Medical device manufacturers must maintain compliance with quality standards. Deviation from quality specifications or regulatory requirements comes with serious consequences including production stoppages, product recalls, regulatory sanctions, and damage to brand reputation.
Streamlining and prioritizing your corrective and preventative action (CAPA) process can ensure alignment ahead of an audit and head off unnecessary challenges. Leading companies turn to Computerized Maintenance Management Systems (CMMS) to bring order to CAPA chaos.
Keeping CAPA Procedures Audit-Ready
Your CAPA procedures will always be evaluated during FDA and ISO audits. Are you ready for that? A CMMS helps to ensure that you are.
A preventable and recurring reason for Form 483 observations tracks back to CAPA deficiencies, or to be more precise—lack of or inadequate CAPA procedures. It’s also a top citation in warning letters.
More specifically, one of the primary reasons why the FDA issues 483 observations to medical device companies is because their CAPA process is not properly defined. This typically means the company’s CAPA process is either not being followed, not compliant, or nonexistent.
There’s another risk as well – that the company has a CAPA process that is not appropriately applied or is overused, with too many in the queue, and things just aren’t getting done as a result.
Understanding Where Your CAPA Process Misses the Mark
It’s easy to see how medical device manufacturers could get bogged down in the CAPA process, as there are many details to track. The FDA’s Corrective and Preventive Action (CAPA) requirements are very clearly defined in 21 CFR Part 820.100:
(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
(b) All activities required under this section, and their results, shall be documented.
The FDA QSIT guide further clarifies the purpose of CAPAs and places a finer point on its complexities identifying it as “one of the most important quality system elements.” It is tasked to “collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.”
The required Corrective and Preventative Actions are also detailed in two separate ISO 13485:2016 clauses—8.5.2 and 8.5.3, respectively.
- Corrective action focuses on eliminating the cause of existing nonconformities to prevent recurrence.
- Preventative action focuses on eliminating the causes of potential nonconformities to prevent their occurrence.
An organized and robust approach to both preventative and corrective actions would save manufacturers the additional time they inevitably spend struggling with a manual process—and it does.
A CMMS Creates an Organized Approach to CAPAs
A Computerized Maintenance Management System (CMMS) offers a centralized database to store and streamline information about assets, work orders, and maintenance history. It organizes information and automates preventive maintenance with alert notifications. A CMMS acts as a dynamic system of record that helps track, maintain, and manage production-related assets and schedule services.
With this central repository for all maintenance, calibration, assignments, and work requests across all users in the company, all documentation and record-keeping are housed in a single location that is accessible from anywhere. This keeps everyone on the same page with detailed audit intel at their fingertips. Reports and audit logs for equipment can be created quickly, ensuring compliance.
Without CMMS software, companies rely on a manual process, like Excel spreadsheets or Access databases, to keep track of all the assets, their maintenance schedules, and work orders. This guarantees something will eventually be missed as it’s just too much to keep track of in this way.
CMMS software creates a comprehensive overview for all assets, including maintenance history, upcoming preventive maintenance tasks, and ongoing work orders. A centralized approach saves time in the long run and, when appropriately applied, contributes to a reduction in CAPA findings.
It’s important, though, to not become overeager in these identifications, and fall victim to the risk posed at the outset of this piece—overusing the CAPA process. This will cause an additional drain on the company’s time while resulting in inconsequential corrective and preventative actions taking place.
Identifying CAPAs Early without Being Overeager
CAPAs are often corrections or reactions to issues that have already occurred. It’s essential to have systems in place that can assess and identify issues before they become problems.
This means identifying the root cause of a problem and taking steps to address it before it can happen again. Too many times, root cause analyses get hung up on the challenges faced in each instance and do not address the broader underlying issues . This can result in a constant stream of CAPAs without resolution that pop-up again and again.
It also means deciding if every event requires a formal CAPA investigation. Each CAPA request should be run through a rapid risk analysis to make this determination before moving forward, and to head off creating unnecessary CAPAs.
If it warrants a formal CAPA, it must then be prioritized for resolution to ensure urgent matters are not delayed. With this plan in place, you can move from reacting to situations to being proactive and identifying and addressing CAPAs early, without creating additional new challenges for your company.
Defining your CAPA prioritization process is critical, and we can provide resources to help you take those first steps as you implement your CMMS solution. Reach out for more information!
