A Standard Procedure For Quality Assurance Deviation Management
A deviation is a deviation from the standard procedure or specification which results in non-conforming materials or processes, or in cases where there have been strange or unproven incidents that can have an impact on the quality of the product or system integrity, as well as your safety. In order to ensure that the product is in compliance with GMP and for the purpose of continual improvement, these deviations are reported by way of Deviation Report (DR).
Types of Deviations:
1. Here are a few examples of deviations that have been raised in different areas of business operation. Production Deviation is usually caused by the manufacturing of batches.
3. EHS Deviation — raised due to health, environmental, and safety risks.
4. Qualitative Improvement Deviation — may be signaled if weakness has been discovered and the implementation requires project approval.
5. Audit Deviation — highlighted to indicate any non-conformity that was discovered in external, internal, corporate, or supplier audits.
6. Customer Service Deviation was raised to track steps to implement measures related to complaints from customers.
7. Technical Deviation can be raised to address the reason for validation inconsistencies. Examples include changes to Manufacturing Instruction.
8. Material Complaint — raised to document any issues with regards to non-conforming, superseded, or obsolete raw materials/components, packaging, or imported finished goods.
9. The System Routing Deviation is raised to track modifications made to the Bill of Materials in response to an artwork modification.
When to Report Deviation:
A Deviation Management must be declared whenever there is an inconsistency with the methods or procedures that are specified in documents for manufacturing materials control documents, Standard Operating Procedure for Products and verified out of specification results, and also from the event or observation that suggests the existence of the genuine or potential quality related problem.
Any deviation must be reported when a pattern emerges that needs more analysis.
Any deviations in batch production (planned or unintentional) including every manufacturing facility, equipment operations, distribution processes, systems, and record-keeping must be investigated and reported to determine prevention and corrective action.
The reporting of deviations is mandatory regardless of the final batch’s disposition. If a batch is rejected, a deviation report is still necessary.
Different Levels of Deviation Risks:
To help assess the risk, any deviation could be classified in one of the three categories 1,2, and 3 based upon the amount and seriousness of the deviation.
Level 1: Critical Deviation
Deviation from Company Standards and/or current regulatory expectations that provide an immediate and significant risk to product quality, patient safety or data integrity or a combination/repetition of major deficiencies that indicate a critical failure of systems
Level 2: Serious Deviation
CAPA Management from Company Standards and/or current regulatory expectations that provide a potentially significant risk to product quality, patient safety, or data integrity or could potentially result in significant observations from a regulatory agency or a combination/repetition of “other” deficiencies that indicate a failure of the system(s).
Level 3: Standard Deviation
A few observations of a less significant or isolated nature, that aren’t considered critical or major, but that require correction or suggestions about how to improve the efficiency of systems or processes that are conforming but could use improvements (e.g. incorrect data entry).
How to Manage Reported Deviation:
The manager of the department or delegate is required to initiate the report making use of a typical deviation report form when the deviation is discovered. Make a brief explanation of the incident and include a name in the column on the form. Then inform your Quality Assurance department within one business day to determine the source of the problem.
QA is required to assess the deviation and determine the impact on the quality of the product, validation, and the regulatory requirement. All deviation investigations that are completed have to be reviewed by QA Director or delegate. The QA Manager must justify whether the deviation is Critical serious, Serious, or Standard nature. If the deviation is of a serious or critical nature QA delegate must arrange the Cross-Functional Investigation.
In the case of a normal type deviation, for a standard type deviation, a Cross-functional Investigation (CFI) is not required. Immediate corrective action must be taken before the final decision of the batch. Final batch disposal is the responsibility of the Quality Assurance Department.
If a serious or critical deviation causes the formation of a CFI Corrective and preventive steps should be identified, and follow-up duties should be assigned to the representatives of the area. Follow-up tasks must complete within thirty days after the detection of deviation. If a deviation that is detected by CFI is not completed within 30 days of the date the interim report must be prepared to describe the reasons for the delay as well as the progress to date.
Following the successful completion of the Follow-up tasks, Deviation must be completed and attached to the Batch Report/Audit report Product complaint report/Safety investigation report as required.
