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GEP In Projects – To Practice, Or Not To Practice?

By Bob Perry , October 17, 2017

As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project.  The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle.  A critical component for assuring stakeholder requirements are satisfied is following good engineering practice (GEP).  While GEP is an expectation in the life sciences industries, the basic GEP elements required as a basis for GxP (good “anything” practice) quality guidelines and regulations compliance can, and should be, applied to all projects.

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The core concepts of GEP for GxP projects are risk management, cost management, and organization and control.  These core concepts are applicable to all phases of the project lifecycle and are typically grouped into project engineering, common practices, and operations and maintenance.  While the concepts I’ve listed are from the ISPE Good Practice Guide: Good Engineering Practice, they are very similar to the processes found in PMI’s A Guide to the Project Management Body of Knowledge. 

GEP is a critical component in all project phases.  For simplicity, let’s use the typical project stage phases (gates) defined in the ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry – Feasibility, Concept Development, Project Delivery Planning, Project Delivery Design, Project Delivery Implementation, and Project Close-out.  Following are some of the GEP tasks performed in each of the project phases:

  

PROJECT PHASE

GEP TASKS

Feasibility

Process design, regulatory support, preliminary process flow drawings (PFDs), sustainability criteria, cost analysis, etc.

Concept Development

User requirements (URS) development support, conceptual design review, PFD review, preliminary basis of design (BOD) concept, utility requirements, value reviews, etc.

Project Delivery Planning

Design management strategy, testing (CQV) strategy, BOD development, procurement strategy, start-up strategy, etc.

Project Delivery Design

BOD review, design reviews, equipment selection reviews, utility matrix reviews, regulatory reviews, non GxP regulatory reviews, maintainability reviews, sustainability reviews, design risk management, design change control, etc.

Project Delivery Implementation

Procurement specifications review, proposal response review, submittal reviews, field engineering support, change order reviews, testing (CQV) support, training support, red-lined drawing reviews, SOP reviews, engineering change control, etc.

Project Close-out

As-built drawing reviews, TOP (turnover package) reviews, preventative maintenance program development, regulatory reviews, controlled documentation storage/maintenance, etc.

From the table above it is evident that GEP is engrained in the entire project lifecycle.  The elimination or reduction of GEP in any project phase will affect the quality of the project and, potentially, the ability to achieve regulatory approval.  Resist the temptation to limit engineering involvement on projects under the misguided belief that this will help save time and money.  Any design mistakes that make it through the feasibility, concept, delivery planning, or design phase to the project implementation phases will result in increased costs for rework, compromised quality, and may cause schedule slippage.  This slippage has a direct impact on the project’s completion date and product time to market.

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“GEP in projects - to practice or not to practice?” should never be a question for debate.  Under estimating the importance of GEP in any/all project phases, especially the early project phases, will result in increased project costs, compromised quality, and could extend product time to market.  As responsible Project Managers, we owe it to our project stakeholders and their clients (patients, shareholders, consumers, etc.) to assure adequate GEP participation throughout the project lifecycle.

Reach out to our Owner’s Project Management Business Area Lead, Bill Deckert, with any questions or concerns when it comes to GEP in your projects.

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Topics: OPM, Compliance, Regulatory