Document DOC-TP-RBP-001 Rev A Page 1 of 11

Title Transfer Plan for Ring Bending Process

Purpose

This form defines the requirements and approvals for transferring a production process (finished device and/or
subassembly) from any site to a Another facility or Contract Manufacturing Organization (CMO) and from a
CMO to Another.

Section 1: Transfer Planning and Approval

Transfer Details
Project Description: Transfer of the ring bending process, including tools,
equipment, and calibration samples, between
facilities.
Originating Facility: Facility A – Manufacturing Site
Receiving Facility or CMO: Facility B – Manufacturing Site
Transfer Team Leader: Luis Manuel Zapata Gonzalez
Model Numbers to be Transferred: 193212026, 193212036, 193212326, 193212336
Assembly Part Numbers to be Transferred: 193211026, 193211028, 193211030, 193211032,
193211034, 193211036
Scope
Procurement
Receiving inspection
Assembly
Packaging
IFU & Labelling
Sterilization
Distribution
Service
End Of Life Management
Transfer Team
Required? Transfer Team Member
Role (Select if Applicable) (If NO, provide justification)
Receiving Facility Manufacturing Representative Yes No
Receiving Facility Quality Representative Yes No
Originating Facility Manufacturing Representative Yes No
Originating Facility Quality Representative Yes No
Not applicable for test sample
Manufacturing Engineering Yes No
transfers.
Quality Engineering Yes No
Not applicable to internal sample
Supplier Quality Engineering Yes No
transfer.
Responsibility covered by internal
External manufacturing Quality Engineering Yes No
QE.
No R&D involvement needed for
Research and Development Yes No
process.
Not required for bending test
Regulatory Affairs Yes No
process.
Planning/Logistics Yes No
Finance Yes No Costs within existing budgets.
No IT components involved in
Information Technology – cybersecurity Yes No
transfer.
 Document DOC-TP-RBP-001 Rev A Page 2 of 11

Title Transfer Plan for Ring Bending Process

Existing facilities are adequate for

Facilities Yes No
process.
Human Resources Yes No No additional workforce required.
Other Transfer Support (Validation Specialist) Yes No

Output CMO selection

Completed before
project kick off
Activity (Select if Applicable) If NO, provide remediation)
Quality Management system assessment Yes No
Technical assessment Yes No
Commercial assessment Yes No
Schedule leadership alignment
Leadership assessment Yes No
meeting
Cybersecurity program assessment Yes No
Perform assessment of
Sterilization Assessment Yes No
sterilization processes
Product Development capabilities Yes No
Conduct a review of lifecycle
Product Lifecycle management capabilities Yes No
management tools
 Document DOC-TP-RBP-001 Rev A Page 3 of 11

Title Transfer Plan for Ring Bending Process

Transfer Plan Objectives– List the Quality, Operational Performance, and Stability Metric Requirements to
Measure Effectiveness of the Transfer to the Receiving Facility. (For example: yield, daily volume, critical
process performance, cost, Quality metrics, etc.)
Transfer Objective: Yield: Ensure the receiving facility achieves a minimum first-pass yield of ≥98% within
the first three production batches.
Transfer Objective: Daily Volume: Attain a daily production volume of [specific quantity] units by the
second month post-transfer.
Transfer Objective: Critical Process Performance: Validate and maintain critical process parameters
within defined specifications to ensure consistent product quality and compliance.
Transfer Objective: Quality Metrics: Maintain a non-conformance rate below 2% for all critical attributes
and achieve zero critical defects during the first six months of operation.

Regulatory Approval Regional Requirements

(Within the table below identify impact to existing regulatory submissions and actions required to release
product for distribution)
Other
(e.g. Canada,
Model # Part # CE Mark PMA IDE Japan)
193212026 193212026 Not Required Not Applicable Not Applicable Not Applicable

193212036 193212036 Not Required Not Applicable Not Applicable Not Applicable

193212326 193212326 Not Required Not Applicable Not Applicable Not Applicable

193212336 193212336 Not Required Not Applicable Not Applicable Not Applicable

Regulatory Action Required and estimated timing: Not Applicable

Critical Transfer Element Review

Transfer Team
Owner
Required? (if no, provide Required
Process Area (Select if Applicable) justification) Deliverable
For interim release? Luis Manuel ECR-Setup-Ref-
Yes No Zapata Gonzalez 001
Set-up (transfer model/assembly structure
For transfer plan
in)
closure?
Yes No
For interim release? Luis Manuel ECR-Config-Ref-
Yes No Zapata Gonzalez 001
Configuration (menus, versions, processing
For transfer plan
option and data selection configuration)
closure?
Yes No
For interim release? Luis Manuel ECR-Label-Ref-
Yes No Zapata Gonzalez 001
Labeling System Update/Label Creation For transfer plan
closure?
Yes No
 Document DOC-TP-RBP-001 Rev A Page 4 of 11

Title Transfer Plan for Ring Bending Process

Transfer Team
Owner
Required? (if no, provide Required
Process Area (Select if Applicable) justification) Deliverable
For interim release? Luis Manuel ECR-CQ-Ref-001
Construction Qualification (including Yes No Zapata Gonzalez
modifications or additions to existing For transfer plan
building systems) closure?
Yes No
For interim release? Luis Manuel ECR-EV-Ref-001
Environmental Re-Validation Assessment Yes No Zapata Gonzalez
(impact of additional equipment and For transfer plan
manpower) closure?
Yes No
For interim release? Luis Manuel ECR-EHS-Ref-
Yes No Zapata Gonzalez 001
For transfer plan
closure?
EHS (New Chemicals, Waste Streams, Yes No
Noise etc.) For interim release? Luis Manuel ECR-EHS-Ref-
Yes No Zapata Gonzalez 001
For transfer plan
closure?
Yes No
Device Master Record Review – Review all Luis Manuel ECR-DMRR-Ref-
For interim release?
Mfg. SOPs, specifications, product Zapata Gonzalez 001
Yes No
drawings, tooling and fixture drawings, etc.
For transfer plan
and compare to existing sending operation,
closure?
identify gaps & discrepancies and issue
Yes No
Remediation Plan.*
Additional activities Device Master Record For interim release? Luis Manuel ECR-ADMR-Ref-
(transfer to CMO): approval of procedures Yes No Zapata Gonzalez 001
by sending site at the receiving site. For transfer plan
Management of translations with approved closure?
company / engineers. Yes No
For interim release? Luis Manuel ECR-pFMEA-
Yes No Zapata Gonzalez QCP-Ref-001
pFMEA/QCP Review (Check for alignment
For transfer plan
to new operation and need for updates*)
closure?
Yes No
For interim release? Luis Manuel ECR-Kaizen-Ref-
Kaizen for CTQs and CCP mapping at Yes No Zapata Gonzalez 001
originating facility, CCP implementation at For transfer plan
receiving facility closure?
Yes No
For interim release? Luis Manuel ECR-Sterilization-
Yes No Zapata Gonzalez Ref-001
Sterilization Validation For transfer plan
closure?
Yes No
 Document DOC-TP-RBP-001 Rev A Page 5 of 11

Title Transfer Plan for Ring Bending Process

Transfer Team
Owner
Required? (if no, provide Required
Process Area (Select if Applicable) justification) Deliverable
For interim release? Luis Manuel ECR-EQL-Ref-001
Yes No Zapata Gonzalez
EQL Submission For transfer plan
closure?
Yes No
For interim release? Luis Manuel ECR-Raw-
Raw materials / parts cleaning assessment Yes No Zapata Gonzalez Materials-Ref-001
and qualification at new manufacturing For transfer plan
location. Cleaning router set-up. closure?
Yes No
For interim release? Luis Manuel ECR-Packing-Ref-
Yes No Zapata Gonzalez 001
Packing & Shipping Validation for Finished
For transfer plan
Goods
closure?
Yes No
For interim release? Luis Manuel ECR-Sub-
Yes No Zapata Gonzalez Assemblies-Ref-
Packing & Shipping Validation for Sub-
For transfer plan 001
Assemblies Shipped between sites’ Plants
closure?
Yes No
Process Validation Plan (Installation Luis Manuel ECR-Process-
qualification (IQ) including Tooling and For interim release? Zapata Gonzalez Validation-Ref-001
Fixture IQ (TFIQ), Operation Qualification Yes No
OQ), Performance Qualification (PQ), Test For transfer plan
Method Validation (TMV), Software closure?
Validation (SWV), Construction Yes No
Qualification (CQ)s)
For interim release? Luis Manuel ECR-Receiving-
Yes No Zapata Gonzalez Ref-001
Receiving Inspection Process Setup and
For transfer plan
Component Transfer
closure?
Yes No
For interim release? Luis Manuel ECR-Part-
Yes No Zapata Gonzalez Qualification-Ref-
Part Qualification Process For transfer plan 001
closure?
Yes No
For interim release? Luis Manuel ECR-Supplier-
Yes No Zapata Gonzalez Qualification-Ref-
Approval as supplier (Supplier Qualification-
For transfer plan 001
Required to transfer to CMO)
closure?
Yes No
For interim release? Luis Manuel ECR-Training-Ref-
Training plan (required to transfer to CMO):
Yes No Zapata Gonzalez 001
in compliance with requirements and
For transfer plan
certification at originating site. Product
closure?
training. Face to face training.
Yes No
 Document DOC-TP-RBP-001 Rev A Page 6 of 11

Title Transfer Plan for Ring Bending Process

Transfer Team
Owner
Required? (if no, provide Required
Process Area (Select if Applicable) justification) Deliverable
For interim release? Luis Manuel ECR-Training-
Update training structures for new Yes No Zapata Gonzalez Structure-Ref-001
documents implemented at the receiving For transfer plan
site closure?
Yes No
For interim release? Luis Manuel ECR-Sterilization-
Receiving site procedure updates to
Yes No Zapata Gonzalez Procedure-Ref-
sterilization and bioburden procedures.
For transfer plan 001
Task to be completed prior to termination of
closure?
PQ validation builds.
Yes No
For interim release? Luis Manuel ECR-Live-
Live Manufacturing Process Review. Yes No Zapata Gonzalez Manufacturing-
(Identify mistake-proofing needs and For transfer plan Ref-001
Implementation Plan*) closure?
Yes No
For interim release? Luis Manuel ECR-Mfg-
Manufacturing Procedure Walk-through
Yes No Zapata Gonzalez Procedure-
(build devices and identify any inaccuracies
For transfer plan Review-Ref-001
or clarifications required in mfg procedures
closure?
prior to implementation)
Yes No
Resource Needs – Identify the total number For interim release? Luis Manuel ECR-Resource-
and types of all resources needed to run the Yes No Zapata Gonzalez Needs-Ref-001
operation after transfer, based on For transfer plan
completion of the DMR review above. closure?
Develop hiring & training plans and timeline. Yes No
For interim release? Luis Manuel ECR-Training-
Update Production, Quality Inspector and Yes No Zapata Gonzalez Plans-Ref-001
Product Verification training plans and For transfer plan
identify certifications required. closure?
Yes No
For interim release? Luis Manuel ECR-Stability-Ref-
Yes No Zapata Gonzalez 001
Stability Metrics For transfer plan
closure?
Yes No
Any items identified as critical transfer elements shall be incorporated into the project schedule/task activities
based on input from the identified team owner.
* Requires participation from QE & ME at both sites
 Document DOC-TP-RBP-001 Rev A Page 7 of 11

Title Transfer Plan for Ring Bending Process

Inventory Controls - Describe how inventory will be controlled prior to approval for commercial/clinical
distribution. Include physical controls (location), router controls, and electronic system controls.
[Link] Controls (Location):
 Storage Locations: Inventory will be stored in designated storage areas within the receiving facility
that are secure, temperature-controlled, and monitored. Each location will be clearly labeled to prevent
mix-ups and ensure traceability.
 Access Control: Access to inventory areas will be restricted to authorized personnel only. Security
measures such as access logs, security badges, and surveillance cameras will be implemented to
monitor inventory.
 Inventory Inspection: Inventory items will undergo visual inspection to confirm condition and quantity
before distribution. Items will be tagged with unique identifiers to track their movement.

[Link] Controls:
 Routing System: A computerized routing system will be used to track the movement of inventory
between departments, stages of processing, and shipping destinations.
 Routing Instructions: Each inventory item will have specific routing instructions that detail the order in
which items should be processed, tested, and shipped. These instructions will be followed to maintain
product integrity and compliance.
 Status Updates: The system will provide real-time status updates on inventory locations and
processing stages, allowing quick adjustments to schedules if necessary.

[Link] System Controls:

 ERP System Integration: An Enterprise Resource Planning (ERP) system will be used to manage
inventory data, including stock levels, order status, and shipping records. This system will also facilitate
order processing, invoicing, and compliance tracking.
 Access Permissions: Access to the ERP system will be controlled based on user roles to prevent
unauthorized changes. Only authorized personnel will have access to inventory data, and all changes
will be logged for auditing purposes.
 Data Backup and Security: The ERP system will have robust backup protocols to protect data
integrity and prevent data loss. Security measures such as encryption and firewalls will be implemented
to protect sensitive information from unauthorized access.

Production Ramp and Volume Forecast - Describe expected timing, initial production volume, and expected
production volume post transfer at the receiving site. Describe expected changes to product volume at the
sending facility. Determine inventory levels required to support customer demand.
[Link] and Initial Production Volume at the Receiving Site:
 Expected Timing: The transfer of the bending process is scheduled to start in [specify timeframe, e.g.,
next quarter or month] and will take approximately [specify duration, e.g., two months] to fully
implement.
 Initial Production Volume: The initial production volume at the receiving site is projected to be
[specify quantity, e.g., 5,000 units per month]. This volume is based on the capabilities and capacity of
the receiving facility, which has been upgraded to support the new production line.
 Expected Changes to Production Post Transfer: Once fully ramped up, the production volume is
expected to stabilize at [specify quantity, e.g., 10,000 units per month] within the first six months post-
transfer. This projection considers an additional shift being added to meet increased demand and to
optimize production efficiency.

[Link] to Product Volume at the Sending Facility:

 Document DOC-TP-RBP-001 Rev A Page 8 of 11

Title Transfer Plan for Ring Bending Process

 Expected Changes: The product volume at the sending facility is expected to decrease as a result of
the transfer. Initially, there will be a reduction in production volumes as resources and staff are
redirected to support the new line at the receiving facility. Over time, it is anticipated that the sending
facility will maintain only a core production line that will handle maintenance and support activities
rather than full-scale production.

[Link] Levels Required to Support Customer Demand:

 Inventory Levels: To support customer demand during the ramp-up phase at the receiving site,
inventory levels will be managed carefully. The following inventory strategies will be adopted:
 Safety Stock: A safety stock of [specify quantity, e.g., 2,000 units] will be maintained to buffer any
unforeseen delays in production or supply chain issues.
 Reorder Points: A reorder point system will be in place to automatically trigger replenishment orders
once inventory reaches a certain threshold.
 Cross-Inventory: Cross-inventory management will be implemented to balance inventory levels
between the sending and receiving sites, ensuring that production needs are met at both locations.

TRANSFER PLAN APPROVALS

Receiving Facility Manufacturing Representative
Receiving Facility Quality Representative
Originating Facility Manufacturing Representative
Originating Facility Quality Representative
External Manufacturing Leader (in case of CMO)
External Manufacturing Quality Leader (in case of CMO)
Worldwide Engineering (WWE) (if required by the
transfer plan)
Regulatory Affairs Representative
Research and Development Representative (if required
by the transfer plan)

Section 2: Transfer Interim Release and Approval

Document the required regulatory action, finished device and/or subassembly part number, and the transfer
output applicable to the phase for which the interim release is required. Attach supplemental information as
necessary.
Regulatory Action [Ex: Reference Attachment 1, Phase Number]
Finished Device and/or Subassembly Part Number (s) [Ex: List finished device and/or sub-assembly
model number as applicable to the interim
release]
Transfer Output Reference or Attachment
Refer to Section 1 (critical transfer elements) to document [Ex: Reference Attachment 1, Phase Number]
the transfer element (s) applicable to the phase.

TRANSFER INTERIM RELEASE APPROVALS

Receiving Facility Manufacturing Representative
Receiving Facility Quality Representative
Originating Facility Manufacturing Representative
 Document DOC-TP-RBP-001 Rev A Page 9 of 11

Title Transfer Plan for Ring Bending Process

Originating Facility Quality Representative

External Manufacturing Leader (in case of CMO)
External Manufacturing Quality Leader (in case of CMO)
Worldwide Engineering (WWE) (if required by the transfer
plan)
Regulatory Affairs Representative
Research and Development Representative (if required by
the transfer plan)

Section 3: Transfer Execution Approval

Transfer Project Activity List and Schedule. Attach completed summary of project activities (Gant chart or
other summary) that details the activities, timing, assigned resources, and completion status. Consideration to
be made for activities in the following areas: Project budgeting and approval, facilities evaluation, Information
Technology support, BOM and router set-up, lab equipment, process validation plan and validation protocols,
review and update of critical documents (pFMEA, QCP, SOPs, etc.), manufacturing equipment/fixtures/tooling,
supply chain/logistics, human resources, manufacturing line set-up, environmental validation, operator
training, test builds, laboratory submissions, and regulatory submissions.
Transfer Team Leader Approval Reference Attachment A

Transfer Objectives Results – Document the results for each of the approved transfer objectives. Attach
supplemental information as necessary.
Transfer Objective Results:
Transfer Objective Results:
Transfer Objective Results:
Transfer Objective Results:

Regulatory Actions/Approvals
(Reference NOC, Audit Reports, etc. indicating approval for commercial distribution)
Regulatory Action Reference or Attachment
CE Marking Attachment [#]

PMA (Premarket Approval) Attachment [#]

Documentation
NOC (No Objection Attachment [#]
Certificate) from Local
Authorities
Compliance Certificates Attachment [#]
Sterilization Validation Attachment [#]
Reports
Audit Reports Attachment [#]

Transfer Outputs – Document transfer project outputs, attach supplemental information or reference report
numbers, ECR numbers, or protocol numbers as appropriate.

Required? Reference or
Transfer Output (Select if Applicable) Attachment
Construction Qualification (CQ) Report Yes No
Environmental Validation Report Yes No
EHS Summary Report Yes No
 Document DOC-TP-RBP-001 Rev A Page 10 of 11

Title Transfer Plan for Ring Bending Process

Required? Reference or
Transfer Output (Select if Applicable) Attachment
ECR-Device-Master-
Device Master Record Review/Change Summary (ECRs) Yes No
Record-Ref-001
Device Master Record Review summary (for transfer to ECR-DMR-Review-
Yes No
CMOs) Ref-001
ECR-pFMEA-QCP-
pFMEA/QCP Review Summary and Remediation Plan Yes No
Ref-001
Kaizen for CTQ and CCP mapping and implementation ECR-Kaizen-Ref-001
Yes No
summary
ECR-Sterilization-Ref-
Sterilization Validation Report Yes No
001
EQL Approval or Waiver Yes No ECR-EQL-Ref-001
Raw materials / parts cleaning assessment and / or ECR-Raw-Materials-
Yes No
qualification summary / ECR’s Ref-001
Packaging and Shipping Validation Report Yes No ECR-Packing-Ref-001
ECR-Process-
Process Validation Plan Report Yes No
Validation-Ref-001
ECR-Receiving-Ref-
Summary of Receiving Inspections Routers Changes (ECRs) Yes No
001
ECR-Part-
Part Qualification Process report Yes No
Qualification-Ref-001
Summary of training plan updates (ECRs) to Production, ECR-Training-Plans-
Yes No
Quality Inspector and Product Verification training plans. Ref-001
Summary of Training update and records (for transfer to ECR-Training-Update-
Yes No
CMOs) Ref-001
ECR-Training-
Summary of Training updates (ECRs) Yes No
Updates-Ref-001
Resource and Training Summary (Training Requirements) ECR-Resource-Needs-
Yes No
guidelines. Ref-001
Summary of document updates (ECRs) for receiving site ECR-Sterilization-Doc-
Yes No
sterilization, bioburden and shelf-life procedures. Update-Ref-001
Manufacturing process review summary completed and plan ECR-PFMEA-
implemented (form 28443 or evidence of live PFMEA walk- Yes No Walkthrough-Ref-001
through)
Manufacturing Process Review Summary (form 50844) and ECR-Manufacturing-
Yes No
Plan implemented Review-Ref-001
ECR-Labeling-
Summary of Labeling Changes (ECRs) Yes No
Changes-Ref-001
ECR-SQR-Approvals-
Summary of SQR Approvals Yes No
Ref-001
ECR-BOM-Router-
Summary of BOM/Router Changes (ECRs) Yes No
Changes-Ref-001
ECR-Stability-Metrics-
Stability Metrics Yes No
Ref-001

TRANSFER EXECUTION APPROVALS

Receiving Facility Manufacturing Representative
Receiving Facility Quality Representative
Originating Facility Manufacturing Representative
 Document DOC-TP-RBP-001 Rev A Page 11 of 11

Title Transfer Plan for Ring Bending Process

Originating Facility Quality Representative

External Manufacturing Leader (in case of CMO)
External Manufacturing Quality Leader (in case of CMO)
Worldwide Engineering (WWE) (if required by the
transfer plan)
Regulatory Affairs Representative
Research and Development Representative (if required
by the transfer plan)