Control of Documents SOP - CMS MedTech



1. PURPOSEThis procedure describes the management of feedback coming from the various sources, but not limited to customer surveys, written/verbal feedback, complaints and staff within Manufacturer.2. SCOPEThis procedure is applicable to the feedback provided by customers and/or staff that impacts product and services provided by Manufacturer. These feedbacks need to be reviewed and if necessary, trigger the issuing of a non-conformance report (NCR), corrective and preventive action (CAPA) and/or updating of the risk management files.3. RESPONSIBILITIESThe QA Engineer is responsible for the implementation of this feedback management procedure.4. REFERENCE DOCUMENTSISO 13485: 201621 CFR 820 etcControl of Non-Conforming Product SOPCorrective and Preventive Action SOPField Safety Corrective Action (FSCA) Reporting SOPAdverse Event Reporting SOPControl of Records SOPRisk Analysis SOP5. DEFINITIONSNIL6. PROCEDURE6.1. Feedback ProcessFeedback is generally obtained from various channels that include but not limited to:Written or verbal information received from customers Customer surveys initiated by ManufacturerStaff within ManufacturerRegulatory Authorities websites and publications6.2. Customer Complaint HandlingIf the feedback is received from a customer, a Requestor will officially log in the details via the Customer Feedback Form. If required, the team will discuss with other departments to evaluate if this feedback would be classified as a complaint. Upon receiving the feedback, the customer needs to be informed within 48 hours that an investigation is on-going and will be hearing from a staff as soon as there is an outcome. Internally, the Requestor will need to ensure that the investigation does not take longer than 2 calendar weeks. If additional time is required, the team will inform the customers that investigation is still in process and will get back to them once the investigation is completed.Once the feedback is regarded as a complaint, the Control of Non-Conforming Product SOP?will be adhered and the Non-Conformance Report Form?must be completed, followed by a Corrective and Preventive Action Form. If the customer feedback investigation via the NC process classifies the case to be an incident that needs to be filed with the authorities, the Adverse Event Reporting SOP?must be adhered to. If the incident subsequently requires a field safety corrective action (FSCA) to be executed, the procedure stated in the Field Safety Corrective Action (FSCA) Reporting SOP?must be adhered to.All customer complaint reports, which may include confidential information, are kept safely with limited access as stated in the Control of Records SOP.6.3. Customer SurveyCustomer survey forms can be created for data collection from time to time to evaluate the quality of products and services provided by Manufacturer.?The Customer Survey Form is used to gather feedback from customers, which includes parameters such as Training, Quality of Product/Service and Support.?Feedback can also be collected internally from the staff working in the organisation. Results can be evaluated during management review meetings to evaluate if processes such as CAPA and Risk Management need to be triggered for improvements.6.4. Post Market SurveillanceAny updates on regulatory requirements during the post-market phase are obtained from several channels that include but not limited to:Review of Singapore’s Health Science Authority website for medical device product advisories Subscription to US Food & Drugs Administration alertsReview of European Database – EUDAMEDRegular updating on competitors’ advancements, including new competitorsPost-market surveillance of competitors for incident reports/recall via the media and alerts.The QA Engineer will review the post-production phase information annually and set up a meeting for discussion to evaluate the impact to Manufacturer’s products and services. The Risk Management, CAPA, Adverse Event, FSCA Reporting would need to be triggered accordingly when required, especially if previously unrecognized hazards are present or estimated risk arising from a particular hazard is no longer acceptable.7. ATTACHMENTSCustomer Feedback FormCustomer Survey FormThis is the end of the document.Author: QA Engineer representing QA department.DCR No.Version No.AuthorReviewerApproverImplementation DateDescription of Change01QA/ RA EngineerQA/ RA ManagerQA/ RA ManagerInitial Release ................
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