ISO 22716 Corrective Actions for Audit Findings

ISO 22716 Corrective Actions for Audit Findings
Cosmetics Industries

ISO 22716 Corrective Actions for Audit Findings

Last Updated on October 24, 2025 by Hafsa J.

Why Corrective Actions Matter in ISO 22716 Audits

Most cosmetic companies take their audits seriously. They prep the documents, walk auditors through production areas, and breathe a sigh of relief when it’s over. But what happens next — the corrective actions — is where real improvement starts.

In my experience, many teams treat corrective actions as a “formality.” They fill out the CAPA sheet, close it quickly, and move on. Then six months later, the same finding reappears.

ISO 22716 isn’t just about fixing what went wrong; it’ about understanding why it happened and making sure it never happens again. This article will show you how to manage corrective actions step-by-step, from root cause to verification, so you can turn audit findings into lasting improvements — not recurring headaches.

Understanding Corrective Actions Under ISO 22716

Under ISO 22716, corrective actions are part of your GMP system — specifically linked to Clause 8: Internal Audits and Management Review.

A Correction fixes the immediate issue.
A Corrective Action fixes the reason it happened.

Here’s a quick example:
If an SOP wasn’t followed, rewriting it is a correction. Figuring out why the operator skipped it — unclear instructions, time pressure, or poor training — that’s corrective action.

Pro tip: Ask “why” at least three times. The first answer is usually a symptom, not the cause.

Common mistake: Jumping straight to a solution like “we’ll retrain staff” without digging deeper. Training isn’t a cure-all — sometimes the problem is the process, not the person.

ISO 22716 Corrective Actions for Audit Findings Managing Corrective Actions After an Audit

A strong CAPA process follows a simple rhythm. I teach clients this five-step flow because it works every time:

  1. Identify the finding. Write it objectively, referencing the ISO 22716 clause. Avoid blame.
  2. Analyze the root cause. Use structured tools — 5 Whys, Fishbone Diagram — to see where things broke down.
  3. Plan the action. Decide what needs to change, who’s responsible, and when it’ll be done.
  4. Implement. Update SOPs, retrain staff, or improve the process.
  5. Verify effectiveness. Check that the fix worked — and that it’s sustainable.

Pro tip: Keep all corrective actions in one CAPA log. It makes audits smoother and lets you see recurring themes.

Example: A cosmetics lab I worked with used to lose track of CAPAs across departments. After moving to a shared tracker, they cut closure time from 90 days to 45 — and passed their next surveillance audit without a single repeat finding.

Root-Cause Analysis Techniques That Actually Work

I’ve seen many teams write “human error” as the cause of everything. It’s easy, but it’s almost never accurate. Real causes go deeper — poor instructions, unclear roles, or unrealistic deadlines.

Here are tools that help you dig deeper:

  • 5 Whys: Keep asking “why” until you uncover the real source.
  • Fishbone Diagram: Great for visualizing process, equipment, environment, and training factors.
  • Pareto Chart: Helps identify which causes lead to the most non-conformities.

Pro tip: Never stop your analysis at the first answer. If someone didn’t follow a procedure, ask why. Maybe the procedure was outdated or buried in a folder no one reads.

Common mistake: Using the same cause (“lack of training”) repeatedly. Auditors can tell when root-cause analysis is superficial.

Tracking and Monitoring Corrective Actions

Closing a CAPA isn’t the finish line — verification is.

Auditors want to see that you not only implemented a fix but also confirmed it’s working. That means tracking progress, assigning owners, and setting clear deadlines.

Here’s how to stay organized:

  • Maintain a CAPA register with columns for status (Open / In Progress / Closed / Verified).
  • Review open actions in management meetings.
  • Archive evidence — revised SOPs, training records, photos, or audit notes — to prove effectiveness.

Pro tip: Color-coding helps. A quick red-yellow-green visual keeps everyone accountable.

Example: One packaging facility I consulted added color tracking in Excel. Management could see delays instantly — and CAPA completion jumped from 60% to 95% on time.

Preventing Recurrence – Turning CAPA Into Continuous Improvement

The best organizations don’t just close findings — they learn from them.

Every completed CAPA should feed back into your system:

  • Update SOPs or work instructions.
  • Adjust risk assessments.
  • Strengthen internal-audit checklists.

Pro tip: Add a “lesson learned” note in your CAPA file. It turns a single fix into long-term knowledge for your team.

Common mistake: Closing CAPAs too quickly to meet deadlines. If you haven’t checked effectiveness after 30 days, it’s not really closed — it’s just delayed recurrence.

Integrating Corrective Actions Into Management Review

Your management review isn’t just a compliance formality. It’s the point where leadership decides whether your system actually works.

When you present CAPA data in that meeting, focus on trends, not just numbers:

  • How many non-conformities were repeated?
  • Which processes generate the most findings?
  • How long does it take to close each CAPA?

Pro tip: Use a simple dashboard — graphs showing CAPA status and root-cause categories. It makes decision-making easier and shows auditors that management is actively involved.

When leadership sees data, not just text, they start driving improvement instead of reacting to it.

FAQs About ISO 22716 Corrective Actions

Q1: How long should we take to close a CAPA?
Usually within 30–60 days. But if it’s a major GMP risk, act immediately and use interim controls.

Q2: Do we need to show CAPA evidence to the auditor?
Yes. External auditors want to see proof of implementation and verification. Keep supporting documents ready — updated SOPs, photos, or records.

Q3: What if the same issue happens again?
That’s a sign the root cause wasn’t fully addressed. Reopen the CAPA, expand your investigation, and look beyond the process — sometimes the real problem is resource or culture-related.

Turning Findings Into Real Improvements

Corrective actions aren’t about satisfying auditors. They’re about protecting your brand, your customers, and your credibility. Every finding is a clue — follow it to strengthen your GMP system.

At QSE Academy, we’ve helped hundreds of cosmetic companies build CAPA programs that not only meet ISO 22716 but actually reduce non-conformities year over year. The difference? A mindset shift — from “fixing problems” to “preventing them.”

Ready to close your audit findings with confidence?
[Download the ISO 22716 CAPA Form Template] and start documenting corrective actions that drive real improvement.

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