# CAPA Form Template (Corrective and Preventive Action)

> Source: https://netray.co/tools/capa-corrective-and-preventive-action-form-template
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

Structured CAPA form covering source, risk, root cause, actions, effectiveness check and closure approvals.

## Category

quality

## Industry

Medical Devices

## Audience

- Quality manager
- Regulatory affairs
- Quality engineer

## Tool

**Kind:** template

**Output:** document

**Fields:**

#### Company

**Key:** company

**Type:** text

**Default:** Acme Precision Ltd

#### CAPA number

**Key:** capa_no

**Type:** text

**Default:** CAPA-2026-019

#### Date opened

**Key:** date

**Type:** date

**Default:** 2026-10-20

#### CAPA owner

**Key:** owner

**Type:** text

**Default:** R. Nakamura, Quality Engineering

#### Source of issue

**Key:** source

**Type:** select

**Options:**

- Customer complaint
- Internal audit
- Supplier issue
- NCR trend
- Process monitoring
- Management review
- Regulatory inspection

**Default:** NCR trend

#### Action type

**Key:** type

**Type:** select

**Options:**

- Corrective
- Preventive
- Both

**Default:** Corrective

#### Risk level

**Key:** risk

**Type:** select

**Options:**

- Low
- Medium
- High
- Critical

**Default:** Medium

#### Problem statement

**Key:** problem

**Type:** textarea

**Default:** Seven NCRs in 90 days for burrs on cross drilled holes in PN-31007, all from the same machining cell. Three were found at final inspection.

#### Correction (immediate fix of the product)

**Key:** correction

**Type:** textarea

**Default:** Affected lots reworked with a deburring step and 100 percent inspected. Two lots scrapped.

#### Root cause analysis and method used

**Key:** root_cause

**Type:** textarea

**Default:** 5 whys and fishbone. Drill exit burr forms because the peck cycle was removed in a program revision to cut cycle time. No change review covered burr risk.

#### Corrective / preventive action plan

**Key:** action

**Type:** textarea

**Default:** Restore the peck cycle in the program. Add burr check to the change review checklist. Update PFMEA line for drill exit burr.

#### Effectiveness verification plan and criteria

**Key:** effectiveness

**Type:** textarea

**Default:** No burr NCR on PN-31007 for 3 months and 10 consecutive lots. Review by quality on 2027-01-20.

**Blocks:**

#### Corrective and Preventive Action (CAPA) Form

**Body:** Company: {{company}}
CAPA number: {{capa_no}}
Date opened: {{date}}
Owner: {{owner}}

#### Initiation

**Table:**

**Columns:**

- Field
- Detail

**Rows:**

**0:** Source

**1:** {{source}}

**0:** Action type

**1:** {{type}}

**0:** Risk level

**1:** {{risk}}

#### Problem statement

**Body:** {{problem}}

#### Correction (containment)

**Body:** {{correction}}

#### Root cause investigation

**Body:** {{root_cause}}

#### Action plan

**Body:** {{action}}

#### Action tracking

**Table:**

**Columns:**

- Action
- Owner
- Due date
- Completed

**Rows:**

#### Effectiveness verification

**Body:** {{effectiveness}}

Result of verification: ____________________
Effective: Yes / No (if No, reopen or open a new CAPA)

#### Approvals

**Signatures:**

- CAPA owner
- Quality manager
- Process owner
- Management representative

**Notes:** A starting point, not a controlled form. Align it with your CAPA procedure, risk method and regulatory needs such as ISO 13485 clause 8.5.2 and 8.5.3 or 21 CFR 820 requirements where they apply.

## Content

**Intro:** A CAPA turns a problem into a controlled change: investigate, fix the cause, check the fix worked. This form template guides the record from source and risk through root cause, action plan, effectiveness check and approvals, and exports for your quality system.

**Sections:**

#### How to complete the CAPA form

**Body:** Begin with the source and a risk rating, since they decide how much investigation the issue deserves. Write a problem statement with counts, dates and the process involved. Record the correction separately from the corrective action: correction fixes this product, corrective action removes the cause. Name the root cause method and conclusion, then list actions with owners and due dates. Finally write the effectiveness criteria before work starts, with a review date. Writing the pass criteria upfront stops the CAPA from closing on opinion.

**Bullets:**

- Separate correction from corrective action.
- Rate risk to scale the depth of investigation.
- Give every action an owner and date.
- Define effectiveness criteria in advance.

#### Corrective versus preventive action

**Body:** Corrective action addresses a nonconformity that has already happened, so it does not recur. Preventive action addresses a potential nonconformity found through trends, risk analysis or near misses. ISO 9001:2015 moved to a risk based approach and no longer has a separate preventive action clause, but many sites, and ISO 13485 and FDA regulated organisations, still keep CAPA as a combined process. Use the action type field to keep both visible in reporting.

#### Common mistakes

**Body:** Frequent weaknesses are closing the CAPA when actions are complete rather than when they are shown to work, naming retraining as the only action, and opening a CAPA for every single defect until the system is buried. Use trending and risk to decide what deserves a CAPA. Also avoid vague due dates and shared ownership. One person should own the CAPA, even if many people own tasks. Link the CAPA to the NCRs, complaints or audit findings that triggered it.

**Cta:** If your CAPAs sit in spreadsheets, we can help connect them to ERP nonconformance and supplier data so trends are visible.

**Faq:**

#### When should I open a CAPA instead of just an NCR?

**Answer:** Open a CAPA when the issue is repeated, systemic, customer visible, safety or regulatory relevant, or when the cause is unknown. A one off defect with an obvious cause and a completed correction may need only an NCR.

#### How is effectiveness verified?

**Answer:** By evidence over a defined period: no recurrence, improved capability, audit results or reduced complaint rate. Set the metric and period when the plan is written, and have someone independent of the action owner review it.

#### How long should a CAPA stay open?

**Answer:** It depends on risk. Many procedures aim for root cause within 30 days and closure within 90 to 180 days, with longer allowed for effectiveness monitoring. Set the targets in your own procedure and track overdue items.

#### Is this form acceptable for FDA or ISO 13485 audits?

**Answer:** It captures the usual elements, but acceptance depends on your documented procedure and records being followed. Use it as a base, adapt it to your controlled form format and confirm requirements with your regulatory lead.

## Search terms

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