Quality · NCR and CAPA
From a bad part to a fixed process.
Report the nonconformance, decide what happens to the parts, prove the fix, and close the record. When the problem deserves a root-cause fix, the CAPA opens from the NCR and carries the same trail forward.
Burr on flange face, lot 22-117
Machining · CNC-3 · 40 pcs · found at final inspection
- Report(done)
- Triage(done)
- Decide(done)
- Fix(current step)
- Close out
Decision
Rework
Deburr the flange face and re-inspect all 40 parts.
Re-inspection
Checked by: R. Chen
At close out:Is corrective action needed?
- Triage firstA new NCR has no owner. It waits in the Unassigned tab until quality picks one.
- Proof the fix workedRework and repair need a pass or fail re-inspection. A fail sends the NCR back to review.
- The CAPA questionA major or critical NCR cannot close until someone answers it, with a reason if the answer is no.
- View
- NCR record
- Kind
- Product
- Severity
- Major
- Route
- Report to close out
The NCR route
Five steps, and none of them optional.
A product NCR is about parts, so it needs a decision about them before it closes. A process NCR is about how the work was done, so its owner writes a review instead and the two middle steps fall away.
- Reported
- In review
- Decision made
- Closed
- 01
Report
Anybody can report one, in three steps: the basics, the origin and the part, then a review. Photos and PDFs attach as evidence. The number is given at save.
- 02
Triage
A new NCR has no owner on purpose. It waits in the Unassigned queue until quality gives it one, and starting the review makes you the owner.
- 03
Decide
The owner picks the disposition and writes the reason. Accepting parts that do not meet the requirement needs a second signature, from a manager your approval policy names.
- 04
Fix
The work done is recorded with the name of the person who checked it. Rework and repair also need a pass or fail result, and a fail sends the record back to review.
- 05
Close out
A critical or major NCR cannot close until somebody answers the corrective-action question. An answer of no needs a reason, and an answer of yes opens the CAPA.
01 / Dispositions
What happens to the parts, and who says so.
A product NCR cannot close without a disposition. Two of them accept parts that do not meet the requirement, so they need a concession signed by somebody other than the person proposing it. Two change the parts, so they need a re-inspection result before the record can close.
- A refused concession removes the decision, and the owner decides again with the comment in front of them.
- A failed re-inspection sends the NCR back to review and marks the old signature superseded.
- A process NCR has no parts, so it has no disposition. Its owner writes a review instead.
| Disposition | Sign-off | Re-inspection |
|---|---|---|
| Use as-is | Required | Not required |
| Rework | Not required | Required |
| Repair | Required | Required |
| Regrade | Not required | Not required |
| Scrap | Not required | Not required |
| Return to supplier | Not required | Not required |
| No defect | Not required | Not required |
Sign-off comes from a quality or area manager, through your approval policy. Your workspace can add its own dispositions and severities.
02 / Root cause
Five whys, or your own words.
The investigation ends in one sentence: the root cause. Get there through the five-why grid or through free text, attach what you found, and the actions that follow each carry their own owner and evidence.
- The method locks once there is text in it, and switching clears that text, with a confirmation first.
- A failed effectiveness check starts a new round, and the record only moves on once an action is completed after that failure.
- One CAPA for each NCR. A second one on the same record is refused.
Porosity in TIG joints on frame welds
- Open(done)
- Investigation(done)
- Actions(done)
- Effectiveness(current step)
- Closed
5 Why
- Why 1Gas coverage was lost at the joint.
- Why 2The purge flow was set below spec.
- Why 3The flow meter on cell 3 reads high.
- Why 4The meter was not in the calibration plan.
- Why 5New equipment is not added to the plan at install.
Root cause: new equipment is not added to the calibration plan at install.
Actions
- Add an install step to the calibration procedureD. Moreau
- Calibrate the cell 3 flow meterR. Chen
The CAPA stages
The record says where it is.
Nobody sets a stage on a CAPA. The application reads the record after every write and moves it: text in the investigation, actions on the plan, all of them complete, a check recorded, a closure signed.
- 01
Open
Created with the problem statement, the site and a target close date, and linked to its source. Like an NCR, it starts with no owner and waits in the queue.
- 02
Investigation
Work the five whys, or write free text, then state the root cause in one line. The first person to write becomes the owner.
- 03
Actions in progress
One action for each piece of work, each with an owner, assignees, a due date and its own evidence. People see their actions across every CAPA on their dashboard.
- 04
Effectiveness
Possible only when every action is complete. Record effective, or not effective with notes, which starts another round of work.
- 05
Closed
The closure summary goes to a quality manager, who signs it with a comment. A closed record is permanent: the application refuses every later write.
Both registers
What the trail is worth.
An audit asks what happened, who decided it, and what proved it worked. Both registers answer in the same shape.
Records that cannot vanish
Neither an NCR nor a CAPA can be deleted, and a closed one refuses every later write. What happened stays readable.
The queue stays honest
Unassigned, mine and open tabs with live counts, filters for kind, status and severity, and an age column that turns red at 10 days.
Signatures by policy
Concessions and CAPA closures go to the people your approval policy names. A refusal always carries a comment.
Evidence on every layer
The report, the fix, each action and each check take their own images and PDFs, up to 10 MB each, plus links.
Everybody hears once
Each event tells only the person who has to act next, and closing the record clears what it raised.
Your severities and dispositions
The lists are yours to edit. The default values carry the rules, and a value you add behaves as a plain choice.
ISO 9001
Clause 8.7 and clause 10.2.
One clause covers the parts in front of you, the other covers the cause behind them. The two records line up with the two clauses.
| Clause | What it asks for | What ForgeSpex keeps |
|---|---|---|
| 8.7.1 | Control nonconforming output, and act on it: correct it, hold it, or accept it under concession. | The disposition is the action, and the two that accept parts as they are need a concession signed by a manager. |
| 8.7.2 | Keep a record of the nonconformity, the action taken, any concession, and who decided. | One numbered NCR holds the description, the decision and its reason, the signature, the work done, the re-inspection result and the evidence. |
| 10.2.1 | React to the nonconformity, then decide whether the cause has to be eliminated. | A critical or major NCR cannot close until that question is answered, and an answer of yes opens the CAPA from the record. |
| 10.2.2 | Keep a record of the nonconformity, the actions taken, and the results of the corrective action. | The CAPA carries the root cause, each action with its owner and evidence, the effectiveness result, and the signed closure. |
ForgeSpex keeps the records. It does not certify anybody, and an auditor still judges what you keep in it.
Questions
NCR and CAPA, answered.
What quality managers ask before they retire the NCR log.
- Who can report a nonconformance?
- Anybody who signs in. The form takes three steps and asks for the severity, the title, the description and the department. Photos and PDFs attach as evidence, up to 10 MB each.
- Do we have to use 5 Why?
- No. The five-why grid is the default, and free text is the other option. Both end in the same place: one root-cause statement. The method locks once you have written in it, and switching clears that text.
- Can we use our own severities and dispositions?
- Yes, both lists are editable. The default values carry the rules: an observation can close from triage, a critical or major NCR must answer the corrective-action question, and use as-is and repair need a concession. A value you add behaves as a plain choice.
- Does every NCR need a CAPA?
- No. A critical or major NCR has to answer the question, and an answer of no needs a reason. Everything else closes without one. Each NCR can have one CAPA, and a second is refused.
- Can a record be deleted?
- No. Neither register has a delete or an archive. A closed record is permanent, and the application refuses every write to it, which is what makes the trail worth keeping.
- Who signs a closure?
- An approval policy decides. By default a quality manager signs a CAPA closure, with a comment, and a concession goes to a quality or area manager. A refusal comes back with the reason, and the owner proposes again.
Catch it. Fix it. Prove it stays fixed.
Report the first nonconformance today, and the register starts building its own history.