Warning, Pass

Not Required in any

Not Required

None contain Failure or Warning

Pass in any

Pass

None contain Failure

Warning in any

Warning

Failure in any

Failure

Note: Composite Specification Status flags do not need to be ignored as they do not effect Workflow Status flags, so are therefore not associated with any process to ignore a failure.