Quality control throughout the project
Neyret Group has developed its own Quality Assurance system to manage the entire project from design to commissioning.
The quality department supervises all the quality requirements of the projects and ensures the final quality acceptance of the project to satisfy the customer specifications. There are 2 objectives:
- Design, fabrication, quality features controls
- Regulatory requirements and machine specifications compliances
Acceptance: from design to SAT
At each project milestone, a complete documentation is prepared and complies with the GMP, GAMP or FDA standards. Neyret Group can also prepare the FAT and SAT protocols or assist the customer to write them. A FMEA process risk analysis is generally done at the beginning of the project.
At Lagniel facility, for the continuous motion machines, the FAT can be run in a mobile clean room ISO8 that we place around the machine.
DESIGN
At the design phase of the project many documents can be submitted at the customer request. They include FDS (functional design specification), SDS (software), VDS (vision), FMEA. They can complete the Design Qualification (DQ) of the machine.
INTERNAL TESTS – PRE-FAT
Just before the FAT step, Neyret group is running an internal review of the machine and ensures the contractual requirements compliance, especially speed performance, efficiency, reject rate, electrical inputs/outputs and adequation with default warnings, quality and capabilities. This step validates that the machine will be fully ready to then run the FAT along with customer representatives.
FAT – FACTORY ACCEPTANCE TESTS
Prior to the machine is delivered to the customer site, the FAT is performed in our premises. The objectives are to check the proper functioning of the machine, the safety and the performances in the same production conditions later at the customer site. There are several FAT steps:
- Check the conformance of the machine – fabrication, documentation, functions
- Static tests (equivalent to Installation Qualification IQ) to make sure that the machines have been fabricated as per the Design Approval (DQ)
- Dynamic Tests (equivalent to Operating Qualification OQ) during short runs to demonstrate the proper expectations
- Programs backup
- Machine performances (OEE, reject rate, product quality, capabilities according to ISO 2859-1)
COMMISSIONING AND SAT (SITE ACCEPTANCE TEST)
After successful FAT validated by the customer, equipment is delivered to the customer location. The machine is installed then commissioned as before leaving our plant. If requested, Neyret group can prepare and execute the SAT protocol or running the SAT along with the customer. The SAT validates the conformity on site like it was done prior to delivering.
Project management
DESIGN AND INTERNAL MANUFACTURING
Neyret Group us fully integrated including extensive Engineering department with mechanical engineering, electricals study, Programming department, Industrial vision and complete workshop, machining and assembly. Mastering the complete project, based on proven standard, our machines are robust, reliable at fast speed, requiring very low maintenance. All steel fabricated parts done in house or subcontracted are all 100% checked before assembly. Purchased sub-equipment are also subjected to quality checks when delivered. We have qualified many suppliers.
STANDARD PROCESSES
All process stations are fully studied, fabricated and programmed internally. All is documented and standardized in order to get the requested performance. If a new standard raised up, then our teams will develop new standards to ensure perfect product assembly.
PROJECT MANAGEMENT
The real starting point of a project is the customer’s product. Ergonomics, machine’s environment are also taken into account for optimizing the solution. Already at the proposal phase our technical engineers collaborate with the customer. Once the order is awarded to neyret group, then a project leader is dedicated as well as a quality representative, a programming and a vision engineer. The project leader coordinates, does the follow-up until the SAT. The quality representative warrants the whole qualification testing execution. (pre-FAT, FAT and SAT).
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