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”