Maintaining Sample Product and Specifications

Overview

A product is a substance that has a suite of grades, where each grade relates to a specific product specification. A product may be produced by a plant, or be any other substance with known specifications (for example, an environmental air sample).

A specification is a set of internal assessment and reporting limits for scheme version analytes, for a given unit.

A sample is associated with a product when it is recognised as being of a specific material that satisfies various specifications.

A sample with a Primary Analytical Type of Unknown can be assessed against specifications associated with the product or against any other specification to set a sample scheme analyte specification's Specification Status which is an indication of the quality of the sample against expected limits. The sample's primary product is used to set a sample scheme analyte's Specification Status which rolls into the sample scheme analyte's Composite QC Status.

Process

Maintaining Products and Specifications on Samples

A product can be added to an interim sample associated with a sample group, single sample or multiple samples.

When a product is added to a sample, then the specifications associated with the product are added to the sample, with the product's primary specification being set on the related specification on the sample.

Individual specifications can be added to an interim sample associated with a sample group or single sample.

When a specification is added to a sample, either by adding a product to the sample or by specifically adding the specification, then sample scheme analyte specifications are created to hold any deviated limits from the default limits in the specification.

If a product is linked and specifications are added to an interim sample, when the sample group is expanded, then the product is linked and the specifications are created for all expanded samples.

Tip: Specify any linked product or specifications that are applicable to the sample group BEFORE THE SAMPLE GROUP IS EXPANDED, as these details cannot be updated during a multiple sample update, but can only be applied to individual samples at a time.

Upon maintaining sample product and specifications:

The event is audited. Refer to Reviewing Operational Data Audits.

Maintain sample product and specifications

The Product Code identifies the material comprising a sample within market context.

A sample can have multiple specifications. A sample specification's Specification Code identifies the set of specification limits imposed on the sample's analysis.

A sample scheme analyte specification's Specification Status defaults to Not Tested and is read-only and updated by specification assessment when a result is received for the sample.

One sample specification can be identified as the Primary Specification. The primary specification is used to set a sample scheme analyte's Specification Status which rolls into the sample scheme analyte's Composite QC Status. A sample scheme analyte's Specification Status defaults to Not Tested and is read-only and updated by specification assessment when a result is received for the sample.

When the sample specification is Reportable, then the sample specification is included in reportable record sets.

Linked to Sample Product indicates whether the specification was added to the sample due to linking the sample to a product.

Product Specification Result Notes can be added to a sample to comment on the outcome of product specification assessment.

Canned comments are available to quickly entered pre-canned text. When canned comments are accessed for a given note field, the canned comments are filtered by Canned Comment Type and Canned Comment Subtype.

The Canned Comment Type of GLOBAL, JOB, SAMPLE or SCHEME, and the Canned Comment Subtype of GLOBAL, REGISTRATION, RECEIPT, ANALYSIS, RELEASE, VALIDATION, REPORT or INVOICE.

or:

The list of category codes entered in the Category Code. The category codes are initially populated from the categories whose code appears in the related preference, where the preference changes according to the particular notes field being updated:
- NOTES_SAMPLE_PRODUCT_CATEGORIES.

Specifications are created using the CCSPFN—Specification application, which is also accessed using the Analysis Setup » Specifications menu option.

Where lines of business (LOB) 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.

Numeric and Numeric Only Analytes

Where the scheme version analyte has an Analyte Data Type of Numeric or Numeric Only, scheme limit assessment uses the specification scheme version analyte's internal absolute limits, where the warning and failure ranges are absolute.

There is the option to enter these limits as relative values, where a percentage around the target value for warning and failure limits is designated, however, the system determines the equivalent absolute values and uses them for the accuracy assessment.

A specification scheme version analyte unit's numeric limits are bound by any or all of the following:

< or = Internal Minimum Value—The lowest acceptable amount of substance for the specification to be satisfied, below which the material would fail the standard lot's specification.
< or = Internal Minimum Warning Value—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 Target Value—The target value for the acceptable amount of substance in the material.
> or = Internal Maximum Warning Value—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.
> or = Internal Maximum Value—The highest acceptable amount of substance for the standard lot's specification to be satisfied, above which the material would fail the specification.

Text Analytes

Where the scheme version analyte has an Analyte Data Type of Text, the specification can be configured to assess strings with or without case-sensitivity.