Introduction and support package Guidance on the concept and use of the process approach for management systems Document: ISO/TC 176/SC 2/N544R2(r) 13 May 2004

过程方法的概念和应用
ISO22000老师
ISO_22000@qq.com


引  言  
       本教程旨在提供对ISO 9000族质量管理体系标准的“过程方法”的概念、意图和应用的理解。不论组织的类型或规模如何，过程方法均可用于任何的管理体系。这包括但不限于下列的管理体系：

        ISO 14000 族环境管理,
        职业健康和安全管理,
        商业风险管理,
        社会责任管理.

      过程方法的目的是增强一个组织在取得其确定目标时的有效性和效率。
引言（待续）
      过程方法的好处：
        过程的整合和结合，使达到计划的效果；
        能够把努力的焦点放在过程有效性和效率上；
        对顾客和其他相关方提供该组织一贯表现的信心；
        在组织内运作的透明度；
        通过有效使用资源，降低成本和缩短周期时间；
        结果得到改善、始终一致和可预知；
        为受关注的和优先的改进行动提供机会；
        鼓励人们的参与和责任的阐明。
什么是过程？
        “过程”可以定义为“把输入转化为输出的一组相互关联的或相互作用的活动”。这些活动需要资源（诸如人和物质）的配置。下页的图1展示了一般的过程。
        与其他方法比较，过程方法的一个主要优点在于这些过程间的相互作用和组织的职能部门之间的接口的管理和控制。
图 1. 一般的过程
什么是过程?
        输入和预定的输出可能是有形的（如设备、材料或零件）或无形的（如能源或信息）。输出也可能是非预定的；例如废料或污染。
        每个过程均有顾客和（既可是组织内部或外部的）其他相关方，这些顾客和相关方受该过程的影响，并按他们的需求和期望确定所要求的输出。
        应用一个系统来收集数据，这些数据可进行分析以提供过程绩效和纠正措施或改进需求的信息。
        所有的过程应与组织的目标一致，并用来增加价值，与组织的范围和复杂性相匹配。
        过程的有效性和效率可通过内部或外部评审来进行评估。
过程的类型
    可确定下列类型的过程：
        组织的管理过程，这些过程包括与战略规划、确立方针、建立目标、进行沟通、确保获得所需资源和管理评审相关的过程。
        管理资源的过程，这些过程包括所有提供管理一个组织、产品实现和测量的过程所需资源的那些过程。
        产品实现的过程，这些过程包括提供组织预定输出的所有过程。
        测量、分析及改进的过程， 这些过程包括测量和收集用于绩效分析和有效性与效率改进的数据所需要的那些过程。它们包括测量、监视和审核的过程、纠正和预防措施 ，并且是管理职责、资源管理和产品实现过程的一个完整组成部分。
理解过程方法
        过程方法是组织和管理工作活动如何为顾客和其他相关方创造价值的一种强有力方法。
        各组织经常构建成职能单位的层级。根据在职能单位间划分的预定输出的责任，各组织常常是垂直管理的。对于所有的参与者来说，最终顾客或其他相关方并不总是可见的。其次，在接口边界出现的问题常常给予比本单位的短期目标不那么优先的考虑。这就导致很少或无针对相关方的改进，因为措施往往以职能为关注的焦点，而不是组织的总体利益。
        过程方法导入水平管理，穿越不同职能单位之间的壁垒并把他们的关注焦点集中到组织的主要目标上。它也改进了过程接口的管理。（参见图2）
图2. 一个组织中过程联系的例子
理解过程方法
        一个组织的绩效可以通过过程方法来改进。通过建立和了解这些过程的网络和它们的相互作用，这些过程作为一个系统加以管理。

   注释：这个网络始终一贯的运行常被称作管理的“系统方法”。
        来自一个过程的输出可以是其他过程的输入并与整个网络或系统相互联系在一起。
图 3. 一般过程顺序的例子
图 4. 过程顺序和它的相互作用
实施过程方法
      下列实施方法可用于任何类型的过程。步骤顺序只是一种方法，而不是要有意指定这样做。 某些步骤可同时进行。
1 . 组织过程的识别
2 . 过程的策划
3 . 过程的实施和测量
4 . 过程的分析
5 . 过程的纠正措施和改进
1. 组织过程的识别
组织过程的识别
组织过程的识别
组织过程的识别
组织过程的识别
2. 一个过程的策划
一个过程的策划
3. 过程的实施和测量
按计划，实施过程和它们的活动；
组织可为过程实施开发一个方案，它包括但不限于：
        沟通；
        意识；
        培训；
        变更管理；
        管理层参与；
        适用的评审活动；
按计划，实施测量、监视和控制。
4. 过程的分析
5. 纠正措施和过程改进
(Plan-Do-Check-Act)
(Plan-Do-Check-Act)
PDCA 方法可以是确定、实施和控制纠正措施和改进的一种有用工具。这种方法同样适用于高级战略过程和简单的运行活动。

过程方法的概念和应用
ISO22000老师
ISO_22000@qq.com

Introduction and support package
Guidance on the concept and use of the process approach for management systems

Document: ISO/TC 176/SC 2/N544R2(r)
13 May 2004


1. Introduction

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 of the type or the size of organization. This includes but is not limited to management systems for:

Environment (ISO 14000 family),
Occupational Health and Safety,
Business Risk,
Social Responsibilities.
This guide also aims to promote a consistent approach to the description of processes and use of process related terminology.

The purpose of the process approach is to enhance an organization's effectiveness and efficiency in achieving its defined objectives.

Benefits of the process approach are:

Integration and alignment of processes to enable achievement of planned results.
Ability to focus effort on process effectiveness and efficiency.
Provision of confidence to customers, and other interested parties, about the consistent performance of the organization.
Transparency of operations within the organization.
Lower costs and shorter cycle times, through the effective use of resources.
Improved, consistent and predictable results.
Provision of opportunities for focused and prioritized improvement initiatives.
Encouragement of the involvement of people and the clarification of their responsibilities.

2. What is a process?

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 the generic process.

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 hierarchy of the organization (as further explained in section 4).



Figure 1 - Generic process

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.

Each process has customers and other interested parties (who may be either internal or external to the organization) that are affected by the process and who define the required outputs according to their needs and expectations.

A system should be used to gather data, which can be analyzed to provide information about process performance and to determine the need for corrective action or improvement.

All processes should be aligned with the objectives of the organization and be designed to add value, relative to the scope and complexity of the organization.

Process effectiveness and efficiency can be assessed through internal or external review processes.

3. Types of processes

The following types of processes can be identified:

Processes for management of an organization. These include processes relating to strategic planning, establishing policies, setting objectives, providing communication, ensuring availability of resources needed and management reviews.
Processes for managing resources. These include all those processes for the provision of the resources that are needed for the processes for managing an organization, for realization, and for measurement.
Realization processes. These include all processes that provide the intended output of the organization.
Measurement, analysis and improvement processes. These include those processes needed to measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring and auditing processes, corrective and preventive actions and are an integral part of the management, resource management and realization processes.

4. Understanding the process approach

A process approach is a powerful way of organizing and managing how work activities create value for the customer and other interested parties.

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. 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 overall benefit to the organization.

The process approach introduces horizontal management, crossing the barriers between different functional units and unifying their focus to the main goals of the organization. It also improves management of process interfaces (see Figure 2).



Figure 2 - Example of Process linkages across departments in an organization.

The performance of an organization can be improved through the use of the process approach. The processes are managed as a system, by creating and understanding a network of the processes and their interactions.

Note: The consistent operation of this network is often referred to as the "system approach" to management.

The outputs from one process may be inputs to other processes and interlinked into the overall network or system (for generic examples, see Figure 3 and Figure 4).




Figure 3 - Example of a generic process sequence




Figure 4 - Example of a process sequence and its interactions

5. Implementing the process approach

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.


5.1. Identification of processes of the organization

引用:

原帖由 iso_22000 于 2008-6-14 11:17 发表
5. Implementing the process approach

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. So ...

Steps in the process approach	What to do?	Guidance
5.1.1 Define the purpose of the organization	The organization should identify its customers and other interested parties as well as their requirements, needs and expectations to define the organization's intended outputs.	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. 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.
5.1.2 Define the policies and objectives of the organization	Based on analyses of the requirements, needs and expectations, establish the organization's policies and objectives	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 intended outputs (e.g. products, environmental performance, occupational health and safety performance)
5.1.3 Determine the processes in the organization	Identify all the processes that are needed to produce the intended outputs	Determine the processes needed for achieving the intended outputs. These processes include Management, Resources, Realization and Measurement & Improvement. Identify all process inputs and outputs, along with the suppliers, customers and other interested parties (who may be internal or external).
5.1.4 Determine the sequence of the processes	Determine how the processes flow in sequence and interaction	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 what are their characteristics, - Timing and sequence of the interacting processes, - Effectiveness and efficiency of the sequence. Note: As an example, a realization process that results in an output, such as product delivered to a customer, will interact with other processes (such as the management, measurement and monitoring, and resource provision processes). Methods and tools such as block diagrams, matrix and flowcharts can be used to support the development of process sequences and their interactions.
5.1.5 Define processownership	Assign responsibility and authority for each process	Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each process and its interactions. Such an individual is usually referred to as the "process owner". To manage process interactions, it may be useful to establish a "process management team", that has an overview across all the processes, and which includes representatives from each of the interacting processes.
5.1.6 Define process documentation	Determine those processes that are to be documented and how	Processes exist within the organization and the initial approach should be limited to identifying and managing them in the most appropriate way. There is no "catalogue", or list of processes, that have to be documented. The main purpose of documentation is to enable the consistent and stable operation of the processes. The organization should determine which processes are to be documented, on the basis of: - The size of the organization and its type of activities, - The complexity of its processes and their interactions, - The criticality of the processes, and· - The availability of competent personnel. When it is necessary to document processes, a number of different methods can be used such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods. Note: For more guidance see the ISO 9000 Introduction and Support Package module Guidance on the Documentation Requirements of ISO 9001:2000

5.2 Planning of a process

Steps in the process approach	What to do?	Guidance
5.2.1 Define the activities within the process	Determine the activities needed to achieve the intended outputs of the process	Define the required inputs and outputs of the process. Determine the activities required to transform the inputs into the required outputs.Determine and define the sequence and interaction of the activities within the process. Determine how each activity will be performed. Note: In some cases, the customer may specify the way the process is to be performed.
5.2.2 Define the monitoring and measurement requirements	Determine where and how measuring and monitoring should be applied. This should be both for control and improvement of the processes, as well as for the intended process outputs. Determine the need for recording results.	Identify the measures and monitoring criteria for process control and process performance, to determine the effectiveness and efficiency of the process, taking into account factors such as: - Conformity with requirements, - Customer satisfaction, - Supplier performance, - On time delivery, - Lead times, - Failure rates, - Waste, - Process costs, - Incident frequency.
5.2.3 Define the resources needed	Determine the resources needed for the effective operation of each process	Examples of resources include: - Human resources, - Infrastructure, - Work environment, - Information, - Natural resources, - Materials, - Financial resources
5.2.4 Verify the process and its activities against its planned objectives	Confirm that the characteristics of the process and its activities are consistent with the purpose of the organization (see 5.1.1 and 5.2.1)	Verify that all the requirements identified in 5.1.1 are satisfied. If not, consider what additional process activities are required and return to 5.2.1 to improve the process.

5.3. Implementation and measurement of the process

Implement the processes and their activities as planned.

The organization may develop a project for implementation that includes, but is not limited to

Communication,
Awareness,
Training,
Change management,
Management involvement,
Applicable review activities.
Perform the measurements, monitoring and controls as planned.


5.4. Analysis of the process

Evaluate process data obtained from monitoring and measuring, in order to quantify process performance. Where appropriate, use statistical methods.

Compare the results of process performance measurements with the defined requirements of the process to confirm process effectiveness, efficiency and any need for corrective action.

Identify process improvement opportunities based on process performance data.

Report to top management on the performance of the process, as appropriate.


5.5. Corrective action and improvement of the process

The method for implementing corrective actions should be defined, to eliminate the root causes of problems (examples of problems include errors, defects, lack of adequate process controls). Implement the corrective action and verify its effectiveness.

Once the planned process requirements are achieved, the organization should focus its efforts on actions to improve process performance to higher levels, on a continual basis.

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.

Risk analysis tools may be employed to identify potential problems. The root cause(s) of these potential problems should also be identified and corrected, preventing occurrence in all processes with similarly identified risks.

The PDCA methodology (Plan-Do-Check-Act) could be a useful tool to define, implement and control corrective actions, and improvements. The methodology applies equally to high-level strategic processes and to simple operational activities.

Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies;
Do: implement the processes;
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results;
Act: take actions to continually improve process performance;
Extensive literature exists about the PDCA cycle in numerous languages.