September 3rd, 2024
This leƩer is to request an extension on the implementaƟon phase of CAR-00740 for three (3) months,
changing due date from October 2024 to January 2025. This will allow to ensure every finding is addressed
to deliver a high-quality outcome that meets all expectaƟons.
Due to the root cause analysis will have to be re-evaluated and new acƟons will have to be addressed
during this process for this CAR.
In addiƟon, There has been new acƟons idenƟfied during the implementaƟon process on a two addiƟonal
CAR’s; CAR-00730 & CAR-00731 has due dates more closed. Here is the main reason why I am requesƟng
the extension and thus focusing on the aƩenƟon of the two cars menƟoned.
Based on this request, the new acƟon plan will be completed as follows:
From:
MQP update for Acufex MQP-062 and Shoulder Rope MQP-096:
Roberto Ávalos Quality Engineering 5-Dec-24
- Add inspection point for material outside the BOM of the FG
Update PFMEA-000087:
Roberto Ávalos Quality Engineering 5-Dec-24
- Include or reevaluate the risk of include non-BOM material in the FG
Extension request submission Juan Hernández Quality Assurance 4-Oct-24
Table 1 - Current AcƟon Plan
To:
Extension request submission Juan Hernández Quality Assurance 4-Oct-24
Reevaluation of RCA and CAPA Plan Roberto Ávalos Quality Engineering 15-Oct-24
MQP update for Acufex MQP-062 and Shoulder Rope MQP-096:
Roberto Ávalos Quality Engineering 20-Jan-25
- Add inspection point for material outside the BOM of the FG
Update PFMEA-000087:
Roberto Ávalos Quality Engineering 20-Jan-25
- Include or reevaluate the risk of include non-BOM material in the FG
Table 2 - Proposed AcƟon Plan
Roberto Avalos
Sr. Quality Engineer
