Mastering CAPAs with Dynamic Quality Event Management Processes

A corrective action/preventive action (CAPA) system is sometimes called the most important tool a quality control professional has. It is true that a CAPA is the essential mechanism used to contain systemic quality events, identify root causes, and correct them. But in order for a CAPA system to be an effective tool, it must leverage dynamic process capabilities to help a quality organization move beyond the corrective realm into the preventive realm and ultimately into a state continuous improvement.

Before further exploring the preventive potential of a CAPA system and why data is essential to accomplishing this shift, it’s helpful to make some basic distinctions between the different types of CAPA activities surrounding nonconformances that fall within quality event management (QEM).

Quality Event Management Terminology

• Corrections: Correcting Course

A correction is any activity that corrects a nonconformance. It may involve containment and quarantine actions, rework, recalls, dispositions of nonconforming materials. It is not the same thing as correcting the cause of the problem.

• Corrective Actions: Changing Course

A corrective action is any action taken to eliminate the cause of a nonconformance. A root cause must be identified and corrected in order to prevent a recurrence. Various quality event management investigation methods can be employed to identify the totality of the root cause including flow diagrams, the five W’s, is/is not elimination, interviews, brainstorming alternate possibilities, and so forth.

• Preventive Actions: Charting a Course

Preventive action is taken to prevent a future cause or potential cause of a nonconformance. It entails efforts that go beyond the current crisis to identify potential for errors in other times and places that may or may not directly relate to the current event. These actions may be initiated as a result of internal audits, complaint investigations, training assessments, or monitoring and measuring products and processes.

Good Data Leads to Good CAPAs

There are various methods that abound in quality circles and online to help quality professionals investigate and determine root causes as part of their quality event management efforts. However, without accurate and up-to-date data it can be more difficult to complete investigations. Further, more time and resources must be invested to monitor their accuracy and effectiveness over time. If the data you have doesn’t support your findings, you have to start the investigation over.

In the era of Quality 4.0, quality managers have greater capacity to link root causes to data using electronic quality management systems (eQMS). Access to more data within an eQMS makes CAPA management more efficient as long as there is a good connection between data and the processes that generate it or are impacted by it. There is a corollary that follows when you can connect your people directly with your data. Not only can you determine root causes more effectively, but you can also get buy-in without blame from responsible personnel as you strive to contain and correct problems.

Access to Quality Event Management Data Enables a Culture of Quality

Enhancing visibility into your data is key to building a culture of quality. According to Harvard Business Review, one of the essential characteristics of an organization seeking to establish a culture of quality is “employee ownership of quality issues.”¹ “Message credibility” appears in the same short list of the top four factors that drive quality as a cultural value. Having access to good data about your quality management system (including documents, training, and quality events) and being able to share it freely and securely across your organization suggests you will be more successful in achieving quality objectives. The numbers show it is well worth it as “a company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.”²

Adopting the Preventive Paradigm

The preventive aspect of managing CAPAs and the quality events that trigger them can prove to be the most difficult. How do you solve a problem that hasn’t happened yet? Trying to identify problems before they occur is hard work even for seasoned professionals. This is why adopting digital quality event management tools becomes imperative. You don’t want to waste resources looking in a haystack for a needle that doesn’t exist or one that doesn’t add business value.

An eQMS can provide the following CAPA support:

• Generate a CAPA report to help you assess both your current and past activities.
• Launch and link related quality event management processes to expand your visibility and control over multiple processes at once.
• Automate all CAPA-related documents and tasks, including routing, follow-up, escalation, and approval.
• Provide mechanisms for closed-loop QEM and continuous improvement.

There are new software solutions being developed that are enabled with predictive capabilities that can further support preventive actions. Intelligent systems that can establish rules and utilize logic and machine learning are emerging as viable solutions for dynamic quality event management with conditional routing. This makes it possible to manage multiple scenarios using a single form without having to start from scratch as new information emerges.

Advancing Quality Event Management

Due to the unexpected nature of most quality events, managing them can place considerable strain on a quality system. The strain is compounded when low-level events are unnecessarily escalated to a CAPA, which should be reserved for systemic, frequent, and high-impact events. The goal is to adequately redirect resources to identify, analyze, and resolve a CAPA without compromising the system or letting anything fall through the cracks. This requires a degree of precision that derives from personalization.

Even with eQMS solutions available, the ability to customize processes is the crucial component that quality managers need, yet currently lack, to master CAPAs. eQMS solutions equipped with advanced process capabilities fulfill this need and help quality professionals streamline quality event management and CAPAs in the following ways:

• The ability to customize, expand, and modify processes in real time helps them resource and resolve events more quickly.
• The flexibility to add/remove data captures to/from quality event management forms and workflows makes it possible to link actions to verifiable data as it becomes available.
• Quality leaders are free to develop their own innovative processes rather than remain fettered by rigid workflows, inadequate forms, and other limitations dictated by inflexible systems.
• The quality system is tempered over time with the intelligence of the quality professionals themselves.
• Connected processes allow them to seamlessly update documents and manage training requirements and support continuous improvement efforts.

An effective quality event management solution needs to reflect the level of expertise and experience of the quality professionals who administer it. Over time, as the quality professionals’ skill sets expand, the tools they use must also evolve to match. With the right tool, quality event management processes can be adjusted and calibrated to perfection without requiring expensive coding from a software vendor.

Considering Digital Solutions for Your Quality Event Management Processes

When considering digital solutions for managing CAPAs and their correlated quality events, it’s helpful to return to the three main functions of a CAPA and identify how a viable solution will support all three.

• Corrections: Correcting Course

A natively connected eQMS makes it possible to collect and share quality event management data across your organization. It also makes remediation processes move along more efficiently with automated routing and approval workflows and timely email notifications. Multiple users can work from the latest versions of secured documents and collaborate with real-time data as soon as it is entered. Electronic records make it possible to launch one quality event process from another when necessary and search for related processes to keep moving without delays.

• Corrective Actions: Changing Course

It is difficult to effectively eliminate root causes if rigid quality processes, workflows, and forms prevent the changes that are needed. It is difficult to identify root causes in the first place without access to good data. An eQMS with robust reporting and analytical functions can record and store all the pertinent data and documentation in a centralized repository. Any authorized users can access documents and data, even remotely via cloud solutions, to understand necessary changes and be responsible for complying with them.

• Preventive Actions: Charting a Course

Insights available from a large data lake make it possible to track and trend quality events. These insights can help quality professionals catch potential problems before they happen. A software solution that is enabled with artificial intelligence (AI) can equip professionals with truly predictive capabilities, as well as be trained to reflect the hard-earned intelligence of the human talent that uses it.

Conclusion

Whereas regulated companies are mandated to establish and maintain CAPA protocols, most are woefully inadequate due to the unplanned and complex nature of quality event management. The latest software solutions take this into account and allow you to reconfigure your processes and make iterative improvements over time. This is the way of the future for quality event management. Putting power into the hands of quality professionals with advanced process capabilities is allowing them to take ownership, design successful outcomes, and innovate in ways they haven’t been able to previously.

References:

1. “Creating a Culture of Quality,” by Ashwin Srinivasan and Bryan Kurey, Harvard Business Review, April 2014.
2. Supra note 1.