Deviation assessment is process for assess identified deviation in process, process control for prevent deviations and documenting the assessment activities for standardize the system.
Define the standard procedure that designate identification process. The procedure apply in processes for control, in case of deviation from the existing processes such as:
- Standard operation procedures
- Instructions and methods
- Process parameters, including pre-established.
- Validation / re-validation and values
The deviation case be transitory non-conformity from the operational procedures, equipment, devices, instrument. Its related processes and activities are considered as deviation. The procedure describes and control on deviations. That the affect the product quality, processes or the safety of personnel in workplace. This procedure is sample procedures that helps to implement and apply for the assessment. Reporting concern to deviation within the organization which can directly affecting activities are:
- Raw materials and purchase management.
- manufacturing processes of the product.
- Instruments / equipment / devices and utilities systems and the validation related processes.
- Control during the process.
- Management and controls on the final / packed product.
- Operation and maintenance of the utilities systems.
- Maintenance tasks at various locations.
- Performance of the actions according to the applicable procedures and delivery of the product.
Generally, the document preparation, updating and implementation of the procedure of deviation assessment is conducted by quality assurance team. But if in case of the quality team and management agreed to joint operation to implementation of documentation in internal management system. In the preparation of the processes and implementation of documentation are handled according to standard procedures as responsibility assigned by management is handled.
How to apply deviation assessment procedure in system?
The non-conformity from the various documentations, procedures, internal system, method or any process parameters at any location of manufacturing / process unit steps are considered as deviations. Which should be included all the installed machinery, equipment, infrastructure dedicated for manufacturing should be considered accordingly. The non-conformity are considered in three major classifications: (1) Critical (2) Major (3) Minor.
Critical Type Deviation
The critical type section deviations are considered in case of the non-conforming such deviations may affect the quality of the products. This deviations presenting situations that affecting safety, quality and efficiency. The critical type deviation is serious that needs to more attention to compliance. The defined quality and actions including corrective, preventive actions and documentation of deviations to tracking all the activities. As well as present situations.
Major Type Deviation
The major category deviation which is the non-critical deviation are considered. That may lead to the obtainment of the product which may failed to comply specifications. The deviations needs to emergence, corrective & preventive actions that minimize risk to affect the quality of product. The minor categorized deviation needs corrective and preventive action. And have a minimize risk to affect product quality hence each actions should be maintained in separate document that is deviation tracking log:
Minor Type Deviation
The minor type of deviations is managing through actions that considered non-critical working parameters. The deviations from the validation, approved condition. Or which that minor specification compliance. The minor deviations need to comply specific requirements. That is corrective and preventive actions and have a low risk to affect the quality of product. The deviation should be properly identified, recorded and should investigated at appropriate location. The deviations results in a non-confirming product, they must be properly documented.
The purpose of the correcting identified deviations & prevention from their recurrence. An investigation that should implement the appearance of the deviation. The methods required for its correction should be initiated. When any employee identified deviation should immediate inform to concern authority that is quality assurance. For the collect the information on the deviation identified. Establish investigation process at appropriate deviation location and occurred where applicable.
In the document management, each reporting should be properly followed by standard operating procedures. That document should be filled out and signed by the person detecting the deviation. Such employee shall describe deviation details and related information. The request of filled details provides to quality assurance team for further action & investigation. Quality assurance team is responsible for collect those information. Categorize risk and deviation as per deviation reporting. Measure the deviation and record information accordingly. The investigations to be carried out by qualified assurance person with respect of deviation.
The quality assurance department is responsible for identify, categorize, measure of risks levels. Corrective & preventive action as well as monitoring on the processes at appropriate location. Where deviation is identified, the investigation on each deviation should properly maintained are manage accordingly. The deviations shall be reviewed by responsible personnel from quality assurance team. General stages of deviation assessment are:
- The investigation & results through identification, measure & related processes.
- Root causes of each identified deviation.
- Risk Assessment & actions of risk level reduction.
- Determination of the corrective & preventive actions.
- Closing & monitoring.
The team members, the personnel involved in assessment in deviation process should be needs to identify appropriate problems i.e. deviation in the processes. Informs the responsible of the department where person carries activities. The description of each deviation are needs to record it immediate reporting to concern. The quality assurance is responsible for deviation. The identifies are recorded to quality assurance and quality assurance team should identify, measure and close the deviation by approving corrective & preventive actions at appropriate levels. The quality assurance responsible for records in the Deviation Tracking Form and classifies the deviations according to the defined classification.
Investigation results carried out in concern to appropriate deviation should be communicate to the quality assurance team. The deviation reporting is conducted by specialist from the relevant department. All the deviation records should be maintained in deviation reporting, activities, and investigation concern activities. Which is affected by such deviation, the results and the conclusions of the investigation. The corrective measures that must be takes to the preventive measure required. Hence that other possible deviations should be prevent from occurring and the completion of the investigation.
In case further investigations or processes are remains or needs on after review should be reporting to concern authority for actions. The quality assurance team is verifying that whether the deviation affects the previously produced materials / lots. The affect the future production or not are verified by concern authority. On control management & change records should be verified each method or processes.