(校稿任务) 第106篇 A Tale of Two Deviations
本帖最后由 小编D 于 2013-7-1 14:56 编辑
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翻译：lilianxiang8288
A Tale of Two Deviations
两种组织文化
From two companies worlds apart in organizational culture
两种企业截然不同的组织文化
It stands to reason that pharmaceutical companies in compliance trouble also have problems with their deviation management and corrective and preventive action (CAPA) systems. After all, maintaining a good compliance profile as well as an efficient operation requires the ability to detect problems, determine the root cause, and permanently eliminate the problems.
显然，随着管理和纠正预防措施系统的失效，制药企业在遵从法规方面也会遇到问题，毕竟，维护一个好的法规遵从性配置性文件与有效操作要求公司有发现问题、确定根本原因和长期消除问题的能力。
Good companies rejoice that a problem was detected and reward the one who detected it. It’s another opportunity to improve—one more problem that the company never has to deal with again. It rises to the challenge to find technical solutions and engineer-out the problem. The company supports its thinkers who mindfully apply their education and experience. It celebrates finding and permanently expunging recurring problems. Management is aware of, and measures, recurring problems. They have no tolerance for it and hold department managers accountable for measurable results.
好的公司对于发现问题感到欣慰并对发现问题者给予奖励。公司从没处理过的问题是另一次改善的机会，对于找到解决问题的技术方案和工程将是一大挑战。公司支持那些全力运用他们知识和经验的思考者。企业管理就是要意识和预测到问题的重复发生。公司不能容忍问题重复发生并对部门经理进行目标化考核。
For not-so-good companies, deviations are a way of life. Deviations are anticipated, and the rewards go to those who heroically work the long hours to jump through the usual hoops to close the deviations so the lot can get out the door. They know they will have to go through the same effort the next time. It’s an exercise in onerous paperwork and checking procedural boxes. They celebrate getting the lot out the door—finally. Management measures delayed investigations and backlogs. Everyone knows what the routine problems are, and management asks no more than they be handled in the routine way—just more quickly.
对于不太好的公司来说，管理失效恰是一种生存之道。实际上很多失效是可以预先考虑到的，奖励给那些跳过常规的思维结束这种失效并长期为公司卖命的员工，因此很多失效是可以遏制的。公司清楚的知道问题发生他们将付出同样的努力，繁琐的文件编制和程序审核对于公司来讲只是一种训练，他们最终庆幸失效没有出现。管理层会预测到延迟的调查和积压的问题，每个人都知道常规的问题有哪些，只是管理层不会超出常规的方式来处理这些问题。
As in Charles Dickens’ A Tale of Two Cities, the two companies are worlds apart in organizational culture. One can’t change culture by policies or procedures; it’s a force that emanates from the top. It’s a force that can’t help but become infused into every breathing soul. Culture invigorates and identifies who we are in our very essence.
正如查尔斯•狄更斯所著的《双城记》，两种不同的企业有着截然不同的组织文化。一个不能通过质量方针和程序文件来改变文化的公司，只能通过管理层号召强制执行。其实强制执行没有帮助反而会阻碍公司发展。企业文化鼓舞和认同了那些精英。
It’s leadership. And leaders who work to build a positive culture would ask, “Why wouldn’t we permanently irradicate problems at their festering roots—even if it’s one of us?”
这就是领导作用，建立了积极文化的领导会问：“即使这只是我们其中的一个问题，我们为什么不能长期确立问题的根本？”
ABOUT THE AUTHOR关于作者
The QA Pharm
QA Pharm, the person behind The QA Pharm blog, is an observer of the pharmaceutical industry from inside and out for more than 30 years. This individual worked at the lab bench and on the management board. If you have a passion for quality assurance and understand the relationship of current good manufacturing practices to your patients and your business, you will find a kindred spirit at The QA Pharm. The QA Pharm blog is straight talk about quality assurance in the pharmaceutical industry. Not the technical aspects as much as the challenges faced by company management and their internal quality assurance professionals—sometimes side-by-side and often toe-to-toe.
QA Pharm, QA医药博客的支持者，制药企业内外从事30多年的观察员，工作于实验室和管理部门。如果你有对质量保证的热情和对你的病人和业务能理解当前良好的规范关系，你将会在The QA Pharm找到志趣相投的人，QA医药博客是在制药工业中的质量保证直谈，公司管理层和内部质量保证专业人员近距离的面临技术方面不一样的挑战。
来自http://www.qualitydigest.com
请对以下文章有翻译兴趣的组员留下你的预计完成时间和邮箱地址，以便小编登记翻译者信息以及文章最终完成时间
翻译：lilianxiang8288
A Tale of Two Deviations
两种组织文化
From two companies worlds apart in organizational culture
两种企业截然不同的组织文化
It stands to reason that pharmaceutical companies in compliance trouble also have problems with their deviation management and corrective and preventive action (CAPA) systems. After all, maintaining a good compliance profile as well as an efficient operation requires the ability to detect problems, determine the root cause, and permanently eliminate the problems.
显然，随着管理和纠正预防措施系统的失效，制药企业在遵从法规方面也会遇到问题，毕竟，维护一个好的法规遵从性配置性文件与有效操作要求公司有发现问题、确定根本原因和长期消除问题的能力。
Good companies rejoice that a problem was detected and reward the one who detected it. It’s another opportunity to improve—one more problem that the company never has to deal with again. It rises to the challenge to find technical solutions and engineer-out the problem. The company supports its thinkers who mindfully apply their education and experience. It celebrates finding and permanently expunging recurring problems. Management is aware of, and measures, recurring problems. They have no tolerance for it and hold department managers accountable for measurable results.
好的公司对于发现问题感到欣慰并对发现问题者给予奖励。公司从没处理过的问题是另一次改善的机会，对于找到解决问题的技术方案和工程将是一大挑战。公司支持那些全力运用他们知识和经验的思考者。企业管理就是要意识和预测到问题的重复发生。公司不能容忍问题重复发生并对部门经理进行目标化考核。
For not-so-good companies, deviations are a way of life. Deviations are anticipated, and the rewards go to those who heroically work the long hours to jump through the usual hoops to close the deviations so the lot can get out the door. They know they will have to go through the same effort the next time. It’s an exercise in onerous paperwork and checking procedural boxes. They celebrate getting the lot out the door—finally. Management measures delayed investigations and backlogs. Everyone knows what the routine problems are, and management asks no more than they be handled in the routine way—just more quickly.
对于不太好的公司来说，管理失效恰是一种生存之道。实际上很多失效是可以预先考虑到的，奖励给那些跳过常规的思维结束这种失效并长期为公司卖命的员工，因此很多失效是可以遏制的。公司清楚的知道问题发生他们将付出同样的努力，繁琐的文件编制和程序审核对于公司来讲只是一种训练，他们最终庆幸失效没有出现。管理层会预测到延迟的调查和积压的问题，每个人都知道常规的问题有哪些，只是管理层不会超出常规的方式来处理这些问题。
As in Charles Dickens’ A Tale of Two Cities, the two companies are worlds apart in organizational culture. One can’t change culture by policies or procedures; it’s a force that emanates from the top. It’s a force that can’t help but become infused into every breathing soul. Culture invigorates and identifies who we are in our very essence.
正如查尔斯•狄更斯所著的《双城记》，两种不同的企业有着截然不同的组织文化。一个不能通过质量方针和程序文件来改变文化的公司，只能通过管理层号召强制执行。其实强制执行没有帮助反而会阻碍公司发展。企业文化鼓舞和认同了那些精英。
It’s leadership. And leaders who work to build a positive culture would ask, “Why wouldn’t we permanently irradicate problems at their festering roots—even if it’s one of us?”
这就是领导作用，建立了积极文化的领导会问：“即使这只是我们其中的一个问题，我们为什么不能长期确立问题的根本？”
ABOUT THE AUTHOR关于作者
The QA Pharm
QA Pharm, the person behind The QA Pharm blog, is an observer of the pharmaceutical industry from inside and out for more than 30 years. This individual worked at the lab bench and on the management board. If you have a passion for quality assurance and understand the relationship of current good manufacturing practices to your patients and your business, you will find a kindred spirit at The QA Pharm. The QA Pharm blog is straight talk about quality assurance in the pharmaceutical industry. Not the technical aspects as much as the challenges faced by company management and their internal quality assurance professionals—sometimes side-by-side and often toe-to-toe.
QA Pharm, QA医药博客的支持者，制药企业内外从事30多年的观察员，工作于实验室和管理部门。如果你有对质量保证的热情和对你的病人和业务能理解当前良好的规范关系，你将会在The QA Pharm找到志趣相投的人，QA医药博客是在制药工业中的质量保证直谈，公司管理层和内部质量保证专业人员近距离的面临技术方面不一样的挑战。
来自http://www.qualitydigest.com
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lilianxiang8288 (威望:0) (江苏 无锡) 其它行业 主管
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