Key takeaways
Short answer: A quality hold process segregates suspect product, decides whether to release or scrap, and clears the hold. The design must be fast (hours not days), traceable (every unit accountable), and reversible. Bad design halts the plant, piles up inventory, and loses traceability. Good design isolates the hold quickly and lets production continue on non-affected SKUs. See also Quality by Design vs Quality by Inspection.
Speed at each step matters. Slow holds amplify the cost.
Each is legitimate. The process must handle all of them.
Holds that take days produce:
Most holds should resolve in hours, not days. Set the SLA explicitly.
Every unit affected must be:
Without traceability, the hold cannot guarantee containment.
Release. Investigation cleared. Product moves forward.
Rework. Product can be fixed. Process the rework and re-inspect.
Scrap. Product unfixable. Document and dispose.
Concession. Release with customer agreement on the deviation. Documented exception.
Each requires different workflow and tracking.
1. Manual segregation. Operators have to find and tag affected units. Hours.
2. Paper traceability. Tracking which units are on hold requires paper trail. Lost paper means lost hold.
3. Manual notification. Quality team learns about the hold by phone or email. Hours to days.
4. Investigation without data. Without process data, root cause takes longer.
5. Disposition approval chain. Multiple sign-offs slow the decision.
1. Hold means stop everything. The hold should be targeted; production on unaffected SKUs continues.
2. Hold inventory accumulates. Without disposition discipline, the hold area grows.
3. Bypass for production pressure. Releasing held product under pressure without proper investigation. Risks escape rate.
4. Hold cleared without CAPA. Same issue recurs.
End-to-end hold time can drop from days to hours.
Quality holds appear in OEE Quality as held product. Some plants count holds as Quality loss; others wait for disposition.
Consistent definition matters. Document the rule.
1. No SLA on hold resolution. Holds extend indefinitely.
2. Manual tracking. Holds get lost in spreadsheets.
3. No data-driven investigation. Root cause guessed rather than determined.
4. Disposition without CAPA. Recurrence guaranteed.
A modern OEE platform integrates with QMS for hold workflow, supports automatic identification of affected lots from process data, and surfaces process signatures for investigation.
Fabrico's OEE module integrates with QMS for hold workflow, identifies affected lots automatically based on process data, and supports data-driven hold investigation.
See how Fabrico captures this automatically — explore OEE for manufacturing or book a demo.
No. Target the affected SKU or lot. Production on other SKUs can continue if not at risk.
2-8 hours for typical holds. 24 hours for complex investigations.
Document the rule. Common approaches: count as Quality loss at hold; restate after disposition.
Quality engineer typically; senior approval for concessions or large scrap.
Yes, for any hold with disposition other than release. Recurrence prevention is the point.
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