A Standard Procedure For Quality Assurance Deviation Management
A deviation refers to a departure from the standard procedure or specification that results in non-conforming materials and/or procedures or when there has been unpredictably or unexpected events that could have a negative have an impact on the quality of the product and integrity of the system or your safety. To ensure compliance with GMP and for continuous improvement, deviations are documented by way of the Deviation Report (DR). Types of Deviations: 1. Here are a few examples of deviations that have been raised from various functional areas of business. Production Deviation - typically caused by the manufacturing of batches of. 3. EHS Deviation - raised due to environmental, health, and safety hazard. 4. Qualitative Improvement Deviation - may be signaled if weakness has been discovered and the implementation of the plan will require approval from the project. 5. Audit Deviation - flagged to highlight any non-conformity that was discovered in external, internal, corporate, or sup