The steps 10.2.1 requires
| Step | Clause | Content |
|---|---|---|
| React | 10.2.1 a | Control and correct the nonconformity; deal with consequences (correction, containment) |
| Evaluate need | 10.2.1 b | Review the nonconformity, determine its causes, check whether similar ones exist or could occur |
| Act | 10.2.1 c | Implement the actions needed |
| Review effectiveness | 10.2.1 d | Did the action stop recurrence? |
| Update | 10.2.1 e, f | Update risks and opportunities; change the QMS if needed |
| Record | 10.2.2 | Nature of the nonconformity, actions, results of corrective action |
Correction vs corrective vs preventive
| Term | Acts on | Example |
|---|---|---|
| Correction | The nonconforming item | Scrap 77 parts; 100% sort of stock |
| Containment | Suspect product everywhere | Quarantine stock, check transit and customer |
| Corrective action | The cause of a nonconformity that happened | Tool-life interlock at 220 parts |
| Preventive action (2015: risk-based thinking) | The cause of a potential nonconformity | Apply the interlock to the other three lathes before they fail |
ISO 9001:2015 dropped the separate "preventive action" clause; extending an action to similar products, machines and sites (10.2.1 b 3) and the risk register (6.1) cover it. Many companies still use the term CAPA.
When a CAPA is required
Always for: customer complaints and escapes, repeat nonconformities, major audit findings, safety or regulatory issues, high-cost events. Optional for one-off minor internal NCRs (trend them instead). Define the triggers in the procedure so the decision is not ad hoc.
Root cause quality
- Find the cause of occurrence (why it was made wrong) and of escape (why it was not detected).
- A root cause is verified when you can switch the problem on and off, reproduce it, or show it with data.
- "Human error" is never a root cause: ask why the process made the error possible, likely and undetected.
- Use 5 Why for simple chains, fishbone for many possible causes, 8D for customer or cross-functional problems.
Effectiveness check
| Element | Example |
|---|---|
| Criterion (measurable) | 0 bore NCRs and Cpk >= 1.33 |
| Window | 3 months or 6 lots, enough opportunities for the problem to recur |
| Method | NCR log + SPC review; customer scorecard |
| Owner and date | Quality engineer, 2027-03-01 |
| If not effective | Re-open root cause analysis; do not extend the date silently |
See capa-effectiveness-checker for the statistics.
CAPA stage limits (typical)
| Stage | Limit |
|---|---|
| Containment | 24 hours to 7 days |
| Root cause | 30 days |
| Actions implemented | 60-90 days |
| Effectiveness verified | 90-120 days after implementation |
8d-problem-solving-report-writer
Write and review 8D problem-solving reports for customer complaints and serious nonconformities (automotive and aerospace practice: Ford Global 8D, VDA, GM, Stellantis formats): D0 emergency response, D1 cross-functional team and champion, D2 problem description with 5W2H and is / is-not and no cause in the statement, D3 interim containment within 24 hours with verification and clean point, D4 verified occurrence and escape (non-detection) root causes plus systemic cause, D5 permanent corrective actions for each cause verified before implementation, D6 implementation, validation with production data and removal of containment, D7 PFMEA, control plan and read-across to similar products, D8 closure and recognition. Checks an 8D discipline by discipline for missing content, human-error root causes, missing escape cause or action, late containment and dates out of order.
acceptance-sampling-plan-selector
Select and evaluate acceptance sampling plans for incoming, in-process and final inspection: ANSI/ASQ Z1.4 / ISO 2859-1 single sampling under normal inspection (code letter from lot size and inspection level I, II, III, S-1 to S-4; sample size, Ac and Re from AQL, following the table's arrows to the correct plan; 100% when n reaches the lot size; AQLs above 10 per 100 units), operating characteristic curves (Pa at any quality, producer's quality level, indifference point, LTPD, AOQ and AOQL, binomial or hypergeometric), plans designed from producer and consumer risk, and c = 0 zero-acceptance plans. Covers AQL choice by defect class, switching rules between normal, tightened and reduced inspection, when sampling is not appropriate, and random sampling.
approved-supplier-list-manager
Manage and audit an approved supplier list (ASL) / external provider register for ISO 9001 8.4.1, IATF 16949 8.4 and AS9100 8.4.1: supplier status (approved, conditional, probation, pending, disqualified), scope of approval by commodity and process, risk class, certification and expiry, re-evaluation intervals by risk, conditions with end dates, single-source contingency, approver and customer-directed sources. Audits the list for expired or expiring certificates, overdue re-evaluations, conditional or probation status past its decision date, high-risk suppliers without the required certification, single-source suppliers without backup and missing approvers, and checks purchase orders for suppliers that are off-list, disqualified or pending, or buying outside the approved scope. Covers ERP blocks, PO requirements, off-list and emergency purchases.
apqp-phase-planner
Plan and track Advanced Product Quality Planning (AIAG APQP 3rd edition, IATF 16949) for a new or changed automotive part: back-schedule the five phases (plan and define, product design, process design, product and process validation, launch and feedback) from the start-of-production date by program complexity, with overlap, PPAP lead and safe-launch period; list the deliverables and gate for each phase (DFMEA, DVP&R, feasibility, process flow, PFMEA, control plans, MSA, Ppk, run at rate, PPAP, safe launch, lessons learned); adjust for build-to-print suppliers; flag compressed timelines and late or untracked deliverables against a status list. Covers gate reviews, red/yellow/green status reporting, run at rate and safe-launch exit criteria.
as9100-gap-analyzer
Run an AS9100D / EN 9100:2018 gap analysis for aviation, space and defence suppliers on the requirements added to ISO 9001: on-time delivery and conformity focus, management representative, ethics and human-factors awareness, operational planning and operational risk management, configuration management, product safety, counterfeit-part prevention, special requirements, critical items and key characteristics, external provider register and flow-down, FOD prevention, tooling and NC program control, special process validation, first article inspection (AS9102), traceability, in-service data and nonconforming product control. Generates and scores a worksheet, grades missing core controls as major, and checks invalid n/a claims. Covers AS9101/AS9104, OASIS, AS9102 FAI forms, counterfeit standards (AS5553, AS6174, AS6081), NADCAP and the planned IA9100 transition.
audit-report-writer
Write internal, supplier and pre-certification audit reports with the content ISO 19011:2018 6.5 expects: audit objectives, scope, criteria with revisions, dates, team and auditees, method and sampling statement, specific strengths, findings table and three-part finding details (requirement, evidence, statement), conclusion on the degree of fulfilment of criteria, diverging opinions, follow-up deadlines and distribution. Builds a Markdown report from a JSON audit record, generates the conclusion from the findings (major / minor / none) and flags reports missing required content or findings without clause or evidence. Covers conclusion wording, closing meetings, response expectations and verifying corrective actions.