CAPA (Corrective And Preventive Action)

Notes

The read-across step, applying the fix to sister products and lines, is the part most often skipped and most often audited.

Overview

CAPA (corrective and preventive action) is the formal quality system for recording a problem, finding its root cause, putting in place a change that removes that cause, checking that the change worked, and applying the lesson to similar products and processes so the problem cannot recur elsewhere. It is a core requirement of quality management systems in the chip industry and its customers.

How it works

A CAPA starts from a trigger: a customer complaint or return, a qualification failure, an audit finding, a process excursion or an internal defect. The issue is recorded and contained, for example by holding affected material or screening stock. A team then investigates root cause using tools such as fishbone diagrams, five whys, failure analysis and data analysis.

The corrective action removes the root cause of the problem that occurred, such as changing a process setting, fixing a design or retraining. The preventive part extends the fix to places where the same problem could arise but has not yet, such as other products on the same process or other sites with the same equipment. Each action has an owner and a due date, and effectiveness is verified with data before the CAPA is closed.

In the automotive supply chain the work is usually documented in an 8D report, a structured eight-step problem-solving format. AEC-Q100, for example, requires all qualification failures to be analysed for root cause, with corrective and preventive actions proven effective and the 8D completed before a part is considered qualified.

Examples

• An 8D report for a customer return traced to a contaminated wire bonding step, with actions applied to all similar lines.
• A qualification failure analysed to root cause before the part can be declared qualified.
• An audit finding about missing calibration records closed with a new tracking system and checks.
• A process change made on one product, then applied preventively to two sister products on the same process.

Why it matters

CAPA is how organisations learn from failures instead of repeating them, and customers and auditors judge suppliers by how well they do it. Quality engineers, customer quality engineers, failure analysis engineers, process engineers and product engineers all take part, and slow or superficial CAPAs damage customer relationships and certifications.

In the chip lifecycle CAPA runs throughout: qualification failures during development, excursions and yield problems in production, and customer returns in the field.

Related terms

• 8D
• RCA
• Containment
• ISO 9001

Where it appears on the Hub

Used on 35 pages of the Hub. In each group, the pages that mention it most come first.