How can you manage exceptions and deviations from SOPs in manufacturing?

1 Define exception and deviation

An exception is a temporary change from the SOP that is approved by a competent authority before it is implemented. It is usually caused by unforeseen circumstances that prevent the normal execution of the SOP, such as equipment failure, material shortage, or customer request. A deviation is a non-conformance or departure from the SOP that is detected after it has occurred. It is usually caused by human error, miscommunication, or process variation. Both exceptions and deviations need to be documented, justified, and resolved in a timely manner.

3 Communicate effectively

Communication is key to managing exceptions and deviations from SOPs. You need to communicate clearly and promptly with all the relevant stakeholders, such as supervisors, managers, quality assurance, customers, and suppliers. You need to inform them of the reason, impact, and resolution of the exceptions and deviations, as well as any changes or updates to the SOPs. You also need to listen to their feedback and suggestions, and address any concerns or issues they may have.

4 Document and track

Documentation and tracking are essential for managing exceptions and deviations from SOPs. You need to record the details, evidence, and outcomes of the exceptions and deviations, as well as the actions taken to resolve them. You need to use a standardized format and system for documenting and tracking them, such as forms, logs, databases, or software. You need to ensure that the documentation and tracking are accurate, complete, and accessible to the authorized personnel.

5 Analyze and improve

Analysis and improvement are important for managing exceptions and deviations from SOPs. You need to analyze the root causes, patterns, and trends of the exceptions and deviations, as well as the effectiveness and efficiency of the actions taken to resolve them. You need to use appropriate tools and methods for analysis, such as fishbone diagrams, Pareto charts, or statistical process control. You need to use the results of the analysis to identify and implement improvement opportunities for the SOPs, processes, and systems.

6 Train and educate

Training and education are vital for managing exceptions and deviations from SOPs. You need to train and educate your staff on the SOPs, the protocol for exceptions and deviations, and the quality and safety standards and expectations. You need to provide regular and refresher training and education, as well as on-the-job coaching and mentoring. You need to evaluate the effectiveness and impact of the training and education, and adjust them as needed.