Managing Deviations and Non-Conformances in Cell Manufacturing
Managing Deviations and Non-Conformances in Cell Manufacturing

In cell manufacturing, deviations and non-conformances can pose significant challenges to the process, often leading to delays, reduced efficiency, and ultimately, loss of time and money. Deviations refer to any variations from standard operating procedures, while non-conformances are errors or defects found in the quality of the end product. Managing these deviations and non-conformances is critical to ensuring that cell manufacturing processes remain reliable, consistent, and effective. In this article, we explore the best practices for managing deviations and non-conformances in cell manufacturing.

Identification of Deviations and Non-Conformances

The first step in managing deviations and non-conformances is identifying their sources and potential causes. This process entails conducting comprehensive quality assessments and data analyses to determine the frequency and severity of deviations and non-conformances. The data collected should also provide insights into the root causes of these issues. Once deviations and non-conformances have been identified, the next step is to classify them according to their severity.

Classification of Deviations and Non-Conformances

Classifying deviations and non-conformances enables manufacturers to prioritize corrective actions based on the level of risk posed by the issue. There are typically three classes of deviations and non-conformances, i.e., Class I, Class II, and Class III.

Class I deviations and non-conformances pose the most significant threats to process functionality, product quality, and consumer safety. It is critical to resolve them immediately with urgent corrective actions.

Class II deviations and non-conformances are less severe than Class I issues but can still have a significant impact on manufacturing processes and product quality. They should be prioritized and dealt with as soon as possible.

Class III deviations and non-conformances have the least impact on manufacturing processes and product quality, and corrective actions can be scheduled in line with regular maintenance and improvement activities.

Implementation of Corrective and Preventive Actions

After classifying deviations and non-conformances, implementing corrective and preventive actions is critical. Corrective actions aim to eliminate the root cause of an issue, while preventive actions aim to prevent similar problems from occurring in the future. Corrective and preventive measures may include process redesign, system upgrades, employee training, or changes in standard operating procedures. They should be designed to address the identified deviations or non-conformances and be implemented as quickly as possible.

Management of Corrective and Preventive Action Plans cell manufacturing quality system
Managing corrective and preventive action plans entails monitoring and tracking the progress of changes made to the manufacturing process and verifying that they achieve the desired outcomes. This process requires establishing procedures for assessing the effectiveness of corrective and preventive actions, as well as documentation of the corrective and preventive measures taken.

The documentation of corrective and preventive measures should include clear audit trails to ensure traceability of actions taken and evidence that the process has been improved.

Continuous Improvement

Continuous improvement is critical to ensuring that cell manufacturing processes remain efficient, reliable and of high quality. Regular reviews should be conducted to identify areas for improvement, and the effectiveness of corrective and preventive measures should be monitored and reviewed to ensure they continue to meet the desired outcomes. By prioritizing continuous improvement, manufacturers can ensure that deviations and non-conformances do not occur in the first place, and when they do, they are swiftly and effectively resolved.


Managing deviations and non-conformances in cell manufacturing requires identifying potential issues through quality assessments and data analysis, classifying those issues by severity, implementing corrective and preventive measures, managing action plans, and committing to continuous improvement. By following these steps, manufacturers can reduce the risk of deviations and non-conformances occurring, improve product quality, and ensure continuous process improvement and a successful production process.