NON CONFORMING EVENTS

A Non-Conforming Event (NCE) is a deviation from established policies and procedures. Examples in the laboratory include:

• Unlabeled/mislabeled specimens

• Missing specimens

• Specimen preparation errors

• Delay in turnaround times

• Incorrect delivery of reports

• Corrected reports

It is crucial for quality assurance that staff and managers log all NCEs and their follow-ups.

NCE Management Steps

1. Reporting an NCE

2. Creating a Corrective Action Plan

3. Monitoring the Corrective Action Plan

4. Closing an NCE Report

1. Reporting a Non-Conforming Event (NCE)

1. Open the menu by clicking the hamburger icon.

2. Navigate to the Non-Conform module in the OpenELIS menu.

3. Click Report Non-Conforming Event.

4. Search for the lab number associated with the NCE and click Search.

5. Select the implicated sample and click Go to NCE Reporting Form.

6. Verify pre-filled details and fill in:

   • Name of the person reporting (if different)

   • Date of the NCE

   • Reporting Unit

   • Description of the NCE

   • Suspected Cause

   • Proposed Action

7. Click Submit. A confirmation message will appear.

2. Creating a Corrective Action Plan

1. Select View New Non-Conforming Event from the menu.

2. Search using Lab Number or NCE Number and click Search.

3. Verify the NCE details.

4. Fill in:

   • Laboratory Component

   • NCE Category

   • CE Type

   • Severity

   • Likely Recurrence

   • Corrective & Preventive Actions

5. Click Submit. A success message will be displayed.

3. Monitoring an NCE Corrective Action Plan

1. Select Corrective Actions from the menu.

2. Search using Lab Number or NCE Number and click Search.

3. In the Corrective Action Log section:

   • Enter Date of Discussion and click Add New Date.

   • Describe the Corrective Action Taken and select Action Type.

   • Enter the Responsible Person’s Name and Date Completed.

4. Click Save to log the corrective action.

5. Repeat for additional corrective actions if necessary.

4. Closing a Resolved NCE

1. Select Corrective Actions from the menu.

2. Search using Lab Number or NCE Number and click Search.

3. Scroll to the NCE Resolution section.

4. Click Yes if corrective actions resolved the NCE.

5. Enter the Date Completed.

6. Click Submit Resolved NCE to close the report.

7. A confirmation message will indicate successful closure.

By following these steps, laboratory staff can ensure accurate tracking, resolution, and documentation of all NCEs, supporting overall quality assurance.