(初稿任务) 第113篇 ISO 9001: Conspicuous by Its Absence
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You know a quality standard is effective when it’s invisible
People often ask for examples of benefits from implementing ISO 9001-compliant quality management systems (QMS). Such examples are often difficult to provide, at least in terms of immediate results. The reason is that the effects of ISO 9001 and its automotive counterpart ISO/TS 16949 are largely preventive, which means they are most conspicuous through their absence.
An ancient Chinese story about three doctors is highly instructive. Three brothers were doctors. The youngest used heroic methods to cure serious illnesses—much like manufacturing professionals who fix serious production and quality problems. His name was known throughout the realm. The middle brother cured illnesses in their early stages, so his name was not known beyond his village. The eldest brother prevented the diseases. Nobody knew his name.
This also is true of ISO 9001: When it is in place and functioning properly, the organization takes it for granted and it soon becomes unnoticeable.
Tubecon, a South African tubing company, says this explicitly: “When standards are absent, it is soon noticed!” The company also uses the phrase, “Invisible when present, visible when absent,” which was how I found the company on Google. I was trying to find quotes that exemplify “visible when absent,” and Tubecon came up on the first page of the results.
Det Norske Veritas vs. the Carpathia
Jim Mroz in his article, “A Riveting Tale of Nonconformances” (Quality Digest, April 1998), that, had the Titanic’s builder and suppliers been ISO 9001-compliant, the ship might have survived its encounter with the iceberg. The wrought-iron rivets that held the hull plates together had up to 9 percent slag vs. the standard 2 percent, which may have aggravated the damage to the ship’s hull. An ISO 9001-compliant quality system would not have allowed nonconforming rivets to reach a customer, and an ISO 9001-compliant purchasing system would have ensured that nonconforming rivets were not accepted.
ISO 9001 did not, of course, exist in 1909, when Titanic’s construction began, although registrar Det Norske Veritas (DNV) was actually founded in 1864. Its mission at the time was to assess the technical condition of Norwegian merchant vessels, and it is still a leading authority in the maritime industry. Had the White Star Line used DNV’s services, few people today would even know the name of the Titanic, much less make movies about the ship. As matters stand, however, far more people know about the Carpathia, the ship that rescued the Titanic’s survivors, than about DNV. This reinforces the lesson of the three Chinese doctors: the one who prevents the trouble remains largely unknown, while the one who saves the patient from a preventable disease becomes famous.
The airline industry
Quality Digest readers are extensively familiar with the poor service of the airline industries, whether through personal experience, news reports, or H. James Harrington’s “Lost in the Service Quality Void,” which appeared in the November 2005 issue of Quality Digest. The latter drew a response from American Airlines’ CEO Gerard Arpey that said, in part, “We carry about a quarter of a million people every day, and, inevitably, there will be mistakes that impact our customers.” A magazine for quality professionals is not the right place to say that mistakes are inevitable, and Arpey’s failure to so much as mention a closed-loop corrective action response for the problems that Harrington reported suggests that American could never satisfy provision 8.5.2 (Corrective Action) of ISO 9001. I have in fact not been able to identify any domestic airline company that is registered to the standard, although several foreign ones are.
Design, process, and service failure mode effects analysis (FMEAs) support provisions 7.3 (Design) and 7.5 (Production and Service) of ISO 9001:2008, and the absence of FMEA is emphatically conspicuous in the airline industry. A year or so after Arpey told Quality Digest’s readers that mistakes are inevitable, his company stranded passengers on a runway for more than eight hours. In the Jan. 6, 2007, issue of The Wall Street Journal, Scott McCartney wrote in his article, “Runway-Bound: A Holiday Flight Becomes Ugly”:
“After hours of sitting on the runway, the toilets on the American Airlines jet were overflowing. There was no water to be found and no food except for a box of pretzel bags. After more than eight hours on the ground, and 12 hours after the plane had left San Francisco, the captain told passengers he was going to an empty gate, even though he didn’t have permission.”
Lack of water and overflowing toilets are direct menaces to human health and safety, which qualifies this situation for a severity rating of 9 on the FMEA’s standard 1 to 10 scale. (A plane crash would qualify for a 10.) Northwest had similarly stranded passengers several years earlier, but it’s obvious that American did not react to Northwest’s experience with a corrective and preventive action (CAPA) process. Subsequent identical incidents, meanwhile, show that American’s and Northwest’s domestic competitors took no corrective or preventive action either.
The absence of ISO 9001-compliant quality systems is therefore very conspicuous in this industry, and the development of online conferencing technology will hopefully provide businesses with a way to dispense with the airlines’ so-called services.
Health care
The United States spends about $2.5 trillion annually on health care. In a December 2005 article for Quality Digest, “Taking the QMS Cure,” I wrote that 30 to 60 percent of that is wasted on the costs of poor quality. The Journal of the American Medical Association (JAMA) conservatively puts the costs at 20 percent. This includes the cost of malpractice, and fatal medical mistakes such as the attachment of a feeding tube to an intravenous line; see “U.S. Inaction Lets Look-Alike Tubes Kill Patients,” by Gardiner Harris (The New York Times, Aug. 20, 2010). An FMEA would assign a severity of 10 to an event of this nature, which should prompt an immediate CAPA process. It apparently did not prompt one because patients have actually been killed in this manner, although Nestlé recently introduced an error-proofed SpikeRight system that makes it impossible to attach enteric food containers to an IV line. An ongoing litany of serious and fatal medical mistakes is yet another example of ISO 9001 being most conspicuous when it’s absent.
“Invisible when present, conspicuous when absent” is therefore the best way to explain the benefits of ISO 9001 to gain buy-in from management, the workforce, and other organizational stakeholders.
You know a quality standard is effective when it’s invisible
People often ask for examples of benefits from implementing ISO 9001-compliant quality management systems (QMS). Such examples are often difficult to provide, at least in terms of immediate results. The reason is that the effects of ISO 9001 and its automotive counterpart ISO/TS 16949 are largely preventive, which means they are most conspicuous through their absence.
An ancient Chinese story about three doctors is highly instructive. Three brothers were doctors. The youngest used heroic methods to cure serious illnesses—much like manufacturing professionals who fix serious production and quality problems. His name was known throughout the realm. The middle brother cured illnesses in their early stages, so his name was not known beyond his village. The eldest brother prevented the diseases. Nobody knew his name.
This also is true of ISO 9001: When it is in place and functioning properly, the organization takes it for granted and it soon becomes unnoticeable.
Tubecon, a South African tubing company, says this explicitly: “When standards are absent, it is soon noticed!” The company also uses the phrase, “Invisible when present, visible when absent,” which was how I found the company on Google. I was trying to find quotes that exemplify “visible when absent,” and Tubecon came up on the first page of the results.
Det Norske Veritas vs. the Carpathia
Jim Mroz in his article, “A Riveting Tale of Nonconformances” (Quality Digest, April 1998), that, had the Titanic’s builder and suppliers been ISO 9001-compliant, the ship might have survived its encounter with the iceberg. The wrought-iron rivets that held the hull plates together had up to 9 percent slag vs. the standard 2 percent, which may have aggravated the damage to the ship’s hull. An ISO 9001-compliant quality system would not have allowed nonconforming rivets to reach a customer, and an ISO 9001-compliant purchasing system would have ensured that nonconforming rivets were not accepted.
ISO 9001 did not, of course, exist in 1909, when Titanic’s construction began, although registrar Det Norske Veritas (DNV) was actually founded in 1864. Its mission at the time was to assess the technical condition of Norwegian merchant vessels, and it is still a leading authority in the maritime industry. Had the White Star Line used DNV’s services, few people today would even know the name of the Titanic, much less make movies about the ship. As matters stand, however, far more people know about the Carpathia, the ship that rescued the Titanic’s survivors, than about DNV. This reinforces the lesson of the three Chinese doctors: the one who prevents the trouble remains largely unknown, while the one who saves the patient from a preventable disease becomes famous.
The airline industry
Quality Digest readers are extensively familiar with the poor service of the airline industries, whether through personal experience, news reports, or H. James Harrington’s “Lost in the Service Quality Void,” which appeared in the November 2005 issue of Quality Digest. The latter drew a response from American Airlines’ CEO Gerard Arpey that said, in part, “We carry about a quarter of a million people every day, and, inevitably, there will be mistakes that impact our customers.” A magazine for quality professionals is not the right place to say that mistakes are inevitable, and Arpey’s failure to so much as mention a closed-loop corrective action response for the problems that Harrington reported suggests that American could never satisfy provision 8.5.2 (Corrective Action) of ISO 9001. I have in fact not been able to identify any domestic airline company that is registered to the standard, although several foreign ones are.
Design, process, and service failure mode effects analysis (FMEAs) support provisions 7.3 (Design) and 7.5 (Production and Service) of ISO 9001:2008, and the absence of FMEA is emphatically conspicuous in the airline industry. A year or so after Arpey told Quality Digest’s readers that mistakes are inevitable, his company stranded passengers on a runway for more than eight hours. In the Jan. 6, 2007, issue of The Wall Street Journal, Scott McCartney wrote in his article, “Runway-Bound: A Holiday Flight Becomes Ugly”:
“After hours of sitting on the runway, the toilets on the American Airlines jet were overflowing. There was no water to be found and no food except for a box of pretzel bags. After more than eight hours on the ground, and 12 hours after the plane had left San Francisco, the captain told passengers he was going to an empty gate, even though he didn’t have permission.”
Lack of water and overflowing toilets are direct menaces to human health and safety, which qualifies this situation for a severity rating of 9 on the FMEA’s standard 1 to 10 scale. (A plane crash would qualify for a 10.) Northwest had similarly stranded passengers several years earlier, but it’s obvious that American did not react to Northwest’s experience with a corrective and preventive action (CAPA) process. Subsequent identical incidents, meanwhile, show that American’s and Northwest’s domestic competitors took no corrective or preventive action either.
The absence of ISO 9001-compliant quality systems is therefore very conspicuous in this industry, and the development of online conferencing technology will hopefully provide businesses with a way to dispense with the airlines’ so-called services.
Health care
The United States spends about $2.5 trillion annually on health care. In a December 2005 article for Quality Digest, “Taking the QMS Cure,” I wrote that 30 to 60 percent of that is wasted on the costs of poor quality. The Journal of the American Medical Association (JAMA) conservatively puts the costs at 20 percent. This includes the cost of malpractice, and fatal medical mistakes such as the attachment of a feeding tube to an intravenous line; see “U.S. Inaction Lets Look-Alike Tubes Kill Patients,” by Gardiner Harris (The New York Times, Aug. 20, 2010). An FMEA would assign a severity of 10 to an event of this nature, which should prompt an immediate CAPA process. It apparently did not prompt one because patients have actually been killed in this manner, although Nestlé recently introduced an error-proofed SpikeRight system that makes it impossible to attach enteric food containers to an IV line. An ongoing litany of serious and fatal medical mistakes is yet another example of ISO 9001 being most conspicuous when it’s absent.
“Invisible when present, conspicuous when absent” is therefore the best way to explain the benefits of ISO 9001 to gain buy-in from management, the workforce, and other organizational stakeholders.
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You know a quality standard is effective when it’s invisible
你知道只有当一个质量标准看不见时才有效
People often ask for examples of benefits from implementing ISO 9001-compliant quality management systems (QMS). Such examples are often difficult to provide, at least in terms of immediate results. The reason is that the effects of ISO 9001 and its automotive counterpart ISO/TS 16949 are largely preventive, which means they are most conspicuous through their absence.
人们经常询问通过实施ISO 9001类质量管理体系（QMS）获得效益的例子。这类例子通常很难提供，至少没有立竿见影的例子。原因在于ISO 9001及其在汽车行业的副本ISO/TS 16949的作为很大程度上是预防性的，这就意味着它们以不出事故而闻名。
An ancient Chinese story about three doctors is highly instructive. Three brothers were doctors. The youngest used heroic methods to cure serious illnesses—much like manufacturing professionals who fix serious production and quality problems. His name was known throughout the realm. The middle brother cured illnesses in their early stages, so his name was not known beyond his village. The eldest brother prevented the diseases. Nobody knew his name.
一个古老的关于三个大夫的中国故事很有意义。三兄弟都是大夫。最年轻的弟弟用熟练的手段治疗严重的疾病——非常像制造专家解决严重的产品和质量问题。他因此闻名全国。二哥在病人患病初期就治疗，所以他只在村内有名。大哥防止人们患病，没有人知道他的名字。
This also is true of ISO 9001: When it is in place and functioning properly, the organization takes it for granted and it soon becomes unnoticeable.
ISO 9001也是这样的处境：当它坚守岗位并发挥作用时，组织认为这是理所应当的，并且很快变得无人问津。
Tubecon, a South African tubing company, says this explicitly: “When standards are absent, it is soon noticed!” The company also uses the phrase, “Invisible when present, visible when absent,” which was how I found the company on Google. I was trying to find quotes that exemplify “visible when absent,” and Tubecon came up on the first page of the results.
Tubecon，一家南非电子管公司说得很清楚：“当标准缺失，人们马上就会注意到!”因为这家公司也用成语“在时不惜，追悔莫急”，所以我才在谷歌上搜索到这家公司。当我尝试搜索例证“缺时重视”的例子时，Tubecon出现在搜索结果的第一页。
Det Norske Veritas vs. the Carpathia
挪威船级社与卡帕西亚号
Jim Mroz in his article, “A Riveting Tale of Nonconformances” (Quality Digest, April 1998), that, had the Titanic’s builder and suppliers been ISO 9001-compliant, the ship might have survived its encounter with the iceberg. The wrought-iron rivets that held the hull plates together had up to 9 percent slag vs. the standard 2 percent, which may have aggravated the damage to the ship’s hull. An ISO 9001-compliant quality system would not have allowed nonconforming rivets to reach a customer, and an ISO 9001-compliant purchasing system would have ensured that nonconforming rivets were not accepted.
Jim Mroz在他名为《一个不合格铆钉的故事》（《质量文摘》，1998年4月）中提到，假如泰坦尼克号的制造商和供应商都通过了ISO9001质量体系认证，这艘船也许就能从与冰山的相撞事故中幸存下来。连接船体板的铸铁铆钉中炉渣含量高达9%，远高于标准要求的2%，这可能加剧了船体的损坏。通过ISO9001认证的质量体系不会允许不合格的铆钉流向顾客，通过ISO9001认证的采购系统也将确保不合格铆钉被拒收。
ISO 9001 did not, of course, exist in 1909, when Titanic’s construction began, although registrar Det Norske Veritas (DNV) was actually founded in 1864. Its mission at the time was to assess the technical condition of Norwegian merchant vessels, and it is still a leading authority in the maritime industry. Had the White Star Line used DNV’s services, few people today would even know the name of the Titanic, much less make movies about the ship. As matters stand, however, far more people know about the Carpathia, the ship that rescued the Titanic’s survivors, than about DNV. This reinforces the lesson of the three Chinese doctors: the one who prevents the trouble remains largely unknown, while the one who saves the patient from a preventable disease becomes famous.
当然，ISO9001在1909年泰坦尼克号开始建造时不存在，虽然DNV在1864年就成立了。它当时的目标是评估挪威商船的技术条件，它还是航运业的权威。体验着运用DNV服务的白星航线的现代人，甚至很少有知道泰坦尼克号名字的，更不用说关于这艘船的电影。但是，知道营救泰坦尼克号幸存者的Carpathia号的人比知道DNV的人多得多。这印证了三个中国大夫的教训：预防疾病的默默无闻，而治愈因未及时预防而病入膏肓病人的成了名。
The airline industry
航空业
Quality Digest readers are extensively familiar with the poor service of the airline industries, whether through personal experience, news reports, or H. James Harrington’s “Lost in the Service Quality Void,” which appeared in the November 2005 issue of Quality Digest. The latter drew a response from American Airlines’ CEO Gerard Arpey that said, in part, “We carry about a quarter of a million people every day, and, inevitably, there will be mistakes that impact our customers.” A magazine for quality professionals is not the right place to say that mistakes are inevitable, and Arpey’s failure to so much as mention a closed-loop corrective action response for the problems that Harrington reported suggests that American could never satisfy provision 8.5.2 (Corrective Action) of ISO 9001. I have in fact not been able to identify any domestic airline company that is registered to the standard, although several foreign ones are.
质量文摘读者普遍熟悉航空业的服务差，无论是通过个人的经验，新闻报道，或H. James Harrington发表在2005年11月发行的《质量文摘》中的《迷失在服务质量真空》。这篇文章在某种程度上得到了来自美国航空公司的首席执行官Gerard Arpey的回应，“我们每天运送大约二百五十万人，不可避免地会出现失误，影响到我们的客户。” 一本面向质量专业人士的杂志不是说“错误不可避免”的正确地方，Arpey针对这个问题提到的闭环纠正措施如此离谱，以至于Harrington的报告预测美国将永远无法满足ISO 9001的条款8.5.2 （纠正措施）。事实上，我迄今没有发现任何一家国内航空公司获得了质量体系认证，虽然有几个国外的有。
Design, process, and service failure mode effects analysis (FMEAs) support provisions 7.3 (Design) and 7.5 (Production and Service) of ISO 9001:2008, and the absence of FMEA is emphatically conspicuous in the airline industry. A year or so after Arpey told Quality Digest’s readers that mistakes are inevitable, his company stranded passengers on a runway for more than eight hours. In the Jan. 6, 2007, issue of The Wall Street Journal, Scott McCartney wrote in his article, “Runway-Bound: A Holiday Flight Becomes Ugly”:
设计，过程和服务失效模式及影响分析（FMEAs）支持条款7.3 （设计）和7.5 （生产和服务）的ISO 9001:2008 ，缺乏FMEA在航空业尤其突出。就在Arpey告诉《质量文摘》读者失误无法避免时，他的公司已经将乘客滞留在机场超过8小时。在2007年1月6日发行的《华尔街日报》中，Scott McCartney在他的文章中写道，“跑道绑定：一个假日飞行变得丑陋”。
“After hours of sitting on the runway, the toilets on the American Airlines jet were overflowing. There was no water to be found and no food except for a box of pretzel bags. After more than eight hours on the ground, and 12 hours after the plane had left San Francisco, the captain told passengers he was going to an empty gate, even though he didn’t have permission.”
“坐在跑道上数小时后，美国航空公司客机上的厕所都满溢。除一盒饼干袋外没有食物也没有水。经过八个多小时的地面等待和飞离旧金山12小时后，机长告诉乘客他要一个空门，尽管他没有权限。
Lack of water and overflowing toilets are direct menaces to human health and safety, which qualifies this situation for a severity rating of 9 on the FMEA’s standard 1 to 10 scale. (A plane crash would qualify for a 10.) Northwest had similarly stranded passengers several years earlier, but it’s obvious that American did not react to Northwest’s experience with a corrective and preventive action (CAPA) process. Subsequent identical incidents, meanwhile, show that American’s and Northwest’s domestic competitors took no corrective or preventive action either.
钦用水短缺和厕所满溢对人体健康和安全有直接威胁，这在FMEA严重度1—10级标准中属于第9级（飞机坠毁将被定为10级）。Northwest几年前出现过类似的乘客滞留事件，但American明显没有针对这类失效采取纠正预防措施。与此同时，随后的相同事件证明全美航空和西北航空的辆竞争对手也没有采取纠正预防措施。
The absence of ISO 9001-compliant quality systems is therefore very conspicuous in this industry, and the development of online conferencing technology will hopefully provide businesses with a way to dispense with the airlines’ so-called services.
因此，ISO 9001认证质量体系的缺失在这个行业的影响十分突出，在线会议技术的发展将有望提供一种方式来淘汰航空公司所谓的服务。
Health care
医疗保险
The United States spends about $2.5 trillion annually on health care. In a December 2005 article for Quality Digest, “Taking the QMS Cure,” I wrote that 30 to 60 percent of that is wasted on the costs of poor quality. The Journal of the American Medical Association (JAMA) conservatively puts the costs at 20 percent. This includes the cost of malpractice, and fatal medical mistakes such as the attachment of a feeding tube to an intravenous line; see “U.S. Inaction Lets Look-Alike Tubes Kill Patients,” by Gardiner Harris (The New York Times, Aug. 20, 2010). An FMEA would assign a severity of 10 to an event of this nature, which should prompt an immediate CAPA process. It apparently did not prompt one because patients have actually been killed in this manner, although Nestlé recently introduced an error-proofed SpikeRight system that makes it impossible to attach enteric food containers to an IV line. An ongoing litany of serious and fatal medical mistakes is yet another example of ISO 9001 being most conspicuous when it’s absent.
美国每年医疗保险的花费为2.5万亿。我在2005年12月为《质量文摘》写的名为《用质量管理体系治疗》中写到其中的30%—60%浪费在劣质的开销上。美国医学会杂质（JAMA）保守估计为20%。这包括不当治疗和致命医疗事故，比如将流食管插到了静脉上；见Gardiner Harris发表在2010年8月20日出版的纽约时报中的文章《美国的不作为让相似的医用软管杀死病人》，一个FMEA为自然中的任意事件指定一个严重度，并立即引发一个纠正预防措施过程。很明显，它并没有引发这样的过程，因为病人实际上已经被这样的习惯杀死了，尽管雀巢最近引进了一款显错订正系统，使得将流食容器插入静脉变得不可能。持续发生的一系列严重而致命的医疗事故仍然是ISO9001质量体系缺失造成严重后果的又一个例子。
“Invisible when present, conspicuous when absent” is therefore the best way to explain the benefits of ISO 9001 to gain buy-in from management, the workforce, and other organizational stakeholders.
因此“在时忽略，缺时后果严重”也是最好的方法去解释ISO9001为管理者、员工和组织利益相关者带来的好处。