Why should we establish such a system?
Establish the corrective and preventive action (CAPA) management system, and take corresponding corrective or preventive measures to eliminate the causes of existing or potential non conformity, so as to prevent the recurrence of non conformity or potential non conformity, and ensure the continuous improvement of the company's quality management system.
The following describes the content of CAPA corrective and preventive measures management system
1. Definition
1.1 corrective actions (CA)
Measures taken to eliminate the occurrence of non conformity or other unexpected situations.
1.2 preventive actions (PA)
Measures taken to eliminate the occurrence of potential nonconformity or other unexpected conditions in potential years.
2. Responsibilities
2.1 the management department is responsible for corrective and preventive measures.
2.1.1 organize relevant departments to analyze the causes of non conformity and formulate, implement, inspect and review the corrective measures;
2.1.2 according to the abnormal fluctuation of product quality, organize relevant departments to analyze the causes of potential non conformity, evaluate the feasibility of preventive measures, evaluate the suitability and rationality of preventive measures, and supervise the implementation of preventive measures.
2.1.3 be responsible for the formulation, implementation, inspection, review and other management activities of the corrective and preventive measures for the unqualified items in the quality management system audit and management review;
2.1.4 be responsible for the sorting and filing of records during the implementation of corrective and preventive measures.
2.2 the engineering equipment department is responsible for the formulation, implementation and inspection of corrective and preventive measures for process equipment and public works, and participates in the effectiveness evaluation of corrective and preventive measures.
2.3 the production department and relevant responsible departments shall participate in the formulation of corrective and preventive measures and be responsible for the implementation of corrective and preventive measures.
3. The management process is as follows

       4. Management contents and requirements
4.1 conduct investigation through user investigation, user complaint, product recall, company internal self inspection, external audit, production process monitoring and product inspection results, process performance and quality inspection trend analysis to identify and confirm the non conformity and potential quality risks.
4.2 cause investigation and analysis
4.2.1 in case of the following situations, the defect occurrence department must conduct cause investigation and analysis.
(1) When the user complains about quality or the same bad quality factor appears again;
(2) Recall from the market due to adverse events or defects or suspected defects of products;
(3) Deviation or major quality accident occurred in the production process;
(4) Non conformity items (including requirements of laws and regulations) during self inspection or external inspection;
(5) When the quality improvement meeting decides to change the process or change the equipment, facilities, instruments and inspection methods;
(6) When adverse trend is found in product quality review;
(7) When the adverse trend or obvious change of the product is found during sample observation or continuous stability inspection;
(8) When adverse trend or disqualification is found in environmental test, pharmaceutical water test or other routine inspection;
(9) In the production process, the instrument, instrument or equipment does not meet the requirements (failure, damage, adjustment and maintenance) and affects the product quality;
(10) When the inspection results of the same supplier or the same material are unqualified;
(11) When pollution accident occurs in the production environment.
4.2.2 the defect occurrence department shall identify the identified quality risks or potential quality risks, organize relevant personnel to analyze the causes, find out the main causes of risks, and make records.
4.3 formulation of corrective and preventive measures
4.3.1 on the basis of analysis, the defect occurrence department shall fill in the corrective and preventive measures treatment sheet and submit it to the quality management department for review and evaluation;
4.3.2 the plan of corrective and preventive measures shall have clear responsibilities, operability and completion time limit.
4.4 the quality management department shall evaluate the corrective and preventive measures, and the system administrator of the quality management department shall number the handling sheet of the corrective and preventive measures.
4.4.1 the number format is capa-xxxxx
4.4.2 CAPA is the abbreviation of corrective and preventive measures. A has five Arabic numerals. The first two digits represent the year, and the last three digits are the serial number. Starting from 001, the preparation shall be carried out according to the sequence of occurrence in a year, and no skipping number is allowed. For example, the number of the 10th corrective and preventive action in 2012 is capa-12010.
5. Implementation and record of corrective and preventive measures
5.1 the corrective and preventive measures approved by the evaluation shall be implemented by the responsible department within the specified time, and the implementation process shall be recorded.
5.2 QA of quality management department shall track the implementation effect during the implementation of corrective and preventive measures, determine its effectiveness and operability, and continuously improve the corrective and preventive measures.
5.3 quality control department shall inspect and supervise the implementation process of corrective and preventive measures to ensure the implementation of corrective and preventive measures.
6. Effectiveness review of corrective and preventive measures
6.1 after the completion of corrective and preventive measures, the company's quality management department shall review the effectiveness of the corrective and preventive measures, and the effective corrective and preventive measures confirmed by the review shall be included in the daily management.
6.2 for the corrective and preventive measures that are found to be invalid after implementation, new corrective and preventive measures shall be re analyzed and formulated.
7. Level of corrective and preventive measures
7.1 minor defects.
7.2 general defect items.
7.3 serious defects.
8. Completion time limit of corrective and preventive measures
8.1 minor defects of nature shall be corrected immediately.
8.2 general defect items shall be completed within one month.
8.3 serious defects:
8.3.1 if the corrective and preventive measures do not need to be approved by the superior competent department, they shall be completed within three months;
8.3.2 corrective and preventive measures shall be approved by the superior competent department: if approved, the internal procedures of the company shall be completed and reported to the superior competent department within six months;
8.4 if the corrective and preventive measures cannot be completed on schedule due to objective reasons, the corrective measures implementation department shall explain the reasons to the enterprise quality management department, request for extension, and modify the implementation plan of corrective and preventive measures after approval.
9. Verification of corrective and preventive measures
9.1 after the implementation of corrective or preventive measures, the responsible department shall inform the quality management department, and the quality management department shall verify according to the corrective or preventive measures treatment sheet.
9.2 the quality management department shall make necessary communication to users after the implementation of measures for user visit (including quality problems or complaints on products).
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