15记录控制程序

文件名称 File name 记录控制程序 Record Controlling Procedure 文件编号 File No. LAB/CX-15 编制/日期 Compiled by/Date 版号/修订次 Version/Revise No. B/2 审核/日期 Reviewed by/Date 分发至 Issued to 质管部、实验室 QA, Lab. 批准/日期 Approved by/Date 生效日期 EFF. from 编制依据 Compilation Basis ISO/IEC 17025 检验与校准实验室认可准则 Inspection and calibration laboratory accreditation criteria. 1 目的 Purpose 对记录保持识别、收集、索引、存档、存放、维护和清理。 Keep record identification, collection, index, archive, storage, maintenance and clean. 2 适用范围 Scope 所有质量/技术记录。 The whole quality/technical records. 3 职责 Duties 质量/技术负责人组织对质量/ 技术记录进行编制。 Quality/ Technical Leader is responsible for compiling quality/technical records. 实验室主任批准质量/技术记录。 Laboratory Director is responsible for approving quality/technical records. 4 工作程序 Working procedure 4.1 质量/技术记录的编制、审核、批准 Compilation, review and approval of quality/technical records 质量/技术负责人根据质量手册 、 程序文件 、 管理规程 、 标准操作规程组织人员 编制相应的记录，记录按照过程来编制，以满足过程的复现性。其编制、审核、批准、变 更执行文件控制程序 Quality/ Technical Leader is responsible for compiling the related records in accordance with Quality Manual , Program Files, Management Procedure, and Standard Operating Procedure. The compilation shall conform to their process to meet the reproducibility. The compilation, review, approval and change refer to File Controlling Procedure. 4.2 记录的识别 Record Identification 采用记录的文件名称、记录编号来进行识别。规定如下： Identify the records with file name and record number. The provisions are as the following: 序号 No. 文件类别 File Type 编号 Serial Number 编号说明 Instruction 1 质量记录 Quality records LAB/RECZL-NN(or 或 NN.N) LAB-实验室代号 Laboratory No. SC-质量手册 Quality Manual DDDD-发布年份 Year CX-程序文件 Program Files NN(或 NN.N)-文件顺序号 Serial Number NNN(或 NNN.N) -文件顺序号 Serial Number RECZL-质量记录 Quality Record 2 技术记录 Technical records LAB/RECJS-NN(or 或 NN.N) RECJS-技术记录 Technical Record 01-取样记录 Sampling Record 02-成品检验记录 Inspection Record of Finished Product 03-中间控制检验记录 Inspection Record of Intermediate Control 04-原料检验记录 Inspection Record of Raw Materials 05-水质检验记录 Inspection Record of Water Quality 06-包材检验记录 Inspection Record of Packing Materials 07-环境监测记录 Environment Supervision Record 08-检验报告 Inspection Report 09-试剂和溶液记录 Reagent and Solvent Record 010-内校记录 Internal Calibration Record 011-各种统计记录 012-验证(012.1-仪器验证方案； 012.2-仪器验证报告；012.3-分析方法验证方案；012.4- 分析 方法验证报告) 4.3 记录的填写 Records Filling in 各种质量/技术记录应实时如实记录，认真填写、内容完整； All the quality/technical records shall be timely and faithfully recorded and carefully filled in with intact contents. 记录采用黑水钢笔或签字笔规范填写、字迹清晰，不得潦草。不得使用圆珠笔或者铅笔填 写； Records shall be standardly filled in with black pen or roller pen and the writing shall be clear without scrawl. Do not use ball pen or pensil. 记录表格不允许出现空项，数据项不需要填写时，应用斜线“/” ； Any column in the form shall not appears empty. If the data item need not filling in, write a slash “/“. 检验工作完成后，由熟悉该项目的检验人员对记录进行复核，复核是否完整、正确。 After inspections are finished, inspectors who are familiar with that project shall review the integrity and correctness of the records. 4.4 记录的更改 Record Changes 记录形成后发现错误时,不允许涂改，应划改，并签上姓名、日期。并能清楚辨识更改前的 记录； If mistakes are found after records have been formed, do not obliterate, but cross out and rewrite, then sign with name and date. The previous records shall be clearly identified. 4.5 记录的收集、归档 Record Collection and Archive 检测人员负责及时收集、整理，保证记录不丢失和损坏，保证记录的完整和清晰，按照月 或年度定期送文件管理员归档，文件管理员填写记录归档登记 。 Inspectors are responsible for timely collecting and sorting out to ensure that records wont be lost and damaged and to keep record integrity and clarity. Inspectors shall monthly or yearly archive records, and fill in Registration Form of Record Archive. 4.6 记录的索引 Record Index 文件管理员对保存的记录，按要求进行分类、编制索引目录，以便于检索。 As for the reserved records, file manager shall classify and compile index catalog in accordance with requirements, so that it will be convenient to search. 4.7 记录的存档 Record Archive 记录保存在有防止损坏、变质、丢失的适宜环境的设施中。文件管理员编制记录清单 ， 规定各种记录的保存期限。一般情况下人员、设备档案、验证、稳定性试验等技术资料长 期保存；电子记录保存时间至少 10 年，产品检验记录保存至有效期后一年。 Records shall kept in a suitable environment which can prevent records from damage, deterioration and lost. File Manager is responsible for compiling Record List and stipulating the retention period of each record. In general, technical information including personnel, equipment files, validation and stability tests shall be kept in long term；electronic records shall be kept for at least 10 years; product inspection records shall be kept for one year after the expiry date. 4.8 记录的维护 Record Maintenance 存放于硬盘、软盘等介质中的记录数据每一年时间，必须把数据刻录成光盘，以便保存； 资料柜应具备空气流通、防潮、防火、防霉变、防虫蛀、防丢失等措施，必要时应有温度 与湿度控制措施，外来人员未经许可不得进入； Yearly record the data which is stored in hard disks, floppy disks and other media into a CD in order to preserve. Filing cabinet shall be protected with measures wich can promote air flow and prevent moisture, fire, mildew, moth and lose, and be equipped with temperature and humility controlling devices if necessary. Unauthorized visitors are not allowed to enter in. 在保护客户机密的前提下，记录可以借阅。借阅人必须是实验室与对应检验项目有关人员， 其它人员不得查阅。借阅时须填写文件借阅登记 ，经文件管理员确认； In the premise of protecting client confidentiality, records can be borrowed. The borrower must be someone in the laboratory who is related with the corresponding inspection item, and others are not allowed to borrow. While borrowing, the borrower shall fill in File Borrowing Registration Form which should be confirmed by file manager. 记录须复制时须经质量负责人批准，审批证明材料由文件管理员随记录保存。 The copy of records shall be subject to quality leaders approval and the approved supporting evidence shall be kept together with records by file manager. 4.9 记录的清理 Record Cleaning 对超过保存期限的记录，由文件管理员列出过期记录清单，报质量负责人审核、实验室主 任批准后销毁。销毁时须有两人以上在场并签字确认，填写文件销毁记录 。 File Manager shall list those records which have been beyond retention period, report to quality leader for review, and conduct destruction after being approved by laboratory director. While destroying the records, there are at least two person on site with their signature for confirmation. Besides, File Destruction Record needs filling in. 4.10 电子记录按照电子数据管理规程执行。 According to Management Procedure of Electronic Data, execute electronic