In this article, you will learn what is Preventive Maintenance (PM) according to the FDA requirements.
Preventive maintenance is the routine service work to keep equipment up and running at optimum conditions, preventing any unplanned downtime and expensive costs from unanticipated equipment failure.
Preventive maintenance (PM) is also defined as a routine for periodically inspecting with the goal of noticing small problems and fixing them before major ones develop.
The preventive maintenance must be carefully planned and scheduled for each specific piece of equipment before there is an actual problem as well as keeping accurate records of past inspections and servicing reports. It is mandatory for the cGMP regulated industries to comply with the preventive maintenance requirements expected by the FDA and other organizations as ISO, ICH, etc.
The PM schedules must be established ahead to extend the life of each piece of equipment and prevent any failures caused by fatigue, neglect, or normal before they cause a system failure.
WHAT ARE THE BENEFITS OF PREVENTIVE MAINTENANCE?
Preventive maintenance brings important benefits including, but not limited to:
In theory, preventive maintenance will prevent equipment failure before it occurs.
It will save time, reduce costs, and keep an operation running efficiently and productively.
Since preventive management can be very challenging, especially for industries with many types of equipment. Therefore, exists different preventive maintenance software to help organize and carry out all preventive maintenance needs.
TYPES OF PREVENTIVE MAINTENANCE
WHAT IS PREVENTIVE MAINTENANCE MANAGEMENT SYSTEM? (PMMS)
The Preventive Maintenance Management System is structured and designed to handle the entire preventive maintenance operations.
It will manage the preventive maintenance requirements, activities, spare parts, and preventive maintenance records. Moreover, it organizes preventive maintenance works, schedules, preventive maintenance delivery, grading, and history.
A preventive maintenance management system is a program either manual or electronic intended for the administration, documentation, tracking, and reporting of equipment preventive maintenance works. Some companies use dedicated software for this purpose, other companies handle their preventive maintenance management system manually.
The preventive maintenance management process includes managing and maintaining preventive maintenance records of the organization’s equipment and instruments. In some cases, they are capable to manage financial aspects, including budget forecasting and cost-tracking.
WHAT KINDS OF PREVENTIVE MAINTENANCE MUST YOUR ORGANIZATION ACCOMPLISH?
Even though preventive maintenance is an activity for many industries in general, this article aims more specifically to the GMP Preventive Maintenance necessary and required by the FDA and the QMS Quality Management System. Sometimes initial preventive maintenance is followed by a requirement of additional recurrent re-preventive maintenances based on a lapse of the time or equipment use, cycles, etc.
WHAT IS THE FREQUENCY OF YOUR EQUIPMENT’ PREVENTIVE MAINTENANCE?
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 noise, vibration, lubricants, consumable parts, duration of actual preventive maintenance time or frequency, etc.
In some cases, each company establishes its own frequency of equipment preventive maintenance based on a risk assessment. Based on this information, a recurrent preventive maintenance date or frequency can be generated, and certificates of preventive maintenance completion must be sent and stored in the document control file.
WHEN IS NECESSARY A PREVENTIVE MAINTENANCE?
Preventive maintenance shall be done based on the following information and inputs:
More specifically, preventive maintenance must be performed to any equipment or machinery related to the following areas:
WHY IS MANDATORY A PREVENTIVE MAINTENANCE PROGRAM?
Government regulations require that regulated companies bring preventive maintenance to their instruments and equipment.
Some industries work under stricter preventive maintenance requirements due to the type of process and product.
Failing to comply with the preventive maintenance requirements, can cause fines, loss of business, or damage to a business’s reputation.
Moreover, the cGMP and the QSR Quality System Regulations mandate to establish a reliable preventive maintenance program.
In addition, the preventive maintenance management system serves as a logbook and tracking system of all preventive maintenance in the chronological order that was done. It helps to bring the evidence that preventive maintenance has been done to each equipment by date during its life cycle.
REGULATORY CONSEQUENCES TO NOT PERFORM AN ADEQUATE PREVENTIVE MAINTENANCE ON-TIME?
Failure to adhere to proper preventive maintenance program and schedule is considered a violation of US Federal Regulations on good manufacturing practices. As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to bring preventive maintenance actions, and failed to design and implement an effective preventive maintenance control program or management system either manual or electronic. In some cases, it may result in an FDA warning observation, product hold, product recall, etc.
HOW TO FILL A PREVENTIVE MAINTENANCE RECORD FORM?
The preventive maintenance record may include, but, is not limited to complete the following sections and information related to the preventive maintenance work performed to the equipment, (as applicable)
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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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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