CAPA: corrective and preventive actions with five whys
When a problem keeps coming back, raise a CAPA. Ask why five times, write the root cause, and plan corrective and preventive actions with owners and dates. Have the plan approved, and close it only when you have checked that it worked.
PLANSScale only
The problem it solves
- The same burr on the same part is rejected every month, and each time the fix is to sort the lot.
- A customer complaint is answered with an apology, and the cause is never found.
- Actions agreed in the quality meeting have no owner and no date, so nothing happens.
- An auditor asks for proof that a corrective action worked, and there is none.
How it works
- Raise a CAPA from a non-conformance with Raise CAPA. Or make one under Quality > Problems > CAPA for a customer complaint, an audit finding or an internal problem.
- Fill in the five whys: each Why? with its Because. The first question is written for you from the non-conformance. Then write the root cause.
- Add the actions: corrective or preventive, what to do, who and by when. Press Send Plan for Approval; it needs a root cause and at least one action.
- A quality manager, or the levels of your CAPA chain, approves the plan. Each action becomes a to-do for its owner with its date.
- Owners record Done On as they finish. When the last action is done, the CAPA moves to To Verify by itself (or press Ready to Verify).
- Write how it was checked and choose Worked or Did Not Work, then Close. Did Not Work sends it back to In Progress for new actions; Worked closes it and clears the to-dos.
Everything it does
The CAPA
- Problem, source (Non-conformance, Customer Complaint, Audit, Internal), customer or supplier, the non-conformances it covers
- Five Whys: as many Why? and Because lines as you need
- Root Cause, Owner (you, to start with), Close By date
- How It Was Checked and Result: Worked or Did Not Work
- Numbered by itself; every change is tracked in its history
Actions
- Corrective or Preventive, What to Do, Who, By When, Done On, Note
- Each action with an owner becomes a to-do with its date when the plan is approved
- Listed in date order
States
- Draft, Plan to Approve, In Progress, To Verify, Closed, Cancelled
- Send Back returns the plan to Draft with the reason
- Only a Draft or Plan to Approve CAPA can be cancelled; one at work is closed with its result
- Close needs the verification written and a result
Links
- Raised from a non-conformance, it takes its problem, party and source (a customer complaint stays a complaint)
- The non-conformance shows its CAPA
- CAPA sits beside Non-conformances and Lots on Hold under Quality > Problems
Who uses it
Quality InspectorRaises a CAPA, works out the whys and proposes the actions.
Quality ManagerApproves or sends back the plan, checks the result and closes it.
Action ownerGets a to-do, does the work and records when it was done.
Plant headCan be added as a level of the CAPA chain for plans that need them.
Where you use it
- Web: Quality > Problems > CAPA, and Raise CAPA on a non-conformance
- Web: action owners see their to-dos in the activity list
- Not in the app
What you control
Settings
- CAPA approval chain: the quality managers to start with; add levels or set it to Approved at Once
Approvals
- CAPA: the plan of root cause and actions waits for a quality manager with no set-up, or the levels you add. Whoever raised it may approve at a level they hold
Notifications
- Request Waits for Your Approval: to the approvers of a CAPA plan. In the app inbox and by email (app push built in, not switched on yet)
- Action owners get a to-do with the action's date when the plan is approved
- Each person can switch off email for themselves; in-app notices always arrive
Questions
Can a CAPA be closed without proof that it worked?
No. Close needs How It Was Checked written and a result. If the result is Did Not Work, the CAPA goes back to In Progress for new actions.Do people get reminded of their actions?
Each action with an owner becomes a to-do with its date when the plan is approved. The to-dos are cleared when the CAPA is closed.Can one CAPA cover several non-conformances?
Yes. Link every non-conformance with the same cause to one CAPA; each of them shows it.Is it only for problems found in our checks?
No. A CAPA can come from a customer complaint, an audit finding or an internal idea, as well as from a non-conformance.Which plan has CAPA?
Scale. Checks, holds and non-conformances start in Growth.Related features
PLANNING, QUALITY AND COSTQuality checks with sampling (AQL), held lots and non-conformanceCheck material as it comes in, each step on the floor, the finished product and goods going out. Each check has a sheet and a sample worked out from the lot. A failed check holds the lot, raises a non-conformance whose decision is approved, and a Rework decision makes the rework order.PLANNING, QUALITY AND COSTSPC charts with Cp and CpkDraw a control chart from the measurements your inspectors already record. Every value shows in date order with its control limits and specification limits. Points out of control are marked, a moving range chart sits below, and Cp and Cpk are worked out for you.PLANNING, QUALITY AND COSTGauge calibration, and checks that refuse an overdue gaugeKeep every vernier, micrometer, weighing scale and thermometer with its calibration due date, history and certificates. Quality managers get a to-do before a gauge falls due. A check cannot be finished with a gauge that is overdue or out of service.ACROSS SMARTMY MANUFACTURINGApproval chainsDecisions that cost money or change how you build go to the right people in order before they take effect. They cover failed goods, engineering changes, corrective actions, store requests and asset changes. With no set-up the usual managers approve; you add levels without code.PLANNING, QUALITY AND COSTRecall list: forward to customers, back to suppliersPick a lot or serial number and see, in one list, every lot made from it and every customer who received them. Or go backwards: every component lot and supplier that went into it. Export the list and call the right customers.
See your shop floor on it.
Tell us what you make, how many machines and people you run, and how production is recorded today. We will set up a line with you and run a job on the terminal.