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Line Transfer & Reshoring
Whether it’s across town or across the globe, moving your operations from one facility to another can be a challenge. Line transfers and reshoring require careful planning to minimize disruptions to production, maintain product quality and safety, and ensure compliance with regulatory requirements. When done correctly, line transfers can enable the expansion or consolidation of facilities to accommodate growth, streamline operations, optimize costs, and/or leverage new technologies.
Speak with an ExpertLearn more about our line transfer and reshoring capabilities
Ascential - Empowering Line Transfer and Reshoring
Ascential works with you to ensure a smooth transition with minimal disruptions to production and compliance. Our experts help you define the goals for a line transfer or reshoring, such as cost reduction, better quality control, improved resilience, and speed to market. As your trusted partner, Ascential works with you to streamline the transfer process, set up your new line or facility, and mitigate risks before, during, and after the move.
Comprehensive Planning and Documentation
Our experts partner with you to develop a detailed project plan which outlines all aspects of your line transfer. Beginning with a comprehensive assessment of the current manufacturing line, including equipment, processes, personnel, and regulatory requirements, they help you to define the goals for the line transfer.
They can design a strategic plan which outlines the scope of the project, with a focus on ensuring seamless operational continuity and maintaining the highest standards of quality and compliance. This includes detailed project timelines, resource allocation, risk management strategies, and a clear communication plan to ensure all stakeholders are informed and aligned throughout the process. It can also outline the technical and logistical aspects of the transfer, including equipment relocation or procurement, staff training requirements, and validation protocols to ensure the new line meets all regulatory standards.
Equipment and Operations
Our team can also assist in building equipment and setting up operations in your new facility or line. They can build tools used in your unique manufacturing process, either to replicate an existing process or improve upon it. To enhance efficiency and productivity, they can assist you in leveraging automation and robotics technology for the production line. This could include robotic assembly systems, automated material handling systems, and machine vision systems for inspection and quality control.
With deep expertise developing manufacturing equipment, cleanrooms, and automation solutions, our experts can help you execute on your goals for the new line or operation.
Our Certifications:
ISO 9001: 2015
ISO 13485:2016
FDA Registered
CA Medical Device Manufacturing License
Regulatory Compliance
Ensuring regulatory compliance during a line transfer is critical to avoid potential delays, fines, or product recalls. Our team has extensive knowledge of these requirements, including FDA regulations and Good Manufacturing Practices (GMP), and can help you prepare for your line transfer. Our experts can also assist with updating documentation and validating equipment and processes accordingly.
Ascential leverages a robust Quality Management System (QMS) and can help with personnel training and process management to ensure regulations are met. Working together, our experts can help you prepare the facility and conduct audits for regulatory compliance.
Our Certifications:
ISO 9001: 2015
ISO 13485:2016
FDA Registered
CA Medical Device Manufacturing License
Risk Management
Our team can help you identify potential risks associated with the line transfer process, including logistical challenges, regulatory compliance issues, equipment failures, and workforce training gaps. Then, they can assist in developing strategies to mitigate identified risks. This may involve implementing contingency plans, establishing protocols for addressing disruptions, enhancing equipment maintenance procedures, and conducting thorough training for personnel.
Our experts also work with you to design monitoring and quality control procedures to proactively assess and manage any issues during and after the transfer.
