Quality is Everyone’s business - The CAPA Confrontation

CAPA is an activity which impacts not only the quality of the products manufactured, but also the way in which a plant achieves and remains compliant
(PresseBox) (Dresden, ) One of the most important aspects of quality in manufacturing is being able to detect, correct and prevent incidents which cause a product or batch to go OOS (out of specification) or affect the conformity of the end product with the required specs. CAPA (corrective and preventive action) is the process responsible for detecting and correcting non conformances, it is also the activity which prevents and limits the impact of the non-conformance creating incident.

In the recent articles we have seen how an MES with an integrated QMS would be ideal to manage and control quality at an organizational level. CAPA management is a crucial part of complete quality management. Today we will explore the desired functionality of CAPA management module which is embedded in the MES and what are the benefits most manufacturers stand to gain if they have CAPA residing in their MES.

As the name suggests corrective and preventive actions are required to be taken when incidents occur which are not supposed to happen. Such incidents could be triggered due to a number of reasons, right from faulty material entering the shop floor, to breaking of an oil seal during operation, from wrong data/parameter entry, to incorrect routing of material.

The primary goal of CAPA activity is to first correct the fault occurred, i.e. as soon as an issue is detected, the CAPA kicks in and provides instructions to the personnel as to what is the next course of action, in order to prevent the incident from impacting further. Next the CAPA works on containment, i.e. detecting the total batches/products affected, holding production, raising alarms and recording the probable reasons which caused the event. Finally based on the data recorded in real time, the CAPA compares the event with other similar events in historical data and tries to detect and highlight the root cause of the event. Once the root cause of the event is detected, depending on its nature, whether it’s a recurring or unique reason, future improvements can be made, which constitute the preventive action part of the CAPA module.

For manufacturers with complex production processes and globally spread supply chains, the role of software applications (like the MES) in process management is vital. CAPA on the other hand is an activity which impacts not only the quality of the products manufactured, but also the way in which a plant achieves and remains compliant, bearing minimum possible loss from non-conformity events.

For more information about CAPA Confrontation click here to read the complete blog post http://goo.gl/N9GAVP.

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Critical Manufacturing Deutschland GmbH
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Franziska Seidler
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