Maintaining Specifications for Product Use

Overview

A product specification is a set of internal assessment and reporting limits for scheme version analytes used to define the analytical range that is achievable for a known product.

Process

Maintaining Specifications

Maintain specifications for product use

Product specifications are created and maintained using the CCSPFN—Specification application.

Product specifications are created either with org-scope or lab-scope and must be assigned a Specification Type of Product.

Specifications have a tri-state activity Status:

  • Draft (default)
  • Active
  • Suspended.

The flows are:

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

Product specifications must be activated for use.

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.

Product specifications returned from a search can be exported to a report. Refer to Generating Grid Reports. Available report templates are defined in the SEARCH_REPORT_CCSPFN application preference.

Maintaining Specification Limits

Each specification contains a set of limits, where each limit is scoped Scheme Code, Scheme Version, Analyte Code and Unit Code. Limits can be of text or numeric type, based on the given analyte.

With respect to absolute internal failure limits, analytical work containing control samples with results outside these limits are likely to be rejected. These limits mark the 99.8% confidence in the mean (or expected value). Only 1 to 1000 samples is expected below or above and still be correct.

With respect to absolute internal warning limits mark the 95% confidence interval on the mean (or expected value). Only 1 to 40 samples is expected above or below the limits and yet still be acceptable.

Reporting limits are optional and can be included on a report containing a sample with this specification.

Any scheme version analyte that has a Data Type of Numeric, and subject to a specification, can be bound by:

  • Internal assessment limits comprising a text string, target value, lower and upper warning limits, failure limits, and an evaluation script for custom assessment—these are the limits used for scheme limit assessment.
    • An internal minimum value—The specification scheme version analyte unit's Internal Min Value is the lowest acceptable amount of substance for the specification to be satisfied, below which the material would fail the specification.
    • An internal minimum warning value—The specification scheme version analyte unit's Internal Min Warning Value is the lowest acceptable amount of substance for the specification to be satisfied without warnings, below which the material would satisfy the specification but with warnings.
    • An internal target value—The specification scheme version analyte unit's Internal Target Value is the target value for the acceptable amount of substance in the material.
    • An internal maximum warning value—The specification scheme version analyte unit's Internal Max Warning Value is the highest acceptable amount of substance for the specification to be satisfied without warnings, above which the material would satisfy the specification but with warnings.
    • An internal maximum value—The specification scheme version analyte unit's Internal Max Value is the highest acceptable amount of substance for the specification to be satisfied, above which the material would fail the specification.
  • Reportable limits comprising a text string, target value, lower and upper warning limits, failure limits, and reporting details, including a pass, warning and failure statement—these details are for inclusion on reports, but do not apply to the actual assessment.

Relative values can be entered, but are converted to, and persisted as, absolute limits.

For each specification, a specification code, type, name and scope should be recorded as a minimum.

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.

Once scheme version analyte unit can be added at a time, or multiple scheme version analytes can be added using a scheme analyte search. Specification scheme version analytes added this way have their Description set to the scheme version analyte's Description, the Limit Check Method set to Relative, Is Reportable set to true and Critical For Validation set to false by default.

Configuring an Evaluation Script for the Product Specification

A product specification can be linked to an evaluation script, such that, when a result is captured, then the system a) assesses the results against the limits in each sample specification, for the limits matched by Scheme Code, Scheme Version, Analyte Code and Unit Code to set the sample scheme analyte specification's Specification Status, b) runs this evaluation script to perform any additional logic for the specification, and c) runs any product script linked to the sample's product to perform any additional logic for the specification.

Exporting Product Specifications

When a product is approved for export and subsequently imported, then any specifications associated with the product are approved automatically for export and imported also.