A supplier may say that a defect was fixed, rejected pieces were removed, or a failed batch is under control. Those statements do not show where the goods are, how many are affected, whether the defect applies to material, work in process, finished products, packaging, or labels, or who authorized the next action. The risk is not only the visible defect. A rejected component can return to an assembly line. A mixed carton can enter packing. A reworked lot can be counted as complete without a defined reevaluation.
A China supplier nonconforming goods quarantine process gives the buyer a traceable hold-to-disposition record. It identifies the affected item and lot, applies a stated physical or digital status, records the source of detection and evidence, assigns a decision owner, and reconciles the quantity through a documented outcome. It does not decide whether a defect is acceptable, a product is safe, rework is effective, a deviation is approved, or a shipment can be released.
In the finished-pharmaceutical context, 21 CFR 211.89 requires rejected components, drug product containers, and closures to be identified and controlled under a quarantine system designed to prevent use in unsuitable operations.1 FDA educational material about nonconforming product, in a medical-device context, describes identification, documentation, evaluation, segregation, and disposition. It gives locked cages, digital controls, and separate areas as examples of segregation.2 These sources do not create universal requirements for ordinary China imports. They support a practical buyer sequence: identify the affected goods, control their status, record the evaluation, and route disposition through authorized owners.
Define what puts goods on hold
The buyer should agree with the supplier on hold triggers before an issue occurs. A trigger can be a failed incoming check, in-process finding, final inspection issue, packaging error, label mismatch, material mix-up, dimension outside the buyer requirement, test result requiring review, returned goods, customer complaint record, or supplier-disclosed process deviation. The exact triggers depend on product and buyer requirements.
The supplier should not wait until it has diagnosed root cause before it identifies affected goods. A buyer needs an immediate scope statement: what is known, what is unknown, where the goods are, and whether the supplier has stopped use, production, packing, or shipment. Investigation and final disposition can follow through the appropriate process.
| Hold trigger | Supplier record should identify | Initial buyer question |
|---|---|---|
| Incoming material issue | Material ID, source, lot, quantity, storage location, and buyer order link | Could this material have entered production already? |
| In-process defect | Product or WIP ID, operation, line, time range, quantity, and current location | Which operations and lots may be affected? |
| Finished-goods inspection issue | SKU, lot, quantity, inspection record, defect description, and pack status | Is any affected quantity already packed or staged? |
| Packaging or label mismatch | Packaging component, artwork or label revision, quantity, and location | Could product and packaging be mixed? |
| Supplier process deviation | Process, tool, line, material, time range, and output quantity | Does the deviation affect an agreed product requirement? |
| Returned or customer-reported issue | Product, lot if known, reason, location, and connected supplier record | Does the supplier need to identify related stock or production? |
The buyer should define terms precisely. A hold means the item is not authorized for the next defined action. Quarantine can refer to a physically separated area, a locked container, a location code, a warehouse status, an ERP block, or another stated control. Disposition is the documented decision about what happens to the affected goods. Do not assume every supplier uses these words the same way.
Identify the affected lot, quantity, and location
A supplier can only control what it can identify. Require the supplier to create a nonconforming-goods record with a unique ID, date and time, purchase order, SKU or material code, revision where relevant, lot or batch reference, affected quantity, unit of measure, location, source of detection, stated requirement, observed issue, attached evidence, and person who opened the record.
A photo is useful when it shows the item, label, location, and visible condition. It does not prove full lot scope, a test conclusion, material identity, a hidden defect, or effective isolation on its own. Treat photos as supporting evidence and retain the factory’s original file names and timestamps when available.
| Record field | Why it matters | Example of a weak entry |
|---|---|---|
| Nonconformance ID | Links later actions to one issue record | “Defect from Monday” |
| Product or material ID | Identifies the actual item | “Blue parts” |
| Lot and order link | Connects the issue to traceability and commercial scope | “Current production” |
| Quantity and unit | Supports later reconciliation | “Some pieces” |
| Location and status | Shows where the goods are and what control applies | “In warehouse” |
| Requirement and observation | Separates the buyer requirement from the supplier’s finding | “Bad quality” |
| Detection source | States whether the issue came from inspection, production, packaging, or another event | “Found by factory” |
| Evidence link | Preserves supporting record, image, report, or sample ID | “See chat” |
If the supplier cannot state the affected lot or quantity, require it to report that uncertainty. The buyer can then decide whether to widen the hold, request a lot map, or route the issue for qualified review. A made-up scope is worse than a clearly recorded unknown.
Require real segregation, not a status label alone
A quarantine control should match the supplier’s process and the risk of unintended use. It may be a marked cage, dedicated rack, sealed container, separate warehouse location, system block, controlled work-order status, or a combination. FDA’s training material uses locked cages, digital controls, and separate areas as examples of segregation in its medical-device context.2 A buyer should not copy a regulated-product system without considering its own product and supplier operation. It can require the supplier to state exactly how the identified goods are prevented from moving to the next activity.
Ask the supplier to provide the location, status label or code, quantity, responsible person, and evidence that the hold applies to the stated goods. If physical identification is impractical for a defined bulk material or process condition, require a controlled description of the lot, storage container, line status, work order, or system block used instead.
| Control type | Supplier should state | Buyer limitation |
|---|---|---|
| Physical separation | Location, container or rack ID, marking, and responsible person | A photo does not prove every item is separated. |
| Digital block | System status, affected lot or order, and who can remove the block | A system record does not show the physical state by itself. |
| Work-order hold | Work order, operation, line, and next action blocked | It may not cover finished stock or packaging elsewhere. |
| Packaging hold | Carton, label, insert, artwork, or pallet quantity and location | It does not determine whether product inside conforms. |
| Shipment hold | Goods, documents, release status, and handover stage | It does not confirm freight or customs status. |
Do not ask the supplier to relabel, rework, or move quarantined goods before the required evidence is captured. The record needs to show the condition and scope at the time the issue was identified.
Separate evaluation from disposition authority
Evaluation asks what happened, what requirement may be affected, which goods are in scope, and what evidence is available. Disposition decides what happens next. The same person or group may handle both in a small supplier, but the record should still show the distinction.
FDA’s educational material describes procedures addressing identification, documentation, evaluation, segregation, and disposition, and notes that disposition procedures define responsibility and authority in the medical-device context.2 For a buyer process, use the narrow idea: identify who can propose an action and who can authorize it. A factory quality manager may propose sorting, rework, return, scrap, additional inspection, or a request for buyer deviation. The buyer should route acceptance of any buyer requirement difference to the designated owner.
| Supplier-proposed outcome | Buyer record should show | Who may need to review |
|---|---|---|
| Sort or screen | Method, population, inspection criterion, records, and remaining quantity | Quality owner |
| Rework | Proposed process, affected lots, evidence plan, and reinspection request | Product, engineering, or quality owner |
| Return to supplier | Material, quantity, source, and replacement plan | Procurement or quality owner |
| Scrap or destruction | Item, lot, quantity, method, and proof required by buyer process | Quality, operations, or finance owner |
| Use as-is or deviation request | Exact requirement difference, scope, justification, and evidence | Authorized product, quality, technical, or compliance owner |
| Hold pending review | Scope, location, interim control, and next decision date | Assigned buyer owner |
Do not treat “use as-is” as a routine factory choice when it differs from a buyer specification. The buyer’s authorized owner must decide whether to accept a stated deviation under the buyer’s own process. Regulatory, safety, technical, engineering, and product-compliance questions need qualified review.
Control rework and reinspection
Rework can change the original product condition. Before rework, require the supplier to state what will be done, which goods are included, what current requirement applies, which process record will be created, and what evidence or reevaluation will follow. FDA’s training material describes rework procedures, retesting and reevaluation in its regulated context.2 That is not a universal rule for general imports. A buyer can still require a simple answer: after the supplier changes a held item, what record will show that the final condition meets the buyer’s stated acceptance plan?
Keep the original nonconformance ID on reworked goods and link any new inspection, test, photograph, sample, or production record. Do not erase the original finding by replacing it with a new pass result. A valid reinspection record may show a subsequent observation. It does not remove the need to account for the original defect, affected quantity, and authorized disposition.
| Rework control | Supplier evidence | Buyer review question |
|---|---|---|
| Alcance | Lot, quantity, location, and item IDs | Did the supplier rework only the approved population? |
| Método | Work instruction, operation, or stated corrective action | Is the proposed method within the buyer’s approved process where required? |
| Trazabilidad | Link between hold record, rework record, and final lot | Can the buyer follow the goods through the process? |
| Reinspection | Stated criterion, method, result, and reviewer | Does the evidence address the defined requirement? |
| Quantity reconciliation | Starting hold quantity, reworked quantity, scrap, return, and remaining balance | Does every affected unit have a stated status? |
Reconcile quantities before packing or shipment
A nonconforming-goods record should close only when the supplier has accounted for the affected quantity. Start with the quantity placed on hold. Reconcile sorted good units, reworked units, rejected units, returned material, scrap, samples, remaining hold quantity, and any quantity under buyer review. Use the same unit of measure used on the order or lot record.
The record should also state whether affected goods can move to packaging, final inspection, cargo staging, or shipment under the buyer’s process. A supplier may complete a rework operation while the buyer still needs to review a deviation, test result, or packaging impact. Keep those decisions separate.
| Quantity status | Meaning in the supplier record | Shipment implication |
|---|---|---|
| On hold | Identified and not authorized for next defined action | Do not include until authorized process allows it |
| Under evaluation | Scope or evidence remains under review | Do not treat as available inventory |
| Rework pending | Action is proposed or approved but incomplete | Keep linked to hold record |
| Reworked, evidence pending | Supplier completed action but reevaluation is not complete | Do not count as accepted goods |
| Disposition recorded | Authorized outcome exists with quantity and owner | Apply buyer’s downstream release process |
| Closed with reconciliation | Every affected quantity has a stated final status | Does not by itself authorize shipment |
Connect the nonconformance record to the final inspection, packing list, production reconciliation, and shipment records where relevant. If the final shipment quantity differs from the purchase order because of rejected goods, record the commercial and operational decision through the buyer’s process. The hold record provides evidence. It does not decide payment, replacement, contract remedies, or shipment acceptance.
Supplier request wording and FAQ
When goods do not meet, or may not meet, a buyer requirement, open a nonconforming-goods record before further use, rework, packing, or shipment. Identify the PO, SKU or material ID, revision where applicable, lot, affected quantity, location, source of detection, stated requirement, observed issue, and supporting evidence. Apply the stated physical or digital hold control and report the proposed disposition. Do not release, rework, combine, relabel, pack, or ship the affected goods until the required buyer owner records the applicable decision. Reconcile the full held quantity through final disposition and link the record to related inspection and shipment evidence.
What is the difference between quarantine and disposition?
Quarantine or hold controls the current status of affected goods. Disposition records the approved next action, such as sorting, rework, return, scrap, or a buyer-approved deviation. A supplier should not treat a hold label as the final decision.
Does every defect require a buyer approval?
The buyer can define which issues the supplier may correct under an approved procedure and which require buyer review. Any difference from a buyer-approved product requirement, technical specification, packaging, or shipment release condition should follow the buyer’s designated approval path.
Can a supplier rework held goods before telling the buyer?
The buyer should state its requirement in advance. For issues requiring buyer review, the supplier should hold goods and submit the proposed method and evidence plan before it begins. Urgent safety, regulatory, or product decisions require the appropriate qualified owner.
What evidence should a supplier provide for a hold?
Request the nonconformance ID, item and lot identity, quantity, location and hold method, defect description, source of detection, relevant photos or records, proposed disposition, decision owner, and final quantity reconciliation. Ask for additional technical evidence only when the buyer needs it for a decision.
Keep rejected goods visible until the record is closed
A China supplier nonconforming goods quarantine process makes it harder for an informal defect fix to disappear into normal production. It identifies the affected goods, controls their status, separates evaluation from authorization, preserves rework and reinspection evidence, and reconciles every held unit before the record closes.
Start with one product that has repeated inspection findings, packaging mixups, or material substitutions. Create a supplier hold form, location-and-status field, disposition authority list, rework record link, and quantity-reconciliation table. The first record often shows whether the supplier can identify affected lots and keep them separate from production and shipment flow.
Supplier Ally can help buyers coordinate supplier hold records, evidence collection, lot tracing, rework follow-up, inspection preparation, and shipment documentation. For technical, engineering, safety, regulatory, legal, laboratory, product-compliance, deviation, or final acceptance decisions, use the appropriate qualified owner before releasing goods.
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