Overview	Top

Instrument Certification allows you to establish Calibration and Maintenance requirements for Instruments and their Parts. Regular Calibration and Maintenance can be scheduled and, based on successful completion, may be used to determine whether or not the Instrument is available for use.

A Certification process can be established based on date and time, the amount of time an Instrument has been in use and optionally by evaluating Certification Samples. A Certification Schedule allows you to schedule regular Calibration and Maintenance. The Certification Schedule automatically initiates a Workorder requesting calibration or maintenance on the Instrument. If calibration or maintenance is not completed in the allotted time (as defined by the Schedule) the Instrument (or Part) will become Unavailable.

Before defining an Instrument or Parts you may want to define Instrument Types and Models. Defining these categories helps organize the Instruments you define and allows you to establish Certification Schedules that default to any Instruments associated with a particular Instrument Model. See Instruments for detailed Information.

LES Worksheet Generation can also be generated based on Instrument Models and Instrument Types.

Defining Instrument Types and Models	Top

Before adding Instruments you may want to identify and define Instrument Types (such as pH Meter or Balance) and Instrument Model (the manufacturer's specific model of the Instrument Type). As your organization will likely have many of each Type and Model, grouping Instruments will give you easier access to a specific Instrument. At the Model level you can also define a Certification Schedule that will default to all Instruments added with that Model.

You must define Instrument Types (LabAdmin → Certifications and Resources → Instrument Types) before Instrument Models (LabAdmin → Certifications and Resources → Instrument Models). See Simple Instruments for information about defining Instrument Types and Models.

Adding Instruments	Top

Add Instruments using the Instrument List page. You can access this at LabAdmin → Certifications and Resources → Instruments or LIMS → Instrument Certification → Instruments.

Clicking"Add" opens the Add Instrument page.

Use the Instrument tab to define the Instrument, identify Host information, and determine a Certification process. Here you can also take an Instrument in or out of Service.

The Usage tab defines how to track an Instrument's use. The Certification Schedule considers these values when determining when to initiate calibration or maintenance of the Instrument. See Instrument Use and Certification Schedule for information about how use is determined.

Defines specific information about the Instrument.

Additionally, you can define notes related to the Instrument in the Notes tab, as well as add Categories.

The detail tabs that are displayed afer saving the Instrument depend on decisions you make in the Instrument tab.

Field	Decision	Detail Tabs
Instrument Part?	No Not Checked	The Instrument is not a Part of another Instrument. The Part tab is displayed, where you can associate Parts to the Instrument. Clicking the "Add" button opens the Select Instrument window where you can select the Instrument Part(s) you want to add. See Instrument Parts for more information.
	Yes Checked	The Instrument is a Part. The Part tab does not display.
Certification Required	Yes	The Certifications tab becomes available. Choose this option if you want to keep track of Instrument Certification without automatically generating Workorders. Define a manual Certification to be completed by a certain date, which can be extended by a grace period. You can add only one Certification. Field Description Type Type of Certification to be performed (defaults to Instrument). Status Status of the Certification. This can be Valid, Invalid, In Training or None. Use these values to manually define the Instrument's status. Expiration Date by which the Calibration or Maintenance must be completed. Grace Period Number of "days" (as determined by the Grace Period Units) past the Expiration date during which the Instrument can be used. Grace Period Units Defines the Grace Period in Years, Months, Weeks or Days.
	No Certification	No Certification is Required. The Certification tabs will not be displayed. The Instrument is Available.
	Scheduled	Allows you to Plan regular Certification and Maintenance as defined by a Certification Schedule. See Adding a Certification Schedule for more information.

Instrument Parts	Top

An Instrument Part is an Instrument that is "Part" of another Instrument. For example, some laboratory instruments record columns of data that are actually used to reference different instruments. Each column has its own Calibration and Maintenance history. These component parts can be defined as Instrument Parts. Once you have added an Instrument and its Parts, you can associate multiple Instrument Parts with one Instrument. You can define a Certification process for Instrument Parts.

Define Instrument Parts in the same way you define an Instrument at LIMS → Instrument Certification → Instruments. Check the Instrument Part box.

Once you save the Instrument Part, you can define a Certification process. See Options after Saving Instrument for more detailed information.

Track Usage and Instrument Parts

Instrument Parts with Track Usage "ON" can only be associated with an Instrument whose "Track Usage" is also "ON". For example a Part whose Track Usage is "ON" cannot be associated with an Instrument whose Track Usage is "OFF". Parts with Track Usage "OFF" can be associated with any instrument (with Track Usage "ON" or "OFF").

Unavailable Parts

If for any reason an Instrument Part becomes Unavailable, the associated Instrument will also become Unavailable. You must manually return the Instrument to "Available" when the Instrument Part becomes Available.

Adding a Certification Schedule	Top

Implementing a Certification Schedule allows you to schedule regular Instrument Calibration and Maintenance. Schedules can be defined by date/time or based on an Instrument's use. At the scheduled time, Workorders are generated. The Workorders require some action be taken to Calibrate or Maintain the Instrument. The Instrument can be Available or Unavailable depending on completion of these actions. You will also have the option to include Samples during Instrument testing.

Add a Certification Schedule in two ways:

Note that before adding a Certification Schedule, you must first add a Schedule Plan and related Tasks. These Tasks determine what needs to be done to the Instrument in order to complete the Workorder. The Tasks will be available in the Task field when adding a Certification Schedule using the Scheduler.

Location

LIMS → Instrument Certification → Instruments

To add a Certification Schedule, choose "Scheduled" in the Certification Required field. "Save" the Instrument. The Certification Schedule Tab becomes available.

In the Certification Schedule tab, define a schedule for Certifying Instruments (see Scheduled Tasks).

Enter Schedule Details

Define information about what to test and when.

See Managing a Schedule Plan for more information about managing the Schedule Plan.

The Icon indicates whether the Schedule is on or off .

Schedule Plan

Lookup and select a predefined Schedule Plan. See Managing a Schedule Plan for more information.

Time Zone

Select the Time Zone within which this Plan will be executed.

Description

Describe the Plan Item.

Recurrence

Clicking the Lookup Icon opens the Edit Schedule window. Following are the options depending on the frequency you choose:

Start Date

Specify the date to begin using the Certification Schedule. Click the calendar icon to choose the date from a calendar.

End Date

Specify the date the Certification Schedule expires. Click the calendar icon to choose the date from a calendar.

Recurring Task

Select the Task to perform when the Scheduled Plan Item executes. The list of Tasks is determined by the Tasks associated with the Instrument SDC. See Scheduled Tasks for more information about Tasks.

Clicking the Task Node icon opens the Choose A Task window.

In the dropdown, choose the Task to perform. In the example above, the Task is SDICertification.

Choose the Workorder Task to perform when Scheduled. In the example below, "pHMeterMaintenance" has been selected.

Clicking the "OK" button adds the Task to the Schedule. You can choose only one Task.

A default Task can be defined for the TaskNode.

Edit Task Properties - Adding Samples, Defining Workorders

Clicking the Edit Task icon opens the Edit Task Properties window. Here you can further define the Workorder and add Certification Samples.

See Certification Samples for detailed infomation about adding Certification Samples. See Workorders for detailed information about defining Workorders.

View Schedule Information

The Calendar icon at the far right of the Certification Schedule displays information about the Schedule.

The Certification Schedule tab is Configured by the planitemmanager Element.

Certification Samples	Top

When Certifying an Instrument, you can include Instrument Samples, Tests and Specifications. These Samples are considered during the Certification process to determine whether or not the Instrument is available for use. Certification Samples are added to a Workorder Task by Clicking the Edit Task iconin the Certification Schedule tab. Define the number of Samples to create, choose a Sample Template, and (if desired) include Tests and Specifications for each Sample. Use the "Add Item" button to add additional Tests and Specifications.

The Edit Task icon displays as "filled in" when changes have been made to the Task.

View and manage Certification Samples on the following Pages:

Manage Certification Samples

At the LIMS → Instrument Certification → Manage Certification Samples tramstop, you will see all Samples associated with an Instrument that have a Status of Initial or InProgress. After selecting the Sample, you can perform Data Entry, Reject, and Approve Samples, as well as View associated Data Sets.

From the Sample List you can select the Sample and do the following:

Review Certification Samples

Displays all Certification Samples that have been Reviewed and are Completed.

Column	Description
Sample	Unique identifier for the Sample. Clicking the Sample displays the View Samples window where you can view Sample details.
Description	Description of the Sample.
Status	Status of the Sample (Initial, Received, InProgress, Reviewed, Rejected, Cancelled).
Instrument Id	Instrument with which the sample is associated.
Icons	When Tests and Specs are associated with the Sample, the Tests Icon displays. Clicking the Icon opens the Grid with Params Samples and Specs window where you can view Data Entry for the sample.
WorkOrder	The Workorder with which the Sample is associated. Clicking the Workorder displays the Workorder List page, where you can view details about the Workorder.

From the Sample List you can select the Sample and do the following:

All Certification Samples

Here you will see a list of all Certification Samples associated with Workorders and Instruments.

Samples and Instrument Certification

When Samples are added to a Certification, they must be Reviewed and Completed before Workorders can be Accepted and the Instrument can be Certified.

Certification Workorders	Top

Certification Workorders are generated when all criteria defined in a Certification Schedule is met, or an Adhoc Certification is executed. LabVantage generates a Workorder Task for the desired Certification process. This "Task" or Workorder must be completed within the defined time period (including any defined Grace Period) in order for the Instrument to remain Available.

In the Certification Schedule tab, click the Edit Task Properties icon to define the Workorder that will be generated.

You can view Certification Workorders associated with a specific Instrument on the Edit Instrument page or on the following List pages:

Workorders are created by the SDICertification Schedule Task. This Task is configured by clicking the Edit Task Properties icon at the far right of the "Recurring Task Details" field on the "Certification Schedule" tab.

The "Create Workorder" property collection (example shown below) defines messages that describe the Workorder, Users and Departments to whom the Workorder is assigned, Grace Periods, and Incidents that can be recorded. Certification Types and and Certification Intervals further define calibration and maintenance events. See the SDICertification Schedule Task for the most recent details concerning these properties.

In the Certification Schedule tab on the Edit Instrument page, click the Edit Task Properties icon to define details about the Workorder.

The Workorder tab on the Edit Instrument page lists all Pending Workorders for the Instrument.

Once all Calibration or Maintenance has been completed for the Instrument and all associated Samples have been Reviewed and Completed, you can Accept the Workorder and Complete the Certification process.

From LIMS → Instruments → Pending Certifications, you can View, Edit, Accept, Reject or Cancel pending Workorders on the Workorder List page.

Select a Workorder and do any of the following:

From the Workorder List, you can View and Edit the Workorder by clicking the Workorder ID and View Pending Samples by clicking the icon.

Column	Description
Workorder	Automatically generated number identifying the Workorder. Clicking the Workorder opens the View Workorder window where you can view details.
Status	Status of the Workorder (Pending, Complete, Cancelled).
Assigned To	User to whom this Workorder is assigned.
Assigned Department	Department to which the Workorder is assigned
Due Date	Date by which the Workorder must be completed.
Certification Samples	Indicates there are pending Certification Samples that must be Completed. Clicking the icon opens the Sample List where you can perform Data Entry, Approve or Reject the Samples. Indicates that all Samples associated with the Instrument are Completed and Approved if Sample's REVIEWREQUIRED flag is ON. Indicates that not all Samples associated with the Instrument are Approved.
Past Grace Period?	Indicates whether or not the Workorder has passed the defined Grace Period. If so, the following icon appears . Clicking the icon opens the View Instrument window, where you can view information about Current and Past workorders.
Certification Type	Type of Certification being performed.
Instrument ID	Identifier of the Instrument for which the Workorder is pending.

Once all Certification Samples (if any) are complete and the Calibration or Maintenance has been performed, the Workorder can be Accepted (Approved). Select a Workorder from the list and click the "Accept" button. The Acceptance Note dialog opens. Enter a note regarding the Workorder Acceptance.

Cliking "OK" approves the Workorder and completes the Certification process.

Once the Workorder is complete, the Certification Schedule Current Count field returns to 0 if the Schedule Rule is "After Max Value + Grace Period" or subtracted by the Max Value if the Schedule Rule is "Every Max Value + Grace Period" if Instrument Usage is being Tracked.

Note that the Sample Status is independent of the Workorder Status. If Samples are Reviewed and Accepted, you may reject the Workorder. If a sample is Reviewed and Rejected, LabVantage issues a warning, but you can choose to continue and Accept the Workorder.

The Workorder List page shows all Certification Workorders.

LES Worksheet Generation can be generated on the Instrument Certification Workorders that are created by the SDICertification Schedule Task. In general:

For more information, see LES Worksheet Generation.

Instrument Use and Certification Schedule	Top

An Instrument is considered "used" when either Data Entry has been performed on a Data Set or a reading from the Instrument is taken (Simple Instrument Reading). Either of those actions equals one use. Instrument Use is considered by the Certification Schedule when generating Workorders for the Certification process. Each time the Instrument is used, Usage counters are updated. The Schedule Rule is then compared to the Usage Count to determine when the Instrument needs to be tested or maintained.

Workorders are initiated based on Instrument use either by Data Entry or Instrument Reading.

Instrument Reading

Dataset Data Entry

Samples are logged in and associated with a Data Set. You must assign the Instrument to the Data Set. Find and select the Samples you want to assign to the Instrument on the Dataset List page (LIMS → Tests → Manage Datasets).

Clicking the Assign Instrument button opens the Select Instrument window.

Click the Instrument you want to assign to the Samples. The selected Instrument is shown in the Assigned Instrument Column of the Data Set List.

The Instrument is now associated with the Dataset and Sample.

Count Fields

Once Data Entry is performed for the Sample, the Instrument's Total Use Count will increment by 1. The Current Count field in the Edit Instrument page Certification Schedule tab will increment by 1 times the Default Usage Time (the length of time the Instrument is typically used per use). For example, if Default Usage Time is 5 minutes, each time the Instrument is used the Current Count will increment by 5. This equals the total time the instrument has been used since the last Certification. Once the Workorder is complete the Count returns to 0 if the Schedule Rule is "After Max Value + Grace Period" or subtracted by the Max Value if the Schedule Rule is "Every Max Value + Grace Period".

Managing Instrument Certifications	Top

Once you have added Instruments and defined a Certification Process you can easily manage all Certification components from the Instrument List page at LIMS → Instrument Certification → Instruments.

Columns on the Instrument List page: 

Selecting an Instrument from the Instrument List and clicking "Edit" opens the Edit Instruments page, where you can make changes to the Instrument, its Usage, the Certification process, and associate Instrument Parts.

See Adding Instruments for a description of each field and tab.

Instrument Availability	Top

Instrument Availability depends on successful completion of a Certification process. It can also be controlled Manually. Following is a description of when the Status of an Instrument will change. 

Unavailable Status

Following are other instances in which an Instrument might become Unavailable.