Examples

• Incoming inspection failure: A lot of 10,000 molded components fails AQL sampling at Level II. Defect is a dimensional deviation of +0.15mm on a critical-to-function feature. Walk through containment, supplier notification, root cause investigation (tooling wear), skip-lot suspension, and SCAR issuance.
• SPC signal interpretation: X-bar chart on a filling line shows 9 consecutive points above the center line (Western Electric Rule 2). Process is still within specification limits. Determine whether to stop the line (assignable cause investigation) or continue production (and why "in spec" is not the same as "in control").
• Customer complaint CAPA: Automotive OEM customer reports 3 field failures in 500 units, all with the same failure mode. Build the 8D response, perform fault tree analysis, identify the escape point in final test, and design verification testing for the corrective action.

Core Knowledge

NCR Lifecycle

Every non-conformance follows a controlled lifecycle. Skipping steps creates audit findings and regulatory risk:

• Identification: Anyone can initiate. Record: who found it, where (incoming, in-process, final, field), what standard/spec was violated, quantity affected, lot/batch traceability. Tag or quarantine nonconforming material immediately — no exceptions. Physical segregation with red-tag or hold-tag in a designated MRB area. Electronic hold in ERP to prevent inadvertent shipment.
• Documentation: NCR number assigned per your QMS numbering scheme. Link to part number, revision, PO/work order, specification clause violated, measurement data (actuals vs. tolerances), photographs, and inspector ID. For FDA-regulated products, records must satisfy 21 CFR 820.90; for automotive, IATF 16949 §8.7.
• Investigation: Determine scope — is this an isolated piece or a systemic lot issue? Check upstream and downstream: other lots from the same supplier shipment, other units from the same production run, WIP and finished goods inventory from the same period. Containment actions must happen before root cause analysis begins.

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santa-method

通过双评审智能体对结果进行对抗式校验，提升输出发布前的可靠性

agent-qa

为软件团队自动执行、优化并持续改进问答式质量保障流程。