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Early-stage Consultation
Our expert consulting engineers and business development managers work with customers to evaluate their needs and challenges and outline the requirements and needs.
Release of RFQ and URS
Based on initial joint discussions and evaluations, our customers provide us with a detailed RFQ which will be based on their URS. If there is no URS, we will work with our customer to help develop a detailed URS document to ensure all specifications and requirements are defined and included.
Response to RFQ
We conduct a Comprehensive review of the RFQ and URS, and clarify all assumptions. We will then prepare a detailed Risk Assessment document to highlight all areas of potential risks along with recommended risk mitigation steps. Additionally, as part of our Compliance process, we will develop a detailed Traceability matrix and include all assumptions, exceptions, tasks and execution steps.
Start of Design
Immediately after conformation of the contract and PO acceptance, a dedicated team of project design engineers will start the initial mechanical design concept in 3D and upon review and acceptance of Design Concept, detailed design will commence, and in parallel, electrical and controls design efforts will start. Once the entire design is approved, BOM for all mechanical and electrical firmware and hardware will be released to purchasing.
PLC, PC and Controls
At this stage, the assigned controls and software engineers will develop the controls architecture for the HMI, Robots, PLC and other machine functions according to the commissioning plans of the equipment/line.
The metal fabrication and machine shop will then manufacture all mechanical components, fixtures and parts, in full support of quality and medical device compliance processes, as dictated by the QPP (Quality Planning Process) documents. In parallel, all parts on BOM are in procurement process to ensure on-time availability and delivery to the assembly floor.
Using a KANBAN and 5-sigma methodology, all parts, sub-assemblies, and components will be coming together for assembly and full integration process. During this process, individual station commissioning plans are conducted and the start of pre-FAT processes are initiated.
FAT, IQ and OQ
As the integration is completed, with customer on site at Maider, all the FAT, IQ and OQ (for validation and documentation) are initiated and completed. It is in this phase that equipment and line optimization efforts are concluded to ensure the performance meets customer’s URS and in full compliance of GAMP requirements.
Ship, Install and SAT
Upon acceptance and sign-off of the FAT by customer, all equipment and deliverables are shipped to customer’s site, with Maider’s installation engineers to complete the installation and SAT process to ensure satisfaction of the contract obligations are reached and obtained. Shortly after this period, a complete set of standard documentation package is sent to customer. Project is now complete and handed-off to customer, and at this point, project is transitioned to Maider’s customer service team to ensure full support of the warranty and performance expectations of customer.