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Discrepancies
Discrepancy and defect reporting are fully integrated and initiated directly from an Inspection Order. The inspector is required to initiate a Discrepancy report if any of the characteristic data collections are rejected or out of limits. Discrepancies are automatically routed to the appropriate personnel. Discrepancies caused by a supplier will affect the supplier’s performance rating.
The disposition, review and approval workflow is configured to handle complex routing requirements for different types of discrepancies. Communications further complement the process, documenting review and discussion threads.
Discrepancies and defects are classified by responsible processes, defect types, symptom types and cause types. Analysis of defect classifications provides the basis for needed corrective actions.
A unit’s disposition can include instructions to rework, repair, or scrap the unit. A defective installed component or subassembly can be fixed in place or removed.
Quality Concern and Defect Containment
Defect Containment Holds prevent further shipment of suspect parts without verified corrective action, over inspection, or explicit approval. Alerts are immediately placed on all affected Inspection Orders. Visibility of Holds is never lost throughout the process.
Solumina includes various types of holds including red-decal type of holds which identify an item that is authorized to ship because an issue cannot be resolved at the supplier site. Corrective Action Holds are also automatically placed on any Inspection Order for parts that have pending Corrective Actions with the supplier. The Hold can be lifted by the buyer or quality manager to approve shipping even though Corrective Action is still pending.
Corrective and Preventive ActionSolumina’s closed-loop Corrective and Preventive Action (CAPA) process manages investigation, action items and verifications. Each corrective action is a project coordinated by a facilitator responsible for following up on investigation and action items until there is an agreement and commitment on resolutions.
Corrective action can be requested from either discrepancies or Corrective Action Requests. Corrective Action Requests are created to track process improvement suggestions or issues like recurring defects, or customer satisfaction concerns. Several requests can be linked to a single corrective action.
The corrective action tracks investigation, root-cause analysis, and resolution commitments. Action items are routed according to the responsibility identified. The root-cause analysis process can be escalated according to the severity of the issue and more participants can be added to the investigation team from multiple disciplines.
The corrective action process is not complete until implementation is verified and proven effective. Solumina allows scheduling of implementation verification tasks according to the commitment dates. Containment processes are tied to the Corrective Action until subsequent effectiveness verification is recorded to verify the success of the prescribed solutions.
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