Frequently Asked Questions: Deviation Management
What is a deviation?
The definition of a deviation varies slightly depending on the industry, but in general, a deviation is any departure from an approved process, procedure, specification or established standard. FDA current good manufacturing practice (cGMP) defines a deviation as any result that falls outside the expected range or fails to fulfill a specific requirement.
What is deviation management?
Deviation management is the systematic process undertaken to identify, document, investigate and address any unplanned events that deviate from approved processes during manufacturing, distribution, storage or testing. The goal of having a method for managing deviations is to avoid larger problems by promptly identifying, investigating and resolving any deviations.
What are deviation management guidelines?
Deviation management guidelines will vary depending on the guiding authority. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require companies to maintain documented and approved procedures for controlling deviations. These procedures should use a systematic approach to recording, investigating and correcting deviations to prevent recurrence.
What are planned and unplanned deviations?
A planned deviation is one that is pre-approved and intentional. For example, a planned deviation would occur if a manufacturer were testing process improvements or the use of an alternative material.
An unplanned deviation is an unexpected departure from approved procedures, such as an equipment failure, material contamination or unforeseen manufacturing disruption.
What is the relationship between deviation and CAPA management?
When an unplanned deviation occurs, the corrective and preventive action (CAPA) process is used to evaluate, investigate and resolve the cause of the deviation. Preventive actions are put in place to ensure the deviation does not reoccur.
Why should I use QT9 QMS to help with deviation management?
QT9 QMS has 25-plus interconnected modules that come standard, including Deviation Management, which seamlessly integrates with other key applications, such as CAPA management, risk management, customer feedback, and supplier management. Its cloud-based platform allows you to keep track of deviations and synchronize records with anyone, anywhere.
QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.
With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.
