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Detailed Design to Construction in Factory Construction

The three major elements that need to be managed during the construction phase are quality, cost, and schedule. Once construction work starts, a multitude of drawings, such as construction plans and procedures, inspection procedures, and construction and fabrication drawings, will be submitted, and the client will be required to approve them. These approval actions must be performed promptly to ensure quality while keeping the project on schedule.

Furthermore, in pharmaceutical factories…Awareness of GMPFurthermore, in pharmaceutical factories…Awareness of GMP

It is also important to comply with GMP requirements. Even if the construction company (contractor) has extensive experience in building pharmaceutical factories, its construction managers might not fully understand the characteristics of formulation factories and the essence of GMP. Amidst inevitable design changes, the client (factory owner/user) must accurately judge whether GMP requirements are being adhered to. CM Plus is a professional in pharmaceutical factory construction. We support the client in these tasks, reduce the client’s workload, ensure construction quality, evaluate the validity of additional claims, and manage proper construction progress.

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Detailed Design to Construction Phase Implementation

Building the Framework for Project Execution – “Project Execution Procedure” (PEP)

The Project Execution Procedure (PEP) is a document that clarifies the project’s objectives, processes, related construction companies, contact points, and document management procedures. It serves as a reference for smooth project operations by sharing an understanding among stakeholders on how the project will be executed.
Examples of items to be included in the PEP are as follows. Items are set as needed, considering the characteristics of the project.

  • 1)Project objectives
  • 2)Master schedule
  • 3)Related company organizations
  • 4)Contact persons for each company
  • 5)Communication methods
  • 6)Methods for verifying inquiries and technical documents
  • 7)Document issuance procedures and document approval procedures
  • 8)Document change procedures
  • 9)Establishment of regular meetings
  • 10)Segmentation of inspection attendance during construction
  • 11)Inspection attendance categories and inspection attendance application procedures
  • 12)Government inspections
  • 13)Acceptance conditions and procedures
  • 14)As-built documentation requirements
  • 15)Procedures for managing contractual additions and changes

Schedule Management

The master schedule serves as the compass for schedule management. The master schedule includes not only the construction company’s work items but also the order, production, and site delivery timings of production equipment directly ordered by the factory owner, as well as major validation activities.
The Construction Manager (CMr) leads and ensures that all stakeholders adhere to this master schedule.

Execution Budget Management

The execution budget is based on the estimate agreed upon with the construction company. As detailed design and construction progress, changes and adjustments may become necessary, leading to additional change requests from the construction company. This requires continuous management. Project managers and Construction Managers (CMr) need to thoroughly read the contractual terms and develop negotiation scenarios, as negotiations with construction companies and suppliers will be frequent.
Also, as a risk management measure for the client, it is customary to secure a contingency allowance for additional costs, separate from the construction contract amount.

Procurement Management

Procurement management requires oversight in terms of delivery timelines and quality. Especially for long-lead items (such as production equipment, structural steel, HVAC systems, and other large equipment), it is necessary to identify these during the initial stages of schedule planning and to adjust the schedule to include major events from order placement to delivery (such as specification determination, material ordering, and inspections). For quality control, suppliers are asked to submit material certifications, inspection items, and methods, and it is verified that these are carried out thoroughly.

Governmental Applications and Inspections

Construction projects require governmental applications. In Japan, this includes many pre-construction tasks such as building confirmation applications, development permission applications, energy-saving conformity assessments, and factory location laws. Governmental inspections are also conducted during construction and upon completion. It is necessary to list all application and notification items early in the scheduling process and to clarify the scheduled application dates. Additionally, the required applications may differ based on local government requirements and the characteristics of the specific site, so caution is necessary. Some applications require the approval of other permissions, so it is essential to clarify these relationships when listing application items.
Overseas, the legal frameworks may be inadequate or still evolving. Consequently, even if activities are conducted according to published laws, unexpected guidance may be received. Hiring consultants experienced in the specific country’s circumstances allows for planning that anticipates the actual submission periods.

At CM Plus…

Team Familiar with Production Facilities

Team Familiar with Production Facilities

CM Plus is a professional in production facilities. Our team, including Construction Managers (CMr), understands the characteristics of production facilities and is experienced, thus ensuring the quality of our clients. Our strength lies in our ability to coordinate not only construction equipment but also production machinery directly ordered by our clients. CM Plus supports construction projects by understanding the complexities of scheduling coordination between formulation machinery work and construction work, utility and HVAC system start-up planning with an eye on production machinery trial runs, and providing construction guidance that considers cleanliness and pest control.

Communication with Contractors and Suppliers

Communication with Contractors and Suppliers

Regardless of the order form, CMr has the responsibility to accurately convey the client’s intentions to the contractors and suppliers. Meetings, phone calls, and emails are used for this purpose. Recently, due to the COVID-19 pandemic and the global dispersion of stakeholders, web conferencing systems using internet connections have become more popular. The use and rules of these communication tools are documented in the Project Execution Procedure (PEP) to promote smooth communication.

Schedule Management and Progress Monitoring

Schedule Management and Progress Monitoring

Based on the master schedule, CMr leads stakeholders to ensure adherence. Specifically, regular integrated schedule coordination meetings are held with participants from construction companies and equipment manufacturers to submit detailed schedules for confirmation and progress checking. Additionally, site inspections and confirmations are conducted during the construction period. The key aspects of schedule management are the achievement of major milestones and progress. Milestones are managed with attention to the relationships between different construction activities, and the interrelations are shown and managed on the master schedule.

Progress is monitored as an indicator of accomplishment, with progress (achievement) quantified, visualized using graphs, and managed accordingly.

Examples of Progress Graphs

Change and Cost Management

Change and Cost Management

Change management utilizes forms such as business communication notes and maximizes the use of drawings and lists. It is crucial that project participants clearly understand the changes and that these changes are accurately revised without omissions. Changes vary from small to large, requiring appropriate management and meticulous, persistent efforts. Building good relationships with stakeholders, including the construction company, is also essential. Change management intersects with cost and schedule management, so the presence and impact of changes on cost and schedule, their influence, and the attribution of the cause of the change are managed transparently. Regular meetings to discuss additional items are held periodically even during project execution, depending on the project’s scale.

Document Control

Document Control

Once construction work begins, a wide variety of documents are submitted. Many of these documents require revisions, and their revised versions are submitted. Therefore, projects often involve more than 1000 submitted documents. Ensuring appropriate construction and inspections necessitates the accurate execution of final versions and subsequent change management within this vast array of documents. CM Plus manages document statuses using CORRESSA, a proprietary document management system. This system facilitates the sharing of the latest documents and their management statuses on the web with our clients, construction companies, and suppliers.

Features of CORRESSA

Features of CORRESSA

CORRESSA is equipped with document control and correspondence functions, allowing for the management of communication histories, including business communications between various suppliers. Developed as an application on the Salesforce.com cloud platform, CORRESSA offers a stable operating foundation and robust security. It can be accessed from anywhere with an internet connection.

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Related Contents

Useful Information

Please also refer to the articles on our information dissemination site, “GMP Platform.” Although the title contains “Pharmaceutical Factory Construction,” the content is applicable to the construction of factories in various industries, not limited to pharmaceutical factories.

“How to Build a Pharmaceutical Plant”

“How to Build a Pharmaceutical Plant”

Integrating know-how for the success of pharmaceutical factory construction projects. It explains the framework for project execution (PEP), budget management, and coordination during the construction period.

“Owner’s Project Management in Pharmaceutical Facility Construction 2nd Edition”

“Owner’s Project Management in Pharmaceutical Facility Construction 2nd Edition”

A series on “Owner’s Construction Project Management” from detailed design to the fabrication and construction stages.

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(Japanese only)

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