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Brenda Percy

Quality Insider

Five Ways Corrective Action Benefits Your Organization

Taking the subjectivity out of CAPA

Published: Monday, March 24, 2014 - 14:19

In the first installment of this series, we considered four traits to look for in an automated quality management system (QMS) that will provide the most long-term value for your money. Now we’ll take a more in-depth look at the automated QMS by breaking it down into its core functionalities and discussing the benefits of each. Let’s begin with the corrective and preventive action (CAPA) system.

The CAPA system aims to identify, eradicate, and reduce the chance of adverse events recurring. Adverse events can result through any number of ways—whether through a complaint, an audit, or shop-floor event—and the corrective action process is often initiated at this point. But do all adverse events require a corrective action? Should all adverse events be managed equally? Does your business have the resources to manage a CAPA system? These are questions that cash-strapped small to medium-sized enterprises (SMEs) ask themselves when assessing their QMS.

Here are five ways in which an automated CAPA can make the process of managing adverse events easier and cost-effective for SMEs.

1. Streamline CAPA workflow. When complaints start coming in, many companies will automatically assign each complaint a corrective action, regardless of the level of criticality. Over time, these will add up to an immense quantity of corrective actions with varying levels of criticality that you will need to address individually. This is a massive workload. Translated—lots of man-hours equaling lots of dollars. Automation ensures that the process is kept on track and on schedule by pushing all tasks involved through a workflow process that takes over the duty of filtering through adverse events to find those most critical to your business. You will also be able to highlight critical events and more easily manage them, allowing you to stay on top of the process without spending unnecessary resources.

2. Easier notification. When managing the process of corrective action, there may be people involved from all over the organization. By automating your notification process, you can assign tasks to these employees and ensure that everyone has been tasked with the appropriate responsibility. On top of this, you will have visibility into what each employee is doing, how far he has gotten in the process, and whether any tasks are overdue. Without an automated system, this process would be tracked using an Excel spreadsheet, for example. Meaning you will have to track down each person who is tasked with a role and get updates to enter into the spreadsheet; all of this would be done manually.

3. Provides an action plan. When going through a corrective action, the main goal is to figure out what caused the problem and what you can do to fix it—for good. This is done through the use of action plans. An action plan involves determining the correct people needed for each role and assigning them deliverables and action items that must be accomplished in order for the corrective action to be successful. The action plan outlines the process needed to finish tasks correctly. The QMS’s automated workflow capability and intelligent business rules help to move the process along without missing a step and ensuring that tasks are completed on time. The “preventive” part of CAPA may be the most important part of the process for SMEs that simply cannot afford to bleed resources due to recurring problems.

4. Easily verify action effectiveness. After you’ve gone through the corrective action process, and before you celebrate its completion, you need to make sure that it was effective. This is where your action plan comes into play again. Having a plan laid out will serve as your roadmap later to look back on, see the corrective actions taken, and easily see whether they were effective. If not, you will have a road map to look back on and see what needs to be done differently.

5. Integrated reporting. With so much data flowing through the corrective action process, the ability to report on these data are critical. The QMS can integrate corrective action with the reporting function to give you visibility into all corrective actions in real-time, show which phase the corrective action is in, and any hazards associated with the corrective action.

The reporting feature allows you to see exactly what you’ve done throughout the process, complete with drill-down charts so you can dig even deeper into the information. You can then use this information to find trends in adverse events across your enterprise, allowing you to easily see whether your approach to corrective actions has been a success.

Conclusion

Corrective action is a critical aspect of resolving adverse events within your organization. The automated QMS makes the steps of corrective action more intuitive by taking it out of your hands and putting it through a workflow to guide the process and keep the right people in the loop.

Automating this process takes any subjectivity out of the process—i.e., the human aspect—leaving you with an objective and repeatable method for future corrections.

Corrective action is just one aspect of a QMS that will provide long-term value for your organization. In the next installment of our series, we will focus on document control, and discuss the need for automating this process as well as the benefits you can expect to achieve by doing so.

Brenda Percy is the product marketing analyst at Verse Solutions, a Quality Digest content partner.

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About The Author

Brenda Percy’s picture

Brenda Percy

Brenda Percy is the product marketing analyst at VERSE Solutions, based in Farmingdale, New York. She is responsible for communicating overall technology trends and compliance initiatives to the market, and has an extensive background in quality and compliance technologies.

Comments

Title misleading

The title of this article is a little misleading. Instead of "Five Ways Corrective Action Benefits Your Organization", it should say Five Ways a Corrective Action SYSTEM benefits Your Organization.  This article isn't about the things that Corrective Action (CA) does, like reduce costs, improve process efficiency.  It talks about the advantages of having an integrated automated system for CAs.