A deviation is described as a departure from an approved procedure or specification. It represents a failure to meet requirements in the manufacture of product, in-process specifications or production requirements. There is a difference between a planned or unplanned deviation. Planned deviations have been approved before execution, whereas unplanned deviations (also called incidents) are technically a form of non-compliance from the designated procedure.
ISO 9000 discusses the concept of a deviation permit, which is defined as “permission to depart from the originally specified requirements of a product prior to realization.” A deviation permit is typically allowed for a specific quantity or period of time. These are typically short-term deviations and/or changes in workflows or processes that are intended to run once, in a controlled manner.
All deviations must be routed through Quality Assurance for approval. The impact of the deviation (planned or unplanned) is evaluated, and discussed with other members of the management team, as needed. A deviation may lead to a Corrective or Preventive Action, as well as utilization of any risk management tools to evaluate the overall implications of the deviation. All deviations need to be thoroughly and completely recorded and investigated. The risk arising from the deviation must be assessed, and an evaluation of the potential impact on other batches needs to take place. In addition, deviations are tracked, trended and discussed in the Management Review as an indicator of how stable the current processes and workflows are.
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