We are unique in the sense that we can bring a highly skilled and experienced engineering team with a diverse set of skills to design and manufacture your next project. Drawing from a staff of highly skilled mechanical engineers, as well as component, lighting, analog, digital, software and power engineers our staff will team together to design, certify, and produce your next product following AS9100 processes. A design and development process has been documented to ensure the provision of products and services that are fully compliant to all requirements. Please reference the next tab for our process. We practice collaborative design to provide solutions for specialized needs.
Commitment and Focus
An engineering focal person is assigned to develop all the tasks required by the project in accordance with documented procedures and project specific requirements. A Program Plan is developed as the overall framework of the project that may include elements, such as: an Engineering Development Plan, Configuration Management Plan, Software Development Plan and/or Quality Assurance Plan depending on the size and scope of the specific project. These plans tailor the applicable processes to project and define the organization and responsibility, the resources, the task sequences and all the mandatory steps required by the project. Program plans are reviewed and updated as required during the design and development process. Updates or changes to these plans may require customer approval when specified by the contract.
The design input requirements are defined either by the customer’s Statement of Work, the customer’s product specification, military and other governing specifications, and internal product specifications in the case of development projects, and/or the contract. The documents identify characteristics such as function, performance, reliability, physical constraints, spare capacity and safety. Requirements are defined so that their achievement can be verified to ensure customer satisfaction. The design input is reviewed for adequacy. Any conflicting, incomplete, or ambiguous requirements are escalated to the responsible engineering focal as appropriate for resolution and, where necessary, discussed with the customer.
The engineering focal ensures that formal hardware and/or software design reviews are conducted for each program. Reviews are supported by independent design review expertise as required to ensure adequacy of the design to satisfy the contractual, quality and productivity requirements of the end product. The design reviews identify problems and proposed necessary actions, and authorize progression to the next stage. Records of design reviews are maintained as quality records in accordance with section 220.127.116.11.
During the product development phases the designs are checked to assure that they meet the requirements of specifications, customer and contract requirements. The approval and release of the documents (drawings, parts lists, schematics, etc.) is the evidence that the design meets the requirements of the specification. As an integral part of design verification, designs are verified through analysis, alternative calculations, test, demonstration, and design similarity analysis. Records of the results of the verification are reviewed before being released and are maintained as quality records.
Validation follows successful design and/or verification. Validation of the design assures that the product will meet the requirements of its intended use. Product function and performance are validated in accordance with the customer, internal or product specifications. These activities typically include standard and environmental condition tests, reliability and maintainability demonstrations, formal qualification testing and acceptance testing. Records of the results of validation are maintained as quality records. Validation is normally performed under defined operating conditions on the final product, but may be necessary in earlier stages prior to product completion. Multiple validations may be performed if there are different intended uses.
At the completion of design and development, the organization ensures that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions.
Where tests are necessary for verification and validation, these tests are planned, controlled, reviewed, and documented to ensure and prove the following:
· Test plans or specifications identify the product being tested and the resources being used, defined test objectives and conditions, parameters to be recorded, and relevant acceptance criteria
· Test procedures describe the method of operation, the performance of the test, and the recording of the results
· The correct configuration standard of the product is submitted for the test
· The requirement of the test plan and the test procedures are observed
· The acceptance criteria are met.
The design output is a product definition package that meets the design input requirements and satisfies the acceptance criteria. This definition is contained in design specifications, drawings, parts lists and test procedures, which are all reviewed before release. As appropriate, the product definition data package specifies the characteristics that are essential to the safe and proper functioning of the product and identifies key characteristics, when applicable, in accordance with the design or contract requirements.
All pertinent data required to allow the product to be identified, manufactured, inspected, used and maintained are defined:
· Drawings, part lists, specifications
· A list of those drawings, part lists and specifications necessary to define the configuration and the design feature of the product
· Information on material, processes, type of manufacturing and assembly of the product necessary to ensure conformity of the product
Design changes can result in a change to existing documentation or the generation of new documentation. Design change documentation is reviewed, approved, controlled, recorded and issued in accordance with established configuration management procedures by the same functions involved in the original issue. Controlled documents, which include drawings, test procedures, engineering change, etc., are reviewed and approved prior to their initial release or revision. Changes to controlled documents are approved by the same authorized functions/organizations that reviewed and approved the original document, unless specifically authorized otherwise by those functions/organizations, in accordance with the configuration management process. The change control process provides for customer and/or regulatory authority approval of changes, when required by contract or regulatory requirement.
Project team meetings, peer reviews, and formal design reviews are conducted as defined in the Program Plan throughout the design, development, and qualification phases of product development in order to control, coordinate, and track the project status.
Periodic project design reviews as defined in the Program plans and project phase reviews as mandated by the Phase Review Process are conducted by the responsible engineering focal to evaluate the progress of the project.