How to Establish the Frequency of the Equipment’ Preventive Maintenance

In this article, you will learn what is the best frequency of your equipment’s preventive maintenance according to the FDA requirements.

Many federal regulations and company policies require to comply with specific preventive maintenance schedules, control of preventive maintenance tools and features, view completion dates, test results, and detailed information such as:

1. Noise,
2. Vibration,
3. Lubricants,
4. Consumable parts,
5. Duration of actual preventive maintenance time or frequency, etc.

In some cases, each company establishes its own frequency of equipment preventive maintenance based on two factors:

1. Risk assessment,
2. Manufacturer’s recommendations.

Based on this information, a recurrent frequency of the Equipment’ Preventive Maintenance date can be generated, and certificates of preventive maintenance completion must be sent and stored in the document control file.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

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REFERENCES: FREQUENCY OF YOUR EQUIPMENT’ PREVENTIVE MAINTENANCE

STATUTORY AND REGULATORY REQUIREMENTS – 

TITLE 21–FOOD AND DRUGS

PART 211 — CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart D–Equipment

Sec. 211.67 Equipment cleaning and maintenance.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67

TITLE 21–FOOD AND DRUGS

PART 820 Medical Devices

Subpart G–Production and Process Controls

Sec. 820.70(g) Production and process controls.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

For more information about what is the recommended frequency of your equipment’ preventive maintenance, refer to:

httpss://www.fda.gov/media/73942/download

httpss://www.fda.gov/media/94076/download

httpss://www.fda.gov/media/70106/download

httpss://www.fda.gov/media/102633/download