Register / MIQ-ART-013

Control of Nonconforming Outputs: What Clause 8.7 Wants Before the CAPA Starts

Clause 8.7 is the ninety-minute clause: everything it requires happens between finding a bad part and deciding what to do about it. Here's what identification, segregation, and disposition actually require, who gets to sign a use-as-is, and why the quarantine cage is where audits go wrong.

Document No.
MIQ-ART-013
Revision
A
Effective Date
Jul 27, 2026
Category
Nonconformance
Prepared By
My ISO Consultants

Most quality teams think of nonconformance as the start of a paperwork process: write the NCR, maybe open a CAPA, close it out. Clause 8.7 is about something faster and more physical. It covers the first ninety minutes, the window between the moment someone notices a bad part and the moment a decision with a name attached gets made about it. Everything in the clause exists to answer one question: how do you make sure a known-bad output can’t quietly rejoin the good ones?

That question sounds easy until you walk your own floor. The red bin with three unlabeled parts in it. The pallet marked “HOLD” in marker, sitting next to an identical pallet that isn’t. The rework bench where corrected parts and waiting parts share a tote. None of these are hypothetical; they’re the standard set of findings, and auditors collect them because they take one lap of the shop to spot.

What the clause actually says

Clause 8.7.1 requires you to identify and control outputs that don’t conform to requirements, to prevent their unintended use or delivery. It then lists the dispositions: correction, segregation, containment, return, or suspension of provision of products and services, informing the customer, and obtaining authorization for acceptance under concession. When nonconforming outputs are corrected, conformity must be verified again.

Clause 8.7.2 is the records half: retain documented information that describes the nonconformity, describes the actions taken, describes any concessions obtained, and identifies the authority deciding the action. Four things, every time. Most NCR forms capture the first two and go quiet on the last two, and the last two are the ones that carry the legal and customer weight.

Note what the clause does not require: root cause analysis. That belongs to clause 10.2, and only for the nonconformities that warrant it. Conflating 8.7 with 10.2 is how teams end up either five-whysing every scratch or, worse, delaying containment while the investigation form circulates for signatures. Contain first. Investigate the ones that deserve it, on their own clock.

Identification: the part has to carry its own status

The control problem is fundamentally about information travelling with material. A part on a shelf is just a part; nothing about it announces that inspection rejected it on Tuesday. The clause’s demand for identification means the status has to be attached to the thing, not stored in someone’s memory or a spreadsheet two buildings away.

The failure mode is almost always a gap between the physical and the recorded. The NCR exists, dutifully filled out, while the parts it describes sit unmarked because tagging them was somebody else’s job. Or the reverse: parts wearing red tags that no record can explain, which tells an auditor your identification system produces orphans in both directions. The test is simple. Pick up any item in your hold area and ask the nearest person what it is, why it’s there, and what happens to it next. If the answer requires a phone call, the identification is decorative.

Segregation is a verb, not a cage

Most shops interpret segregation as a fenced quarantine area, and a cage is fine as far as it goes. But the clause’s real concern is preventing unintended use, and a cage only helps if material actually moves into it promptly, stays there, and leaves only through a disposition. The cage with a broken latch, the cage used as overflow storage for good material, the “temporary” staging spot beside the cage that has been temporary for two years: each one converts segregation from a control into a prop.

Containment is segregation’s wider cousin, and it’s where the clock matters most. When a nonconformity surfaces, the immediate question is blast radius: what else did this process touch since the last known-good check? Parts already at the customer, parts in finished goods, parts two operations downstream. A disciplined containment answer looks like a bounded list with locations, produced within hours. If your system can’t tell you where the suspect lot went, the honest containment boundary is “everything,” and that’s an expensive sentence to say to a customer.

Disposition: someone with a name decides

Every nonconforming output ends its journey at a decision: rework it, scrap it, return it to the supplier, or accept it as it is. The last one, the concession or use-as-is, is where clause 8.7.2’s demand to identify the deciding authority earns its keep. A use-as-is is an engineering judgment that the requirement didn’t matter this time, and that judgment needs an author who was authorized to make it. If the requirement is a customer’s, the concession is the customer’s to grant, not yours. An auditor who finds a use-as-is signed by whoever was nearest to the form has found a real finding, and a customer who finds one has found something worse.

Rework carries its own trap: re-verification. Corrected outputs must be verified against requirements again, which means the reworked part goes back through inspection, not back into the bin it came from. The rework bench with a direct path to the good tote, no inspection step between, is one of those findings that looks minor on paper and isn’t, because it means your verified population contains unverified members.

Why this clause hates spreadsheets

Clause 8.7 is a workflow with state: open, contained, dispositioned, verified, closed, and material physically moves as the state changes. Spreadsheets record states; they don’t enforce them. Nothing in a spreadsheet stops a disposition field from being filled in while the parts sit untagged, or a closure from happening before re-verification, or an NCR from being created without anyone answering the containment question. A system that treats the NCR as a record with required fields, a named disposition authority, and a link to the resulting CAPA when one is warranted turns the clause from a training issue into a default.

The audit prep for 8.7 is the cheapest in the standard: walk your own floor with fresh eyes, once a month. Every red tag should have a record, every record should have parts you can put your hand on, and every closed NCR should show who decided and what the customer was told. If the walk takes notes, your system has homework.

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