CAPA Example

CAPA Example for Supplier Quality Issue

Supplier quality CAPAs often fail when teams stop at 'supplier error' and never explain why the issue escaped both the supplier and receiving inspection.

Below is a structured example of a CAPA investigation for an incoming dimensional nonconformance tied to a critical machined component.

It shows how a supplier issue can be documented in a way that supports audit readiness, supplier accountability, and prevention of recurrence.

Nonconformance Description

During incoming inspection of stainless valve bodies from an approved supplier, 12 of 50 sampled units were found to exceed the maximum bore diameter specification by 0.04 mm to 0.07 mm.

The affected lot was contained before release to production. A review of prior lots found borderline measurements in the preceding two shipments, but no formal escalation had been opened at that time.

Potential impact included assembly leakage, reduced pressure performance, and downstream product reliability risk if the parts had reached finished goods.

Problem Statement

A supplier-provided critical component failed to meet dimensional requirements due to unknown causes, creating a major supplier quality nonconformance with potential product performance implications.

Root Cause Analysis (Summary)

A structured Ishikawa and 5-Why analysis identified contributing factors across supplier process control, incoming inspection strategy, and communication controls.

Key contributing areas:

  • Supplier process drift - bore machining results shifted after an unvalidated tooling change
  • Control plan weakness - supplier reaction limits did not trigger escalation soon enough
  • Incoming inspection strategy - sampling did not increase after earlier borderline readings
  • Communication gaps - change-notice expectations were not consistently enforced

Leading hypothesis:

The most probable root cause is supplier machining drift following an unvalidated tool change, combined with a control plan that did not force timely escalation when readings began trending toward the upper tolerance limit.

Additional contributing causes remain plausible, including inadequate receiving inspection response to borderline prior-lot data.

Corrective Actions (Overview)

Corrective actions were structured across four layers:

1. Containment

  • Affected lots were placed on hold at receiving inspection
  • Open supplier orders were paused pending investigation and disposition

2. Immediate Correction

  • Joint review of machining records, offset history, and last-tool-change documentation
  • 100% sort of suspect inventory and in-transit lots

3. Systemic Corrective Actions

  • Requalification of the supplier machining process after tool replacement
  • Updated control plan with tighter process triggers and mandatory notification rules
  • Revised incoming inspection sampling based on supplier risk and recent performance

4. Preventive Actions

  • Supplier scorecard updated to track repeated dimensional drift events
  • Supplier quality engineers retrained on change-notice enforcement and escalation timing
  • Similar critical suppliers reviewed for the same control-plan weakness

Effectiveness Checks

Effectiveness was defined using measurable and auditable criteria:

  • Three consecutive accepted supplier lots with zero critical dimensional escapes
  • Documented evidence that supplier process capability returned above the approved threshold
  • Receiving-inspection trend review for 60 days with no repeat deviations
  • Escalation audit confirming supplier change notifications are submitted before shipment

These criteria demonstrate that both the supplier process and the receiving-inspection response have been strengthened.

Why This Matters

One of the most common supplier CAPA failures is stopping at a vendor complaint without asking why the issue was not prevented or detected earlier.

In this case, the deeper issue was systemic:

  • weak linkage between supplier change activity and incoming inspection severity
  • insufficient escalation of borderline measurement trends
  • overreliance on supplier paperwork instead of objective process evidence

That is the level of investigation auditors and supplier quality teams expect - not just what failed, but how the quality system responded.

See How This Was Generated

This CAPA example was generated using CAPA Engine, a structured investigation tool designed for regulated industries including medical devices, pharma, aerospace, and manufacturing.

It helps quality teams move from unstructured nonconformance descriptions to complete CAPA investigations with:

  • root cause analysis
  • supplier-focused corrective action plans
  • measurable effectiveness checks
  • investigation reasoning and confidence

Frequently Asked Questions

What is a CAPA example?

A CAPA example shows how a nonconformance is investigated, including root cause analysis, corrective actions, and effectiveness checks.

What should be included in a CAPA?

A CAPA should include a clear problem statement, root cause analysis, corrective actions, and measurable effectiveness checks.

Related CAPA Examples

Curious how this compares to using ChatGPT for CAPA? Read our breakdown of where generic AI helps, where it falls short, and what a more structured CAPA approach looks like.

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This example was generated using CAPA Engine.

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