E03B Project Quality System

What is a Project Quality System?

It is a term used to describe the overall framework and processes, and the various elements (procedures, forms and resources) involved in improvements to projects. Improvements include quality of work, compliance, cost and schedule.
Project Quality System model – the flowchart below shows the processes, procedures and forms for the system.

WHY DO WE NEED A PROJECT QUALITY SYSTEM?

Common weaknesses in executing GMP-Projects are:
1) that the Regulatory/GEP/GMP requirements expected by the Client are not well defined and relayed to the Contractor
2) Client as well as Contractor does not have a quality system in place – there is no baseline to benchmark
3) the processes and expectations are not mapped out – so that every team member understands the requirements, procedures and expected outcomes

The quality system model will take you through each logical step to ensure deliverables to GMP Projects are met with maximum quality, compliance, cost and timeline benefits.

A QUALITY SYSTEM SHOULD:
1) Set project quality standards, targets, deliverables and acceptance criteria ie Quality Policy and Plan
2) Define how those quality targets will be measured, documented and tested
3) Take the actions needed to measure quality
4) Identify quality issues and improvements
5) Define the Testing and Qualification processes to report how the required acceptance criteria are met.

WHEN A QAULITY SYSTEM IS PROPERLY IMPLEMENTED:
1) it will minimise rejects, rework and project scope variations
2) the processes and documentation generated are transferable from design through to equipment qualification – ie avoid repetitive documentation
3) the expectations from all stakeholders can be met, and so on.

SCOPE OF A QUALITY SYSTEM:

1) The procedures and forms in the system cater for all stakeholders from the Client, Equipment Suppliers to Contractors.
2) The procedures are practical “no-frills” approach and written for the “layman” – easy to understand and implement. The system is most suited to medium size project but can be extended for larger projects and multiple disciplines (eg electrics and controls).
3) all the processes, procedures and forms are well proven and have been implemented by many Design/Construct Contractors and by Client Project Teams in GMP Facilities.

The processes, procedures and forms are listed in the flowchart below.

A Free Whitepaper is available for download – E03-5000 A Simple Quality System Model for GMP Projects (also see listing below)

Showing 1–10 of 22 results


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    E03-5000 A SIMPLE QUALITY-SYSTEM MODEL FOR GMP PROJECTS

    Some GMP projects fail to deliver effective results because the deliverables are not fully interpreted and communicated among parties, especially the Contractor. This white paper provides a simple process map for your GMP projects. This is a FREE DOWNLOAD

    Free! Add to cart

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    E03-5000A PROJECT QUALITY SYSTEM FLOWCHART (Adobe PDF)

    The quality system model will take you through each logical step to ensure deliverables to GMP Projects are met with maximum quality, compliance, cost and timeline benefits.

    Free! Add to cart

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    E03-5000A PROJECT QUALITY SYSTEM FLOWCHART (MS Visio)

    The quality system model will take you through each logical step to ensure deliverables to GMP Projects are met with maximum quality, compliance, cost and timeline benefits.

    This is in Microsoft Visio format to allow you to edit to suit your Quality System.

     

    $15 Add to cart

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    E03-5001 POLICY STATEMENT GMP-PROJECT QUALITY SYSTEM

    A Project Quality System ensures deliverables to GMP Projects are met with maximum quality, compliance, cost and timeline benefits. This Policy highlights the need for procedures and forms in the system essential to the Client and Project Contractor.

    $40 Add to cart

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    E03-5002 PROJECT CHANGE CONTROL

    Change control is a core concept of Project Quality System. This procedure and form provide a method to monitor and control project change. The form provides a checklist to evaluate the impact of a project change on scope, compliance, cost and schedule.

    $45 Add to cart

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    E03-5002 PROJECT CHANGE CONTROL

    Change control is a core concept of Project Quality System. This procedure and form provide a method to monitor and control project change. The form provides a checklist to evaluate the impact of a project change on scope, compliance, cost and schedule.

    $45 Add to cart

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    E03-5003 PROJECT QUALITY PLAN

    A Project Quality Plan is a set of activities planned at the beginning of a project that helps achieve Quality in the Project being executed. The template includes procedures and checklist to develop the plan. “Fail to plan, then plan to fail”

    $45 Add to cart

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    E03-5004 PROJECT CONSTRUCTION CHECKLIST

    This Project Procurement/ Construction Check list / Form is a tool evolved from “Right-first-time” principles by contracting companies to avoid unnecessary rework and waste of human resources. 130 items in the checklist cover the start-finish of a project.

    $45 Add to cart

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    E03-5101 PROJECT DOCUMENTATION & TESTING REQUIREMENTS

    This process is one of the most important in a GMP Project as it lays the expectation from the Client to the Contractor or Supplier.

    This procedure/Form provides a checklist of the processes, documentation and testing required for the contract between Client and Contractor as well as for the qualification process. This document forms the basis of your Validation Plan.

    $35 Add to cart

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    E03-5301 PROJECT PROCUREMENT & INSPECTION PROCEDURE

    This procedure ensures the specifications and acceptance criteria for equipment and project are relayed to materials/equipment suppliers and sub-contractors during procurement and inspection. It includes a Procurement Form and an Inspection form.

    $50 Add to cart