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Quality · Quality Manager · 8 minutes

CAPA Workflow (Corrective + Preventive Action)

Open a CAPA, assign root-cause investigation, track corrective action to closure.

CAPA vs NCR

NCR = one defective batch, one disposition. CAPA = systemic fix. "This keeps happening; let's solve the underlying cause."

CAPAs are the engine of continuous improvement. Auditors look hard at CAPA cycle time and effectiveness.

Menu: Plating → Quality → CAPAs.

CAPA list

Box ① + New (usually auto-created from an NCR). Box ② column headers. Box ③ open a CAPA.

CAPA states

  1. Opened — just created, awaiting investigator.
  2. Investigating — root cause being analyzed.
  3. Action Planned — corrective action defined, awaiting implementation.
  4. Implementing — action in progress.
  5. Verifying — effectiveness check.
  6. Closed — verified effective.
  7. Cancelled — decided not to act (justification required).

Creating a CAPA

Usually auto-created from an NCR. Manual creation:

Field Purpose
Source NCR / Audit finding / Customer complaint / Management review / Continuous improvement
Description The recurring problem
Root Cause Why it happens (5-whys / fishbone)
Corrective Action What you'll DO to fix it
Preventive Action What you'll DO to stop recurrence
Responsible Person Owner
Target Close Date Commitment

Root-cause investigation

Open the CAPA → Investigation tab. Fill:

  • 5 whys (literal 5 "why?" questions digging down).
  • Or Ishikawa (fishbone) diagram with cause categories (Method / Machine / Material / Man / Measurement / Environment).
  • Evidence (batch data, logs, witness statements).

Quality Manager reviews; sign-off on root cause before proceeding.

Corrective vs preventive

Corrective Action Preventive Action
Fixes THIS problem Stops the problem from RECURRING
"Replace the pH probe" "Add pH probe to monthly calibration schedule"
"Reinstate the first-piece gate" "Training refresh for all operators"
"Revise the SOP" "Add SOP review to quarterly audit schedule"

Both are required. Many organizations' CAPAs fail audit because only corrective was implemented.

Implementation + verification

Once actions are defined:

  1. Assign due dates + owners to each action.
  2. Track completion (checkboxes on each action).
  3. When all actions are complete → state flips to Verifying.
  4. Define effectiveness criteria (e.g. "no recurrence in 6 batches" / "zero related NCRs for 90 days").
  5. Monitor the criteria window.
  6. If criteria met → Close. If not → reopen, revisit root cause.

Metrics the Quality dashboard shows

  • Open CAPA count per category.
  • Average cycle time (created → closed).
  • Effectiveness rate (verified vs reopened).
  • Overdue CAPAs (past target close date).

What can go wrong

CAPA stays open forever

No action dates, no owner, no verification criteria. The Quality Manager's weekly review should catch these.

Closed too fast without effectiveness

Audit hit. Effectiveness verification is required; closing prematurely is a classic finding.

Same CAPA re-opened multiple times

Indicates corrective action didn't address the true root cause. Redo the 5-whys, dig deeper.