Creating QC Samples using QC Masks

• Creating QC Samples using QC Masks
  • Overview
  • Process
    • Creating QC Samples by Applying QC Masks to a Registered Job
    • Creating QC Samples by Applying QC Masks to a Laboratory or Subcontract Batch Job
    • Creating QC Samples using QC Masks
    • Upon Creating a QC Sample
    • Modifying QC Samples for a Job Scheme, or in a Laboratory or Subcontract Batch Job
    • Updating QC Sample Scheme Analytes for Selected Job Schemes

Overview

This process details how QC masks are used to add QC samples to registered and batch jobs.

• QC samples can be added to job schemes in registered jobs by using QC masks on the related sample schemes.

• QC samples can be added to job schemes in laboratory and subcontract batch jobs, based upon the samples within the batch job.

  • Adding QC samples to laboratory batch jobs is one of the most important components of the batching process. In applying QC samples at the point of batching, the operator is in complete control of the sample-to-QC ratio. Decisions can be made as to which QC samples would be most appropriately placed with the current batch of samples.

  • Once a collection of samples is selected for batching, the operator has three choices as to how QC is added. The option of no QC means that QC samples can be dispensed with entirely should the situation justify, for example, where QC samples are included in the laboratory batch job from a registered job. The other options are to add QC samples using the QC masks on the registered sample schemes, or to add QC samples using the QC masks on sample schemes in a selectable job template.

  • Adding QC using a selected template job allows the operator to select a particular QC distribution to provide the best possible quality assurance for the current batch of samples. In order to make best use of this option a collection of job templates is created in which the scheme QC masks inherited into the template sample schemes within the template job is adjusted to suit the QC demands of specific samples or a particular customer with special QC requirements. At batching time, the operator simply needs to select which template job from which to draw the QC mask.

A sample's Primary Analytical Type and Secondary Analytical Type are used to apply fundamental QC assessment to the sample's results and can be used to apply auxiliary QC assessment to the sample's results, by applying rules in a custom script. Results held in QC history can be accessed using the primary and secondary QC type.

• A sample's Primary Analytical Type denotes its primary QC assessment type: Unknown, Duplicate, Replicate, Blank, Standard or Spike.

• A sample's Secondary Analytical Type denotes that it may undergo secondary QC assessment after it has undergone primary QC assessment.

Changing the sample's Primary Analytical Type or Secondary Analytical Type changes the type of QC assessment performed on its results.

A sample's Standard Code is used to determine the identity of the sample. A sample Standard Lot Code is used to determine the Specification Code which prescribes the specification used in the standard assessment.

Results held in QC history can be accessed using the primary and secondary analytical type.

QC samples can be included at various points in the analytical process. A sample's QC Source denotes the phase in the job's life-cycle at which the sample was added and determines which QC samples are removed when a QC overwrite is made, and which QC samples are owned by a laboratory batch job, and which QC samples are owned by a production job during a workbook session, quality assessment and reporting, etc.

• 1—Registered unknown or QC samples, added during registration. These samples are 'owned' by the production job.
• 2—QC samples added by applying the QC masks linked to sample schemes for selected or all schemes in a job. These QC samples are 'owned' by the production job and include duplicate QC samples created by applying a sample preparation scheme, or replicate, blank, standard or spike QC samples created by applying an analytical preparation or analytical scheme.
• 3—QC samples added when a laboratory or subcontract batch job is created. These QC samples are 'owned' by the laboratory batch job and include duplicate QC samples created by applying a sample preparation scheme, or replicate, blank, standard or spike QC samples created by applying an analytical preparation or analytical scheme.

Appendix—The Different Types of QC Samples

The Different Types of Analytical Limits used in CCLAS

Process

Creating QC Samples by Applying QC Masks to a Registered Job

Append or overwrite QC samples for a job

When Maintaining Job Tests, the Append QC and Overwrite QC processes add QC samples to a job based upon the sample scheme's QC masks, for each indicated job scheme. The Overwrite QC process works in the same way as the Append QC process, except that QC samples that have a QC Source of 2 are deleted before new QC samples are added.

For detailed information on the Append QC or Overwrite QC process, refer to Processing a Job Scheme to Add QC Samples by Applying QC Masks.

QC samples created in this way are assigned a QC Source of 2.

This enumerator is used to denote which samples have been created by an Append QC process, and therefore, if an Overwrite QC process is run on the job, it indicates which QC samples are deleted before more QC samples are added to the job using QC masks on its sample schemes.

QC samples that are added to a registered job can be amended by Maintaining Batch Samples, with any added QC samples also being assigned a QC Source of 2.

Creating QC Samples by Applying QC Masks to a Laboratory or Subcontract Batch Job

Append batch QC using registered sample scheme QC masks

Append batch QC using template sample scheme QC masks

When Batching Samples for Analysis, QC samples can be added to the laboratory batch using QC masks defined on the incoming sample schemes or on sample schemes in a selected batch template job.

QC masks are used to add QC samples to job schemes in laboratory or subcontract batch jobs by setting Sample Scheme QC Mode to Scheme QC or Template QC when creating a laboratory batch in the CCBTCH—Batch application.

QC samples created in this way are assigned a QC Source of 3. This allows the system to distinguish between QC samples passed into the laboratory batch job from a registered job, and QC samples created and therefore owned by the laboratory batch job.

QC samples that are added to a laboratory batch job can be amended by Maintaining Batch Samples, with any added QC samples also being assigned a QC Source of 3.

Creating QC Samples using QC Masks

A QC sample created by applying a QC mask is given a Primary Analytical Type and Primary QC Type Code based on the QC mask member's Analytical Type and QC Type Code.

Where the QC mask member's Number To Apply > 1, then multiple QC samples of that analytical type are to be placed. In this case, the second and subsequent QC samples generated based on that QC mask member have their Primary Analytical Type and Primary QC Type Code set accordingly, and also have their Secondary Analytical Code set to the QC mask member's Secondary QC Type Code and Secondary QC Type Code set to the secondary QC type's Analytical Type. For example:

• If a pair of blank QC samples are added for a job scheme, although the Primary Analytical Type is set to Standard, the Secondary Analytical Type is set to Replicate, so that the pair of samples can both undergo standard assessment, but the second standard sample of the pair also undergo precision assessment with the first standard sample.

When a pair of blank QC samples are added for a job scheme, although the Primary Analytical Type is set to Standard, the Secondary Analytical Type is set to Replicate, so that the pair of samples can both undergo standard assessment, but the second standard sample of the pair also undergo precision assessment with the first standard sample.

Refer to Processing a Job Scheme to Add QC Samples by Applying QC Masks.

Upon Creating a QC Sample

When QC samples are created, various properties of the QC sample are set based upon the type of QC sample.

Default Settings for Duplicate or Replicate QC Samples

Default Settings for Blank and Standard QC Samples

Default Settings for Spike QC Samples

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

QC samples in a job can be viewed either:

• On the job's sample grid, as long as the DISPLAY_ALL_ANALYTICAL_TYPES application preference is configured to do so. Refer to Maintaining Samples.
• Via the job scheme's sample grid. Refer to Maintaining Job Tests.
• Via batch sample maintenance (a batch is the equivalent of a job scheme). Refer to Maintaining Batch Samples.

Modifying QC Samples for a Job Scheme, or in a Laboratory or Subcontract Batch Job

There are instances in which the laboratory supervisor needs to update QC samples that are added to job schemes. These are those QC samples that have a QC Source of 2 or 3. Refer to Maintaining Batch Samples.

Updating QC Sample Scheme Analytes for Selected Job Schemes

Where a sample scheme has been included in a laboratory or subcontract batch job, where the registered job is updated, such that, an analyte is added to the sample scheme, then the analyte can be added to the batch job. Refer to Maintaining Batch Samples.