Managing Non-Conformances (QMS)

A non-conformance is a failure to meet a requirement. Logging and closing them systematically is the backbone of continual improvement, and it is what an ISO 9001 auditor asks to see.

Everything below lives on one screen: Compliance & QHSE → Quality Management (QMS), which has five tabs — Dashboard, Non-Conformances, CAPA, Documents and Reviews.

Step 1 — Raise an NCR

Open the Non-Conformances tab and click + NCR. The button only appears while that tab is selected.

The form has four fields:

• Title — e.g. "Incorrect firmware deployed to 3 customer routers"
• Description — what happened, in full
• Severity — Minor, Major or Critical
• Category — Product, Process, Supplier, Customer or Safety

That is the whole form. There is no ISO clause field, no detected-by or detected-in, and no date picker — the detection date is stamped as the moment you save. Anything else worth recording (the clause, who found it, which process, immediate containment) belongs in the description.

The report is numbered for you as NCR-0001, NCR-0002 and so on, and opens in open status.

Step 2 — Raise CAPA actions

Corrective and preventive actions live on the CAPA tab. Click + CAPA:

• Title — the action to be taken
• Description — including the root cause, if you have established one
• Type — Corrective (stop it recurring) or Preventive (stop it happening)
• Due Date

CAPA actions carry no assignee, so nobody is emailed and no task is created elsewhere in Plenix. Name the owner in the title or description if you need one visible — for example "Rewrite firmware checklist (owner: J. Adams)".

An overdue action shows in red on the list and is counted on the dashboard, so the due date is what drives follow-up.

Linking CAPA to an NCR: the list shows the related NCR when a link exists, but the create form has no NCR picker. Quote the NCR number in the CAPA title to keep the trail readable.

Step 3 — Close things out

Both closures are a single click, with no verification step and no comment box:

• an open NCR shows Close
• an open CAPA action shows Complete

Once closed there is no reopen action, so be sure before you click. If you need to record how effectiveness was verified, put it in the description before closing.

Step 4 — Watch the dashboard

The Dashboard tab is the management view:

• Open NCRs out of the total, split by critical and major
• Open CAPA Actions, with an overdue count that turns the tile red
• Approved Documents out of the total, with drafts called out
• Reviews Due (30d)
• recent management reviews

There is no monthly quality report and no PDF export. For evidence at audit time, work from these tabs on screen, or pull the underlying records through the reporting module.

Related tabs

Documents — controlled documents with a number, version and type (Procedure, Work Instruction, Policy, Form, Record) plus a review date. A draft shows Approve to publish it.

Reviews — management reviews with a title, date and Planned/Completed status.

Internal audits

Scheduled audits are a separate screen: Compliance & QHSE → Compliance Audits, where Schedule Audit records a Title, Audit Type (free text — write "ISO 9001 internal" if that is what it is), Auditor, Scope and Scheduled Date.

That screen schedules and lists audits. There is no detail view, no findings capture and no way to raise an NCR from an audit — log findings as NCRs on the QMS screen and reference the audit in the description.

Good practice

• One NCR per problem. Three routers with the same bad firmware is one non-conformance, not three.
• Severity drives urgency. Critical means the customer is affected or the product is unsafe; keep the bar high or the dashboard stops meaning anything.
• Watch for repeats. Several NCRs in the same category in one quarter points at a process to redesign, not a run of one-off fixes.
• Write for the auditor. Because the fields are deliberately few, the description is your evidence — clause, containment, root cause and verification all go there.

Where to go next

• Understand the whole module → How Compliance & QHSE Works
• Next in this module → Compliance — Deadlines, Audits & QHSE Training
• Run an Audit
• Log an Incident
• See where this fits in the bigger picture → Start Here: What Plenix Is and How It Fits Together