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:
In some cases, each company establishes its own frequency of equipment preventive maintenance based on two factors:
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 email@example.com.
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM procedure templates in .pdf format.
To see the complete list of the most popular quality procedures templates, click here.
In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.
Silver Option. We Can Bring You Formal Training about how to determine the optimum frequency of the equipment’ preventive maintenance (PM).
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.
Gold Option. We Can Create Customized Quality Procedures.
One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.
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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
Sec. 211.67 Equipment cleaning and maintenance.
TITLE 21–FOOD AND DRUGS
PART 820 Medical Devices
Subpart G–Production and Process Controls
Sec. 820.70(g) Production and process controls.
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