Quality

Quality plans set the inspection rules: what they apply to (a product, a category, a supplier or everything), the sampling plan (100 percent, an AQL level or skip-lot) and the characteristics to check. Inspections record the type (incoming, in-process, final release or supplier audit), what was inspected, the lot, quantities inspected, accepted and rejected, the disposition, notes and the inspector.

Rejected or out-of-spec material becomes a nonconformance with a severity (minor, major or critical), defect code, quantity affected and disposition: rework, scrap, return to vendor, use as is or pending. Nonconformances move from Open through Under Review and Contained to Closed. Where a root cause needs fixing, a corrective or preventive action is raised with an action plan, due date, owner and effectiveness check, and moves from Open through In Progress and Verification Pending to Closed.

• Plan-driven inspection. The plan decides the sampling, so inspection is consistent across receivers.
• Nonconformance for every reject. Rejected quantities are recorded with severity and disposition.
• CAPA to fix the cause. Repeated or serious issues get an owner, a plan and a check that the fix worked.

Agree quality plans for critical products and suppliers. Agree severity definitions and who may set Use As Is. Agree when a nonconformance needs a CAPA. Agree how supplier nonconformances feed vendor scorecards and tier reviews.

The 40 torn resin bags from lot R-2602 become a Major nonconformance with defect code PKG-TEAR and disposition Return to Vendor. The Quality Manager contains it by moving the bags to quarantine. It is the third packaging nonconformance from this supplier in a quarter, so she raises a corrective action owned by the buyer: the supplier must switch to reinforced bags by April 30.

The supplier confirms the change. In May, three deliveries arrive without torn bags; the effectiveness check is recorded and the action is Closed. The supplier’s quality acceptance on the next scorecard reflects the improvement.

• Open Nonconformances — Open, under-review and contained nonconformances with severity, quantity and disposition.
• Open CAP as — Corrective and preventive actions in progress with owner and source nonconformance.
• Receipts Pending QC — Deliveries waiting for incoming inspection.

• Purchase order to goods receipt: Incoming inspection on receipt.

Review roles before assigning CAPA owners.