Quality Zone [Weekly Topic] 2011.06.25--06.30

The production process is an important stage in the formation of a company’s product quality. Quality variations generally occur at the production site, and the production workshop is a key location and essential part of this process; it is crucial for controlling production quality. In a company’s quality system, the production workshop is generally not considered an element under the jurisdiction of the management department in charge; yet its quality activities cover most of the elements of the ISO 9000 quality assurance model standards. On-site management in the production workshop serves as both the convergence point and entry point for the quality-related activities of various corporate management departments, as well as a \"window\" through which the quality of enterprise management can be seen, and it is an important aspect of on-site quality control. Therefore, properly understanding the key aspects of quality system audits in production workshops and effectively carrying out on-site audits are of great significance for ensuring that processes remain under control, reducing, eliminating, and preventing the occurrence of defects, as well as for continuously achieving, maintaining, and improving product quality.

The main aspects include: 1. Material management 2. Mechanical equipment management 3. Management of changes to process documents 4. Establishment of quality control points in production processes 5. Application of process control methods 6. Error-prevention measures in product manufacturing 7. Quality traceability throughout the manufacturing process 8. Tracking of standard compliance 9. Management of civilized production 10. Management of on-site production

Reply to 1# ray1513: 1) The production process must be verified to ensure that products meeting the specifications are manufactured. It is necessary to identify the operations related to the characteristics of the product or its manufacturing process that have a significant impact on product quality, and to apply necessary controls to these operations in order to ensure that such characteristics meet the specified requirements, or to make appropriate modifications or improvements. (2) Auxiliary materials and facilities that play an important role in quality characteristics should have specified limits, and their use should be controlled and verified. (3) The handling of products should be properly planned and controlled. For materials entering the factory, as well as for processed materials and final products, there should be specific written regulations or systems in place to guide handling from delivery until the products are put into use.

The topic posed by the original poster is a bit too broad. Various devices have their own manufacturing processes and characteristics, and each factory also has its own unique skills. Generally speaking, the requirements for the product manufacturing process are: compliance with **laws, regulations, and relevant standards and specifications ； It meets the contractual and design requirements, and is manufactured in accordance with relevant processes.

The production process must be continuous; the various stages of the production process need to be coordinated; the form of the production process should be flexible; and the production process must have a rhythmic flow

The production and manufacturing process is an important stage in the formation of a company’s product quality. Quality variations generally occur at the production site, and the production workshop serves as a key location and essential link in this process, playing a crucial role in controlling production quality. In a company’s quality system, the production workshop is usually not considered part of the management elements overseen by specific departments; however, its quality activities cover most of the elements outlined in the ISO 9000 quality assurance standards. On-site management in the production workshop serves as both a point of convergence and entry point for the quality-related activities of various company departments, as well as a “window” through which a company’s management capabilities can be assessed, and it is also an important aspect of on-site quality control. Therefore, properly understanding the key points of quality system audits for production workshops and carrying out effective on-site audits are of great significance for ensuring that processes remain under control, reducing, eliminating, and preventing defects from arising, and for continuously achieving, maintaining, and improving product quality. Production workshop audits generally consist of two components: office-based audits and on-site audits.

I. Quality control requirements for the production process During the technical preparation phase of product manufacturing, it is necessary to conduct process analysis on the products and components, determine the appropriate manufacturing processes, and create process flow diagrams. 　　The requirements for quality control in the production process are reflected in the following four aspects: 1. Strictly implement the production quality control plan. In accordance with technical requirements and the production quality control plan, a responsibility system is established to effectively control the factors that affect process quality (5M1E, namely people, machines, materials, methods, measurement, and environment). 　　2. Ensure that process quality is under control. By using control measures, quality abnormalities can be detected in a timely manner, their causes identified, and corrective actions taken to bring the process back under control, thereby ensuring stable product quality that meets the requirements specified in the production quality control plan. 　　3. Effectively control the production pace, address quality issues promptly, and ensure balanced production. 　　4. Contents of quality control in the production process. The contents of quality management in the production and manufacturing process typically include: quality control of process preparation; quality control during the production process; and quality control of auxiliary service processes. 　　II. Quality Control in Process Preparation Process preparation involves systematically and rationally organizing resources such as materials, equipment, tools, energy, measurement techniques, operators, specialized knowledge, and production facilities, in accordance with the product design requirements and production scale. It entails defining clear manufacturing methods and procedures, analyzing factors that affect quality, and taking effective measures to ensure that production proceeds according to the specified processes, thereby ensuring that the quality of the products meets the design requirements and control standards. Process preparation is the core component of production technical preparation and the main system element that directly affects the quality of product production. 　　1. Develop a quality control plan for the production process: (1) Examine and study the feasibility of the product manufacturing process to ensure its smooth operation; (2) Determine the processing methods, routes, procedures, and computer software to be used; (3) Select equipment that meets the requirements related to quality characteristics, and provide the necessary instruments and meters; (4) Test and verify new materials, processes, technologies, and equipment; (5) Design, produce, and validate specialized tools, storage and transportation equipment, as well as auxiliary devices; (6) Formulate a quality control plan for each production step. Implement focused process control over key processes, areas, and stages, and establish process quality control points for the quality characteristics that require special attention. Prepare the necessary product inspection plans, specifying inspection procedures, methods, tools, quality characteristics to be checked, and inspection standards; (7) Train operators, providing training for those who are responsible for carrying out specific processes as well as for conducting inspections; (8) Establish reasonable quotas for material consumption and labor hours; (9) Determine at what appropriate stages during product development inspections should be carried out, and define acceptance criteria for all characteristics and requirements; (10) Investigate measures and methods to improve production quality and process capability; (11) Identify and prepare quality records, quality control documents, and quality inspection specifications for the production process. 　　2. Verification of process capability Process capability refers to the actual processing capacity of a process when it is under controlled conditions. In the production process, the manufacturing steps are the fundamental elements in determining product quality; therefore, during process preparation, it is necessary to verify that these steps have the capability to produce products that meet quality requirements. 　　3. Quality control in procurement 　　The materials and goods purchased by a company, such as materials, parts, and components, are all components of the products and have a direct impact on their quality. Therefore, all procurement activities must be controlled. The requirements regarding procurement quality in ISO9004:1994 specify that the elements related to procurement within a quality system should include at least the following: (1) Providing appropriate specifications, drawings, purchase documents, and other technical materials; (2) Selecting qualified suppliers; (3) Quality assurance agreements; (4) Agreements on verification methods; (5) Provisions for resolving disputes; (6) Inspection procedures for incoming goods; (7) Control over incoming goods; (8) Records of control over incoming goods.

Reply to 1# ray1513: The issue involves many aspects; here are a few key points in brief: 1. Standardized management of production processes: [1] Production supervisors, technical staff in the production department, team leaders, and even frontline operators must all understand the production processes, as well as the quality requirements and the actual needs of customers. Otherwise, no matter how much is produced, it will be ineffective； 　　【2】Minimize changes in process technology, otherwise production organization and cost control will become very difficult, and it will be hard to improve production efficiency. 　　【3】When designing products, developers must consider the possibility of mass production; research and development that is technically feasible but economically unviable is meaningless. Simplify product design, use inexpensive materials whenever possible, prefer local materials, and source components domestically whenever feasible ； 　　【4】By continuously training employees in the production processes, once they become skilled workers, the defect rate and scrap rate will naturally **decrease**. The specific steps consist of 2 phases: 　　(1) First phase: 　　① For each production task and each type of machinery, the best and safest operating procedures and methods should be documented to create an operational standard ； 　　② What are the special precautions and key points for this process step? Write them down in the operating procedures ； 　　③ A quick inspection method to determine whether this process meets the standards should be included in the operating procedures, covering the inspection areas, inspection frequency, inspection tools, inspection methods, and inspection criteria. 　　(2) In the second step, the operational standards established in the first step are turned into written documents, which are then used to continuously train employees in order to improve their performance and proficiency. The operators have all become skilled workers, so naturally there are fewer defective parts and products produced by them. 　　【5】Establish a production process improvement team to study 4 tasks: （1） Improve production equipment such as machines, tools, cutting tools, molds, and fixtures in order to enhance production efficiency ； 　　(2) Study production actions and production times, eliminate unnecessary and wasteful actions, and continuously improve work standards ； 　　(3) Improve production processes and the allocation of personnel and machinery to achieve simpler and more efficient operations. For example, the production lines for consecutive processes can be placed closer to each other, thereby reducing handling time and waiting times. 【6】When producing goods based on customer orders, it is necessary to agree in advance with the customer on the standard products and inspection criteria; even the calibration standards for inspection instruments and measuring tools should be determined in advance, as well as what constitutes a qualified product. This helps to avoid disputes during the inspection process. 2. Some requirements regarding production management: 【1】Implement a system of small-batch trial production of new products to identify issues in the production process at an early stage. For example, bottlenecks in the production process may be detected during these trials, and the production department will have to invest significant amounts of manpower, resources, and time in addressing those bottlenecks. At this point, it is necessary to design various tools, molds, and fixtures, as well as to implement technical upgrades and improvements in order to enhance production efficiency and facilitate large-scale manufacturing ； At the same time, employees from the R&D department, production department, and quality control department should meet regularly to discuss together what aspects of the production process need improvement, come up with various proposals, engage in discussions, and then work to solve the problems. Everyone is concerned about controlling production costs, and through discussions it became clear that effective production control requires every department and every employee to do their own job well ； 　　【2】Design a set of management reports to record the daily production volume, as well as the production efficiency of each machine, each production line, each production team, and even each individual worker, with a summary prepared once per week. The specific formula indicators will be detailed later ； 　　【3】Identify production bottlenecks and eliminate them immediately. High production efficiency necessarily requires that the entire production process be highly smooth. If a problem occurs in a certain stage of production and it gets blocked, it will cause the entire production line to come to a halt and reduce the production speed. I’ll add more if there’s a chance

This post was last edited by ray1513 on 2011-6-24 at 14:51. 1. Requirements for machinery and equipment； 2. Requirements for personnel’s operational capabilities ； 3. Requirements for the condition of raw materials ； 4. Requirements for the production environment ； 5. Requirements for process operation methods ； 6. Process inspection requirements.

This post was last edited by sun-rock on 2011-6-24 15:08. The requirements for the production process are as follows: 1. The production process must be verified to ensure that products meeting the specifications are produced. It is necessary to identify the operations related to the characteristics of the product or its manufacturing process that have a significant impact on product quality, and to apply necessary controls to these operations in order to ensure that such characteristics meet the specified requirements, or to make appropriate modifications or improvements. 2. Auxiliary materials and facilities that play an important role in quality characteristics should have specified limits, and their use should be controlled and verified. 3. The handling of products should be properly planned and controlled. For materials entering the factory, as well as for processed materials and finished products, there should be specific documents or systems in place to guide their handling, from delivery until the products are put into use. Quality traceability in the manufacturing process: Traceability, also known as trackability, refers to the ability to follow the history, usage, and location of an entity based on recorded identifiers. Quality traceability in the manufacturing process refers to the ability to identify a product and its origin. Specifically, it refers to the use of scientific management methods during the process of ensuring product quality, in order to accurately understand the impact of various factors on quality, clarify the quality responsibilities of each department, team, and individual, ensure that quality-related information is well documented, and ultimately guarantee the quality of the products.