Deviation record and report
Any deviation from the predetermined production process, material balance limits, quality standards, inspection methods, operating procedures, etc. shall be recorded immediately on the relevant records of the post and filled in the Deviation Report Form by the personnel. The content should include: Time, place or position, description of deviation, known cause, name and batch number of products or materials that may be affected by the deviation, specification, name and number of equipment and instrument, etc. If urgent corrective or control measures are adopted, they should also be explained. The Deviation Report Form, which is completed within 30 min after the deviation occurs, will be reported to the supervisor and QA on site, the supervisor and QA on site shall examine appropriateness of the emergency corrections and control measures taken by post personnel, and take necessary supplementary corrective or control measures to effectively control the effects of deviations. If necessary, they can seek the support of the superior management, technical personnel and personnel of Quality Management Department. The supervisor shall also examine the deviations reported by the personnel against the relevant approved procedures, regulations or standards, and preliminarily determine the types of deviations and report to the deviation administrator from Quality Management Department within 16 hours after the deviation occurs. Finally, the type of deviation is determined by the deviation administrator of Quality Management Department.
Investigation and handling of deviations
Secondary deviation
For secondary deviations, the person in charge of the Deviation Occurrence Department shall organize investigation and analysis, determine the causes, effects and handling opinions of the deviations, and formulate corrective and preventive measures. After the Deviation Occurrence Department fills in the deviation brief description, reasons for deviation occurrence, deviation impact and deviation handling, it shall be recorded in the by the deviation administrator of the Quality Assurance Department.
Major deviations
Deviation investigation
For major deviations, the deviation administrator should immediately rush to the scene, assist the deviation department to investigate and collect evidence, and report to the head of Quality Assurance Department. When it comes to multi-departmental deviations, a cross-functional team is needed to investigate the deviations, identify the root causes and assess the impact of the deviations. Generally speaking, the deviation administrator of the Quality Assurance Department should organize relevant personnel to set up a deviation investigation team to investigate the major deviation. The investigation team usually includes the following personnel:
Personnel related with Deviation Occurrence Department
Personnel related with production
Personnel related with quality control
Personnel related with Quality Assurance Department
Personnel related with equipment engineering
The factors considered during the investigation of the cause of the deviation include, but are not limited to:
Personnel / behavior: Whether the personnel have received the corresponding training, whether the training effect meets the requirements; In the process of operation, whether there are SOP violations, unauthorized modification of process parameters, non-standard record filling/modification, operation errors or omissions.
Equipment / instruments: Equipment and facilities required for production/laboratory (e.g. production equipment, monitoring instrument and vacuum gauges used; Whether the appliances/containers, stainless steel barrels, even the packaging bags used, etc. are in normal working condition. Whether they are properly cleaned, intact, or confirmed/checked, or properly maintained.
Products / materials: Including the starting materials, intermediates, water, etc. involved in production, whether these materials have been tested to meet the standards, or whether they are found abnormal in the course of use though they have been tested to be qualified, or whether they are contaminated in the process of use and brought into production, or whether they are monitored in accordance with regulations.
Documents / records: Whether the existing SOP and record setting is reasonable, whether it meets the process and production requirements, whether it meets the quality requirements, whether it meets the GMP requirements, whether there are unknown defects, etc.
Environment: Including the general production area and clean area environment, whether the number of suspended particles and the microorganisms in the environment have been effectively monitored and maintained, and whether they meet the requirements of GMP. Whether insects or other animals enter the production area, whether there are other kinds of pollution generated by the non-production system processes or brought in from the outside.
Other factors that are not mentioned above.
The following assessments should be made to assess the impact of deviations:
Impact on quality of products and materials directly involved
Impact on related materials and other products (such as the impact of adjacent batches of deviant products)
Impact on validation status
Impact on listing permit documents / registration documents
Impact on customer quality agreement
Is it necessary to carry out additional inspection on the product?
Impact on product expiration date
After the investigation and analysis of the major deviations by the investigation team, the person in charge of Deviation Occurrence Department shall fill in the Deviation Investigation and Treatment Form with a brief description of the deviation, the cause of the deviation, the impact of the deviation (which can form a quality risk management report) and the deviation treatment recommendations, and deliver to Deviation Administrator for preliminary examination. After it is qualified through the initial examination, it will be sent to the investigation team by Deviation Administrator for confirmation and signing. If the deviation administrator or the investigation team confirms that the contents of the Deviation Investigation and Treatment Form need to be supplemented, the person in charge of the Deviation Occurrence Department shall supplement the relevant content in time.
After the Deviation Investigation and Treatment Form is confirmed by Deviation Administrator and the members of the investigation team, it will be handed over to the head of Quality Management Department by the deviation administrator for final decision.
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