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第五十二篇Quality Management Systems: The 10 Most Common Myths

本帖最后由 小编D 于 2012-6-12 14:45 编辑

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Quality Management Systems: The 10 Most Common Myths
质量管理体系:10个最广为流传的误区

Debunking the misconceptions about when or if to implement a quality management system.
揭开对何时或是否需要运行质量管理体系的误解

Management system standards trace their beginnings to the use of simple preventive practices that were developed and used at the beginning of the industrial revolution. These preventive practices included responses to common problems, for example, ensuring changes are communicated to everyone who needs to know about the change, and attacking the cause of a problem, not just the symptom. Management systems evolved from these simple beginnings and eventually became the formally defined preventive methodologies that today contain a long list of universally accepted preventive practices.
管理体系标准的起源要追溯到在工业革命初期发展起来并得到应用的简单预防措施,这些预防措施包括对普遍发生问题的响应,比如:确保在出现变更时所有需要知道变更的人能够及时得到沟通,以及能够深入挖掘问题的根本原因而不仅仅只是表面症状。管理体系由最简单的起源演变而来,最终变成了被正式采用的预防方法论,包含了当今被全世界都广泛接受的预防措施。


From the time widely accepted management system standards (such as ISO 9001, ISO 14001, and others) came into common use in the late 1980s and early 1990s, many myths and misunderstandings related to their implementation and use have emerged. Belief in these myths is the most common barrier to the use of management system standards and, in addition, the greatest cause of frustration and diminished benefits on the part of users. Understanding these myths can help organizations choose to adopt a management system and ultimately achieve the intended benefits embedded within all management system standards. This paper has been written to identify and debunk the most common myths.
自被广泛接受的管理体系标准(比如ISO9001,14001及其他)在二十世纪80年代末至90年代初得到普遍使用以来,许多有关管理体系运行和使用的误区和误解也产生了。对这些误区的迷信成为了使用管理体系标准的最大障碍,并且还是使部分使用者感到挫败及受益少的最大原因。了解这些误区能够帮助组织选择采用管理体系并最终取得预期的所有管理体系标准内在的收益。本文在于识别和揭露最广为流传的误区。

  1. Management systems require excessive documentation and paperwork
1、管理体系要求过多的文件及文书工作

The most popular management system standard in the world, ISO 9001, requires only six documented procedures, enough to provide transparency, structure, and confidence to the organization, its customers, and its employees. Beyond this, the number of documented procedures depends upon the organization’s size, types of activities, and operational needs. Excessive documentation will, in fact, reduce the management system’s value to the organization and its customers and should be considered counterproductive.
世界上最流行的管理体系ISO9001,只要求6个文件化的程序,足以为组织及其顾客和员工提供透明度、结构及信任。除此之外,文件化程序的数量取决于组织的规模、活动的类型以及运行上的需要。事实上,过多的文件将降低管理体系对于组织及顾客的价值,甚至或许会产生不良后果。

Points to consider
考虑要点

• An organization that adopts a management system standard should proceed with a focus on results and practicality, not documents. The intent should be to add bottom-line value to the organization and its customers. The implemented management system should become part of the day-to-day operation of the organization.
• 采用管理体系标准的组织应当关注结果和实用性,而不是文件。这种意图对组织及其顾客来说应当最低限度的增值。质量管理体系的运行应当成为组织日常运作的一部分。

• Many management system failures come from organizations creating documents that do not add value. This is often because the organization incorrectly believes that the management system is all about documents and procedures.
•许多管理体系的失效都源于组织制作了过多不增值的文件。这常常是因为组织错误地迷信文件和程序就是管理体系的全部。

  1. Management systems don’t add value but I have to have one because my customers want me to have one.
2、管理体系不增值但我必须有一个,因为顾客希望我有

Management systems provide bottom-line cost savings and improved profitability and performance through embedded preventive practices.1 Organizations of any size performing activities of any kind that are considering adopting a management system standard can expect to see increased value to customers and greater return on investment through appropriate discipline and communication.
管理体系通过嵌进预防措施提供最低成本节约并改善利润和绩效。采用了管理体系标准的组织,不管是何种规模、进行何种活动,都期望看到增值并且通过适当的约束和沟通能够取得更大的回报。

Points to consider
考虑要点

• Management systems help organizations avoid mistakes and save resources, time, and money.
• 管理体系帮助组织避免犯错并节约资源、时间及资金。

• Organizations that are not achieving value from their management systems may not be clear on their true purpose and may be just going through the motions.
• 不能从管理体系获得益的组织可能对他们的真正目的并不清楚,并可能只是通过一些议案而已。

  1. Management systems are a net cost to my organization
3、管理体系是组织的净成本

Studies by Levin and Toffel2, Schmeidler, et al.3, and Terlaak and King4 have shown that preventing a problem is less expensive—and in many cases much less expensive—than dealing with the consequences after a problem occurs. If an organization implements a management system standard and its net cost increases, the organization needs to examine and reconsider its approach to implementing the management system
李文和托菲尔、施梅德勒等以及特拉克和金的研究显示:预防一个问题的成本并不比发生问题后处理问题的成本高——在很多情况下要低得多。如果一个组织运行管理体系标准并且其净成本上升了,那么就需要检讨并重新考虑运行体系的方法了。

Points to consider
考虑要点

• Excessive costs associated with management systems often come from an organization’s failure to take ownership of the completed management system. This is particularly true if there is a lack of ownership on the part of top management.
• 与管理体系有关的过高的成本通常源于组织对整个管理体系的不成功掌控。尤其是在部分最高管理层对管理体系缺乏掌控的情况下。

• If you create a system that you are unwilling to work with on a daily basis, it will provide little or no value, and, in fact, may be a net cost to the organization.
• 如果建立了一个你不愿每天都运行的体系,那么它将产生很小的价值或者压根就不产生价值,并且实际上可能成为组织的净成本。

  1. Management system standards do not allow my organization to be flexible and innovative
4、管理体系标准不允许组织有灵活性和创新

During management system implementation, the organization will need to make decisions that allow it to remain flexible where flexibility is important, while at the same time providing enough structure to ensure good discipline where discipline is needed.
Point to consider
在管理体系运行过程中,组织将需要做出决策:在灵活性很重要情况下,体系运行应当保持灵活性,与此同时,在需要严格性的情况下能够提供足够支持来确保良好的严格性。

Management systems are written in a way that serves any organization. If an organization has an inflexible management system that ties the organizations hands, it is because the management system was created that way. Careful decisions are required to balance the need for discipline and structure on one hand and the need for flexibility on the other.
管理体系以一种适合于任何组织的方式描述出来。如果一个组织的管理体系不灵活而束缚了组织,原因就是管理体系是那样建立的。为了平衡一方面严格性及结构的需要和另一方面适合灵活性的需要,组织应当做出谨慎的决策。

  1. Management system certification is not required; therefore, my organization doesn’t need it
5、不需要管理体系认证,因此,我的组织不需要管理体系

Management system standards contain a collection of best practices that have evolved over the last 200 years. Management systems provide a pragmatic, systematic methodology for organizations, helping them achieve results for themselves and their customers. Certification of a management system by an internationally recognized accreditation body (such as the ANSI-ASQ National Accreditation Board—ANAB) will verify the successful adoption of the imbedded preventive practices and will foster confidence in customers and stakeholders.
管理体系标准涵盖了过去200多年演变的关于质量管理的最佳措施的集合。管理体系为组织提供了实用的、系统的方法论,帮助组织达到组织自己及其顾客想要的结果。由国际认可的评定机构(如ANSI——ASQ国家评定委员会——ANAB)对管理体系的认证将验证组织对内嵌的预防措施的成功使用并且培养组织在顾客及股东中间的信任度。

Points to consider
考虑要点

While it is unlikely that legal or regulatory requirements will mandate adoption or certification to a management system standard, certification provides compelling benefits. Management systems provide a clear path and associated transparency related to an organization’s methods, measurements, and results, thus providing confidence in the organization's ability to meet both customer and legal requirements. It is likely that management system standards will become increasingly important in the future because they provide:
尽管对管理体系标准的认证不是法律或法规的强制性要求,认证也会给组织提供令人信服的收益。管理体系提供了一个与组织的方法、测量和结果相联系的清晰途径及相关的透明度,从而对组织满足顾客和法律要求的能力提供了信任。将来,管理体系标准的重要性极有可能越来越大,因为其提供了:

• A proactive methodology for meeting legal, regulatory and other related obligations.
• 满足法律、法规及其他责任的主动方法论。

• Internal financial and other benefits associated with the preventive practices embedded in each management system standard.
•与内嵌于每一个管理体系标准中的预防措施相关的内部财务和其他的收益。

• Benefits to customers, stakeholders, and the broader marketplace that is communicated when the certification is issued by a certification body accredited by an internationally recognized accreditation body such as ANAB.
• 在由类似ANAB这样的国际认可的评定机构发布认证证书后,对顾客、股东以及更广阔的市场空间都有好处。

  1. Management systems don’t help my business; in fact, they distract my organization from its core activities
6、管理体系对我的业务没有帮助,事实上,管理体系使组织从核心活动上分心。

This myth will almost certainly come true for organizations that use a plug-and-play approach to implementing a management system, instead of making sure documents and practices fit their businesses.
对采用“即插即用” 而不是确保文件和程序适合业务需要的方法来运行管理体系的组织而言,这个谬误几乎肯定会成为现实。

Point to consider
考虑要点

Organizations can avoid this problem by adopting management system standards and implementing them in a manner that fulfills its needs and the needs of its customers and stakeholders. Organizations that recognize this and live by their management systems on a daily basis will achieve benefits that greatly exceed any cost or effort.
组织可以通过采用和运行一种满足组织及其顾客、股东需要的方式的管理体系来避免这个问题。意识到这个问题并依赖管理体系的日常运行的组织会获得远远超过任何成本或努力的利益。

  1. Management systems are a fad
7、管理体系就是跟风

Organizations have been using management system standards and their precursors in one form or another for more than 200 years. If management system standards had never been developed, organizations would need to follow preventive practices anyway. The preventive practices embedded in management systems standards will always make sense.
组织以一种形式或其他形式使用管理体系和管理体系的前身已经有200多年了。如果管理体系标准不曾被发展起来,组织无论如何应该需要采用预防性措施。内嵌于管理体系标准中的预防性措施将一直有意义。

Point to consider
考虑要点

Management systems contain universally accepted preventive practices that will not fade away.
管理体系中包含普遍接受的预防性措施,这些措施永远不会消逝。

  1. Management system standards do not guarantee product quality
8、管理体系标准不保证产品质量

Nothing can absolutely guarantee product quality. However, management systems can go a long way toward preventing problems from occurring in the first place, thus providing dramatic improvements in results while reducing costs.
没有什么能绝对地保证产品质量。然而,管理体系对于在第一时间预防问题的发生能够产生很深远的效果,并且在降低成本的结果上提供重大改善。

Points to consider
考虑要点

While management systems do not assure absolute results, the preventive steps embedded in management systems will dramatically increase the likelihood of consistent product and overall business success.
尽管管理体系不能保证绝对的结果,内嵌于管理体系中的预防性步骤将显著提高连续生产及整体业务成功的可能性。

  1. My customer is already inspecting and auditing my organization and our products , so I shouldn’t need to adopt a management system and have it certified
9、顾客已经检验并审核了组织及其产品,所以我不需要采用管理体系也不需要认证。

Certification bodies are accredited to audit the full range of an organization’s activities. These audits are undertaken by personnel fully qualified to perform these audits, thus providing confidence to the organization, its stakeholders, and its customers. Your customer may be equally qualified to conduct these audits—or perhaps not.
认证机构被认可去审核组织全范围内的活动。这些审核由经过资格认证的能够承担审核活动的人员来执行,从而向组织及其顾客、股东提供信任。你的顾客可能一样经过资格认证能够执行这些审核,也许不能。

Accredited certification bodies are themselves audited by an independent third party such as ANAB. This is unlikely to be true of your customer’s auditors.
一个经过评定的认证机构本身就由一个独立的第三方比如ANAB审核过了。而你的顾客那方的审核员却未必经过了这样的认证。

Points to consider
考虑要点

• Use of and certification to management systems standards ensures the successful implementation of preventive steps throughout the organization. Success is then confirmed by a disciplined and consistent audit program that is often more consistent and rigorous than customer audits.
• 对管理体系标准的使用和认证确保在整个组织内成功运行地预防性步骤。这种成功由一个经过严格的并连续一致的审核程序来确认,这通常比顾客的审核更有连续性、更为严格。

• An audit by one customer does not necessarily convey the same confidence as does the formal process associated with management system use and certification.
• 由一个顾客进行的审核未必能传达出由一个与管理体系的使用和认证相关的正式过程所传达的同样的信任度。

  1. I already have other certifications (FDA, UL, GLP, GMP), so I don’t need to adopt a management system and have it certified
10、我已经有了其他认证(如FDA、UL、GLP、GMP),所以我不需要采用管理体系并获得认证。

None of these certifications represent full management systems that are verified by accredited certification bodies. In fact, many of these deal only with product attributes and inspections. They are often narrowly related to production and do not touch on the full range of preventive practices embedded in true management systems.
上述认证没有一个能够代表由经过评定的认证机构验证的全部管理体系。实际上,这些认证只是代表了产品的特性及检验。他们只是很狭隘的与产品有关,但并不全面地触及到内嵌于一个真正管理体系中的预防措施。

Point to consider
考虑要点

Many of the certifications that organizations receive are not associated with how their organizations are managed. Certification to internationally accepted management system standards by an accredited certification body ensures organizations are managed and that preventive practices are embedded throughout the entire organization.
组织获得的许多认证都与如何管理组织无关。由一个经评定的认证机构进行的对国际认可的管理体系标准进行认证确保组织得到良好的管理,并且预防措施嵌入到整个组织中。

Avoiding Common Mistakes
避免常识性错误

Many of the myths discussed above result from mistakes commonly made during the implementation of the management system. The secret to successful implementation is to allow flexibility where flexibility is important and provide structure where structure is needed. Mistakes in deciding how much flexibility will be allowed within the management system can dramatically reduce positive results and can inflict significant negative consequences for an organization that does not fully understand the customer satisfaction and cost benefits that can be achieved from successful implementation.
前面讨论过的很多误区在管理体系运行中导致常识性错误。成功运行体系的密决是在灵活性很重要的情况下允许灵活性并在需要结构性的时候提供结构性。对于一个没有完全理解能从管理体系的成功运行中获得顾客满意和成本收益的组织,在决定管理体系内部可以有多大灵活性上的失误能够明显减少积极的结果并造成重大的负面影响。

One of the more common mistakes is delegating implementation to subject-matter experts—for example, ISO 9001 implementation to quality professionals or ISO 14001 implementation to environmental professionals. Inputs from these personnel will be key to your success but should not provide the sole basis of the implementation. A management system describes the way an organization intends to manage itself to target and achieve benefits, reduce costs, and meet objectives set by top management. All personnel, especially top management, need to be involved (along with internal experts and practitioners) from the beginning of the project. A clear understanding that the end result may be a fundamental change in how the business operates will help organizations make the transition from reactive management to preventive management.
更普遍的错误之一就是委派主题性的专家来运行,如由质量专业人士来运行ISO9001体系,由环境专业人士来运行14001体系。这些人士的输入对您的成功将起关键性作用,但不能提供运行的唯一性基础。一个管理体系描述了一个组织旨在管理自身以向着目标并获取利益、降低成本及满足最高管理层的目标的途径。所有的员工,特别是最高管理者层,需要在项目一开始的时候就参与(与内部专家及从业者一起)进来。对于最终结果可能会在业务运营方产生根本性变革的一个清晰理解将有助于组织实现由事后响应性管理向事前预防性管理的转变。

What your organization should not do
组织不应该做的事情

Your organization should not turn the project over to outside experts. Overuse of outside experts can dramatically reduce the organization’s ownership of the completed management system. It can result in top management and employees not understanding what is happening or why changes are being made. A knowledgeable external consultant may be able to provide valuable insight and can help streamline your project, but day-to-day ownership on the part of your organization is the single most important attribute of successful implementation.
您的组织不应该将项目转向外部的专家。对外部专家的滥用将显著的降低组织对完整管理体系的掌控程度。这将导致最高管理层和员工不能理解正在发生的事情或为什么发生了改变。一个知识渊博的外部顾问可能能够提供有价值的洞察力并帮助简化您的项目,但是就您组织而言,对管理体系的日常维护是成功运行体系的唯一的最重要的属性。

Your organization should not implement a management system and associated procedures just because they have been developed and successfully used by another organization. No two organizations do things in exactly the same manner. What works for one organization will not achieve the same success for another. The worst-case scenario is that you implement a management system that another organization has used to become certified, but they have only received the certification and not all of the corollary benefits embedded within the management system.
组织不能仅仅因为别的组织成功运行了管理体系及相关过程就运行一个管理体系。没有任何两个组织的运行方式是一模一样的。对一个组织有效东西在另一个组织未必能够同样成功。最坏的局面就是:你运行了一个管理体系,其他组织用这个体系来认证,但他们仅仅是获得了证书而已,并没有获得内嵌于管理体系中的所有必然利益。


Conclusion
结论

Put simply, management systems prevent problems. They work efficiently and effectively whenever organizations can get past the myths addressed in this article. Use of management systems standards and the associated accredited certification process should reduce costs, improve results, and provide confidence to customers, stakeholders, and organizations.
简单地将管理体系用来预防问题。任何时候组织能够超越本文所述的谬误,管理体系都将会有效并高效的运行。对管理体系标准的使用及相关的认可认证过程应该降低成本、改善结果,并向顾客、股东及组织提供信任。

Notes:
注:
  1. Mark Ames, Reg Blake, Michael J. Caruso, and Phil Heinle, “Evidence That Sets the Record Straight—How Management System Standards Add Value to Any Organization,” unpublished article, 2011.
1、Mark Ames, Reg Blake, Michael J. Caruso, and Phil Heinle, “设置直接记录的证据——管理体系怎样才能为任何组织增值”,尚未发表的论文,2011

  1. David I. Levine, and Michael W. Toffel, “Quality Management and Job Quality: How the ISO 9001 Standard for Quality Management Systems Affects Employees and Employers,” Harvard Business School, 2008.
2、David I. Levine, and Michael W. Toffel, “质量管理与工作质量:ISO9001质量管理体系标准怎样影响雇主和雇员”,哈弗商学院,2008

  1. Peter Schmeidler, Robert King, and Paul Scicchitano, “Study of the Value of ISO 14001 Certification,” Wharton Risk Management and Decision Processes Center in cooperation with the ANSI-ASQ National Accreditation Board and QSU Publishing Co., 2007.
3、Peter Schmeidler, Robert King, and Paul Scicchitano, “ISO14001认证的价值研究”,Wharton风险管理及决策过程中心与ANSI-ASQ国家评定委员会和QSU初版公司合作,2007

  1. Ann Terlaak and Andrew A. King, “The Effect of Certification with the ISO 9000 Quality Management Standard: A Signaling Approach,” University of Wisconson—Madison Tuck School of Business, 2006.
4、Ann Terlaak and Andrew A. King, “ISO9000质量管理标准认证的效果:一个信号方法”,威斯康辛大学——麦迪逊 塔克商学院,2006

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