Recently, I launched an article on writing a deviation survey. I received feedback from some readers and wanted to know something about the definition, management and process of deviation events. So this time, I will talk about deviation management and process first.

To manage a survey well, in addition to a good management process, you also need to learn how to manage it effectively. Here are some insights from the DST team.

Definition of deviation:

First of all, how to define deviation, what is the case of deviation, effective deviation management is based on effective, sufficient to control the production process and drug quality procedures or standards. Without pre-defined rules, there will be no bias.

For example, an enterprise's definition of deviation: deviation refers to any deviation from approved procedures (guidance documents) or standards. Including any abnormal conditions related to product quality, such as abnormal storage of materials and products, equipment failure, excessive verification results, excessive environmental monitoring results, excessive or abnormal verification results of analysis methods, customer complaints, etc., as well as accidents or deviations that do not conform to drug-related laws and regulations or approved standards, procedures and instructions.

Identification of deviations:

With the definition of deviation as the basis, then the identification is the starting point of the deviation processing activity. Identification ability depends on all drug production quality related personnel, and those personnel need to go through the corresponding deviation management training, understand the concept of deviation and have the ability to identify deviation, which is linked to the usual training, experience accumulation and personal ability.

Deviation recording and reporting supervisor:

When personnel identify deviations or abnormal situations, they should fill in relevant records in time. Therefore, the design of GMP records (such as batch production records, log files, etc.) should be able to keep a certain position to record various deviations or abnormal situations, so as to ensure that relevant personnel can conveniently record any deviation in production quality activities in time and ensure the traceability of deviation investigation and treatment process.

At the same time of filling in the records, they should also report to the superior immediately, explaining the time, place, person, what things or processes, etc. Based on the description of the reporting person, the supervisor determines whether urgent measures need to be taken to prevent the deviation from expanding or worsening.

Common emergency measures include:

suspension of production;

Material or product isolation;

Suspension of equipment;

Emergency shelter, etc.

All emergency actions performed must be recorded in a timely and complete manner in the deviation record.

Report to quality management department;

In the event of a deviation, the head of the department or his authorized personnel shall immediately provide true and comprehensive deviation information to the quality management department. Whether to report to the quality management department immediately is a prerequisite for the quality management department to effectively classify deviations and conduct deviation investigations in conjunction with other departments.

Classification and assessment of deviations:

Classify the deviations according to their nature, extent and potential impact on product quality (e. g. major, moderate, minor). For major deviations, such deviations may have serious consequences on product quality, safety or effectiveness, product image, product expiration date, etc., or may lead to product scrapping, finished product recall, and it is also necessary to consider whether additional inspection is required. Such deviations must be investigated in depth to identify the root cause, and in addition to corrective action must be taken, long-term preventive measures must be established and stability studies of products involving significant deviations must be conducted.

Investigation and handling of deviations:

Investigation and analysis shall be carried out in accordance with the prescribed procedures to find out the root cause of deviation. Common root cause analysis methods include brainstorming method, fish bone method, 5Why method, etc., and corrective and preventive measures CAPA shall be formulated. In principle, the CAPA formulated shall be implemented and rectified only after approval by the quality department. The deviation investigation report shall be reviewed and signed by the quality management department.

Correction and Prevention of Deviations CAPA:

The corrective and preventive action CAPA for deviation shall be implemented to ensure that the measures are reasonable, effective and timely. If the CAPA developed is continuous or cannot be completed in the short term, the deviation can be closed first, provided that the product quality is not affected, but additional records are required for tracking and regular review. For deviations that are not closed within the specified time limit, a periodic report should be drafted to explain the progress of the investigation, develop necessary short-term actions, assess potential risks, and apply for and obtain the approval of the quality department before extension.

Review and evaluation of deviations:

Enterprises should regularly review and evaluate deviations, especially in the review to pay attention to whether there is a repeat of the same type of deviation, which may lead to the failure of the deviation system, the need to develop effective preventive measures.

Deviation Record Filing:

Relevant records and reports shall be filed and kept in a timely manner, and the enterprise shall clearly specify the responsibilities, methods and retention periods for deviation investigation, handling documents and record keeping. The preservation method should ensure traceability with related products, easy to find and can be quickly provided in internal and external audits.

Knock on the blackboard:

The main concerns of deviation management are as follows:

Whether the established deviation management procedure defines the responsibilities and authority of each department and personnel in the deviation handling process;

Whether the relevant personnel of production quality activities are trained in deviation management procedures, understand the concept of deviation and have the ability to identify deviation;

If the deviation needs to be reported to the competent personnel and the quality management department immediately, then whether the deviation procedure clearly stipulates what is "immediate" and whether the specified time limit is reasonable;

Whether the deviation classification standard is reasonable, whether the deviation classification is carried out by the quality management department, and whether the classification judgment of specific deviation is appropriate;

Whether the root cause investigation of deviation is timely, comprehensive and thorough, whether the investigation and handling of major deviation is conducted by the quality management department in conjunction with other departments, whether the root cause cannot be identified is common, and whether the identified root cause is reasonable;

Deviation impact assessment, including the impact on product quality and the impact on the quality management system, whether the appropriate product disposal can ensure the safety, effectiveness and quality control of the drug;

Whether the corrective measures for deviation are effectively implemented and tracked;

Whether corrective and preventive measures for similar deviations are effectively implemented and tracked;

Whether the same or similar deviations occur repeatedly.

The above process ensures that deviations are properly managed and prevents future deviations from occurring.

What else do you want to know, question or suggestion? Please leave a message in the comment area below.