Quality

Quality control throughout the project - FRANKLIN AUTOMATION controls each project from design to production. Our Quality supervisor oversees the design, fabrication, assembly and tuning of all machine builds with the following objectives:

  • Control design, manufacturing, assembly and programming processes

  • Compliance with both regulatory and customer requirements

QUALIFICATIONS: FROM DESIGN TO SAT

Our qualified teams ensure the control and qualification of your equipment, taking into account the regulations in force, your own specifications and the operating sector of the machine. To meet the needs and requirements of the medical sector, our machines are designed to produce in clean room environments.

At each validation step, FRANKLIN AUTOAMTION provides necessary documentation and carries out FAT and SAT protocols; or assists the client when the latter wishes to draft them internally. Furthermore, when project are launched, we carry out, when necessary, a process risk analysis according to the FMECA methodology.

DESIGN

In the first phase of machine design, depending on the customer's request, we can draw up a wide variety of technical documents. These are technical specifications and process risk analyzes (FMECA) resulting in Design Qualification (DQ).

INTERNAL TESTS – PRE-FAT

Before any execution of the FAT, FRANKLIN AUTOMATION carries out its own internal tests and ensures that the contractual data is achieved (rates, efficiency and scrap rate). This step ensures that equipment meets expectations and standards before moving on to the next step. Our quality manager carries out the Pre-Qualification with protocols as close as possible to those which are carried out during FAT.

FAT (FACTORY ACCEPTANCE TEST)

The objective of the FAT, which is performed prior to delivery and in the presence of the customer, is to verify the operation, safety and performance of the machine in real production conditions. The FAT takes place in several stages:

  • Evaluation of the conformity of the machine (realization, documentation, functions)

  • Static tests (Installation Qualification – IQ) validate the compliance of the installation with the approved design specifications

  • Dynamic testing (Operational Qualification – OQ) demonstrates that equipment operation meets operational specifications

  • Evaluation of equipment performance (TRS, scrap, and quality sampling)

COMMISSIONING AND SAT (SITE ACCEPTANCE TEST)

After validation of the FAT by the customer, FRANKLIN AUTOMATION installs and starts-up the equipment at the customer's premises. At the client's request, FRANKLIN can write and execute SAT protocols or simply support you in their implementation. The purpose of the SAT is to validate the conformity of the machine on site.

PROJECT MANAGEMENT

IN-HOUSE DESIGN AND MANUFACTURING

FRANKLIN AUTOMATION has its own design offices and production workshops guaranteeing total control of the entire project. As a manufacturer, our assembly platforms are manufactured using proven standards that guarantee robustness. Our machine shop secures the supply of essential parts, while other components come only from our approved suppliers and are 100% inspected according to internal protocols.

STANDARDIZED AND REPEATABLE PROCESSES

All stations are designed, manufactured and programmed internally. Thanks to this expertise, all processes are documented, standardized and can be reproduced with guaranteed performance. Our innovative vision not only makes it possible to achieve objectives, but surpass them in order to build new standards.

PROJECT MANAGEMENT

The starting point of any project is the customer's product. In this context, FRANKLIN AUTOMATION takes into account the required work load and production environment to provide optimal concepts. Furthermore, our technical and commercial teams work in close collaboration with customer teams to develop best solutions.  For each project we dedicate a technical project manager and a quality representative. The project manager coordinates the communication, timing, follow-up and realization until delivered. The quality representative guarantees the execution of reception protocols (Pre-FAT and FAT).

DISCUSS YOUR PROJECT WITH OUR TEAM