Medical Product Outsourcing (MPO)

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Columns It's Raining CAPAs
November 12, 2007
It’s Raining CAPAs
By Nikki Willett, Pilgrim Software

2. 4/19/2016 It's Raining Capas ­ Your online source for medical device product information ­ Medical Product Outsourcing
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The pressure on regulatory compliance is increasing business risks and putting
pressure on costs and performance. Corrective Action Preventive Action (CAPA) management is integral to process control efforts conducted by medical device organizations to
adhere to FDA and cGMP regulations. The consequences of CAPA non­compliance are costly and significant, resulting in damaged brand reputation and, potentially, a
company’s long­term profitability. Effective CAPA management is more than just a regulatory requirement. A good business practice can reduce company liability and warranty
claims and increase customer satisfaction.
FACT: In 2006, CAPA continued to top citations for 483s and warning letters for medical device companies.
FACT: In just the past two years, media has exploded over quality issues and product recalls in the medical device industry.
With CFR 820.100, cGMP, ISO 9000/13485/14971, QSIT and automated systems for quality, has CAPA evolved during the past decade, and are we moving in the right
direction?
From a regulatory perspective, CAPA implementation and effectiveness are leading indicators of the overall quality systems effectiveness. Why are companies struggling to
achieve and maintain compliance?
So many are using a variety of manual, semi­automated and homegrown systems. CAPA is an independent piece of the quality system and often recognized as “Quality’s” job.
The organization’s processes are fragmented and disconnected. Procedures are not always well documented. Required process steps are not always completed. Employees
don’t always know or understand their responsibility or authority. Not all source inputs to potential nonconformances are identified. Information is not measured, monitored or
shared across different product lines or business units. Trending data are not always visible to the appropriate level in the organization. Companies tend to look at product and
material issues and correcting them, and neglect to look beyond into the processes and procedures of their quality systems. Their focus is on products rather than the efforts to
resolve systemic issues, or they fast­forward to a solution without really identifying the “root cause.”
Because of this, medical companies have difficulty in following and enforcing standard and consistent procedures and having organization­wide trending data to predict quality
across all products and processes. There is no real­time visibility of compliance and quality activities across the company. Moreover, a lack of good reporting and trending
capabilities makes it difficult for top management to make accurate assessments about the issues, risks and especially costs facing the organization. Not only disconnected, but
a lack of fully closed­loop processes across key compliance systems are preventing organizations from having the effective data for analysis that would provide early warnings
and minimize any surprises.
So how can medical device companies achieve an improved CAPA system? They must think about the system as a whole. It starts with people, quality and the ability to train
and maintain employees who will provide the backbone to a CAPA system.
An effective CAPA management system revolves around a global program, trained employees, well­documented standard operating procedures and using technology properly
to put global practices and procedures in place.
Key Areas of Focus
Following are some areas in which your organization can focus on to gain maximal benefit.
Planning—The foundation of a successful CAPA system is adequate planning and setup. Before setting up a CAPA system, you need to define Code Rules and Ownership.
What are the rules and variances to the rules? What are the processes and who are the owners? What will the failure modes be? How should we define severity levels? Who
will enter the information? Make the Nonconformance Control/CAPA system scalable, simple, risk­based and easily integrated throughout the organization. Ensure that sufficient
mechanisms are in place so that all steps are completed for each event. It’s very important that you determine the right people to involve in the CAPA process and when. You
will need to determine how procedure revisions will be handled and how you will enforce these rules and procedures on a global level.
Source error tracking—Many companies have a lack of connected data sources. Alternatively, companies cross­reference source errors, deviations and other events across
files, dates, lots and other criteria by hand requiring significant amount of time and opportunities for impacts and trends to be missed. This approach leads to serious
inefficiencies and continued repetition of mistakes. The first step is to identify, collect and record any information that can occur anywhere throughout your product or process’s
value chain.
You will need to identify everything from problems that may occur at business partners’ sites, through the final manufacturing, labeling and distribution lifecycle to any possible
customer complaints. Key to recording problems is to drive to the root cause and focus on prevention and correction actions. The more knowledge you have, the faster you can
react. Tracking problems will allow you to develop best practices and verify effectiveness. The system may build on existing infrastructure, but eventually all data should be
routed to one location. Without an integrated system, identifying root causes is little more than guesswork. Assumptions are made based on rumor and conjecture, rather than
accurate, reliable data. Islands of information created by multiple data streams lead to inconsistencies and waste. Real measuring tools enable managers to determine precisely
where and when mistakes are occurring and why.
A sole repository of information throughout the entire organization that includes external and internal inputs from product lifecycle, processes and quality systems, ensures that
supervisors and managers can quickly access information, compare and contrast solutions to determine best practices and monitor overall performance. In other words, having
a closed loop nonconformance control and CAPA system, with a few “clicks of the mouse,” a manager can see what’s happening company­wide, rather than consulting multiple
documents and files.
Trending, analysis and risk management—Once source error information is correctly captured, many companies escalate these immediately to CAPAs to begin the investigation
process. Everything is a CAPA! This behavior, enforced by the FDA on good investigations and by the company’s own internal policies to close CAPAs within a short timeframe,
may lead to an overload of data that doesn’t inherently provide the important impacts of what’s failing across the organization. With a volume of CAPAs, companies cannot
always assure 100% effectiveness of its corrective/preventive action plans; what the trending really is telling you; and, if the information provided back to the product design is
really going anywhere—there’s just too many.
Use the data you collect to detect minor problems quickly before they become major problems. However, change the behavior of the organization by applying risk techniques
throughout the CAPA program. The progress of risk management has been seen in many companies implementing risk mitigation plans and assessing FMEA/FTAs as part of
the overall product development cycle. However, such risk techniques have been left to the front or back part of the process, leaving each designated department (QA/MFTG,
Engineering) to track, trend or analyze data individually. Progressive companies need to bring in and integrate risk techniques as part of the nonconformance and CAPA process
to correctly categorize and prioritize those critical problems—focus. For these critical CAPAs, the company’s risk management team should be integrated into the investigation
and root cause analysis process of the CAPA itself where analysis shouldn’t be left to just product but also process, therapy and users/usage. This will help increase the view of
critical problems to management and help each department focus on the key areas of impact for both effectiveness and overall product and process improvement, moving an
organization from reactive to proactive.
Trending is still a key within an organization to monitor the pulse­point of an organization’s overall health of its quality systems. Implement measurement, data analysis tools,
and processes for different levels of the organization. Assure that there are linkages between products, processes, quality systems, and across multiple divisions and/or facility
locations. Configure data such that problems related to product, process, or the quality system can be identified and acted upon quickly. Leverage as much information as
possible to draw targets and assess effectiveness. Harmonization of sources, failure and root cause codes is essential to drawing meaningful conclusions. Results of the
analysis and/or any further decision to take action are identified as an output of the nonconformance/CAPA system.
Change can be a result of a CAPA process or a part of your continuous improvement initiative. Regardless, by taking the information you have gathered and analyzing it, you
are able to detect areas where you can improve and change. The CAPA process should be tied to a company’s overall change management strategy to more effectively
respond to issues as they arise.
Employee accountability and management visibility—Drive for employee understanding and ownership (accountability) by implementing consistent and sustainable practices
and a tiered training program. Train employees at all levels of the organization, and in many departments, on sound investigation methods, good documentation techniques and
the meaning/purpose of all the CAPA elements. Management can help change the behavior of its employees to embrace quality throughout the organization by instigating new
programs. Provide a bonus for compliance factors:

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• Timely implementation and documentation of CAPA
• No 483 observations
• Getting a CE mark or keeping one
Alternatively, institute a disciplinary system for non­compliance:
• Letters of reprimand for not meeting commitments
• Dismissal for repeated failure to comply
Closed­loop CAPA processes allow management to see where the problems are. In addition, with the data you collect, you can monitor the cost of quality and provide key
metrics to management to help justify further investments in CAPA and global quality systems. Quantify cost of noncompliance by calculating scrap and rework; customer
complaints; corrections and recalls; delay in 510(k) or PMA clearance; suspension of government contracts; not getting certificates for product for export; shutting down of your
operations; product liability actions; and shareholder suits.
Such trending of data cannot only help you with improvements but also help the organization realize that preventive action is cheaper than corrective action.
It Is All About the Business
The trend now is of continuous process improvement and the implementation of closed­loop integrated CAPA across the enterprise. A constant flow of information across your
value chain can reduce time to diagnose and resolve problems, avoid supplier shortfalls and help to meet customer expectations. The collaboration that is required to bring
products to market faster and safer, avoid regulated actions and improve customer satisfaction demands an integrated CAPA system to plan and manage all variability, risks and
visibility.
Close the circle of quality assurance by developing, implementing and maintaining a “closed loop” CAPA system that integrates compliance into business practices and quality
systems. Use your CAPA system to improve profitability by decreasing the cost of quality. High cost of quality impacts the bottom line (rework, scrap, delays in product approval,
resource inefficiency, etc.). Drive actions based on data and risk—to help determine where to focus actions and resources.
By detecting and reducing errors across the enterprise, quality and, therefore, customer safety improves. You reduce risk, improve customer satisfaction, reduce variability and
keep product quality visible across the organization. A well developed CAPA process and system is a business advantage.
Nikki Willett is vice president of marketing and regulatory products for Tampa, FL­based Pilgrim Software, Inc., a world­leading provider of enterprise compliance and quality
management solutions for small to global organizations. Named 2007 North American Enterprise Compliance & Quality Management Company of the Year by Frost & Sullivan,
Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim
Software’s Web site at www.pilgrimsoftware.com.
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