Maintaining Scheme Limit Specifications

• Maintaining Scheme Limit Specifications
  • Overview
  • Process
    • Text Analytes
    • Numeric and Numeric Only Analytes
    • Setting the Activity Status of a Specification
  • Using Scheme Limit Specifications
    • Inheriting the Scheme Limit Specification upon Registration
    • Using of Scheme Limit Specifications during Data Entry
    • Using of Scheme Limit Specifications during Reporting
    • Exporting Specifications associated with Schemes

Overview

A scheme limit specification is a set of internal assessment and reporting limits for scheme version analytes, used to define the natural range of results that is suitable for a particular test, to ensure that the test method is suitable for relatively large or small results.

Process

Specifications are created using the CCSPFN—Specification application.

Where lines of business (LOBs) are implemented, only specifications within schemes belonging to the same LOB as a laboratory can be used (those outside of the laboratory's LOB are not visible to users of the laboratory).

Schemes available for adding as a limit are displayed in a drop-down list. Refer to the Effect of Scheme Scope when Adding Specification Limits.

Specifications are scoped by type: standard, scheme limit, and product. This process covers those scoped by scheme limit.

Scheme limit specifications are created either with org-scope or lab-scope. An organisation or laboratory can contain multiple specifications.

Limits of assessment are located by matching Scheme Code, Version Number, Analyte Code and Unit Code.

Text Analytes

Where the scheme version analyte has an Analyte Data Type of Text, then scheme limit assessment is based upon a list of accepted text strings.

• Text Spec Case Sensitive—Indicates whether the comparison is made with or without case-sensitivity.

• Specification List)—One accepted text string is entered per line.

Numeric and Numeric Only Analytes

Where the scheme version analyte has an Analyte Data Type of Numeric or Numeric Only, then scheme limit assessment is based upon numerical absolute limits around an Internal Target Value for a given Scheme Code, Version Number, Analyte Code and Unit Code.

Absolute limits display when the Limit Check Method is set to Absolute:

• Internal Min Value and Inclusive Flag—The lowest acceptable amount of substance for the specification to be satisfied, below which the material would fail the standard lot's specification.

• Internal Min Warning Value and Inclusive Flag—The lowest acceptable amount of substance for the specification to be satisfied without warnings, below which the material would satisfy the standard lot's specification but with warnings.

• Internal Max Warning Value and Inclusive Flag—The highest acceptable amount of substance for the standard lot's specification to be satisfied without warnings, above which the material would satisfy the specification but with warnings.

• Internal Max Value and Inclusive Flag—The highest acceptable amount of substance for the standard lot's specification to be satisfied, above which the material would fail the specification..

Limits can be entered as relative values when the Limit Check Method is set to Relative:

• Internal Percentage Warning Value

• Internal Percentage Failure Value.

Where Recalculate Internal Limits is selected, then absolute limits are calculated from the relative limits upon submit.

A similar set of limits are maintained for inclusion on certificate reports. This allows for the reporting of tighter limits compared to what was used for internal assessment.

Setting the Activity Status of a Specification

Specifications have a tri-state activity statuses:

• Draft
• Active
• Suspended.

The flows are:

• Activate: Draft --> Active or Suspended --> Active
• Suspend: Active --> Suspended.

The difference between a draft and suspended specification is minor: both states prohibit the selection of the specification on a drop-down choice. However, suspension implies the specification was previously active and now should NOT be used, whereas draft implies that the specification is still undergoing checking and validation processes so is not yet ready for use by the laboratory. This only can occur after activation.

When deactivating or suspending a specification, the user is given the option to enter a reason as to why the action is being performed.

Using Scheme Limit Specifications

Inheriting the Scheme Limit Specification upon Registration

Where a scheme is linked to a scheme limit specification, when the scheme is registered on an unknown, duplicate or replicate sample, then the sample scheme is linked to the scheme specification.

Using of Scheme Limit Specifications during Data Entry

Where a sample has a primary analytical type of unknown, when a result is entered for a sample scheme, then the result is assessed against the internal limits within the sample scheme's scheme limit specification, for the matching scheme, version, analyte and the sample scheme analyte's Unit Code, to set the sample scheme analyte's Limit Status. This status rolls into the sample scheme analyte's Composite QC Status.

Using of Scheme Limit Specifications during Reporting

When a sample scheme is included in a report, the reporting limits within the related scheme limit specification are available for inclusion in the report result set.

Exporting Specifications associated with Schemes

When a scheme is approved for export and subsequently imported, then any specification associated with the scheme is approved automatically for export and imported also.