A properly implemented CAPA system will ensure that root causes of contamination are found and dealt with in a timely manner

By Matthew Kopecky, Sparta Systems

In today’s increasingly regulated business environment, environmental health and safety (EHS) remains the critical factor in the day-to-day contamination control operations of organizations. With the multitude of regulations being imposed by government bodies from 21 CFR 25 to 40 CFR and ISO 14001, the need for businesses to track EHS issues and actions is becoming a critical job–not to mention an increasingly difficult one.

To date, the most widely-used and effective process for ensuring the safety and quality management of contamination control departments is a closed-loop corrective and preventive action system (CAPA). Successful CAPA management ensures that any contamination control issues that appear unexpectedly in the manufacturing process can be addressed quickly and efficiently, with processes implemented that can make certain these issues never appear again. This allows organizations to anticipate any future issues with regulatory bodies that may arise and saves an enormous amount of time and resources that can impact the ability to generate revenue from the clean manufacturing process.

The concept of CAPA management will likely be nothing new to the average contamination control professional. This is a notion that has existed for years in various permutations across industries and one that is generally viewed as an efficient way of dealing with any quality issues that arise in the manufacturing process.

However, the truth of the matter is that many organizations in this industry have yet to adopt an effective closed-loop CAPA management process, and even fewer have implemented a system for addressing the quality of the processes in place to track and report CAPA issues. Many, in fact, are still using rudimentary tools like spreadsheets, databases, and paper-based systems to track their CAPA issues and efforts. Why are organizations so reticent to adopt effective CAPA management, and why are those that have so far behind in the methods they’re using? Most importantly, what will it take for companies to realize that CAPA management doesn’t need to be as much of a drain on time and resources as they think?

This article will explore the needs and effectiveness of correct CAPA control, how to implement a successful system, and examine just why CAPA still matters.

The issue at hand

While the needs of different contamination control professionals and departments may vary across industries–such as biopharmaceuticals, semiconductor manufacturing, or food processing–the goal of most of these departments is often the same: to manufacture and ship product as efficiently as possible and to do so with as little detrimental effect on the manufacturing environment as can be achieved. This means that no matter the industry, professionals must always maintain a manufacturing environment that is free of any potentially damaging pollutant, contaminant, or impurity that may result in a flawed or even harmful product.

Figure 1. A centralized dashboard helps companies manage corrective actions. Image courtesy of Sparta Systems.Click here to enlarge image

This becomes even more of a challenge when government regulations are introduced. With new lawsuits making headlines almost daily and companies being made and broken based on their ability to maintain a contamination-free environment, the need for effective quality management processes in the manufacturing environment takes on entirely new importance. The importance of minimizing risk and ensuring compliance with regulatory issues while upholding an efficient and profitable operation is a balance companies continue to seek, and many are able to do so.

Despite companies’ best efforts to implement processes and systems for maintaining control over the manufacturing environment, it’s frankly impossible to ensure that incidents never happen. No matter how clean the facility or what kind of systems are in place to ensure the quality of the process, the introduction of contaminants is inevitable, and when these incidents do arise, it’s vital that companies be prepared to deal with them as quickly as possible.

This is where corrective and preventive action management comes into play and emerges as an essential process for stemming the issues associated with contamination of the manufacturing environment. In theory, CAPA management should be the hub of an organization’s quality management initiatives, as it should allow them to log events and problems, investigate them to determine the root cause, propose corrective and preventive action plans to ensure that issues are anticipated and become a non-issue for the future, and measure effectiveness to ensure the root cause has been eliminated. This kind of system usually involves an approach that includes a business intelligence system for the tracking and efficient handling of the aforementioned issues.

So why aren’t more companies doing this? The single biggest reason why more companies don’t implement a CAPA management system is the myth among C-level executives that CAPA management is a significant drain on company resources and time. When it comes down to it, the fact is that many companies never even reach the stage in which they are able to implement an effective corrective action, let alone one that ensures that the same issues don’t crop up in future environments. Once a contaminant or pollutant is introduced into the manufacturing process, companies will immediately go into “panic mode” and hastily throw a solution at the problem that only serves as a band-aid rather than a preventive solution for future incidents. Once this has happened and the product is tainted and shipped, only then is the issue examined in the proper level of detail to identify what went wrong. Monday morning quarterbacking is an all-too-prevalent practice.

The irony of companies’ failure to implement the proper CAPA processes is that when CAPA management works correctly as originally intended, it can actually save the time and resources that they are so reticent to employ in implementation. Ideally, a CAPA system that functions as intended should lower costs by consolidating redundant systems, enhancing collaboration between departments, and fueling cost savings in process implementation. Such a system will eliminate costly repeat problems by improving investigation into the root causes of incidents quickly, and will eliminate the potential of lost information by electronically and securely managing all information needed to comply with industry regulations.

This is the promise that many companies have thus far failed to realize. The next step is to examine how to correctly implement a CAPA system that will achieve these results.

Taking action with CAPA

When implementing a closed-loop CAPA management system in a contamination control environment, the most important thing to remember is that it is not a magic pill for curing all companies’ regulatory woes. At best, proper CAPA management can aid in reducing costs that would feasibly be spent on aiding in quality initiatives within other organizational departments, but as previously mentioned, CAPA can go a long way to ensuring that actions are taken to solidify the effectiveness of future quality endeavors.

The first step is to make certain that the CAPA system is centralized and controlled from a single office, thereby consolidating operations and eliminating overlap between departments. Whether the location for this centralized system is an office in the facility or the company’s corporate headquarters, conducting CAPA management from the centralized office will avoid confusion when incidents occur and serve to minimize the chaos of verbal communications and e-mails between departments claiming that they each know what went wrong and how to correct it.

The next step is to generate an effective system for tracking all incidents and events that occur. This should be electronic and should rely on a centralized system accessible to as few personnel as possible within the organization, eliminating confusion between departments. Often companies will use databases or spreadsheets to serve as their tracking system, while some will track issues manually via paper documentation. In a day and age that has become so sophisticated with new electronic quality management solutions readily available from a number of different vendors, this should no longer be an option–centralized quality management systems for tracking of incidents should be the de facto solution for any organization regardless of size.

Figure 2. A complete CAPA overview provides monthly management of incidents. Image courtesy of Sparta Systems.Click here to enlarge image

Whatever the system in place, implementation of a centralized quality management system will allow organizations to log and manage all issues and incidents that have occurred, which will ensure that they reach the desired conclusion when it comes time to correct issues, determine the causes, and take the necessary steps to prevent future occurrences.

Once the foundation has been laid for CAPA management via centralized, electronic incident tracking, the company is now ready to effectively deal with incidents and correct unforeseen problems. This arrives in the form of corrective action, which translates into the steps that need to be taken at the time of incident occurrence. For this to happen, companies need to be able to close deviations faster and more efficiently than previous processes have allowed, and incidents need to be reported with minimal hesitation so that response time is minimized.

Again, an electronic quality management system is the only way to ensure efficient incident reporting, ultimately resulting in faster responses for organizations and containment of contamination issues that occur in the manufacturing process. What this also entails is that escalation procedures are applied so that the right people are notified of incidents and these occurrences don’t become more pronounced than they need to be. It is absolutely essential that organizations take the time to map out an effective escalation procedure plan that incorporates quality management but also provides an escalation path without involving facility-level employees.

Figure 3. A deviations management function monitors all deviations within an organization’s quality management operations in a given month. Image courtesy of Sparta Systems.Click here to enlarge image

This can be a tricky proposition. If escalation procedures are manual, and the right people aren’t paying attention to the people and processes, even greater problems may occur. As a result, problems must be solved internally before they “get out the door” and damage the company’s brand reputation. It’s surprisingly easy for issues to go unnoticed because today’s clean manufacturers are doing much more work with far fewer people. In short, quality can easily take a backseat to production and profit, but it is nevertheless vital that organizations include these escalation procedures in their CAPA plans and do so in a way that strikes a balance between profitability and commitment to quality.

As soon as a corrective action has been efficiently enacted and the problem dealt with, the preventative action can begin. The most important components of preventative action are investigation and root-cause analysis, both which can once again be accomplished through quality management. Accountability needs to be maintained via assigning responsible parties to investigate the catalyst for the contamination control issue, and these parties need to be kept on a strict timeline for concluding what went wrong; otherwise, it’s possible that the correct solution will never be reached.

A quality management system can automate this process and alert executives of deadlines and ongoing investigations, providing increased visibility to the C-level and ensuring accountability across departments. Additionally, quality management can serve as an effective way of tracking and determining the progress of root-cause analysis so that the timeline is maintained and conclusions are reached efficiently and correctly.

The final piece of the closed-loop CAPA process for contamination control is tracking of effectiveness checks, or the measure of how well the preventative solution is working post-implementation. When these checks are streamlined and tracked effectively, the correct personnel are assigned and are committed to testing the success of the preventative action and correctly identifying how well the solution is working. This will essentially “close the loop” on the CAPA process and provide executives with the tools they need to ensure that compliance with regulatory bodies is maintained, anticipating and preventing future trouble from these bodies.

Not perfect, but good enough

The simple fact is that even when correct CAPA management has been mandated and instituted within an organization, it still won’t cure all of the company’s compliance ills or provide complete protection against future incidents. It’s just the nature of the beast. Pollutants will continue to impact the clean manufacturing process and cause compliance headaches for organizations of all sizes.

Of the systems available to effectively deal with such contamination emergencies, CAPA management has been proven time and again as the most efficient system for preventing future occurrences with minimal drain on the time and resources that companies generally view as impediments to profitability. Successfully implementing a CAPA management system as part of an overall quality management initiative can ultimately reduce costs and resources and provide organizations with the tools they need to anticipate future emergencies and maintain business growth for years to come.

Matthew Kopecky, manager, Solutions Architecture at Sparta Systems (www.sparta-systems.com), is responsible for the Solutions Architecture group, which provides complete consultative/technical support to prospects throughout the sales process and through the transition into the implementation phase.

By Hank Hogan

In one sense, the recent purchase by Entegris (Chaska, MN) of a stake in privately held Integrated Materials, Inc. (Sunnyvale, CA) is just the latest example of a tradition among semiconductor cleanroom equipment manufacturers: When there’s a downturn, merger and acquisition activity often picks up. Such activity is one way for companies to find somebody–or some technology–that can help them weather the economic storm.

For Entegris, the deal offers technology that extends the company’s product line into the processing chamber. Integrated Materials builds high-quality, high-temperature operation wafer processing boats out of polysilicon instead of the more traditional quartz or silicon carbide. That difference pays off, says Entegris vice president of corporate relations Steve Cantor. “The breakthrough advantage to the end customer is substantially higher yield and lower contamination.”

The addition of IMI’s unique, consumable solution, which uses a polysilicon material to significantly reduce particle contamination and improve yields, is expected to considerably extend Entegris’s wafer handling business and material science expertise. Photo courtesy of Entegris.Click here to enlarge image

This improvement happens, he explains, because the boat is made of the same material as the wafer. While the actual yield bump is proprietary, one measure of the benefit is the mean time between preventative maintenance in a processing chamber. There, the savings can be close to 50 hours a month, says Cantor.

As for the deal itself, he notes that the initial phase is an investment by the larger company in the smaller one. The first phase will be followed by a second if certain closing conditions are met by the private firm. “The intention of Entegris is to buy the remaining equity within a relatively short period of time,” explains Cantor.

This deal isn’t the only recent merger and acquisition activity related to semiconductor cleanrooms. Within the last few months, Lam combined forces with SEZ in a seemingly friendly deal (See “Lam Hopes to Clean Up with SEZ,” CleanRooms, February 2008, p. 8). More combative was an unsolicited bid by Sumitomo Heavy Industries (Tokyo) with regard to Axcelis Technologies (Beverley, MA) and a similar offer from Aquest Systems (Sunnyvale, CA) and others for Asyst Technologies (Fremont, CA).

Although these deals involve companies of different sizes pursuing various strategies and technologies, they all revolve around the same economic realities, says Gartner research vice president Dean Freeman. “Smaller firms are struggling with trying to make margins, trying to be profitable. You really need a critical mass of a certain extent.” He estimates that a semiconductor cleanroom tool company needs to be in the $200 million annual revenue range.

In looking around for a solution to the problem of size, firms can come up with a friendly and mutual merger or attempt one that’s decidedly less congenial, but the drive to find some synergism and make a situation more profitable is always there and can be especially strong during a downturn.

The current tight credit environment, however, may limit the amount of such activity during this business cycle because funds may not be as readily available. Another brake on current mergers and acquisitions, notes Freeman, is that photovoltaics, light-emitting diodes, and other high-tech areas may be more attractive investment opportunities than semiconductor manufacturing equipment.

The issue isn’t the tools but rather the market they serve. “The biggest problem in the semiconductor space right now is growth overall is only going to be on a 5 to 8 percent CAGR,” says Dean.