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Tim Lozier


Eight Traits of an Effective Corrective Action System

Organizations must streamline their corrective action process to react quickly to systemic issues

Published: Tuesday, May 22, 2018 - 12:03

Corrective action is often an effective means of identifying and correcting quality and compliance events within the organization that can arise through the result of complaints, audits, incidents, nonconformances, or any adverse events. Traditionally, the corrective action process is designed to handle systemic events—things that pose a major threat to the overall health of the quality management system (QMS) or environmental health and safety (EHS) system. The challenge becomes how to discern what constitutes a corrective action, and how to properly and efficiently handle it.

Although an important part of compliance, corrective action is often implemented and used inefficiently. Too many corrective actions, not enough data, or disjointed workflow can hinder a corrective action. The most important element to corrective action is ensuring that actions are taken quickly and effectively.

This article will discuss eight traits of successful corrective action. These capabilities will ensure that its effectiveness is not hampered, and that critical events are not lost in the midst of less significant events.

1. Workflow types for multiple types of corrective actions

There are many different ways people issue corrective actions, typically from different causes. For example, there could be a corrective action resulting from an internal audit, customer concern, or external source. These different types of corrective actions may have different workflows, and different people may need to be involved. A good corrective action process has multiple workflows used by different people. This is beneficial because a safety corrective action may not be the same as quality corrective action. Having a workflow system allows an organization to create multiple types of corrective actions based on the type of event. This helps an organization ensure the appropriate people are handling corrective actions.

2. Integrating adverse events into corrective action process

Having a corrective action system that is automatically integrated into an adverse-event tracking system (e.g., complaints, incidents, audits, nonconformances) eliminates double entry of data and automatically pulls data into the corrective action record. The organization should make sure there is a seamless transition from event detection to event correction. A corrective action can be tied directly to the source of the adverse event through automatic field updates and reciprocal links.

3. Not everything needs to be a corrective action

A lot of times, people open a corrective action for every adverse event, which leads to every event becoming a corrective action. However, best practices dictate that if a minor event can be immediately corrected, the organization should correct it right there. By nature, the corrective action system is designed to address systemic issues. These issues are not just limited to minor events, but larger problems within the organization. Having a corrective action system that allows immediate corrections is an effective capability to have within the system. This can be done through its own “pre-corrective action” or investigation that will allow the organization to record the results of adverse events and go through investigations without going through the full corrective action process. This speeds the process and minimizes number of corrective actions.

4. Filtering

Many organizations will use time as a metric for prioritizing corrective actions. They will address those closest to their due date or most overdue. In this case, the organization could be unaware of a critical situation if it has not yet neared its due date. How can an organization effectively filter corrective actions? It needs to have a function that allows it to filter corrective actions by their critical nature. Most companies today use risk as a benchmark for filtering corrective actions; some use decision trees. By using risk management tools, an organization can prioritize an adverse event or investigation by its risk level. This is an objective means of determining what events have the most impact on the organization. By using risk-based filtering, organizations can filter corrective actions by what’s most critical, not what’s most overdue.

5. Action plans

Action plans drive effective corrective action management. In many cases, steps taken to correct anything in a corrective action are multifaceted. They may involve multiple people, actions, or could even be a full-blown project. The organization needs to look for a system that can create an action plan—assign roles, deliverables, and action items that need to happen to get to corrective action. A system that can outline a defined action plan with workflow and intelligent business rules, which in turn allows an organization to accomplish the goal of that plan within a set time period, is critical. Action plans lay out the steps and deliverables needed to accomplish set tasks during root cause and corrective action phases to make sure work is kept on track, and that due diligence is being met when conducting the corrective action. Automation helps speed up the process and makes it more efficient, ensuring it is kept on track and in scope.

6. Measuring effectiveness

The ability to review a corrective action’s effectiveness is critical. It must be a part of the workflow in the system, but there also needs to be a defined way to measure effectiveness. There are many ways to accomplish this. The big one is using concepts like risk—even decision trees. Using these methods, the organization can determine the risk level and whether it has been reduced. For example, verification of a corrective action ensures that the actions taken are effective. By conducting a risk assessment during verification, organizations are determining that the actions taken are not only effective, but also within acceptable risk parameters. If the risk is still too high, then perhaps the corrective action taken was not truly effective. Risk helps to further mitigate recurrence of a systemic issue.

7. Linking corrective action to change management

At the end of a corrective action, the organization may have something that has to change—processes, production, design, for example—in order to foster continuous improvement in the QMS or EHS system. Integrating corrective action with change management helps to streamline the results of a corrective action directly to change management and continuous improvement initiatives. Similar to linking adverse events to corrective action, an organization must link corrective action to change management, in order to properly transfer the data and results from one process to the next. A corrective action may lead to a full-blown change management initiative. It’s important to link data from corrective action to change management to eliminate double entry of data, and to create traceability from the source of the adverse event to the corrective action to the changes that arise out of that corrective action.

8. Traceability and reporting

Corrective actions are an important part of any compliance system. Because they are critical, they need as much traceability and history as possible. So if an organization was to get audited (or were simply doing its due diligence), it must understand how the corrective action came to be. It needs visibility from the source event to the corrective actions to take, to any change management. Having an integrated system, where there is an unbroken line from identification to correction to change, is critical. Look for a system that allows this level of traceability. Some systems can generate a corrective action history report that will take the entire “story” of that corrective action event into a single comprehensive report—a digital paper trail of corrective action. It is beneficial for audits, reporting metrics, and more to have this level of traceability.

Did you know?

QMS and EHS solutions have added benefits, including:

• Flexibility: A configurable system that can match the look and feel of an organization’s familiar systems in your organization with something as simple as colors and styles can make all the difference. A QMS that matches a company’s branded image, without programming, will contribute to overall adaptability and comfort with the system.
• Integration: The QMS’s tools are able to essentially “talk” to each other and are linked to other tools across the enterprise. This ability to interact with outside systems and collaborate and coordinate across the business is key to uncovering any gaps in processes, and creates visibility from one operational area to the next.
• Intuitiveness: Continually improved functionality and a user-friendly experience are an important aspect of business today. A web-based environment enhances the user experience, improves productivity, and simplifies quality operations.
• Automation: Automated document control helps mitigate the chance of human error while ensuring efficient completion of tasks. The QMS also enables automation of other business processes and workflows, such as employee training and audits. This is necessary because in a complex system, there are often many employees and many training materials. Ensuring timely completion of training cannot be achieved without the use of automated tools.

With so much information coming into the corrective action, it’s crucial to report on it. Reporting enables the organization to know the status of corrective actions and where it is in different corrective action phases, as well as what the risks are. The report will ultimately show whether an organization is effectively managing corrective actions. Visibility is key to determining this.

Closing thoughts

The corrective action system is an essential tool—but it needs to be efficient to be truly effective. It is the best method of tracking the source and cost of all adverse events; however, lack of visibility, too many open corrective actions, and ineffective filtering to prioritize by level of urgency can hinder the process. It is important for organizations to streamline and organize their corrective action process in order to react quickly to systemic issues and correct them quickly and effectively. Adapting these eight traits of effective corrective action will ensure a process that is efficient and works for an organization, not against it.


About The Author

Tim Lozier’s picture

Tim Lozier

Tim Lozier is the director of product strategy for EtQ, in Farmingdale, New York. He has extensive experience in the software industry, and has been involved in the creation of leading-edge technologies in user-interface design and development. He began his career in digital marketing before taking a turn into software design and marketing at Quark Inc. Since then, he’s never looked back—helping to foster the development (and blog about) leading quality management software solutions.