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CCSPFN—Specification Detail
Processes associated with this form
Screen flows
- Submit—Validate and save the changes.
- Submit and Return—Validate and save the data entered on the screen, then return to the previous screen.
- Refresh—Reloads the original data. Any changes made since the last submit are lost.
- New—Create a new item related to the application.
- Save As—Creates a new item based on the information provided by an existing item.
- Delete—Confirm and delete the current item.
- Open—Display a dialog box to enter an existing item to display its detail.
- New Search—Return to the Search screen and clear the search results and the search criteria.
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Activate—Activate the current item making it available for use.
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Suspend—Suspend the current entity making it unavailable for use.
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Add Multiple Scheme Analytes—Add scheme version analytes to the specification.
Header
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Organisation Scope
Indicates whether this entity is available organisation-wide or laboratory-wide.
- Checked—The entity is available to users who are logged into any laboratory within the organisation.
- Unchecked—The entity is only available to users who are logged into the current laboratory.
Setting the specification's scope upon successful creation depends upon the user's security level for the CCSPECIFICATION:CREATE resource. The possible security levels for the resource, from greater scope to lower scope, are:
- full—full
- 3—LAB AND ORG
- 2—ORG ONLY
- 1—LAB ONLY
A user can have multiple roles, and each role can contain different rights. Any of these role-right combinations may contain the resource.
If the resource does not exist across all role-right combinations for the user, then the user has no access to the resource. Otherwise the user's security level for the resource is determined as the greatest scope across all role-right combinations for the user. For example, if a user has Role1 that contains RightA, and Right A contains security level 2 for the resource, and the same user has Role2 that contains RightB, and RightB contains security level 1 for the resource, then the user has a security level of 2 for the resource.
The selection in this field can determine the visibility for other fields in this form, and the content of various drop-down selection lists.
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Specification Code
The unique code assigned to specification.
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Name
The name of the specification.
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Description
The description of the specification.
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Specification Category
A category assigned to the specification. Selected from categories with a Category Type of SPECIFICATIONS.
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Specification Type
The specification type denotes the use of the specification:
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Product—Product Specifications use
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Scheme—Scheme Limit Specification use
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Standard—Standard Lot Specification use.
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Status
The status of the specification. Display only. This can be:
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Draft—The specification is under development.
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Active—The specification is ready for use by the laboratories in scope, for linking from scheme limits, standard specifications, product specifications, or sample specifications.
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Suspended—The specification is no longer available for use.
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Status Changed Date
The date-time at which the last change was made to the status of the entity. Display only.
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Status Changed Reason
The reason for the change in status. Display only.
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User Code
The code of the user who changed the status. Display only.
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Report Name
The reportable name of the specification.
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Report Description
The reportable description of the specification.
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Specification Title
The title of the specification.
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Specification URL
The URL to access more information about the specification.
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Release Date
The date-time at which the specification was released for use.
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Is Auto Promoted
Indicates whether the specification is returned from a specification search in which the Is Auto Promoted search criteria is checked. Note that this specification search criteria can only be used in conjunction with a Specification Type of Scheme.
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Evaluation Script
The code of the script run during a scheme limit assessment, standard assessment or specification assessment to perform custom assessment based on the specification. A script may be selected from the drop-down list that contains active scripts in scope with a Script Type of Specification, as configured in the CCSCRT—Script application. Click the field hyperlink to display the CCSCRT—Search Script screen, select the appropriate value and click Select and Return to populate the field with the selected value.
Specification Limits Tab
Specification limits for individual scheme version analyte units. Internal and report target values can be updated in the grid. Upon submission, the related fields are recalculated. When the Limit Check Method is Relative, then the limits (for QC standards) are calculated automatically based upon values in the scheme version analyte properties.
The internal and external limits for a specification are optional. During QC assessment using specification, if the internal limits are not defined then they are not tested. During reporting, if the reportable limits are not defined then they are not tested.
A specification can have a pass, warning and/or fail statement for use in reporting.
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Specification Scheme Analyte Search Criteria
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Tab flows
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Submit—Perform a search for specification scheme analytes using the entered search criteria and display the results in the grid.
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Scheme Code
Search specification scheme analytes by the code of an associated scheme. A scheme may be selected from the drop-down list that contains active schemes in scope with a Price Type of something other than Not Priced, as configured in the CCSCHM—Scheme application. Click the field hyperlink to display the CCSCHM—Search Scheme screen, select the appropriate value and click Select and Return to populate the field with the selected value.
The list of available schemes that display are:
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Org-scope and lab-scope schemes that have no line of business assigned
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Org-scope schemes that have a line of business assigned that is in the laboratory's lines of business
All other schemes are invisible.
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Analyte Code
Search specification scheme analytes by the code of an associated analyte. A code may be selected from the drop-down list.
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Show Latest Version only
Search specification scheme analytes where the specification limit's scheme version is the latest version within the associated scheme.
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Specification Limits Grid
The specification limits for the specification scheme analytes returned from the search.
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Grid flows
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Create Specification Scheme Analyte—Create a specification scheme analyte limit.
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Scheme Code
The code of the scheme on the specification.
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Version Number
The version number of the scheme on the specification.
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Analyte Code
The code of the analyte on the specification.
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Analyte Data Type
The type of data expected for the analytical result for the analyte. Display only. This can be:
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Numeric Only—A numeric value is expected; only numeric result values are stored.
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Numeric—A numeric value is expected, however, depending on permissions, a string value can be entered; only a numeric result or string result is stored.
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Text—A text string is expected; a string result is stored.
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Boolean—0 or 1 is expected; a Boolean result is stored.
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Date—A date string is expected (for example, 01/12/2014); a date result is stored.
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Datetime—A date-time string is expected (for example, 01/12/2014 14:15:11); a date-time result is stored.
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Image—An image upload is expected; the image result points to the EFS file containing the image.
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Document—A document upload is expected; the document result points to the EFS file containing the document.
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Limit Check Method
The method by which the limits are entered:
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Absolute
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Relative
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List
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By Script (Reserved for future use)
Different fields display depending on the option. If the Limit Check Method is either Absolute or Relative, then numeric fields are optional.
During the update of a standard Specification type, if the Limit Check Method is toggled between Relative and Absolute, then all values for the numeric fields are preserved regardless of whether they are visible on the UI.
During the update of a standard specification type, if the Limit Check Method is Absolute, then all the numeric fields can be manually edited including those that are previously calculated.
If the Limit Check Method is Relative, then the values in the non-displayed fields are preserved.
Internal Percentage Warning Value = 1.96 / 3.09 x ( ( 100 x scheme version analyte's Rep Statistical Detection Limit / Internal Target Value ) + scheme version analyte's Rep Limiting Repeatability)
Internal Percentage Failure = (100 x scheme version analyte's Rep Statistical Detection Limit / Internal Target Value ) + scheme version analyte's Rep Limiting Repeatability)
Report Percentage Warning Value = 1.96 / 3.09 x ( ( 100 x scheme version analyte's Rep Statistical Detection Limit / Report Target Value ) + scheme version analyte's Rep Limiting Repeatability)
Report Percentage Failure Value = ( 100 x scheme version analyte's Rep Statistical Detection Limit / Report Target Value ) + scheme version analyte's Rep Limiting Repeatability
Note: Limits are assessed against the entered or calculated absolute values.
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Unit Code
The code of the unit of comparison on the specification.
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Internal Specification
The description of the internal limits for the analyte on the specification. Defaults to a concatenation of the individual internal absolute limits.
- Internal Target Value
The internal target value for the analyte on the specification, based on the given Unit Code, used by the system to calculate the absolute limits where the Limit Check Method is Absolute or Relative.
- Internal Min Value and Inclusive Flag
The minimum value, at, or below, which a lower failure occurs for limit assessment, and where the check box is:
Checked—The value is included within the minimum failure range, such that, any result less than or equal to the limit returns a Lower Failure.
Unchecked—The value is not included within the minimum failure range, such that, any result less than the limit returns a Lower Failure.
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Internal Min Warning Value and Inclusive Flag
The minimum warning value, at, or below, which a lower warning occurs for limit assessment, and where the check box is:
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Checked—The value is included within the minimum warning range, such that, any result less than or equal to the limit returns a Lower Warning.
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Unchecked—The value is included within the minimum warning range, such that, any result less than the limit returns a Lower Warning.
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- Internal Max Warning Value and Inclusive Flag
The maximum warning value, at, or above, which an upper warning occurs for limit assessment, and where the check box is:
Checked—The value is included within the maximum warning range, such that, any result equal or greater than the limit returns an Upper Warning.
Unchecked—The value is included within the maximum warning range, such that, any result greater than the limit returns an Upper Warning.
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Internal Max Value and Inclusive Flag
The maximum value, at, or above, which an upper failure occurs for limit assessment, and where the check box is:
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Checked—The value is included within the maximum failure range, such that, any result equal or greater than the limit returns an Upper Failure.
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Unchecked—The value is included within the maximum failure range, such that, any result greater than the limit returns an Upper Failure.
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Internal Percentage Warning Value
The relative percentage difference from the Internal Target Value below and above which a lower warning occurs for limit assessment.
Hidden on the grid, by default.
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Internal Percentage Failure Value
The relative percentage difference from the Internal Target Value below and above which a lower failure occurs for limit assessment.
Hidden on the grid, by default.
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Report Specification
The description of the reportable limits for the analyte on the specification. Defaults to a concatenation of the individual report absolute limits.
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Report Target Value
The reportable target value for the analyte on the specification, based on the given Unit Code, for inclusion on a certificate report.
- Report Min Value and Inclusive Flag
The minimum value, at, or below, which a lower failure is reported, and where the check box is:
Checked—The value is included within the minimum failure range, such that, any result less than or equal to the limit returns a Lower Failure.
Unchecked—The value is not included within the minimum failure range, such that, any result less than the limit returns a Lower Failure.
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Report Min Warning Value and Inclusive Flag
The minimum warning value, at, or below, which a lower warning is reported, and where the check box is:
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Checked—The value is included within the minimum warning range, such that, any result less than or equal to the limit returns a Lower Warning.
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Unchecked—The value is included within the minimum warning range, such that, any result less than the limit returns a Lower Warning.
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- Report Max Warning Value and Inclusive Flag
The maximum warning value, at, or above, which an upper warning is reported, and where the check box is:
Checked—The value is included within the maximum warning range, such that, any result equal or greater than the limit returns an Upper Warning.
Unchecked—The value is included within the maximum warning range, such that, any result greater than the limit returns an Upper Warning.
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Report Max Value and Inclusive Flag
The maximum value, at, or above, which an upper failure is reported, and where the check box is:
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Checked—The value is included within the maximum failure range, such that, any result equal or greater than the limit returns an Upper Failure.
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Unchecked—The value is included within the maximum failure range, such that, any result greater than the limit returns an Upper Failure.
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Report Percentage Warning Value
The relative percentage difference from the Report Target Value below and above which a warning is reported.
Hidden on the grid, by default.
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Report Percentage Failure Value
The relative percentage difference from the Report Target Value below and above which a failure is reported.
Hidden on the grid, by default.
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Notes Tab
Notes associated with the specification.
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Specification Notes
Notes regarding the specification.
Rich text formatting can be used to control the appearance of the information, with basic formatting ribbon and hyperlink entry field. For example, the name of a contact can be entered in bold, the telephone number in italics, and hyperlinks can be used. The formatting is saved along with the actual content.
Reporting Tab
The reportable text for the specification.
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Is Reportable
indicates whether the specification is included in a report record set.
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Pass Statement
The reportable text used to indicate that the results are within specification limits.
Rich text formatting can be used to control the appearance of the information, with basic formatting ribbon and hyperlink entry field. For example, the name of a contact can be entered in bold, the telephone number in italics, and hyperlinks can be used. The formatting is saved along with the actual content.
Multi-language support. All reportable, visible and enabled text area fields provide multi-language support, if multi-language preferences and availability are set up for the laboratory. The main text area holds text in the default language, click the icon to display input areas that correlate with any languages set up for the laboratory. Enter the core text and the translated text in the respective text areas, the content from both is saved. The content in the appropriate language is used in reports depending on the specified report template.
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Warning Statement
The reportable text used to indicate that the results are within specification limits, but outside warning limits.
Rich text formatting can be used to control the appearance of the information, with basic formatting ribbon and hyperlink entry field. For example, the name of a contact can be entered in bold, the telephone number in italics, and hyperlinks can be used. The formatting is saved along with the actual content.
Multi-language support. All reportable, visible and enabled text area fields provide multi-language support, if multi-language preferences and availability are set up for the laboratory. The main text area holds text in the default language, click the icon to display input areas that correlate with any languages set up for the laboratory. Enter the core text and the translated text in the respective text areas, the content from both is saved. The content in the appropriate language is used in reports depending on the specified report template.
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Fail Statement
The reportable text used to indicate that the results are outside critical specification limits.
Rich text formatting can be used to control the appearance of the information, with basic formatting ribbon and hyperlink entry field. For example, the name of a contact can be entered in bold, the telephone number in italics, and hyperlinks can be used. The formatting is saved along with the actual content.
Multi-language support. All reportable, visible and enabled text area fields provide multi-language support, if multi-language preferences and availability are set up for the laboratory. The main text area holds text in the default language, click the icon to display input areas that correlate with any languages set up for the laboratory. Enter the core text and the translated text in the respective text areas, the content from both is saved. The content in the appropriate language is used in reports depending on the specified report template.
