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Modules / Corrective Action

Actions that close the cause, not the ticket.

Issues and actions on one living record, each with its owner, its due date, its evidence and its effectiveness check, so leadership, clients and regulators see the improvement, not the backlog.

Corrective action was the FDA's most-cited device finding in 2022 · 193 observations
See it on your plant drawingA working session on your own plant.
  1. Raisefrom any finding
  2. Ownone person, one date
  3. Actwith evidence
  4. Verifydid it hold
  5. Proveat the audit
Why careful plants still get it wrong

The action list is long. The effective ones are few.

Most plants track actions in a spreadsheet, and closure is a date typed in. Whether the fix held is a question for the next audit.

NEXUS runs issues and actions as one record: the issue from any module, the action with its owner, date and evidence, the check that says whether it held, and the trend. One board per program shows leadership, a client review or a regulator the same thing: what was found, what was done, whether it held, and how fast the plant improves. Continuous improvement becomes something you show, not something you claim.
How it works

Raise it. Own it. Prove it held.

01

Raise from any finding

An inspection, a nonconformance, an audit or a walk opens an action with the record attached.

02

Own and act

One owner, one date, and evidence to close. The owner sees what they owe; the manager sees who owes what.

03

Verify, then show

A later check, on a date the record sets, says whether the cause is gone; an action that did not hold reopens. The board per program carries the improvement to the management review, the client audit and the regulator.

What each person gets

What I owe. What held.

The action owner

What I owe, by when

My actions, their evidence, their dates, on one screen.

The quality director

Overdue and ineffective, by program

Not a spreadsheet: the record, with the finding it came from.

The executive

Improvement you can show

Open, overdue, verified and the trend by site, with the record one click away for the board, the client and the regulator.

Proof

Numbers we can stand behind.

193

Corrective and preventive action (21 CFR 820.100(a)) was the most-cited finding on FDA medical device inspections in 2022, with 193 observations; complaint handling was second.FDA Form 483 observations, calendar 2022

Every count NEXUS shows you is measured on your own records: actions open, overdue, closed with evidence, verified effective. We do not quote averages from someone else's pilot.

Connected

One record, eight modules.

Quality Engineering

The finding behind the action

Cause and analysis attached.

Quality Control

Holds that need an action

Raised from the inspection.

Documents

The procedure the action changes

Revised from the record.

Clarity

Actions by program

Open, overdue, effective.

Starting

A walkthrough on your own action list.

Bring your open action list, as it is today. In a working session NEXUS takes it in, each action gets its owner, date and evidence rule, and you see the first overdue one surface. No slides, no migration, nothing to install.

What you need

One list. One hour.

The spreadsheet and the person who chairs the quality meeting. No intelligence in this module: a record, an owner, a date, evidence and a check.

See it on your plant drawing.

Actions that close the cause, not the ticket.

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