Learn how to:
- Create new equipment
- Create qualification documentation for equipment
Outcomes and Prerequisites
Section 1: Creating Equipment Record – Initiator
To create Equipment Records, the initiator needs to be part of the Manufacturing User Group.
Step 1.1 – Create new equipment
There are multiple ways to create equipment in SimplerQMS:
- In the Create New section, on your Home page, click on Equipment.
2. Click on the Create (+) next to the Home tab and choose Equipment from the dropdown list
3. On the left side of the screen, expand Create and click on Equipment
A Metadata Card will pop up.
Step 1.2 – Fill out the metadata card
Part 1: Equipment Information
If you need to create a periodic calibration schedule for this equipment, then fill in these fields:
Part 2: Periodic Calibration Scheduling Values
Part 3: Intervals
When you are done filling in the relevant fields, then click Create.
Section 2: Classifying the new equipment – Responsible Person
Select the new equipment you just created.
Under “State Transition” on the left side, you can pick
- “Quality-Critical” Equipment or
- “Standard” Equipment
- If this is a calibrated equipment, then click Quality-Critical in the Task Area under State Transition:
- The state should be “Pending Calibration”
- Calibration Status should be “Not Calibrated”
- Quality Category should be “Quality Critical”
- Refer to Section 3.
3. If this is Standard equipment, click Standard in the Task Area under State Transition.
a. Calibration Status should be “Not needed for standard equipment”
b. Quality Category should be “Standard”
4. Proceed to Section 4.
Section 3: Calibrating an Equipment – Responsible Person
Step 3.1 – Equipment Calibration
Complete this step to finish the equipment calibration.
Select the relevant equipment and click “Create Quality Document” under “Actions “on the left side of the screen
Search for the Equipment Calibration Template in the overview, which then pops up and select the template.
Step 3.2 – Completing Equipment Calibration
To complete the Equipment Calibration, refer to the instructions from “Work Instruction: Managing Quality Documents” on how to work with Quality Documents.
After completing the Equipment Calibration, click “Calibration Task Completed” in the Task Menu under the “State Transition” in the top left corner.
Enter your electronic signature and click Sign to complete Calibration Task.
After completing this step, the equipment is now classified as a qualified equipment.
In the metadata card, a Periodic schedule for re-calibration is automatically populated. This means that the responsible person will be notified on the activation date for re-qualification.
The “Upcoming Dates” are based on the scheduling values as below:
Section 4: Reviewing a Standard Equipment – Responsible Person
When a standard equipment needs to be reviewed regularly, scheduling values can be set.
Find the equipment that needs to be reviewed and click on “Send for Review”.
State should be “Pending Review” and the scheduling values can now be edited and set.
When the scheduling values are set, click on “Review Task Completed”
Enter your electronic signature and then click OK.
The state should now be “Review Task Completed”, and the next qualification dates have been set.
Note: The equipment review can be on the state of “Review Overdue!” when it is past the Period End Date. The responsible person will receive a notification 3 days before it goes on overdue. In this case, the review must be completed immediately by clicking on “Review Task Completed” and then enter the electronic signature.
Section 5: Recalibrating an Equipment – Responsible Person
In case the equipment changes status from being Calibrated Equipment, you can reclassify the equipment by following these steps:
- Search for the equipment and select the equipment
- In the Task Area click Reclassify Equipment.
3. In the Task Area choose Standard or Quality-Critical and go to Section 3.
Section 6: Making the equipment Not Current – Archived – Responsible Person
If the equipment is no longer used, it needs to be marked as Not Current – Archived.
Search for the equipment and select it.
In the Task Area under the “State Transition” on the left side of the screen click “Not Current – Archive”.
The equipment is now marked as Not Current – Archived and can no longer be related to documents, products etc.
If the equipment is to be used again, after it was marked obsolete, then:
Search for and select the equipment.
In the Task Area click Reactivate Equipment.
Section 7: Adding assignments to an Equipment – Responsible Person
When an assignment is created to an equipment, the person assigned to it will be notified to make updates or changes. The task to carry out is defined by the initiator of the assignment in the Assignment Description of the metadata card.
Search for the equipment and under Document Actions, click on “Create Equipment Assignment”.
For further instructions, refer to Work Instruction: Working with Assignments, Periodic Tasks and Reminder Rule.