Is your company managing its Corrective and Preventative Action (CAPA), or is the CAPA process managing your business? It’s an important question because the truth is CAPA systems can be difficult to manage, especially if your organization is trying to go it alone. There is a better way to do things, though, and it doesn’t have to be complicated.

Breaking Down CAPA

Doing things better should start with a clearer understanding of the CAPA system itself. After all, it’s difficult to fix something if you’re not even sure where you’re failing. So, to start, let’s look at the two main components of the CAPA system:

Corrective Actions – designed to eliminate root causes of adverse events to prevent recurrence

Preventative Actions – designed to address potential non-conformities that haven’t happened yet to prevent the occurrence of adverse events

These two main components can then be broken down into four types of corrective actions—patches (single occurrences), corrective actions (repeated occurrences), preventative action (prevents adverse events), and developmental actions (applied to new products/processes/procedures to prevent adverse events).

These four actions better define the CAPA, and they help to combat some of the most common misconceptions about corrective actions versus preventative actions, including the belief that both components are essentially the same thing.

Understanding Where CAPA Goes Wrong

While CAPA systems can help improve production and profits in all departments, there are some definite drawbacks to using them. Most of these drawbacks relate to either misconceptions about the CAPA system, or a lack of organization while using it.

Some of the most common issues include:

  • Wasted time and manpower spent on routing and management of manual-based programs
  • Clogged processes that can make for inaccurate reports across some or all departments
  • Slowed auditing processes
  • Difficulty retrieving documents needed for audits
  • Difficulty tracking and monitoring the cost of quality
  • Inconsistent data lists that lead to non-compliance, confusion, and hesitancy in taking action when necessary
  • Incorrect, duplicated, or erroneous data
  • Difficulty taking preventative action, due to root causes being difficult to determine

Getting CAPA Under Control

With the right tools, businesses can get their CAPA systems back under control, and working for them, rather than it being the other way around. Namely, those tools should include a CAPA software program that can help keep information and data organized while prioritizing corrective actions to ensure that the most crucial are addressed first.

Benefits of the right CAPA software include:

  • Improved workflows that ensure processes stay on track
  • Automated notification processes that ensure everyone receives their assigned responsibilities on time
  • Built in tracking and visibility that save time and prevent loss
  • Clearly outlined action plans that fix adverse events for good
  • Reduced risk of human error, lowering the need for further corrective action
  • Analytics, reporting, and online charting that make it easier to take a proactive approach to managing the QMS
  • Securely and centrally stored documents that make the auditing process easier and faster
  • Trend reports that help Top Management make confident quality management decisions
  • Less manpower and resources needed for the corrective action process

Want a more in-depth look at the CAPA system and where it can go wrong? Looking for more information on how the right software can help your organization get the CAPA system back on track? Check out this blog about understanding the CAPA process. For other questions or assistance, click here to contact us.