Effectively Manage Your Corrective Action Process

Transcription

1 Effectively Manage Your Corrective Action Process

2 At the core of every quality management system (QMS), there is a corrective and preventative action process (CAPA). Essential for meeting internationally recognized standards for quality, safety, and environmental management systems, CAPA processes are designed to identify, eliminate, and reduce the occurrence of adverse events. Manage the CAPA process effectively and a business will reap a number of benefits, including limited financial loss and improved quality and/or safety. If managed ineffectively, however, the company is likely to experience wasted manpower, a delay in addressing critical events, clogged processes, and more. Before long, they re likely to wonder where things went wrong and may become so overwhelmed, finding their way back to the track to success can feel nearly impossible. This doesn t have to happen to your business! By understanding the CAPA process, how it works, and what can be done to ensure it runs smoothly and efficiently, your company can reduce the negative impact of adverse events, be it on the shop floor, with customers, or in meeting and complying with safety and quality management standards. As a result, higher profits and overall work environment can be realized. Understanding the CAPA Process There are two main components to the CAPA process: the corrective action and the preventative action. The corrective action is meant to eliminate the root cause of non-conformities to prevent recurrence of adverse events. The preventative action determines and eliminates the causes of non-conformities that haven t happened yet in order to prevent occurrence. 1 1 Preventative and Corrective Actions (CAPA) Guidelnes by R.M. Baldwin

3 It sounds rather straightforward and simple. Unfortunately, there are still some very common misconceptions about the differences between the two. This can lead to some serious problems for quality management personnel and, in turn, many other aspects of the business, including quality, safety, and compliance. Before being able to effectively manage a CAPA system, these misconceptions must be addressed. Common Misconceptions About Corrective and Preventative Actions: 2 1. Every occurrence of non-conformity must be documented or assigned to a corrective action. 2. Preventative and corrective actions are essentially the same. 3. Preventative action is not effective or necessary for new (or reengineered) products, processes, services, equipment. To combat these misconceptions and effectively understand the CAPA process and how it works, it s suggested that the process be separated into four types of action: A patch, or a single occurrence of non-conformity, may not need to be recorded because it carries very little risk or it is unlikely to reoccur. A corrective action, a more serious nonconformity that carries risk. Perhaps this risk is present because the nonconformity has occurred more than once, or perhaps it has the potential to affect many different departments. The non-conformity and the steps or actions taken to prevent future occurrences should be documented. A preventative action is taken when no problem currently exists. The goal is to address what if scenarios that could have severe or far-reaching consequences and develop a solution to prevent such occurrences. Long-term testing and documentation are often key components in carrying out successful preventative action processes. A developmental action process, which is treated the same as a preventative action, ensures that new products, processes, procedures, and equipment (or those being reengineered) have the best chance out the gate. The quality team should check to ensure that no nonconformance issues exist, and that no potential for one has been detected during the developmental action process. 2 Corrective vs. Preventative Action by Russ Westcott via The American Society for Quality

4 CAPA System Drawbacks Unfortunately, CAPA systems can be tedious and exhausting to manage. This is particularly true when misconceptions exist and a corrective action is taken for every non-conformance. However, even when there is full understanding of the CAPA process and its components, problems may exist, including: Extra time and manpower spent routing and management of manualbased programs like Word or Excel. Clogged CAPA processes that can make it difficult to run accurate reports across some or all departments. Slowed auditing processes and difficulty retrieving necessary documents Cost of quality may be difficult to track and/or monitor. Data lists may be inconsistent, leading to confusion, non-compliance, and hesitancy to take action when necessary. Crucial information or data may be duplicated or incorrect, leading to error, inconsistency, increased customer complaints, financial loss, and an overall need for future corrective actions Preventative action may be difficult to take because root causes are difficult to determine, making it nearly impossible for a company to be proactive or achieve continual improvements in quality and/or safety. But, with the right tools and resources, companies can finally get a handle on their CAPA process, thereby giving them the opportunity to improve, grow, build, and potentially reach a higher level of overall success, satisfaction, and profit. Benefits of CAPA Management Software CAPA management software isn t just about automating the corrective action process. It s about improving the entire QMS. The following are just a few benefits that businesses may reap when implementing corrective action management software: 3 Workflows ensure critical adverse events are handled first, ensuring the entire process stays on track. Notification processes are automated, eliminating the need for extra manpower to ensure that everyone receives their assigned responsibilities on time. 3 Five Ways Corrective Action Benefits Your Organization by Brenda Percy

5 Visibility and tracking are built in, saving time and preventing loss of critical documents. Action plans that are clearly outlined help to fix problems for good. Real-time reporting functions show you right where you and your employees are in the corrective action process, making it easier to measure for effectiveness and spot opportunities for improvement. Automation reduces the risk of human error, thereby reducing the need for further corrective actions. Tracking can help prevent incidents that would escalate into events through the use of analytics, reporting, and online charting, making it possible for companies to take a proactive approach to managing their QMS. Documents are securely and centrally stored, making the investigation and audit processes faster and easier to complete. Trend reports are supplied to senior managers, giving them the critical information they need to make confident quality management decisions. Addressing the Bottom Line - The Need to Do More with Less At the heart of all quality management software, particularly corrective action management software, is the need to do more with less. It s not just about profit and loss. It s about customer satisfaction and an improved work environment. It s trying to ensure that your company is the go-to for your product or service because no one can deliver it better. Want to find out more about how CEBOS can help make sure that happens? With our best-in-class, closed loop, automated, configurable Corrective Action Software - and thanks to our software s drag and drop capabilities - improved reporting for your company is just a touch away. Or maybe you re just interested in hearing how our Corrective Action software can help to ensure your company meets quality management standards while saving you time, increasing profit, and improving customer satisfaction? Whatever it is you re looking for, CEBOS can help and we d like to show you how. Call us at (810) or info@cebos.com for more information.