Project Management: "made simple" using quick connects
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Transcript of Project Management: "made simple" using quick connects
Project Management“Made Simple”
Using Technical and Behavioral Quick Connects
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Project Management Made Simple:
from the Introduction of Mitch Manningby 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 LewisFormer 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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• 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:
Technical Quick Connects
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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Project Vision andMission Statements
Identify Desired Outcome
Identify Customers
Identify CustomerRequirements
Identify SupplierSpecifications
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 andControl the Project
EvaluateOutcome
Desired OutcomeAchieved?
Monitor
YesCause
Identified?
1 2 3
Top-down Flow Chart
Flow Chart
Work Flow Diagram
Document & Standardize
Yes
Quality Systems Approach
NoYes
No
Explore CausesCause-Effect
Diagram
Collect & Analyze Data
Pareto Diagram
6 3 9631
11111111 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
... ... .
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 OverviewHow Where When Who
Initiating Headquarters First Quarter SponsorMembers Sponsor/ClientMoney Sponsor/ClientMachines Sponsor/ClientMaterials Sponsor/ClientMethods 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/ClientMembers OperationsMoney FinanceMachines OperationsMaterials OperationsMethods Administration Defining
Scoping
Risk Analysis
Scheduling
Executing On-site Second - Fourth Quarter TeamBasic Process Model
Controlling On-Site/Headquarters/Client Second - Fourth Quarter Sponsor/Team/ClientSituation 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 AssignmentsDate:_____________Time:___________________Location:______________Objectives: ___________________________________________________________________________________________________________________________________________________________________________________
Assignment Responsible Party Due Date______________________________________________________________________________________________________________________________
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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 VisionEnsuring 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
Strategic Plan
Goals
PrioritiesPriorities
Focus Areas & Initiatives
Focus Areas & Initiatives
Scorecards & Budget
Scorecards & Budget
Execution &Evaluation
Execution &Evaluation
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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
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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 GoalsWe'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 Clock StopsStops
Consults Complete
PMA Received
Status Letter
Filing Letter
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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?
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”!
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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
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Apply the Key Principles
Know what you needKnow when you need itKnow what you can pay
Follow the GuidelinesPriorities BasedProcess FocusedAlignedIntegratedResults Driven
Mitchell W. Manning Sr. [email protected] Priorities Officer 252.714.3481 cellPriorities Limited LinkedIn.com
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Project Management Made SimpleThe Corporate University Catalog
Corporate Training for the Management TeamInterview Skills Clinic
Grant Writing Project Proposal WorkbookTeambuilding for an FDA Inspection
Our Leadership for an FDA InspectionRegulatory Compliance 2010
Process MappingCareer 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 protected] Priorities Officer 252.714.3481 cellPriorities Limited LinkedIn.com
For other presentations and documents by Mitch:google “Mitchell Manning’s presentations on SlideShare”