CAPA: Effective implementation with smart digitization

CAPA and continuous improvement

In the day-to-day hustle and bustle, all organizations occasionally make mistakes or get unexpected process results. Within quality management, we then talk about deviations. In the industrial era, the CAPA methodology was then developed to correct and, if possible, prevent these deviations. With the continued development of quality management over the years, other views have since been developed. Does the traditional CAPA still fit in today’s industry and other sectors?

CAPA, the distinction between actions

CAPA terminology is often used when one wants to eliminate process deviations. With CAPA, one distinguishes between corrective and preventive actions. The purpose of the corrective action is to prevent further damage in the short term. The preventive actions seek to prevent recurrence of the deviation in the future. So actually the preventive action is also a corrective action, only in the longer term. The interpretations of both definitions has also led to much theoretical discussion. And that adds little in practice!

CAPA, the preventive measure banned from SO9001:2015

The preventive measure is therefore no longer explicitly named within ISO9001:2015. The idea behind this is that one will always take quick corrective action to limit the damage. And that the PDCA improvement cycle ensures proper assurance in the future. Indeed, the mechanism of continuous improvement within the PDCA automatically ensures that one also determines the effectiveness of the corrective action. The focus thus becomes more on the corrective actions.

Smartly organize and analyze corrective actions

Because deviations and errors can be prevented in many places in organizations, it is smart to take a generic approach. A security incident, product or process deviation and a supplier complaint are essentially all unexpected and unplanned events that you can therefore investigate with a set protocol and eliminate in the future with a good effective measure. The advantage of a standardized approach is that it is much easier to implement in an organization. Moreover, a common approach also allows you to get much better insight into trends of the actual source cause in the organization. After all, you are analyzing company-wide with the same tool.

Practical tips CAPA management

CAPA management only really works when it fits the way the business operates. Many organizations use the ability to classify deviations into major and minor based on self-appointed criteria. The large deviations are settled through a comprehensive investigation involving multiple functions. The smaller deviations are recorded and are analyzed as trends and picked up as needed. In this way, the largest disturbances are treated with priority but also repetitive small deviations are eliminated as yet.

Thus, the continuous improvement process is almost naturally fed. For proof and determining effectiveness of the measure, evidence can of course be attached to the original report. A nice side benefit is that by digitizing the deviation forms, a knowledge base is also built up. So with a smart CAPA approach, you can really contribute to the continuous improvement process in your organization!

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