Control of Documents SOP
1. PURPOSEThis procedure specifies the requirement for analysing data collected to monitor customer feedback, suppliers, reported NC products, CAPA, audits and other important parameters. This data helps Manufacturer to review all processes and allocate resources for improvement and progression.?This review is performed during the Management Review meeting that is conducted 1?time(s) in a year.2. SCOPEThis procedure is applicable to the key quality parameters stated minimally in the Quality Objectives, which need to be tracked and analysed by Manufacturer. The parameters tracked are made known within Manufacturer so that everyone can do their part to meet the required targets.3. RESPONSIBILITIESThe QA Manager is responsible to collate, analyse, and report this information during the Management Review meetings in order to propose any areas for improvements within the Quality Management System (QMS).4. REFERENCE DOCUMENTSISO 13485: 201621 CFR 820 etcControl of Non-Conforming Product SOPCorrective and Preventive Action SOPFeedback and Complaint Management SOPInternal and External Audit SOPControl of Records SOP5. DEFINITIONSNIL6. PROCEDURE6.1. Data AnalysisAll the parameters stated in the Quality Objectives must be reviewed accordingly. The analysis of data includes data generated from the monitoring and measurement of the following inputs:Feedback from various stakeholders (e.g., customers, partners, post market surveillance data such as CAPA, NCR and etc.),Conformity to product requirements (e.g., incoming and outgoing inspection checks and trending issues),Characteristics and trends of processes and product, including opportunities for improvements,Suppliers,Audit, andService reports.The Management review meeting is conducted 1 time(s) in a year to review the QMS’s suitability, effectiveness and area of improvements.?Minimally, the management and department heads are involved in these meetings.Whenever required, Manufacturer can also design customer survey forms to collect feedback from clients, with the aim to improve the product and services quality.6.2. Data CompilationThe QA Manager compiles the results of these initiatives for discussion during the Management Review meetings. These results can be presented by using appropriate tools and software that help in deriving a conclusion and identifying areas of improvement. The use of any methods (e.g., statistical techniques, software and etc.), as well as the extent of their use for determining, collecting and analysing of data, are to be provided. For any follow-up action initiated, the QA Manager will propose and discuss with the management, and ensure that it is effectively implemented.6.3. Management Review Meeting InputsAll the data collected as part of section 6.1 are also included as discussion points (inputs) in the management review meeting. The management review meeting often includes other broader topics such as:QMS (Management Representative)Feedback coming from customers as well as internally, Internal and external audits,Supplier evaluation and supplier audits, Status of training activities,Corrective action, Preventive action,Update on validity of internal and external documents (check if details are still relevant), Follow-up actions from previous management reviews,Any changes that could affect the quality management system, Recommendations for improvement.Quality Assurance/Regulatory AffairsMonitoring and measurement of processes (e.g., manufacturing, quality controls), Monitoring and measurement of product (e.g., non-conforming product),Any applicable new or revised regulatory requirements.Clinical AffairsStatus of clinical projects, Survey on new literature, Status of clinical evaluation.Research & DevelopmentStatus of R&D projects,Product conformity status (e.g., testing, verification), Status of production management and coordination, Overview of new equipment and systems.Sales & MarketingCustomer complaints and customer satisfaction (feedback), Marketing and sales activities,Service reports (if any), Post market surveillance.Safety Officer (A requirement in EU)Adverse event (AE) reporting and respective field safety corrective actions (FSCA) to regulatory authorities, Risk management review and updates.In countries where a Safety Officer is not required by law, these responsibilities will fall on the Management Representative (QMS).ManagementSuitability of Quality Policy and Objectives to align with business directions, Current status of resource and infrastructure,Summary and acceptance of improvement proposals, Conclusion of management review meeting.6.4. Management Review Meeting OutputsThe decisions and action plans are recorded in the minutes of meeting, including information such as action plans and the respective staff responsible to follow up. This includes information such as:Improvement needed to maintain the suitability, adequacy, and effectiveness of the QMS and its processes, Improvement of the medical device related to any new/revised customer requirements,Changes needed to respond to applicable new or revised regulatory requirements, Resource needs, such as training, hiring and outsourcing.6.5. RecordsManagement Review meetings are usually presented over a PowerPoint presentation. All communications and action items are listed using the Minutes of Meeting Form. All records are to be maintained in accordance with the Control of Records SOP.7.ATTACHMENTSNILThis is the end of the document.Author: QA Manager representing QA department.DCR No.Version No.AuthorReviewerApproverImplementation DateDescription of Change01QA/ RA ManagerCEOCEOInitial Release ................
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