Last Updated on October 24, 2025 by Hafsa J.

Why an ISO 22716 Gap-Analysis Is the Smartest First Step

If you’re starting your ISO 22716 journey, here’s one truth I’ve seen over and over: the fastest-moving cosmetic manufacturers are the ones who start with a gap analysis.

Why? Because they don’t waste months fixing the wrong things. They know exactly where they stand, what’s missing, and what needs improvement.

In my experience, teams that skip this step usually end up redoing half their work later—especially when auditors start asking the hard questions.

This guide will show you how to use an ISO 22716 Gap-Analysis Checklist to evaluate your Good Manufacturing Practices (GMP) against real-world requirements. By the end, you’ll know how to assess your system, rank your gaps, and plan your next steps without confusion or guesswork.

Understand What ISO 22716 Gap Analysis Really Means

Let’s make this simple. A gap analysis is just a comparison—what you’re doing now versus what ISO 22716 expects.

It’s not about judgment. It’s about clarity. You’re looking at every clause of the standard and asking, “Do we have this covered?”

Here’s how to approach it:

1. List the ISO 22716 requirements.
2. Review your current practices and records.
3. Mark where the gaps are—and write down what needs to change.

Pro Tip: Use a color-coded system to stay organized.

• Red = Major gap (no system in place)
• Yellow = Partial compliance
• Green = Fully compliant

I’ve seen small teams cut their prep time in half just by using this visual approach.

Common Mistake: Treating the checklist like paperwork. The goal isn’t to “fill in boxes.” The goal is to understand how your process performs in real life—on the production floor, not just on paper.

How to Structure Your ISO 22716 Gap-Analysis Checklist

A good checklist follows the flow of the ISO 22716 standard. It helps you cover everything without missing key areas. Here’s a simple structure you can use:

• Premises & Equipment: Layout, maintenance, and cleaning routines.
• Personnel & Hygiene: Staff training, health checks, and protective clothing.
• Production & In-Process Control: Batch records, deviations, and labeling accuracy.
• Laboratory Control & Testing: Raw material verification, release testing, and retention samples.
• Storage & Distribution: Traceability, temperature control, and segregation of returns.
• Complaints & Recalls: Investigation procedure and recall readiness.
• Change Control & Internal Audits: Monitoring, updating, and improving processes.

Pro Tip: Start with high-impact areas—production, testing, and hygiene. Those usually cause 80% of non-conformities.

I once worked with a skincare manufacturer that discovered most of their issues came from storage practices, not production. A simple checklist review saved them weeks of rework.

Step-by-Step: Conducting the Gap Analysis Efficiently

Now that you’ve structured your checklist, it’s time to put it to work.

Step 1: Assign a responsible person—ideally your Quality Manager or internal auditor.
Step 2: Go through each checklist item and compare what’s written in your SOPs to what’s actually happening.
Step 3: Record your findings honestly. Mark each clause as compliant, partial, or missing.
Step 4: Rate each finding—High, Medium, or Low risk—to prioritize actions.

Pro Tip: For every gap you find, create an action plan immediately. Don’t just say “needs improvement.” Assign a person and a timeline.

Common Mistake: Waiting until the end of the project to summarize findings. By then, the details are gone and half the context is lost. Document as you go—it keeps your data fresh and accurate.

Turn Findings into a Practical ISO 22716 Implementation Plan

Once your checklist is complete, you’ll have a clear view of where the gaps are. Now it’s time to turn that data into a plan that actually drives results.

Create a simple GAP → ACTION → RESULT table:

Gap Identified	Corrective Action	Responsible Person	Target Date
No cleaning-record format	Develop cleaning-log SOP	QA Manager	Week 3
Outdated raw-material labels	Update labeling procedure	Production Head	Week 2
No recall test conducted	Schedule mock recall	QA Manager	Week 5

Pro Tip: Schedule quick weekly reviews to track progress. You’ll catch issues early and keep momentum.

Common Mistake: Focusing only on documents. Many compliance issues come from behavior—like skipping equipment cleaning or incomplete batch logs. Fixing processes means changing habits, not just updating SOPs.

Tools & Templates to Simplify the Process

You don’t need to reinvent the wheel. There are plenty of tools that make this easy:

• Excel or Google Sheets: Simple, customizable, and easy to share.
• QSE Academy’s ISO 22716 Gap-Analysis Template: Ready-to-use checklist aligned with every clause of the standard.
• Cloud-based QMS systems: Great for real-time tracking and team collaboration.

Pro Tip: Keep your checklist as a “living document.” Update it after each audit, inspection, or process change. That’s how you build continuous improvement into your system.

A client I worked with switched from a paper checklist to a shared cloud tracker. Their audit prep time dropped by almost 30%—just from better visibility.

FAQs – Common Questions About ISO 22716 Gap Analysis

1. How often should we perform a gap analysis?
At least once a year—or before a certification audit, product launch, or facility expansion.

2. Can a small cosmetics company do this without a consultant?
Absolutely. A well-structured checklist makes it manageable. Still, a short external review adds an extra layer of objectivity.

3. What’s the difference between a gap analysis and an internal audit?
A gap analysis identifies what’s missing. An internal audit verifies that what you implemented actually works.

Bridge the Gaps, Build Confidence

An ISO 22716 gap analysis isn’t just a formality—it’s your secret weapon for smooth certification. It highlights what matters, saves you from rework, and builds confidence across your team.

I’ve guided dozens of cosmetic manufacturers through this process, and the pattern is always the same: those who start with a clear checklist finish stronger and faster.

If you’re ready to see exactly where your GMP system stands, grab the ISO 22716 Gap-Analysis Checklist Template and start evaluating your compliance today.

[Download Your Template] or [Book a Consultation with Our GMP Experts]