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No: PRO_SYS_03 Procedure for Correction, Corrective and Rev.No/ Issue Date 0 / 01-05-2023 Preventive Action Procedure for Correction, Corrective and Preventive Action 1.0 Purpose This procedure describes a system for correction and taking corrective and preventive action to promptly detect conditions which are adverse to the quality and Product safety of the company's product, process, and Product safety management system. The causes of actual or potential non-conformances are investigated, documented and prevented. 2.0 Scope It covers corrective action for nonconformities and preventive action for potential nonconformities identified for product, Product safety management system, process and quality management system, either during supervision or review and internal audit, as listed below. It is also applicable to all customer or third party complaints and handling and analysis of the same. Product Incoming materials’ inspection and testing, In-process inspection and testing, and Final products’ inspection and testing. Process At any stage of manufacturing, Department-wise monitoring of Product safety and quality objectives (results against target to ensure effectiveness of process) Internal / External Audit Handling of customer complaints and analysis of customer satisfaction Failure of inline instruments Any incidents
3.0 Responsibility 3.1 Top Management, Management Representative and Functional Heads are responsible for reviewing and determining causes of non-conformances as well as potential non-conformance for major defects / repeated type of defects. They are also responsible for determining and implementing corrective action and preventive action necessary to prevent its recurrence in their area of work for Product / Process Management System. They are also responsible for reviewing corrective and preventive action in their area. 3.2 Product Safety Team Leader is responsible for: Necessary correction and taking corrective and preventive action for Quality System and Product Safety System related nonconformities, based on review of audit reports. Reviewing corrective and preventive action taken by concerned person for effectiveness and preparing information for discussion in management review meeting as well as maintaining of records. 4.0 Description of Activity
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Management Representative 1 of 6 Doc.Ref.No: PRO_SYS_03 Procedure for Correction, Corrective and Rev.No/ Issue Date 0 / 01-05-2023 Preventive Action 4.1 Analysis and Action 4.1.1 Analysis of nonconformity (actual and potential) is done and corrective action / preventive action is taken whenever it is identified in: Materials Purchase. Product / Process Non-Conformance Reports. Non-Adherence to the Stipulated Documents and Product Safety System Failure (Data Analysis). Customer Complaints / Customer Satisfaction Reports. Non-Achievement of Production Plans. Review of Results of Department-wise Objectives and Output of Management Review Non-achievement of Production Plan. Areas for improvement and updation of system based on experience of mistakes, withdrawals, etc. Trends of higher incidence of potentially unsafe products. Analysis of corrections done for non-achievement of CCP or loss of control of operational PRPs. 4.2 Corrections: If any operational PRPs or critical control point is found out of limit then Functional head/ Product safety head is informed to take necessary actions. They review the impact of such things on Product safety, and if required, segregate such lots from the routine production line and properly identify them. In such cases evaluation is done for causes of nonconformity and proper records are maintained for evaluation with respect to causes of nonconformity as well as consequences and handling of potentially unsafe product.
4.2.1 Necessary actions are taken to prevent the nonconforming products from entering the Product chain, unless: The Product safety hazard(s) of concern has (ve) been reduced to the defined acceptable levels; The Product safety hazard(s) of concern will be reduced to identified acceptable levels prior to entering into the Product chain; or The products still meets the defined acceptable level(s) of the safety hazards of concern despite the nonconformity; The operational PRPs are brought to acceptable limits. All lots of nonconforming products are kept under control of organization. If nonconforming product is identified after delivery or its use has started, then company takes appropriate action regarding the consequences of the nonconformity, and interested parties are informed to withdraw the material as per product withdrawal procedure. 4.2.2 Evaluation for release All nonconforming products are released as safe when any of the following conditions apply: Evidence other than the monitoring system demonstrates that the control measures have been effective; Evidence shows that the combined effect of the control measures for that particular product complies with the performance intended; The results of sampling, analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels for the Product safety hazards concerned.
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Management Representative 2 of 6 Doc.Ref.No: PRO_SYS_03 Procedure for Correction, Corrective and Rev.No/ Issue Date 0 / 01-05-2023 Preventive Action 4.2.3 Disposition of nonconforming products The nonconforming products are reviewed after inspection in accordance with the documented procedure and subject to decision taken as per following: Re–processed to meet the specified requirements Re-gradation / Rejected and/ or Scrapped 4.2.4 Withdrawals Top management has appointed and authorized the Product safety team leader for initiating and executing withdrawals. The product withdrawal system is followed as per established system given in procedure PRO/HACCP/06.
Record of the withdrawal is maintained and reported to the top management as a basis of input to the management review. The effectiveness of the withdrawal program is verified and records are maintained.
4.3 Corrective action may include review in following way:
The corrective action planning should include evaluation of the significance of problems affecting Product safety of the product or Product safety management system. The major or repetitive nonconformities are identified for taking corrective action in the areas listed in Para 4.1 a. The Functional Heads review nonconformities (including customer complaints) identified in their areas and analyze it. b. The root cause of nonconformities are identified in the areas like man, machine, material, management (system), money (resources). c. Considering the evaluation and aspects like costs of nonconformance vs. action taken, random failure, customer satisfaction, etc., need for action is evaluated to ensure that non-conformities do not recur. For nonconformity of minor nature or random failure, it is recorded in Quality and Product Safety Objectives forms and no CAR is raised. After analysis of the nonconformities or deficiencies for major or repetitive problems, corrective actions are taken as described in the table below: Sr. Identified Area Nonconformities Frequency Action On Responsibility No Customer Product Safety Any genuine For all serious Product / Complaints / Team Leader / 1. customer customer Process / Market Head of complaint complaint System Complaints Production / QC Quarterly and Product / 2. Not achieved need identified Objectives Process / Functional Head 4. against target by Functional System Head Product / Top At any point of 3. CCP Not achieved Process / Management / time System Functional Head
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Management Representative 3 of 6 Doc.Ref.No: PRO_SYS_03 Procedure for Correction, Corrective and Rev.No/ Issue Date 0 / 01-05-2023 Preventive Action Note: The respective employee may take corrective and preventive action in areas other than listed above or if frequency is less as listed above, as a part of improvement. Also the records of such corrective actions taken may be maintained in the related records where analysis is done, and is maintained. The corrective or preventive actions are also taken based on the review of quality and Product safety objectives for the non-achieved criteria or the criteria touching the borderline. Also, in such cases, corrective action may not be recorded in the corrective action report but the same are recorded in the form for quality objectives / Product safety objectives in the related records. d. Based on root cause analysis, corrective action to be taken is determined. If it is applicable for other department(s) then CAR Form is forwarded to the concerned function. Necessary corrective action is implemented. e. The results of action taken is recorded in CAR Form and compared for results in nonconformity V/s results after action taken. If it is found unsatisfactory then the whole process is repeated. f. After completion of corrective action, form is forwarded to the MR for review of corrective action taken. He reviews effectiveness of the corrective action and the adequacy of such measures. The summary of effectiveness of corrective action is discussed and reviewed in the management review meeting.
4.4 Preventive action may include review in following way:
The preventive methodologies are used by Functional Heads to identify the causes of potential non-conformances. Examples of such methodologies include department wise analysis of achievement of Product Safety Objectives on quarterly basis, defect analysis, any special areas identified by Functional Head, etc. a. Based on analysis of various records as listed in Para 4.1.1, the Functional Heads determine potential nonconformities. They initiate action and if any resource is required then same is approved from Top Management. The causes of such potential nonconformities will be in the areas of man, machine, material, and system and resource requirement. The same are reported in preventive action form (PAR). b. The Functional Head evaluates the need for action to be taken considering cost of action V/s benefit achieved by the company. Such potential nonconformities are related to Product safety, quality or customer satisfaction. Revised target / action are decided in management review meeting, and then Functional Head takes preventive action. For minor or random potential nonconformities the preventive action is not taken. c. The preventive action to be taken is identified and if it is related to other department then such PAR form is forwarded to concerned department. Necessary preventive action is implemented as needed and reported in preventive action form (PAR form). Some Long-term preventive actions (more than 6 months) are also taken. Action is taken in phased manner as per action plan. d. The records for results are also maintained and summarized in PAR form. e. The PAR form is forwarded to MR after completion. He reviews its effectiveness and further review is done in Management Review Meeting.
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Management Representative 4 of 6 Doc.Ref.No: PRO_SYS_03 Procedure for Correction, Corrective and Rev.No/ Issue Date 0 / 01-05-2023 Preventive Action 4.5 On review and identification of the probable causes, corrective and preventive actions are taken to eliminate causes of nonconformity, for major nonconformity / repeated type of minor nonconformity identified by Management Representative / Functional Heads. The records of actions are maintained by originator Management Representative after completion of action taken. The originator maintains copy of CAR or PAR Forms. 4.6 It is not the intention to raise corrective and preventive action form for every little deficiency but it should be raised to bring improvement in the organization.
4.7 Process for Follow-up of CAR/PAR (Review, Investigation and Implementation)
Product Safety Team Leader and concerned person review the CAR/PAR. They may obtain inter-departmental help, if required, in proposing and undertaking corrective and preventive actions. After review and investigation of the observed or potential nonconformance or improvement suggestion or complaint, the reviewer proposes corrective and preventive actions in the CAR / PAR form. The responsible person nominated in CAR/PAR implements the proposed actions. Implementing personnel monitors the effects of the corrective and preventive actions. In case of customer complaints, the Top Management / Heads of Marketing, Production and QC replies in writing to the client regarding the investigation results and corrective and preventive measures taken to eliminate the cause of nonconformance. Changes in procedures resulting from corrective and preventive actions are implemented and recorded by the Management Representative /Product Safety Team Leader. Concerned person investigates the root cause and corrective actions are taken, such as training, change in methodology, development of vendor, change in document, inspection method, etc., and recorded in the same form. If problem is identified and one department generates form but action has to be taken by other department then CAR form is sent to concerned department through Management Representative /Product Safety Team Leader. They take action and CAR form is reverted back to Management Representative /Product Safety Team Leader giving feedback on result of investigation and action taken. Product Safety Team Leader maintains such records. The concerned persons are informed to change documents wherever required for taking action. If concerned HODs / Functional Heads identify to take further preventive action to eliminate potential causes in such areas then necessary preventive actions is taken. They determine steps needed to prevent recurrence and recorded in the PAR form. For all audit (internal as well as external) NCRs, disposal action and corrective action taken is recorded in the same NCR form. 4.8 Follow-up Follow-up monitoring is undertaken by Management Representative / Functional Heads or their nominated representative to verify that the corrective and preventive actions are implemented and to ensure that the desired goals are achieved. The CAR/PAR is signed off and closed, if the corrective and preventive actions are satisfactory. If the results are not satisfactory, the new nonconformance observed is treated as per this procedure.
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Management Representative 5 of 6 Doc.Ref.No: PRO_SYS_03 Procedure for Correction, Corrective and Rev.No/ Issue Date 0 / 01-05-2023 Preventive Action 4.9 Management Representative monitors effectiveness of corrective action by reviewing results for suitable time on case to case basis. 4.10 If any major changes in any of the relevant documents are necessary by way of corrective and preventive action, then this is done as per procedure PRO/SYS/02 on Document and Data Control, and records are maintained.
5.0 References 5.1 PRO/SYS/05 Procedure for Internal Audit. 5.2 PRO/SYS/02 Procedure for Document and Data Control. 5.3 PRO/HACCP/05 Procedure for Emergency Preparedness and Response 5.4 PRO/HACCP/06 Procedure for Product Withdrawal
