Last Updated on October 24, 2025 by Hafsa J.

Turning Deviations into Improvement Opportunities

Every cosmetic manufacturer faces unexpected issues — a mislabeled bottle, a skipped cleaning step, a wrong temperature setting. These things happen.
But here’s what I’ve noticed after years helping ISO 22716 clients prepare for audits: it’s not the deviation itself that worries auditors — it’s how you respond to it.

Under ISO 22716, documenting and investigating deviations is a core requirement. It’s your proof that you don’t just fix problems — you learn from them.
That’s where a well-structured Deviation & CAPA Form comes in. It helps you capture what went wrong, find out why it happened, and make sure it doesn’t happen again.

In this guide, I’ll show you exactly how to structure your CAPA form, what to include, and how to make it practical for daily use — not just another piece of paperwork.

Understanding Deviations, Non-Conformities, and CAPA in ISO 22716

Let’s start with the basics — and strip away the jargon.

• A Deviation is any unplanned departure from an approved procedure or expected outcome.
• A Non-Conformity means a requirement wasn’t met — maybe an SOP step was skipped or a parameter exceeded.
• CAPA stands for Corrective and Preventive Action — it’s how you address and prevent recurrence of the root cause.

ISO 22716 doesn’t expect perfection. It expects proof of control.
Every deviation should trigger a review: what happened, why, and what’s the plan to stop it from happening again?

Pro tip: Treat deviations as data, not drama. They’re early warnings that your process needs attention.
Common mistake: Writing “operator error” as the root cause and closing the case. That’s not investigation — that’s blame without learning.

Core Sections of a Deviation & CAPA Form

A strong form keeps your investigation focused, structured, and transparent.
Here’s how to build one that stands up during audits and actually helps your team improve.

1. Basic Information

Include deviation ID, date, department, and responsible person.
It sounds simple, but this info links your record to batch documents and traceability logs.

2. Description of Deviation

Describe what went wrong — factually, without assumptions.
Reference the relevant SOP, batch record, or work instruction.

Pro tip: Stick to the facts first; analysis comes later.

3. Immediate Action Taken

What did you do as soon as you discovered the issue?
Examples:

• Quarantined affected batch
• Stopped production line
• Informed QA

Goal: Contain the problem before it spreads.

4. Root-Cause Investigation

Now dig deeper. Use tools like the 5 Whys or a fishbone diagram to find the real cause.
Was it training? Equipment? Procedure design?

Common mistake: Jumping straight to solutions before confirming the cause.
In one facility I worked with, repeated weighing errors weren’t due to “operator negligence” — the scale’s calibration schedule was outdated. Once fixed, the errors disappeared.

5. Corrective Action Plan

These are steps you’ll take to fix the current problem — updating an SOP, retraining staff, or adjusting parameters.
Assign each action to a responsible person and set a clear due date.

Pro tip: Keep corrective actions short and realistic — vague goals never get done.

6. Preventive Action Plan

Now go beyond fixing — prevent recurrence.
This could mean:

• Adding a verification step to a process
• Updating training frequency
• Revising a checklist

Preventive actions show auditors that you think long-term, not just short-term.

7. Verification of Effectiveness

How will you prove your actions worked?
Examples:

• Follow-up inspection
• Trend analysis after three months
• Internal audit review

If the same deviation repeats, your CAPA wasn’t effective — update it and close the loop properly.

8. Approval & Closure

QA should verify everything is complete before closure.
Include:

• Signatures
• Closure date
• Reference to linked documents (like batch records or SOPs)

Pro tip: Keep your CAPA forms concise — one to two pages is ideal. Long forms discourage completion and consistency.

How to Integrate CAPA into Daily GMP Practices

The best CAPA systems aren’t separate from daily operations — they’re embedded in them.
Hold short monthly reviews to discuss open CAPAs, assign priorities, and track trends.

Example: One skincare manufacturer started logging similar labeling deviations monthly. The pattern revealed a training gap with new staff, not a packaging defect. One targeted refresher fixed the issue completely.

Pro tip: Use CAPA logs as learning tools in team meetings. They remind staff that CAPA isn’t punishment — it’s improvement.

Common pitfall: Treating CAPA like audit paperwork instead of a process-improvement engine.

Digital vs Paper CAPA Systems

Both can work — the choice depends on your setup.

Paper Forms
Simple to use
Easy to misplace
Hard to trend or search

Electronic CAPA Systems
 Auto-tracking, notifications, analytics
 Easier cross-department coordination
 Requires setup and training

Pro tip: Even a shared Excel tracker is a great starting point. What matters most is that the process is consistent and traceable.

Example: A cosmetic lab I worked with switched to an online CAPA tracker and cut their closure time by 40 %. No more lost forms, no more follow-up chaos.

Example: ISO 22716 Deviation & CAPA Form Layout

Here’s a simple format that covers everything you need:

Section	Example Entry
Deviation ID	CAPA-2025-014
Description	Incorrect label applied to batch #L-205
Immediate Action	Batch quarantined; labels verified
Root Cause	Missing label-verification step in SOP
Corrective Action	SOP updated; operators retrained
Preventive Action	Label verification added to batch checklist
Verification	QA follow-up audit confirmed compliance
Approved By	QA Manager – 15 Oct 2025

Pro tip: Keep the form visual and easy to read. Complex layouts discourage completion — simplicity drives compliance.

Common Audit Findings Related to CAPA

From what I’ve seen during ISO 22716 readiness checks, auditors often flag:

• Repeated use of “operator error” without deeper cause analysis
• No evidence of follow-up or effectiveness check
• CAPAs left open indefinitely
• Missing closure signatures or approval dates

Pro tip: Sample a few old CAPAs during internal audits to verify they’re actually closed and documented correctly. It shows control and discipline in your QMS.

FAQs: ISO 22716 Deviation & CAPA Practices

Q1. How long should CAPA records be kept?
For at least as long as the product’s batch record retention period — usually five years or more, depending on regulations.

Q2. Do all deviations require a CAPA?
Not necessarily. Minor deviations can be handled without a full CAPA — but document the rationale for that decision.

Q3. Who approves the CAPA?
Typically QA or the Quality Manager, someone independent from the process involved.

From Deviation Reports to a Culture of Improvement

In ISO 22716, deviations aren’t failures — they’re opportunities to strengthen your system.
A well-built CAPA process turns every incident into valuable feedback.

I’ve seen companies completely transform their quality culture once they stopped fearing deviations and started learning from them.
Your Deviation & CAPA Form isn’t just a compliance tool — it’s a mirror showing where your processes can evolve.

Ready to make your system bulletproof?
Download our ISO 22716 Deviation & CAPA Form Template and start building a process that drives real improvement, not just audit checkboxes.