ISO 22716 On Site: 20 Audit Items Buyers Should Verify
If you’re planning to visit a skincare OEM/ODM factory, the ISO 22716 standard is your golden guide. I often tell my clients — this certification is not just a fancy label. It’s a complete quality management system for cosmetic production. Knowing what to check during your factory visit can save you from compliance headaches later.
So, let’s walk through the 20 must-verify audit items every serious skincare buyer should review on-site.
1. Factory Layout and Hygiene Control
Cleanliness tells you everything about a manufacturer’s discipline. Look for organized workspaces, controlled air filtration, and designated zones for raw materials, filling, and finished goods. ISO 22716 guidelines emphasize hygiene separation to prevent cross-contamination.
2. Raw Material Verification
Ask how raw materials are stored and labeled. A compliant factory will use globally trusted suppliers like BASF, Dow Corning, or DSM — just as we do at Amarrie. Each ingredient must have a Certificate of Analysis (COA) and traceability records.
3. Personnel Hygiene and Training
Check the staff facilities — changing rooms, uniforms, and hygiene policies. Every operator should receive ongoing GMP and ISO 22716 training. Well-trained staff reduce contamination risk.
4. Equipment Calibration and Maintenance
Inspect whether mixing tanks, filling lines, and pH meters have calibration logs. ISO 22716 requires periodic verification to ensure product consistency.
5. Water Quality Management
For skincare, purified water is non-negotiable. Ask about their RO (Reverse Osmosis) or distilled water systems and microbial testing frequency. Learn more from the World Health Organization’s GMP water guidelines.
6. Raw Material Quarantine Area
Every new batch of materials should be quarantined until it passes inspection. This prevents untested or contaminated batches from entering production.
7. Production Record Keeping
ISO 22716 demands traceable batch records — from formulation to packaging. Ask to see how they document each production run.
8. Filling Room Conditions
Observe if filling rooms are temperature- and humidity-controlled. The more premium the skincare, the stricter the control.
9. Label and Packaging Verification
All packaging materials must undergo incoming inspection. At Amarrie, we run five rounds of inspection including label print quality and carton durability. Defect rate? Less than 0.001%【14†Amarrie Service capabilities.docx】.
10. Traceability and Batch Coding
Each bottle should have a clear batch number linking back to production data. This helps in recalls or quality reviews.
11. In-process Control
Check how operators record pH, viscosity, and appearance during production. Real-time testing prevents wasted batches.
12. Product Release Procedure
The QA team should approve each batch before release. Ask to see their Product Release Checklist — it should include microbiological and stability results.
13. Microbiological Testing Lab
If the factory has an internal lab, confirm they use standardized test methods (ISO or equivalent). External lab partnerships are also acceptable but must be documented.
14. Packaging Cleanliness and Handling
Dust-free packaging zones are a must. Cleanroom or semi-cleanroom conditions ensure no micro-particles enter the product.
15. Storage of Finished Products
Look for humidity and temperature monitoring systems. Finished goods should never sit under direct sunlight or near chemicals.
16. Complaint and Recall Procedures
A professional OEM should show you their recall flowchart. This is part of ISO 22716 traceability compliance.
17. Change Control Records
Any formula, packaging, or label change must go through a documented approval process. This is crucial for private-label brands.
18. Internal Audit Schedule
Ask when they last conducted an internal audit. Frequent audits mean the factory takes ISO seriously.
19. Supplier Evaluation and Approval
ISO 22716 requires ongoing assessment of ingredient and packaging suppliers. A good sign? If they only buy from certified global brands — just like we do at Amarrie.
20. Training and Continuous Improvement
Lastly, check how they track team performance and corrective actions. Continuous improvement is the heart of ISO compliance.
Quick Reference Table: ISO 22716 Audit Essentials
| Category | Key Items | What to Check |
|---|---|---|
| Environment | Hygiene, layout | Clean zones, air filters |
| Materials | Raw & packaging | COA, quarantine tags |
| Production | Mixing, filling | Batch logs, in-process data |
| Quality | Lab testing | Microbial, stability reports |
| Traceability | Coding, recall | Batch tracking system |
Why This Audit Matters
I’ve seen too many buyers skip the site audit — only to face product recalls later. ISO 22716 isn’t just paperwork; it’s your assurance that what’s inside your skincare bottles is safe, stable, and compliant.
If your OEM partner ticks all 20 boxes, you’re working with a serious manufacturer.
For further reading, explore these updated, authoritative resources:
And yes, if you’d like a factory that already passes these audits — our Amarrie facility is certified with GMP, ISO 9001, and ISO 22716, and all our products comply with EU, FDA, and MSDS standards【21†Customer Reception FAQ.docx】.
👉 If you’re planning your next skincare line, and want to ensure full ISO compliance from day one, feel free to reach out. We’ve guided hundreds of brands through successful audits and private-label launches.
Let’s make your next inspection a success story.