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Grade
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Description
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0
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Commercial parts and practices used in the design. No documented part selection and part management process exists.
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1
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Parts and practices are used in the design with a documented part selection and part management process plus:
• Data is available to assure that COTS (commercial off-the-shelf) assemblies have a good history of reliability.
• A design compliance checklist exists to ensure that all parts are properly applied, operating at sufficient margins with respect to environmental and operational stresses, and take into account lessons learned.
• Part specifications reflect environmental and regulatory compliance requirements for the specific intended application.
• Procedures and processes must be in place to identify and handle critical reliability components (derating, screening, failure response, etc.).
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2
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All elements of grade 1 plus:
• There is a preferred parts list (PPL) with an evaluation and qualification process to add parts to the PPL.
• Teaming relationships are established with critical component suppliers. Critical parts are burned in for at least 24 hours.
• Future releases of a part will be compatible with respect to form, fit, and function
• Likely part developments, evolution, and extensions of critical/custom part have been identified by the supplier.
• Any COTS equipment is certified and marked to sell in Europe (CE marked).
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3
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All elements of grade 2 plus:
• Critical parts are QS9000 certified.
• Parts control drawings as well as device specifications exist for critical and custom parts.
• Critical suppliers must supply timely notice of impending part changes to allow the developer to assess the impact.
• Suppliers in the case of complex part assemblies have supported the developer in performing Failure Modes and Effects Analyses (FMEA) on supplied assemblies.
• A Design of Experiments (DOE) part evaluation, considering variations as well as manufacturing variations, is conducted.
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