The medical device industry is worth hundreds of billions of dollars, but companies who take their eye off the ongoing need for quality management could find themselves under an unwelcome federal compliance spotlight.
According to a recent U.S. Food and Drug Administration (FDA) Medical Device Enforcement and Quality Report, the agency has increased annual inspections at manufacturing facilities by 46 percent since 2007. In 2017 alone, the FDA conducted 2,592 inspections, the report said, with foreign facility inspections increasing by 243 percent in the same ten-year period.
Year after year, FDA records show that corrective and preventive action (CAPA) problems remain one of the top contributors to FDA Form 483 inspectional observations and warning letters. In fact, around 50 percent of all 483 letters relate to CAPA failures.
Needless to say, being on the FDA’s radar for CAPA issues is no place any company wants to find themselves. What is of concern, however, are the implications of an ineffective CAPA process. To put it simply, failing to adhere to the stated quality requirements means more adverse events, more recalls, more potential harm to patients and irreparable brand damage.
So what is the FDA looking for in a CAPA process, and how can device manufacturers make sure that process is truly effective? Moreover, what should this process look like in light of long-anticipated changes in the FDA’s regulatory approach?
To answer these questions, let's take a look at what medical device manufacturers should know and what they need to do.
CAPA process requires inspectional objectives
Somewhat helpfully, the FDA has a free inspection guide on its website detailing its Quality Systems Inspection Technique (QSIT), which the agency uses when performing inspections.
This document provides comprehensive information on how the FDA assesses a company’s quality systems, and includes 10 inspectional objectives for the CAPA process. These objectives can be summarized as follows:
- CAPA procedures are defined and documented.
- Data on existing product and quality problems are analyzed to assess what needs corrective action.
- Data on unfavorable product and quality trends are analyzed to assess potential future problems requiring preventive action.
- CAPA system data are complete, accurate and timely.
- Statistical methods are used to detect recurring quality problems, comparing data from different sources.
- Failure investigations are conducted according to nonconformity risk, with controls for preventing distribution of nonconforming products.
- Appropriate actions are taken for quality problems.
- CAPAs are effective and verified or validated before implementation, and they don’t adversely affect the device.
- CAPAs are implemented and documented.
- Information on quality issues and CAPAs is shared, including during management review.
Defining the CAPA Process: A Practical Approach
Naturally, the FDA doesn’t say what, specifically, an organization’s CAPA process must be. And while the agency’s QSIT guidance document may seem frustratingly vague (and possibly dated), it leaves room to create a system that conforms to a company’s needs.
With that in mind, medical device manufacturers should generally use some variation of the following approaches:
- Identify and describe the problem
- Investigate the problem’s extent and its root cause
- Create an action plan to correct the problem, including who’s responsible for each step and appropriate timelines
- Implement and track the action plan’s timely completion
- Verify CAPA effectiveness and review results, including in management reviews
QMS feeds the process
When you look closer at the FDA’s QSIT guidance, it’s clear that quality management system (QMS) data must feed the CAPA process. Organizations also need to integrate controls to ensure procedures are documented, implemented and receive appropriate follow-up.
QMS automation solves all of these challenges, preventing problems from falling through the cracks by enabling:
- Documentation of CAPA procedures
- Integration of production data within quality management activities
- Analysis of data to identify problems and trends, as well as for statistical process control (SPC)
- Workflow automation to keep CAPAs moving at each step and prevent bottlenecks or delays
- Risk assessment for prioritizing CAPAs and measuring CAPA effectiveness at reducing risk to acceptable levels
On a practical level, the ability to quickly access data and documentation through automated processes also makes a more favorable impression during an inspection, rather than scrambling to find paper records.
Coming Soon: CAPA Guidance Changes
The FDA has already announced its intent to transition to ISO 13485:2016, with a proposed rule to replace the current Quality Systems Regulation (QSR) set to come out in fall 2019. In addition, the FDA plans to use Medical Device Single Audit Program (MDSAP) audits—where scoring is based on ISO 13485—to replace the QSIT model.
The goal is ultimately to reduce the compliance burden and harmonize requirements internationally, and the agency says the differences between the existing QSR and ISO 13485 are minor. Even so, officials admit the move will have significant implications, which will include changes to the long-standing inspection model.
So, what does this mean for medical device companies when it comes to creating a compliant CAPA process?
The answer is that while QSR and the QSIT model are still in effect for the moment, ISO 13485 and MDSAP certification should be on every organization’s immediate planning priorities. Taking that into account, and with full implementation on the horizon, our recent white paper - 'How to Prepare for FDA Migration from QSR to ISO 13485 and QSIT to MDSAP' - takes a deeper dive into what companies need to know.
One of the biggest changes that will affect CAPA processes in the not-so-distant future is that risk-based thinking will replace preventive action, just as it did in other quality standards like ISO 9001:2015. Taking that into account, this is another area where an automated QMS will provide a strategic advantage moving forward, allowing companies to incorporate risk into corrective action and other quality processes.
At the end of the day, the FDA looks more at results, reliability and documentation than a rigid set of specific steps around corrective action. Ultimately, an automated QMS delivers on all of these counts, allowing manufacturers to adapt workflows to their own needs as well as evolving regulatory requirements.
ETQ has been a leader in quality management software since 1992, and is trusted by over 550 global customers. With more than one million end users in a variety of industry sectors, ETQ’s mantra that quality creates limitless possibilities drives our SaaS solution forward, providing companies with the insights that they need to succeed in a competitive marketplace.