Meaning
International quality management provisions mandate that organizations identify, segregate and control non-conforming process outputs to prevent their unintended delivery or use. Within manufacturing management structures, iso 9001 clause 8 7 defines formal obligations for handling defective raw materials, in-process subassemblies and finished goods that fail to meet baseline engineering requirements. The clause governs containment procedures, concession authorizations, rework authorizations and post-delivery corrective actions.
It ceases to apply once products are verified as compliant and released into standard commercial distribution.
Control Mechanism
Quality procedures establish mandatory workflows for quarantining defective output immediately upon discovery. Under the provisions of iso 9001 clause 8 7, organizations select appropriate disposition pathways including scrap, rework, customer concession or return to supplier. Authorized technical personnel must review and approve all proposed disposition actions.
Production Exposure
Transitioning from prototype fabrication to volume manufacturing without rigorous non-conformance controls results in widespread process contamination. Pilot builds often manage defective parts through informal engineer-to-technician communications, but high-rate automated assembly lines rapidly mix non-conforming lots with acceptable stock if physical and digital containment barriers fail. Invoking customer concessions prematurely to maintain factory schedule adherence damages supplier credibility and creates downstream assembly failures.
A supplier forecast of low scrap counts cannot substitute for demonstrated physical containment procedures that halt unverified lots during production line interruptions. Documented disposition discipline ensures that flawed components never reach assembly lines.
Audit Requirement
External registrars examine physical quarantine areas, concession records and digital traceability logs to verify standard compliance. Auditors verify that corrective action workflows document the exact nature of defects and the identities of approving authorities. Non-compliance findings prevent management system certification.