Project Management

Made Simple

Using Technical and

Behavioral Quick
Connects

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 Project Management Made Simple:

from the Introduction of Mitch Manning

by Matt Lewis at the 23rd 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

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 Project Management Made
Simple:

Key Principles
Know what you need
Know when you need it
Know what you can
pay

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Project Management Made
Simple:

Guidelines
Priorities Based
Process Focused
Systems Aligned
Systems Integrated
Results Driven

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 Project Management Made Simple:

Technical Quick
Connects
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

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 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

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 Project Management Made Simple

Analyze The Project

Opportunity
Define the Project
Explore the Project
Analyze the Project
Identify Potential
Solutions
Select Solution(s)

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 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

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 One Page Project Map
Phase I: Initiating Project Phase II:Planning Project Phase III: Executing the Project
Project Vision and
Mission Statements Define the Project Design the
Project Plan
Identify Desired Outcome Explore Causes
Cause-Effect
Diagram
Execute and
Identify Customers Control the Project
Analyze the Opportunity
Identify Customer Collect & Analyze Data

Requirements Type
Size
11
1111
1 3
11 6 Evaluate
6 3 9
Pareto Diagram Check Sheet Outcome
Identify Supplier
Specifications
Histogram Run Chart

. .. . . .
Identify Steps in the Process Desired Outcome
Tools: Achieved?
Top-down Flow Chart Yes No Yes
Scatter Diagram Control Chart
1 2 3
Cause
Flow Chart Identified Yes
Identify Choices ?
Document &
No
Standardize
Work Flow Diagram
Select Best-Balanced Quality Systems
Approach
Choice
Monitor
Identify Measures
 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?

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 Project Management Made Simple:

One Page Project Overview

Initiating
Planning
Executing
Controlling
Closing

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 Project Management Made Simple:

One Page Project Initiating

Worksheet
Initiating
Members
Money
Machines
Materials
Methods
Create/Innovate
Negotiate
Communicate
Motivate
Educate
Administrate

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 Project Management Made Simple:

One Page Project Planning

Worksheet
Planning
Members
Money
Machines
Materials
Methods
Defining
Scoping
Risk Analysis

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 One Page Project
Initiating
How
Overview Where
Headquarters
When
First Quarter Sponsor
Who

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

 Project Management Made Simple:

One Page Effective Meeting

Worksheet
Roles
Attendance
Date
Cost
Start
History
Action
Rate
Plan
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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

_______________________________________________________________
_______________________________________________________________
CDRH Strategic Plan

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 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

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 CDRH Strategic Plan

Our Vision
Ensuring the health of the public
through out the Total Product
Life Cycle (TPLC)

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CDRH Strategic Goals
Goal 1: Public Health Impact

Goal 2: Magnet for Excellence

Goal 3: Knowledge Management
Goal 4: Total Product Life Cycle
(TPLC)

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 Strategic
Plan
Goals
Execution &
Evaluation Priorities

Scorecards & Focus Areas &

Budget Initiatives

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 Execution

In its most fundamental sense,

execution is a systematic way of
exposing reality and acting on it

We dont think ourselves into a

new way of acting, we act
ourselves into a new way of
thinking

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How do we execute the strategic
plan?
Project Management Plans
Long term projects
New initiatives

Scorecards
Performance in Key Result Areas (KRAs)

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 Meeting MDUFMA Performance
Goals
We're setting 320
milestones
days for review

PMA Received
Clock
Filing Review Stops

Filing Letter

Scientific Review Scientific Review Interactive Review

Consults Panel Go/No Go Status Letter

Complete
Panel Planning

Major
Deficiency Panel Meeting
Letter
Closeout Review

Final Decision
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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

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So why do we need a strategic
plan?
Were 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!
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And what do we need from
you?
Awareness
Energy
Ideas
Patience
Support

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 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. manningmitch@aol.com

Chief Priorities Officer 252.714.3481 cell
Priorities Limited LinkedIn.com
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For other presentations and documents by Mitch:
google Mitchell Mannings 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
Mitchs programs can be customized to your site, and your
organization, and piloted within one week of contracting.

Mitchell W. Manning Sr. manningmitch@aol.com

Chief Priorities Officer 252.714.3481 cell
Priorities Limited LinkedIn.com
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