Thread Content
1.0 Purpose: When non-conformities (potential non-conformities) are identified, effective corrective or preventive actions must be taken to eliminate the causes of such non-conformities (potential non-conformities), ensuring that the quality/environmental systems, production/operational processes, and products meet the required standards. 2.0 Scope of application: Applicable to the corrective and preventive actions taken by an organization regarding non-conformances (potential non-conformances). 3.0 Responsibilities: 3.1 Each department shall submit a \"Corrective (Preventive) Action Report\", namely CAR, for any non-conformities (potential non-conformities) identified. 3.2 The person in charge or the supervisor of the responsible department analyzes the issues mentioned in the CAR, identifies the causes of those issues, seeks solutions to them, and implements improvement measures until the non-conformities are effectively eliminated. 3.3 The management representative is responsible for analyzing and assessing the significance of the issues mentioned in the CARs as well as the associated risks, in order to decide whether to issue such CARs. The management representative is also responsible for following up to verify the effectiveness of the corrective and preventive actions taken. 4.0 Procedures: 4.1 Sources of defective information include (but are not limited to) the following aspects: A) Feedback from the customer’s environment ； B) Inspection and test reports ； C) Environmental control in the production process ； D) Observations and feedback from on-site workers ； E) Internal and external environment audits and audit reports; F) Analysis of various statistical data; G) Environmental monitoring and measurement ； H) In the event of major environmental/quality management incidents ； I) When it is deemed necessary after handling batch returns of products or customer complaints (complaints and grievances from relevant parties), 4.2 The main causes of non-conformity (potential non-conformities) include, but are not limited to, the following: A) Defects in processes or other documents ； B) The purchased materials do not meet the requirements ； C) The equipment, tools, environment, or other production conditions do not meet the requirements ； D) The workers lack the necessary skills or are in an abnormal emotional state ； E) Inadequate environmental systems, production plans, and quality plans, or failure to enforce them strictly, etc. 4.3 When non-conformities are identified, the importance and impact of the issue as well as the department responsible for it are first analyzed to determine whether to submit a CAR. 4.3.1 When the issue directly affects product quality, the production process, or the quality system, a CAR should be submitted ； 4.3.2 When a problem recurs or represents a certain type of issue, a CAR should be submitted ； 4.3.3 When potential non-conformities, issues with significant hazards, or widespread problems are identified, preventive measures should be proposed ； 4.3.4 When potential non-conforming defects or other undesirable situations are identified, preventive measures should be taken to eliminate the causes of these problems ； 4.3.5 For quality issues reported by customers, the person in charge of the Quality Management Department will issue a CAR depending on the severity of the issue ； 4.3.6 Unmet quality objectives and non-conformities identified in internal and external audits require a CAR to be issued ； 4.3.7 When the department responsible for addressing an issue is our own, employees at all levels should report directly to their department heads, who will be responsible for resolving it. If the issue remains unresolved for a long time after it is raised, or if similar issues keep occurring, a CAR can be submitted directly. 4.4 Implementation of corrective actions: 4.4.1 The person in charge of the relevant department or a supervisor at or above that level shall investigate and analyze the reasons for non-conformity within one week, determine the corrective actions, and respond to the department that issued the request. 4.4.2 The department that issues the corrective action report or non-conformity report is responsible for following up on the implementation of the corrective actions, verifying their effectiveness, and documenting it. 4.5 Preventive measures: Each department is responsible for taking preventive measures as necessary, based on potential causes of non-conformities. 4.5.1 Utilize the following information sources to identify and analyze the potential causes, and take preventive measures to eliminate them. 4.5.1.1 Results of management review ； 4.5.1.2 Process statistical status ； 4.5.1.3 Quality statistics status ； 4.5.1.4 Production and operation process. 4.5.2 The department head shall determine the necessary action steps for preventive measures in response to potential causes of defects, fill out the \"Correction (Preventive Measure) Report\" (Appendix 1), submit it to the management representative for approval, and ensure that these measures are implemented. 4.5.3 The first part of the CAR is to be filled out by the submitter, who must clearly indicate the time, location, and detailed reasons for non-conformity (potential non-conformity). 4.5.4 Upon receiving a CAR, the manager’s representative first analyzes the severity of the issue and the level of risk involved, in order to decide whether to issue a CAR. If it is not necessary to issue one, the CAR should be returned to the person who submitted it, with an explanation of the reasons given to their supervisor. If a CAR is necessary, the manager’s representative shall obtain additional signatures from the person who submitted it. 4.5.5 The CAR is issued by the General Manager/Management Representative to the responsible department. Upon receipt of the CAR, the supervisor of that department must sign for it on the status sheet, complete an analysis of the issues mentioned in the CAR within three days, specify the causes and corresponding corrective (preventive) actions, set a deadline for completion, and return the completed original CAR to the Management Representative. 4.5.6 Three days after the management representative issues a CAR, if no response is received from the responsible department, the reason must be investigated. If the random inspections and analyses related to the issues mentioned in the CAR have not been completed, nor have corresponding corrective (preventive) actions been established, the management representative shall issue a second CAR; following this same procedure, a third CAR, if necessary, must be signed additionally by the supervisor at the person who issued it. 4.5.7 The responsible department shall effectively implement preventive measures before the committed completion date to eliminate the causes of non-conformities (potential non-conformities), and retain relevant records. 4.5.8 The manager’s representative is responsible for verifying the outcomes of the corrective (preventive) actions taken. If those actions prove effective, the follow-up verification results should be recorded in Part 3 of the CAR; once this is done, the CAR is considered complete ； If it turns out that no corrective (preventive) actions have been taken or that the actions taken were ineffective, the management representative must identify the reasons. Depending on the situation, they may issue a second CAR or discuss solutions with the responsible department. The responsible department may delay the deadline for taking action, but such a delay is allowed only once. 4.6 Any non-conformity (potential non-conformity) mentioned in a CAR shall not be considered resolved until the cause that gave rise to such non-conformity (potential non-conformity) has been effectively eliminated, at which point the CAR is deemed closed. 4.7 If the same problem occurs repeatedly and persists even after corrective actions have been taken, a quality audit should be considered. 4.8 If the department responsible for the issue is the supplier, the CAR will be sent to the supplier following the same procedure. 4.9 The CAR is part of the records and is kept properly by the management representative. 4.10 Before each quality management review meeting, the management representative is responsible for compiling relevant corrective (preventive) actions such as CARs, and presenting them for discussion at the environmental management review meeting. 4.11 Corrective/preventive actions involving changes to quality management system documents shall be carried out in accordance with the Document Control Procedure. 5.0 Reference Documents: 5.1 Control Procedure for Management Review 6.0 Relevant Records: 6.1 Report on Corrective and Preventive Actions