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The Training Paradox: Unraveling the Blame Game in Deviations and Nonconformances

Updated: Jan 20

For FDA-regulated industries, deviations and nonconformances are inevitable challenges. When these issues arise, it is common for the blame to be directed at the training program in place. The question that arises is:


Why is training often singled out as the culprit for deviations and nonconformances?


To begin with, many employees do not like their company’s training program. Training programs especially in pharmaceutical and medical device, can be burdensome with too many training requirements and inadequate training sessions (including the infamous Read Only’s). Having said that, it is essential to recognize that training plays a pivotal role in any organization's success. A well-structured and comprehensive training program ensures that employees are equipped with the necessary skills, knowledge, and competencies to perform their tasks effectively.


However, the very nature of training can become a double-edged sword when it comes to addressing deviations and nonconformances.


Four Reasons Why Training Is Chosen as The Culprit




Reason 1: Lack of Knowledge


One reason behind the tendency to blame training is the assumption that a lack of knowledge or understanding is the root cause of deviations and nonconformances. While it is true that inadequate training can contribute to errors, it is overly simplistic to lay the blame solely at the feet of training programs. Deviations and nonconformances are often multifaceted issues, influenced by a combination of factors such as process complexities, system failures, and external variables.


Reason 2: Rushed and Incomplete Training


The pressure to meet production targets or deadlines can lead to a rushed or incomplete training process. In such scenarios, employees may not receive the depth of training required to manage the intricacies of their roles. Consequently, when errors occur, the immediate reflex is to question the effectiveness of the training rather than examining the broader organizational context.


Reason 3: One and Done


Another aspect contributing to the training blame game is the misconception that training is a one-time event. Learning is an ongoing process, and organizations must invest in continuous training and development to keep pace with industry advancements and changing regulations. When errors occur, it is crucial to assess whether there is a gap in ongoing training and reinforcement rather than attributing the issue solely to initial training sessions.


Reason 4: Lack of Interdepartment Communication


In some cases, the blame assigned to training may stem from a lack of communication between different departments within an organization. Siloed operations can result in inconsistencies in understanding and implementation of procedures, leading to deviations and nonconformances. Bridging these communication gaps and promoting cross-functional collaboration is essential to ensure that training is effectively integrated into the entire workflow.





While training is a critical component of preventing deviations and nonconformances, it is not the solitary factor at play. Organizations must adopt an integrated approach, recognizing the connections of various elements such as organizational culture, ongoing training, and effective communication. Instead of hastily attributing blame to training, a more fruitful strategy involves conducting thorough root cause analyses that consider the broader context in which deviations and nonconformances occur. By addressing these underlying issues, organizations can create a more resilient and adaptable workforce, ultimately minimizing the occurrence of deviations and nonconformances.


If you would like to assess your overall training program, or to get help with designing your training program, please contact us at kwallbank@qualitysystemsservices.com or click the button below. We have helped many companies assess their processes for gaps and determine the right solutions.




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