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 supplier audits.

6. Customer Service Deviation was raised to track steps to implement measures related to complaints from customers.

7. Technical Deviation - may be raised in the event of the reason of 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 Material Complaint - raised to document any issues with regards to non-conforming, superseded or obsolete raw materials/components, packaging, or imported finished goods.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 in order to track the changes to the Bill of Materials in response to changes to the artwork.

When to Report Deviation:

A Deviation must be declared whenever there is a deviation from the procedures or procedures that are specified in documents for manufacturing or material control documents. Standard Operating Procedure for Products and confirmed out of specifications results, and also from the occurrence of an incident and/or observation suggesting the existence of the genuine or potential quality related problem.

Any deviation management must be reported If a pattern is observed that needs more analysis.

Any deviations in batch production (planned or unintentional) including every manufacturing facility, equipment operations, distribution processes, systems, and record-keeping should be documented and investigated to determine remedial and preventative measures.

The reporting of deviations is mandatory regardless of the final batch's disposition. If the batch is not accepted, a deviation report is still necessary.

Different Levels of Deviation Risks:

To make it easier to assess the risk of any deviation, it is possible to be classified into one of 3 levels 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

Deviation 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

Less serious observations or isolated nature, are not considered to be significant or critical, however, they require correction or suggestions on ways to improve the system or processes that are conforming, but could use enhancement (e.g. incorrect data entry).

How to Manage Reported Deviation:

The manager of the department or delegate must initiate the deviation report making use of a typical deviation report form when the deviation is discovered. Then, write a brief description of the situation and include a name in the column on the form. Then inform that department's Quality Assurance department within one business day to determine the source of the problem.

QA must evaluate the CAPA Management and determine the impact on the quality of the product, validation, and the regulatory requirement. The deviation investigation that is completed has to be reviewed by QA Director or delegate. The QA Manager must justify whether the deviation is Critical Serious, Standard, or way. In the event of a deviation that is either serious or critical in nature, QA Delegates must organize a Cross-Functional Investigation.

In the case of a normal type deviation, a Cross-functional Investigation (CFI) is not required. The immediate corrective action must be carried out prior to the final disposal of the batch. Final batch disposal is the sole responsibility of the Quality Assurance Department.

If a serious or critical deviation causes the formation of a CFI Corrective and preventive measures should be identified, and follow-up tasks must be assigned to the representatives of the area. Follow-up work should complete within thirty days from the time of observing the deviation. If a deviation that is detected by CFI cannot be addressed within 30 days of the date the interim report must be prepared to describe the reasons for the delay and the progress made so far.

After the successful completion of Follow-up tasks, Deviation must be completed and uploaded along with the Audit report/Batch Reporter Product complaint report/Safety investigation report, if necessary.