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当过程的输出不能由后续的监视或测量加以验证时，此过程应进行确认，以确保过程的输出能持续满足预定要求。4.4.1设备管理部门负责设备的安装确认，运行确认与工艺确认中相关参数...
当过程的输出不能由后续的监视或测量加以验证时，此过程应进行确认，以确保过程的输出能持续满足预定要求。
4.4.1 设备管理部门负责设备的安装确认，运行确认与工艺确认中相关参数的调试，并对设备的维护保养做出明确规定。
4.4.2 质量部门确保在进行确认前所有相关仪表经过校准合格，并进行相关样品的检测。
4.4.3技术部门根据检测结果进行分析，需要时对方案进行更改。
4.4.4 生产部门在确认的全过程中给予人员、材料、空间等的配合。
过程确认的结果必须形成记录，通常应以报告的形式，经总经理审批后存档。
4.7 技术部门应根据确认报告的结果，确定出最佳的工艺参数用于日常生产。
4 程序
4.1 常规合同Routine Contract
4.1.1物流部门在接到总公司的常规合同后，应组织生产部门和财务部门进行合同评审，确认物料采购周期及库存情况。
4.1.2生产部门应对生产能力、交货日期、设备、人员等进行评审，以确认是否能按合同交期及时交货。
4.1.3 财务部应确认合同价格是否与报价相符。
4.1.4如果合同评审结果为可接受，则物流部门应及时以书面形式（通常格式为电子邮件）向总公司物流部进行确认。若合同经评审认为不可接受，则物流部门应及时与总公司物流部进行沟通更改合同要求或撤消合同。
4.1.5 一旦接受合同，物流部门应对合同进展情况进行跟踪。若合同进行过程中发生任何更改，应记录在合同更改单上，并获得总公司物流部的书面认可。
4.1.6 合同完成后，所有相关记录（包括合同、合同评审表、合同变更记录等）由物料部进行保存，参见QP02《记录控制》程序。
4.2 特殊合同 Special Contract
4.2.1物流部门在接到总公司的特殊合同后，应组织相关部门进行合同评审。相关部门包括技术、质量、生产、物流、财物、总经理等。
4.2.2技术部门负责评审总公司下发的产品技术要求是否齐全，技术要求一般包括产品标识、配件图、产品组装图、包装组装图等。
4.2.3质量部负责评审产品检测标准是否齐全，检测设备是否齐全等。
4.2.4生产部门应对生产能力、交货日期、设备、人员等进行评审，以确认是否能按合同交期及时交货。
4.2.5物流部负责评审物料采购周期及库存情况等。
4.2.6财务部应确认合同价格是否与报价相符等。
4.2.7 总经理负责合同的最终审批。
4.2.8如果合同评审结果为可接受，则物流部门应及时以书面形式（通常格式为电子邮件）向总公司物流部进行确认。若合同经评审认为模糊或不可接受，则物流部门应及时与总公司物流部进行沟通要求澄清、更改合同要求或撤消合同。
4.2.9 一旦接受合同，物流部门应对合同进展情况进行跟踪。若合同进行过程中发生任何更改，应记录在合同更改单上，并获得总公司物流部的书面认可。
4.2.10合同完成后，所有相关记录（包括合同、合同评审表、合同变更记录等）由物料部进行保存，参见QP02记录控制程序。
5. 附录
5.1 附录1 KQP16-F01A 《合同评审表》
5.2 附录2 KQP16-F02A 《合同更改单》
6. 参考
6.1 ISO13485:2003,医疗器械--质量管理体系--规范要求
6.2 21 CFR PART 820,质量管理体系规范 展开
4.4.1 设备管理部门负责设备的安装确认，运行确认与工艺确认中相关参数的调试，并对设备的维护保养做出明确规定。
4.4.2 质量部门确保在进行确认前所有相关仪表经过校准合格，并进行相关样品的检测。
4.4.3技术部门根据检测结果进行分析，需要时对方案进行更改。
4.4.4 生产部门在确认的全过程中给予人员、材料、空间等的配合。
过程确认的结果必须形成记录，通常应以报告的形式，经总经理审批后存档。
4.7 技术部门应根据确认报告的结果，确定出最佳的工艺参数用于日常生产。
4 程序
4.1 常规合同Routine Contract
4.1.1物流部门在接到总公司的常规合同后，应组织生产部门和财务部门进行合同评审，确认物料采购周期及库存情况。
4.1.2生产部门应对生产能力、交货日期、设备、人员等进行评审，以确认是否能按合同交期及时交货。
4.1.3 财务部应确认合同价格是否与报价相符。
4.1.4如果合同评审结果为可接受，则物流部门应及时以书面形式（通常格式为电子邮件）向总公司物流部进行确认。若合同经评审认为不可接受，则物流部门应及时与总公司物流部进行沟通更改合同要求或撤消合同。
4.1.5 一旦接受合同，物流部门应对合同进展情况进行跟踪。若合同进行过程中发生任何更改，应记录在合同更改单上，并获得总公司物流部的书面认可。
4.1.6 合同完成后，所有相关记录（包括合同、合同评审表、合同变更记录等）由物料部进行保存，参见QP02《记录控制》程序。
4.2 特殊合同 Special Contract
4.2.1物流部门在接到总公司的特殊合同后，应组织相关部门进行合同评审。相关部门包括技术、质量、生产、物流、财物、总经理等。
4.2.2技术部门负责评审总公司下发的产品技术要求是否齐全，技术要求一般包括产品标识、配件图、产品组装图、包装组装图等。
4.2.3质量部负责评审产品检测标准是否齐全，检测设备是否齐全等。
4.2.4生产部门应对生产能力、交货日期、设备、人员等进行评审，以确认是否能按合同交期及时交货。
4.2.5物流部负责评审物料采购周期及库存情况等。
4.2.6财务部应确认合同价格是否与报价相符等。
4.2.7 总经理负责合同的最终审批。
4.2.8如果合同评审结果为可接受，则物流部门应及时以书面形式（通常格式为电子邮件）向总公司物流部进行确认。若合同经评审认为模糊或不可接受，则物流部门应及时与总公司物流部进行沟通要求澄清、更改合同要求或撤消合同。
4.2.9 一旦接受合同，物流部门应对合同进展情况进行跟踪。若合同进行过程中发生任何更改，应记录在合同更改单上，并获得总公司物流部的书面认可。
4.2.10合同完成后，所有相关记录（包括合同、合同评审表、合同变更记录等）由物料部进行保存，参见QP02记录控制程序。
5. 附录
5.1 附录1 KQP16-F01A 《合同评审表》
5.2 附录2 KQP16-F02A 《合同更改单》
6. 参考
6.1 ISO13485:2003,医疗器械--质量管理体系--规范要求
6.2 21 CFR PART 820,质量管理体系规范 展开
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When the process output cannot performs the confirmation by thefollowing surveillance or the survey, this process should carry on theconfirmation, guarantees the process the output to be able to continuesatisfiedly to prearrange the request.
4.4.1 equipment control section is responsible for the equipment theinstallment to confirm that, the movement confirmed and the craftconfirmed is connected the parameter debugging, and makes the explicitstipulation to the equipment maintenance maintenance.
4.4.2 quality departments guarantee in carry on before theconfirmation all correlations measuring appliance to be qualifiedafter the calibration, and carries on the correlation sample theexamination.
4.4.3 technical departments basis examines the result carries on theanalysis, when the need to the plan carries on the change.
4.4.4 production departments give the personnel, the material, thespace in the confirmation entire process and so on the coordination.
The process confirmed the result must form the record, usually shouldreport the form, examines and approves after general manager puts onfile.
4.7 technical departments should act according to confirmed the reportthe result, determined the best craft parameter uses in the dailyproduction.
4 procedures
4.1 conventional contracts Routine Contract
4.1.1 thing flow the department after to receive the maincorporation the conventional contract, should organize the productiondepartment and the financial department carries on the contractappraisal, the confirmation material purchase cycle and the stocksituation.
4.1.2 production departments should to the productivity, the deliverydate, the equipment, the personnel and so on carry on the appraisal,confirmed whether can according to the contract 交期 promptdelivery.
4.1.3 finance departments should confirm whether the contract pricedoes tally with the quoted price.
4.1.4 if the contract appraisal result for may accept, then the thingflows the department to be supposed promptly (usual form as email) toflow take the written form to the main corporation to carry on theconfirmation. If the contract after the appraisal thought cannotaccept, then the thing flows the department to be supposed promptly toflow with the main corporation to carry on the communication changecontract requirement or to abolish the contract.
4.1.5 once accepts the contract, the thing flows the department to besupposed to carry on the track to the contract progress situation. Ifthe contract carries on in the process to have any change, shouldrecord on the contract change list, and obtains the main corporationto flow a written approval.
After 4.1.6 contracts complete, all correlations recording (includingcontract, contract appraisal table, contract changes record and so on)to carry on the preservation by the material department, sees alsoQP02 "Recording Control" the procedure.
4.2 special contracts Special Contract
4.2.1 thing flow the department after to receive the maincorporation the special contract, should organize the correlationdepartment to carry on the contract appraisal. Related departmentincluding technology, quality, production, class, belongings, generalmanager and so on.
4.2.2 technical departments are responsible for the productspecification which appraises under the main corporation to send iswhether complete, the specification generally includes productmarking, the fitting chart, the product assembly chart, the packingassembly chart and so on.
4.2.3 quality department are responsible to appraise the productexamination standard whether complete, the check-out facility iswhether complete and so on.
4.2.4 production departments should to the productivity, the deliverydate, the equipment, the personnel and so on carry on the appraisal,confirmed whether can according to the contract 交期 promptdelivery.
4.2.5 thing flow to be responsible to appraise the material purchasecycle and the stock situation and so on.
4.2.6 finance departments should confirm whether the contract pricedoes tally and so on with the quoted price.
4.2.7 general managers are responsible for the contract the finallyexamination and approval.
4.2.8 if the contract appraisal result for may accept, then the thingflows the department to be supposed promptly (usual form as email) toflow take the written form to the main corporation to carry on theconfirmation. If the contract after the appraisal thought fuzzy orcannot accept, then the thing flows the department to be supposedpromptly to flow with the main corporation to carry on thecommunication request to clarify, the change contract requirement orto abolish the contract.
4.2.9 once accepts the contract, the thing flows the department to besupposed to carry on the track to the contract progress situation. Ifthe contract carries on in the process to have any change, shouldrecord on the contract change list, and obtains the main corporationto flow a written approval.
After 4.2.10 contracts complete, all correlations recording (includingcontract, contract appraisal table, contract changes record and so on)to carry on the preservation by the material department, sees also theQP02 recording control procedure.
5. appendices
5.1 appendices 1 KQP16-F01A "Contract Appraisal Table"
5.2 appendices 2 KQP16-F02A "Contract Change List"
6. references
6.1 ISO13485:2003, medical instrument -- quality controlsystem -- standard request
6.221 CFR PART 820, quality control system standard
4.4.1 equipment control section is responsible for the equipment theinstallment to confirm that, the movement confirmed and the craftconfirmed is connected the parameter debugging, and makes the explicitstipulation to the equipment maintenance maintenance.
4.4.2 quality departments guarantee in carry on before theconfirmation all correlations measuring appliance to be qualifiedafter the calibration, and carries on the correlation sample theexamination.
4.4.3 technical departments basis examines the result carries on theanalysis, when the need to the plan carries on the change.
4.4.4 production departments give the personnel, the material, thespace in the confirmation entire process and so on the coordination.
The process confirmed the result must form the record, usually shouldreport the form, examines and approves after general manager puts onfile.
4.7 technical departments should act according to confirmed the reportthe result, determined the best craft parameter uses in the dailyproduction.
4 procedures
4.1 conventional contracts Routine Contract
4.1.1 thing flow the department after to receive the maincorporation the conventional contract, should organize the productiondepartment and the financial department carries on the contractappraisal, the confirmation material purchase cycle and the stocksituation.
4.1.2 production departments should to the productivity, the deliverydate, the equipment, the personnel and so on carry on the appraisal,confirmed whether can according to the contract 交期 promptdelivery.
4.1.3 finance departments should confirm whether the contract pricedoes tally with the quoted price.
4.1.4 if the contract appraisal result for may accept, then the thingflows the department to be supposed promptly (usual form as email) toflow take the written form to the main corporation to carry on theconfirmation. If the contract after the appraisal thought cannotaccept, then the thing flows the department to be supposed promptly toflow with the main corporation to carry on the communication changecontract requirement or to abolish the contract.
4.1.5 once accepts the contract, the thing flows the department to besupposed to carry on the track to the contract progress situation. Ifthe contract carries on in the process to have any change, shouldrecord on the contract change list, and obtains the main corporationto flow a written approval.
After 4.1.6 contracts complete, all correlations recording (includingcontract, contract appraisal table, contract changes record and so on)to carry on the preservation by the material department, sees alsoQP02 "Recording Control" the procedure.
4.2 special contracts Special Contract
4.2.1 thing flow the department after to receive the maincorporation the special contract, should organize the correlationdepartment to carry on the contract appraisal. Related departmentincluding technology, quality, production, class, belongings, generalmanager and so on.
4.2.2 technical departments are responsible for the productspecification which appraises under the main corporation to send iswhether complete, the specification generally includes productmarking, the fitting chart, the product assembly chart, the packingassembly chart and so on.
4.2.3 quality department are responsible to appraise the productexamination standard whether complete, the check-out facility iswhether complete and so on.
4.2.4 production departments should to the productivity, the deliverydate, the equipment, the personnel and so on carry on the appraisal,confirmed whether can according to the contract 交期 promptdelivery.
4.2.5 thing flow to be responsible to appraise the material purchasecycle and the stock situation and so on.
4.2.6 finance departments should confirm whether the contract pricedoes tally and so on with the quoted price.
4.2.7 general managers are responsible for the contract the finallyexamination and approval.
4.2.8 if the contract appraisal result for may accept, then the thingflows the department to be supposed promptly (usual form as email) toflow take the written form to the main corporation to carry on theconfirmation. If the contract after the appraisal thought fuzzy orcannot accept, then the thing flows the department to be supposedpromptly to flow with the main corporation to carry on thecommunication request to clarify, the change contract requirement orto abolish the contract.
4.2.9 once accepts the contract, the thing flows the department to besupposed to carry on the track to the contract progress situation. Ifthe contract carries on in the process to have any change, shouldrecord on the contract change list, and obtains the main corporationto flow a written approval.
After 4.2.10 contracts complete, all correlations recording (includingcontract, contract appraisal table, contract changes record and so on)to carry on the preservation by the material department, sees also theQP02 recording control procedure.
5. appendices
5.1 appendices 1 KQP16-F01A "Contract Appraisal Table"
5.2 appendices 2 KQP16-F02A "Contract Change List"
6. references
6.1 ISO13485:2003, medical instrument -- quality controlsystem -- standard request
6.221 CFR PART 820, quality control system standard
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When the output process can be measured or monitored by the follow-up test, the confirmation process should be conducted,The output can be sustained to ensure that the process is scheduled to meet requirements.4.4.1 equipment management department confirmed the installation of equipment, operational parameters related to the recognition and confirmation process debugging,Equipment maintenance also made clear.4.4.2 The quality of all the relevant departments to ensure that the validation after calibration instrument qualified, and associated sample testing.4.4.3 technology sector based on the results of analysis necessary for the program to change.4.4.4 production sector in the entire process of granting recognition, materials, space and other support.The results must be confirmed by the process of forming records normally be in the form of a report, the president's approval filing.4.7 technology sector should confirm the findings of the report, to determine the optimum parameters for the day-to-day production.4 4.1 conventional contract Routine procedures 4.1.1 Contract logistics departments in the conventional Corporation received a contract,Financial departments should organize production and contract review, confirmed procurement cycle and inventory.4.1.2 production deal with production, delivery dates, equipment, staff assessment,able to confirm whether or not the contract period is timely delivery of goods.4.1.3 Finance Department should confirm whether the contract price in line with the quotations.4.1.4 If the contract results to be acceptable.timely logistics departments will be in written form (usually format for e-mail) to confirm Corporation Logistics Department.If the contract is unacceptable that assessment.Logistics is the logistics department in the Ministry of timely communication with the corporation to change the contract or cancellation of contracts.4.1.5 once they have accepted the contracts, the logistics department should track the progress of the contract.If any change took place in the course of the contract, the contract shall be recorded in change orders, and was approved in writing by the Department of Logistics Company.4.1.6 Upon completion of the contract, all relevant records (including contract, the assessment formsContract change records, etc.) by the Department for the preservation of materials, see QP02< records control "procedures.4.2 Special Contract 4.2.1 special contracts in the logistics sector Corporation received a special contract,should organize relevant departments to conduct joint assessment.Related departments, including technology, quality, production, logistics, property, and other general manager.4.2.2 Technology Corporation issued by the department was responsible for assessing the technical requirements are complete products.general technical requirements, including product labels, accessories plans, product assembly map, a map of the packaging assembly.4.2.3 responsible for the quality of product testing standards are complete assessment, detection equipment and food.4.2.4 production deal with production, delivery dates, equipment, staff assessment,able to confirm whether or not the contract period is timely delivery of goods.4.2.5 Logistics is responsible for the assessment and inventory of materials such as the procurement cycle.4.2.6 Finance Department should confirm whether the contract price quotations and so on.4.2.7 General Manager responsible for the final contract approval.Accountability assessment results to be acceptable if the contract.timely logistics departments will be in written form (usually format for e-mail) to confirm Corporation Logistics Department.If the contract is ambiguous or unacceptable that assessment.Logistics is the logistics department in the Ministry of timely communication with the corporation requested to clarify that the contract change or cancellation of contracts.9.3.13 once they have accepted the contracts, the logistics department should track the progress of the contract.If any change took place in the course of the contract, the contract shall be recorded in change orders, and was approved in writing by the Department of Logistics Company.4.2.10 after the completion of the contract, all relevant records (including contract, the assessment formsContract change records, etc.) by the Department for the preservation of materials, see QP02 records control procedures.5. Appendix Appendix 1 5.1 5.2 KQP16-F01A "Contract Review List" Appendix 2 KQP16-F02A "Contract single change" 6. 6.1 reference ISO13485 :2003, the Quality Management System Medical Devices -- 21 CFR PART 820 -- 6.2 specifications.quality management system standard
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