How to handle deviation

Deviation is an unexpected departure from any approved procedure, system or established  standards. It is usually discovered after its occurrence. Deviation can also be defined as may arise due to (a) Breakdown or failure of an Equipment (b) Malfunctioning of equipment (c) Utility / Service (d) Human Error, or any other.

Written procedures are the approved and controlled documents, which are followed for the execution of various activities, performed in the organization viz., manufacturing, packaging, analysis, distribution procedures, Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), General Test Procedures (GTPs) and various protocols followed for the execution of validation studies, stability studies, etc.  

1. Deviation could be brought to notice by operator / supervisor to area in charge who shall immediately convey the same to the your senors to take appropriate action to rectify.
2. Head of department of the concerned department shall undertake the primary investigation with corrective and preventive action(s) as appropriate to the nature of deviation. This investigation shall be conducted in a manner the impact of occurred deviations should    be evaluated with the product quality, safety, impact of other products, batches, personnel system and procedures, in case of other department involve to review deviation require same shall be follow and at last forwarded to quality unit for further evaluation ,approval and rejection.
3. Quality unit shall review the impact of deviation on the product quality, process performance, product release, yield, GMP, stability/qualification / validation, training required, required regulatory  evaluation and approval, evaluation and approval by contract giver required and any similar deviations in past.
4. On the basis of evaluation quality unit shall assign the class of deviation as Critical, Major or Minor and approve/ reject the same.

• Critical Deviation: The deviation that affects the quality of a product, or a Component that may have a direct impact on the quality of the product. e.g. Manufacturing instructions are not followed, wrong batch details are printed, SOP’s or methods of testing not followed during analysis etc.
• Major Deviation: The deviation could or may have a significant impact on the Quality of the product. e.g. Line clearance is  not taken from QA, physician sample wrongly printed with price, Batch No. Skipped, Uses of obsolete documents.
• Minor Deviation: The deviation is unlikely to have a detectable impact on the Quality of the product.  This shall include impact on the aesthetics of product like Shade variation etc. e.g. Raw material is received in a damaged container, manometer reading in the sampling booth are crossed the action limits etc.

A formal risk assessment shall be done for critical & major deviation as per written procedure of quality risk management to mitigate the risk of deviation to followed by root cause analysis procedure.

All deviations shall be supported by a time frame for completions of activity related with the closure of deviations.It shall not be greater than 30 days from the occurrence of deviation. However, in cases where, the deviation requires additional data, which may require extended period beyond the stipulated closure time, adequate justification shall be provided by the Initiator department.