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Faizan
Deviations from established standard operating procedures (SOPs) are required to be documented, investigated and resolved to comply with federal, state and city regulations and corporate policies. Tracking the documentation describing these investigations is important to make sure the deviations are dealt with, resolved on a timely basis and approved by the proper authorities. The Quality Assurance (QA) function is typically charged with these tasks. The documentation process can be tracked by hand or by using deviation tracking software.
Familiarize yourself with the investigation process as defined in the appropriate QA deviation investigation procedure. Note that each step in the process must be signed off and dated by the QA representative and then reviewed, approved and signed off by the QA supervisor according to the time frame established in the QA procedure. Set up a “tickler” system to make sure all responses are received as required.
Assuming you are the authorized QA recipient of deviation reports, log in the time and date of the deviation report, which should have been sent to the Quality Assurance function within 24 hours of discovery of the deviation. Assign the report a unique identification number, and examine the report to make sure you have sufficient information to proceed with the investigation. Seek additional data if necessary. Review possible causes for the deviation.
Conduct a primary investigation and assess the level of risk of the deviation. Evaluate the extent of the problem. Find out how many batches, customers or end-users are affected. Search the database of deviation reports to see if there is an identifiable deviation trend.
Assess the impact on product or system quality, and decide how serious the consequences are to customers/end-users. Gauge the regulatory and compliance effects of the deviation. Consider if it is necessary to initiate a market withdrawal, recall, or other market action.
Determine within one business day what corrective/preventive actions are required, and send the results of the investigation to the area where the deviation was observed. Require acknowledgement from the area manager or supervisor that the report was received and understood and require a summary of any corrective action taken by the area manager and any suggestions for preventive action within two business days.
Refer the response to the QA manager who will review the response for its effect on product quality and regulatory risk. If the review is satisfactory, the QA manager will approve the response. Otherwise, the QA manager will require additional data from the area manager.
Require any follow-up tasks to be completed and reported to QA within 30 days unless the QA manager approves an extension up to 90 days. When the investigation is completed, the QA supervisor will close it out and file it as appropriate.
Familiarize yourself with the investigation process as defined in the appropriate QA deviation investigation procedure. Note that each step in the process must be signed off and dated by the QA representative and then reviewed, approved and signed off by the QA supervisor according to the time frame established in the QA procedure. Set up a “tickler” system to make sure all responses are received as required.
Assuming you are the authorized QA recipient of deviation reports, log in the time and date of the deviation report, which should have been sent to the Quality Assurance function within 24 hours of discovery of the deviation. Assign the report a unique identification number, and examine the report to make sure you have sufficient information to proceed with the investigation. Seek additional data if necessary. Review possible causes for the deviation.
Conduct a primary investigation and assess the level of risk of the deviation. Evaluate the extent of the problem. Find out how many batches, customers or end-users are affected. Search the database of deviation reports to see if there is an identifiable deviation trend.
Assess the impact on product or system quality, and decide how serious the consequences are to customers/end-users. Gauge the regulatory and compliance effects of the deviation. Consider if it is necessary to initiate a market withdrawal, recall, or other market action.
Determine within one business day what corrective/preventive actions are required, and send the results of the investigation to the area where the deviation was observed. Require acknowledgement from the area manager or supervisor that the report was received and understood and require a summary of any corrective action taken by the area manager and any suggestions for preventive action within two business days.
Refer the response to the QA manager who will review the response for its effect on product quality and regulatory risk. If the review is satisfactory, the QA manager will approve the response. Otherwise, the QA manager will require additional data from the area manager.
Require any follow-up tasks to be completed and reported to QA within 30 days unless the QA manager approves an extension up to 90 days. When the investigation is completed, the QA supervisor will close it out and file it as appropriate.
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