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capa-effectiveness-checker

Verify whether a corrective action actually worked (ISO 9001 10.2.1 d, IATF 16949, 8D D6) with statistics instead of 'no complaints so far': before/after defect-rate comparison with an exact conditional binomial test for Poisson counts and a minimum practical reduction, zero-defect demonstration size (n = ln(1-C)/ln(1-p), rule of three) with progress so far, and exact Clopper-Pearson upper bounds on the post-action defect rate. Returns effective, not yet demonstrated (with the units still needed) or not effective. Covers setting effectiveness criteria when the CAPA is opened, choosing the window by problem frequency, leading indicators for rare failures (Cpk, SPC stability, error-proofing checks, LPA), and traps such as volume changes, detection changes and containment masking. Use when closing a CAPA or 8D, deciding how long to monitor, or challenging a CAPA closed on its implementation date.

Implementation is not effectiveness. A corrective action is effective when the defect rate has dropped by a meaningful amount and the data is strong enough to rule out luck. scripts/effectiveness.py answers the three questions this needs: did the rate drop significantly, how many defect-free units prove a target, and what is the worst rate still consistent with the data?

Trigger Conditions

Activate this skill when the user:

  • Wants to close a CAPA or 8D and needs to show it worked
  • Asks how long to monitor, or how many parts without defects are enough
  • Has before/after defect counts and wants a verdict
  • Is reviewing CAPAs closed on their implementation date

The CAPA itself: capa-plan-writer.

Workflow

text
1. CRITERION -> at CAPA opening: metric, baseline, target, window, evidence source, owner, date
2. COLLECT   -> defects and units before and after, measured at the process (not after a sort)
3. TEST      -> python scripts/effectiveness.py rate --before 12 --before-units 4000 --after 1 --after-units 3500
4. RARE      -> python scripts/effectiveness.py zero --target 0.001 --so-far 1200
5. STATE     -> python scripts/effectiveness.py upper --defects 0 --units 3000 --target 0.001
6. DECIDE    -> effective: close and remove containment; not yet: keep monitoring; not effective: re-open root cause

Verdicts

VerdictConditionAction
EFFECTIVEp < alpha and reduction >= min-reduction (default 50%)Close, remove extra containment
NOT YET DEMONSTRATEDRate fell but not significantly, or reduction too smallContinue to the stated quantity
NOT EFFECTIVEAfter rate >= before rateRe-open root cause analysis
text
Before: 12 defects in 4000 units = 3,000 ppm (0.3000%)
After:  1 defects in 3500 units = 286 ppm (0.0286%)
Reduction: 90%   one-sided p-value (after < before): 0.0035
Verdict: EFFECTIVE - significant at alpha 0.05 with 90% reduction (>= 50%)

Criterion elements, monitoring windows by problem frequency, leading indicators and traps: effectiveness-criteria.md. The test, zero-defect table, upper bounds and continuous characteristics: statistics-guide.md.

Output Format

Deliver:

  1. Criterion - metric, baseline, target, window.
  2. Data - before and after defects and units, source, and whether measured before any containment sort.
  3. Result - effectiveness.py output (rate test, upper bound, zero-defect progress).
  4. Verdict and next step - close, continue to N units, or re-open the root cause.

Scripts

bash
python scripts/effectiveness.py rate --before 12 --before-units 4000 --after 1 --after-units 3500 [--alpha 0.05 --min-reduction 0.5]
python scripts/effectiveness.py zero --target 0.001 --confidence 0.95 --so-far 1200
python scripts/effectiveness.py upper --defects 1 --units 3500 --confidence 0.95 --target 0.002

Exit codes: 0 effective / requirement met, 1 not effective or not yet demonstrated, 2 usage error.

Additional Resources

FileContent
effectiveness-criteria.mdCriterion elements, windows, leading indicators, verdict actions, traps
statistics-guide.mdExact rate test, zero-defect sample sizes, Clopper-Pearson bounds, practical vs statistical significance
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