Engineering

Guidelines

18-Aug-2013

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Mylan Engineering Guidelines

Mylan Engineering needs to:

– Provide a consistent approach to the Management of Capital Projects.

– Provide a similar product irrespective of location or assigned Engineer.

Engineering Guidelines

– to facilitate a consistency of approach and output

– provide staff with a toolbox to assist them in the preparation, execution

and reporting of projects.

– support and are supported by Good Engineering Practices and

Corporate Policies and Procedures.

– do not replace requirements contained in Corporate Policies and

Procedures

Guidelines apply to:

– All Capital Project Requests (CPR) that include monies for facilities,

utilities, or equipment when "total project" costs are in excess of U.S.

$50k.

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Mylan Engineering Guidelines

Procedure

PCG-00

PCG-01

PCG-02

PCG-03

PCG-04

PCG-05

PCG-06

Title

Introduction & Contents

Project Initiation – Global Engineering Review & Approval

Project Scoping – Conceptual Studies & Basis of Design

Development Guideline

Cost Management, Forecasting and Invoice Approval

Project Change Orders

Project Scope Change Process

Capital Project Reporting

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Additional Project Controls

Mylan Engineering Guidelines

Project Initiation – Global Engineering Review & Approval

• All Capital Project Requests (CPR) that include monies for facilities, utilities, or

equipment when "total project" costs are in excess of U.S. $50k. These CPRs must

be approved by Mylan Global Engineering at the initial planning stage of the project.

PCG-01

Based on the larger capital investment, additional project controls are required for

projects that fall under this Guideline.

Global Engineering Review & Approval (Signature / e-mail) > $50k

CPR Submission Supporting Data Checklist > $50k

Capital Project Cost Estimate Form > $250k

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Mylan Engineering Guidelines

Global Engineering Review & Approval (Signature / e-mail)

• Review to occur as part of annual budget process (Capital Project Pre-Approval

Form) and during formal Capital Project Request (CPR) submission.

• Approval is to be maintained as part of the complete CPR documentation.

CPR Submission Supporting Data Checklist

• Help to facilitate the review process

• Required to be completed as support for the project and included with the Capital

Project Pre-Approval Form or Capital Project Request (CPR) at time of submission

for review by Mylan Global Engineering.

• As projects can vary greatly, the supporting information provided should support the

overall project narrative.

Capital Project Cost Estimate Form

• The Cost Estimate should give the necessary resolution to support the “Amount

Requested”

• Standardizes format

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Mylan Engineering Guidelines

Project Scoping – Conceptual Studies & Basis of Design

Development Guideline PCG-02

Conceptual Studies & BOD Development

• Poor scope definition in an engineering design project increases the risk of

increased project time and costs.

• Document defines the minimum engineering deliverables necessary to support

Conceptual Studies and Basis of Design (BOD) Development

• Utilized to help ensure that the design objective meets the project objectives, and to

allow for key design decisions to be made early in the design process.

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Mylan Engineering Guidelines

Cost Management, Forecasting and Invoice Approval

This guideline establishes accounting and financial record keeping and control reporting

requirements covering capital projects.

PCG-03

Standard templates to use.

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Mylan Engineering Guidelines

Project Change Orders PCG-04

Project Scope Change Process PCG-05

This guideline establishes accounting and financial record keeping and control reporting

requirements regarding change orders to an original scope of work of a contact that

occur during project execution.

• Applies to changes to specification & design intent that are proposed from the time

of BOD Approval to the completion of Performance Qualification

• For a change to be in the context of this guideline, it must be a rather a fundamental,

far reaching change to an Approved Design

• Used to identifying significant changes and assessing their effect on the project so

that the Project Team may decide to adopt or to reject a change, knowing the

implications of the decision.

• Allows for audit trail to be maintained

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Mylan Engineering Guidelines

Capital Project Reporting PCG-06

• Guideline details the specific requirements in updating and presenting project

information on a monthly basis.

• Standardizes a monthly report that shall be generated - a one-page summary under

the three headings of Scope, Cost and Schedule.