范围定义似乎是欧美质量步骤中的固定项目。在看VDA6.3，开始也是先定义范围。
个人觉得对于PFMEA而言，范围定义有一个特别重要的意义。我们在讨论风险时，容易无限扩大化，将很多前端或者关联的风险都包含进来。因为制程本身是在客观世界存在，所以关联的内容也很多。如果团队的成员对于范围没有形成共同的认识，那么往往在后续的分析中，容易陷入扩大化，或者局部遗漏的情况，需要花费很多时间去反复统一认识。因此，范围定义看起来很简单，认真分析，统一认识对于后面分析顺利开展尤为重要。
3.1 Process FMEA 1st Step: Scope Definition PFMEA第一步：范围定义
3.11 Purpose 目的
The purpose of the Process Scope Definition is to describe what product/processes are to be included of excluded for review in PFMEA project
The process takes into account that all processes within the facility can be analyzed or reanalyzed using PFEMA. This process allows an organization to review all processes at a high level and to make a final determination which processes will be analyzed. The overall advantage of scoping is to focus resources on processes with the highest priority.
制程范围定义的目的是为了描述哪些产品/制程是被包含或者不包含在PFMEA项目的审视对象。
该流程认为工厂内所有制程都可以使用PFMEA进行分析或再分析。该流程让组织从高层面去审视全制程，并最终确定哪些制程将被分析。范围定义的整体优势是将资源集中在具有最高优先度的制程上。
The main objectives of defining the Process Scope Definition are:
l Project Identification – What process/part of a process is being analyzed?
l Project Plan – Development of list of potential team members, project timeline. Etc.(5T’s)
l Define the boundaries of the analysis – what is included, what is excluded?
l Identifying relevant Lessons learned and determining information that should be used, such as: best practices, guidelines, standards, error-proofing methods, etc.
过程范围定义的主要目标为：
l 项目定义 – 哪些制程/部分制程将被分析
l 项目计划 – 建立潜在团队成员，项目时间表等（5T）的清单
l 定义分析边界 – 什么是包含，什么是不包含
l 识别需要学习的相关课程，确定哪些信息需要是使用，如：最佳实践，指南，标准，防呆方法等。
The scope needs to be established at the start of the process to assure consistent direction and focus, e.g. an entire process line, process item/process element.
Processes within the plant that can impact the product quality and can be considered for PFMEA analysis: receiving processes, part and material storage, product and material delivery, manufacturing, assembly, package, product and material delivery, manufacturing, assembly, packaging, labeling, completed product transportation, storage, maintenance processes, detection processes and rework and repair processes, etc.
范围必须在该流程开始就被明确，以确保一致的方向和聚焦。例如：一个全流程产线，制程项目/制程要素。
工厂中的制程都可能影响到产品品质，可以考虑进行PFMEA分析：收货过程，部品和材料储存，产品和材料运输，制造，装配，包装，标签，完成品运输，储存，保养过程，检查过程，返工和修理过程，等。
图示3.1-1 缩小范围的流程范例
步骤1 定范围：全流程层面
步骤2 定范围：部门层面
步骤3 定范围：产线层面
步骤4 结构分析：制程结构
Items that may assist in determining whether a existing PFMEA should be included in the final scope:
l New development of products & processes
l Changes to products or processes
l Changes to the operating conditions
l Changed requirements(laws/regulations, standards/norms, customers. state of the art)
l Manufacturing experience, 0 km issues, or field issues/Warranty
l Process failures that may result in hazards
l Findings due to internal product monitoring
l Ergonomic issues
l Continuous improvement
下面是一些能够帮助决定一个现有的PFMEA可能包括哪些最终范围：
l 新设计的产品和制程
l 产品或制程的变更
l 作业环境的变更
l 需求（法律法规，标准规范，客户，业界动向）
l 制造经验，0 km issues，或现场问题/保证
l 影响巨大的制程失效
l 内部产品监控的调查结果
l 人机工学问题
l 持续改善
During Scope Definition, the header of the PFMEA document should be filled out. The header includes some of the basic PFMEA information, as follows.
通过定义范围，PFMEA文件的抬头可以填充完整。抬头包括以下基础的PFMEA信息，如下：
Company Name: Name of company of the PFMEA
Plant Location: what is the location of the plant – Geographical designation for manufacturing and/or line unique identifier
Customer Name: Name of customer(s) for this document and System /Subsystem /Component /Part
Model Year / Platform ：Starting vehicle model year and/or vehicle program as applicable
Subject： Name of PFMEA project
PFMEA Start Date: The date on which the PFMEA project stated
Cross-Functional Team: Team whose members include personnel from the organization and may include customer and supplier representatives; team members may internal or external to the organization
PFMEA Revision Date: The revision of the specific unique PFMEA document(latest date it was changed)
PFMEA ID Number: A unique identification number for the PFMEA document
Process responsibility: Name of person who is responsible for the PFMEA
Confidentiality level: The level of confidentiality determined by the PFMEA owner, e.g. Internal Business Use, Proprietary, Confidential.
公司名称：PFMEA的公司的名称
工厂位置：工厂位置在哪里-生产地的地理描述和/或 产线独特标示
客户名称：这个文件和系统/子系统/构件/部件的客户的名称
车型年份/平台：开始车型年份 和/或 实施的车型项目
项目：PFMEA项目名称
PFMEA开始日期：PFMEA项目开始的日期
多功能组：组织内成员包括人事，可能包括客户或供应商代表；团队成员可能来自组织内部或组织外部。
PFMEA生效日期：特定唯一PFMEA文件的版本（被变更的最后日期）
制程职责：对于PFMEA负责的人的名字
保密程度：由PFMEA负责人确定保密等级，如内部使用，专利，保密。
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