Exploring the FreeQMS Complaints Module: A Comprehensive Guide - Part 4.

Part 4 - Verification of Effectiveness and Closure

Hello and welcome back,
In this fourth and final part of our series, we're reaching the culmination of our FreeQMS Complaints module journey. We've been navigating the complexities of managing an electronic complaint, focusing on a fictional medical device product.

Verification of Effectiveness:
In this installment, we'll complete the Verification of Effectiveness (VOE) activity for our complaint, titled "LifeGuard 600 PCA Pump Over Infusion to Hospitalized Patient." This crucial step aims to ensure the corrective actions taken, particularly the new firmware rollout, are effective.

Quick Recap:
In Part 1, we initiated the complaint, detailing an infusion pump over-infusing a patient. In Part 2, we investigated the root cause, and in Part 3, we implemented corrections and corrective actions, including a field notice to notify customers.

Verification of Effectiveness Process:
We start by clicking on "Create Complaint Activity" and selecting "Verification of Effectiveness." This step involves assessing the effectiveness of our corrective actions by analyzing trends related to the firmware update process.

Example Input:
For instance, we'll track the total number of pumps in the field with affected firmware, pumps returned to headquarters, and those serviced in the field. This data will be presented during management review.

Why Management Review?:
Management review is crucial for several reasons:
Awareness of the issue and affected individuals.
Understanding the steps taken for remediation.
Evaluating the effectiveness of the corrective actions.
Deciding the extent of firmware updates and associated risk.

Closing the Complaint:
Once the VOE is complete, we move to the final step - closing the complaint. We engage FreeQMS's electronic approval process, complying with 21 CFR Part 11.

Electronic Signature Process:
By adding an approval cycle and selecting appropriate approvers, we validate the complaint's closure. This electronic approval mirrors the physical signature space on a paper complaint form.

Conclusion:
We've taken you through every step, from initiation to closure, tracking each activity in FreeQMS. Our fictional example illustrates the importance of effectively implementing corrective actions and ensuring they reach the field.

What's Next:
We appreciate your journey with us through this video series. Stay tuned for more insightful videos on quality processes from the FreeQMS channel.
If you have any questions or feedback, feel free to share them with us.