Reviewing Operational Data Audits

Overview

This process shows you how to review operational data audits and produce audit reports to assist with your laboratory's accreditation procedures.

This process is pertinent to:

  • Job registration operators who register jobs and maintain the job's samples and their scheme-analyte assignments.
  • Data entry operators who enter, calculate or capture results.
  • Data entry operators who wish to review the audit, to see previous changes to the details of their work.
  • Supervisors or QC Managers who review the audit trail, either to identify unauthorised changes, or to problem solve when an issue arises with a job or sample.
  • QC Managers who configure the analysis and QC environment, and present the operational data audit trail as part of the laboratory's toolkit to meet the accreditation requirements of the laboratory, or during accreditation inspections.
  • Workbook or registration script writers who want to record some specific business event in the audit trail as it was performed by a script that the system or operator initiated.

Process

The Jobs, On-line, Data Entry and Report applications audit changes to jobs and samples, and their tests. The number of audits written for a job is large when you consider the job's lifetime. The LIMS is configured to control:

  • Whether changes for each scheme/analyte selected in the MDE application are audited separately or collectively for the scheme.
  • Whether changes made to the formatted value by the Jobs, On-line, Data Entry and Reports applications are audited.
  • Which functions are audited in the Data Entry application.
  • Whether all changes to PJCSA fields by the Data Entry or On-line applications are audited, or only changes subsequent to the initial entry are audited.
  • Which fields are audited, by audit function.
  • Whether QC failures or check statuses set by the Data Entry or On-line applications are audited.

The Job Audit application allows you to review these audits, job by job.

Finding Job Audit Records

Job audit records are located either using forms containing custom search criteria, via client and project, or directly by the jobs list.

Find audited jobs

Once a job number is located, the job is opened to review and report the operational data audits for the job.

Review the audit trail for a job

Once a job number is located, the job is opened to display its audit records in the list view where they can be sorted in ascending or descending order, and reported. User events can also be added to the job audit trail.

Note: At any time in the Job Audit application, press the F5 function key to refresh all job details.

Recording User Events for a Job

Record a user event

Creating Job Audit Reports

Create an operational data audit report for a job