# Root Cause Analysis (RCA) | Botable Glossary

https://www.botable.ai/glossary/root-cause-analysis-rca

> This is a vendor-hosted glossary/article from Botable that gives an explanatory overview of RCA and cites relevant regulations; use it as a concise, practical primer and site-authored definition, and attribute technical or regulatory claims to Botable rather than treating them as primary regulatory source text.

## Summary

Defines Root Cause Analysis (RCA) as the mandatory investigative step within formalized processes like CAPA to determine underlying causes of failures or nonconformities so they do not recur, and describes common techniques, regulatory expectations, and integration with CAPA software.

## Audience

Quality professionals and regulated-industry practitioners (e.g., medical device quality/regulatory teams)

## Prompts this page answers

- What is Root Cause Analysis (RCA) and why is it required in CAPA?
- How does RCA relate to FDA 21 CFR 820 and ISO 13485 requirements?
- What common techniques are used for Root Cause Analysis in quality management?
- How is RCA typically integrated into CAPA management software?

## Purpose

Provide a concise glossary definition and practical overview of Root Cause Analysis (RCA) for quality management, including its role in CAPA, regulatory context, common techniques, and technology integration.

## Highlights

- RCA is the mandatory investigation within formalized processes (like CAPA) to determine underlying causes of failures rather than treating symptoms.
- RCA is an essential step in the CAPA process and follows issue identification and prioritization.
- Regulatory frameworks cited: FDA 21 CFR 820, ISO 13485:2016, and EU MDR/IVDR require investigating nonconformities and actions to prevent recurrence.
- Common RCA techniques include the 5 Whys, Fishbone (Ishikawa) diagrams, and proactive tools like FMEA; RCA functionality is often integrated into CAPA management software.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/root-cause-analysis-rca

## Publisher



## Topics

- Root Cause Analysis
- RCA
- CAPA
- FDA 21 CFR 820
- ISO 13485
- EU MDR
- 5 Whys
- Fishbone diagram
- FMEA

## Key entities

- **Root Cause Analysis (RCA)** (other): Glossary entry defining RCA and describing techniques, role in CAPA, and regulatory context. — https://www.botable.ai/glossary/root-cause-analysis-rca
- **Corrective and Preventive Action (CAPA)** (service): CAPA process referenced as the formal process in which RCA is a mandatory step. — https://www.botable.ai/blog/capa-system-ai-the-future-of-corrective-and-preventive-actions
- **FDA 21 CFR 820** (other): U.S. Quality System Regulation cited as requiring investigation of causes of nonconformities.
- **ISO 13485:2016** (other): International standard cited regarding corrective action requirements and investigating nonconformities.
- **EU MDR/IVDR** (other): European regulations cited as requiring robust CAPA systems that rely on identifying root causes.
- **5 Whys** (other): A common RCA technique referenced on the page. — https://www.botable.ai/blog/the-5-whys-method-using-ai
- **Fishbone (Ishikawa) Diagram** (other): A common RCA technique referenced on the page.
- **Failure Modes and Effects Analysis (FMEA)** (other): A proactive risk-analysis tool referenced as used for early mitigation in high-risk products.

## Metadata

- Type: article