Last Updated on October 24, 2025 by Hafsa J.

Why Equipment Cleaning & Maintenance Define ISO 22716 Compliance

If you’ve ever walked through a production room and spotted residue on a mixer that “should’ve been clean,” you already know how quickly things can go wrong.
In my years working with cosmetic manufacturers, I’ve noticed that most audit findings trace back to something simple—unclear cleaning steps, missing maintenance logs, or forgotten calibration checks.

Under ISO 22716, clean and well-maintained equipment isn’t just a “good practice.” It’s a core compliance requirement. It ensures that your products are safe, consistent, and contamination-free.

In this guide, I’ll break down how to create an SOP for Equipment Cleaning & Maintenance that’s practical, compliant, and easy for your team to follow. You’ll learn how to set cleaning schedules, assign responsibilities, and document everything in a way that makes your next audit smoother—and your operations more reliable.

Understanding Equipment Cleaning & Maintenance Under ISO 22716

Here’s the truth: ISO 22716 doesn’t expect fancy equipment. It expects controlled and traceable processes.

Your cleaning and maintenance program should ensure that every piece of equipment is:

• Clean before use, with no residue or cross-contamination risk
• Maintained in working order, to prevent unexpected breakdowns
• Verified, so there’s documented proof it’s ready for production

The goal is simple—consistent quality.
In my experience, the biggest mistake companies make is treating cleaning as “housekeeping.” It’s not. It’s a validated, recorded process that protects your entire production chain.

Pro tip: Design your SOP around how production actually flows, not how documents look on paper. If cleaning happens between shifts, build that timing into the procedure.

Key Elements of an ISO 22716 Equipment Cleaning SOP

A strong SOP gives your team confidence. It removes guesswork and helps auditors see your control.

Here’s what every cleaning & maintenance SOP should include:

1. Purpose & Scope

Explain why the procedure exists and which equipment it covers—mixers, tanks, filling lines, etc. Keep it clear and focused.

2. Responsibilities

Define who does what:

• Operators perform the cleaning
• Maintenance handles repairs
• QA verifies and approves

3. Cleaning Instructions

Specify:

• What cleaning agents to use
• Step-by-step cleaning sequence
• Required disassembly (if any)
• Frequency—after each batch, daily, or weekly

Pro tip: Include photographs or diagrams in your digital SOP for clarity.
Common mistake: Leaving instructions too vague, like “clean thoroughly.” That phrase means nothing during an audit.

4. Maintenance Program

Outline your preventive-maintenance plan—what gets checked, when, and by whom.
Link maintenance with calibration records to show your system works as a whole.

5. Records & Logs

Create a log sheet that records:

• Date and time of cleaning or maintenance
• Product previously processed
• Agent used
• Operator name and signature

6. Verification & Approval

Your QA team should verify cleaning effectiveness before releasing equipment back into service.
Keep signatures visible and organized—auditors love traceability.

Structuring Your Equipment Maintenance Plan

Maintenance keeps you compliant and productive—it’s preventive, not reactive.

Start with an equipment list and categorize each piece by risk or frequency of use. Then create a maintenance calendar that includes:

• Lubrication schedules
• Filter replacements
• Calibration intervals
• Safety inspections

Pro tip: Combine cleaning and maintenance data in one record system. That way, when an auditor asks, “When was this last maintained?”—you’ll have the full picture ready.

Example: A filling line manufacturer I worked with used to track maintenance on sticky notes (yes, really). After moving to a shared logbook, they cut downtime by half and finally aced their ISO 22716 audit.

Common pitfall: Doing the work but forgetting to document it. If it’s not written down, it didn’t happen.

Cleaning Validation & Verification in ISO 22716 Context

You can’t just assume equipment is clean—you need to prove it.

Your SOP should explain how cleaning is verified, such as:

• Visual inspection for residues
• Rinse-water testing
• Swab sampling for high-risk areas

Pro tip: Establish acceptance limits for residues and note them directly in your log form.
Common mistake: Relying on “visually clean” only. It’s subjective and won’t satisfy auditors.

Example: One skincare brand I helped added a simple “before-and-after” photo record to their cleaning checks. It made verification fast and added solid visual proof during inspections.

Equipment Cleaning & Maintenance Logs: What to Record

Every record should tell a clear story—who cleaned what, when, how, and with what result.

Your log should include:

• Equipment name and ID
• Product last processed
• Cleaning method and agent
• Maintenance activity performed
• Operator and QA signatures
• Notes on deviations or re-cleaning actions

Pro tip: Combine cleaning & maintenance into one sheet per equipment. It reduces confusion and keeps your documentation tight.
Pitfall: Using separate, unlinked logs that don’t align during audits.

Training & Continuous Improvement

Even the best SOP won’t help if your team doesn’t follow it properly.
Training is what turns “rules” into habits.

Here’s how to build consistency:

• Train new staff during onboarding
• Refresh training annually or after any SOP update
• Use visual aids and hands-on demonstrations

Pro tip: Use a “cleaning checklist” tag on equipment. It reminds operators of the steps and gives QA a quick verification cue.
Example: One manufacturer reduced missed cleaning entries by 40% just by holding short weekly refreshers.

FAQs: Equipment Cleaning & Maintenance in ISO 22716

Q1. How often should equipment be cleaned?
After each batch or shift change for high-risk products, and at regular intervals for continuous lines.

Q2. Do I need to disassemble equipment every time?
Not always. The SOP should specify when partial cleaning is enough and when full disassembly is required.

Q3. Is cleaning validation required for all equipment?
No. Validation is essential for high-risk or complex systems where residues could impact quality.

Keep Your Equipment—and Compliance—Running Smoothly

Clean, well-maintained equipment doesn’t just keep you compliant—it keeps your products safe, your team confident, and your audits stress-free.
I’ve seen companies go from repeat non-conformities to zero findings simply by tightening their cleaning & maintenance SOPs.

If your current process feels scattered, start fresh.
Document what you actually do, train your team to follow it, and keep the logs consistent.

Ready to make it easy?
Download our ISO 22716 Equipment Cleaning & Maintenance SOP Template—fully editable and structured for compliance success.