Write a Final Capstone Reflection Paper

<Johnson & Johnson >

<Soumitra Girish Shilotri>

<11/02/2019>

<Kim Young- Sponsor, PMO>

< Develop and Implement Project RoadRunner in China >

Project Charter

Revision <1.0>

PMGT 699 Project Charter v.1 April 2018 (Adapted from Document Code: PMBOK4.1.3.1)

List of Changes

Table of Contents 1. General Provisions 4 2. Terms, Notations, Abbreviations 4 3. Project Purpose 4 4. Measurable Project Goals and Objectives 5 5. High-level Project Description and Boundaries 6 6. High-Level Requirements 6 7. Overall Project Risk 7 8. High Level Constraints and Assumptions 7 9. Summary Milestone Schedule 8 10. Key Project Deliverables 8 11. Preapproved Financial Resources 9 12. Key Stakeholder List 9 13. Project Approval Requirements 9 Project Exit Criteria 9 Project Managers 10 Name 10 Position 10 Signature 10 Date 10 Appendixes 10

This document refers to the project "< Develop and Implement Project RoadRunner in China >", which is implemented by the organization "<Johnson & Johnson >".

The Project Charter formulates the practical requirements and documents the high-level description of the product, service or other deliverable that should meet these requirements and will be result of the project.

The Project Charter is issued and signed by the Initiator or Sponsor of the project and formally legitimized the existence of the project. It provides the Project Manager with the authority to use the organizational assets in the project operations.

The approved Project Charter formally initiates the project.

If the project consists of several phases, the Charter can be updated to verify or improve the decisions taken during the previous iteration of the Project Charter development. In such a case the Charter is re-issued and signed as amended.

The purpose of this project is to Develop and Implement Project RoadRunner in China Market. Project RoadRunner is an Implant medical device that is used extensively in bariatric surgeries. Project RoadRunner will improve the stapling and cutting quality of the device. Hence, improving the performance on the device and decrease in market complaints. 3-D staples will be used to improve the quality and performance of the device.

Following factors are equally important for the purpose of the project:

· Market demand – China is one of the biggest market for Johnson & Johnson devices. There is an constant demand in China market for such devices.

· Organizational need – From business point of view Johnson & Johnson wants to be ready to deliver quality devices, thus by stopping any other competitors to enter the business.

· Customer request – There is an unmet need for quality devices in China. Johnson & Johnson wants to meet this unmet need for their customers.

· Technological advance – This new device will resolve the CAPA issue for the legacy devices and the new device will be marketed with 3-D staples technology which is currently the most technologically advance system and not available in the the legacy devices.

· Legal requirement – As the legacy devices have complaints, Johnson & Johnson had to open a CAPA to fix these designs. From legal point of view it is very important that the company fix this issue, to avoid any patient complaints that could lead to major legal financial consequences and even affecting company brand name.

Project Goals:

· Successful development of the project's procedures of initiation, planning, execution, regulation and closure.

· To provide guidance to the project team's operations towards achieving all the agreed upon goals within the set scope, time, quality and budget standards.

· To finish project RoadRunner on time with minimum risk to business with respect to time and budget

· To follow regulatory guidelines to ensure it meets China’s regulatory requirement.

· Control budget, time, quality and scope of the project.

· Provide proper communication across industry to various involved departments.

· Set up weekly meetings with all the involved project teams.

· Achieve SMART (Specific, Measurable, Achievable, Relevant, Time-based) Goals.

Business Goals:

· Increase revenue income by 10% by end of year 2020 for RoadRunner Devices in China market.

· Reduce complaints and increase quality and performance of RoadRunner Devices in China market.

· Increase market share in China by 15% by end of the year 2020, thus reducing competition from other companies.

· Reach out to maximum hospitals and doctors and make them aware of the new medical device that Johnson & Johnson is planning to launch in China that will make surgeries more comfortable for surgeons.

· Build a robust quality system, validation system and post market surveillance that will catch any non-conformance in the device at the manufacturing site or before entering the market. That will reduce complaints during surgery from doctors / patients.

· Do an in-depth market study in China to understand what other companies are marketing and what are the concerns that doctors are facing in other companies device. Use them at advantage and develop robust design that will resolve those complaints and then start marketing those devices to doctors.

The purpose of this project is to Develop and Implement Project RoadRunner in China Market. Project RoadRunner is an Implant medical device that is used extensively in bariatric surgeries. Project RoadRunner will improve the stapling and cutting quality of the device. Hence, improving the performance on the device and decrease in market complaints. 3-D staples will be used to improve the quality and performance of the device.

Currently, the boundary for this product is non-CE mark and can’t be sold in other markets that require CE marking. Current strategy is to only develop this product for China market and develop local IFU’s for China only.

For successful development and implementation of Project RoadRunner in China following requirements needs to be fulfilled:

· Approval from higher management to execute the project.

· Approved financial budget and timeline for this project

· Project initiation requirements -

· Successful completion of process for generating new product codes for China

· Creating manufacturing assembly for component development

· Manufacturing site vision system software validation upgrades

· Design Validation

· Performance Qualification Testing

· Labelling Requirements to be approved as per China Regulatory Body

· Regulatory Approval Process

· Project Documentation

· Design Change documentation

· Labelling documentation

· Packaging documentation

· Manufacturing documentation

· Regulatory documentation

Constraints:

· Time zone constraint to work with China team on the project.

· Manufacturing equipment constraint to work in manufacturing facility during validation.

· US government shutdown delayed US FDA approval.

Assumptions:

· China Regulatory Approval will be done in 6 months.

· US FDA Regulatory Approval will be done in 3 months.

· The device design will resolve the issue of complaints in China.

Project approval requirements will be performed by Johnson & Johnson designated Subject Matter Expert’s (SME’s) employees, through the approval of the project's deliverables listed in Section 10 of this document

Final Project Approval will be performed by the Change Review Board Members that will include SME’s from Research & Development (R&D), Project Management, Manufacturing, Regulatory Affairs, Quality Assurance, and Marketing.

Product Review Approval form (PRA) needs to be signed and sent to PMO office for exit criteria.

Kent Baker and Craig Smith will be acting as the Project Manager from Johnson & Johnson for the RoadRunner Project for China. They will be responsible from initiating stage to execution stage of the RoadRunner project and also making sure all tasks are completed on time for project completion from other SME’s as well.

Signed/Project sponsor(s) or charter approving authority

<N/A>