CAPA Process Design
Fit-for-purpose CAPA workflow, classification, ownership and closure criteria.
A CAPA programme that closes issues at root cause — with verified effectiveness and measurable KPI change, not another line in the register.
The disciplined handling of non-conformances, customer complaints and audit findings through structured root-cause analysis, corrective and preventive action, verified closure and effectiveness review — with a measurable link back to process KPIs.
Most CAPA programmes fail one of two ways: findings are 'closed' with a training record and reappear the next quarter, or the register grows faster than issues get closed. We fix both — with proper root-cause methodology, verified corrective action, effectiveness checks and dashboarded ageing that keeps the register honest.
Fit-for-purpose CAPA workflow, classification, ownership and closure criteria.
5-Why, Ishikawa, fault-tree and Apollo-style RCA led by trained facilitators.
Structured action plans with owners, dates and objective closure evidence requirements.
Post-implementation KPI verification — did the action actually stop the recurrence?
Dashboards, ageing, escalation and management-review reporting on the live CAPA register.
Trend analysis, systemic RCA and preventive action programmes across similar findings.
The same disciplined workflow for every non-conformance — no shortcuts, no premature closures.
Immediate containment and disposition of non-conforming product or process.
Structured root-cause analysis led by a trained facilitator.
Corrective and preventive actions with clear owners, dates and closure evidence.
Post-implementation effectiveness verification against defined KPIs.
Delivered across North America, with India and the UAE coming soon.
Corrective action eliminates the cause of an actual non-conformance so it does not recur. Preventive action eliminates the cause of a potential non-conformance so it does not occur in the first place. Both are required by ISO 9001 and both are covered by our CAPA programme.
5-Why for straightforward issues, Ishikawa (fishbone) for multi-cause problems, fault-tree for safety-critical events and Apollo-style RCA for complex, multi-condition incidents. The method is chosen to fit the problem — not the reverse.
Every CAPA closure requires (a) objective closure evidence attached to the register and (b) an effectiveness verification against a defined KPI after a set observation period. Nothing is 'closed' on the strength of a training record alone.
Yes — either as a facilitated one-off RCA workshop on a specific issue, or as part of a broader CAPA programme engagement.
We deliver CAPA and performance improvement across North America from our Mississauga (Ontario) and Austin (Texas) offices, with additional coverage in India and the UAE coming soon.
Send us your current register and top three chronic issues — we'll propose a recovery plan within one business day.