Full Life Cycle Design & Project Management
Machinelab offers full life cycle Design and Project Management services including URS appraisal, Design Review, Design Qualification, Functional, Hardware and Software Design Specifications, Factory Acceptance Test and Site Acceptance Testing, Validation Support and Documentation.
Project Management System
At Machinelab we have developed our own Project Management System, using GANT, Agile and SCRUM Methods.
From the point of Customer Purchase Order Receipt, we will follow a clearly defined Process Map. Each Process has a Process Owner who is responsible for making sure that all of the process steps are followed. Agile Methodology, using SCRUM is the chosen method of Project Management.
- Solution Development & Finalise URS
- Project Launch / Pre-Design
- Design /Design Qualification (DQ)
- Work Orders / Procurement
- Build
- Software
- Test (FAT)
- Deliver
- Install (SAT) IQ/OQ
- PQ Support
Risk Management
Our Risk Management System based on:
- Clarifying the Requirements and Constraints
- Planning
- Risk Assessment
- Design Review
Our Target is to complete Design Qualification with all risks analysed, mitigated and documented before we go to manufacture.
If Pre-Design Proof of Concept work is required to clarify Technical Uncertainties, this is prioritized and carried out before Design work commences.
Design Reviews are carried out throughout the process using Checklists and Process Flows. Design Reviews address functional Requirements, Critical Quality Attributes as defined in the User Requirements, Technical Specifications, Operator Interface and Ergonomics, Maintenance & Cleaning, Materials of Manufacture and Design.
Validation & GAMP5
At Machinelab we understand GAMP5. We demonstrate this by:
- GMP Design features which facilitate Line Clearance, Cleaning & Maintenance.
- Critical Quality Attributes understood by the Design Team.
- Lifecycle approach to Design and Build.
- Tested, Documented and Traceable to URS.
- Effective Leadership
- Focus on Quality and Continuous Improvement.
- Use of evidence and data.
- Effective Supplier Relationships.
Documented Life cycle
- Traceability Matrix to URS
- Design Qualification (DQ)
- Design Specifications
- FAT Protocol IQ/OQ
- SAT Protocol IQ/OQ
- Traceability Matrix
- PQ Protocol Support
Validation Expertise
Site Acceptance Test
Depending on the project scope, additional tests are added for SAT such as HMI, MES, OEE Integration, Line Logic and Interfaces with other equipment.
User Requirement
The Customer User Requirement Specification is evaluated in detail and a list of Responses made (Response Matrix)
Factory Acceptance Test
The FAT Test protocol is developed following DQ. The FAT consists of IQ and OQ Tests and some Machine Running Tests with Hand Fed Product.
Design Qualification
The Functional, Hardware and Software Design Aspects are reviewed at Design Qualification. Where Validation Services are being provided as part of the project, a Design Qualification Protocol is issued for Sign off along with FDS, HDS and SDS
Other Services
Design Services
Machinelab have a fully serviced Internal Design Department using Solid Works and Product Design Libraries, we can provide Design Services for Proof of Concept, Reverse Engineering and Customised Machine Design.
Proof of Concept
In cases where there are Technical Uncertainties, Machinelab can assist with developing Proof of Concept modules for purpose of Project De-Risking and URS Clarification.
CNC Machining
We have a fully equipped Tool Room with 3 Axis and 5-Axis CNC Milling Centres, 3-Axis CNC Lathe Centres, Wire EDM Centre, 3D Printing and Laser Etching. We can assist our customers with providing Engineering and Programming support for Customers.
Fixture Design & Manufacture
For many of our customers, their processes and products are made with a high degree of manual labour. Fixtures are custom built assemblies which facilitate the process of manufacture. We offer the full life cycle Design Service from Design Qualification to FAT at our Factory and Installation on Site.
