Try it while you read
Open the free CAPA and NCR Tracker tool and click Load sample: it reproduces the case study below.
Theory: one register, two record types
ISO 9001 (8.7 and 10.2) and IATF 16949 (8.7, 10.2.3 to 10.2.6) require that nonconforming outputs are identified and controlled, and that corrective actions remove the cause and are checked for effectiveness. A single register for NCRs and CAPAs makes both visible in one place.
The workflow
| Status | What happens |
|---|---|
| Open | Problem recorded: what, where, how many, source and severity |
| Containment | Suspect parts blocked and sorted; disposition decided (MRB) |
| Root cause | Cause found with 5 Why, fishbone or data; category (man, machine, method…) |
| Action | Corrective action with owner and due date |
| Verification | Effectiveness checked with evidence |
| Closed | Effective, lessons learned recorded |
Key figures
- Open and overdue records, and items due in the next 7 days.
- Aging: open records by age (0–30, 31–60, 61–90, over 90 days). Old records are a typical audit finding.
- Days to close and the on-time rate (closed by the due date).
- Effectiveness: effective, not effective, pending.
- Cost of nonconformance and the root cause categories, to see systemic causes.
Key point
Step by step
- Log each case in the CAPA and NCR tracker: type, title, source (customer, internal, supplier, audit, process), severity, part, quantity, cost.
- Contain and choose the disposition. For customer complaints, start an 8D report in parallel.
- Root cause: category and description; use the 5 Why or fishbone tool for the analysis.
- Action: owner and due date. Move the status forward as the work progresses.
- Verify after enough time or lots and set the effect to effective or not effective.
- Review the dashboard weekly: overdue list, aging, owners with most open items, repeat causes.
Case study: register of a gearbox shaft plant
The Load sample register holds 9 records: 4 CAPAs and 5 NCRs from customers (2), internal findings (3), suppliers (2), an audit and a process problem.
| Figure | Value |
|---|---|
| Open / closed | 6 / 3 |
| Overdue | 3 |
| Average age of open records | 36.7 days |
| Average days to close | 26.3 days |
| Closed on time | 33 % |
| Effective / not effective | 2 / 1 |
| Cost of nonconformance | € 10,890 |
| Most frequent root cause category | Method (3), then supplier (2) |
The three overdue items are the critical customer complaint “bearing seat oversize” (in verification), the audit finding on overdue micrometer calibration (still in root cause after 75 days) and repeated tool breakage on line 2. Method is the top root cause category: three problems trace back to missing or unclear instructions.
Result
Common mistakes
- Closing a CAPA when the action is done, without an effectiveness check.
- Due dates moved without a record, so nothing is ever overdue on paper.
- Containment that forgets parts in transit and at the customer.
- No link between NCRs: the same problem opened ten times as a new case.
- Root causes in the people category with “retrain” as the only action.
Frequently asked questions
What is the difference between an NCR and a CAPA?
An NCR records a nonconforming product or situation and decides what happens to it (disposition). A CAPA removes the cause so it does not happen again. Not every NCR needs a CAPA, but every repeated or serious NCR should lead to one.
What does MRB mean?
Material review board: the people (quality, production, engineering, sometimes the customer) who decide the disposition of nonconforming material: use as is, rework, repair, scrap, return to supplier or sort.
When is a CAPA effective?
When the problem has not come back over a period long enough to prove it, for example three months or a number of production lots, and the evidence (data, audit, measurements) is recorded. Closing on the day the action is done is not an effectiveness check.