Releasing and Validating Results during Job and Sample Validation

• Releasing and Validating Results during Job and Sample Validation
  • Process of Releasing and Validating Results during Job and Sample Validation
  • Dependencies and Restrictions on Ignoring a Composite QC Failure on a Result
  • List of Reasons for Ignoring a Composite QC Failure
  • Effect of Ignoring a Composite QC Failure upon a QC History Precision Assessment Record
  • Effect of Ignoring a Composite QC Failure upon a QC History Standard Assessment Record
  • Restrictions on Releasing and Validating Results

Depending on the number and levels of authorisation that might be required (which can depend on the test or the type of laboratory), once the test is complete, the operator might need to release their test results. This means that they have done all that they can do on the tests, and have delivered the results to the next person or system that is performing the checking. Some analytes in some tests do not need to undergo a release process as results can be passed on as soon as they are entered or captured or calculated. Some laboratories function on the premise that the person who performed the test should not authorise/validate it. Results can be released by the operator, even if there are QC errors, because it might be beyond that operator’s skills or authority to clear/ignore the failures.

Process of Releasing and Validating Results during Job and Sample Validation

Samples cannot be released or validated until all sample scheme analyte results are released or validated, respectively. If result release or validation is not done during result entry, it can be done during the sample and job validation session.

When a sample scheme analyte is released, it achieves a workflow status of released. When a sample scheme analyte is validated, it achieves a workflow status of completed and its validated date is stamped. A sample scheme analyte that is analysed has to be released before it is validated.

An operator can released and/or validated sample scheme analyte results manually at point of entry using the CCWKOP—Open Workbook application, or the system can release and/or validate sample scheme analyte results automatically at point of entry. Refer to Taking Action after the System has Processed Results for more information on these lower levels of release and validation at point of result entry.

However, where the operator does not have enough privilege to do this, a section head can validate results in their section using the CCVALN—Job and Sample Validation application.

A sample may need to be analysed by multiple tests across many analytical disciplines. Each analytical discipline is usually aligned with a laboratory section, for example, wet chemistry, x-ray, fire assay. The section head and the operators of the various instruments in that section are responsible for the results of all tests performed in their section.

1. View Sample Scheme Analyte Results for a Sample

The workbook for a job or worklist for a sample can be opened from a validation session.

1. Open Workbook for a Job from Job and Sample Validation
2. Open the Worklist Dialog for a Sample from Job and Sample Validation.

Sometimes a result may have a detection limit failure. Where this is flagged as being critical for validation, the sample scheme analyte show a Workflow Status of Check. Since a result with a critical detection limit failure cannot be released nor validated, there are two pathways to manage a check result during the validation session.

The first pathway is by ignoring the detection limit failure. The permission to do this is controlled using the ALLOW_IGNORE_DL_FAILURES preference.

1. Set the ALLOW_IGNORE_DL_FAILURES Preference
2. Ignore a Critical Detection Limit Failure on Sample Scheme Analyte Results.

The second pathway is by requesting a repeat of analysis. The permission to do this is controlled using the ALLOW_SET_REPEAT application preference.

1. Set the ALLOW_SET_REPEAT Preference
2. Request a Repeat Analysis for Sample Scheme Analytes.

If the result has no detection limit failure but was not released at point of analysis, it can be released during the validation session.

1. Configure the Release Result User Group for a Section
2. Configure a section for a scheme when Maintaining Schemes
3. Release Sample Scheme Analyte Results.

If the result was released but not validated at point of analysis, or the result was just released during the validation session, then it can be validated during the validation session, as long as there is no composite QC failure. A composite QC failure can result from the result failing scheme limit assessment, standard assessment, precision assessment or specification assessment. There is one pathway to manage a composite QC failure during the validation session, as a result with a composite QC failure cannot be validated. The permission to do this is controlled using the ALLOW_IGNORE_QC_FAILURES application preference.

1. Set the ALLOW_IGNORE_QC_FAILURES Preference
2. Ignore a Composite QC Failure on Sample Scheme Analyte Results.

If the result was released but not validated at point of analysis, or the result was just released during the validation session and it has no composite QC failure, then it can be validated during the validation session.

1. Configure the Validate Result User Group for a Section
2. Configure a section for a scheme when Maintaining Schemes
3. Validate Sample Scheme Analyte Results.

Typically a section head would be a member of the section's release and validation user groups, and thus be able to release and validate results from schemes performed in their section.

If this first-level release mechanism is not required, then analytes can be flagged to be released automatically. Results can also be flagged to be validated automatically.

Dependencies and Restrictions on Ignoring a Composite QC Failure on a Result

When a sample scheme analyte has a result that fails either scheme limit assessment, standard assessment, precision assessment or specification assessment, this results in the Composite QC Status being set to one of the failure statuses. Since a composite QC status failure is critical, then this also results in the sample scheme analyte's Workflow Status not being able to proceed beyond Analysed, or in the case of the sample scheme analyte being automatically or manually released then beyond Released; that is, any attempt to automatically or manually validate the result to set the Workflow Status to Completed does not proceed.

In this scenario, then if you have enough privilege, you can ignore the QC failure on the sample scheme analyte result, such that, as soon as the Workflow Status is set to Released either through automatic or manual release, then the Workflow Status could proceed to Completed either through automatic or manual validation.

If the QC_IGNORE_REASON_MANDATORY application preference is defined and selected, when you attempt to ignore a composite QC failure, then you must enter a reason why for the ignore action to proceed. If the preference is not defined, or is defined and is not checked, when you attempt to ignore a composite QC failure, then you do not have to enter a reason why for the ignore action to proceed.

If that the ALLOW_IGNORE_QC_FAILURES application preference is defined and selected, when you attempt to ignore a composite QC failure, then the action proceeds. If the preference is not defined, or is defined and is not checked, when you attempt to ignore a composite QC failure, then the action does not proceed.

List of Reasons for Ignoring a Composite QC Failure

The list of available reasons for ignoring a QC failure are entered as System Table Codes with a Table Type of CC32—QC Ignore Reasons, as configured in the MSETBL—Table Code Service application.

Examples of the list of reasons for ignoring a QC failure:

Table Type	Table File Code (System Short Form)	Table file entry description	Table File Associated Values
CC32	CONTAM	Contamination
CC32	INCCONF	Incorrect configuration
CC32	INCCORR	Incorrect correction
CC32	INSUFWT	Incorrect dilution
CC32	WDIL	Insufficient weight
CC32	WQCS	Wrong QC sample

The Table Code can be set to any combination of letters, digit, and symbols, as appropriate (maximum length is 18).

The Entry description can be modified as appropriate for reporting purposes (maximum length is 50).

The list of available user QC statuses are entered as System Table Codes with a Table Type of C33—User QC Statuses, as configured in MSETBL—Table Code Service application, and are ordered by Table Code in any drop-down that displays them. For example, using the table above, the drop-down list presented when marking workbook cells with a user QC status is ordered: CONTAM, INCCONF, INCCORR, INSUFWT, WDIL, WQCS.

To change this default order, where a pipe character (|) is included in the Table File Associated Values, then the portion before the pipe character contains the sequence for display, and the portion after the pipe character contains the actual user status. For example:

Table Type	Table File Code (System Short Form)	Table file entry description	Table File Associated Values
CC32	CONTAM	Contamination	6|
CC32	INCCONF	Incorrect configuration	5|
CC32	INCCORR	Incorrect correction	2|
CC32	INSUFWT	Incorrect dilution	3|
CC32	WDIL	Insufficient weight	4|
CC32	WQCS	Wrong QC sample	1|

populates the drop-down list of available reasons for ignoring a QC failure in the order: WQCS, INCORR, INSUFWT, WDIL, INCCONF, CONTAM.

Where only some of the entries have the sort order defined, then the drop-down list is ordered first by those that have a sort order in the given sort order, and secondly by those that do not have a sort order in the given table order.

Use wild-cards to apply filtering on the drop-down list.

Effect of Ignoring a Composite QC Failure upon a QC History Precision Assessment Record

If the QC sample had undergone precision assessment due to the sample having a Primary Analytical Type or Secondary Analytical Type of Duplicate or Replicate, and the scheme version analyte was flagged to be assessed for QC, and the scheme version analyte was also flagged to have QC results written to QC history, then a record was written to QC history for the precision assessment.

When a record is written to QC history upon precision assessment, the QC history record's QC Status is set to the sample scheme analyte's Precision Status.

If the sample scheme analyte's Composite QC Status was Failure due to the precision assessment setting the sample scheme analyte's Precision Status to Failure, Upper Failure (only possible via script), Lower Failure (only possible via script) or Trend Failure (only possible via script), then a subsequent ignore of the composite QC failure status updates the QC Status on that QC history record:

• Failure--> Ignore Failure
• Upper Failure -- Ignore Upper Failure
• Lower Failure --> Ignore Lower Failure
• Failure--> Ignore Failure.

Note that this ignore process does not update the sample scheme analyte's Precision Status itself, only the QC Status on the QC history record.

Effect of Ignoring a Composite QC Failure upon a QC History Standard Assessment Record

If the QC sample had undergone standard assessment due to the sample having a Primary Analytical Type or Secondary Analytical Type of Blank, Standard or Spike, and the scheme version analyte was flagged to be assessed for QC, and the scheme version analyte was also flagged to have QC results written to QC history, then a record was written to QC history for the standard assessment.

When a record is written to QC history upon standard assessment, the QC history record's QC Status is set to sample scheme analyte's Standard Status.

If the sample scheme analyte's Composite QC Status was Failure due to the standard assessment setting the sample scheme analyte's Standard Status to Failure(only possible via script), Upper Failure, Lower Failure or Trend Failure (only possible via script), then a subsequent ignore of the composite QC failure status updates the QC Status on that QC history record:

• Failure --> Ignore Failure
• Upper Failure --> Ignore Upper Failure
• Lower Failure --> Ignore Lower Failure
• Failure--> Ignore Failure.

Note that this ignore process does not update the sample scheme analyte Standard Status itself, only the QC Status on the QC history record.

Restrictions on Releasing and Validating Results

Users can release results only if the scheme is not linked to a section or the section does not have a Release Result User Group Code defined. If the scheme is linked to a section and the section does have a Release Result User Group Code defined, then a user can only release a sample scheme analyte's result if they are a member of the user group.

Users can validate results only if the scheme is not linked to a section or the section does not have a Validate Result User GroupCode defined. If the scheme is linked to a section and the section does have a Validate Result User Group Code defined, then a user can only validate a sample scheme analyte's result if they are a member of the user group. For example, if you are only a member of a validation group linked to the AAS section, you can only validate results for sample scheme analytes which include schemes linked to the AAS section.