• sns03
  • sns02
  • anji hongde medical company facebook

2021 Annual Quality Integrity Report

 image2

February 2022

About this report

1. Compilation instructions

The quality integrity report issued by the company is written in accordance with relevant national quality laws, regulations, rules and relevant industry quality standards and norms. The company’s quality integrity and quality management in the report is a true reflection of the company’s current situation. The company is responsible for the objectivity of the report’s content and the authenticity and scientificity of the relevant statements and conclusions.

2. Scope of the report

This report takes Anji Hongde Medical Supplies Co., Ltd. as the main body, and expounds the content of the company’s performance of quality and integrity in 2021 .

3. Appellation description

For the convenience of expression, the report refers to ” Anji Hongde Medical Products Co., Ltd.” as “Hongde” and “Company” for short.

4. Reporting time and frequency

Report time range: From January 1 , 2021 to December 31 , 2021 , some data and content are beyond the above range.

Report release cycle: This annual report is the second release, and it will be released annually from 2020 .

5. Format of report release

This report is published as an electronic document, which is available at http://www.hdbandage.com/ website to download and read.

 

Company Profile

Founded in 2006 , the company is located in the Bamboo Industry Science and Technology Entrepreneurship Center, Xiaofeng Town, Anji, Zhejiang, with a registered capital of 1.6 million yuan, an area of 25 acres, a construction area of 23,000 square meters, and a total asset of 66.54 million. It is a research and development, design, production , sales and service as one of the medical dressing product manufacturers.

The main products are viscose plaster bandages, elastic bandages, plaster pads, polymer fixed bandages, medical polymer splints, tongue depressors, elastic bandages, vaseline gauze, disposable medical masks and other products are sold domestically and exported to Europe and the United States, Middle East and Southeast Asia and other countries and regions.

The company won the five-star home for the disabled in Zhejiang Province, the 2019 Independent Innovation Award, the small and medium-sized technology enterprise, the county-level R&D center, the model site for practicing the ” two mountains ” concept in 2019 , the advanced collective of model students, and the county in 2020 . Government Quality Award and other honors.

target   record

Chapter One  Quality Concept

1.1 Company Mission

1.2 Corporate Vision

1.3 Corporate Values

1.4 Corporate Culture

1.5 Quality, Environment, Occupational Health and Safety Management Policy

1.6 Guiding ideology

1.7 Quality Integrity Commitment

Chapter two  Enterprise Quality Management

2.1 Quality management organization

2.2 Quality management system

2.3 Quality and safety risk management

third chapter  Quality Integrity

3.1 Quality Commitment

3.2 Operation Management

3.3 Marketing Management

Chapter Four  Quality basis

4.1 Standardized management

4.2 Measurement management

.3 Certification Management

4.4 Inspection and testing management

chapter Five  Product Quality Responsibility

5.1 Product Quality Level

5.2 Product after-sale responsibility

5.3 Corporate Social Responsibility

5.4 Quality credit record

Knot  language

 

Chapter One  Quality Concept

1.1 Company Mission

Build a first-class brand and create an industry benchmark.

1.2 Corporate Vision

Lead the disabled to escort global human health.

1.3 Corporate Values

Integrity, pragmatism, innovation, dedication and care for the disabled.

1.4 Corporate Culture

In the years of development practice, Hongde has always regarded corporate culture as the support point and guiding ideology of development, and has gradually built a unique corporate culture in terms of corporate mission, vision, and values around the development and growth of the company. As a spiritual resource, corporate culture constantly drives the company to move forward.

company takes “building a first-class brand and creating industry benchmarks” as its corporate mission, “leading the disabled to escort global human health” as its corporate vision, adheres to the core concept of “carrying forward the humanitarian spirit and developing the cause of disabled people”, and strives to build a Hongde enterprise. culture.

1.5 Quality, Environment, Occupational Health and Safety Management Policy

Hongde strictly abides by the “Product Quality Law”, “Special Equipment Safety Law” and other national laws and regulations and the requirements of national mandatory standards to produce and sell products. In order to standardize enterprise management and improve product quality, the company continues to improve and improve the level of quality management system, so that Hongde’s quality management level and product quality have been significantly improved.

Under the guarantee of qualified product quality, we will continuously improve product quality to meet customer needs. In the on-site production environment of the enterprise, the 6S of “organizing, rectifying, cleaning, cleaning, literacy, and safety” is used to effectively manage the production factors such as personnel, machines, materials, and methods in the production site, and provide employees with a healthy and safe environment for work and life. . Company leaders care for employees, respect the rights of all employees to voluntarily organize and join trade unions and conduct collective bargaining, regularly organize employees to undergo physical examinations, and do a good job in the prevention and treatment of occupational diseases. To externally formulate the corresponding ” Quality Manual” from the R&D, procurement, production, sales, after-sales maintenance process of quality management documents to ensure that customers are provided with safe, efficient and suitable products.

1.5.1 Quality Policy:

The company’s quality policy is:

Establish a business with refinement and win with quality.

In terms of quality, it is necessary to satisfy customers and other relevant parties with advanced technology, high-quality products, professional and first-class service and management through continuous technological innovation, so as to meet customer requirements and legal and regulatory requirements, and to continuously improve the effectiveness of the system. sexual commitment.

1.5.2 Quality Integrity Policy:

Quality is the root, character is the foundation, innovative design, fine manufacturing

1.6 Guiding ideology

The leaders of the company pay attention to the construction of the quality management system, appoint special personnel to be responsible for quality management, propose to strengthen the “combat” (spirit, system, incentive) mode, improve the mechanism and enhance capacity building, and clarify the guiding ideology of “quality creates value, service creates quality”.

1.7 Quality Integrity Commitment

Hongde pays attention to the construction of corporate culture, cultivates the moral quality of employees who are diligent, dedicated, and responsible, and has established a team of high-quality employees who are responsible and professional. Under the premise of abiding by laws and regulations, the company takes customer needs as the center, carries out production and operation activities by means of high-quality products and services, infiltrates the concept of manufacturing high-quality products into the thoughts of all employees of the company, and continuously strengthens the cohesion of the company and improves Corporate image, to achieve sustainable development of the enterprise. For products with quality problems, according to the actual situation of the problem, the company makes up for it to varying degrees.

Under the normal conditions of transportation, storage and use of the product, within 24 months of storage in a dry environment, if there is a mold problem, the manufacturer should replace it. And set up a customer service line, respond to customer service requirements within 48 hours , and propose solutions in a timely manner.

 

Chapter two  Enterprise Quality Management

2.1 Quality management organization

2.1.1 Organization Chart

According to the requirements of the “Company Law” and the “Articles of Association”, the company establishes an organizational structure and implements the general manager responsibility system. According to the existing business and strategic vision, there are six functional departments: Production Technology Department, Quality Technology Department, Bidding and Purchasing Department, General Management Department, External Development Department, and Planning and Finance Department. The general manager of the company ensures that the responsibilities and authorities of the above-mentioned departments and related positions are stipulated, and each department performs its own duties and cooperates with each other to make full use of human resource allocation, capital investment, infrastructure, equipment, etc. to ensure the effective operation of the management system.

image3

2.1.2 Management representatives

Appointed and authorized by the general manager of the company to command and control the operation of the system in the quality management system. Responsible for promoting the specific implementation of the company’s quality policy, quality objectives, and quality strategy, as well as evaluating and improving them. Specific responsibilities include:
a) According to EN ISO 13485:2016 (IDT ISO 13485:2016), YY/T0287:2017), Good Manufacturing Practice for Medical Devices (No. 64) and MDD93/42/EEC as amended by 2007/47 /EC requirements to ensure the establishment, implementation and maintenance of the company’s quality management system; b) responsible for the general manager; c) responsible for establishing, implementing and maintaining a quality management system in accordance with the requirements of regulations and standards, combined with the actual situation of the company; d) reporting to the general manager The manager reports on the operation of the quality management system and improvement needs; e) is responsible for the coordination of the operation of the system to ensure the normal operation and effective implementation of the quality management system; f) ensures that the awareness of meeting the applicable regulatory requirements and the requirements of the quality management system is raised throughout the company ; g) Responsible for organizing the review and disposal of major non-conforming products; h) Responsible for establishing and realizing external communication and contact on matters related to the quality management system;
i ) Responsible for the review of the quality manual and the approval of procedural documents.
2.1.3 Quality Technology
Department As the basic department to control product quality, the Quality Technology Department is also the centralized management department of the company’s quality management system, and plays a vital role in the construction of quality management. At the same time, there are many responsibilities and obligations in the management process, as follows: j) Responsible for the inspection and testing of products (including raw materials, semi-finished products and finished products), storage and release; k) Responsible for the monitoring and measurement of quality control points, responsible for important l) Responsible for the collection and analysis of product quality information (data); m) Organize unqualified review, propose and implement disposal methods, and conduct supervision and verification;
n) Responsible for the processing of unqualified products and process monitoring ;
o) Responsible for the management of testing equipment, establish testing equipment files, and supervise the testing work; p) Formulate product inspection instructions and supervise the implementation; q) Assist in handling quality problems of manufactured products; r) Do a good job in product inspection and testing Status identification; s) Formulate and confirm relevant technical standards and specifications of products; t) Carry out research and development of new products, etc. u) Cooperate with technical problems in product after-sales service; v) Assist management representatives to implement internal audit activities; Process technical guidance.

2.2 Quality management system

Hongde obtains customer satisfaction with its products with high-quality brand and service attitude, and constantly makes strategic improvements to the quality policy and quality goals to suit the company’s development. According to the ISO 13485 standard, the company has established a quality management system integrating design, development, production, sales and service, and the products have passed CE certification. In order to meet the needs of the company’s rapid development, continuously strengthen the quality management work, and improve the high-quality brand image of product quality, the company has continuously carried out the work of changing the quality management system. Through brand promotion, the company has significantly improved the popularity of the Hongde brand in this field, and also promoted the Hongde brand to the international market.

The company implements continuous improvement of the system through annual internal audit, management review and external supervision and audit to ensure the effectiveness of the quality management system, thereby ensuring product quality. According to the requirements of ISO 13485 standard, the company conducts standardized and standardized management of the company through the implementation of the “Quality Manual”, procedure documents and third-level documents to ensure the realization of the company’s quality, environment, occupational health and safety policies and quality objectives, so that customers and related to obtain satisfactory service.

2.2.1 Quality Integrity Education

the principle of sustainable and healthy development of law-abiding operation, honesty and trustworthiness, Hongde has formulated and implemented training programs for quality and integrity education through the “Human Resource Control Procedures” and “Training Control Procedures” to test the feasibility of quality and integrity education and training programs. Company-wide publicity and promotion of the spirit of quality integrity. From the management to the front-line employees, Hongde always insists on product quality first, and regards quality and integrity as the key to opening the door to the market . Quality control; at the same time, organize the construction, publicity and activities of corporate integrity culture; arrange for employees to conduct systematic training on the environment and occupational safety and health. Quality and integrity education is the endogenous force for doing a good job in quality and integrity management. It is a long-term work to establish and condense the core values of the enterprise. Hongde makes unremitting efforts for it.

2.2.2 Integrity and self-discipline

Hongde has always attached great importance to the construction of enterprise quality and integrity while its brand awareness has been continuously improved. It has established the corporate values of ” integrity, pragmatism, innovation, dedication, and caring for the disabled “. The company strictly abides by national and local laws and regulations, relevant national, local and industry social responsibility standards, and presents the company’s rules and regulations in a true, accurate, timely and complete manner.

2.2.3 Management objectives

In the management system of quality improvement, Hongde faces internal and external environmental pressures and constant changes in the needs of related parties, as well as the company’s solutions to risks and opportunities. The management objectives of each department are formed and the quality management objectives of each department are formed.

The general manager of the company clearly understands that the market competition is ultimately the competition of talents, and strengthens the staff’s efforts in product quality education and business ability training in an all-round way, adheres to the principle of combining training and assessment, and adopts a combination of internal and external training methods. Continuously improve the education and training management system. From the two aspects of employee needs and company development, the training content is carefully and reasonably arranged, and multi-level, multi-form, multi-channel and differentiated training is carried out to enrich employees’ abilities in internal business capabilities, quality management capabilities and other aspects. Through continuous training and adjustment, the company’s existing management talents and technical talents are distinct, and each job position has a good transfer echelon, which has laid a personnel foundation for the healthy development of quality management.

2.2.4 Quality objectives

a) According to the requirements of EN ISO 13485:2016 (IDT ISO 13485:2016), YY/T0287:2017), Good Manufacturing Practice for Medical Devices (No. 64) and MDD93/42/EEC as amended by 2007/47/EC Ensure the establishment, implementation and maintenance of the company’s quality management system;

b) Responsible to the general manager;

c) Responsible for establishing, implementing and maintaining a quality management system in accordance with the requirements of regulations and standards and in light of the actual situation of the company;

d) Report the operation of the quality management system and improvement needs to the general manager;

e) Responsible for the coordination in the operation of the system to ensure the normal operation and effective implementation of the quality management system;

f) ensure that awareness is raised throughout the company to meet applicable regulatory requirements and quality management system requirements;

g) Responsible for organizing the review and disposal of major non-conforming products;

h) Be responsible for establishing and realizing external communication and contact on matters related to the quality management system;

i ) Responsible for the review of the quality manual and the approval of the procedural documents.

2.1.3 Quality Technology Department

As the basic department to control product quality, the quality technology department is also the centralized management department of the company’s quality management system, and plays a vital role in the construction of quality and quality management. At the same time, there are many responsibilities and obligations in the management process, as follows:

j) Responsible for the inspection and testing of products (including raw materials, semi-finished products and finished products), storage and release;

k) Responsible for the monitoring and measurement of quality control points, and responsible for roving monitoring of important processes;

l) Responsible for the collection and analysis of product quality information (data);

m) Organizing non-conformity review, proposing and implementing disposal methods, and conducting monitoring and verification;

n) Responsible for the treatment of non-conforming products and process monitoring;

o) Responsible for the management of testing equipment, establish testing equipment files, and supervise testing work;

p) Formulate product inspection instructions and supervise their implementation;

q) Assist in dealing with the quality problems of the manufactured products;

r) Do a good job of product inspection and test status identification;

s) Formulate and confirm relevant technical standards and specifications of products;

t) Carry out research and development of new products, etc.

u) Cooperate to deal with technical problems in the after-sales service of products;

v) Assist management representatives in the implementation of internal audit activities;

w) Provide technical guidance to the process.

In the process of continuous improvement and development, the product is defined in the direction of quality with higher requirements for precision and performance, the company’s industry competitiveness is improved, and challenging quality goals are set. The company’s quality objectives are shown in the “Quality Objective Decomposition Table”, and some of the objectives are as follows:
a. The qualified rate of one-time inspection of products reaches 96%. b. The product complaint rate is not more than 2%; C. The production safety accident is zero.

Figure 2 Statistical table on the completion of quality goals in 2021

Assessment target

Monthly assessment results

January

February

March

April

May

June

July

August

September

October

November

December

The qualified rate of finished products is ≥96 %.

100

100

100

100

100

100

100

100

100

100

100

100

The product complaint rate does not exceed 2%

0

0

0

0

0

0.3

0

0

1.9

1.0

0

0

Production safety accident is 0

0

0

0

0

0

0

0

0

0

0

0

0

2.2.5 Measurement target

With the support of accurate inspection tools and standard inspection methods, the equipment is regularly calibrated to ensure that the inspection rate of the inspection equipment reaches 100%, and the training and assessment of the relevant inspection personnel requires a 100% pass rate of the personnel in the key measurement process.

2.2.6 Quality regulations

In order to strengthen the quality supervision and management of products, improve the level of product quality, clarify product quality responsibilities, and protect the legitimate rights and interests of customers, we specially identify quality laws and regulations, such as the “Product Quality Law of the People’s Republic of China” and “Medical Device Quality Management System “. Requirements for Regulations “, “Quality Management Practice for Medical Device Production”, “Regulations on the Supervision and Administration of Medical Devices”, “Medical Device Classification Rules”, “Medical Device Instructions and Labeling Management Regulations”, “Medical Device Generic Name Naming Rules”, ” ISO13485 : 2016″ ” MDD 93/42/EEC (2007/47/EC) “, etc., requires the production of high-quality products in a reasonable environment and the Hongde brand in a law-abiding environment.

2.2.7 Quality management system

Hongde has formulated the “Quality Control Procedure”, “Verification Control Procedure” and “Substandard Product Control Procedure” in quality management. Starting from raw materials, the workpiece processing process is equipped with testing equipment for each operator to implement self-inspection , and daily inspections are arranged. Carry out quality sampling inspection of process products, inspectors fully inspect before leaving the factory, strictly control product quality, and achieve 100% qualified delivery. The company has formulated “Purchasing Control Procedures” and “Quality Control Procedures” for business management processes such as marketing management process, design and development management process, procurement management process, production management process, inspection management process, packaging, transportation management process, outsourcing management process and warehouse management. 》 and other related systems to track, monitor and manage the whole process of products to achieve the effect of preventing problems before they occur, so as to ensure and improve product quality .

Every week, the company integrates the production department and the quality technology department to hold regular meetings to discuss the problems existing in the product quality feedback from customers, jointly discuss reasonable solutions from the concept of eradicating quality problems, and record the quality problems reported by customers to be vigilant. Improve and perfect the quality management system to meet management requirements and market needs.

2.2.8 Compensation for quality liability

Quality is the foundation of Hongde. To gradually control the quality of products from the source, the first step is to control the quality of incoming raw materials. The raw materials purchased from external factories need to be tested by professional inspectors to meet all the material properties required by the company before they are accepted. The material company is required to have a special negotiation department to provide additional responsibilities for the supplier in order to provide inspections for bad conditions. The specific solution depends on the quality problem. The second step, strict process control, as the name implies, is the production and processing control in the factory. The company has mature production lines and production equipment and experienced operators, design product processing diagrams according to customer needs, and formulate reasonable processing technology routes. Production and processing are strictly in accordance with The process requires operation, the operators in each process conduct self-inspection, and there are corresponding inspectors in each link to conduct inspections. A final inspection is set up for the finished products after processing, and 100% full inspection is performed on the products . The third step is to provide high-quality after-sales service for the ex-factory products. No matter what happens during the product warranty period, the company will take the initiative to take responsibility and provide solutions and technical support for quality problems in order to achieve customer satisfaction.

The company improves product quality and reduces production costs through total quality management. According to the company’s overall development requirements, and in accordance with the principle of linking the company’s product quality and overall benefits with the interests of employees, relevant systems have been formulated. In order to avoid the frequent occurrence of quality accidents, establish a problem tracing mechanism, sort out the causes and take solutions. At the same time, in order to ensure the legitimate rights and interests of customers, the company always provides customers with qualified products with quality assurance. The planning department formulates relevant sales policies, manages customer complaints and returns, promotes internal improvement of the company, and evaluates the corresponding responsible persons.

2.3 Quality and safety risk management

2.3.1 Quality complaints

Hongde always pays attention to customer requirements, implements the tenet of “serving with heart and developing scientifically”, regards customer satisfaction as our eternal goal, and includes customer satisfaction as the company’s quality goal. In order to facilitate customer complaints, the company has established a special person responsible for complaint reception. The company has formulated systems such as “Customer Satisfaction and Feedback Control Procedures”, “Adverse Event Monitoring and Re-evaluation Control Procedures”, and “After-sales Supervision and Control Procedures” to properly handle customer relations. Clearly define the responsible department for handling customer complaints, solve problems for customers in the first time, and achieve rapid response.

Chart 3 Customer Complaint Handling Process

process

Job Description

Responsible department

use form

Sales acceptance

The customer feedbacks the problem to the planning department, and conducts preliminary understanding and communication

Ministry of Planning

see documentation

 

Feedback to Quality Technology Department

The quality and technical department characterizes the nature, judges whether the complaint is established, and determines whether the quality complaint or non-quality complaint

Quality Technology Department

Internal investigation

Determine the cause of the complaint

Quality Technology Department

Corrective action formulation

Develop initial corrective measures and write response letters

office

Reply to customer

Reply to the customer to confirm whether the customer approves

General manager

Rectification and implementation

follow up

 

2.3.2 Quality Risk Monitoring

2.3.2.1 Quality Control Points

Hongde conducts key assessments on the risks existing in the key characteristics, key parts and weak links of product quality, and formulates a process management system to manage them. Set up a special person in charge to control each link. The person in charge has a certain ability to plan, equipment planning, material planning, operation instruction planning, environmental planning, evaluation planning and other coordination capabilities, and makes use of the control of quality control points. It makes the risks existing in the key characteristics, key parts and weak links of product quality under control.

2.3.2.2 Quality Supervision and Audit

Hongde has set up a quality technology department, a quality inspection specialist to inspect and supervise the production process of each series of products, and a process management specialist to supervise the implementation of each production site and process discipline. According to the quality incentive assessment and process management system formulated by the company, the problems found in the quality supervision and inspection and the bad situation found by the operators in the production process are rectified and supervised according to the actual production situation.

2.3.3 Quality incident emergency management

The company establishes and maintains a quality credit emergency preparedness and response mechanism to make quick and timely responses to potential quality untrustworthy events or emergencies or emergencies. The company has established a complete after-sales service network, set up customer service telephones to accept customer complaints, and organized after-sales service personnel to provide after-sales service and customer complaint handling. The “After-sales Supervision and Control Procedures” have been formulated for after – sales personnel, and a customer complaint handling process has been established . If the same quality problem has been dealt with 3 times during the warranty period and still not resolved, the company will give replacement. The Planning Department will follow up and return to each complaint handling to ensure that the complaint is closed and the customer is satisfied. So far the company has not had a single news exposure event.

third chapter  Quality Integrity

3.1 Quality Commitment

Hongde solemnly promises to the whole society and self-discipline:

1. Be responsible to employees and establish a quality and integrity education and reward and punishment system. Formulate quality and integrity regulations, regularly organize employees to learn quality and integrity norms, strengthen quality and integrity awareness, and require relevant records; implement quality integrity responsibilities in combination with employees’ job responsibilities, establish quality integrity performance evaluation and reward and punishment mechanisms, and promote employees to actively participate in corporate quality. Integrity construction.

2. Be responsible for the company and establish a quality integrity inspection system. In accordance with relevant regulations, the inspection and testing equipment in use shall be regularly verified or calibrated to ensure that the inspection and testing equipment meets the requirements of national standards; under the condition of accurate standard testing equipment, qualified or correspondingly capable inspectors shall be provided to inspect raw materials and outsourced products. , outsourced parts are strictly inspected or verified, and relevant inspection or verification records are kept as required; necessary factory inspection equipment is equipped, and the final product is strictly inspected and controlled in accordance with the standard requirements, so that unqualified products do not leave the factory. requirements, and keep the factory inspection records of qualified products according to regulations;

3. Responsible for customers, establish complaint handling personnel and after-sales service system. Products sold to customers are accompanied by inspection certificates, and provide customers with product instructions; file and divide customers to keep in mind the special requirements of special customers for products; establish a complaint acceptance team and after-sales service network, within the promised time. Help customers solve problems encountered during product use, properly handle customer complaints and complaints about product quality, and strive to make customers satisfied; carry out customer satisfaction surveys, understand customer needs, and continuously improve product quality.

4. Be responsible to the society and establish a complete product tracking system. Products found to be defective can be recalled in a timely manner; product quality accidents that have occurred can be properly handled in a timely manner, and relevant responsible persons shall be held accountable, and an improvement plan shall be formulated and implemented, and the quality integrity and self-discipline behavior of using logos to indicate the ownership of the products. Express or make public commitments and be responsible for the characteristics of the raw materials used in the product, product coating process or product performance that reflect the quality of the product.

If the quality problem of the company’s products leads to domestic and foreign notification, return or destruction, the company voluntarily accepts the relevant treatment made by the state and relevant treaties in accordance with the regulations.

3.2 Operation Management

3.2.1 Improve the quality system and strengthen quality management

Over the years, Hongde has always adhered to customer needs as the focus, and continuously improved quality management work according to product quality requirements. Under the constraints of national standards and industry standards, Hongde has continuously optimized production processes, improved equipment configuration, and produced more efficient and energy-saving products. High quality product. The efficient operation of quality management system, environmental management system, occupational health and safety management system and other systems within the enterprise has greatly promoted the improvement of work quality and product quality, and promoted the rapid development of Hongde brand .

3.2.2 Strict node control and emphasis on process management

According to the quality control of raw materials, semi-finished products and finished products, the company’s quality technology department realizes a management system that covers all inspection items and checks the production process at every level. Adopt a series of effective process management, such as setting posts and responsibilities, process inspection, quality assessment, accountability, quality traceability, data statistical analysis, etc., so as to supervise the key control of key processes and the standardized operation of common processes. The quality technology department ensures product quality through comprehensive control of the production process and effective supervision of key nodes.

Chart 4 Quality inspection process

image4

 image5

3.2.3 Establish a supervisory mechanism and implement responsibility management

The company divides each production management group and determines the regional responsible person to supervise and inspect the quality of each production group. The Quality Technology Department and related teams respond quickly to customer complaints about product quality , actively implement the requirements of customer complaints and supervise the improvement of product processing progress. Customer complaint team and responsible person.

3.2.4 Encourage the participation of all staff to achieve quality improvement

The company attaches great importance to the construction of quality culture, and regards character as the core of quality training and education. Guide all employees to participate in quality management. Through continuous and in-depth measures such as rationalization construction, quality improvement proposals, and equipment automation improvement, the majority of employees can fully participate in every link of quality improvement. At the same time, employees are required to conduct self-inspection and mutual inspection. , to jointly improve product quality and share the results of quality improvement.

3.2.5 Upgrade information transmission and strengthen indicator monitoring

On the premise of the requirements of the quality policy, Hongde plans the quality objectives for the next year every year, and decomposes the overall objectives into various functional departments. During the period, the implementation plan will be tested and tracked, and the deficiencies will be actively discovered and improved in time to meet the quality goals and requirements of the company. In order to improve the accuracy and timeliness of quality information transmission, the company has upgraded the quality information system. Real-time transmission of information and fast and accurate statistics are realized through the information sharing system.

3.3 Marketing Management

The company formulates a marketing plan every year, and decomposes it into monthly digital tasks and corresponding salespeople, and divides the salespeople who are responsible for the region. The company conducts factory inspection on all Hongde products sold , and can provide corresponding inspection index data. The company’s products are sold all over the country and become the preferred business partner of customers. The company carries out market expansion activities in a targeted manner, continuously strengthens the brand image and taps potential customers. The company’s senior management and high-quality strategic customers have established a good strategic cooperative relationship through regular mutual visits and meetings between senior management and other means. The salesman establishes and maintains a good cooperative relationship with customers by means of regular return visits and telephone communication. And in the “handling of quality problems with customers”, a relatively complete customer complaint mechanism has been established. Can receive and handle customer complaints in a timely manner to improve customer satisfaction with the company.

Innovate the marketing mechanism, expand the marketing team, strengthen management, be loyal to the enterprise, and improve the incentive competition mechanism, with clear goals and responsibilities, and quantified performance distribution to people. Improve and standardize the marketing network, establish customer files, continue to develop domestic and foreign marketing windows, and implement performance-linked responsibility to people. Build a good corporate network, release product information in a timely manner , and actively expand online marketing.

Chapter Four  Quality basis

4.1 Standardized management

The company has always adhered to standardized management, and has formed three series of standardized document guidelines: management standards, technical standards, and work standards.

The company is mainly based on the general manager and supplemented by the heads of various departments. It plans and guides the formulation of enterprise quality development strategies, annual quality work plans, and quality safety assurance measures. Regular meetings are held to discuss better management policies and formulate a book in the company. implemented within. The company is meeting the requirements of customers for products, and at the same time, in the process of design and production, the company actively adopts international standards for standardization ( ISO), national standards (GB), industry standards and other national standards to test product quality, which greatly improves the product quality. Quality has promoted the development of the company’s brand in domestic and foreign markets. The company’s general management department establishes the job responsibilities of each post, establishes detailed work standards for the company’s decision-making level and each job position, formulates the function description of each department, and more clearly defines the job responsibilities of each post.

4.2 Measurement management

Hongde has established an effective measurement management policy in accordance with national laws and regulations, and set up a special laboratory to plan and manage measurement equipment. Set up full-time measuring staff, responsible for the management of the company’s measuring instruments. In recent years, the company has introduced domestic advanced testing equipment, which has effectively solved the difficulty of testing and provided a strong guarantee for the manufacture of high-quality products. Effective and reliable measurement data are detected by standard measuring instruments to control and guide production, and have achieved good economic and social benefits.

4.3 Certification Management

The company produces high-quality products that meet customer requirements under the condition that environmental management complies with national laws and regulations, and legally produces, sells and operates under the medical device production license issued by the Zhejiang Provincial Drug Administration. In line with the company’s development requirements, the production mechanism has been continuously improved and improved. The company has successfully passed the ISO 13485 quality management system certification, and the products have passed the CE certification , which ensures the production of high-quality products and ensures the norms and standards of various production and operation activities. ,Better development.

4.4 Inspection and testing management

With the goal of building ” Hongde” into a leading enterprise in the field of cost and promoting the brand to the world, the company continuously expands the inspection team, strengthens the professional ability of inspectors, and improves product quality more efficiently. According to the production process route assigned by the company according to specifications and types, a peer-to-peer inspection team is set up to conduct inspections at various levels. The company sets up a ledger for testing equipment, and provides equipment and technical support for regular maintenance of testing instruments and equipment, as well as customer-entrusted testing.

The quality inspectors of the inspection equipment have undergone professional training and can only take up their posts after passing the assessment. Regularly organize quality inspectors to exchange various problems encountered in testing, and formulate corrective measures in time to improve the inspection level and work quality of quality inspectors. In the process of inspection and management, various systems, job responsibilities, instrument operating procedures, safety common sense, precautions, etc. are all on the wall for easy implementation.


chapter Five  Product Quality Responsibility

5.1 Product Quality Level

The production and processing of each product of the company has a complete and mature production process, equipped with advanced processing equipment and experienced professional and technical personnel, in order to grasp the product quality from the beginning of production. All types of products produced by the company have a pass rate of more than 9.8 % in the final inspection every day. During the quality inspection process, we resolutely do not accept, do not manufacture, and do not release substandard products. We collect statistical data on defective products every month and conduct variance analysis. , Solve the problems affecting the quality from the root cause, through the implementation of the quality management policy, the company’s product defect rate has been gradually reduced, the key and important characteristics of the product are 100% qualified before delivery to customers, and the products are delivered to customers only after they are qualified.

In 2021, the company’s products will be sent to Zhejiang Medical Device Inspection Institute for testing in 2 batches, and the test results meet the quality standards.

Chart 5 Product inspection report

image6 

Chart 6 Comparison of the company’s product technical indicators with advanced technical indicators at home and abroad

Main Specifications

The enterprise (organization) level

Domestic advanced level

International advanced level

Product Category

Technical indicators

plaster bandage

curing time

3 – 8 minutes

2 – 15 minutes

3 – 4 minutes

Immersion time

≤ 5S

≤ 1 5S

≤ 10S

Vaseline gauze

Gram weight

2 00 – 300 g /m 2

2 00 ± 20/m 2

280 g /m 2

Figure 7 Viscose plaster bandage product and service performance

Technical indicators

The enterprise (organization) level

Domestic advanced level

International advanced level

curing time

3-8min

2-15min

3-4min

plaster bandage dipping time

≤5S

≤15S

≤10S

Mass per unit area of plaster bandage

Not less than 400g/m2

less than 380g/m2

less than 380g/m2

plaster bandage plasticity

Should have good plasticity, should not have lumps and coarse grains, feel fine and smooth

There should be good plasticity, there should be no lumps and coarse grains

There should be good plasticity, there should be no lumps and coarse grains

Surface quality after curing

plaster bandage is cured and dried for 1 hour, wipe the surface of the plaster with a cloth and there should be no powder falling .

curing and drying for 1 hour, wipe the surface of the plaster with a cloth, there is a phenomenon of falling powder

curing and drying for 1 hour, wipe the surface of the plaster with a cloth, there is a phenomenon of falling powder

5.2 Product after-sale responsibility

Hongde has a professional after-sales service team to provide high-quality after-sales service. The company has formulated the “After-sale Supervision and Control Procedures” and the “Medical Device Recall Control Procedures”. When there are quality problems in the ex-factory products and failures in use during the warranty period, the company can quickly trace and recall and other processing methods to ensure the smooth operation of products with poor quality. Accurate recall and effective treatment, in order to improve customer satisfaction with the company, the after-sales department provides the following help:

1. Technical support, choose reasonable product structure and material according to different materials and processes;

2. Analyze and answer on-site product conditions and give rationalization suggestions;

In the process of product service, we earnestly perform our responsibilities and obligations in strict accordance with relevant regulations and contracts, and the products provided are guaranteed to meet the requirements of quantity, quality, specification and performance stipulated in the contract. Hongde hopes to win the support and recognition of our customers with professional design, processing, testing and after-sales.

5.3 Corporate Social Responsibility

Hongde can achieve achievements and develop into its current scale, which is inseparable from the support of national policies, the help of partners and the hard work and dedication of Hongde employees. Hongde has always adhered to the three-level social responsibility of “laws, interests, and morality”, and constantly improves the company mechanism.

At the regulatory level, since its establishment, the company has strictly complied with various national tax laws and regulations, and has formulated relevant financial systems and procedures for various types of expense declaration, approval, and reimbursement of the company, and constantly regulates tax management and improves financial management. Pay taxes in accordance with laws and regulations, pay taxes in full and in time, manage taxation work by special personnel, train financial personnel, improve taxation awareness, professional quality and management level, and ensure that taxation work is carried out in an orderly and lawful manner . Emission reduction, environmental protection” as its own responsibility, optimize production technology, upgrade production technology and equipment, achieve product upgrades and adjustments, reduce pollutant emissions, and actively build a resource-saving and environment-friendly enterprise.

Interest level, since the establishment of the company, relying on the cultural precipitation of the employee home, combined with the company’s actual situation, it has strived to provide employees with support for individual needs at different levels. Every year, it regularly organizes medical examinations for employees, distributes holiday benefits and items, visits and condolences to retired employees and provides financial assistance to the needy, etc. to give back to employees in all aspects. The company pays attention to the integrated construction of the supply chain, continuously improves the customer procurement process and mechanism, establishes a fair and impartial evaluation system, and creates a good optimal solution for customers. Establish strategic cooperative relations with important customers, promote the improvement and transformation of customers or suppliers in terms of supply guarantee, quality, price and service, agree with Hongde’s management and procedures from the concept, form consensus, complement each other’s advantages, and share benefits. The company establishes and implements the “Procurement Control Procedures”, regulates and restricts the procurement process and the management of customers or suppliers, and signs relevant bilateral cooperation agreements and strategic agreements with customers or suppliers. Our company strictly abides by the stipulations in the signed contract, reconciles accounts with customers or suppliers in a timely manner, completes the payment work, and establishes an honest cooperation platform for customers or suppliers.

At the moral level, Hongde actively responds to various social and moral indicators issued by the state, and constrains employees to actively cooperate and abide by them. The company continues to grow and develop, never forgetting to give back to the society, relying on Hongde’s comprehensive resources, supporting charitable donations, new rural construction, assistance and other public welfare undertakings, and fulfilling social responsibilities.

5.4 Quality credit record

Because of its excellent quality, it is trustworthy. The company has never received exposure from the market, nor has it received any disputes from customers about quality, nor has it received any punishment from the market supervision and management department. In recent years, Hongde has achieved many outstanding achievements, and has been commended and rewarded by government departments at all levels for many times, and its quality credit has been affirmed by all sectors of society.

 

Knot  language

Quality is the foundation of the survival of an enterprise, and the level of quality is an important basis for reflecting the comprehensive strength of an enterprise. If an enterprise wants to be in an invincible position in the fierce competition, it must pay close attention to quality and continuously improve its quality management level.

In maintaining the original quality culture management, Hongde constantly researches and develops new products and new processes, with better products and simpler and more efficient work methods, so that the company can continue to maintain a leading level and position in the industry. Hongde always adheres to the quality policy of “establishing a business with precision, winning with quality”, and controls the quality of products from raw materials, semi-finished products and finished products internally , and guarantees 100% qualified product quality before delivery to customers. At the same time, regular training and assessment management are carried out for the corresponding inspectors to ensure that the inspection knowledge of the inspectors is improved and updated to adapt to the impact of the diversified quality requirements brought about by the company’s development.

The construction of quality integrity system is a long-term and systematic task. Adhering to the quality management principle of “not accepting defective products, not manufacturing defective products, and not releasing defective products”, strictly control the quality threshold, and promote the construction of quality culture, in order to ” The goal of “Made in Zhejiang” is domestically leading and world-class, and we will continue to work hard!

 


Post time: Feb-22-2022