By Nero Haralalka
During the design phase the quality management team sets the quality objectives and specifies the operational processes and related resources to fulfill those objectives. This begins with clearly stating the specifications with which a product, process, service or other activity must conform. These can include process or test specifications, or relate to the product itself, including product characteristics, performance levels, and engineering drawings.
During planning, supplier control determines what will be acquired and what the products or service must provide. Supplier evaluation should start once the technical requirements are stable and include the review of current suppliers’ historical performance. A risk profile can help identify the inherent safety and business risks, and how to mitigate those risks.
Technical Requirements | Quality Requirements | Business Requirements |
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As part of the planning activities, design teams should identify risks associated with the products or services to be obtained. Due consideration should be given whether the part is custom built or off-the-shelf, as well as the manufacturing complexity. If the part is critical, one needs to determine if a failure mode and effects analysis (FMEA) was conducted and review the risk priority number (RPN) and mitigation plans.
The experience level of the supplier should be considered as well, especially if this is their first attempt at making the specific part or type of part.
The identified risks – including any regulatory requirements — should be evaluated to determine the type and extent of controls needed. These controls should be defined and documented and include any quality requirements. Manufacturers often evaluate first-tier suppliers but do not give enough consideration to second- and third-tier suppliers.
Finally, quality engineering must establish and maintain procedures for receiving and acceptance of incoming product. These procedures include inspection, testing and verification of conformance to specified requirements. Acceptance or rejection should be documented.
Quality management oversees all activities that must be accomplished throughout the life cycle of a product. This includes the creation and implementation of quality planning and assurance, as well as quality control, while dealing with any gaps through quality improvement. When a product or service exceeds customers’ needs and desires – of which quality is a key factor – it can create customer delight contributing to customer loyalty and long-term success.
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