Originally Published MX November/December
2001
GOVERNMENTAL & LEGAL AFFAIRS
Managing for Quality
Enterprisewide management systems can help device manufacturers comply with FDA CAPA requirements.
Marie Fair
In
today’s fast-paced economy, managing product quality and customer satisfaction
is a tremendous challenge for any medical device company. The ability to manage,
correct, and prevent product-quality issues can be a crucial component of a device
company’s success or failure. Device manufacturers are held to especially
high quality standards by FDA and other government agencies to ensure that their
products are safe and effective.The Federal Food, Drug, and Cosmetic Act requires FDA to conduct biennial quality system (QS) and good manufacturing practices (GMP) inspections of companies that manufacture Class II or Class III medical devices.1 In an attempt to decrease inspection time and sharpen the focus of medical device inspections, FDA developed an approach for conducting inspections under the QS regulation called the quality system inspection technique (QSIT).2
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Sidebar: |
CAPA is a common-sense concept that was largely taken for granted by most medical device companies in the past. In recent years, however, device manufacturers have come to realize that an effective CAPA management system is the cornerstone of all corporate quality-improvement programs. It is now widely understood that sophisticated mechanisms should be in place to identify existing product-quality issues and to investigate and undertake corrective action for those issues.
In the past, it also has been expected that the CAPA process should strive to prevent future problems. However, making a CAPA management system work smoothly and effectively to address existing problems and prevent future issues isn’t easy. It takes an ability to look beyond today’s immediate product issues, across the enterprise and the product life cycle, to incorporate information from every possible source throughout the organization.
Basic CAPA Principles
Before investigating
the merits of enterprisewide CAPA systems, a review of the basic tenets of a
CAPA management system—electronic or otherwise—is necessary.
Once a product-quality issue occurs, a comprehensive failure investigation should
be undertaken, beginning with identification and definition of the problem in
order to understand its potential scope and impact. This should include a documented
risk analysis. The investigation itself should include results of any data,
process, or operations analyses, or the rationale for not having conducted any
such analyses. Then an action plan should be constructed.
Product or quality issues are considered significant if there is potential for
compromise of user or patient safety, if there is a reliability issue, or if
the issue causes the product to fall outside its established specifications.
CAPA procedures should be designed to ensure that, once a significant product-quality
issue is identified, the affected products are contained prior to distribution
whenever possible. When affected products have already been distributed, communication
may be necessary to notify affected medical professionals or patients.
An integral part of the CAPA process is determining the root cause of a product-quality
issue. The root cause may indicate that other products or processes are affected
beyond the product initially identified.
A good CAPA management system should be a closed loop, with safeguards in place
to ensure that all necessary steps in the process are completed, and that the
appropriate individuals have input and conduct reviews. While a CAPA system
should provide mechanisms to encourage timely completion of individual tasks,
it must also provide the tools necessary to manage a corrective or preventive
action at a high level. Upon completion, the effectiveness of the corrective
or preventive action should be documented through objective evidence.
It’s important to be able to provide FDA investigators and other auditors
with documentation that corrective and preventive actions have been implemented
and are effective. This can be demonstrated through engineering change orders,
process or product verification and validation records, training records, corrective-
or preventive-action reports, nonconformity reports, effectiveness evaluations,
or trend reports. While FDA cannot dictate the degree of corrective or preventive
action that should be taken, a CAPA management system should provide documentation
of risk analysis indicating the basis for the type and extent of action taken.
Enterprisewide CAPA Management
CAPA management
systems are driven by data, but data alone cannot ensure that companies will
arrive at definitive conclusions and actions regarding product-quality issues.
The problem is that in many medical device companies, data are housed in a number
of different repositories, making the process of converting data into useful,
timely management information difficult and time-consuming.
Fortunately, the software industry currently offers systems that allow device
manufacturers to manage and resolve corrective and preventive action quickly
and efficiently, while meeting FDA and other regulatory requirements. Such tools
enable device companies to synthesize data into powerful management information
across the enterprise, while allowing individual departments and employees the
flexibility to do their respective jobs as they see fit.
The following are 10 reasons why medical device companies can benefit from an
enterprisewide CAPA management system.
1. Better, faster
information means better, faster decisions.
Medical device executives today need comprehensive information from many sources
in minutes, rather than days or weeks, in order to make accurate, timely business
decisions. Employing an enterprisewide CAPA system allows real-time access to
product-quality information from any company location or department. Reports
are available in formats tailored to the user.
Executives of device companies that operate on a global scale especially can
appreciate the number and variety of strategic advantages that an enterprisewide
system for gathering and using product-quality information throughout a product’s
life cycle offers. For example, successful management of premarket study data
ensures a vital competitive edge in the important race to market. Also, once
a product is launched, careful monitoring of product safety and performance
reduces the potential for regulatory and legal risk. In addition, if a problem
should occur, having all relevant data quickly accessible minimizes the possibility
of a product recall and enables device companies to actively address situations
with serious health and financial consequences. Furthermore, the advent of Web-based
systems can broaden a company’s capabilities, allowing decision making
to originate instantaneously from virtually anywhere in the world.
2. Wider analysis
provides early warnings. An enterprisewide CAPA system can facilitate the
early identification of similar types of problems as well as problems that may
share a common root cause. This could mean preventing a future customer complaint,
reportable event, or even a product recall. A device company that can spot trends
using data from diverse and widespread sources is less likely to be surprised
by emerging issues, and is more likely to respond at an earlier point in time.
Wider analysis also provides corporate management with the necessary information
to determine if individual business units are adequately addressing quality
issues, and can provide device companies with a meaningful scorecard.
3. Broader scope
brings sharper focus. Over the past decade, quality control software has
continued to gain acceptance in medical device companies. However, most of these
systems are unable to integrate data from all sources of CAPA information. A
good CAPA management system should be able to combine information from a variety
of areas (see sidebar). In
addition, most systems usually do not have the capability to combine that data
with other business metrics to provide a comprehensive bottom-line-oriented
quality information system.
It is also important that a CAPA management system provide direct input into
the design-control segment of its quality system. Software systems that facilitate
this flow of information stimulate a faster, tighter design and development
process, while ensuring design-control compliance.
4. Increased
efficiency allows time for what really matters. Medical device manufacturers
want to improve their efficiency level and reduce CAPA paperwork whenever possible.
With enterprisewide CAPA management systems, employees no longer have to enter
and maintain information about products, customers, medical professionals, distributors,
and patients over and over again in multiple databases. Instead, the information
is entered once and is simple to maintain.
When medical device companies merge databases that have traditionally stood
alone, additional efficiency improvements are seen in training, computer resources,
and information technology support.
In addition to reducing personnel requirements for data entry, enterprisewide
CAPA management systems also free valuable professional and management staff
for higher-level pursuits, such as new product development and other activities
that enhance the bottom line.
5. Integrated
data minimize regulatory issues. Medical device companies today operate
with enormous knowledge bases. FDA oversees a considerable portion of this data,
such as design input, preclinical and clinical study data, adverse events, material
and manufacturing nonconformities, equipment service records, product complaints,
postmarket MDRs, CAPA, patient registries, and product tracking. In addition,
there are nonregulated sources of product-quality information, including requests
for new products, competitive information, distributor comments, and scientific
papers.
As this information is often scattered throughout many departments or subsidiaries,
many of which use a combination of manual and computerized systems and therefore
a variety of formats, redundancies are inevitable. Not only do these redundancies
drain valuable financial resources, but they also provide opportunities for
discrepancies and miscommunication, which may contribute to regulatory problems.
With an enterprisewide system, all of the clinical and regulatory data are located
in a single database, making cross-functional access and analysis much easier,
and enabling many users to share information at the same time.
6. Integrated data foster effective processes. Process-management systems address the impact of tasks on data and normally have three broad functions in medical device data management:
A good CAPA management
system should look beyond product issues into problems associated with systems
and processes. While it may be easy for a device manufacturer to conclude an
investigation once a nonconforming product or part has been identified and corrected,
the awareness and continual improvement of the company’s quality system
processes is equally important. Whenever practical, processes and procedures
should be reviewed and considered as potential root causes for product-quality
issues. Enterprisewide data can facilitate the understanding of how common processes
and procedures affect product quality.
As quality systems mature, emphasis shifts from corrective action to preventive
action. Medical device companies need to be certain that the CAPA management
system they select is flexible and configurable enough to accommodate the processes
that change as part of this quality evolution. It makes no sense to allow the
software to dictate the processes, or for a device company to change its processes
to accommodate the software.
7. Effective
processes minimize surprises.
Many medical device manufacturers have to manage multiple deadlines for multiple
products in multiple locations, which can be a nightmare, but software that
provides automatic alerts and due-date notifications helps ensure that deadlines
won’t be missed.
Missed deadlines can have an enormous financial impact on device manufacturers,
not only because of regulatory risk, but also because of the cost of rushed
last-minute activities and the ripple effect of pulling critical employees from
other projects.
8. Electronic records and signatures meet regulatory requirements. As specified by FDA’s 21 CFR Part 11, electronic records and signatures are suitable for product-quality recordkeeping.4 However, when such electronic records are used, changes to data stored on electronic media require an audit trail, among other data-security measures. Beyond the requirements imposed by FDA, effective audit trails provide device companies with essential review capabilities. Such reviews can highlight flawed procedures.
9. Flexibility equals usability plus scalability. An enterprisewide CAPA management system must accommodate a wide range of user needs. In the context of medical device manufacturing, such systems must be able to perform the following key functions.
- Integrate with existing business management applications.
- Handle complex present and future needs.
- Be user-friendly enough to find wide acceptance.
- Allow for quick and easy implementation.
- Adapt to the changing requirements and growth of a device manufacturing company.
By accommodating the requirements and skills of a wide range of users, a CAPA management system can reach out to collect the widest range of information sources, yet provide experienced users with the sophisticated tools they need to do their jobs. Daily users have different needs than do infrequent or limited users. Different geographic sites may have different requirements as well. Providing supporting information in familiar terminology—even in other languages—can greatly enhance information flow into the product-quality system.
10. Improved Software Technology Supports Competitive Medical Technology. Finally, among the most important reasons behind the growth of enterprisewide technology is the increased recognition by industry experts that success in today’s competitive business environment requires information technology at the enterprise level. In the medical device industry, leading-edge companies are embracing better IT tools and expertise to deliver improved product-quality data. The results are faster time to market, improved operational efficiency, and the ability to view clearly all of a company’s product data, regardless of location. These efficiencies often give medical device companies a competitive advantage in an otherwise mature and frequently product-saturated market.
Conclusion
When it comes to
providing quality products for their customers, there is no middle ground for
device companies. FDA requires comprehensive corrective and preventive action
at all levels of the organization.
While CAPA systems are driven by data, it takes more than that to manage product
quality. Medical device companies must manage this data on an enterprisewide
basis, using up-to-date technology and sophisticated management tools to provide
meaningful, targeted information. In turn, the use of such tools can lead to
greater efficiency, a sharper focus, and fewer regulatory surprises.
REFERENCES
1.
Department of Health and Human Services, Federal Food, Drug, and Cosmetic
Act, U.S. Code, title 21, chap. 9, June 1981.
2. "Quality System Regulation," Code of Federal Regulations,
21 CFR 820.
3. M Allen, M Armstrong, and N Singer, "Points to Consider When Preparing
for an FDA Inspection Under the QSIT Corrective and Preventive Actions Subsystem"
(Washington, DC: AdvaMed, 2001).
4. "Electronic Records and Signatures," Code of Federal Regulations,
21 CFR 11.100.
Marie Fair is a business domain expert at NetRegulus (Oakbrook Terrace, IL), a software and services firm that provides regulatory-data management systems to the medical device industry.
Illustration by Eric Mueller
Copyright ©2001 MX
