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The quality-related ties among engineering, manufacturing, and procurement is concentrated in quality engineering. In addition to being the focal point for quality technical expertise and problem solving, the Quality Engineer provides technical support to suppliers, manufacturing, and inspection in interpretation of requirements and resolution of issues.
- Review, analyze, and approve technical documentation that impacts QA/inspection activities or requirements.
- Perform classification of characteristics to highlight critical design features requirement intensified inspection attention and to establish inspection sampling levels for other features
- Prepare documentation required to support delivery, including verification that applicable changes have been incorporated
- Conduct failure analysis of delivered and in-plant hardware that suggests a deficiency in manufacturing, supplier, and or inspection process; formulate corrective action for previously fabricated and hardware to be built
The mission of the Quality Engineering process, through integrated product/process team participation, is to influence product design for compliance to customer requirements and the prevention of nonconformances.
When developing product requirements, design input, Quality Engineering uses existing information such as lessons learned from past programs and studies, and standards to provide visibility into the manufacturability, reliability, serviceability, and ease of use questions raised.
Quality Engineering participates in design reviews on cross-functional teams to ensure that producibility, inspectability, reliability, safety, and Quality System integrity objectives are met. During these reviews, Quality Engineering ensures that the designs presented have considered appropriate hardware quality attributes and that related quality considerations are well defined.
Quality Engineering works with design engineering to evaluate drawings, specifications, and changes during the formative stages of the design output for factors affecting quality, reliability, safety, production, and operation of the product. Quality Engineering, with nondestructive test engineering, and quality process engineers evaluates drawings and specifications to establish the criteria for inspecting the hardware. The quality engineer then establishes the inspection points and provides specific instructions for inspection.
Concurrent with the development of drawings, is the development of the Supplier Technical Requirements (STR) element of the Build-to-Package. Quality Engineering creates, with the supplier and the balance of the team, the Applicable Requirements List, the Characteristic Accountability, and the Validation Plans of the STR.
Quality Engineering analyzes performance reports and process control statistics in order to determine and improve process capability or product quality. Quality Engineering reviews root cause analyses. Quality Engineering recommends and supports the implementation of corrective actions that are necessary to reduce or eliminate nonconformance to design specifications. |
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