研发质量管理

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如何理解质量管理的三个阶段

几乎所有的企业在产品的质量上都会下一番功夫，书上说那叫质量管理，根据一个叫朱兰的质量管理大师的说法，

质量管理有三个阶段，

最初是质量检验阶段，那个时候企业的管理者认为产品质量是检验出来的，因为通过检验可以把质量不好的产品挑出来，后来发现只是在事后来检验，故事都发生了，返修、报废的损失无法避免，这些损失就是利润呀，所以就思考能不能在制造过程中控制质量呢?

这就到了质量管理的第二阶段：统计质量管理阶段。在这个阶段，著名的新老七大质量管理工具闪亮登场，统计学在质量管理方面的应用得到了充分的发挥，我们在质量改进方面拍脑袋也变得越来越科学，越来越尊重数据了。再到后来，人们发现单纯在制造过程中控制质量也控制不住，而且成本也不低，一些产品缺陷是先天性的，好多产品从娘胎中出来就躺在了担架上，这个时候，人们意识到产品质量是设计出来的，

这就到了质量管理的第三个阶段：全面质量管理阶段。这时，6SIGMA、QBD等质量管理工具开始被一些企业应用到产品规划和产品设计中，从一开始就进行质量的设计，这些企业属于先知先觉。

                               
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How to understand the three stages of quality management

Almost all enterprises will make great efforts on product quality. It is said in the book that it is called quality management. According to a quality management master named Zhu Lan, quality management has three stages.

At first, it is the quality inspection stage. At that time, the enterprise managers thought that the product quality was inspected, because the products with poor quality can be picked out through inspection. Later, they found that it was only an afterthought inspection. All the stories happened, The loss of repair and scrap cannot be avoided. These losses are profits, so we should consider whether we can control the quality in the manufacturing process?

This is the second stage of quality management: statistical quality management. At this stage, the famous seven quality management tools, old and new, came on the scene. The application of statistics in quality management has been brought into full play. We have become more and more scientific in terms of quality improvement and more respect for data. Later, people found that simply controlling the quality in the manufacturing process could not be controlled, and the cost was not low. Some product defects were congenital, and many products were lying on the stretcher from the womb.

At this time, people realized that the product quality was designed, which was the third stage of quality management: the total quality management stage. At this time, quality management tools such as 6SIGMA and QBD began to be applied to product planning and design by some enterprises, which started to design quality from the very beginning. These enterprises were prescient.

                               
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搞好研发质量管理的前提条件是什么？

首先，研发质量管理的基本前提是研发的业务流程要理清楚。很多企业的研发管理者说，我们搞产品开发这么多年了，流程肯定是有的，要不然怎么做得出产品呢?然而，大多数企业的产品开发流程可操作性不强，基本上是按GXP的要求设计的，一般是4到7页纸，产品开发流程独孤一剑(只有一个层次)，有少量的模板或检查表，企业经常是写流程的人不执行流程，执行流程的人不写流程，开发流程是GXP办或质量部或研发管理办为开发人员写的，而研发人员觉得这个流程只是为了应付国家的要求，缺乏可操作性，实际工作中就不按照流程操作，在大多数研发人员眼里按流程操作是做不出产品来的，还不如自己的经验来得实在。

企业对流程的管理也存在两个极端，一是流程经常变，使用人员无所适从，二是流程没有责任人，没有人维护，纸上的规定与实际运作相差太远还没有修订，对于一些新的业务，老流程不适合了也没有人改，业务部门等不及了就自己搞一套，另立山头，也不管是否符合公司的体系，直接挑战公司的权威部门，权威部门没有能力也没有精力管，也就作打鸟状--睁只眼闭只眼。这实际上不仅仅是企业才存在这样的问题，我们国家的法制建设尤为典型，法制建设总是滞后于社会新业务的发展，经常以司法解释对付之，实在对应不了就象对付传销一样把它强制毙掉。企业的管理者也如法炮制，上头一压下来就不顾实际的加大打击力度，导致底层人员怨声载道，干群关系极不融洽，到最后干脆溜之大吉—不干了。

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What are the prerequisites for good R&D quality management?

First of all, the basic premise of R&D quality management is to clarify the business process of R&D. Many R&D managers of enterprises say that we have been engaged in product development for so many years, and there must be some processes. Otherwise, how can we make products? However, the product development process of most enterprises is not very operable. It is basically designed according to the requirements of GXP, which is generally 4-7 pages. The product development process is Dugu Yijian (there is only one level), with a small number of templates or checklists. Enterprises often do not implement the process by those who write the process, and those who implement the process do not write the process. The development process is written for developers by GXP Office or Quality Department or R&D Management Office, However, the R&D personnel think that this process is just to meet the requirements of the country and lacks operability. They do not operate according to the process in actual work. In the eyes of most R&D personnel, operating according to the process can not produce products, which is not as practical as their own experience.

There are also two extremes in the process management of enterprises. First, the process often changes, and the users are at a loss. Second, there is no responsible person for the process, and no one maintains it. The regulations on the paper are far from the actual operation and have not yet been revised. For some new businesses, the old process is not suitable and no one has changed it. The business department can't wait to build a new one and set up a new one, regardless of whether it conforms to the company's system, Directly challenge the authoritative department of the company. The authoritative department has no ability or energy to manage, so it acts like a bird beating -- turning a blind eye. In fact, it is not only enterprises that have such problems. Our country's legal system construction is particularly typical. Legal system construction always lags behind the development of new social business, and it is often dealt with by judicial interpretation. It really can not correspond to the mandatory death of pyramid selling. The managers of the enterprise also did the same thing. As soon as the leaders pressed down, they increased their efforts regardless of the actual situation, which led to the complaints of the bottom staff and the incompatibility between the cadres and the masses. Finally, they simply walked away and quit

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质量管理部门的定位

难道质量管理就是吃力不讨好，专门得罪人的部门?管理者的定位就是服务，毛主席早就说过党员就是要全心全意为人民服务，企业的管理者也是一样，研发的质量管理人员要为研发服务，前提是要把研发业务搞清楚，然而通常情况下质量管理人员又搞不清楚具体的研发业务，研发各业务部门才最清楚具体的研发业务，这就要对研发质量的责任部门/责任人进行定位了，事实上研发各业务部门/主管才是研发质量的责任部门/责任人，质量管理部门是质量专业的行业管理者，质量管理部门要为业务部门提供质量管理的各种方法和工具，而真正的质量责任人是谁做事谁负责。

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Positioning of quality management department

Is quality management a thankless department that specifically offends people? The orientation of managers is service. Chairman Mao has long said that party members are committed to serving the people wholeheartedly, as is the case with enterprise managers. The quality management personnel of R&D should serve R&D on the premise that the R&D business should be clarified. However, in general, the quality management personnel cannot understand the specific R&D business, so the R&D business departments can best understand the specific R&D business, It is necessary to position the responsible department/person for R&D quality. In fact, each business department/director of R&D is the responsible department/person for R&D quality. The quality management department is the professional quality industry manager. The quality management department should provide various methods and tools for quality management for the business department, and the real quality responsible person is who does things.

                               
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如何构建研发质量管理体系

怎么样才能构建好研发的质量管理体系呢?首先必要把GXP的质量管理程序层层落实到研发的各种业务流程中，要构建一套优秀的产品开发流程并不容易，优秀的产品开发流程具有如下6大特征：

清晰的层次结构―――可管理

明确的阶段划分―――可控制

明确的阶段交付―――可衡量

统一的术语定义―――易沟通

明确的角色职责―――易分工

明确的绩效指标―――易评价

只有当研发流程变得很优秀的时候，我们的研发质量才有管理的基础，还要把研发质量管理的活动：质量策划、质量控制、质量保证、质量改进融入到具体的产品开发活动中，否则质量就会变成质量部的事，而质量部又负不起这个责任。

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How to build R&D quality management system

How can we build a good R&D quality management system?

First of all, it is necessary to implement GXP quality management procedures into various business processes of R&D. It is not easy to build an excellent product development process, which has the following six characteristics:

Clear hierarchy -- manageable

Clear stage division controllable

Clear stage delivery measurable

Unified definition of terms -- easy to communicate

Clear roles and responsibilities - easy division of labor

Clear performance indicators -- easy to evaluate

Only when the R&D process becomes excellent, can our R&D quality be managed. We also need to integrate R&D quality management activities: quality planning, quality control, quality assurance, and quality improvement into specific product development activities. Otherwise, quality will become the responsibility of the Quality Department, which cannot take this responsibility.