Deviation management principles

The occurrence of deviation does not necessarily mean that the product will be scrapped or reworked; it is necessary to investigate the deviation, find out the reasons, determine whether the degree of deviation will affect the quality of the product, and then make a decision on the treatment of the product. In terms of the assessment of major deviations, it is necessary to consider whether there is need for additional testing of the product and its impact on the validity of the product and, if necessary, the stability of the product involving major deviations needs to be tested. At the same time, corrective and preventive measures should be put forward to prevent the same deviation next time.

Any person must manage and operate in accordance with approved documents.

Deviations must be reported immediately and processed according to deviation handling procedures.

Any deviation from the production process, material balance limits, quality standards, inspection methods, operating procedures, etc. shall be recorded and immediately reported to the competent personnel and Quality Management Department, which shall be clearly stated. It is strictly prohibited to conceal the deviation and causes or handle the deviation without authorization.

Annual review of deviation management

The Deviation Administrator of Quality Management Department should make Deviation Management Ledger according to the time sequence of deviation, and timely send it to Quality Assurance Manager, head of QC, and all department heads of the company. If necessary, the Deviation Administrator should notify the relevant customers of the deviation.

The deviation administrator should also conduct an annual review of the deviations, which is required to be completed by the end of January of each year. The review should be conducted in accordance with the type of deviation and the Department where the deviation occurs.

The report should review the deviations from the previous year and the relevant investigations as part of the product quality review. The review summarizes the deviations and the findings of the investigation and the accidental factors of the deviations in order to reduce the deviations.

Deviation investigation file management

Deviation Report Form and Deviation Investigation and Treatment Form must be numbered by the deviation administrator of Quality Assurance Department. The rules for numbering are: PC-Z or C- year + * * (the serial number of the year)

PC: The first letter of Chinese Pinyin of Deviation; Z: Major deviation code; C: Secondary deviation code.

For example: The first major deviation in 2012, PC-Z-2012001

If the deviation occurs in the process of production and testing, the original Deviation Report Form and Deviation Investigation and Treatment Form are filed in batch records, and the copies and other relevant records and reports are filed and kept by Deviation Administrator of Quality Assurance Department. Other records and reports of deviations shall be copied and submitted to Deviation Occurrence Department. The original shall be filed and managed by Deviation Administrator.

The annual review report of deviation investigation should be maintained in the Record Room of Quality Assurance Department.

In case of the occurrence of deviations, the relevant parties should implement the Change Management Regulations strictly in accordance with the provisions of each document. 

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