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시정조치 및 예방조치 보고서

시정조치 및 예방조치 보고서(CAPA Report)Section 1 : 시정조치 및 예방조치 요구(CAPA Requests)조치항목(Action Item)□시정조치(Corrective Action)□예방조치(Preventive Action)데이터 출처(Source of data)□고객불만(Complaint Handling)□일탈(Deviation)□변경관리(Change Control)□부적합품(Nonconforming product)□내부감사(Internal audit)□경영검토(Management review)□외부심사( )□기 타(Etc.)( )관리번호(Control Number)접수 일자(Date of reception)요청자(Requestor)수행부서(Executive Department)주 제(Subject)내용(Contents)영향성 평가(Impact Assessment)□ Critical( )□ Non-critical( )첨부문서(Attachment)QA 담당자(Written By)QA 확인자(Reviewed By)품질 책임자(Approved by)수신 (Receipt)수행부서 담당자(Manager by)Section 2 : 시정조치 및 예방조치 계획(CAPA Plan)1. 원인 분석(Cause analysis)2. 조치되어야 할 사항(What needs to be Action)항목(Item)□문서(Document) □시험법(Method) □공정(Process) □시스템(System)□설비(Equipment) □교육(Education) □기타(Etc.)( )조치 부서(Action Department)□품질관리팀(Quality Control Team)□품질보증팀(Quality Assurance Team)□경영지원팀(Management Support Team)□생산팀(Production Team)□연구개발팀(R&D Team)□기 타(Etc) ( )내용(Contents)- 조치 내용 및 부적합의 재발 방지를 보장하기 위한 조치의 필요성 평가Action Contents and evaluating the need for action to ensure that nonconformities do not recur조치 계획 점검(Check Action Plan)항목(Item)완료 예정일(Expected completion date)담당자(Person/s responsible)첨부문서(Attachment)작성자(Written By)작성 부서 책임자(Reviewed By)QA 확인자(Reviewed By)품질책임자(Approved By)Section 3 : 시정조치 및 예방조치 수행(CAPA Performance)1. 조치 진행(Proceed with confirm action)항목(Item)완료일(Expect CompletionDate)담당자(Manager)2. 조치된 사항(Executed Action Items)항목(Item)□문서(Document) □시험법(Method) □공정(Process) □시스템(System)□설비(Equipment) □교육(Education) □기타(Etc.)( )조치 부서(Action Department)□품질관리팀(Quality Control Team)□품질보증팀(Quality Assurance Team)□경영지원팀(Management Support Team)□생산팀(Production Team)□연구개발팀(R&D Team)□기 타(Etc) ( )내용(Contents)- 조치 내용 및 부적합의 재발 방지를 보장하기 위한 조치의 필요성 평가Action Contents and the implementation of the measures to ensure the recurrence of nonconformities첨부문서(Attachment)작성자(Written By)작성 부서 책임자(Reviewed By)QA 확인자(Reviewed By)수신 (Receipt)QA 담당자(Manager by)Section 4 : 시정조치 및 예방조치 평가(CAPA Evaluation)1. 조치 결과 확인(Check Action Results)- 적용되는 규제 요구사항 또는 의료기기 안전성 및 성능을 충족시키는 능력에 부정적 영향을미치지 않음을 검증, 조치의 효과성에 대한 검토verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device2. 의료사고 보고 및 리콜 평가(Medical Incident Reporting and Recall Evaluation)평가결과(Evaluation Results)□ Yes( ) □ N/A* 결정 이유(Reason for decision)보고결과(Report Results)3. 유효성 확인(Effectiveness)□ 검증 확인(Verification) □ 조치 완료(Action Completed)□ 재 시정 조치 요구(Require re-corrective Action)4.결과 통보(Results Notification)□ YES□품질관리팀(Quality Control Team)□품질보증팀(Quality Assurance Team)□경영지원팀(Management Support Team)□생산팀(Production Team)□연구개발팀(R&D Team)□기 타(Etc) ( )□ N/AQA 담당자(Written By)QA 확인자(Reviewed By)품질 책임자(Approved By)FORM-CP001-01/02 시정 및 예방조치 요구서FORM-QD001-01/03 Page 12 / 3F807-1(Rev.06)문서번호(버전번호) 회사로고문서번호(버전번호) 회사로고문서번호(버전번호) 회사로고

부서별서식| 2024.12.16| 4페이지| 2,000원| 조회(1,545)

카파, 조치, 시정, capa, 예방조치, 시정조치, 시정 및 예방, CAPA보고서, 조치보고서

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부적합품 보고서

부적합품 보고서NCR No. :발행부서명발생일자접수부서명수 량발생품명□ 원자재 □ 제품 □ 보관품 □ 생산(공정품) □ 인도 후 제품부적합품내용.회신요구일 : 발행자 : (서명)원인분석및재발방지 대책[원 인 분 석][재발방지 대책]□ 외부기관 조사 통지작 성 일 : 작 성 자 : (서명)품 질 책 임 자 : 검 토 일 : (서명)처분승인□ 수리 □ 재작업 □ 폐기 □ 반품 □ 특채 □ 기타승인일 : 품질책임자 : (서명)처분확인(발행부서)□ 만족 □ 불만족확인일 : 확인자 : (서명)시정 및 예방조치 요구서 발행여부 확인□ 해당 됨 □ 해당 안됨해당되는 경우, 시정 및 예방조치 요구서 발행 번호해당 안되는 경우, 시정 및 예방조치 요구서 미발행 사유

회사서식| 2023.01.27| 1페이지| 500원| 조회(1,032)

부적합, 부적합품, 부적합품보고서, 부적합 보고서, 부적합품 보고서, 부적합 제품

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시정 및 예방조치 요구서

시정 및 예방조치 요구서작 성검 토승 인발행일자발행번호발행처수신처발행구분□부적합품 □내부감사 □품질시스템 □검사결과 □고객불만 □기타부적합사항내용근거원인분석시정 및 예방조치시정조치예방조치일자조치자(인)조치 검증일자검증자(인)영향 평가규제 요구사항 :안전성 및 성능 :일자평가자(인)효과성 검토일자검토자(인)

회사서식| 2023.01.27| 1페이지| 500원| 조회(1,018)

예방, 시정, 시정 및 예방조치, 예방조치, 시정조치

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Field Safety Corrective Action(FSCA) Report

Field Safety Corrective Action(FSCA) Report1. Administrative informationTo which NCA(s) is this report being sent?Type of report[ ] Initial report[ ] Follow up report[ ] Final reportDate of this reportReference number assigned by the manufacturerFSCA reference number assigned by NCAIncidence reference number assigned by NCAName of the co-ordinating national competent authority (if applicable)2. Information on submitter of the reportStatus of submitter[ ] Manufacturer[ ] Authorised representative within EEA, Switzerland and Turkey[ ] Others (identify the role):3 Manufacturer informationNameContact nameAddressPostcodeCityPhoneFaxE-mailCountry4 Authorised representative informationNameContact nameAddressPostcodeCityPhoneFaxE-mailCountry5 National contact point informationNational contact point nameName of the contact personAddressPostcodeCityPhoneFaxE-mailCountry6 Medical device informationClass[ ] AIMD Active implants [ ] IVD Annex II List A[ ] MDD Class III [ ] IVD Annex II List B[ ] MDD Class Iib [ ] IVD Devices for self-testing[ ] MDD Class Iia [ ] IVD General[ ] MDD Class INomenclature system (preferable GMDN)Nomenclature codeNomenclature textCommercial name/brand name/makeModel numberCatalogue numberSerial number(s)lot/batch number(s)Device Manufacturing dateExpiry dateSoftware version number (if applicable)Accessories/associated device (if applicable)Notified body (NB) ID- number7 Description of FSCABackground information and reason for the FSCADescription and justification of the action (corrective/preventive)Advice on actions to be taken by the distributor and the userProgress of FSCA , together with reconciliation data (Mandatory for a Final FSCA)Attached please find[ ] Field Safety Notice (FSN) in English[ ] FSN in national language[ ] Others (please specify):FSN Status[ ] Draft[ ] FinalTime schedule for the implementation of the different actionsThese countries within the EEA and Switzerland and Turkey are affected by this FSCAWithin EEA, Switzerland and Turkey:Candidate Countries:[ ] HR [ ] All EEA, Candidate Countries, Switzerland and TurkeyOthers:8 CommentsI affirm that the information given above is correct to the best of my knowledge.………………………………………………………SignatureName City DateSubmission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorizedrepresentative or the national competent authority that the content of this report is complete or accurate, that themedical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to thealleged death or deterioration in the state of the health of any person.

회사서식| 2023.01.27| 6페이지| 600원| 조회(1,135)

Corrective Action, field safety, FSCA Repo..

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Incident Report

Incident Report1. Administrative informationRecipientName of National Competent Authority (NCA)Address of National Competent AuthorityDate of this reportReference number assigned by the manufacturerReference number assigned by NCAType of report[ ] Initial report[ ] Follow-up report[ ] Combined Initial and final report[ ] Final reportDoes the incident represent a serious public health threat?[ ] Yes[ ] NoClassification of incident[ ] Death[ ] Unanticipated serious deterioration in state of health[ ] All other reportable incidents[ ] Identify to what other NCAs this reportIdentify to what other NCAs this report was also sent2. Information on submitter of the reportStatus of submitter[ ] Manufacturer[ ] Authorised Representative within EEA, Switzerland and Turkey[ ] Others: (identify the role) :3. Manufacturer informationNameContact nameAddressPostcodeCityPhoneFaxE-mailCountry4. Authorised Representative informationNameContact nameAddressPostcodeCityPhoneFaxE-mailCountry5. Submitter’s information (if different from section 3 or 4)Submitter’s nameContact nameAddressPostcodeCityPhoneFaxE-mailCountry6. Medical device informationClass[ ] AIMD Active implants [ ] IVD Annex II List A[ ] MDD Class III [ ] IVD Annex II List B[ ] MDD Class Iib [ ] IVD Devices for self-testing[ ] MDD Class IIa [ ] IVD General[ ] MDD Class INomenclature system (preferable GMDN)Nomenclature codeNomenclature textCommercial name/ brand name / makeModel numberCatalogue numberSerial number(s) (if applicable)Lot/batch number(s) (if applicable)Software version number (if applicable)Device Manufacturing dateExpiry dateImplant date (for implants only)Explant date (for implants only)Duration of implantation (to be filled is the exact implant or explant dates are unknown)Accessories/ associated device (if applicable)Notified Body (NB) ID-number7. Incident informationUser facility report reference number, if applicableManufacturers awareness dateDate the incident occurredIncident description narrativeNumber of patients involved (if known)Number of medical devices involved (if known)Medical device current location/disposition (if known)Operator of the medical device at the time of incident (select one)[ ] health care professional [ ] patient [ ] otherUsage of the medical device (select from list below)[ ] initial use [ ] reuse of a single use medical device[ ] reuse of a reusable medical device [ ] re-serviced/refurbished[ ] other (please specify) [ ] problem noted prior use8. Patient informationPatient outcomeRemedial action taken by the healthcare facility relevant to the care of the patient9. Healthcare facility informationName of the health care facilityContact person within the facilityAddressPostcodeCityPhoneFaxE-mailCountry10. Manufacturer’s preliminary comments (Initial/Follow-up report)Manufacturer’s preliminary analysisInitial corrective actions/preventive actions implemented by the manufacturerExpected date of next report11. Results of manufacturers final investigation (Final report)The manufacturer’s device analysis resultsRemedial action/corrective action/preventive action / Field Safety Corrective ActionTime schedule for the implementation of the identified actionsFinal comments from the manufacturerFurther investigationsIs the manufacturer aware of similar incidents with this type of medical device with a similar root cause?[ ] Yes [ ] NoNumber of similar incidents.If yes, state in which countries and the report reference numbers of the incidents.For Final Report only: The medical device has been distributed to the following countries:Within EEA, Switzerland and Turkey:Candidate Countries:[ ] HR [ ] All EEA, Candidate Countries, Switzerland and TurkeyOther:12. CommentsSubmission of this report does not, in itself, represent a conclusion by the manufacturer and / orauthorized representative or the National Competent Authority that the content of this report iscomplete or accurate, that the medical device(s) listed failed in any manner and/or that the medicaldevice(s) caused or contributed to the alleged death or deterioration in the state of the health of anyperson.I affirm that the information given above is correct to the best of my knowledge.………………………………………………………Name City date

회사서식| 2023.01.27| 8페이지| 600원| 조회(1,260)

사고, Incident, 사고보고서, Incident Report

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