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Approved by: Managing Director PSA Document Title : Non-Conformance and Corrective Actions Procedure Document Code: QSP–PSA-8.7
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Non-Conformance and Corrective Actions Procedure CODE: QSP–PSA-8.7 1-Objective This method of execution has been developed and implemented to create a system to address the causes of non-conformities and to prevent them from re-establishing them, as well as eliminating potential non-conformities to prevent them from occurring. 2-Scope This implementation method applies to all units covered by the quality management system. 3-Responsibilities All staff are responsible for providing corrective or preventive actions. Responsibility for investigating inconsistencies, reporting conflicting opinions, making proposals, finding the root causes of inconsistencies, and reporting the outcome of a reformist effort are the responsibility of unit managers. Responsibility for determining non-conformities, reviewing and determining the adequacy of the actions undertaken, and following the referenced actions and keeping records is the responsibility of the Managing Director. 4-Definitions Problem Solving Team: Depending on the issue involved, it includes the Quality Assurance Manager, the management and management representative or relevant managers. Non-conformities: Failure to meet a requirement. Correction: Action taken to eliminate non-compliance. Corrective Action: An action taken to address actual non-conformities. Preventive action: An action taken to address potential non-compliance 5-Ref ISO/IEC17065 ISO 9001
6-Method Whenever there is a discrepancy between the inspection services / audit consulting services, the necessary corrective action can be requested by all staff, or all employees can apply for preventive action to avoid potential systemic or service conflicts. Note 1: If a non-compliance sheet is issued repeatedly, at least three times for a subject, a corrective sheet should be issued for it. Note 2: After issuing and requesting corrective action, in case of similar cases, preventive action should be taken. 1-6- Reporting agents of inconsistency or requesting preventive action may include: A) Staff suggestions (B) Internal audit results (C) Customer complaints or comments D) management review sessions E) Data Analysis Report F) The results of non-conforming product reports G)The results of monitoring and measuring the processes of the quality management system H) Change in documentation 6.2 The applicant corrective / preventive action, enter the description of the request in the application form and request the corrective action of the code….. And bring it to the approval of the relevant director. The unit manager also sends it for review to the quality assurance manager. 6.3 If the problem-solving mechanism is needed the relevant unit manager forms the problem-solving team to identify the cause of the non-compliance. 6.4 The problem-solving team is required to review the case and complete the application for corrective action. 6-5. After determining the root causes, the type of measures required, the responsible person, the date, the date of follow-up for the actions taken, and the designated responsible person shall be communicated in the form of corrective action. 6.6 The designated officer shall be obliged to complete the necessary steps and complete the relevant form and report to the Planning and Quality Assurance Unit. 6-7. If the corrective action / preventive action is not carried out by the responsible execution deadline, he will be assigned by the quality assurance manager. If he / she does not re-act, he / she will report to the managing director and follow up the activities in accordance with his / her instructions. 6-8 A new form of action is issued if corrective / preventive measures are not sufficient and not satisfactory.
6-9 Units of quality assurance is required to insert the description of the actions taken in the form of the list of corrective actions.
7-Records The application forms for corrective and preventive actions are kept at the Quality Assurance Department.
8. Annexes Corrective Action Request Form with F-L-73 code Corrective Action List Form with F-L-74 code Follow-up form List of corrective action plans with F-L-75 code
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