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CAPA & Audit Readiness

Quality Systems

Research-backed case study: standardized workflow, traceability to ISO 9001, and audit outcomes.

Executive Summary

CAPA (Corrective and Preventive Action) and nonconformance records were scattered across spreadsheets, email, and shared drives. When external audits approached, the team had to scramble to pull evidence, link corrective actions to findings, and demonstrate closure. This project standardized the CAPA workflow, linked evidence and corrective actions in one place, and created a central audit pack with clear traceability to ISO 9001 (and related clauses). The result was zero major findings in the follow-up audit, faster CAPA closure with clear ownership, and supplier audit scorecards consolidated in one place.

Zero major findings in follow-up audit
Faster CAPA closure with clear ownership
Supplier audit scorecards in one place

Context & Problem

Nonconformances and customer complaints were logged in one system or spreadsheet; corrective actions were tracked in another; evidence (e.g., training records, revised procedures, verification data) lived in emails and folders. Auditors (internal and external) had to ask “where is the evidence for this CAPA?” and the answer often required digging. Closure dates slipped because ownership was unclear, and duplicate or outdated versions of procedures caused confusion. The organization needed a repeatable way to: open a CAPA, assign ownership, link root cause and actions, attach evidence, and close with verification-all traceable to the quality management system (e.g., ISO 9001:2015 Clause 10.2).

Methodology & Frameworks

The approach aligned with ISO 9001:2015 and common CAPA best practices:

ISO 9001:2015 Clause 10.2 (Nonconformity and corrective action) - Requirements for determining causes, evaluating need for action, implementing controls, reviewing effectiveness, and retaining documented information. The workflow was designed so that each step could be demonstrated to an auditor.
Structured CAPA workflow - Defined stages: Open → Root cause → Action plan → Implementation → Verification → Close. Each stage had required fields and optional evidence attachments. Ownership was assigned at open and could be escalated if overdue.
Traceability - Each CAPA was linked to: the originating nonconformance or finding, the relevant QMS procedure(s), and the evidence (documents, records, training). A simple “audit pack” view listed all open/closed CAPAs with links so that auditors could follow the thread from finding to closure.
Document control - Revised procedures and work instructions were versioned and stored in a controlled location so that the “current” revision was unambiguous.

Implementation

Existing CAPAs and nonconformances were inventoried and, where possible, migrated into the new structure (or at least indexed with a pointer to where evidence lived). The workflow was implemented in a combination of a shared system (e.g., SharePoint lists or a dedicated QMS module) and a single “audit pack” document or dashboard that listed CAPAs by audit finding, status, and evidence links. Training was provided so that quality and operations knew how to open a CAPA, attach evidence, and close with verification. Management review included a standing agenda item on CAPA status and overdue items so that closure stayed on the radar.

Supplier audit scorecards (where the organization had responsibility for auditing or monitoring suppliers) were brought into the same structure so that supplier-related nonconformances and CAPAs could be tracked and presented in one place during audits.

Outcomes

Zero major findings in the follow-up external audit. Auditors could easily trace from finding → CAPA → root cause → actions → evidence → closure.
Faster CAPA closure - Clear ownership and visible status reduced “lost” CAPAs and accelerated closure where actions were complete.
Supplier audit scorecards in one place - Simplified both internal review and audit presentation.

Lessons Learned

(1) One workflow and one place for evidence eliminated “which version?” and “where is it?” (2) Mapping the workflow to ISO 9001 (and customer) requirements up front made audit prep straightforward. (3) Assigning ownership and tracking overdue items in management review kept CAPAs from stalling. (4) Keeping the audit pack simple (list + links) made it easy for auditors to navigate. (5) Bringing supplier scorecards into the same framework improved consistency and audit readiness for supplier-related clauses.