Author: CCATS

From process management，to standard quantification，Then there is the quality culture and zero-defect management，and then to the closed loop oriented to customer experience，Huawei's quality management system is gradually improved in line with the development of customers，In the process, Japan was particularly drawn、German quality culture，Actually combined with Huawei，Establish a rules-respecting process、Do things right the first time、A quality culture of continuous improvement。 In the impression of Mars, Director of Mobile Phone Quality and Operations of Huawei Consumer BG，Huawei truly puts quality as its core strategy，It should start with a quality conference in 2000。 1、starting point：Huawei is in the initial stage of development，It clarifies the only value of "customer-centric".。But how quality can help achieve this value，It has not been taken seriously enough by the company。Since 2000，Huawei is on the fast track to development，It has its own complete product system，Start the process of globalization，It seems to be driven by the wheels of the communications industry，Dash forward。 However, with this high rate of growth，Quality issues are also becoming more prominent，Customer complaints are getting louder；Huawei's customer-centric employees，I really don't spare time and cost，Fly to the customer one trip at a time，Replace the broken product，Through after-sales service to make up for the problems caused by quality。 But it's like an endless loop，Customer-centricity is Huawei's core value，The quality of the product is not good，The more orders a customer has，The more you complain。Then，Mars has just been with Huawei for two years，It's kind of a "recruit"。Rapid growth of the company，It gives new employees like him great opportunities for self-growth。"The company is in the process of rapid development，We're all busy grabbing the market，Get as many orders as you can。That's when it happened，Ren Zhengfei personally presided over a quality reflection meeting。Veneers of bad equipment that were exchanged back from the customer，and round-trip airfares，It was framed in a photo frame by Ren Zhengfei, president of Huawei，Be the "prize" of that quality conference。And this "prize" has become the most important decoration on everyone's desk for a long time，It stimulates every person involved at all times。 The conference became a starting point for Huawei's core strategy of quality。But the construction of the quality system，It's a longer one、Tortuous process。Mars has worked at Huawei for nearly 20 years，Worked in different departments，It has also experienced the whole process of building Huawei's quality system。 2、The first stage of the quality system that grows up with the customer，Based on the process to grasp the quality of Huawei in 2000，Target IBM，I wanted to learn management from IBM, the world's largest IT company at the time。back then，IBM helped Huawei build an integrated product development IPD process and an integrated supply chain ISC system。then，Indian software began to rise rapidly，Ren Zhengfei believes that software quality control must learn from India。So Huawei established the India Research Institute，Introduced the CMM Software Capability Maturity Model to Huawei。IPD+CMM is the first stage of Huawei's quality management system。IPD and CMM are the world's most common language systems，This period was also a period of significant growth in Huawei's international business，The global language enables customers to understand Huawei's quality system，and can accept Huawei's products and services。   In the first phase, Huawei achieved a process-based approach to quality。in the production process，Due to the difference in people, the product will be very different，And this system ensures product consistency through strict business processes。   The second stage，Focusing on quality based on standards With Huawei's business in Europe, it has been carried out in a large area，New problems have arisen：There are many countries in Europe，There are many operators，There are many standards, too。When Huawei is serving different carriers，You need to carefully understand the standards of each company，Then the standard information is reversed back to the domestic design、exploitation、Manufacturing links。Customers in Europe determine whether the quality of the supplier is good，There is a detailed set of quantitative indicators，For example, what is the speed of access，What is the stable operation time，Wait a minute。A few years ago，There are times when new phones are released in the industry，There are different release times in different countries，The reason for this is that the needs of users in each country are different、Government regulatory requirements differ、Industry quality standards are also different，Mobile phone manufacturers must adapt to different countries before releasing them。After years of groping，Huawei is now able to release new phones globally，And this is entirely based on the exploration of standards over the years。   This is the second stage of Huawei's quality system construction，In the process of honing it，Huawei is gradually realizing the role of standards in quality management。   With the growth of the European business，It is Huawei's own set of "integrated quality standards"。At this stage，On a process basis，The quality requirements of the standard are strengthened，Through quantitative indicators, the products are recognized by customers。   The third stage，Grasp quality based on culture Next，Huawei's focus is on Japan、South Korea and other markets，The demanding requirements of customers from these markets have given Huawei a deeper understanding of quality。When expanding the European and American markets，As long as the product has a certain compliance rate, it can meet customer requirements，is defined as a good product。However, the product compliance rate will not work in Japan，In the opinion of Japanese customers，Even if it's one percent、One in a thousand defects，As long as there are defects, there is room for improvement。Craftsmanship，Zero defects，Extreme，These words torment Huawei employees all the time。Outside of processes and standards，There are higher requirements for quality，This requires a large quality system，It is more necessary to build a corporate quality culture。Only by turning quality into a culture，Penetrate into every capillary of the company，All employees have a common understanding of quality，It is possible to advance to "zero defect".。 2007April，More than 70 middle and senior managers of Huawei held a high-level quality seminar，Take Crosby's "Four Basic Principles of Quality" (definition of quality、Quality system、Standards of work、Quality Measurement) establishes Huawei's quality principles，This is the "Third Plenary Session of the 11th Central Committee" in Huawei's quality history。After the meeting，Crosby's book, Quality Is Free, was a big hit on Huawei，The supervisor sends his subordinates，Meetings as gifts，This bestseller is actually hot again at Huawei。This is the third stage of Huawei's quality system，From that time，Crosby's zero-defect theory was introduced，Do quality management for all employees，Build a culture of quality，Everybody at work，Be flawless。Customer needs are changing，No quality system is set in stone。   The fourth stage，A closed-loop quality management system based on customer experience completes the process、standard、The construction of the latitude of culture，Huawei has encountered a new problem：How to make customers happier。At this time，Kano's concept of quality has become a new direction for Huawei's learning。Dr. Noriaki Kano of Japan defines three levels of user needs：Basic requirements、Expectant demand and excitatory demand，He was the first master of quality management to introduce the criteria of satisfaction and dissatisfaction into the field of quality management。 A basic requirement is an attribute or function that a customer considers a product to be a "must have".，For example, the call function of the mobile phone，When its characteristics are insufficient，The customer was very unhappy；When its characteristics are sufficient，Customers don't care if they're satisfied or not。The product or service provided by the expectation demand is relatively good，However, it is not a "mandatory" product attribute or service behavior，Some of the desired needs are not even clear to the customer，But what they wanted。Excitatory demand requires that customers be offered something completely unexpected，Surprise your customers。When its characteristics are insufficient，And are irrelevant characteristics，The customer doesn't matter，When the product provides the services that are required in this category，The customer will be very satisfied with the product，This increases customer loyalty。 Around customer satisfaction，Huawei's quality construction has entered the fourth stage：Customer-centric, closed-loop quality management system。This requires zero defects in basic quality，Pay more attention to the user's experience。It is also because of this customer-centric closed-loop quality management system，As a result, Huawei won the "China Quality Award" in 2016。 3、Huawei's concept of great quality：Forward and reverse closed-loop systems from process management，to standard quantification，Then there is the quality culture and zero-defect management，and then to the closed loop oriented to customer experience，Huawei's quality management system is gradually improved in line with the development of customers，In the process, Japan was particularly drawn、German quality culture，Actually combined with Huawei，Establish a rules-respecting process、Do things right the first time、A quality culture of continuous improvement。Huawei has complex business lines，The quality system is also quite complex，The two parts of culture and mechanism complement each other and support each other，It is difficult to illustrate Huawei's quality system in a complete architecture diagram。In Mars's words：Quality is not independent，is a result。To achieve the quality of the product，The quality of everyone's work needs to be guaranteed。If it's just an independent organization as a regulator to focus on quality，It's definitely not good to catch。   Within such a system，Everyone contributes to the final quality。Quality and business are not two skins，It's about product development、Production and sales、throughout the service。"So，Huawei's quality management is integrated into the work processes of each department。On the quality management itself，Innovative ideas are also needed、tool、method。Huawei has invested heavily in establishing a complete process management system，Covers insights from consumers、Technical insights、Technical planning、Product planning、Technology & Product Development、Validation testing、Manufacturing delivery、Listed for sale、service maintenance and other fields，And there is a dedicated team to do continuous optimization and improvement。   Huawei established a special organization in 2010：Customer Satisfaction & Quality Management Committee (CSQC)。The organization exists as a virtual organization at all levels of the company。At the corporate level，The company's rotating CEO is the director of CSQC，And each of the following levels also has a corresponding responsible person。"That's it，To ensure that every level of our organization has a deep understanding of quality，Know what your customers want，Turn what customers care about most into our motivation for improvement。This is a positive system that follows the management level of the company。   At Huawei, we also have a system for reverse quality management from our customers。   For example, the operator BG，A user meeting is held every year。At this conference，Invite CXOs from more than 100 key customers around the world to Huawei，With three days、Discussions were divided into different themes，The purpose of the seminar is to solicit opinions from customers，Sort out a TOP worksheet for Huawei that needs to be improved。Then Huawei based on this TOP list，Each one is paired with a customer，and build a quality improvement team internally，Targeted solutions to major problems。When the General Assembly is held the following year，The first thing to do is to report on the top 10 improvements in the previous year，And let customers vote。   This reverse management is based on Huawei's "big quality concept"。   Huawei believes that quality is more than just durability as everyone generally recognizes、Not bad，It's a big quality system，Includes basic quality and user experience，It's not just about getting the product right，We also need to continue to improve the consumer buying experience、User experience、After-sales service experience，Put the product、retail、channel、serve、Every end-to-end element that consumers can experience and perceive, such as device-cloud collaboration, is done。   A positive system that originates from the management level，A reverse system that originates from the customer，How to close the loop? CSQCs at all levels must regularly review customer satisfaction in their jurisdiction，Of course, the quality of the product itself，It also includes the experience of each link，And find out what customers are most concerned about，to develop projects to focus on improvement，Ensure that customer concerns are resolved quickly。meantime，It is also necessary to draw inferences from customer complaints，Then we will continue to improve the quality management system，This allows the system to evolve in line with the requirements of customers。   Globally，There are not many companies that can take "zero defect" as their management system，It is even rarer for companies to evolve to a large-quality concept based on customer satisfaction。Crosby's "zero-defect" quality culture has helped Huawei outperform the competition，The next thing that can make Huawei survive in the long run is this，How to focus on customer satisfaction，Continuous improvement of the quality system。   Huawei's values are customer-centric，Therefore, Huawei's quality concept is also different from that of other enterprises。"We look at quality from the customer's point of view，So to meet the needs of customers、What users are looking forward to，should all be counted as quality，We want to continue to improve。Mars said。   4、Zero defects，Do things right the first time The zero-defect concept means that the quality is completely in line with the requirements，Rather than wasting time calculating whether the possible harm of a particular flaw can be tolerated，At its core, it's all about "getting things right the first time."，And it's about getting things right the first time in everything。For the company，It's about getting things right at every level。Huawei believes that this needs to be broken down in layers，Full participation：At the company level, there needs to be a clear goal to pull in，There should be clear responsibilities at the management level，At the employee level, there must be a willingness and ability to participate as a whole。  At the highest level of the company，Every year, the rotating CEO sets quality targets，Implement target traction。The principle of setting goals by the rotating CEO is:： If the quality is not the best in the industry，Then aim for the best in the industry，Improve as soon as possible；If it has reached the best in the industry，It will be improved at a rate of no less than 20% every year。 Huawei introduced Gallup in 2001 to conduct annual customer surveys，and rate the quality，This score becomes the base for setting goals for the following year。From the management，In different product systems, managers are ranked for quality every year，Managers at the bottom of the rankings are held accountable。This plan is firmly implemented every year，Supervisors who promote backwardness，Let every supervisor run forward to the best of their ability，Let management really take the lead。  At the employee level，Huawei emphasizes the participation of all employees。There are two levels of total participation to solve：One is willingness，The second is ability。   Read More …

In recent years, accidents in confined space operations have occurred frequently, causing heavy losses to people's lives and property，Strengthen the safety management of confined space operations to prevent accidents，It is of great significance to ensure the safety of the lives and property of the operators, in order to further deeply learn the lessons of the accidents in confined space operations，Strictly supervise and urge enterprises operating in limited space to earnestly implement the main responsibility of enterprise safety production，It is possible to fully identify the work site with limited space、The management of the operation site is standardized and orderly、The safety supervision ledger is complete and complete、Safety management and operation approval systems are in place，Effectively prevent and curb the occurrence of accidents in confined space operations。 Recently, the Suzhou Municipal Bureau of Work Safety has been bidding in accordance with the government's purchase of services，Entrust Suzhou Kexin Safety Evaluation Company to carry out the second third-party verification and inspection work on 100 key metallurgical and other industrial and trade industry limited space operation enterprises in Suzhou How to carry out the verification and inspection work? Please continue to look down~ one、The period of third-party verification and inspection is from August 20, 2018 to November 30, 2018 II、Service organization: Suzhou Kexin Security Evaluation Company Three、Scope of counseling enterprises: 100 enterprises operating in limited space in the city's key metallurgical and other industrial and trade industries; During the third-party verification and inspection work, the safety supervision departments in all parts of the city will follow up and grasp the verification and inspection work in a timely manner，According to the verification report, the enterprises concerned should be strictly urged to implement rectification measures for existing problems and hidden dangers within a time limit，Enterprises with major potential safety hazards should be suspended for rectification，And track the degree of rectification and improvement in a timely manner, and review it on time，For those who fail to complete the rectification within the time limit without a legitimate reason, they will be punished according to law; ▲ Docking with Kexin Company on the third-party verification work of limited space, the service agency will carry out verification and inspection work in strict accordance with relevant requirements，Earnestly carry out the scene、system and implementation、Verification of ledgers and other aspects In view of the problems existing in the safety management of limited space operations of enterprises, help and guide enterprises to improve and rectify and further improve the level of enterprise safety management, mainly check the following aspects: First, check whether the safety management system is sound。Whether in accordance with the relevant national regulations, all places involving limited space operations in the production and operation process are fully identified，Get a complete picture of the amount of space you have、Basic information such as location and hazards and harmful factors，and risk assessment on a case-by-case basis，Establish a basic ledger for limited space management，Complete rules and regulations such as the safety responsibility system for confined space operations； The second is when entering a confined space operation，Whether to notify the supervisor and safety officer in advance，Strictly implement the approval procedures for safe operations、Outsourcing and signing of the agreement on safe operation of limited space，The contractor is responsible for evaluation, testing, and safety measures before the operation can be carried out； The third is to check whether the safety training is in place。Whether the industrial and trade enterprises with limited space operations have established a training system，Whether the relevant personnel engaged in confined space operations have carried out dangerous and harmful factors and safety precautions for confined space operations、Safety Operating Procedures、Correct use of testing instruments and labor protection equipment、Training on emergency response measures in case of emergency，And have a complete training record，Signed by the participants in the training； Fourth, check whether the conditions of the job site are confirmed。Whether the identification of dangerous and harmful factors has been carried out before entering the confined space operation，and will be dangerous to harmful factors、Inform the relevant personnel of the operation of the prevention and control measures and emergency measures；Whether ventilation measures have been taken，Maintain good air circulation；Whether the oxygen concentration in a confined space is not、Toxic and harmful gases (e.g. carbon monoxide、hydrogen sulfide, etc.).，After the test result is qualified，before you can work；Whether the job site is equipped with respirators、Communication equipment、Safety ropes and other protective facilities and emergency equipment，and the configuration of guardians，Set up security warning signs，Keep entrances and exits clear； Fifth, check whether the management of outsourced operations is standardized。The enterprise contracts the confined space operation to other units for implementation，Whether it is confirmed that the outsourced construction unit has the corresponding safety conditions，And sign a special safety production management agreement with the contractor，Clarify the safety production responsibilities of both parties，Whether the safety work of the outsourced construction unit is included in the unified and coordinated management of the enterprise； Sixth, check whether the emergency plan drill is implemented。Whether the enterprise combines its own reality，An emergency response plan for confined space operations that conforms to the characteristics of the unit has been formulated，and organize emergency drills，Safety management personnel、Whether the on-site operators and relevant rescue personnel can be familiar with emergency handling and rescue methods in the event of an accident。 All relevant enterprises are requested to actively cooperate with the verification and inspection work, actively implement rectification, and do a good job in daily safety production management

Another major regulation in the field of medical devices will be introduced。 8May 22nd，The State Administration for Market Regulation issued a notice on publicly soliciting opinions on the Rules for the Unique Identification System for Medical Devices (Draft for Comments).，It aims to strengthen the research and development of medical devices、produce、Supervision and management of operation and use，Improve the efficiency of supervision and management。 Definition of a "unique identification system".，Draft，Unique identification system for medical devices，Refers to the unique identification of a medical device、A unified identification system for medical devices composed of a unique identification data carrier and a unique identification database。 A unique identifier is a number that appears on a medical device product or packaging、A code made up of letters or symbols，It is used for unique identification of medical devices。 The unique identification data carrier is the data medium that stores or transmits the unique identification of medical devices。 A unique identification database is a database that stores the product identification and associated information of the unique identification of medical devices。 thereinto，The unique identifier shall include the product identifier and the production identifier。 Product identification is used to identify a medical device marketing authorization holder、A unique code for the medical device model, specification, and packaging；The production mark is a code that contains information about the production process of a medical device，According to regulatory and practical application needs，A medical device serial number may be included、Production lot number、Date of manufacture、Expiration date。 meantime，The National Medical Products Administration formulates standards and specifications related to the unique identification data of medical devices，Organize the establishment of a database of unique identification of medical devices，For public enquiries。 The "Opinion Draft" is hereby open to the public to solicit comments on the Consultation Draft，All sectors of the community can log on to the Chinese Government Legal Information Network (website) before September 21, 2018：http://www.chinalaw.gov.cn）, Enter the "Legislative Opinion Collection" column on the main menu of the homepage to put forward opinions and suggestions。 Full text of the attached draft Chapter 1 General Provisions Article 1 [Legislative purpose] is to establish a unique identification system for medical devices，Strengthen the research and development of medical devices、produce、Supervision and management of operation and use，Improve the efficiency of supervision and management，Innovate the regulatory model of medical devices，According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices，These rules are enacted。 Article 2: [Applicable Objects] Sales within the territory of the People's Republic of China、The medical devices used shall comply with the requirements of these rules。 Article 3 [Definition of Unique Identification System] The unique identification system for medical devices referred to in these Rules，Refers to the unique identification of a medical device、A unified identification system for medical devices composed of a unique identification data carrier and a unique identification database。 The unique identification of a medical device refers to the number presented on the product or packaging of the medical device、A code made up of letters or symbols，It is used for unique identification of medical devices。The data carrier of the unique identification of medical devices is the data medium for storing or transmitting the unique identification of medical devices。The unique identification database of medical devices is a database that stores the product identification and associated information of the unique identification of medical devices。 Article 4 [Construction Principles] The construction of the unique identification system for medical devices should actively learn from international standards，Follow the implementation of the main body of the enterprise、Regulatory guidance、Classification is implemented step by step、The principle of overall coordination between all parties。 Article 5 [Responsibilities] The State Drug Administration is responsible for establishing a unique identification system for medical devices，Formulate and publish the implementation plan for the unique identification system of medical devices，Promote all parties to actively apply the unique identification of medical devices for management，Realize data interconnection。 Chapter 2 Unique Identification of Medical Devices Article 6 [Composition of Unique Identification] The unique identification of medical devices shall include product identification and production identification。Product identification is used to identify a medical device marketing authorization holder、A unique code for the medical device model, specification, and packaging；The production mark is a code that contains information about the production process of a medical device，According to regulatory and practical application needs，A medical device serial number may be included、Production lot number、Date of manufacture、Expiration date。 Product occurrence may affect medical device identification、Retrospectively or when regulatory requirements change，A new product identity should be created。 When the sale of medical devices is discontinued、When in use，The product identification shall not be used for other medical devices；Re-sell、When in use，The original product logo can be used。 Article 7 [Basic Principles of Unique Identification] The unique identification of medical devices shall comply with uniqueness、Principles of stability and scalability。 uniqueness：The unique identification of medical devices shall be consistent with the identification requirements of medical devices。 stability：The unique identification of medical devices shall be related to the basic characteristics of the product，If the basic characteristics of the product have not changed，Product labeling should remain the same。 Scalability：The unique identification of medical devices should be adapted to the continuous development of regulatory requirements and practical applications。 Article 8 [Requirements for the Creation of Unique Identification] The marketing authorization holder of medical devices shall create it in accordance with the standards for the preparation of unique identification of medical devices、Maintain unique identification of medical devices。The standards for the compilation of unique identification of medical devices include the relevant standards formulated by the coding agency or the State Drug Administration that meet the requirements of Article 9 of these Rules。 Article 9: [Requirements for Code Issuing Bodies] Code issuing bodies shall be legal entities within the territory of China，And it should have a sound management system and operation system to ensure the uniqueness of the unique identification of medical devices created in accordance with its standards，and comply with the relevant requirements of national data security。The code issuing authority shall provide the medical device marketing authorization holder with the process for implementing its standards and guide the implementation，and provide the NMPA with a report of a unique identifier created in accordance with its standards by January 31 of each year。 The state encourages code issuing institutions to adopt relevant international standards to establish a unique identification operation system。 Chapter 3 Uniquely Identified Data Carriers Article 10 [Requirements for Uniquely Identified Data Carriers] The uniquely identified data carriers of medical devices shall meet the requirements of automatic identification and data collection technology and manual reading。If space is limited or the use is limited，In principle, the carrier form that conforms to the automatic identification and data acquisition technology is preferred。 Automatic identification and data acquisition technologies include 1D codes、QR code or radio frequency tag, etc，Encourage the use of advanced automatic identification and data collection technologies。 When using 1D codes，Product identification and production identification can be concatenated，Multiple lines can also be connected in parallel；When using RF tags，It should also have a 1D code or a QR code。 Article 11 [Requirements for Granting Uniquely Identified Data Carriers] The marketing authorization holder of medical devices shall select the data carrier standards that are compatible with the unique identification of medical devices created by the medical device，The packaging of the sales units of medical devices at all levels or the medical device products listed in its name shall be given a unique identification data carrier，And ensure that the uniquely identified data carrier is firm during the operation and use of medical devices、clarity、Readable。 Chapter 4 Unique Identification Database Article 12 [Unique Identification Database] The unique identification database of medical devices contains the product identification and related data of medical devices。 The National Medical Products Administration formulates standards and specifications related to the unique identification data of medical devices，Organize the establishment of a database of unique identification of medical devices，For public enquiries。 Article 13 [Responsible entity for coding] The marketing authorization holder of medical devices shall upload it in accordance with the requirements of relevant standards or specifications、Maintain and update relevant data in a uniquely identified database，and the authenticity of the data、Accuracy is responsible。 Article 14 [Requirements for Submission of Unique Identification Data] The marketing authorization holder of a medical device shall be approved for registration of its products、Within 60 working days after obtaining the filing or change，And upload the product identification and related data to the unique identification database of medical devices before the product is put on sale。 Chapter 5 Supplementary Provisions Article 15 [Requirements for the Use of Unique Identification] The drug regulatory department may call and manage relevant data according to regulatory needs。 Encourage medical device production and operation enterprises and users to apply the unique identification of medical devices，Adopt advanced information technology to carry out product-related management。 Article 16 Read More …