Only with the consent of the buyer can the enterprise obtain certain benefits. Therefore, we can't lack indispensable production and sales technology and technology to ensure product quality, so as to create a management system that meets customer's product quality requirements correctly and economically.
A.QMS (quality management system) related knowledge
Eight management principles of quality management system: (1) Focus on customers; (2) leading role; (3) full participation; (4) technological method; (5) Management methods of the system; (6) continuous improvement; (7) Decision-making method based on facts; (mutually beneficial relationship with suppliers) ISO(QMS) includes: (ISO 9000) (ISO 9000: 2000 quality management system terms and definitions) (ISO 9004: 2000 quality management system performance improvement guide) (ISO1901:2000 quality.
What is the spirit of ISO: (consistency of speaking, writing and doing)
The six basic contents that cannot be deleted in ISO900 1:2000: 2000 are: (4.2.3 document control) (4.2.4 record control) (8.2.2 internal quality system audit) (8.3 nonconforming product control) (8.5.2 corrective measures) (8.5
Classification of quality system audit: (1) First-party audit: audit of the enterprise's own quality system; (2) Second-party audit: the customer or its representative sends auditors to audit the quality system of its suppliers according to the requirements stipulated in the contract; (3) Third-party audit: the quality system audit of the enterprise applying for registration and certification by the certification registration company or the independent and compliant quality system audit of the enterprise applying for audit by other impartial third parties; Its purpose is not necessarily authentication registration)
Audit basis of internal quality system (1) corresponding national laws and regulations (2) quality assurance standards for industry-specific quality management (3) international quality management and assurance standards (4) quality manual (5) quality procedure book (6) working documents and quality records (7) contract.
Timing and frequency of internal quality system (generally: 1, all quality system documents have been compiled, promulgated, implemented and operated for 3~4 weeks; When all quality activities have problems and records to check. 2. Conduct routine audit according to the annual audit plan. Special: 1, serious quality problems or serious complaints from users. 2. Major changes have taken place in the leadership, affiliation, internal organization, products, quality policies and objectives, production technology and equipment, and production site of the enterprise. 3. Second, the third-party audit or the audit stipulated by laws and regulations will be conducted soon. 4. The third party obtained the certification registration qualification and certificate after the audit, and the certificate is about to expire, so it wants to continue to maintain the certification qualification. )
Audit plan type: (1), centralized audit plan: audit all departments and elements involved in the quality system at one time. 2. Rolling audit plan: audit one or several departments or elements once a month; Every month, review all departments and elements once or more within one year)
Audit steps: (1) Make an audit plan; (2) Establish an internal audit team; (3) make an implementation plan; (4) Collect and review relevant documents; (5) prepare a list; (6) Hold the first meeting; (7) Conduct on-site audit; (8) Hold the last meeting; (9) Propose, approve and approve corrective measures; ( 10)
Classification and definition of audit defects: (Unqualified: failure to meet the requirements of laws and regulations, quality assurance standards, quality manuals, quality plans, contracts, various written procedures and work instructions constitutes disqualification. Unqualified products are usually divided into the following three categories: 1. Main disadvantages: the effectiveness of ISO9000 quality assurance system will be significantly reduced; Main disadvantages: 1, which obviously does not meet the major defects of ISO9000. 2. For the existing important operations, no operating procedures have been established. 3. Failure to follow the established operating procedures leads to obvious failure or serious defects in the operation. There are many shortcomings, which are scattered in many departments and there are more than five new projects. 5. There are many shortcomings, and they are concentrated in the same department: it shows that the quality system of this department is flawed. Second, minor shortcomings: 1, minor shortcomings of the system. 2. Small shortcomings in the system. 3. A single event during execution. 4. Accidental negligence. Three. Observation items: at present, there are no unqualified items, but there is a tendency to become unqualified; Business organizations can do better. )
Definition of quality system audit (to determine whether the activities and related results of quality system conform to relevant standards or documents, whether the provisions of quality system documents are effectively implemented, and whether it is suitable for systematic and independent audit to achieve quality policy objectives)
The input and output of the management review include: (The input information includes: 1, the audit result; 2. Customer feedback; 3. Process performance and product compliance; 4, the implementation of preventive and corrective measures; 5, the previous management review tracking measures; 6. Changes that may affect the quality management system; 7. Suggestions for improvement include: 1, quality management system and its process improvement; 2. Product improvement related to customer requirements; 3. Resource requirements)
Design and development inputs include (1, function and performance requirements; 2. Applicable laws and regulations; 3. Applicable information provided by previous similar designs; 4. Other requirements necessary for designing each development)
What are the disposal methods of nonconforming products: (1, take measures to eliminate found nonconformities; 2. Approved by relevant authorized personnel; Concession to accept, release, scrap or accept unqualified products; 3. Take measures to prevent the original intended use of its various applications. Note: Records of the nature of nonconformities and any follow-up measures, including records of concessions approved, shall be kept; After the nonconforming product is corrected, it should be verified again to confirm that it meets the requirements; When unqualified products are found after delivery or use, the organization shall take measures appropriate to the impact or potential impact of unqualified products.
The role of the internal auditor: (1, supervise the operation of the quality system; 2. Maintain and improve the quality system; 3. Play the role of channel and link in the communication between leaders and employees. ) QMS is a process-oriented management model. )
Definition of quality audit: (a systematic and independent review to determine the activities of the quality system, relevant results and relevant standards or documents, and whether the provisions in the quality system documents have been effectively implemented and are suitable for achieving the quality policy objectives).
Second, EMS (Environmental Management System) related knowledge
WEEE definition: (scrapped electronic and electrical equipment; Refers to the electronic and electrical equipment defined as waste according to Article 1 A of Directive 75/442/EEC, which is included in all parts, components and consumption discarded as part of the product).
ROHS definition: (Directive on certain hazardous substances restricted in electronic and electrical equipment: 2002/95/EC issued by the Council of the European Parliament on 23 October 2003/KLOC-0).
Environmental management materials include: (among the materials contained in parts, sub-materials and materials, there are substances that have such a great impact on the global environment and human body)
The seven major environmental factors are: (1, gas emission; 2. Liquid discharge; 3. Noise pollution; 4. Solid waste discharge; 5. Land pollution; 6. Resource use, energy consumption and material consumption; 7. Environmental problems in other places)
Process of environmental management system: (1, environmental requirements, social responsibilities, customer needs; 2. import; Commitment policy: top management's commitment; Environmental policies and guidelines; 4. Planning: determination and impact assessment of environmental factors, legal objectives and customer requirements; Formulation of objectives/indicators and environmental management plans; 5. Implementation: coordination and integration of environmental management system; Division of responsibilities and knowledge/skills and training operations; Compilation of environmental management system documents; Operation and control operation; 6. Monitoring and evaluation: measure each monitoring; Records and information management; Corrective and preventive measures; Environmental management system review; 7, review and continuous improvement)
Effectiveness of implementing the environmental management system: (1, which helps to improve the company's environmental awareness and management level; 2. It is helpful for enterprises to save energy and reduce consumption and cost; 3. It is helpful to promote cleaner production and realize pollution prevention and control; 4. Reduce pollution emissions and reduce the risk of environmental accidents; 5. Ensure compliance with laws and regulations and avoid environmental criminal responsibility; 6. Meet customer requirements and increase market share; 7. Get a green pass and go to the international trade market. )
The contents of the environmental management system include: (1, ISO 1400 1: requirements and use guide of the environmental management system; 2. Green O 14004: General Guide for Principles and Supporting Technologies of Environmental Management System 3, ISO 140 10: General Principles for Auditing Environmental Management System 4, ISO 140 12: Qualification Requirements for Auditors of Environmental Management System)
The documents in the environmental management system shall include (1, environmental policies, objectives and indicators; 2. Explain the coverage of the geological environment management system; 3. Description of the main elements of the environmental management system and their interactions, as well as the query methods of relevant documents; 4. The documents required by this standard include records; 5. Organize necessary documents, including records, to ensure the effective planning, operation and control of processes involving major environmental factors. )
The meaning of PDCA in environmental management system is: (1, planning: establishing the goals and processes needed to achieve the expected results of organizational environment; 2. Realization: realization process; 3. Inspection: monitor the progress and report the results according to environmental policies, objectives, indicators, laws, regulations and other requirements; 4. Disposal: Take measures to continuously improve monitoring and measurement, and report the results. )
If the corrective and preventive measures in the environmental management system are programmed, it includes the following requirements: (1, identify and correct nonconformities, and take measures to reduce the environmental impact; 2. If the investigation is unqualified, determine the reasons and take measures to avoid recurrence; 3. Evaluate the necessity of taking measures to prevent nonconformity; Implement appropriate measures to prevent it from happening; 4. Record the results of corrective measures and preventive measures; 5, review the effectiveness of corrective measures and preventive measures; The measures taken should be commensurate with the seriousness of the problem and the environmental impact; The organization shall ensure that necessary changes are made to the environmental management system documents. )
The input and output of management review include: (input: 1, the results of internal environmental system audit and regulatory compliance evaluation; 2. Communication with external stakeholders, including complaints; 3. Environmental performance behavior of the organization; 4, the degree of realization of goals and indicators; 5, the status of corrective and preventive measures; 6. Tracking measures of previous management review; 7. Changes in external conditions, including the development of relevant laws and regulations and other requirements; 8. Suggestions for improvement. Output: The output of management review should include decisions and measures related to modifying environmental policies, objectives and other elements of environmental management system, so as to achieve continuous improvement. )
Three, MQM (modern quality management) related knowledge
Composition of modern quality management system: (1, quality assurance system; 2. Process assurance system; 3, check the system)
The utility of modern quality management: (1, defining quality control responsibilities and quality requirements; Establish the whole process quality control system; Establish a quality prediction system; Establish a mechanism for all employees to participate in quality improvement activities; 2, improve the quality awareness and improvement ability of employees)
Three points of pursuing quality: (1, quality meets customer requirements and expectations; 2, the product quality level is determined according to the existing production technology level and customer consumption requirements; On the basis of continuous improvement of technology, we will continuously improve the quality level and meet the needs of customers at economical and competitive prices. )
Maslow's five levels of needs are: (1, physiological needs: hope to be met; 2. Security needs: I hope to have a stable life, a good material environment and avoid danger; 3. I hope to get love, gain social status, be famous and be trusted; 4. Respect for needs: I hope to be affirmed by the society, and I want to finish my work with confidence and in a tone; 5. Potential realization needs: I hope to be creative, and I can give full play to my own ability to realize my potential ability)
Customer's requirements and expectations correspond to Maslow's five levels of needs: (1, physiological needs? Applicability in performance: usability; 2. Security requirements? Credibility: availability, reliability and security; 3. Emotional needs? Emotion: aesthetics; 4. respect the needs? People-oriented design and sales services; 5. Potential realization? Potential realization: improving people's ability. )
What is quality management (1), which refers to the use of systematic concepts and methods to focus on the same goal of improving product quality; 2. Strictly organize the production and business activities of all departments and links of the enterprise, and stipulate their responsibilities, tasks and authorities in quality management; 3. Establish an organization to organize and coordinate these activities; 4. Provide products and services that satisfy customers at the most economical level. )
Resources on which quality management is based: (1 First, product design specifications, which are the specifications followed by quality management. What level the product can reach depends on the specifications of the product at the time of design. In order to ensure that the mass production can meet the design specifications stably, there must be an implementation review process in the design process. 2. Generally, a product can only be completed with the assistance of raw materials provided by suppliers. The supplier's quality management system and level is an important part of the company's quality management and an important input resource for quality management. For this kind of resources, the company should have corresponding organizations to test and constantly urge suppliers to improve their level. 3. The most important resource of quality management is the technicians who master quality management. The process control of quality management is to establish a set of quality management system that can operate effectively. 4. Equipment and instruments that must be used in quality management are indispensable material resources for quality management. The process control of quality management is to establish a set of quality management system that can operate effectively. )
The quality assurance system in modern quality management includes: (1, quality policy and objectives; 2. Responsibility and authority; 3. Quality system; 4. Quality document management; 6. Quality record management; 7. Manage the project; 8. Quality improvement; 9.4M change management; 10, management in case of exception; 1 1, corrective and preventive measures; 12, supplier management; 13, mass production evaluation. )
The process assurance system in modern quality management includes the following contents: (1, preparation of work instructions; 2. The homework instruction class must be attended; 3. Operation realization 4. Management of recycled materials; 5, equipment and fixture management; 6. Batch management and identification; 7. Process control. )
The inspection system in modern quality management includes the following contents: (1, inspection point setting; 2. Check the preparation of specifications; 3. Check the certainty of the specification; 4, check the rigor of adjustment; 5, check the implementation; 6. Batch management and identification; 7, check the equipment management; 8. Management of safety specification parts. )
High-quality finished products refer to: (expenses incurred to ensure and guarantee satisfactory quality and losses caused by failure to achieve satisfactory quality)
Composition of quality cost: (1, prevention cost; 2. Appraisal fee; 3. Loss cost; 4. Quality cost of external activities; )
The preventive cost in quality cost includes: (1, external certification of quality system, ISO9000 certification, etc. ; Fees for certification of safety standards in various regions and countries; 2, guide and assist suppliers to implement the cost of the supply guarantee system; 3. incoming packaging; 4, incoming inspection, manufacturing process, finished product inspection in advance. 5, employee education and training costs)
Appraisal expenses in quality cost include: (1, IQC incoming inspection personnel expenses, and destructive inspection expenses of incoming inspection; 2. Personnel expenses such as process inspection IPQC, online inspection FQC and finished product inspection OQC, as well as the cost of consumables invested; 3. Entrust the appraisal and test fees to the outside; External calibration cost of measuring instruments; )
The loss cost in the quality cost includes: (1), internal loss cost: the loss caused by the failure to meet the quality requirements before the delivery of the product. It is common to provide services again; Processing, rework, maintenance, retesting, scrapping and production stoppage due to quality problems. 2. External losses: expenses incurred after delivery because the products do not meet the quality requirements; Such as product maintenance, warranty return, direct costs, discounted sales due to product defects, product return costs, liability compensation costs, etc. ; )
The external activity cost in quality cost includes: (composed of external quality assurance cost, which refers to the cost paid to provide the required objective evidence according to the customer's requirements under the contract situation. For example, many customers will ask suppliers to provide material certificates and entrust external inspection agencies to issue inspection reports. )
Four, quality assurance related knowledge
IQC function: (Inspect spare parts provided by suppliers according to engineering drawings or contracts, samples, supplier delivery inspection reports, etc. ; And allow qualified products to be put into storage; Rejection, classified inspection and special procurement of unqualified products; And is responsible for tracking defects and supervising suppliers to take improvement measures to prevent the recurrence of defects. )
In manufacturing industry, there are usually four main items (design, material supply, manufacturing technology, storage and transportation) that have a direct impact on product quality. In all walks of life, the proportion of its main quality is as follows:
No industrial project design, manufacturing, storage and transportation.
1 electronic assembly industry 30% 3 to 40% 3% 0.5 to 1%
2 Electronic components 1 in 3 in 4 out 50 in 0. 1 to 1 in.
3 Plastic industry 0. 1 to 0.5% 4 to 50% 4 to 0. 1 to 0.5%
IQC sampling scheme can be divided into: (counting value sampling: testing short board and bad number; Metered value sampling: testing various important and measurable characteristics of materials; Special inspection analysis sampling: mainly reliability analysis or component analysis)
Counting sampling refers to: (refers to the inspection of the samples of this batch of products for defects or unqualified products, such as burrs, stains, short feet, inconsistent sizes, breakage, etc.
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