产品标识和追溯程序-英文版
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Prepared By:起草:Yang XiaoningRevised By:审核:Wenyi LiApproved By:批准:Dunguo PeiTQSP –Quality Management System泰纳瑞斯青岛厂质量管理体系PRODUCT IDENTIFICATIONAND TRACEABILITY产品标识和可追溯性No./编号L3 QA –011Revision/版本10Effective Date/生效日期03/12/2008Total Pages/总页数11Important NoticeThe document that you have printed might be invalid.Before imp lementation, p lease check the latest ap p licableversion posted in Computer System.重要提示:为避免使用过期文件,在实施前,必须核对计算机系统中的最新版本。
1OBJECTIVE目的The objective of this procedure is to set up a guide line to identify products and keep good productstraceability in TQSP.本程序的目的是在青岛泰纳瑞斯建立标识产品和保持良好的产品可追溯性的操作指南。
2SCOPE范围This document is applicable to the identification and status of material and product processed in TQSP.本文件适应于泰纳瑞斯青岛钢管厂生产过程中材料和产品的标识和状态。
3REFERENCE DOCUMENTS参考文件·Tenaris L2 7.01Product realization泰纳瑞斯L2 7.01产品实现·API Specification Q1 –latest Edition.API规范Q1—最新版本·API Specification 5B, 5CT.API5B, 5CT规范4DEFINITIONS AND ABBREVIATIONS定义和缩写·TQSP:Tenaris Qingdao Steel Pipe Mill泰纳瑞斯青岛钢管厂·QMS:Quality Management System质量管理体系·QA: Quality Assurance质量保证·NC: Non-conformity不合格·VERI: Verification Group of Quality 质量验证小组·WMS:Weighing, measuring and stenciling 称重、测量、打印·CSU:Cargo self-storable unit自卸单元5RESPONSIBILITY职责SC Logistics is responsible for identification of tubular material and product stored in yard,andmaintaining the integrity of identification.物流负责货场贮存区域的管材和产品的标识,并维持相关标识的完整性。
Procedure: [Identification & Traceability Proc. Title]1. SUMMARY1.1. This procedure defines the methods used to identify and (where applicable) provide uniquetraceability for [Short Client Name] products. This procedure includes methods:1.1.1. To define the methods for identifying products (what they are)1.1.2. To define the methods for identifying products as to their current inspection or teststatus1.1.3. To define the methods for segregating and discriminating between product andtooling when their appearance is similar1.1.4. To define the methods for providing traceability, including unique serialization, orproduct as applicable1.2. The [who?] is responsible for implementation and management of this procedure.2. REVISION AND APPROVALRev. Date Nature of Changes Approved By[Rev Number] [Date ofIssue]Original issue.[ProcedureApproverName]3. APPLICATION3.1. This procedure applies to all departments which use, handle, transport, store, inspect ormanufacture product, raw materials and tooling, at all [Short Client Name] facilities.3.2. This procedure not only applies to typical product, but also deliverables from services, such asreports, schedules, etc.3.3. Non-critical materials or supplies, which are not incorporated into final product or which serveonly to support facilities or operations, are not subject to this procedure.4. DEFINITIONS4.1. Product4.1.1. “Product” includesany of the following:Any part, assembly or item ordered by the customerDeliverable reports or documentsProduct may refer to finished product, or work in process (WIP)4.2. Raw Materials4.2.1. “Raw materials” include any of the following:Any materials or items (metals, plastics, components, pre-built assemblies, smallparts) which become part of the finished product’s physical construction; some ofthese items may sometimes be referred to as “consumables”.Coatings, paint, plating, adhesives, chemicals or materials which will be incorporatedinto (or onto) the final product.4.3. Tooling4.3.1. “Tooling” can include any of the following:Devices used by manufacturing for setup or production, including fixtures and jigs.Devices used by inspection for determining acceptance of product, including testfixtures.Shop aids, which are simple devices (blocks, spacers, shapes) used to assist inproduction or development, but which are not precision tools and which can be usedfor a variety of applications.4.3.2. Tooling does not include:Cutting tools, drill bits, etc.Hand toolsMachining equipment5. PRODUCT5.1. There are many ways to identify product; this procedure presents the most typical, acceptablemethods. Additional product identification methods may be called out in the design or productiondocumentation.5.2. Identification typically includes the part number, revision, Work Order # and unique serialnumber (if applicable).5.3. Identification is done through any of the following methods:5.3.1. Part marking, by way of ink marking, etching or some other method.5.3.2. Bag-and-tag methods, especially for small parts.5.3.3. Placement of parts on shelves or in containers that are properly marked, withsignage or other methods.5.3.4. Placement of parts near associated paperwork, for the purpose of identification andtraceability, may be used if the paperwork can clearly be identified as relating to theparts in question, typically by way of the inclusion of a drawing which can becompared to the product.5.3.5. Segregating entire areas of the production floor with belt stanchions and attachedsignage, indicating what type of items are allowed, or disallowed, within the enclosedarea.。
1.0 PURPOSE 目的1.1 This procedure defines the product Identification and Traceability system to prevent unintendeduse and ensure the traceability for production and quality.定义产品标识和追溯性系统,防止产品混用,确保对产品质量及形成的过程实现可追溯性。
2.0 SCOPE 范围2.1 Apply to the materials, semi-products and finished products.适用于原料,半成品及成品的标识和追溯。
3.0 DEFINITIONS定义3.1 Product identification: make clear and understandable mark by special number, part number orcomparable mark and status mark.产品标识:通过特定的编号、零件号、或可比较的记号和状态标记,对产品做出清楚的、易理解的标记。
3.2 Traceability: the capability to trace the history, application or location, it refers to resource ofmaterial and component, manufacturing process, distribution status of delivered products.可追溯性:追溯产品的历史、应用情况或所处场所的能力,涉及材料和零件的来源、加工过程、交付后产品的分布状况。
4.0 REFERENCE DOCUMENTS参考文件4.1 ISO/TS 16949 Clause 7.5.3 Identification and Traceability 标识和可追溯性5.0 RECORDS 记录5.1 FN-AS-003 Production batch record form 《生产批号记录表》6.0 RESPONSIBILITY职责6.1 Program department create part number.项目部负责创建材料和产品料号。
标识可追溯性管理程序Identification and Traceability Management Procedure(IATF16949-2016)1、目的1. Purpose防止不同类别、不同检验状态的产品混用和误用,当有规定时,实现产品的可追溯性。
It aims to prevent products with different types and inspection statuses from being blended and misused and realize product traceability if it is specified.2、适用范围2. Scope适用于物料、在制品和成品的产品标识及检验状态标识。
It applies to identification of materials, products in progress and finished products and the inspection statuses.3、定义3. Definition3.1产品标识:为识别、说明产品品种、规格、质量状况、生产状况,附在产品表面或特殊部位的文字、数字、标签等。
3.1 Product identification: Words, figures and labels attached to the surface or special part of the product to identity and state the product kind, specification, quality status and production status.3.2可追溯性:根据记载的标识,追溯实体的历史、应用情况和所处场所的能力。
3.2 Traceability: Trace the history, application condition and location capability of the substance according to the identification recorded.3.3待检品:等待检验的产品。
产品标识和可追溯性控制程序Product Identification and Traceability Control Procedure(ISO9001:2015)1目的:Purpose使所有的物料从购进到交付,都可以由其位置、所贴标签等标识清晰识别,并且可以由标识追溯到相关的人、机、法、环、料。
To make all materials can be clearly identified from purchase to delivery through the place and labels that be marked, and can be traced to relevant personnel, machine, law, environment and materials by the identification.2 适用范围:scope本程序适用于公司所有物料从购进到交付的各个阶段。
Be applicable to each stage of all company materials from coming in to delivery.3 程序:Process:3.1 标识Identification:3.1.1 从原材料到成品,所有的物料都必须按其质检状态放置在规定的区域内。
All materials that from raw material to finished products should be placed in the stipulated areas as per the inspection status.3.1.2 原材料和成品包装上必须有标签可以明确识别其型号、数量、质检状态、物料批次等Packages of raw materials and finished products should have labels that can be used to clearly identify the type, quantity, inspection status, material lot number and etc.3.1.3 车间流动的半成品通过生产流程卡识别其型号、物料批次等。
程序文件编号:NK/QSP-753-01版号:A/0发布日期:2018年02月01日实施:2018年02月01日拟制:审核:批准:受控编号:受控印章:1.目的防止不同类别、不同检验状态的产品混用和误用,当有规定时,实现产品的可追溯性。
2.适用范围适用于物料、半成品和成品的产品标识及检验状态标识。
3.职责3.1.生产部组织实施生产过程中产品标识和可追溯性工作。
3.2. 质量部负责确定生产过程各阶段产品可追溯性的唯一性标识以及标识的位置和方法。
3.3. 质量部负责所有产品标识的监督检查工作及检验状态或印章使用。
3.4. 仓库管理员负责对入库原辅材料、外购外协件和不同品种、规格、批次、货源单位进行明确标识和记录,防止混用。
4.5.仓库、车间负责所属区域产品的标识,负责不同检验状态产品的分区摆放,及所有标识的维护。
4.工作程序4.1.进货物料4.1.1.物料进厂,仓管员负责将其放置于待检区,对于本身未做产品标识或标识不清的物料,需贴物料标识卡,注明物料名称、数量、进货日期等内容。
4.1.2.经质量部检验合格的物料,由检验员签字后方可办理入库手续。
4.1.3.检验不合格的物料保持原有产品标识,放置于不合格品区。
4.1.4.对于紧急放行的物料用“紧急放行”标签或印章对其进行标识,便于追溯(本公司不执行紧急放行)。
4.2.生产过程中的标识4.2.1.对于生产过程中所使用的物料,如未能保持其原有产品标识,车间可在盛装的容器上直接标明其名称、型号(规格),进行标识。
4.2.2.对于待检品,需放置于待检盒,对于合格品,需放置于合格品区,对于不合格品(包括物料),需放置于不合格品区。
4.3.成品标识4.3.1.加工完成或各种原因退回的成品,如包装上已有注明,可不再做产品标识,放置于待检区(检验后,可保持其原有产品标识)。
4.3.2.检验合格的成品,由检验员签字后方可办理入仓手续。
4.3.3.检验不合格的成品,直接将其放置于不合格品区。
rev-00 / 01-19-07 - Approved by: enter name(s) hereCustomization Notes: delete this section on completiona)header - enter revision / date & approver(s)b) 1.0 - change [MyCompany] to your company namec) 2.x - define your Traceable Items, IDs & numbering preferencesd)global - personalize -1.0 Purpose and ScopeThis procedure establishes the system and instructions for product identification and traceability. Itapplies to all materials, in-process products and final products purchased and sold by [MyCompany] .1.1DefinitionsBatch Number : Unique number identifying a volume of -pro“ceinss ” product. Batch numbers accompany the Operation sheet, which documents its content and inspections. After final batchinspections, this volume is transferred to a Production Lot volume.Certificate of Analysis (COA) : A document listing the specification requirements for the productcomprising a unique lot with the actual results obtained from specification testing for that lot. Copies of applicable COAs are provided with customer deliveries, and identify the internal lot number andverification of product conformance to specification.Lot Number : A homogeneous production volume of finished product that is held in a singlecontainer where representative samples are taken and analyzed to provide an authentic certificate of analysis for the specific volume.Operation Sheets: Official production workorder to manufacture product, which is issued anduniquely identified. Operation Sheets consists of a defined sequence of operational steps (e.g.routing, batch), which are required to produce, inspect, and track product batches.Operation sheets further document compliant completion of each step, recording of criticalproduction data ( actual volume vs planned volume) and signoff by person performing task.Responsibility of each step is defined and typically include ( but not limited to) operations andinspection. Operation sheets are intended to be a simplified checklist of tasks performed and verified on completion. SOPs can be referenced to define details of standard operations.Raw Material : Purchased (or internally produced) materials which are required to produce thecompany 's finished products. Supplier, dates, and lot numbers provide traceability.Further, raw material codes also identify “ i-npr ocess ”product which is to be transferred, stored,inspected, and/or further processed.SOP: Standard Operating Procedures. Similar to Operation Sheets, SOPs define a sequence ofoperation. SOPs are typically posted or accessible at point of use. Compliance to step-by-stepactions is procedurally required, but do not require the formal sign-off signature as does theoperation sheet. Operation sheets typically call-out SOPs to define details. SOPs are a controlleddocument ( assigned# & revision).rev-00 / 01-19-07 - Approved by: enter name(s) here2.0 Procedure2.1Purchased Product Identification2.1.1All purchased materials are identified with unique material codes. The identification is the sameas is used on product specifications, bills of materials, purchase orders, etc.2.1.2Purchasing has visibility of the vendor lot number to each lot of purchased materials.Purchasing is able to tie the receipt of raw material to the Purchase Order, supplier and vendor lotnumber.2.1.3Purchasing will maintain a vendor folder for each item that contains certifications, lot controlnumbers and inspection reports. This documentation will be retained for a required period of time.2.1.4Suppliers are required to identify product shipments in accordance with instructions on thepurchase order. Plant Receiving verifies that products are properly identified. If the supplieridentification is not adequate, Receiving is responsible for specifying appropriate identification ofpurchased products, and to correct all paperwork prior to formally receiving the goods. Purchasingwill review all inappropriate identification with the supplier for corrective action.2.1.5Certain materials are specified which require receiving inspection and approval by the QA Lab.The QA Lab is responsible for providing written instructions regarding such material. When such anitem is received, it must be quarantined until the QA Lab approves it for use. The QA Lab will keep a record by material code which includes the material certification and QA Lab Release, as applicable,for a period of two years minimum.2.2 Manufactured Product Identification2.2.1 In-Process products shall be uniquely identified on the operation sheets, as they arebeing processed through the plant.2.2.2 Final Production Lots are identified by Lot Numbers. The lot number shall accompanythe Operation Sheet which documents the included batch volumes, final inspection, and generation of the COA.。
Customization Notes: delete this section on completiona) header - enter revision / date & approver(s)b) 1.0 - change [MyCompany] to your company namec) 2.x - define your Traceable Items, IDs & numbering preferencesd) global - personalize -1.0 Purpose and ScopeThis procedure establishes the system and instructions for product identification and traceability. It applies to all materials, in-process products and final products purchased and sold by[MyCompany].1.1 DefinitionsBatch Number: Unique number identifying a volume of “in-process” product. Batch numbers accompany the Operation sheet, which documents its content and inspections. After final batch inspections, this volume is transferred to a Production Lot volume.Certificate of Analysis (COA): A document listing the specification requirements for the product comprising a unique lot with the actual results obtained from specification testing for that lot. Copies of applicable COAs are provided with customer deliveries, and identify the internal lot number and verification of product conformance to specification.Lot Number: A homogeneous production volume of finished product that is held in a single container where representative samples are taken and analyzed to provide an authentic certificate of analysis for the specific volume.Operation Sheets: Official production workorder to manufacture product, which is issued and uniquely identified. Operation Sheets consists of a defined sequence of operational steps(e.g. routing, batch), which are required to produce, inspect, and track product batches.Operation sheets further document compliant completion of each step, recording of critical production data ( actual volume vs planned volume) and signoff by person performing task.Responsibility of each step is defined and typically include ( but not limited to) operations and inspection. Operation sheets are intended to be a simplified checklist of tasks performed and verified on completion. SOPs can be referenced to define details of standard operations.Raw Material: Purchased (or internally produced) materials which are required to produce the company’s finished products. Supplier, dates, and lot numbers provide traceability.Further, raw material codes also identify “in-pr ocess” product which is to be transferred, stored, inspected, and/or further processed.SOP: Standard Operating Procedures. Similar to Operation Sheets, SOPs define a sequence of operation. SOPs are typically posted or accessible at point of use. Compliance to step-by-step actions is procedurally required, but do not require the formal sign-off signature as does the operation sheet. Operation sheets typically call-out SOPs to define details. SOPs are a controlled document ( assigned# & revision).2.0 Procedure2.1 Purchased Product Identification2.1.1 All purchased materials are identified with unique material codes. The identification is thesame as is used on product specifications, bills of materials, purchase orders, etc.2.1.2 Purchasing has visibility of the vendor lot number to each lot of purchased materials.Purchasing is able to tie the receipt of raw material to the Purchase Order, supplier and vendor lot number.2.1.3 Purchasing will maintain a vendor folder for each item that contains certifications, lotcontrol numbers and inspection reports. This documentation will be retained for a required period of time.2.1.4 Suppliers are required to identify product shipments in accordance with instructions onthe purchase order. Plant Receiving verifies that products are properly identified. If the supplier identification is not adequate, Receiving is responsible for specifying appropriate identification of purchased products, and to correct all paperwork prior to formally receiving the goods.Purchasing will review all inappropriate identification with the supplier for corrective action.2.1.5 Certain materials are specified which require receiving inspection and approval by theQA Lab. The QA Lab is responsible for providing written instructions regarding such material.When such an item is received, it must be quarantined until the QA Lab approves it for use.The QA Lab will keep a record by material code which includes the material certification and QA Lab Release, as applicable, for a period of two years minimum.2.2 Manufactured Product Identification2.2.1 In-Process products shall be uniquely identified on the operation sheets, as they arebeing processed through the plant.2.2.2 Final Production Lots are identified by Lot Numbers. The lot number shall accompanythe Operation Sheet which documents the included batch volumes, final inspection, and generation of the COA.。