Folders
Batches
Review and Approval
Approval Management
Investigation Management
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What is Workflow?
The automation of a business process, in whole or part, during which documents, information or tasks are passed from one participant* to another for action, according to a set of procedural rules.
*participant = human or machine |
In the context of a laboratory the tasks mentioned above are achieved with LIMS. These include logging in samples, assigning tests, preparing samples for analysis, assigning samples to analysts and instruments, recording results, the results approval process and reporting.
In LabWare LIMS there are various managers and mechanisms that play a part in this process, and they may be categorized into three types:
- Managers that group samples together for processing in a certain way.
- Events that initiate and carry out the various status changes that move samples from stage to stage in the process.
- Mechanisms that record what has taken place and when.
The various managers are described in detail elsewhere and the main ones are:
Folder Manager, Project Manager, Lot Manager, Batch Manager, Investigation Manager, Evidence Location Manager and Worksheets.
The events and mechanisms that can be used to initiate and perform the movement from one process to another are:
Event Triggers, Actions, Business Rules, Analysis Rules, Status Rules, Automation Scripts, Bar-codes, Schedulers and manual intervention.
Mechanisms that record what has taken place include:
Audit Trail, Chain of custody, Investigations, Evidence Movement, samples, tests, results, projects, lots, batches (these last six record various key dates and times and responsible persons).
These tools together make it very easy to define workflows of varying complexity and suitability, including those that have time-based dependencies (schedulers, actions) as well as those that are event driven.
While workflows can be used to control the progress of samples through the system very strictly, it is important that LIMS is not totally inflexible in case unanticipated exceptions occur. The comprehensive audit facilities included with LabWare LIMS will ensure that, when they do happen, any deviations will be thoroughly recorded ensuring full traceability.
The following example shows a typical example showing many of the features of workflow available in LabWare LIMS.
Workflow Example
In this scenario we see a sample logged in by one of the schedulers with an initial status of unreceived and a location at reception. When the sample is logged an analysis rule kicks in that adds a test that is required to complete the calculations in one of the other tests.
The folder at reception is set up to contain unreceived samples and the clerk acknowledges the receipt of the sample. This sets off an event trigger which prints a barcode label and sets the location to sample preparation. When the clerk's folder is refreshed (automatically or manually) the sample will no longer appear in the folder. The folder in sample preparation contains samples that have a status of received and a location of sample preparation. So when this folder is refreshed the sample from reception will appear. Here, when the sample is scanned by the operator, an action is initiated which tells LIMS that sample preparation has begun. In this case the preparation requires several hours in a drying oven and at the end of this period the action sends an alert to the operator and changes the location to the laboratory.
Once again the sample will disappear from the folder. This time it will appear automatically in batches for three different analyses. After the first results are entered the status is changed to in progress. After the first two tests the results are in specification, but in the third test results are out of specification. This triggers an event that creates an investigation on that sample and alerts the lab technician who decides to retest the sample. This time the results are in specification and the location is changed so it will appear in the lab manager's folder.
The lab manager then approves the results and an event trigger changes the location again, this time to the QA manager for final release. This causes a further trigger that produces a report which is sent back to the plant and changes the location to sample retention.
Here the clerk uses the inventory manager to record the storage location in the sample retention store.
A complete audit trail is recorded tracking everything that has happened to the sample. |