[质量管理]ISOTC176SC 2N 544R3过程(doc 15页)中英对照

中国最庞大的下载资料库 (整理. 版权归原作者所有 如果您不是在3722.cn 网站下载此资料的,不要随意相信.请访问 3722, 加入)3722.cn必要时可将此文件解密成可编辑的DOC或PPT格式Document: ISO/TC 176/SC 2/N 544R31. Introduction 简介This guidance document provides an understanding of the concepts, intent and the application of the “process approach” to the ISO 9000 family of Quality Management System standards. The guidance may also be used to apply the process approach to any management system regardless the type or the size of organization. This includes but is not limited to management systems for:本指导文件提供了质量管理体系标准ISO 9000族“过程方法”的概念、意图及应用。本指导文件也可用于将过程方法应用于任何管理体系，无论组织的类型和规模。包括但不限于以下管理体系： Environment (ISO 14000 family), Occupational Health and Safety, Business Risk, Social Responsibility.This guide also aims to promote a consistent approach to the description of processes and use of process related terminology. 本指导文件目的：在描述过程和使用过程相关术语方面提供统一的方法。The purpose of the process approach is to enhance an organizations effectiveness and efficiency in achieving its defined objectives. In relation to ISO 9001:2008 this means enhancing customer satisfaction by meeting customer requirements.过程方法的目的是增强组织达成既定目标的有效性和效率。结合ISO 9001：2008，就是通过某种顾客要求增强顾客满意。Benefits of the process approach are: 过程方法的益处： Integration and alignment of processes to enable achievement of desired outcomes 整合过程实现既定目标 Ability to focus effort on process effectiveness and efficiency. 能够关注于过程的有效性和效率 Provision of confidence to customers, and other interested parties, about the consistent performance of the organization. 得到顾客和其他相关方对组织的持续业绩方面的信心 Transparency of operations within the organization. 组织内操作透明化 Lower costs and creation of shorter cycle times, through the effective use of resources. 通过有效利用资源缩短循环产生的时间，降低成本 Improved, consistent and predictable results. 改善，持续的和可预测的结果 Provision of opportunities for focused and prioritized improvement initiatives【Reengineering, Quality Control Circles, 5 S, 6 sigma, Balanced Scorecard, ISO Certification, Just In Time, Cost of Quality, Benchmarking, Total Quality Management, Customer Service Programmes, Taguchi Methods, Quality Function DeploymentJelly】. 为关注于改善行动并将其排序提供机会 Encouragement of the involvement of people and the clarification of their responsibilities. 鼓励员工参与，分清他们的责任2. What is a process? 什么是过程A “Process” can be defined as a “set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials. Figure 1 shows a generic process. “一组相互联系或相互作用的将输入转换为输出的活动”。这些活动需要资源如人和原材料的配置。A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the interfaces between the functional hierarchies of the organization (as further explained in section 4).比较其他方法，过程方法的主要优点体现在这些过程之间的相互作用和职能部门接口的管理和控制（见第4节解释）Figure 1. A generic process 通用过程Inputs and intended outputs may be tangible (such as equipment, materials or components) or intangible (such as energy or information). Outputs can also be unintended, such as waste or pollution.输入和预期输出可以是有形的（如设备、原材料和样件）或无形的（如能源或信息）。输出也可以是非预期的，如废物或污染。Each process has customers and other interested parties (who may be either internal or external to the organization), with needs and expectations about the process, who define the required outputs of the process. 每个过程都有顾客和其他相关方（组织内部或外部），他们对过程有需要和期望，他们确定了所需的过程输出。A system should be used to gather data to provide information about process performance, which should then be analyzed to determine if there is any need for corrective action or improvement. 应该利用系统收集提供过程业绩信息的数据，然后分析这些数据确定是否需要采取纠正措施或改进。All processes should be aligned with the objectives, scope and complexity of the organization, and should be designed to add value to the organization.所有过程应与组织的目标、范围和复杂程度相结合，并以能为组织增值为目的设计这些过程。Process effectiveness and efficiency can be assessed through internal or external review processes.可以通过内外审来评价过程的有效性和效率3. Types of processes 过程类型3.1 References to processes in ISO 9001:2008: 引用ISO 9001:2008相关过程ISO 9001:2008 states: ISO 9001:2008 规定：In sub clause 0.1 General: “The design and implementation of an organizations quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment; its varying needs; its particular objectives; the products it provides; the processes it employs; its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation”.0.1总则条款：“一个组织质量管理体系的设计和实施受下列因素的影响：组织的业务环境、该环境的变化或与该环境有关的风险，组织的不同需求，组织的特定目标，所提供的产品，所采用的过程，组织的规模和组织结构。统一质量管理体系的结构或文件不是本标准的目的”。In sub clause 0.2 Process Approach: “The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“.0.2过程方法条款：“为了产生期望的结果，组织内诸过程组成的系统的应用，连同这些过程的识别和相互作用，以及对这些过程的管理，可称之为“过程方法”。In sub clause 4.1 General requirements: “The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall:a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2),b) determine the sequence and interaction of these processes,c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,e) monitor, measure (where applicable), and analyse these processes, andf) implement actions necessary to achieve planned results and continual improvement of these processes.4.1总要求：组织应按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。组织应：a) 确定质量管理体系所需的过程及其在整个组织中的应用（见1.2）；b) 确定这些过程的顺序和相互作用；c) 确定为确保这些过程的有效运作和控制所需的准则和方法；d) 确保可以获得必要的资源和信息，以支持这些过程的运作和监视；e) 监视、测量(适用时)和分析这些过程；f) 实施必要的措施，以实现对这些过程所策划的结果和对这些过程的持续改进。These processes shall be managed by the organization in accordance with the requirements of this International Standard”.组织依照本国际标准管理这些过程。Based on the above, each organization should define the number and type of processes needed to fulfil its business objectives. It is permissible for a process that is required by ISO 9001:2008 to be part of a process (or processes) that is already established by the organization, or to be defined by the organization in terms that are different to those in ISO 9001.基于上述规定，每个组织都应该确定达成业务目标所需的过程数量和类型。ISO 9001：2008规定的过程可以是组织已经建立的某一（组）过程的一部分，或者以与ISO 9001规定不同的方式确定该过程。3.2 Typical types of processes that can be identified: 过程的典型类型In accordance with 3.1 above, organizations have to define the number and types of processes needed to fulfil their business objectives. While these will be unique to each organization, it is however possible to identify typical processes, such as:按照上面3.1之规定，组织须确定达成业务目标所需的过程数量和类型。由于这些过程对每个组织而言是独特的，但可以识别典型过程，如：- Processes for the management of an organization. These include processes relating to strategic planning, establishing policies, setting objectives, ensuring communication, ensuring availability of resources for the other organizations quality objectives and desired outcomes and for management reviews. - 组织管理过程：包括与为组织质量目标和预期输出和管理评审而进行的战略策划、建立方针、设定目标、沟通保证机制、资源提供保障相关的过程。- Processes for managing resources. These include all the processes that are necessary to provide the resources needed for the organizations quality objectives and desired outcomes. - 资源管理过程：包括为组织质量目标和预期输出提供所需资源所必需的过程。- Realization processes. These include all processes that provide the desired outcomes of the organization. - 实现过程：包括提供组织预期输出的所有过程。- Measurement, analysis and improvement processes. These include the processes needed to measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring, auditing, performance analysis and improvement processes (e.g. for corrective and preventive actions). Measurement processes are often documented as an integral part of the management, resource and realization processes; whereas analysis and improvement processes are treated frequently as autonomous processes that interact with other processes, receive inputs from measurement results, and send outputs for the improvement of those processes.- 测量、分析和改进过程：包括测量和收集用于业绩分析和改进有效性和效率所需的过程。包括测量、监控、评审、业绩分析和改进过程（即，纠正和预防措施）。作为管理、资源管理和实现过程有机整体的一部分，通常测量过程需要记录在案；而分析和改进过程经常被当作是自发的过程，它与其它过程相互影响，把测量结果作为输入，并把输出传递给这些过程的改进。.4. Understanding the process approach 理解过程方法A process approach is a powerful way of organizing and managing activities to create value for the customer and other interested parties. 过程方法是组织和管理为顾客和相关方创造价值的强有力的方法。Organizations are often structured into a hierarchy of functional units. Organizations are usually managed vertically, with responsibility for the intended outputs being divided among functional units. 通常组织的结构是职能部门的层级体系。通常实行垂直管理，实现预期输出的责任被分散到职能部门。The end customer or other interested party is not always visible to all involved. Consequently, problems that occur at the interface boundaries are often given less priority than the short-term goals of the units. This leads to little or no improvement to the interested party, as actions are usually focused on the functions, rather than on the intended output.所有相关部门看不见最终顾客或相关方。其结果是，通常相关部门内的短期目标优先于发生在部门与部门之间的问题。从而导致相关部门改善甚微或没有改善，因为其措施侧重于职能而非预期输出。The process approach introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals of the organization.过程方法引入水平式管理，消除部门之间的障碍统一到组织的主要目标上来。It also improves the management of process interfaces (see Figure 2). 过程方法也改善了过程接口（见图2） Figure 2. Example of Process linkages across departments in an organization.图2 横跨组织内各部门的过程链接举例The performance of an organization can be improved through the use of the process approach. The processes are managed as a system defined by the network of the processes and their interactions, thus creating a better understanding of added value.通过使用过程方法可以改善组织业绩。提供把过程的网络及其相互作用，就这些过程当作系统来管理，这样对增值有更深入的理解。Note: The consistent operation of this network is often referred to as the system approach to management.注：这个网络的持续运作通常被称之为管理的“系统方法“Often the outputs from one process can be the inputs into other processes and are interlinked into the overall network or system (for generic examples, see Figure 3 and Figure 4).通常一个过程的输出可以是另一过程的输入，并以此连环形成整个网络或系统（通用例子见图3和图4） Figure 3. Example of a generic process sequence图3：通用过程次序举例Figure 4. Example of a process sequence and its interactions.图4：过程次序和相互作用举例5. Implementing the process approach 实施过程方法The following implementation methodology can be applied to any type of process. The step sequence is only one method and is not intended to be prescriptive. Some steps may be carried out simultaneously.以下实施方法可用于各种类型的过程。步骤次序只是一种方法，并无意成为规定。某些步骤可以同时执行。5.1 Identification of the processes of the organization 组织过程的识别（见附页）5.3 Implementation and measurement of the process 过程的实施和测量Implement the processes and their activities as planned.按策划实施过程及其活动。The organization may develop a project for implementation that includes, but is not limited to组织可以为实施建立项目，包括，但不限于： Communication, 沟通 Awareness, 了解 Training, 培训 Change management, 不断变化的环境 Management involvement, 管理层的参与 Applicable review activities. 实用的评审活动Apply the controls, and perform the monitoring and measurements as planned.按策划应用控制并进行监控和测量。5.4 Analysis of the process 过程分析Analyze and evaluate process information obtained from monitoring and measuring data, in order to quantify process performance. Where appropriate, use statistical methods.分析和评价通过监控和测量数据得来的过程信息，以便量化过程业绩。适用时，使用统计方法。Compare the results of process performance information with the defined requirements of the process, to confirm process effectiveness and efficiency and to identify any need for corrective action. 将过程业绩结果信息与规定的过程要求进行对比，确认过程的有效性和效率，识别纠正措施需求。Identify process improvement opportunities based on the results of the analysis of process information.根据过程信息分析结果，识别过程改进机会Report to top management, and other relevant people in the organization, on the performance of the process, as appropriate.适当时，将过程业绩上报最高管理层和组织内其他相关人员。5.5. Corrective action and improvement of the process 纠正措施和过程改进Whenever corrective actions are needed, the method for implementing them should be defined. This should include the identification and elimination of the root causes of the problems (e.g. errors, defects, lack of adequate process controls). The effectiveness of the actions taken should be reviewed. Implement the corrective actions and verify their effectiveness according to plan.无论何时需要纠正措施，应该对实施纠正措施的方法进行规定。应该包括问题（即错误，过失，缺乏足够的过程控制）根本原因的识别和消除。应该评审采取行动的有效性。实施纠正措施并按计划验证其有效性。When planned process outcomes are being achieved and requirements fulfilled, the organization should focus its efforts on actions to improve process performance to higher levels, on a continual basis. 但策划的过程输出得以实现不要要求得以满足时，组织应该关注于持续改进过程业绩至更高的水平。The method for improvement should be defined and implemented (examples of improvements include: process simplification, enhancement of efficiency, improvement of effectiveness, reduction of process cycle time). Verify the effectiveness of the improvement. 应该规定和实施改进方法（改进的例子包括：简化过程，提高效率和改进有效性，减少过程循环时间）。验证改进的有效性。Risk analysis tools may be employed to identify potential problems. The root cause(s) of these potential problems should also be identified and eliminated, preventing occurrence in all processes with similarly identified risks.可以采用风险分析方法识别潜在问题。还应该识别和消除潜在问题的根本原因，防止已同样识别出来的风险在所有过程发生。The Plan-Do-Check-Act (PDCA) methodology can be a useful tool to define, implement and control corrective actions and improvements. Extensive literature exists about the PDCA cycle in numerous languages.PDCA（计划-实施-检查-纠正）方法在规定、实施和控制纠正措施和改进方面是个很有帮助的方法。有各种各样语言的关于PDCA环的文献。The PDCA is a dynamic methodology that can be deployed within each of the organizations processes and across their interactions. It is intimately associated with planning, implementation, verification and improvement. PDCA是种动态方法，可应用于组织每个过程及其相互作用。它将策划，实施，验证和改进有机地结合在一起。Maintaining and improving process performance can be achieved by applying the PDCA concept at all levels within an organization. This applies equally to all processes, from high-level strategic processes to simple operational activities.通过在组织内所有阶层应用PDCA理念就可以实现过程业绩的保持和改进。这同样适用于所有过程，从高层战略过程到简单的操作活动。5.1 Identification of the processes of the organization 组织过程的识别Steps in theprocess approach过程方法的步骤What to do?干什么？Guidance指导内容5.1.1Define the purposeof the organization确定组织目的The organization should identify its customers and other interested parties as well as their requirements, needs and expectations, to define the organizations intended outputs.组织应该识别顾客及其他相关方，还有他们的要求、需求和期望，以确定组织的预期输出。Gather, analyze and determine customer and other interested parties requirements, and other needs and expectations. Communicate frequently with customers and other interested parties to ensure continual understanding of their requirements, needs and expectations. 收集、分析和确定顾客及其他相关方要求、其他需求和期望。频繁与顾客和其他相关方进行沟通确保持续了解他们的要求、需求和期望。Determine the requirements for quality management, environmental management, occupational health and safety, management, business risk, social responsibilities and other management system disciplines that will be applied within the organization.确定组织采用的质量管理，环境管理，职业健康和安全，管理，业务风险，社会责任和其它管理体系原则的要求。5.1.2Define the policiesand objectives ofthe organization确定组织方针和目标Based on the analyses of the requirements, needs and expectations, establish the organizations policies and objectives.基于对要求、需求和期望的分析，建立组织的方针和目标Top management should decide which markets the organization should address and develop relevant policies. Based on these policies, management should then establish objectives for the desired outcome (e.g. products, environmental performance, occupational health and safety performance).最高管理层应该决定组织应该想做的市场，制定相关的方针。基于这些方针，最高管理层应该为预期输出建立目标（即产品、环境绩效、职业健康和安全绩效）5.1.3Determine theprocessesin theorganization确定组织过程Determine all the processes needed to produce the intended outputs. 确定所有产生预期输出所需的全部过程Determine the processes needed for achieving the intended outputs. These processes include Management, Resources, Realization and Measurement, Analysis and Improvement.确定实现预期输出所需的过程。这些过程包括管理、资源、实现和测量、分析和改进。Identify all process inputs and outputs, along with the suppliers, customers and other interested parties (who may be internal or external). 同（内部或外部的）供应商、顾客和其他相关方一道识别所有过程的输入输出5.1.4Determine thesequenceof theprocesses确定过程的次序Determine how the processes flow in sequence and interaction.确定过程依次流动及其相互作用关系Define and develop a description of the network of processes and their interaction. Consider the following: The customer of each process, The inputs and outputs of each process, Which processes are interacting, Interfaces and their characteristics, Timing and sequence of the interacting processes, Effectiveness and efficiency of the sequence.确定和指导过程及其相互作用关系网络的描述。考虑如下内容：l 每个过程的顾客l 每个过程的输入输出l 哪些过程相互影响l 接口及其特性l 相互作用过程的时序l 这些次序的有效性和效率Note: As an example, realization processes (such as product delivered to a customer) will interact with other processes (such as the management, measurement