Write a Final Capstone Reflection Paper

10. Integrated Change Control 34

1.1 Introduction

Johnson and Johnson (J&J) is an American multinational company that develops medical devices, pharmaceutical drugs and consumer products. J&J is one of the largest medical device companies in the world. There are various subsidiaries of J&J, however the medical device business of J&J includes 3 global franchises; mainly Ethicon (surgical), Bio-sense Webster (Cardiovascular & Speciality solutions) and Depuy Synthes (Orthopaedics). J&J has a presence in over 100 countries worldwide and the medical device companies manufactures and does R&D on various different kinds of surgical devices, implants that are used by doctors in laparoscopic surgeries.

Current project that I will be working on is named as Project RoadRunner by the project team. The project is to develop a new medical device implant for China market. The implant is a sterile product that is used by surgeons during bariatric surgeries. This implant is used alongside a vascular stapler and will improve the staple line integrity, force to fire and staple performance during surgery. This will be a big boost in the existing line of stapling implants by improving performance reliability and decrease market complaints. So far for earlier legacy devices, we were using 2-D staples. However, with this project, we will concentrate on getting the 3-D staples in the market, which will improve quality and performance of the implanted device. Currently, the objective and strategy is to only launch this device in China.

1.2 Purpose 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 markets 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.

1.3 Scope

3. Project Scope

· Project Initiation

· Project Planning

· Project Execution

· Project Closing

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.

The key problem in this project is to take care of the complaints that are currently met in the legacy devices. Complaints such as staples are not firing during surgical procedures and that the titanium cartridge clips that are used for stapling the body tissues during surgical procedures were loosened and were simply coming out of the cartridges during surgical procedures. Now these could lead to anxieties during surgery because if the devices dont fire in surgery or misfires in surgery, it could lead to blood loss and tissue injury during surgery. This is a grave concern and hence needs to be fixed.

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 marketing are and what are the concerns that doctors are facing in other company devices. Use them at advantage and develop robust design that will resolve those complaints and then start marketing those devices to doctors.

Due to continuous complaints in the legacy devices, the business decided to take care of this complaint problem, by making technical advances by Research and Development. Technical advances will take care of the CAPA problem that is being arising constantly through the legacy device. The new technical advances in new device will be promoted by using 3-D staples, which is a new technology in the field of surgery. Project RoadRunner is being created as a solution for this problem that will currently target development in China.

· To spread out to maximum hospitals and surgeons globally (starting with China) and make them alert of the new medical device technology that Ethicon is preparing to launch that will make surgical procedures more relaxed for doctors when using the new device.

· Build a superior quality management system and post market surveillance channel within organization, which will help in determining any non-conformance in the device at the manufacturing site or before entering the market. This will help to reduce or diminish any device related complaints during surgical procedures from surgeons.

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.

Dependencies:

· US FDA approval required before China can start with their local FDA registration.

The evolution of this plan was initiated since it was significant for the company to take care of the complaints that the business is fronting with in the legacy devices business that are currently in the market. From a Legal point of view, it is very imperative that the business fixes this problem, to circumvent any patient complaints / deaths that may lead to financial lawsuits against the company.

4.1 Purpose/Overview

There will be a meeting that will be set by project manager with all SMEs that are working on this project to understand requirement for project completion. Project manager will work with SMEs to understand each task and how long it takes to complete the tasks. There will be some buffer that will be created in the project by the project manager. Project manager will create dependencies that are required for the project. Once the project manager creates all tasks they will be reviewed by the SMEs. Depending on the project tasks, and its difficulty and dependency, tasks will be decided when they need to be worked on. Dependencies (internal and external) will be considered during creating the project plan. Project will have biweekly meetings with the SMEs to go through their tasks and understand the status.

Task Dependencies:

1. Finish to Finish:  When 2 tasks have Finish to Finish relationship, and you can’t finish task 2 until task 1 finish.

1. Finish to Start:  This is the most commonly used task dependency.  When tasks 1 and 2 have an “Finish to Start relationship” where task 2 cannot start until task 1 is finished.

1. Start to Finish:  When tasks 1 and 2 have an Start to Finish relationship. In this, task 2 cannot finish until task 1 is started.

1. Start to Start:  When tasks 1 and 2 have an Start to Start relationship. Here, task 2 cannot start until task 1 is started.

4.2 Schedule Baseline

· Major Milestones:

· Approve project charter

· OC Approval to Apply Resources & Budget to Go

· Labeled Carton Drawings

· IFU Released

· Tyvek Artworks Released

· Vision System Software Upgrade at Torres Completed

· Vision System Software Upgrade at ABQ Completed

· Pull GST45 Samples out of Bulk Inventory / Swap Retainers

· Software Validation at ABQ Completed

· WE0380 for PQ Parts (Gen II Cartridges and 45/60 Retainers)

· PQ at Torres Completed

· PQ at ABQ Completed

· PQ Documentation

· FDA Approval for CFG

· China Regulatory Registration Approval Notice

· Final CRB Meeting

· Final CRB Approval

· Batch released finally to China

4.3. Schedule Control

The reason for creating this resource plan is to make sure we can deliver the resource distribution for this project completion and to confirm that stakeholders that allocated to accurate tasks contingent to their Responsibility, Accountability, Control, and Interest. The tasks that are created in the WBS, should be allocated to the precise stakeholder who will confirm that these tasks are executed as per the PMP and proper resources are assigned to individual task. There could be various resources in the project that includes Full time or contactor employees, medical devices, equipment’s, and several other things that will promise effective achievement of the project.

It is PMs accountability to make sure he or she gets all SMEs that are required as resources for the project. Secondly, it is PMs accountability to use the proper resource competently as per project need. PM when resourcing will talk to department leads to recognize how many resources will be required and will be available for task completion. Once, PM gets this information, PM will make a hypothesis of how many hours the resource will be dedicated for the task’s completion. there will be various SMEs from different teams that will assist the project manager to complete tasks during various project management phases such as project initiation, project planning, project execution and project closing to assure the completion of the project. There will be budget resourcing created for the budget and the resources will be attained based on the total budget and timelines of project completion.

At the start of the project, PMO will supply the funds and approve the project. It will be then be PMs responsibility to talk to each department and resource the SMEs that will be responsible to work on the project. PMs job is also to use the funds resourcefully towards task completion and also determine how many resources will be required to get this task completed. Now the PM is now the technical lead having knowledge from all departments, therefore it is assumed that all SMEs from various teams will assist the project manager to complete tasks during various project management phases such as project initiation, project planning, project execution and project closing to assure the completion of the project. All SMEs working on the project shall comprehensive go through SOP/technical training and hands on training before they are assigned to complete the task. There will be a procedure created for the project before preliminary activities. These procedures are formed on foundation of company policies and quality management systems. These trainings will be recorded and reported as per company procedures. Rewards and acknowledgements will be given to employees based on successful completion of project. These rewards and acknowledgements can be monetary based or simply correspondences shall be sent out by higher management to the complete group of participants or SMEs involved in the project.

The main purpose of risk management is to recognize possible problems before they arise so that risk managing activities may be planned as required across the product or project lifecycle and they can be mitigated by avoiding adverse impacts on accomplishing purposes.

A risk management plan is an official document that describes how to deal with precise risks and what risk managing actions need to be taken in order to alleviate or eliminate threat to the project activities and outcomes.

Risk can be identified based on criticality of the risk. It can be categorized into Low, Medium and High Risk. Risk identification are generally documented in a risk register, which contains a list of recognized risks along with their basis, description, impact, probability, severity, response, strategy, category and owner of the risk.

In the project, different risks are identified based on the category it belongs to. Whether it is a technical risk, administrative risk, cost related or is it schedule related. Based on this category, we can describe what the risk is. We can then determine the probability and criticality of that risk-taking place and determine how to mitigate that risk in a proper and timely manner.

6.3 Risk Analysis

Risk Analysis is a process that assists you recognize and manage possible problems that could challenge significant business initiatives within the projects. Therefore, to carry out a Risk Analysis, you need to first recognize the possible risk that you face, and then evaluate the probability of those risks that will emerge.

To analyze a risk, you need to carry out a risk analysis. The first step in risk analysis is –

1. To identify the risk: one needs to first identify the risks that you may face as a challenge. It can be related to resource, material, timeline, gap assessment, improper documentation.

2. Eliminate the risk: Once you've recognized the risks that you are facing, you require to calculate the probability of these threats being realized, and their possible impact.

One way of doing this is, to make your best estimate of the probability of the event occurring, and then to multiply this by the amount it will cost you to set things right if it happens. This gives you a value for the risk:

Risk Value = risk probability x risk impact / 100

As per the risks mentioned in the risk register –

Risk ID number R001 = 0.9 x 90 / 100 = 0.81 (PI Score) which is considered as High Risk.

The risk identification is categorized as follows:

6.4 Risk Monitoring Plan

Risk monitoring is the process which tracks and evaluates the levels of risk in an organization. The results which are produced by risk monitoring processes can be used to help to create new strategies and update older strategies which may have demonstrated to be futile.

Risk monitoring is an ongoing process to monitor risk throughout the project lifecycle. Common elements of risk monitoring are risk identification, risk analysis, risk controls and measurement and communication.

7.1 Overview/Purpose

The purpose of the communication plan is to ensure the Project Management Improvement Project provides relevant, accurate, and consistent project information to project stakeholders and other appropriate audiences. By effectively communicating the project can accomplish its work with the support and cooperation of each stakeholder group.

The communication plan provides a framework to manage and coordinate the wide variety of communications that take place during the project. The communication plan covers who will receive the communications, how the communications will be delivered, what information will be communicated, who communicates, and the frequency of the communications.

The following outlines the targeted audiences, the key communication messages to be delivered, and the method for delivering the information, the communicator, and the frequency of the delivery.

7.2 Communication Message and Delivery (Matrix)

7.3 Communications Guidelines

7.4 Escalation Process

It’s a process where unresolved issues or concerns are immediately addressed by a team of members who have the authority to make high level decisions. In an Escalation process, the SMEs are entitled to address their concern to the project manager who later takes the decision to talk to higher management members. Here a risk management review board meeting takes place and the issue or concern is brought to the forum to discuss at the higher level. The risk board consists of people from every department who are directly or indirectly involved in the project or business decision. Once the review board makes the decision here, it is then documented into company’s Quality Management System and tracked for future reference. A reference number is assigned in case later it is required to be traced back during Audit. Further, the decision is communicated back to the project manager who later communicates back to the remaining stakeholders in the monthly project status meeting.

· Project Initiation Phase:

This document addresses the purchase of manufacturing equipment parts and device components. This plan helps the team with general information for possible purchase requirement.

· Procurement Statement:

The device component parts will depend on research and development activities. For manufacturing equipment parts, they can purchase 2 of each part. 1 part for use and the other part as spare in emergencies.

· Vendor Selection:

All parts and components will be purchased based on companies’ policies and procedure. Since the company is looking from a long -term investment with Micro. Selection will be done by the internal auditing team after vendor audit is approved.

· Selection Process and Criteria:

Vendor audit passes as per ISO 13485 standard procedure.

· Project Procurement Team:

All purchase needs manufacturing plant manager and project manager approval and signature. Requesting the above purchase are project lead, design engineer and process engineer.

· Contract Type:

All contracts use company’s internal policy and standard and use statement of work to control purchase.

· Contract Standards:

All contracting terms are based on company’s policy and company’s standard.

· Vendor Management:

Vendor supplying manufacturing equipment parts/component has service maintenance agreement with the company.

9. Cost

9.1 Introduction

Project costing is one of the important sections of the project because it talks about the project cost and allocation of funds towards the completion of the project. The main aspect of cost management is that the total cost of the project should not surpass the budget. Cost of the project is mainly provided before project kick off. That means the costing is already assigned before the project is started. The importance of this section is making sure that the actual cost will be compared against the predicated cost that was provided during project charter.

Cost Management Plan

9.2 Estimate Cost

9.3 Contingency Reserve Project Purpose or Justification

For contingency, a total of $100,000 are kept aside for the entire project duration. These are kept aside taking regulatory cost, registration cost, material cost, damage done to device and device components during shipping and custom fees that constantly can change.

9.4 Budget

[Once the project costs or cost baseline is determined, a time-phased project budget is developed. Project budget shows how the project cost will be incurred by appropriate periods (months, weeks, quarter, etc.) during project performance period. Describe how your budget is developed.]

Cost Control and Monitoring

[The approved project budget with contingency reserves serves as a baseline for project control. This section usually include project approach to monitor actual versus planned performance, approach ( e.g. Earned Value analysis), and how any cost changes will be managed.]

9.5 Performance Monitoring

[Describe your approach to monitor planned versus actual performance and matrices that will be used]

9.6 Project Reports

[Include name and description of 2 to 3 reports that you plan to use for performance monitoring, status reporting or other reports. These are the reports for which you will be submitting a Microsoft Project mpp file. See section below. ]

9.7 Cost Change Control

[Describe briefly how any changes to the cost baseline will be administered and implemented.]

Microsoft Project Deliverables

9.8 Project Budget

[Include your project WBS (in .mpp format) that represents your project cost. Ensure that contingency reserves as a separate line item. The report submission is in Moodle]

9.9 Microsoft Performance Report

[Include report name and describe how the report will be used]

9.10 Microsoft Performance Report

[Include report name and describe how the report will be used]

Change control process is defined as an internal organizational process to make changes to cost, risk, documentation, manufacturing, product design, component design, material, labelling, packaging, sterilization, quality, etc. This process is controlled by the change specialist and change lead and approved by the change review board.

This process involves all stakeholders that are working on the project. Stakeholders are all made aware before making changes to the process because changing the process can significantly delay the project or the outcome of the project. The change process includes PMP update, approval from review board, and documentation update.

The following process is being followed for change control.

Change Request Process Start

Change Process Initiated

Change Request Recevied

Change Approved

Change Review Decision

Change Request Denied

No