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Columns It's Raining CAPAsNovember 12, 2007

It’s Raining CAPAs

By Nikki Willett, Pilgrim Software

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The pressure on regulatory compliance is increasing business risks and puttingpressure on costs and performance. Corrective Action Preventive Action (CAPA) management is integral to process control efforts conducted by medical device organizations toadhere to FDA and cGMP regulations. The consequences of CAPA non­compliance are costly and significant, resulting in damaged brand reputation and, potentially, acompany’s long­term profitability. Effective CAPA management is more than just a regulatory requirement. A good business practice can reduce company liability and warrantyclaims 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 rightdirection?

From a regulatory perspective, CAPA implementation and effectiveness are leading indicators of the overall quality systems effectiveness. Why are companies struggling toachieve 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. Employeesdon’t always know or understand their responsibility or authority. Not all source inputs to potential nonconformances are identified. Information is not measured, monitored orshared 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 andmaterial 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 toresolve 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 qualityacross all products and processes. There is no real­time visibility of compliance and quality activities across the company. Moreover, a lack of good reporting and trendingcapabilities makes it difficult for top management to make accurate assessments about the issues, risks and especially costs facing the organization. Not only disconnected, buta lack of fully closed­loop processes across key compliance systems are preventing organizations from having the effective data for analysis that would provide early warningsand 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 trainand 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 properlyto 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? Whowill enter the information? Make the Nonconformance Control/CAPA system scalable, simple, risk­based and easily integrated throughout the organization. Ensure that sufficientmechanisms 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. Youwill 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 acrossfiles, 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 seriousinefficiencies 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’svalue 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 possiblecustomer 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 canreact. Tracking problems will allow you to develop best practices and verify effectiveness. The system may build on existing infrastructure, but eventually all data should berouted to one location. Without an integrated system, identifying root causes is little more than guesswork. Assumptions are made based on rumor and conjecture, rather thanaccurate, reliable data. Islands of information created by multiple data streams lead to inconsistencies and waste. Real measuring tools enable managers to determine preciselywhere 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 thatsupervisors and managers can quickly access information, compare and contrast solutions to determine best practices and monitor overall performance. In other words, havinga 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 multipledocuments and files.

Trending, analysis and risk management—Once source error information is correctly captured, many companies escalate these immediately to CAPAs to begin the investigationprocess. 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 cannotalways 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 isreally 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 techniquesthroughout the CAPA program. The progress of risk management has been seen in many companies implementing risk mitigation plans and assessing FMEA/FTAs as part ofthe 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 processto correctly categorize and prioritize those critical problems—focus. For these critical CAPAs, the company’s risk management team should be integrated into the investigationand 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 ofcritical problems to management and help each department focus on the key areas of impact for both effectiveness and overall product and process improvement, moving anorganization 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 facilitylocations. Configure data such that problems related to product, process, or the quality system can be identified and acted upon quickly. Leverage as much information aspossible to draw targets and assess effectiveness. Harmonization of sources, failure and root cause codes is essential to drawing meaningful conclusions. Results of theanalysis 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, youare 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 effectivelyrespond to issues as they arise.

Employee accountability and management visibility—Drive for employee understanding and ownership (accountability) by implementing consistent and sustainable practicesand a tiered training program. Train employees at all levels of the organization, and in many departments, on sound investigation methods, good documentation techniques andthe meaning/purpose of all the CAPA elements. Management can help change the behavior of its employees to embrace quality throughout the organization by instigating newprograms. 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 keymetrics to management to help justify further investments in CAPA and global quality systems. Quantify cost of noncompliance by calculating scrap and rework; customercomplaints; corrections and recalls; delay in 510(k) or PMA clearance; suspension of government contracts; not getting certificates for product for export; shutting down of youroperations; 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 yourvalue chain can reduce time to diagnose and resolve problems, avoid supplier shortfalls and help to meet customer expectations. The collaboration that is required to bringproducts to market faster and safer, avoid regulated actions and improve customer satisfaction demands an integrated CAPA system to plan and manage all variability, risks andvisibility.

Close the circle of quality assurance by developing, implementing and maintaining a “closed loop” CAPA system that integrates compliance into business practices and qualitysystems. 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 andkeep 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 qualitymanagement 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 PilgrimSoftware’s Web site at www.pilgrimsoftware.com.

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