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Establishing manufacturing
management strategies
Clinical Trials Supply New England 2016
Eyal S. Ron, Ph.D.
Chief Technology Officer
501 Boylston Street; Suite 6102
Boston, Massachusetts 02116
Tel: +1 617.308.8200
Email: eron@gelesis.com / Eyal@MADASH.com
Web: www.gelesis.com
Twitter: @EyalSRon
Establishing manufacturing management
strategies and examining selection
processes to ensure the best manufacturer
is selected for your company
 Outline:
 Introduction
 Manufacturing Management Strategies
 Requests for proposals (RFPs)
• The organization's culture and needs
• Project Requirements
• Timeline / Milestones / Deadlines
• “Killer” criteria
• Decision / Evaluation
What is a Manufacturing Management
Strategy?
 A pattern of decision making with certain consistency
 Steady buildup of small decisions that gradually formed as action pattern for
the company (all stake holders)
 Strategy as plan (vision)
• Strategy as "what top management says“
or
• Strategy as pattern (action pattern)
Strategy and implementation are inseparable (and are a vital force
in overcoming resistance to change)
Manufacturing Management Strategies
Business Strategy
Competitive priorities
(e.g., cost)
Decision categories
(e.g., performance)
Manufacturing Strategy
Two major constituents of manufacturing strategy:
competitive priorities and decision categories
Request for Proposal (RfP)
A request for proposal (RfP) is a solicitation, often made
through a bidding process, by an agency or company
interested in procurement of a commodity, service or
valuable asset, to potential suppliers to submit business
proposals. It is submitted early in the procurement cycle,
either at the preliminary study, or procurement stage
https://en.wikipedia.org/wiki/Request_for_proposal
What's the Purpose of the RfP Process, and
When Do You Need One?
 Finding the site/vendor/OM that best suits the needs of the
organization
 an opportunity to interview key stakeholders and bridge the gap
between the vague aspirations that launch a project and the
concrete, measurable requirements that guide it to successful
conclusion
 Accountability and good governance (encourages fairness and
transparency while minimizing the likelihood of favoritism)
Steps in the RfP Process
 Establish the project's boundaries
 Identify key stakeholders and advisors
 Define your project needs
 Draft the RFP
• Create a draft of the scoring criteria
• Review with the team (stakeholders and advisors)
 Select 3 – 5 Regions / vendors / OM
 Submit the RfP
 Q & A
 Review proposals
What Information Should be Included in
the RfP?
 Organizational background
 Project Description / objectives
 Product Description
 Project Requirements / acitivites
 Timeline (create a reasonable timeline)
• Milestones / Deadlines
 Questions and required information
• A “Killer” criteria
• Questions based on past experiences
• MSDS, Product specifics (such as physical properties)
• Fee structure
 Contact information and deadline for submissions
RfP Specifications
Examples of quantitative measures that will be evaluated in the vendor's
response
 Product drawings
 Engineering tolerances
 Service levels
 Technical or Business Requirements
 Functionality
 Hardware requirements
RfP’s “Do Nots”
 Misleading information
 Different verbal and written communication
 Ask for “Freebies”
 Champion receiving lowest prices
http://sunnibrown.com/wp-content/uploads/2009/07/RFP-Evaluation-Process-31.png
RfP Challenges
 Not all vendors with the appropriate capabilities will be interested in the
amount of business that are offered
 Forecasts of future needs are uncertain, but they set the foundation for
credibility with the vendor
 Rushing through the process can lead to costs inaccuracies and mistakes
 Product’s quality must be inline with the competitive priorities and the
decision categories
 With frequent product changes, establishing a single point of communication
 Managing the end of a relationship is often viewed as adversarial and
therefore not addressed until a crisis occurs
 The vendor’s team that wins often isn’t the team that services the business
relationships
 Ensuring compliance with regulatory directives
Evaluation Criteria
 Quality
 Timeline
 Cost
 Quality of communication
 Project leader
 Do they “get us”?
 Contract
Cost True Cost
Quality Defects/ # of lot failures
Delivery Lead time
Innovation Number of ideas / improvements from the vendor
Evaluate RfP
by Alex Lichtenberger • Allgemein, IT Governance
Evaluate RfP - do not judge a vendor
solely on the proposal
 Meet the vendor
• Management
• Team
• Project leader
• Communication style
 Optionally, audit the vendor
 References
 Does the vendor really wants to win the proposal?
Establishing manufacturing management
strategies
 Conduct negotiations
 Consider subjective criteria other than price in the
 Award contract
Relationships / Contracts
Partnership
PO Relationship
Contract
RelationshipManaged
Relationship
Adequacy of the Supplier
Importance
Summary
 A pattern of decision making with certain consistency
 Steady buildup of small decisions that gradually formed as action pattern for
the company
 Manufacturing strategy as pattern (action pattern)
 Strategy and implementation are inseparable
 Exploited through the RfP process
Make Manufacturing a Competitive
Advantage
Thank you!
Eyal S. Ron, Ph.D.
Eyal@madash.com
+1 617-308-8200

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Establishing manufacturing management strategies

  • 1. Establishing manufacturing management strategies Clinical Trials Supply New England 2016 Eyal S. Ron, Ph.D. Chief Technology Officer 501 Boylston Street; Suite 6102 Boston, Massachusetts 02116 Tel: +1 617.308.8200 Email: eron@gelesis.com / Eyal@MADASH.com Web: www.gelesis.com Twitter: @EyalSRon
  • 2. Establishing manufacturing management strategies and examining selection processes to ensure the best manufacturer is selected for your company  Outline:  Introduction  Manufacturing Management Strategies  Requests for proposals (RFPs) • The organization's culture and needs • Project Requirements • Timeline / Milestones / Deadlines • “Killer” criteria • Decision / Evaluation
  • 3. What is a Manufacturing Management Strategy?  A pattern of decision making with certain consistency  Steady buildup of small decisions that gradually formed as action pattern for the company (all stake holders)  Strategy as plan (vision) • Strategy as "what top management says“ or • Strategy as pattern (action pattern) Strategy and implementation are inseparable (and are a vital force in overcoming resistance to change)
  • 4. Manufacturing Management Strategies Business Strategy Competitive priorities (e.g., cost) Decision categories (e.g., performance) Manufacturing Strategy Two major constituents of manufacturing strategy: competitive priorities and decision categories
  • 5. Request for Proposal (RfP) A request for proposal (RfP) is a solicitation, often made through a bidding process, by an agency or company interested in procurement of a commodity, service or valuable asset, to potential suppliers to submit business proposals. It is submitted early in the procurement cycle, either at the preliminary study, or procurement stage https://en.wikipedia.org/wiki/Request_for_proposal
  • 6. What's the Purpose of the RfP Process, and When Do You Need One?  Finding the site/vendor/OM that best suits the needs of the organization  an opportunity to interview key stakeholders and bridge the gap between the vague aspirations that launch a project and the concrete, measurable requirements that guide it to successful conclusion  Accountability and good governance (encourages fairness and transparency while minimizing the likelihood of favoritism)
  • 7. Steps in the RfP Process  Establish the project's boundaries  Identify key stakeholders and advisors  Define your project needs  Draft the RFP • Create a draft of the scoring criteria • Review with the team (stakeholders and advisors)  Select 3 – 5 Regions / vendors / OM  Submit the RfP  Q & A  Review proposals
  • 8. What Information Should be Included in the RfP?  Organizational background  Project Description / objectives  Product Description  Project Requirements / acitivites  Timeline (create a reasonable timeline) • Milestones / Deadlines  Questions and required information • A “Killer” criteria • Questions based on past experiences • MSDS, Product specifics (such as physical properties) • Fee structure  Contact information and deadline for submissions
  • 9. RfP Specifications Examples of quantitative measures that will be evaluated in the vendor's response  Product drawings  Engineering tolerances  Service levels  Technical or Business Requirements  Functionality  Hardware requirements
  • 10. RfP’s “Do Nots”  Misleading information  Different verbal and written communication  Ask for “Freebies”  Champion receiving lowest prices
  • 12. RfP Challenges  Not all vendors with the appropriate capabilities will be interested in the amount of business that are offered  Forecasts of future needs are uncertain, but they set the foundation for credibility with the vendor  Rushing through the process can lead to costs inaccuracies and mistakes  Product’s quality must be inline with the competitive priorities and the decision categories  With frequent product changes, establishing a single point of communication  Managing the end of a relationship is often viewed as adversarial and therefore not addressed until a crisis occurs  The vendor’s team that wins often isn’t the team that services the business relationships  Ensuring compliance with regulatory directives
  • 13. Evaluation Criteria  Quality  Timeline  Cost  Quality of communication  Project leader  Do they “get us”?  Contract Cost True Cost Quality Defects/ # of lot failures Delivery Lead time Innovation Number of ideas / improvements from the vendor
  • 14. Evaluate RfP by Alex Lichtenberger • Allgemein, IT Governance
  • 15. Evaluate RfP - do not judge a vendor solely on the proposal  Meet the vendor • Management • Team • Project leader • Communication style  Optionally, audit the vendor  References  Does the vendor really wants to win the proposal?
  • 16. Establishing manufacturing management strategies  Conduct negotiations  Consider subjective criteria other than price in the  Award contract
  • 17. Relationships / Contracts Partnership PO Relationship Contract RelationshipManaged Relationship Adequacy of the Supplier Importance
  • 18. Summary  A pattern of decision making with certain consistency  Steady buildup of small decisions that gradually formed as action pattern for the company  Manufacturing strategy as pattern (action pattern)  Strategy and implementation are inseparable  Exploited through the RfP process
  • 19. Make Manufacturing a Competitive Advantage Thank you! Eyal S. Ron, Ph.D. Eyal@madash.com +1 617-308-8200