PART 11: NON CONFORMING EVENTS
- Taib
A non-conforming event (NCE) or non-conformity is defined as a non-fulfillment of a requirement. An NCE occurs when there is a deviation from established policies and procedures. In the laboratory, examples of NCEs may include:
Unlabeled/mislabeled specimens
Missing specimens
Specimen preparation errors
Delay in turnaround times
Incorrect delivery of reports
Corrected reports
It is essential for quality assurance in the lab that staff and managers log all NCEs and their follow-up.
Non-Conforming Event management consists of four steps with the following guides:
Reporting a NCE
Creating a Corrective Action Plan
Monitoring the Corrective Action Plan
Closing an NCE Report
How to report a non-conforming event (NCE)
Hover the mouse over the hamburger icon and click to open the menu.
Hover the mouse and click on the drop-down menu under the Non Conform module.
Click on Report Non-Conforming Event sub-menu item.
Hover the mouse over the Non-Conforming Events tab and select Report Non-Conforming Event.
Search for the lab number associated with the non-conforming event by selecting your search term from the drop-down menu and entering the number or name in the search field. Then click Search.
The order and its samples will display. Check the box next to the sample implicated in the NCE. If the NCE is not associated with a specific sample, check all the samples. Click the Go to NCE Reporting Form button.
Verify the details that are automatically displayed: NCE report date (should be the current date), Name, and the lab order number, and specimen number.
Fill in the Name of person reporting if different, if needed.
Note: Name refers to the person filling this form. The staff member filling out the NCE reporting form may not be the same person who noticed or observed the NCE and reported it. Use the Name of person reporting (if different) for the person who first observed the NCE. OpenELIS will automatically assign an NCE Number to the report.
Fill in the date of the NCE (this may be different from the report date).
Select the Reporting Unit.
Enter a Description of the NCE.
Enter the Suspected Cause of the NCE.
Enter the Proposed Action.
Click the Submit button.
A message will show that the form has been saved.
How to create a NCE Corrective Action Plan
After the NCE reporting form has been filled, the next step is to fill the NCE Follow-Up Form. This may be done at a later date, per laboratory procedures.
Select View New Non-Conforming Event from the menu under the Non-Conforming module
Hover the mouse over the Non-Conforming Events tab and select View New Non-Conforming Event.
Select Lab Number or NCE Number as your search term and enter the number in the search field. Click the Search button. In this illustration the lab number DEV12300000000000126 is typed.
Note: The NCE Follow-up Form has two parts: The NCE description section and the Corrective Action Plan.
NCE Follow-up Form: Part 1- NCE Description
Verify the details of the NCE in the form. Fill in the remaining elements of the form using the dropdown lists.
Select the Laboratory Component (the NCE concerns which component of the lab).
Select the NCE Category.
Select the CE Type
Select the Severity
Select the Likely recurrence
The Severity Score is automatically calculated.
NCE Follow-up Form: Part 2- Corrective Action Plan
Enter the Description of the Corrective Action, the Preventive Action or Concurrent Control Action, and any Comments in the designated text boxes of the form.
Click on the Submit button.
Upon clicking on the Submit button, a success message will be displayed at the top of the page.
How to monitor an NCE Corrective Action Plan
After the NCE follow-up form has been filled, activities related to corrective action or closing the NCE report should be logged in the Corrective Actions form, per laboratory procedures.
Select Corrective Actions from the menu under the Non-Conforming module
Hover the mouse over the Non-Conforming Events tab and select Corrective Actions .
Select Lab Number or NCE Number as your search term and enter the number in the search field. Click the Search button.
Note: The NCE Corrective Action form has three parts: the NCE description; the corrective action log section; and the NCE Resolution section.
NCE Corrective Action form: Part 1- NCE Description
This section is view only. Verify that the information is correct.
NCE Corrective Action Form: Part 2- Corrective Action Log
For each discussion with staff regarding the NCE, enter the Date of Discussion and click Add New Date button. The date will appear above the entry field. You may enter more than one date of discussion.
Enter text describing any Corrective Action taken and check the box next to the Action Type.
Check the respective checkbox for Action Type.
Enter the name of the Person Responsible for the corrective action and the Date Completed (the date the corrective action took place).
Note: Turnaround Time is automatically calculated.
Click the Save button to record the corrective action in the log.
You may now navigate to a new page. When you need to add additional corrective actions to the log, repeat steps 1-5.
How to close a resolved NCE
When all corrective action has been completed and the lab manager considers the NCE to be resolved, the NCE report should be closed, per laboratory procedures.
Select Corrective Actions from the menu under the Non-Conforming module
Hover the mouse over the Non-Conforming Events tab and select Corrective Actions .
Select Lab Number or NCE Number as your search term and enter the number in the search field. Click the Search button.
Scroll down to the NCE Resolution section.
If the corrective actions were sufficient to resolve the NCE, click the Yes radio-button and enter the Date Completed (the date the NCE was considered resolved).
Click the Submit Resolved NCE button to close the NCE report. The report will be closed successfully.