Maintaining Products

Overview

A product may be produced by a plant, or be any other substance with known specifications. In CCLAS 6, a product is a substance that has a suite of grades, where each grade relates to a specific product specification. For example, a product could be petrol, but different specifications for petrol could be V98 and V95.

The limits associated with product specifications are used to assess whether a sample passes or fails the critieria associated with being of a particular product.

Process

Maintaining Products

Maintain products

Products are created and maintained using the CCPRDT—Product application.

Products are created either with org-scope or lab-scope. An org-scope product is scoped by line of business, making it visible only to laboratories linked to that line of business.

If a laboratory has one or more lines of business assigned to it, then a product search only returns:

Organisation-scope products that have no line of business assigned.
Organisation-scope products that have a line of business assigned that is in the laboratory's lines of business.
Laboratory-scope products.

The Lines of Business criteria on the CCPRDT—Search Product screen only displays a list of the lines of business that are assigned to the laboratory, and does not display all of the lines of business defined for the organisation. This means that you cannot search for, or edit, any product that is not linked to a line of business assigned to your laboratory.

A product's Status defaults to Draft and its Approved Date and Approved By User fields are empty.

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

Maintaining Product Specifications

A product can be associated with one or more specifications that have a Specification Type of Product. A product specification is a set of internal assessment and reporting limits for a given scheme, version, analyte and unit, and defines the analytical range that is achievable for the product.

Product specifications can be created and maintained via the product or using the CCSPFN—Specification application.

An org-scope product can only link to an org-scope product specification. A lab-scope product can link to an org-scope or lab-scope product specification.

When a product is created, if the PRODUCT_AUTO_CREATE_SPEC application preference is:

Defined and is checked, and a specification exists that has the same Scope and Code as the product, then the specification is associated with the product.
Defined and is checked, and a specification exists that has the same Code as the product but not the same Scope, then you are given a message that the product could not be associated with the specification due to the different scope.
Defined and is checked, and a specification does not exist that has the same Scope and Code as the product, then a specification with the same Scope, Code, Name and Description as the product is automatically created, and associated with the product.
Not defined, or is defined and is cleared, when you successfully create a product, then the product is not automatically associated with a specification.

A product specification can have multiple sets of limits. A set of limits is scoped by a given scheme, version, analyte and unit. Each set of limits has a set of internal assessment and reporting limits comprising:

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.
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.

A product can also link to an evaluation Script Code. When a result is entered for an unknown sample, after product assessment, then the script is run to perform further custom assessment.

A product can have an Auto-validate flag to allow for automatic validation of results, such that, when a result fall within the limits for the sample's primary specification and there are no other QC failures on the sample scheme analyte, then the sample scheme analyte is validated automatically.

Product specifications can be made members of various specification groups which can be used to add product specifications to samples efficiently. Refer to Maintaining Specification Groups.

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

Maintaining Product Types

A product can be associated with one of more product types, to hold the various classifications or synonyms of the product. Reports can be configured to refer to the various types of the product.

Maintaining Product Hazards

A product can be associated with one or more hazards. Labels can be configured to contain hazard warnings for products.

Product hazards can be created and maintained via the product or using the CCHZRD—Hazard application.

An org-scope product can only link to an org-scope hazard. A lab-scope product can link to an org-scope or lab-scope hazard.

Activating and Suspending Products

Products have a tri-state activity statuses:

Draft (default)
Active
Suspended.

The flows are:

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

The difference between a draft and suspended product is minor: both states prohibit the selection of the product on a drop-down choice. However, suspension implies the product was previously active and now should NOT be used, whereas draft implies that the product 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 product, the user is given the option to enter a reason as to why the action is being performed.

When a product is created, if the PRODUCT_AUTO_ACTIVATE application preference is:

Defined and is checked, then the product is automatically activated such that the product's Status is set to Active.
Not defined, or is defined and is cleared, then the product is not automatically activated such that the product's Status is set to Draft.

Using Product Specifications

Attaching Product Specifications to Samples

Where a product is linked to product specifications, when an unknown sample is linked to the product, then the specifications associated with that product are attached to the sample, and the sample's primary specification defaults to the product's primary specification. Additional product specifications can be added to the sample, and the sample's primary specification can be changed to a different sample specification.

Assessing Product Specifications at Result Entry

Where a sample has a primary analytical type of unknown or duplicate, when a result is entered for a sample, then the result is assessed against the internal limits within each product specification on the sample, for the matching Scheme Code, Scheme Version, Analyte Code and Unit Code, to set the sample scheme analyte specification's Specification Status.

Each samples scheme specification's Specification Status is rolled into the sample scheme analyte's Composite Specification Status.

For the sample's primary product specification, where the specification scheme version analyte's internal limits are flagged as Critical for Validation, then the sample scheme analyte specification's Specification Status is used to set the sample scheme analyte's Specification Status.

A sample scheme analyte's Specification Status is rolled into the sample scheme analyte's Composite QC Status, along with the Precision Status, Standard Status and Scheme Limit Status.

Product Failures

If a sample of a known product, achieves results outside the product's limits, then the analyst has several options available in which to proceed:

The test results might be wrong (through a failure of the test to report the correct result). In this case, if the test is repeated (maybe via an alternative method, operator or instrument), then this gives confidence that the initial results were accurate.
The sample may be incorrectly labelled by the laboratory staff, or contaminated by the laboratory’s processes, in which case, if an as-received sample portion is available, then that portion could be retested.
The material may be different to the expected material, for example, through a failure to obtain a correct sample, contamination, incorrect labelling by the client or during the sampling process, or a failing in the production environment. In this case, and as long as the laboratory has excluded the first potential problem, the laboratory cannot do much except to report the results to the client along with any suitable warnings, which may trigger the client to provide another sample, as a cross-check, or to react as if the results are correct for the sample presented to the laboratory.
As indicated earlier, if the sample presented to the laboratory does not represent the original bulk material, then the failure of the tests to confirm the specifications of the product may be due to that reason.

Some laboratories have a requirement to provide an early warning to the client if a preliminary result is not within typical ranges, so that the client has as much notice as possible for the potential reporting of unacceptable results.

Using Product Specifications during Reporting

When a sample is included in a report, then the reporting limits within the related product specifications are available for inclusion in the report result set.