How CMMS software helps manufacturers meet regulatory requirements
Published: 11 September, 2024
Stephen Davis, Director of Marketing at PEMAC explores the main ways in which CMMS software supports regulatory compliance, including documentation, record-keeping, asset management, and preventative maintenance planning
Compliance in manufacturing is a comprehensive approach to ensuring that all elements of a manufacturing process adhere to legal requirements, quality standards, safety guidelines and environmental regulations. Compliance is critical to ensuring the longterm success, reputation and sustainability of a manufacturing organisation.
CMMS (Computerised Maintenance Management System) software plays a vital role in ensuring that manufacturers comply with various industry standards and regulations governing equipment maintenance, safety protocols, and environmental practices.
The regulatory landscape
International manufacturing regulations present a complex web of rules and standards. These regulations vary from country to country, and even within different regions of the same country. They cover a wide range of areas, from product safety and quality standards to environmental regulations and labour laws.
ISO standards are globally recognised guidelines set by the International Organisation for Standardisation (ISO) to ensure the quality, safety, efficiency, or other parameters of certified systems and processes across various industries. ISO certification guarantees that a service, product, system, process, or organisation as a whole corresponds to certain standards as defined by the organisation
Generally, the most important ISO standards for manufacturers include quality management related ISO 9001 occupational health and safety-oriented ISO 45001, ISO 14001 for environmental management and ISO 50001 for energy management systems. The adoption of a reliable CMMS is essential for companies seeking to achieve these standards.
Documentation and record keeping
CMMS software streamlines documentation and record-keeping processes to ensure manufacturing compliance. It does so by digitalising paper-based processes for maintenance work, creating electronic versions for staff to assign, complete, and then archive. This automatically creates a transparent and clear view of maintenance status, task ownership and progress, making team members fully accountable.
Accurate record-keeping is crucial for manufacturing organisations, particularly those subject to high levels of regulatory scrutiny. A CMMS will maintain detailed records of equipment maintenance and calibration to ensure product quality, patient safety, and adherence to industry standards.
In Pharmaceutical and Medical Device manufacturing for example, CMMS software supports site compliance by keeping all actions logged in line with key regulations, such as FDA 21 CFR Part 11. This regulation, as laid down by the US Food and Drug Administration (FDA), requires software providers to ensure electronic records and signatures are trustworthy and reliable through validation, audit trails, secure system access, unique electronic signatures, records retention, operational controls, comprehensive documentation, and data integrity measures.
Inspections and audits
In terms of the various internal and external audits that manufacturers face, CMMS software greatly assists in both the scheduling and conducting of inspections and audits to help firms meet regulatory requirements.
Auditors will typically seek proof of compliance with regulations, documentation of maintenance and safety procedures, and evidence of employee training. A CMMS allows manufacturers to track and document all of these items, providing auditors with the necessary information to demonstrate their compliance with industry standards.
Some of the best CMMS software solutions will enable the following: Digitalising the paper trail – As mentioned previously, a CMMS allows manufacturers to transition from paper to digital records, helping them to keep accurate records of maintenance and safety procedures that can be easily accessed and reviewed by an auditor. This digital approach also saves time and reduces human error. Having all information stored and accessible in a single centralised system makes preparing for inspections and audits faster and less onerous. PEMAC ASSETS CMMS software, for example, includes a FORMS module that digitalises paper-based procedures with integrated workflows and approvals.
Capturing Digital Signatures - Many auditors will require digital signatures to verify compliance with regulations. Digital signatures also facilitate easy access and auditing, saving time and effort in reviewing documents. This process also improves the security and accuracy of records as digital signatures ensure that the document history is genuine, authentic and has not been tampered with.
Documenting Safety Incidents - If a maintenance-related safety incident occurs, a CMMS can help capture and document the necessary information about the incident and any corrective actions taken. These records can be easily accessed and reviewed during an audit.
Contractor Management - this software authorises qualified visitors on-site in a secure and controlled manner. For example, the PEMAC ASSETS Contractor Management Module allows contractor documentation to be tracked, training completed, and skills recorded, presenting one overall view of who is on-site, where they are working, and who is expected to arrive next.
Asset management
CMMS plays an integral role in tracking and managing assets to ensure their compliance with regulatory standards. Not only does CMMS software help manufacturers avoid critical equipment failures and stoppages, but it also prolongs asset lifespans by detecting potential failures before they happen.
CMMS software with predictive maintenance capability enables manufacturers to anticipate issues before they cause costly downtime. CMMS supports manufacturers in achieving ISO 55000 certification, an international standard for asset management that provides a framework for organisations to manage their physical assets. It is designed to help organisations optimise the performance of their assets, reduce costs, and improve safety and sustainability.
From a regulatory perspective in particular, CMMS software supports the ISO 55001 certification which validates an organisation’s conformity to legal, operating, statutory and regulatory requirements. This validation can be used to drive a manufacturer’s reputation, positively influencing sales growth.
Preventative maintenance planning
Preventative Maintenance Compliance (PMC) is a maintenance metric that indicates how many scheduled preventative maintenance tasks have been completed over a certain time period. It benchmarks the effectiveness of preventative maintenance (PM) programs and indicates how well PM schedules are being adhered to. It’s therefore a very important metric in improving a manufacturing plant’s maintenance practices.
CMMS software supports PMC by enabling proactive maintenance planning to prevent compliance issues. Preventative maintenance programmes play a crucial role in ensuring manufacturer safety and compliance by helping to identify and rectify any safety hazards, thereby protecting employees and customers. Keeping manufacturing equipment in line with regulatory standards is much easier with a structured preventative maintenance plan via CMMS software.
Most industries have regulatory standards that require some level of preventative maintenance to be performed on assets. If these standards are not adhered to, companies can often be fined or face other penalties. For example, in the US, The Occupational Health and Safety Administration (OSHA) considers preventative maintenance a form of hazard control in the workplace that prevents injuries. OSHA regulations mandate the implementation of preventative maintenance procedures for certain industries or equipment.
Using CMMS software to schedule regular preventative maintenance ensures that manufacturers comply with such regulations.
Conclusion
Regulatory compliance is becoming increasingly important for manufacturers. While regulatory scrutiny and audit requirements vary from industry to industry, the fundamental principles of Health & Safety Management, Product Quality Control and Environmental Sustainability are universal to all.
CMMS software empowers manufacturers to automate, document, and standardise processes to meet industry standards and adhere to regulations, while also driving greater efficiencies, reliability, and cost reduction across their operations.
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