The document outlines a simplified approach to project management, emphasizing key principles such as understanding needs, timelines, and budgets. It includes various worksheets for project initiation, planning, and evaluation, alongside strategic planning insights and execution strategies. The ultimate goal is to promote efficient project management practices that align with organizational objectives and improve public health outcomes.

1. Project Management “Made Simple” Using Technical and Behavioral Quick Connects

2. Project Management Made Simple: from the Introduction of Mitch Manning by Matt Lewis at the 23 rd Southeast ASQ FDC/FDA Conference on February 12, 2010 “ I can tell you this about Mitch Manning. Mitch is one of the people we, the FDA, went to when we were trying to figure out Process Validation back in 1978. He was already doing Process Validation at Burroughs Wellcome Co. and he helped us to teach the pharmaceutical industry.” Matt Lewis Former FDA Director of the New Jersey District

3. Project Management Made Simple: Key Principles Know what you need Know when you need it Know what you can pay

4. Project Management Made Simple: Guidelines Priorities Based Process Focused Systems Aligned Systems Integrated Results Driven

5. One Page Project Process Map One Page Question to the Void Worksheet One Page Project Overview Worksheet One Page Project Initiating Worksheet One Page Project Planning Worksheet One Page Effective Meeting Worksheet Project Management Made Simple: Technical Quick Connects

6. Project Management Made Simple: Plan The Project Project Mission Identify Desired Outcomes Identify Customers Identify Customer Requirements Identify Supplier Specifications Identify Steps In The Process Identify Measures

7. Project Management Made Simple Analyze The Project Opportunity Define the Project Explore the Project Analyze the Project Identify Potential Solutions Select Solution(s)

8. Project Management Made Simple: Lead The Project Design the Project Plan Implement the Project Plan Evaluate the Outcome Achieve Desired Outcome Yes – Document and Standardize Monitor No- Identify Cause Yes, go to Design Project Plan No, go to Explore the Project

9. Project Vision and Mission Statements Identify Desired Outcome Identify Customers Identify Customer Requirements Identify Supplier Specifications Identify Steps in the Process Tools : Identify Measures Define the Project Analyze the Opportunity Identify Choices Select Best-Balanced Choice Design the Project Plan Execute and Control the Project Evaluate Outcome Desired Outcome Achieved? Monitor Yes Cause Identified ? 1 2 3 Top-down Flow Chart Flow Chart Work Flow Diagram Document & Standardize Yes Quality Systems Approach No Yes No Explore Causes Cause-Effect Diagram Collect & Analyze Data Pareto Diagram 6 3 9 6 3 1 11 1111 11 Type Size Check Sheet Histogram Run Chart Scatter Diagram Control Chart Phase I: Initiating Project Phase II:Planning Project Phase III: Executing the Project One Page Project Map . . . . . . .

10. Project Management Made Simple: Question to the Void What is the project? Why have the project? How to do the project? Where is the project? When is the project? Who does the project?

11. Project Management Made Simple: One Page Project Overview Initiating Planning Executing Controlling Closing

12. Project Management Made Simple: One Page Project Initiating Worksheet Initiating Members Money Machines Materials Methods Create/Innovate Negotiate Communicate Motivate Educate Administrate

13. Project Management Made Simple: One Page Project Planning Worksheet Planning Members Money Machines Materials Methods Defining Scoping Risk Analysis

14. One Page Project Overview How Where When Who Initiating Headquarters First Quarter Sponsor Members Sponsor/Client Money Sponsor/Client Machines Sponsor/Client Materials Sponsor/Client Methods Sponsor/Client Create/Innovate Client/Sponsor Negotiate Sponsor/Client Communicate Sponsor/Client/Manager Motivate Sponsor/Leader/Client Educate Leader/Sponsor/Client Administrate Manager/Sponsor/Client Planning Headquarters/On-Site Second Quarter Sponsor/Manager/Client Members Operations Money Finance Machines Operations Materials Operations Methods Administration Defining Scoping Risk Analysis Scheduling Executing On-site Second - Fourth Quarter Team Basic Process Model Controlling On-Site/Headquarters/Client Second - Fourth Quarter Sponsor/Team/Client Situation Appraisal Team Closing On-site Fourth Quarter Sponsor/Manager/Client

15. Project Management Made Simple: One Page Effective Meeting Worksheet Roles Attendance Date Cost Start History Action Rate Plan

16. TEAM NAME____________________LEADER_____________________DEPT____ FACILITATOR___________________RECORDER__________________DATE____ MEMBERS' NAMES TEAM MEETING COSTS ______________________ _______________ number of members present ______________________ _______________ (times) average hourly rate ______________________ _______________(times) average benefit value ______________________ _______________(equals) meeting costs START : Time______Location______Guests_______ List objectives of This Meeting _________________________________________________________________ _________________________________________________________________ HISTORY : Read and Approve Previous Meeting Minutes Yes____No_____ List Old Business Discussed ______________________________________________________________ ______________________________________________________________ ACTION : Describe How the Objectives of This Meeting Were Accomplished ______________________________________________________________ ______________________________________________________________ RATE : How Do We Feel About This Meeting? _____________________ What Will We Do Different Next Meeting? _________________________ PLAN : Schedule the Next Meeting, List Objectives, List Assignments Date:_____________Time:___________________Location:______________ Objectives: _____________________________________________________ _______________________________________________________________ _______________________________________________________________ Assignment Responsible Party Due Date _______________________________________________________________ _______________________________________________________________

17. CDRH Strategic Plan

18. CDRH Strategic Plan Our Mission Promoting and protecting public health by ensuring the safety and effectiveness of medical devices and the safety of radiological products

19. CDRH Strategic Plan Our Vision Ensuring the health of the public through out the Total Product Life Cycle (TPLC)

20. CDRH Strategic Goals Goal 1: Public Health Impact Goal 2: Magnet for Excellence Goal 3: Knowledge Management Goal 4: Total Product Life Cycle (TPLC)

21. Strategic Plan Goals Priorities Focus Areas & Initiatives Scorecards & Budget Execution & Evaluation

22. In its most fundamental sense, execution is a systematic way of exposing reality and acting on it “ We don’t think ourselves into a new way of acting, we act ourselves into a new way of thinking” Execution

23. How do we execute the strategic plan ? Project Management Plans Long term projects New initiatives Scorecards Performance in Key Result Areas (KRAs)

24. Meeting MDUFMA Performance Goals We're setting milestones for review… Scientific Review Scientific Review Interactive Review Filing Review Panel Planning Closeout Review Panel Go/No Go Panel Meeting Final Decision 320 days Major Deficiency Letter Clock Stops Consults Complete PMA Received Status Letter Filing Letter

25. Quality System for Application Review We're using quality systems to assure quality reviews… Focusing on selected cross-cutting areas e.g., biocompatibility Using retrospective (post-decision) peer assessments Assembling quality assessment teams Continuing with pilot program

26. So why do we need a strategic plan? We’re using strategic planning to meet our challenges… Managing a changing workload Meeting changing stakeholder demands and expectations Making best use of our limited resources Conducting business in an open and transparent manner Looking beyond the next “fire drill”!

27. And what do we need from you? Awareness Energy Ideas Patience Support

29. Project Management Made Simple Conclusion Apply the Key Principles Know what you need Know when you need it Know what you can pay Follow the Guidelines Priorities Based Process Focused Aligned Integrated Results Driven Mitchell W. Manning Sr. [email_address] Chief Priorities Officer 252.714.3481 cell Priorities Limited LinkedIn.com

30. For other presentations and documents by Mitch: google “Mitchell Manning’s presentations on SlideShare” Project Management Made Simple The Corporate University Catalog Corporate Training for the Management Team Interview Skills Clinic Grant Writing Project Proposal Workbook Teambuilding for an FDA Inspection Our Leadership for an FDA Inspection Regulatory Compliance 2010 Process Mapping Career Development: A Fifty Year Process Working With People Mitch’s programs can be customized to your site, and your organization, and piloted within one week of contracting. Mitchell W. Manning Sr. [email_address] Chief Priorities Officer 252.714.3481 cell Priorities Limited LinkedIn.com