The U.S. Food and Drug Administration (FDA) is an essential regulatory agency empowered by the federal government to communicate, implement, and enforce the rules and regulations relating to the manufacture, marketing, and distribution of food, drugs, biological products, cosmetics, medical devices, and other consumer goods.
The rules articulated in Title 21 of the Code of Federal Regulations (also known as 21 CFR) provide the FDA with the framework for implementing rules, enforcing regulations, and following through on its mission. 21 CFR affects the equipment, facilities, documentation procedures, process validation, management review protocols, and maintenance strategies used by a wide spectrum of businesses, including medical device manufacturers.
Overview of 21 CFR part 820
Certain provisions of 21 CFR apply directly to medical device manufacturers and their maintenance teams. One of these key provisions is outlined in 21 CFR Part 820, also known as the Quality System Regulation (QSR) rule. The purpose of Part 820 is to ensure consistency and quality in the production of medical devices by mandating that medical device manufacturers have systems in place for defining, validating, and ensuring quality in their processes and products.
What is 21 CFR?
21 CFR includes a wide range of regulations impacting activities around the consumer food and drug sectors. It also provides the regulatory frameworks for the Drug Enforcement Administration (DEA) and the Office of National Drug Control Policy.
Organizations under the authority of the FDA and beholden to 21 CFR rules may include:
- Pharmaceutical manufacturers
- Medical device companies
- Food and beverage manufacturers
- Cosmetics laboratories and companies
- Biologic product manufacturers
- Veterinary product manufacturers
- Scientific research laboratories
The policies laid out in 21 CFR can have a direct bearing on the day-to-day activities of organizations in each of these sectors, particularly on the maintenance programs employed by these businesses.
Indeed, maintenance teams play a critical role in ensuring compliance with 21 CFR regulations by conducting routine tasks such as:
- Equipment maintenance and upkeep including regular inspections, scheduled calibration, preventive repairs, and proactive replacement of worn parts
- Detailed recordkeeping including documentation of maintenance activities, calibration logs, data on equipment performance, notations indicating nonconformance in processes or equipment, and details on the corrective actions taken
- Electronic records and electronic signatures in compliance with 21 CFR Part 11, which outlines the criteria that maintenance teams must meet to demonstrate that the reliability and integrity of their electronic records and signatures are equivalent to that of paper records and handwritten signatures
- Adequate and continuous employee training, ensuring a full understanding of the regulatory requirements as well as the internal maintenance and repair procedures in place for ensuring compliance with these requirements
- Preventive maintenance (PM) strategies including regular inspections, cleaning, lubrication, and scheduled part replacements
- Change controls prescribe a formal process for approving and implementing any changes to equipment, processes, or procedures
- Internal and external audit support, including presentation of documentation, records, and other supporting evidence of compliance
What is 21 CFR Part 820?
21 CFR Part 820 – Quality System Regulation for Medical Devices
Part 820 establishes the rules and standards that medical device manufacturers must adhere to while implementing Quality System Regulation (QSR) procedures. A compliant program for QSR will include comprehensive details on the design, manufacturing, device packaging, device labeling, storage, and servicing of all the medical devices you produce.
- Subpart A – General Provisions (§820.1) provides an overview of Current Good Manufacturing Practices (CGMP) for medical devices and mandates that manufacturers of finished devices must establish and follow quality systems to ensure consistency, safety, and regulatory compliance.
- Subpart B – Personnel (§820.25) mandates that personnel involved in the production and maintenance of medical devices must have the necessary education, background, training, and experience to perform their assigned tasks.
- Subpart C – Design Controls (§820.30) outlines the regulatory requirements for controlling medical device design to ensure device quality, safety, and efficacy. This section also mandates that manufacturers formalize procedures for design review, design validation, and intended design output.
- Subpart C – Buildings and Facilities (§820.40) requires that facility design, construction, environmental controls, and maintenance all support the manufacturing process as well as the storage and testing of devices in a manner that ensures their continued quality and efficacy.
- Subpart D – Document Controls (§820.40) ensures that all documents related to your organization’s quality system are properly managed, and delineates procedures for the approval, distribution, and use of quality system documents as well as controls for implementing document changes and ensuring that documents are both secure and accessible to authorized personnel.
- Subpart G – Production and Process Controls (§820.70) specifies requirements for equipment maintenance including routine checks, calibration, performance monitoring, and contamination prevention, as well as documentation of related activities such as maintenance schedules, procedures, and any repairs performed.
- Subpart J – Corrective and Preventive Action (CAPA) (§820.100) requires manufacturers to introduce systems for identifying, correcting, preventing, and documenting process- and maintenance-related problems that could affect product quality.
- Subpart L – Handling, Storage, Distribution, and Installation (§820.150) requires manufacturers to have procedures in place for proper equipment installation, storage, and handling to prevent damage, contamination, or ineffectiveness.
- Subpart M – Records (§820.180) requires manufacturers to maintain comprehensive records of all maintenance activities, including the date, personnel involved, and a description of the tasks performed.
Complying with FDA 21 CFR Part 820
Compliance with 21 CFR 820 requires contributions from personnel throughout your organization including facilities managers, maintenance technicians, process engineers, and more. Achieving compliance with key provisions of 21 CFR Part 820 will be an inherently collaborative and cross-functional process.
Below, we offer several tips for how your medical device manufacturing business can ensure compliance with specific aspects of 21 CFR Part 820.
Subpart B – Personnel (§820.25)
The FDA requires that all personnel be qualified to participate in the production and maintenance of medical devices.
Strategies for ensuring compliance with Subpart B include ongoing training and assessment to ensure all personnel involved in manufacturing, maintenance, and quality assurance understand their roles, their responsibilities under the organization’s quality policy, and how to carry these responsibilities out.
Subpart C – Buildings and Facilities (§820.40)
This section of 21 CFR refers to facility design, construction, environmental controls, and maintenance strategies.
Strategies for ensuring compliance with Subpart C include the implementation of standard operating procedures (SOPs) for regular cleaning, upkeep, and contamination prevention as well as continuous monitoring of environmental conditions such as temperature, humidity, and pressure. Adjust these conditions as needed.
Subpart D – Document Controls (§820.40)
Subpart D requires manufacturers to establish controls and procedures for ensuring proper management of documents.
Strategies for complying with these conditions include secure, tech-enabled systems that make documents easily accessible to relevant personnel while preventing unauthorized access, as well as formalized procedures for version control, document review, and approval.
Subpart G – Production and Process Controls (§820.70)
This section of 21 CFR Part 820 requires routine equipment maintenance including testing, calibration, performance monitoring, and contamination prevention.
Improve your organization’s compliance efforts by creating detailed written procedures for all production processes. You can also implement real-time monitoring strategies in order to detect and address deviations promptly. More broadly, establishing a preventive maintenance program that includes routine equipment inspections, scheduled calibration, and preemptive replacement of worn parts can significantly ease the burden of achieving compliance.
Subpart J – Corrective and Preventive Action (CAPA) (§820.100)
This subsection of Part 820 mandates that manufacturers have systems in place to identify, correct, and prevent the recurrence of production or maintenance problems.
Strategies for complying with this subsection include regular analysis of data from various sources including internal audits, real-time process monitoring, and even customer complaint files. Take steps to proactively identify issues by conducting root cause analysis of nonconforming products or process deviations, verifying the effectiveness of proposed corrective actions, and creating detailed records documenting all of these actions.
Subpart M – Records (§820.180)
This subsection of 21 CFR Part 820 requires manufacturers to maintain comprehensive records of all maintenance activities.
Strategies for complying with this subsection are rooted in the implementation of an effective computerized maintenance management system (CMMS). This can provide secure centralized storage, easy access, and ready availability of records for both internal and FDA audits.
Common 21 CFR Part 820 compliance mistakes
Achieving and maintaining regulatory compliance can be challenging, complex, and costly. Manufacturers working toward 21 CFR compliance may be derailed by common compliance mistakes such as:
- Insufficient support, dedication of resources, or long-term commitment from upper management
- Incomplete documentation of procedures, processes, and maintenance plans
- Absence of a comprehensive quality management system
- Inadequate training for personnel involved in quality control-related activities
- Ineffective communication between departments and consequent misalignment or gaps in compliance efforts
Beyond these more general mistakes, there are numerous areas of 21 CFR Part 820 that present the risk of inadvertent non-compliance. Below, we break down some common compliance mistakes as they relate to individual sections of part 820.
Personnel (§820.25)
Common causes of non-compliance with §820.25 include Incomplete or inaccurate records of training sessions and certifications; generic training content that does not cover specific quality system requirements and job functions; or the failure of organizations to perform continuous training or updates even as regulations or internal procedures change.
Buildings and Facilities (§820.40)
Common causes of non-compliance with §820.40 include inadequate control over environmental conditions such as temperature and humidity; poor or inconsistent facility maintenance, cleaning, and sanitation; and facility layouts that do not foster efficient workflows for maintenance activities.
Equipment (§820.70)
Common causes of non-compliance with §820.70 (Equipment) include the absence of preventive maintenance strategies; failure to conduct thorough validation of new equipment before incorporating it into the production process; and a failure to schedule regular calibrations, which can lead to inaccurate measurements, product defects, and process failure.
Production and Process Controls (§820.70)
Common causes of non-compliance with §820.70 (Production and Process Controls) include the absence of detailed written procedures for production processes and an absence of real-time process monitoring.
Document Controls (§820.40)
Common causes of non-compliance with §820.40 include ineffective version control, resulting in duplication or data discrepancies; uncontrolled document access; and a faulty or incomplete document review and approval process.
Corrective and Preventive Actions (CAPA) (§820.100)
Common causes of non-compliance with §820.100 include inadequate Root Cause Analysis (RCA); bureaucratic delays in implementing corrective action; and a failure to verify the effectiveness of corrective and preventive actions and their relation to the root cause of process deviation.
Records (§820.180)
Common causes of non-compliance with §820.180 include Incomplete Device Master Records (DMR); inaccurate Device History Records (DHR); or inadequate Quality System Records. Inconsistencies or errors in these important documents can undermine data analytics and result in 21 CFR audit failures.
CMMS platforms and 21 CFR compliance
Computerized Maintenance Management Systems (CMMS) platforms play a central role in helping organizations comply with 21 CFR Part 820 regulations. Leading-edge platforms like Limble’s CMMS can help manufacturers streamline and automate various maintenance processes.
Limble offers a range of features designed to simplify compliance with 21 CFR Part 820 and help manufacturers in the medical device industry protect their customers, avoid penalties, and remain 21 CFR compliant.
Key Limble CMMS features supporting compliance with 21 CFR Part 820 include:
- Automatic work order generation, streamlining the creation, assignment, and tracking of Work Orders, and ensuring documentation of maintenance activities is easily retrievable for audits
- Preventive Maintenance (PM) scheduling, including regular inspections, calibration, cleaning, sanitation, and upkeep
- Detailed maintenance logs and equipment histories indexing all maintenance activities, including calibration, repairs, and preventive maintenance
- Predictive maintenance capabilities when integrated with advanced condition monitoring technology and equipment sensors
- Training records management documenting employee training, managing certifications, and providing role-based access control
- Document control features ensuring all maintenance-related documents, including SOPs, work orders, and maintenance logs, are current and readily accessible to relevant personnel
- CAPA tracking and management, including documentation of identified issues, corrective and preventive actions taken, and verification of the effectiveness of these actions
- Real-time reporting and analytics, allowing organizations to monitor maintenance activities and identify trends that may require corrective or preventive actions
- Audit trails of all activities, ensuring that organizations can demonstrate compliance with 21 CFR Part 820 during inspections and audits
- Customizable reports providing detailed insights into maintenance activities, equipment performance, and compliance status
Limble’s award-winning software can help to make 21 CFR compliance less challenging, less complex, and less costly. Want to be sure that your organization is in full compliance with current federal regulations? Download our 21 CFR Compliance Toolkit today, read up on Limble’s compliance-promoting features, and prepare to ace your next audit.
Our toolkit is chockful of useful information to give direction to your maintenance team as it navigates complex 21 CFR rules. Free 21 CFR Compliance Toolkit
