The FDA offers very clear and exacting standards for medical product development and manufacturing, and they’re quick to issue a recall when these requirements are not met. Staying ahead of FDA findings doesn’t have to be difficult, but the sheer volume of items to keep track of presents a challenge for many regulated manufacturers. This is why a CMMS makes all the difference in the world.
Safety and quality are top priorities when developing consumer-based health and medical products. When the FDA discovers a product is manufactured to subpar standards, the impact can affect millions and often makes international news.
Impacts Faced When the FDA Demands Recalls
A series of errors can result in an unfortunate situation for a manufacturer and its millions of customers. When the FDA halts sales in the U.S., it typically comes after many months of behind-the-scenes activity, where the manufacturer has time to address any safety concerns or health hazards. If the manufacturer struggles to provide timely solutions the financial implications of the recall can be devastating.
Oftentimes, the crux of the problem is that it’s much harder to work backwards and fix something than it is to be proactive and catch small errors in motion before they can escalate.
A CMMS helps companies head off costly recalls and get the situation under control much faster, as it creates an environment purpose-built for compliance.
A Purpose-built CMMS Creates FDA-Compliant Environments
FDA regulations are myriad and are very detailed, with both the specifications and timelines for maintenance and other preventative actions clearly outlined. The struggle for regulated manufacturers typically revolves around keeping track of them all and checking every box to ensure compliance.
Companies that face recalls aren’t necessarily sloppy, nor do they lack a sense of urgency about consumer safety; it’s purely an organizational dynamic that hasn’t been optimized. And this is precisely what a CMMS that’s purpose-built for regulated manufacturers solves.
Equipment calibration and validation are critical aspects of compliance. A CMMS can help facilitate these processes by scheduling regular calibration and validation tasks based on predetermined intervals or usage thresholds. By automating these tasks and providing documentation of completed activities, a CMMS helps ensure that equipment remains in a validated state and meets regulatory requirements.
Preventive maintenance is essential for ensuring manufacturing equipment’s reliability, safety, and performance. A CMMS enables regulated manufacturers to develop and manage comprehensive preventive maintenance programs by scheduling routine inspections, lubrications, and component replacements. By adhering to manufacturer-recommended maintenance schedules and documenting maintenance activities, manufacturers can demonstrate compliance with FDA regulations and mitigate the risk of equipment failures or product defects.
And maintaining detailed records of equipment maintenance and repair history is crucial for demonstrating compliance during FDA inspections. A CMMS provides a centralized repository for storing and accessing maintenance records, work orders, and equipment service histories.
This comprehensive documentation helps manufacturers track maintenance activities and provides evidence of proactive maintenance practices to regulatory agencies. It streamlines product inspections and ensures traceability by:
- Creating custom digital checklists for inspections
- Receiving automated routing, notification, escalation and approval of inspection forms
- Easily finding and attaching inspection data to non-conformance and CAPA processes
- Generating and digitally archiving Certificates of Analysis (CoA) or Certificates of Conformance (CoC)
- Ensuring traceability between manufacturing equipment and manufactured goods
- Quickly identifying products impacted by out-of-tolerance production and test equipment
And when something needs to change, there’s a process for that as well—an organized approach that ensures the changes are, in fact, made and that they are compliant. Manual files tracking these changes will not do, as they just create an unnecessary administrative burden and are susceptible to human error.
Ensuring Asset Compliance with Audit & Change Controls
When equipment needs to change or be replaced, and when that happens, being proactive with compliance and reporting is crucial. A comprehensive asset information repository with robust and searchable audit trails makes sharing FDA-compliant protocols easy.
Properly documented and validated processes are key to ensuring compliance and product quality. A CMMS facilitates change control procedures by providing workflows for initiating, reviewing, approving, and implementing changes. Tracking and demonstrating adherence to rigorous change control and onboarding processes is easier when it’s all in one organized place.
During FDA inspections, manufacturers must be able to provide comprehensive audit trail documentation that logs all maintenance activities, including work orders, equipment repairs, and preventive maintenance tasks. Nothing less than a detailed audit trail of maintenance operations will do—and this is precisely what can be easily accessed and presented to regulatory inspectors when employing CMMS technology.
As regulatory requirements continue to evolve, implementing a robust CMMS solution can keep regulated manufacturers aligned with changes as they happen. The ability to adapt and thrive will be a differentiator in coming years, particularly in highly regulated environments.
FDA Fallout Can Put Future Developments at Risk
An FDA recall can create a domino effect that spills over into other countries as well—and creates corresponding consumer lawsuits.
Companies with recalls are held accountable by shareholders and the market. One can also assume they’ll be subject to extensive scrutiny by FDA inspectors for years to come. It creates a devastating situation, and one that can be avoided with organized processes in place.
It’s something that leading manufacturers are taking to heart. Staying ahead of costly legal proceedings and complete production shutdowns is compelling manufacturers to consider more robust organizational options as they strategize over the coming months. Reach out for a demo, and we’ll show you how to stay ahead of FDA findings and their associated costs!
