### TJM ACTION TRACKER LOG

Committed
Agn CAR / SCAR CAPA Owner Action Responsible Area
date
218 CAR-00740 Roberto Ávalos Risk assessment justification Roberto Ávalos Quality Assurance 16-Apr-24

218 CAR-00740 Roberto Ávalos Quality Alert Luis López Quality Engineering 22-Jun-23

218 CAR-00740 Roberto Ávalos Root cause analysis Roberto Ávalos Quality Engineering 23-May-24

218 CAR-00740 Roberto Ávalos CAPA plan Roberto Ávalos Quality Engineering 23-May-24

218 CAR-00740 Roberto Ávalos Bin establishment for first artiche on M-68 Roberto Ávalos Quality Engineering 17-Jun-24
Implement new identification method for bins in all work stations for
218 CAR-00740 Roberto Ávalos Shoulder
MQP rope
update forfamily.
Acufex MQP-062 and Shoulder Rope MQP-096: Roberto Ávalos Quality Engineering 10-Dec-24
--Stainless steel tag
Add inspection with
point forSKU number
material for each
outside the bin
BOM of the FG
218 CAR-00740 Roberto Ávalos - Remove exceeding material outside the BOM of the FG Roberto Ávalos Quality Engineering 15-Jan-24
- Bin stablishment for First article location / Identification Label
Update PFMEA-000087:
- Clarifications for First article
218 CAR-00740 Roberto Ávalos Roberto Ávalos Quality Engineering 15-Jan-24
- Include or reevaluate tue risk of include non-BOM material in the FG

Committed
CAR / SCAR CAPA Owner Action Responsible Area
date
Process requalification for Acufex products
296 CAR-00604 Baltazar González Baltazar González Quality Assurance 20-Nov-23

296 CAR-00604 Baltazar González Internal validation protocol opening Baltazar González Quality Assurance 2-Nov-23

296 CAR-00604 Baltazar González Internal validation protocol closure Baltazar González Quality Assurance 23-Nov-23

296 CAR-00604 Baltazar González Send samples for half cycle to Sterigenics Baltazar González Quality Assurance 17-Oct-23

296 CAR-00604 Baltazar González Resistency Test Baltazar González Quality Assurance 22-Sep-23
Perform annual review for Acufex family (2023)
296 CAR-00604 Baltazar González -Revisar norma para ver posibilidad de argumentar con racional la falta de Baltazar González Quality Assurance 15-Aug-23
recalificación de la cámara de esterilización
296 CAR-00604 Baltazar González Perform annual review for Shoulder family Baltazar González Quality Assurance 18-Aug-23

296 CAR-00604 Baltazar González Provide evidence of Bis for Acufex and Shoulder product lines, for 2020-2023 Unice Ortíz Quality Assurance 31-May-23

296 CAR-00604 Baltazar González Document risk assessment in CAPA Baltazar González Quality Assurance 2-Jun-23
Create procedure for validation, requalification and annual review of EO
296 CAR-00604 Baltazar González Baltazar González Quality Assurance 30-Aug-23
Sterilization process (All product families). 3000.098
296 CAR-00604 Baltazar González Train affected personnel Baltazar González Quality Assurance 30-Sep-23

296 CAR-00604 Baltazar González Effectiveness Verification Juan Hernández Quality Assurance 5-Mar-24

289 CAR-00595 Juan Hernández Justificación del riesgo Juan Hernández Quality Assurance 23-May-23

289 CAR-00595 Juan Hernández Análisis de causa raíz Juan Hernández Quality Assurance 23-May-23

289 CAR-00595 Juan Hernández Realizar notificaciones y pedir aprobaciones mediante correo electrónico Juan Hernández Quality Assurance 30-Aug-23

289 CAR-00595 Juan Hernández Curricula confirmation for Originator PQM on Agile Christian Noris Quality Assurance 5-May-23

289 CAR-00595 Juan Hernández Crear una lista de Gerentes sin privilegios en Agile Christian Noris Quality Assurance 1-Jun-23

289 CAR-00595 Juan Hernández Crear una lista de Backups sin privilegios en Agile Christian Noris Quality Assurance 1-Jun-23

289 CAR-00595 Juan Hernández Assing Training for PQM profiles on Agile Christian Noris Quality Assurance 16-Jun-23

289 CAR-00595 Juan Hernández IT Tickets submission for PQM profiles on Agile Christian Noris Quality Assurance 30-Aug-23
Actualizar 3000.133 para incluir a gerentes al momento de la asignación de
privilegios para que puedan modificar documentación y aprobar flujos de
289 CAR-00595 Juan Hernández Christian Noris Quality Assurance 3-Oct-23
aprobaciones en Agile.
7.3.1.4
Asignar entrenamientos de Originador y Aprobador a gerentes en matriz de
289 CAR-00595 Juan Hernández Christian Noris Quality Assurance 12-Sep-23
entrenamientos de ComplianceWire
289 CAR-00595 Juan Hernández Effectiveness Verification Juan Hernández Quality Assurance 20-Jan-24
Revise
Providethe housingawareness
complaint insertion process at thetoworkstation.
and training Instead
on-site operators of one the
regarding
212 SCAR-00366 Maximiliano Suarez person Hank Ho Production 25-Aug-23
issue ofinserting
incorrectboth endsinsertion
housing of the connector
to preventin recurrence.
two steps, change it to one
person inserting the P1 end and placing it in the next workstation's
212 SCAR-00366 Maximiliano Suarez acceptable product box. Another person can then insert the P2 end. This Hank Ho Production 25-Aug-23
approach
Instruct prevents
shift fatigue-related
leaders errors
to perform daily when
visual a single person
inspections is responsible
of workstation
212 SCAR-00366 Maximiliano Suarez for both ends
conditions, and allows
ensuring multiple individuals
no individual products areto left
review theupper
on the housing insertion
surface of Hank Ho Production 25-Aug-23
process
the sequentially.
workstation.
Simulate the use of mis-wiring products, verify that testing personnel identify
212 SCAR-00366 Maximiliano Suarez them, and notify PQC to label and place them in the defective product box Hank Ho Production 25-Aug-23
for further treatment.
Conduct review meetings to communicate this customer complaint incident
212 SCAR-00366 Maximiliano Suarez Hank Ho Production 25-Aug-23
internally.
Introduce a color sequence inspection station to prevent mismatched wire
212 SCAR-00366 Maximiliano Suarez Hank Ho Production 25-Aug-23
colors and incorrect insertion, enhancing prevention measures.
Update PN 14-1058 Inspection Plan to include the verification of the cables
212 SCAR-00366 Maximiliano Suarez Pablo Hernández Quality Assurance 10-Nov-23
as part of the routine incoming inspection.
212 SCAR-00366 Maximiliano Suarez Effectiveness Verification Maximiliano Suarez Quality Assurance 31-Mar-24

377 CAR-00581 Beatriz Angulo Get list of all active PFMEAS Víctor Suárez Engineering 26-Apr-23 CA-01450

377 CAR-00581 Beatriz Angulo Get a list of all PFMEAS that are out of date Víctor Suárez Engineering 26-Apr-23

377 CAR-00581 Beatriz Angulo Root cause analysis 5 whys / Ishikawa Maria de la Luz Engineering 26-Apr-23
Review the current process:
377 CAR-00581 Beatriz Angulo Maria de la Luz Engineering 3-Apr-23
Procedure 7000.037 (Risk Management)
Remediation project for outdated PFMEAs and Appoint responsible to monitor
377 CAR-00581 Beatriz Angulo Víctor Suárez Engineering 19-Apr-23
PFMEA periodic review process and add to notifications Sharepoint
377 CAR-00581 Beatriz Angulo Calendar for PFMEA updating through QMS Sandra Pérez Engineering 20-Jun-23
Schedule monthly reviews on outlook for the next 12 months. (Tracking for
377 CAR-00581 Beatriz Angulo Sandra Pérez Engineering 20-Jun-23
PFMEAs remediation program update)
377 CAR-00581 Beatriz Angulo Establish periodic review request timeframe Maria de la Luz Engineering 26-Apr-23

377 CAR-00581 Beatriz Angulo PFMEAs template update Beatriz Angulo Engineering 12-Jul-23

377 CAR-00581 Beatriz Angulo Development a PFMEA calendar for periodic reviews Beatriz Angulo Engineering 14-Jul-23

377 CAR-00581 Beatriz Angulo Schedule reviews for the fisrt amount of PFMAs to be updated Beatriz Angulo Engineering 1-Aug-23
Create a recurring meeting each 1 month to review the progress of the
377 CAR-00581 Beatriz Angulo Sandra Pérez Engineering 25-Jun-23
PFMEAS
Redefineupdate
triggersastoa update
group PFMEAs (other than periodic review) and
document
First accordingly
bi-monthly PFMEAs thru new local risk management procedure and any
update
377 CAR-00581 Beatriz Angulo Beatriz Angulo Engineering 15-Sep-23
other procedure affected (e.g. CAPAs, NCMRs, Complaints, Fixtures
PFMEA-000087
integration,
Creating etc.)PFMEAS procedure to establish new requirements based on
a local
PFMEA-000083
377 CAR-00581 Beatriz Angulo Secound Beatriz Angulo Engineering 20-Sep-23
3000.262bi-monthly
PFMEA-000038 PFMEAs update
previews review
PFMEA-000077
PFMEA-000033
377 CAR-00581 Beatriz Angulo PFMEA-000082 Sandra Pérez Engineering 30-Aug-23
PFMEA-000067
PFMEA-000025
PFMEA-000115
377 CAR-00581 Beatriz Angulo Third bi-monthly PFMEAs update
PFMEA-000022 Sandra Pérez Engineering 30-Nov-23
PFMEA-PRO-236-10
PFMEA-000084
PFMEA-000102
PFMEA-000116
PFMEA-000106
PFMEA-000046
377 CAR-00581 Beatriz Angulo PFMEA-000080 Beatriz Angulo Engineering 31-Jan-24
PFMEA-000088
PFMEA-PRO-091
Complete
PFMEA-000053the PFMEAs update according 1st CAR Plan
377 CAR-00581 Beatriz Angulo PFMEA-000073
-New format adption 1000.551 Sandra Pérez Engineering 30-Jul-24
PFMEA-000063
-Full process review
377 CAR-00581 Beatriz Angulo Effectiveness Verification Juan Hernández Quality Assurance 28-Mar-24

235 SCAR-00369 Maximiliano Suárez Sent samples of PMS-187 to Enovis for further testing Steve Smicroulis Supplier 23-Aug-23
Dulce Meza / Nestor
235 SCAR-00369 Maximiliano Suárez Run test to confirm if the samples sent by Key tech are functional. Manufacturing 31-Aug-23
Medina
Send samples to Enovis team of PMS-187 corresponding to Enovis graphic for
235 SCAR-00369 Maximiliano Suárez Steve Smicroulis Supplier 18-Sep-23
confirmation
Perform a confirmation run to confirm that the new graphic will comply Dulce Meza / Nestor
235 SCAR-00369 Maximiliano Suárez Manufacturing 31-Oct-23
Enovis requirements. Medina
235 SCAR-00369 Maximiliano Suárez Change from using 4/C process to achieve PMS-187 to a Sport Color process. Steve Smicroulis Supplier 31-Oct-23
Create a work instruction for the DonJoy graphic printing process to ensure
235 SCAR-00369 Maximiliano Suárez Steve Smicroulis Supplier 31-Oct-23
that the new printing method for PMS-187 is followed consistently.
235 SCAR-00369 Maximiliano Suárez Train the operators on the document to be created. Steve Smicroulis Supplier 31-Oct-23

235 SCAR-00369 Maximiliano Suárez Effectiveness Verification Maximiliano Suarez Quality Assurance 30-Apr-24

SCAR-00389 Maximiliano Suárez Pull current inventory for inspection Ben Keller Manufacturing 7-Dec-23
Pull current work orders off the production floor until the issue is resolved
SCAR-00389 Maximiliano Suárez Ben Keller Manufacturing 7-Dec-23
and inspecting tooling/process where necessary and applicable.
Review corrective action plan with the relevant personnel who may be
SCAR-00389 Maximiliano Suárez Ben Keller Manufacturing 8-Jan-24
assigned to check conformity on part 79-65015.
Implement thickness double check will be completed until transition to new
SCAR-00389 Maximiliano Suárez Ben Keller Manufacturing 8-Jan-24
ERP system.
Implement new ERP system which forces operators to perform proper checks
SCAR-00389 Maximiliano Suárez against first articles before the computerized process allows them to Ben Keller Manufacturing 1-Apr-24
continue with the next step of the process.
SCAR-00389 Maximiliano Suárez Effectiveness Verification Maximiliano Suarez Quality Assurance 14-Aug-24

SCAR-00392 Maximiliano Suárez Follow AQL 0.40 instead of 1.0 during final inspection process. Alejandro Jimenez Quality Assurance 12-Dec-23

SCAR-00392 Maximiliano Suárez Generate quality alert to aware all the involved personnel about the issue Alejandro Jimenez Quality Assurance 30-Nov-23

SCAR-00392 Maximiliano Suárez Notify administrative personnel about the issue by email. Alejandro Jimenez Quality Assurance 12-Dec-23

SCAR-00392 Maximiliano Suárez Create a visual aid regarding the rack to be used to avoid having this issue Alejandro Jimenez Quality Assurance 12-Dec-23

SCAR-00392 Maximiliano Suárez Create a work instruction for the hanging process Alejandro Jimenez Quality Assurance 12-Dec-23

SCAR-00392 Maximiliano Suárez Update Platinadora’ s acceptance criteria considering this defect. Alejandro Jimenez Quality Assurance 12-Dec-23

SCAR-00392 Maximiliano Suárez Train all the affected staff about the changes implemented Alejandro Jimenez Quality Assurance 12-Dec-23

SCAR-00392 Maximiliano Suárez Return to previous hanging method. Alejandro Jimenez Quality Assurance 14-Dec-23

SCAR-00392 Maximiliano Suárez Effectiveness Verification Maximiliano Suarez Quality Assurance 31-May-24

244 CAR-00665 Mayra Montoya Risk Assessment Justification Juan Hernández Quality Assurance 19-Oct-23

244 CAR-00665 Mayra Montoya Containment actions Mayra Montoya Manufacturing 19-Oct-23

244 CAR-00665 Mayra Montoya Root cause analysis Mayra Montoya Manufacturing 3-Nov-23

244 CAR-00665 Mayra Montoya CAPA plan Mayra Montoya Manufacturing 10-Nov-23

244 CAR-00665 Mayra Montoya Confirm all personnel is trained on Visual Aid (all shifts) Daniel Vazquez Manufacturing 14-Sep-23
Temporarily 100% Visual inspection on Length for Straps and Hook for the
244 CAR-00665 Mayra Montoya Defiance Pro Critical P/N Daniel Vazquez Manufacturing 9-Feb-24
-On BKPREPAR
244 CAR-00665 Mayra Montoya Feedback inputs on 3000.133 from Engineering Jesus Carrillo Engineering 19-Jan-24

244 CAR-00665 Mayra Montoya Validate Defiance pro part numbers in BKPREPAR Area Jesus Carrillo Engineering 15-Dec-23
Update visual Aid 2000.796-4 clarifying the information for production
244 CAR-00665 Mayra Montoya Jesus Carrillo Engineering 31-Jan-24
operation
Request DWG update with the critical C dimension (Hook Length)
244 CAR-00665 Mayra Montoya Jesus Carrillo Engineering 31-Jan-24
- 12-2891-X Dwg Rev. C to Rev. D (12-2891_2892-X_C)
244 CAR-00665 Mayra Montoya Training to Line lead and Inspectors on DWG Interpretation Jesus Carrillo Manufacturing 19-Jan-24

244 CAR-00665 Mayra Montoya Update PFMEA-000040 to evaluate stich dimentional risk Jesus Carrillo Engineering 17-Feb-24

244 CAR-00665 Mayra Montoya Update 3000.133 procedure Jesus Carrillo Engineering 29-Feb-24
TJM NCMRs generated due to wrong dimension and strap tab sown out of
213 CAR-00665 Mayra Montoya Juan Hernández Quality Assurance 3-Jun-24
strap on WIP (start date 3/19/2024)
VMC NCMRs generated due to wrong dimension and strap tab sown out of
213 CAR-00665 Mayra Montoya Marisela Garay Quality Assurance 3-Jun-24
strap on WIP (start date 3/19/2024)
Process deviations generated by wrong dimension and strap tab sown for M-
213 CAR-00665 Mayra Montoya Juan Hernández Quality Assurance 3-Jun-24
10 (start date 3/19/2024)
244 CAR-00665 Mayra Montoya Verification of effectiveness deck Juan Hernández Quality Assurance 3-Jun-24

356 CAR-00637 Giovanni Hernández Risk assessment justification Edgar Jalil Quality Assurance 25-Jul-23

356 CAR-00637 Giovanni Hernández Deviation submission for OA Adjuster family DEV-002385 Giovanni Hernández Manufacturing 25-Jul-23

356 CAR-00637 Giovanni Hernández Root cause analysis Giovanni Hernández Manufacturing 25-Jul-23

356 CAR-00637 Giovanni Hernández CAPA plan Giovanni Hernández Manufacturing 2-Aug-23
Crear una desviación para correr con dado corregido.
356 CAR-00637 Giovanni Hernández Giovanni Hernández Manufacturing 2-Aug-23
DEV-002385 - OA Adjuster
356 CAR-00637 Giovanni Hernández Update MQP-026 to consider bar bending process with "Buck" dies Edgar Jalil Quality Assurance 11-Aug-23
Update PFMEA-000115 to consider the risk of:
356 CAR-00637 Giovanni Hernández Giovanni Hernández Manufacturing 25-Jul-23
-Buck dies
356 CAR-00637 Giovanni Hernández Develop 2D Buck die drawings Félix Baldomero R&D 24-Jul-23

356 CAR-00637 Giovanni Hernández Develop 3D Buck die drawings Jonathan Matías Tool Room 25-Jul-23

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size XS Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size S Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size M Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size L Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size XL Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size 2XL Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Validation for OA Adjuster Size 3XL Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández New visual aid for Buck dies 2000.977-34 Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández Develop 2D Tigh drawings Félix Baldomero R&D 23-Jan-24

356 CAR-00637 Giovanni Hernández Include the Manometer located in rolling process in to eMaint system Giovanni Hernández Manufacturing 23-Jan-24

356 CAR-00637 Giovanni Hernández NCMRs generated due to wrong bending on WIP Juan Hernández Quality Assurance 7-Jul-24

356 CAR-00637 Giovanni Hernández Customer complaints generated due to wrong bending Juan Hernández Quality Assurance 7-Jul-24

356 CAR-00637 Giovanni Hernández Deviations generated after actual process validation Juan Hernández Quality Assurance 7-Jul-24

356 CAR-00637 Giovanni Hernández Verification of effectiveness Juan Hernández Quality Assurance 7-Jul-24

301 CAR-00658 Joaquín Álvarez Risk Assessment Justification Juan Hernández Quality Assurance 20-Oct-23

301 CAR-00658 Joaquín Álvarez Root cause analysis Joaquín Álvarez Customer Service 13-Oct-23

301 CAR-00658 Joaquín Álvarez CAPA plan Joaquín Álvarez Customer Service 13-Oct-23
Notification and group meeting regarding Customer Complaint Handling and
301 CAR-00658 Joaquín Álvarez Joaquín Álvarez Customer Service 19-Oct-23
Sent an Email recap
301 CAR-00658 Joaquín Álvarez Started to Track an accuracy KPI with reported documentation errors Joaquín Álvarez Customer Service 6-Oct-23
Restrain the entire group with Compliance Wire based on 7000.010 Global
301 CAR-00658 Joaquín Álvarez Joaquín Álvarez Customer Service 19-Oct-23
complaint handling
Develop an internal procedure to establish: 3000.264
301 CAR-00658 Joaquín Álvarez Joaquín Álvarez Customer Service 17-Jan-24
-Monitoring of data accuracy on customer complaints
301 CAR-00658 Joaquín Álvarez Train all involved personel Joaquín Álvarez Customer Service 17-Jan-24

301 CAR-00658 Joaquín Álvarez Verification of effectiveness Juan Hernández Quality Assurance 21-Jun-24