Establishing manufacturing

management strategiesClinical 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

Import

ance

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