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Designed to identify, eliminate, and reduce the occurrence of adverse events, corrective action processes exist at the core of every Quality Management System (QMS). When managed effectively, organizations can expect to reap a multitude of benefits, including limited financial loss and improved quality and safety. If, however, an organization is unable to effectively manage and execute the CAPA process, they are likely to experience a number of issues including wasted manpower, clogged processes, and more.

So how do you effectively manage a CAPA system? Where do you start making improvements when employees are already behind and overworked? Let’s first take a look at what the CAPA process is, and what it isn’t.

Defining the Corrective and Preventative Action Process (CAPA)

The CAPA process contains two main components: the corrective action and the preventative action. The corrective action is designed to eliminate the recurrence of root causes of non-conformities to prevent recurrence, while preventative actions are designed to determine and eliminate non-conformities that haven’t happened yet to prevent occurrence.

Both may sound very similar,but each component has a unique purpose in the CAPA process. Unfortunately, there is still some confusion about the purpose of each, including the belief that both components are (and do) essentially the same thing. Other misconceptions include the belief that every occurrence and nonconformity must be documented or assigned a corrective action, and that preventative actions are not necessary or effective for new processes, products, services, or equipment.

To combat these misconceptions, let’s take a closer look at the CAPA process and how it works.

Four Actions that Simplify the CAPA Process

While the process is complex, it can be simplified down to four main actions to improve understanding of when action should be taken. These four actions include:

  1. A patch, or single occurrence of nonconformity. This does not have to be recorded because it carries little risk or is unlikely to recur.
  2. A corrective action is a more serious nonconformity that carries risk. This can be due to a recurring adverse event, or it may be due to the number of departments it affects. This must be recorded, along with the steps that are taken to prevent future occurrences.
  3. A preventative action is one in which no problem currently exists, but there is a potential risk for an adverse event. The idea is to consider “what-if” possibilities and prevent them from happening.
  4. A developmental action process is one in which preventative action is taken to avoid adverse events in new products, processes, or procedures.

CAPA Advantages and Disadvantages:

Corrective and Preventative Action processes may be necessary for quality management compliance, but one of the keys to success in implementing the process is a clear understanding of the benefits and the disadvantages of CAPA systems. Let’s take a closer look at both.

Advantages:

  • Provides a structured platform which will allow systemic investigation of adverse events
  • Offers a means by which to develop a permanent corrective action, thereby reducing the propensity for adverse event recurrence
  • Provides documentation that corrective actions are effective

Disadvantages:

  • Can be tedious and exhausting to manage
  • Cost of quality may be difficult to track or monitor when disorganization is present
  • Poor management can lead to inconsistent data, confusion, non-compliance, and hesitancy in taking action when needed
  • Misunderstandings about the CAPA process can lead to clogged processes that make it difficult to report across some or all departments

Is your organization searching for a better way to manage your CAPA process in order to prevent some of these disadvantages? Are you tired of wasted manpower, resources, and erroneous data?

Do you want to learn more about managing your CAPA system? Check out this blog where we discuss getting more bang for your buck with your CAPA software. For other questions or assistance, click here to contact us.