Working with Results in Workbook after Product Assessment

• Working with Results in Workbook after Product Assessment
  • Dealing with Results that are Outside of Specification
    • Non-critical Limits
    • Critical Limits

After primary specification assessment takes place, various pathways exist where the assessment does not pass.

• Enumerations related to Core Specification Statuses
• Enumerations related to User Specification Statuses
• Enumerations related to Core QC Statuses
• Enumerations related to User QC Statuses
• Overwriting a Result in a Workbook Session
• Requesting a Repeat Analysis in a Workbook Session
• Ignoring a Composite QC Failure in a Workbook Session
• Forcing the Reassessment of Results in a Workbook Session
• Releasing Results in a Workbook Session
• Validating Results in a Workbook Session

Dealing with Results that are Outside of Specification

Non-critical Limits

If a sample has a specification that is flagged as being a non-primary specification, then all limits within the specification are treated as non-critical.

If a sample has a specification that is flagged as being the primary specification, then all limits within the specification can be flagged as critical or non-critical.

A failure in a non-critical specification limit does not impede validation of the result.

These specification limits are usually only used for reporting, such that, it can be stated on a report whether a sample conforms or does not conform to one or more specifications.

Critical Limits

A failure in a critical specification limit impedes validation of the result.

If a sample scheme analyte's result fails a critical specification assessment, the laboratory has the following options:

• The test results might be wrong (through a failure of the test to report the correct result).

  In this case, if the tests are repeated (maybe via an alternative method, user operator or instrument), then this gives confidence to the laboratory that the results were accurate.

• The sample might be mis-labelled within the laboratory's control or contaminated by the laboratory’s processes. Steps might be required to see if a primary sample portion is available as a potential re-test portion.
• The material might be different to the expected material (for example, through a failure to obtain a correct sample, contamination, mis-labelling by the client or sampling process, or failing in the production environment).

  In this case (as long as the laboratory has excluded the first potential problem), the laboratory cannot do much except report the results to the client with any warnings that might be suitable. This may trigger the client to provide another sample (as cross-check), or to react as though the results are correct for the sample presented to the laboratory and take appropriate action within their business.

It is possible that the sample presented to the laboratory does not represent the original bulk material due to errors in sample preparation, and may be the cause of the failure of the tests to confirm the specifications of the product.

Some laboratories have an early warning requirement to the client if a preliminary result is not within the typical ranges, allowing the client as much notice as possible for the potential reporting of unacceptable results. This is typical in process control laboratories.

Refer to toggling the showing and hiding of the analysis detail lower panel when Using the Workbook Grid.