Weather and Mood: Introduction
Today, the weather is sunny, and the sunlight pours down without reservation, dispelling all the haze and gloom, and bathing the whole world in a sea of brightness and warmth. Such wonderful weather also makes me extremely happy. It's as if there is a cheerful little bird dancing merrily in my heart. In such a pleasant state of mind, let's delve deeply into the basic terms related to the concept of quality in international standards. These terms are like the cornerstones for building the edifice of quality and play a crucial role in various fields.
Scope of the standard
Against the backdrop of today's globalization, international exchanges are becoming increasingly frequent. In order to ensure that different countries and organizations can reach mutual understanding during the formulation and application of quality standards and avoid communication barriers caused by the ambiguity of terms, this international standard has emerged. It clearly defines a series of basic terms related to quality concepts. These terms have wide applicability and can be put to use in the manufacturing industry, the service industry, or any other field. They are like a common language, enabling quality practitioners around the world to communicate and cooperate on the same platform.
Classification of terms and definitions
The terms and definitions in this international standard are carefully classified according to different themes, mainly including general terms, terms related to quality, terms related to quality systems, and terms related to tools and techniques. This classification method is like clearly dividing the books in a large - scale library into different areas, enabling users to quickly and accurately find the information they need.
General terms
1. Entity
An entity is a thing that can be described and considered independently. Its scope is extremely broad, covering all aspects of our lives and work. For example, a specific activity or process, such as a wonderful performance or a complex project implementation; a tangible product, like a smartphone or a luxury car; an organization, system, or person with clear functions, or any combination of them, such as a multinational corporation, an efficient management system, or even a combination of a team and the technical equipment they use. An entity is like a large container that holds various forms of existence.
2. Process
A process can be understood as a set of related resources and activities that transform inputs into outputs. The resources here are diverse. Personnel are the most crucial factor among them. Relying on their professional knowledge and skills, they drive the process forward. Funds provide material support for the implementation of the process, ensuring that all activities can proceed smoothly. Facilities and equipment are the hardware foundation for the implementation of the process, and their performance and condition directly affect the quality of the output. Technology and methods are the soul of the process, which determine how to efficiently transform inputs into outputs. For example, in a bakery, raw materials such as flour and yeast are inputs. Through activities such as the operations of bakers and the heating of ovens, they finally turn into delicious bread. This is a typical process.
3. Program
A procedure is a prescribed way to complete a certain activity. In many cases, procedures need to be documented, such as quality system procedures. These documented procedures are usually referred to as "written procedures" or "documented procedures". A complete written procedure usually includes in detail the purpose and scope of a certain activity, clarifies what to do and who will do it, specifies when, where and how to do it, and also lists the materials, equipment and documents to be used, as well as how to carry out control and record. It is like a detailed map, providing clear guidance for the implementation of the activity.
4. Products
A product is the result of an activity or process. Its forms are rich and diverse, including services, hardware, process materials, software, or combinations thereof. A product can be tangible, such as a tiny electronic component, a barrel of flowing petroleum, etc.; it can also be intangible, such as a professional consulting service, an innovative knowledge concept, etc.; it can even be a combination of the tangible and the intangible, such as the after - sales service that comes with the purchase of a computer. In addition, the production of a product may be intentional, produced to meet the needs of customers; it may also be formed unintentionally, such as the pollution or harmful impacts generated during the industrial production process.
5. Service
Service refers to the results produced by the activities between the supplier and the customer during their contact and the internal activities of the supplier to meet the customer's needs. During the contact process, the supplier or the customer can be represented by personnel or equipment. The activities of the customer during the contact with the supplier often play a crucial role in service delivery, which may directly affect the customer's satisfaction with the service. The provision or use of tangible products may also form part of service delivery. For example, when dining in a restaurant, the food is a tangible product, and the attentive service of the waiters combines with it to create a complete dining experience. Services can also be closely integrated with the manufacture and provision of tangible products. For instance, while selling cars, automobile manufacturers also provide maintenance services.
6. Service provision
Service provision refers to a series of activities that the provider must carry out in order to offer services to customers. These activities may cover multiple aspects such as staff training, equipment preparation, and process design. Only by doing these preparatory work well can the provider ensure the provision of high - quality services to customers.
7. Organization
An organization is a company, society, firm, enterprise or public institution with its own functions and independent management, or a part of them, regardless of whether it is a joint - stock or non - joint - stock entity, or a public or private one. It should be noted that the definition of "organization" in this international standard is different from that in ISO/IEC Guide 2, which reflects the differences in the scope of application and focus of different standards.
8. Organizational structure
The organizational structure is the arrangement of responsibilities, authorities and their interrelationships within an organization according to a certain pattern to perform its functions. It is like the skeleton of an organization, determining the division of labor and cooperation methods among various departments and personnel within the organization. A reasonable organizational structure can improve the operational efficiency of the organization, promote the flow of information and the implementation of decisions.
9. Customer
A customer is the recipient of the products provided by a supplier. In a contractual environment, a customer is usually referred to as the "purchaser". The scope of customers is very broad. They may be end consumers who directly use products to meet their daily needs; they may also be users, such as employees within an enterprise using office supplies purchased by the company; they may be beneficiaries, for example, a community benefiting from a certain public service; or they may be purchasers who put forward specific requirements in a business contract. Customers may be either outside the organization or within the organization. For instance, when a department within an enterprise obtains products or services from another department, the former is the customer of the latter.
10. Supplier
A supplier is an organization that provides products to customers. In a contractual environment, a supplier may be referred to as a contractor. There are various types of suppliers. It may be a manufacturing plant, responsible for manufacturing various products; it may also be a distributor, which promotes products to the market; it could be an importer, introducing high - quality foreign products; or it might be an assembly plant, assembling various components into a complete product; and it could even be a service organization, providing various professional services. Similarly, a supplier may be either external or internal to an organization.
11. Buyer
The demander is the customer in a contractual environment. In commercial transactions, the "demander" is sometimes referred to as the second party in a purchase and sale. They clearly state their requirements in the contract and expect the supplier to provide the corresponding products or services as required.
12. Contractor
The contractor is the supplier in the contractual environment. In some cases, the contractor will be referred to as the first party to the transaction. In French, "titulaire contrat" is sometimes called "contractant". The contractor needs to provide the products or services that meet the requirements for the demander in accordance with the contract and assume the corresponding responsibilities and obligations.
13. Sub - contractors
Sub - contractors provide products to suppliers. In English, "sub - contractor" can also be referred to as "sub - supplier"; in French, it can be called "sous - traitant" or "sous - commandier". Sub - contractors play an important role in the supply chain, and the quality of their products directly affects the quality of the products that suppliers ultimately provide to customers.
Terms related to quality
1. Quality
Quality is the sum of characteristics that reflect the ability of an entity to meet specified and potential needs. In different environments, the definition of "needs" varies. In a contractual or regulatory environment, such as in the field of nuclear safety, the "needs" are clearly specified; while in other environments, the "potential needs" need to be identified and determined. As time passes, the needs often change. Therefore, it is very necessary to conduct regular reviews of quality requirements. The needs are usually transformed into characteristics with specified indicators, which cover multiple aspects, such as product characteristics, usability, credibility (including availability, reliability, maintainability), safety, environmental requirements, economy, and aesthetics. The term "quality" cannot simply be used to indicate the relative degree of excellence in a comparative sense, nor can it be used for technical evaluation in a quantitative sense. To express these meanings, modifying adjectives are needed. For example, "relative quality" is used to rank entities in terms of the degree of excellence or in a relative sense; "quality level" is used in a quantitative sense, such as in acceptance sampling; "quality measurement" is used for precise technical evaluation. Generally speaking, satisfactory quality results are achieved through the activities of each stage of the "quality loop". The role of each stage in quality is sometimes emphasized separately, such as the quality of determining needs, the quality of product design, conformance quality, and the quality of product support throughout the life cycle. In some materials, quality is referred to as "fitness for use", "conformance to purpose", "customer satisfaction", or "compliance with requirements", but these expressions only reflect certain aspects of quality.
2. Grade
Grade refers to the classification or grading of entities with the same functional uses but different quality requirements. It reflects the differences in predetermined or recognized quality requirements and emphasizes the relationship between functional uses and costs. Entities with a high grade, such as luxury hotels, do not necessarily have satisfactory quality. Conversely, entities with a lower grade may also perform excellently in some aspects. When grades are represented by numbers, the highest grade is usually represented by 1, and the lower grades are 2, 3, 4, etc. in sequence. When grades are represented by symbols, lower grades usually use fewer symbols or stars.
3. Quality requirements
Quality requirements are expressions of needs, or expressions of a set of quantitative or qualitative requirements for the characteristics of an entity after transforming needs, with the aim of realizing and checking these requirements. Quality requirements should comprehensively reflect the specified or potential needs of customers. The term "requirements" includes market, contractual and internal requirements of an organization, which need to be developed, refined and modified at different stages of planning. Quantitative requirements for characteristics include nominal values, rated values, limiting deviations and tolerances. Quality requirements must be expressed in vocabulary describing functions and documented for accurate understanding and implementation.
4. Social requirements
Social requirements include obligations stipulated in laws, regulations, rules, statutes, and decrees, as well as other aspects of considerations. "Other aspects of considerations" should especially include environmental protection, health, safety, protection, and the conservation of energy and natural resources. When specifying quality requirements, all social requirements must be fully considered. Social requirements may vary according to different jurisdictions, and the legal and regulatory requirements for quality may differ among different regions and countries.
5. Credibility
Credibility is a collective term used to represent availability and its influencing factors, including reliability, maintainability, and maintenance supportability. Credibility is usually only used for general descriptions in non - quantitative clauses. It is an aspect of quality related to time. This definition and relevant explanations are from the IEC50(191) standard, which also includes relevant terms and definitions.
6. Compatibility
Compatibility refers to the ability of several entities to be used together under specific conditions. It should be noted that the definition of "compatibility" in this international standard is different from that in ISO/IEC Guide 2. In practical applications, ensuring the compatibility between entities is crucial for the normal operation of the system.
7. Interchangeability
Interchangeability refers to the ability of one entity to replace another entity without any modification to meet the same requirements. Depending on specific circumstances, qualifiers such as "functional interchangeability" or "dimensional interchangeability" should be used. There are also differences between the definition of "interchangeability" in this international standard and that in ISO/IEC Guide 2. Interchangeability is of great significance in industrial production. It can improve production efficiency and reduce costs.
8. Security
Safety is a state in which the risk of harm (to people) or damage is limited to an acceptable level. The definition of "safety" in this International Standard is different from that in ISO/IEC Guide 2. Safety is an important aspect of quality. Whether it is a product or a service, it must be ensured that no harm is caused to people or damage is caused to property during use.
9. Qualified
Conformity means fulfilling the specified requirements. The definition of "conformity" in this international standard is different from that in ISO/IEC Guide 2. In quality control, determining whether a product or service conforms is a crucial step, which is directly related to whether the product can enter the market and whether the service can be accepted.
10. Unqualified
Nonconformity refers to the failure to meet specified requirements. This definition includes the deviation from or the absence of one or more quality characteristics in relation to the specified requirements, including elements of dependability or the quality system. Once nonconformity is found, timely measures need to be taken for correction to ensure the quality of products or services.
11. Defects
A defect refers to the non - fulfillment of the expected usage requirements or reasonable expectations, including those related to safety. The expectations here must be reasonable under real - world conditions. When a defect is found in a product or service, it is necessary to conduct an in - depth analysis of the causes and take effective improvement measures to avoid the recurrence of similar problems.
12. Product liability
Product liability is a general term used to describe the liability of producers or others to compensate for losses such as personal injury, property damage or other injuries caused by products. Due to different laws and regulations in different countries and regions, the legal and financial provisions regarding product liability also vary. Producers must fully recognize the importance of product liability and ensure the quality of products to avoid legal disputes and economic losses caused by product problems.
13. Appraisal process
The qualification process is a process of verifying whether an entity can meet the specified requirements. The term "qualification" is sometimes used to refer to this process. Through the qualification process, the quality of the entity can be objectively evaluated, providing a basis for decision-making.
14. Qualified in the appraisal
When an entity has been proven to have the ability to meet the specified requirements, it will be granted the qualification of passing the appraisal. This is a recognition of the entity's quality, indicating that the entity meets the relevant standards and requirements to a certain extent.
15. Inspection
Inspection is an activity that involves measuring, examining, testing, and gauging one or more characteristics of an entity, and comparing the results with specified requirements to determine whether each characteristic is qualified. In French, the term "inspection" can refer to the "quality supervision" activity carried out within the scope of specified work tasks. The definition of "inspection" in this international standard is different from that in the ISO/IEC Guide. Inspection is an important means of quality control, which can promptly identify problems in products or services and ensure the stability of quality.
16. Self-inspection
Self-inspection is the inspection of a certain work carried out by the person who completed the work according to the specified rules. The results of self-inspection can be used for process control. Through self-inspection, staff can promptly identify the deficiencies in their own work and improve the quality and efficiency of their work.
17. Verification
Verification is the confirmation, based on inspection and the provision of objective evidence, that specified requirements have been fulfilled. In design and development, verification refers to the process of checking the results of an activity to determine whether the activity complies with the specified requirements. The term "verified" is used to indicate the corresponding state. Verification can ensure that products or services meet the predetermined requirements during the development process and avoid quality problems.
18. Confirm
Verification is the recognition, based on inspection and the provision of objective evidence, of the fulfillment of specified requirements for a given intended use. In design and development, "verification" refers to the process of examining a product to determine whether it meets the user's needs. Verification is usually carried out on the final product under specified conditions of use, but it may also be necessary at earlier stages. The term "verified" is used to denote the corresponding state. If there are several different intended uses, multiple verifications can be carried out. Verification can ensure that the product or service ultimately meets the actual needs of the user.
19. Objective evidence
Objective evidence is information obtained through observation, measurement, testing or other methods, which is proven to be true and fact-based. It is an important basis in the verification and validation processes and can provide reliable support for decision-making.
Terms related to the quality system
1. Quality Policy
The quality policy is the overall quality purpose and quality direction of an organization officially promulgated by the top management of the organization. It is like a lighthouse for the organization's quality work, indicating the direction of efforts for all members of the organization. A clear and reasonable quality policy can guide the organization to continuously pursue excellence in terms of quality, improve customer satisfaction, and enhance the organization's competitiveness.
Basic concepts of quality management
The quality policy plays a crucial role in the entire management system and is an important part of the overall policy. It is like the cornerstone of a building, stable and indispensable. It is approved by the top management of the organization because the top management, from the strategic height of the organization, can grasp the alignment between the quality policy and the overall goals of the organization at a macro level. Only after careful consideration and approval by the top management can the quality policy truly become the guiding principle for the organization's quality management.
Quality management is a comprehensive and systematic process that encompasses core elements such as determining quality policies, objectives, and responsibilities. Determining the quality policy provides a direction for an organization's quality management, just like a compass in navigation; clarifying quality objectives sets specific goals for an organization's quality management, similar to the finish line in a marathon race; and clear responsibility division ensures that quality management work can be carried out in an orderly manner, with everyone knowing their roles and tasks in quality management. In the quality system, quality management is implemented through a series of activities such as quality planning, quality control, quality assurance, and quality improvement. These activities are interrelated and mutually reinforcing, together forming an organic whole of quality management.
Quality management is the responsibility of managers at all levels, but the guiding role of top managers is crucial. Top managers are like the conductors of an orchestra. Only when they accurately grasp the rhythm and direction can the whole orchestra play a harmonious and wonderful movement. At the same time, the implementation of quality management requires the joint participation of all members of the organization, because quality management is not just a matter for the management. The work quality of each position and each employee will directly or indirectly affect the overall quality level of the organization. In the process of quality management, economic factors must also be considered. This requires us to balance the relationship between quality and cost while pursuing high quality, so as to maximize the economic benefits of the organization.
Quality management-related activities
Quality planning
Quality planning is an important preliminary work in quality management. It mainly aims to determine the goals and requirements for the application of quality and quality system elements. This is like the careful planning carried out by an architectural designer before building a house. Only with a reasonable and scientific plan can a high - quality house be built.
Quality planning encompasses multiple aspects. Product planning involves identifying, classifying, and grading quality characteristics, and establishing corresponding goals, quality requirements, and constraints. This is like when we design a mobile phone, we need to clarify various performance indicators of the phone, such as processor performance, screen resolution, battery life, etc., and classify and grade these indicators according to market demand and corporate positioning, and set reasonable goals and requirements.
Management and operation planning are preparations for the implementation of the quality system, including organizational work and schedule arrangement. This is like the deployment of a battle, which requires the reasonable arrangement of troops, supplies, and time to ensure that all tasks can be completed on time and with high quality.
Preparing a quality plan is also an important part of quality planning. At the same time, predictions for quality improvement should be made. A quality plan is like a detailed battle map, which provides specific action routes and methods for quality management work. And the prediction of quality improvement can help organizations make response measures in advance and continuously improve the level of quality management.
Quality control
Quality control refers to the operational techniques and activities carried out to meet quality requirements. It is like a strict quality inspector, constantly monitoring every aspect of the production process to ensure that the quality of products or services meets the standards.
The purpose of quality control is to monitor the process, promptly identify and eliminate the causes of unsatisfactory results at all stages of the quality loop, so as to achieve economic benefits. For example, in the automobile production process, quality control personnel will strictly monitor the production process of each component. Once a problem is found, measures will be taken immediately for correction to prevent unqualified products from entering the market and causing losses to the enterprise.
Certain activities of quality control and quality assurance are interrelated. Quality control focuses on the monitoring and adjustment of processes, while quality assurance focuses on providing confidence and proof. The two complement each other and jointly ensure the quality of products or services.
Quality Assurance
Quality assurance refers to all planned and systematic activities carried out within the quality system and verified as necessary to make people confident that an entity can meet quality requirements. It is like a reassurance pill, enabling customers and relevant parties to have full confidence in the quality of products or services.
Quality assurance has two purposes, internal and external. Internal quality assurance is mainly to build confidence among managers within the organization. By establishing a sound quality system and strict quality control measures, managers can be convinced that the organization's quality management work can operate effectively and the quality of products or services can be guaranteed.
It should be noted that if the "quality requirements" cannot fully reflect the users' needs, it will be difficult to gain full trust in quality assurance. Therefore, when formulating quality requirements, the users' actual needs and expectations must be fully considered.
Quality system
A quality system refers to the organizational structure, procedures, processes, and resources required for the implementation of quality management. It is like a complex machine. Only when all its components cooperate and work in tandem can the normal operation of the machine be ensured.
The content of the quality system should be determined by the need to meet the quality objectives. Different organizations have different quality objectives, so the content of the quality system will also vary. A quality system of an organization is mainly designed to meet the internal management needs of the organization, and it is broader than the requirements of specific customers. Customers usually only focus on the part of the quality system content relevant to them.
For the purpose of fulfilling contracts or conducting mandatory quality evaluations, it may be necessary to verify the implementation of specified quality elements. This requires the organization to fully consider these external requirements when establishing the quality management system to ensure the effectiveness and verifiability of the quality management system.
Total Quality Management
Total quality management is a management approach in which an organization takes quality as the center and is based on the full participation of all employees. It is like a sports meeting in which all employees participate. Everyone works hard at their own posts to achieve the organization's quality goals.
The purpose of total quality management is to achieve long-term success through customer satisfaction and the benefits to the organization's members and society. "All employees" refers to the personnel in all departments and at all levels of the organizational structure. This means that total quality management is not just the concern of the production department but involves every corner of the organization.
The strong and continuous leadership of top - level managers and the education and training of all members within the organization are the key factors for the success of total quality management. The leadership of top managers is like a locomotive, guiding the organization towards quality goals; while the education and training of employees can enhance their quality awareness and skill levels, providing strong support for total quality management.
In total quality management, the concept of quality is closely related to the achievement of all management objectives. At the same time, the concept of "social benefit" means that an organization should meet "social requirements" and assume corresponding social responsibilities.
Sometimes, "Total Quality Management" (TQM) or a part of it is referred to as "Total Quality" (TQ), "Company-Wide Quality Control" (CWQC), "Total Quality Control" (TQC), etc.
Quality improvement
Quality improvement refers to various measures taken throughout the organization to enhance the effectiveness and efficiency of its activities and processes, aiming to provide increased benefits to the organization and its customers. It is like regularly servicing and upgrading a car to continuously improve its performance and fuel efficiency.
Quality improvement runs through all aspects of an organization, including product quality, service quality, management efficiency, etc. Through continuous quality improvement, an organization can continuously meet the ever-growing needs of customers, enhance its market competitiveness, and achieve sustainable development.
Management review
Management review is a formal evaluation conducted by the top management on the current situation and suitability of the quality system in terms of the quality policy and objectives. It is like regularly inspecting a bridge to assess whether its structure is stable and whether it can meet the current and future traffic needs.
Management review can include a review of the quality policy to ensure its rationality and effectiveness. The results of quality audits may be an input to management review, which can provide objective and accurate information for management review. "Top management" refers to the management of the organization whose quality system is being reviewed. They need to adjust the quality policy and objectives in a timely manner based on the results of management review and optimize the quality system.
Contract review
Contract review is a systematic activity carried out by the supplier before the contract is signed to ensure that the quality requirements are reasonably and clearly specified, the documents are complete, and the supplier can meet them. It is like carefully examining the terms of a housing purchase contract before signing it to ensure that the contract content meets one's own needs and interests.
Contract review is the responsibility of the supplier, but it can be carried out jointly with the customer. This helps both parties communicate fully and clarify quality requirements and their respective responsibilities and obligations. Contract review can be repeated at different stages of the contract as needed to address possible changes during the contract execution process.
Design review
Design review is a comprehensive, systematic and documented examination of the design to assess its ability to meet quality requirements, identify existing problems and propose solutions. It is like inviting experts to review the design scheme after the architectural design is completed to ensure that the design scheme is reasonable and feasible.
Design reviews can be conducted at any stage of the design process, but they must be carried out after the design process is completed. This can identify problems in the design in a timely manner, avoid quality issues in the subsequent production process, and prevent unnecessary losses.
Quality management related documents
Quality Manual
A quality manual is a document that clarifies an organization's quality policy and describes its quality system. It is like an encyclopedia of an organization's quality management, providing comprehensive and systematic guidance for the organization's quality management.
The quality manual can cover all or part of an organization's activities, and its title and scope should reflect the field of its application. It should usually include at least the quality policy, the responsibilities, authorities and interrelationships of personnel who manage, perform, verify or review activities affecting quality, the quality system procedures and detailed rules, as well as the provisions regarding the review, revision and control of the manual.
The quality manual can vary in depth and form to meet the needs of an organization. It can consist of several documents. Depending on the scope of application of the manual, qualifiers such as "quality assurance manual" and "quality management manual" can be used.
Quality plan
A quality plan is a document that specifies special quality measures, resources, and the sequence of activities for a specific product, project, or contract. It is like a detailed combat plan for a specific task, providing a specific action plan for achieving specific quality goals.
Quality plans are usually used as references to the relevant parts of the quality manual applicable to specific situations. Depending on the scope of the quality plan, qualifiers such as "quality assurance plan" and "quality management plan" can be used.
Specification
A specification is a document that sets out requirements. It is like a ruler, providing a clear measure for the quality of products or services.
Qualifiers should be used to indicate the type of specification, such as "product specification" and "test specification". The specification should cover or include drawings, models or other relevant documents, and specify the methods and criteria for checking compliance.
Record
A record is a document that provides objective evidence for completed activities or achieved results. It is like a history book, recording every detail in the quality management process and providing traceability and evidence support for quality management work.
Quality records can be divided into two categories. One category provides objective evidence for the degree of meeting quality requirements, such as product quality records. The other category provides objective evidence for the effectiveness of quality system elements, such as quality system records.
Some purposes of quality records are to confirm traceability, preventive measures, and corrective actions. Records can be in written form or in any information storage method, such as electronic documents, databases, etc.
Traceability
Traceability is the ability to trace the history, application, and location of an entity based on the recorded identifiers. It is like a super detective that can help us understand the ins and outs of a product or service.
In terms of products, traceability may involve the sources of raw materials and components, the production history of the products, as well as the distribution and location of the products after leaving the factory. For example, when we purchase a car with quality problems, through the traceability system, we can learn information such as the car's manufacturer, production time, and the suppliers of the raw materials and components used, so as to better solve the problems.
In terms of calibration, traceability refers to the relationship between measuring equipment and national or international standards, fundamental physical constants, or reference materials with specified characteristics. This ensures the accuracy and reliability of measurement results.
In terms of information collection, traceability refers to the statistical data and figures generated throughout the entire quality loop process, and sometimes it is necessary to trace back to the quality requirements for the entity. If required, all aspects of the traceability requirements should be clearly specified, for example, represented by "time limit", "point of origin" or "mark".
Terms related to tools and technologies
Quality loop
The quality loop is a conceptual model of the interacting activities that affect quality in each stage from the identification of needs to the assessment of whether these needs are met. It is like a circular chain, where each link is interrelated and mutually influential.
The quality spiral is the same concept. It vividly describes the dynamic process of the quality loop and emphasizes that quality is a process of continuous circulation and continuous improvement.
Quality cost
Quality cost refers to the expenses incurred to ensure and guarantee satisfactory quality and the losses resulting from the failure to achieve satisfactory quality. It is like a double-edged sword. A reasonable investment in quality cost can improve the quality of products or services and enhance the competitiveness of enterprises. However, an excessively high quality cost will increase the burden on enterprises and reduce their economic benefits.
An organization classifies quality costs according to its own criteria. Some losses may be difficult to quantify but are very important, such as the loss of reputation. Reputation is an intangible asset of an enterprise. Once it is lost, it may bring huge losses to the enterprise and even lead to its bankruptcy.
Quality loss
Quality loss refers to the loss caused by the failure to unleash the potential of resources in processes and activities. It is like an invisible black hole that continuously devours a company's resources and profits.
There are many examples of quality losses, such as the losses caused by customer dissatisfaction, the losses due to the loss of opportunities to create more value for customers, organizations or society, and the waste of resources and materials. Enterprises should attach importance to the issue of quality losses, take effective measures to reduce quality losses and improve the efficiency of resource utilization.
Quality assurance model
The quality assurance model is a set of standardized or selected quality system requirements to meet the needs of quality assurance in a given situation. It is like a set of standardized templates, providing enterprises with the basic framework and methods for quality assurance.
Different industries and enterprises can select appropriate quality assurance models according to their own characteristics and needs to ensure that the quality of products or services can be effectively guaranteed.
Degree of confirmation
The degree of verification is the extent to which evidence is presented to make people believe that the specified requirements have been met. It is like a court debate, where sufficient and compelling evidence needs to be provided to prove one's point.
The degree of verification can range from "affirmation of reality" to providing detailed and objective evidence that meets requirements. The determination of the "degree" depends on criteria such as economy, complexity, degree of innovation, and considerations regarding safety and the environment. Enterprises should reasonably determine the degree of verification according to the actual situation, and reduce costs and improve efficiency on the premise of ensuring quality.
Quality evaluation
Quality evaluation is a systematic inspection of the degree to which an entity has the ability to meet specified requirements. It is like a strict exam, comprehensively and objectively evaluating the quality ability of the entity.
Quality evaluation can be used to determine the quality capability of the supplier. In this case, depending on the specific circumstances, the results of the quality evaluation can be used for purposes such as qualification, approval, registration, certification, or recognition. Depending on the scope and time of the quality evaluation, qualifiers can be added to the term "quality evaluation", such as "process quality evaluation before contract signing". A comprehensive quality evaluation of the supplier can also include an evaluation of financial and technical resources. In special cases, in English, quality evaluation is sometimes referred to as "quality assessment", "quality appraisal", or "quality survey".
Quality supervision
Quality supervision is to continuously monitor and verify the status of an entity and analyze the records to ensure that the specified requirements are met. It is like a loyal guard, always protecting the quality of products or services.
Quality supervision can be carried out by the customer or the customer's representative, and can also be conducted by the internal quality supervision department of the organization. It may include the observation and monitoring carried out to prevent the entity from deteriorating or degrading over time. "Continuous" means unceasing or at a certain frequency. In French, the quality supervision activities carried out within the scope of the specified tasks are called "inspections".
Quality audit
Quality audit is a systematic and independent examination to determine whether quality activities and related results conform to the planned arrangements, and whether these arrangements are effectively implemented and can achieve the predetermined objectives. It is like a strict audit, conducting a comprehensive and in - depth review of quality management work.
Quality audits are generally used, but not limited to, auditing quality systems or their elements, processes, products, or services. These audits are usually referred to as "quality system audits", "process quality audits", "product quality audits", and "service quality audits".
Quality audits shall be carried out by personnel who have no direct responsibility for the area being audited, but preferably with the cooperation of relevant personnel. One of the purposes of quality audits is to evaluate whether improvement or corrective actions are required. Audits should not be confused with quality surveillance or inspection aimed at solving process control or product acceptance. Quality audits can be conducted for internal or external purposes.
Quality Audit Observation Report
The quality audit observation report is an elaboration of the facts generated during the quality audit process and verified by objective evidence. It is like an investigation report of a quality audit, providing specific basis and suggestions for the organization's quality management improvement.
Quality auditor
A quality auditor is a person who has the qualification to conduct quality audits. The auditor designated to preside over a certain quality audit is called the "audit team leader". They are like experts in quality audits, possessing professional knowledge and skills and being able to conduct quality audit work accurately and objectively.
Auditee
The auditee is the organization being audited. During the quality audit process, the auditee needs to actively cooperate with the audit work and provide true and accurate information and materials so that the auditor can comprehensively and objectively understand the organization's quality management status.
Preventive measures
Preventive measures are actions taken to eliminate the causes of potential non - conformities, defects or other undesired situations so as to prevent their occurrence. It is like a vaccination for a disease. By taking measures in advance, the risk of the disease occurring can be reduced.
Such measures may include modifications to procedures, systems, etc. to achieve quality improvement at any stage of the quality loop. The organization should establish a sound preventive measures system, promptly identify potential quality problems, take effective preventive measures, and avoid the occurrence of quality problems.
Corrective measures
Corrective measures are actions taken to eliminate the causes of non - conformities, defects or other undesired situations that have already occurred, so as to prevent their recurrence. It is like the treatment of a disease. By identifying the cause of the disease and taking effective treatment measures, the disease can be completely cured.
Such measures may include, for example, the modification of procedures and systems to achieve quality improvement at any stage of the quality loop. The organization should take corrective actions in a timely manner to rectify the existing quality problems, prevent the recurrence of the problems, and continuously improve the quality management level.
Analysis of the differences between "correction" and "corrective action"
In the field of quality management, "correction" and "corrective action" are two concepts that are easily confused but have essential differences.
"Correction", in essence, is a direct disposal measure taken in response to existing non - conforming situations. It encompasses a variety of specific methods, such as "rework", "repair" and adjustment operations. "Repair" aims to enable non - conforming products to meet the expected usage requirements, even if they cannot fully comply with the original specified requirements; "Rework" focuses on making non - conforming products ultimately meet the specified requirements; while adjustment involves changing certain parameters, states, etc. of the product to address non - conforming situations. The core purpose of this series of operations is to directly handle the non - conforming situations that have occurred at present.
"Corrective actions" carry a deeper meaning. It is not content with merely dealing with the superficial non - conformities but is committed to eliminating the root causes of non - conformities. Only by identifying and solving the source problems that lead to non - conformities can we avoid the recurrence of similar non - conformities in the long run. This is like treating a disease. "Correction" addresses the symptoms, while "corrective actions" address the root cause. Through in - depth analysis of the causes of problems and the adoption of targeted measures, can we truly improve product quality and the stability of the production process.
Disposal methods for non-conformities
When facing non-conforming entities, corresponding measures need to be taken to address the non-conformance issues. The "measures" here come in a wide variety of forms. "Repair" is a common approach. It can restore the use value of products to a certain extent. For example, repair some products that have malfunctions but can still be fixed. "Rework" means making the products meet the specified requirements through means such as reprocessing. "Downgrading" is to lower the use grade of products to adapt to their current quality level. "Scrapping" is to directly discard those products that cannot be repaired or are not worth repairing. "Deviation concession" allows certain characteristics of products to exceed the specified deviation range under specific circumstances. However, this kind of concession is strictly restricted. It is only applicable to the delivery of products with certain specific non-conforming characteristics within the specified deviation, and there are certain time or quantity limitations. "Modifying documents or requirements" is to adjust the product standards, specifications, etc. at the source to adapt to the actual production situation or solve the existing problems.
Deviation from the connotation of the permission
During the product production process, there are sometimes situations where deviations from the originally specified requirements are needed. "Deviation permit" is the written approval given for such deviations before product production. However, this approval is not unlimited. It is only valid for a certain quantity of products or within a specific time limit, and there are also clear restrictions on the use of the products. This is to ensure that even if there are certain degrees of deviation in the products, they can still meet specific needs within a controllable range, while guaranteeing product quality and usage safety.
Regulations on Concession and Deviation Waiver
Both "concession" and "out-of-tolerance authorization" are essentially written approvals for the use or release of products that do not meet the specified requirements. However, "out-of-tolerance authorization" has more stringent conditional restrictions. It specifically targets certain specific non-conforming characteristics of the product. Only when these characteristics are within the specified deviation range is the product allowed to be delivered for use. Moreover, this kind of authorization has time and quantity limits. This is to prevent products that do not meet the specified requirements from flowing into the market without restraint, so as to ensure the quality and safety of the entire production and use process.
Characteristics of rework and repair
As a type of disposal method for non-conforming products, "rework repair" has unique characteristics. It involves taking remedial measures for products that were once qualified but are now non-conforming to restore their usability. For example, some electronic products develop malfunctions after being used for a period of time, and they can be made functional again through maintenance and other means. Meanwhile, "rework" is also an important way to deal with non-conforming products. Its goal is clear, which is to make non-conforming products meet the specified requirements after reprocessing. Both of these methods play important roles in quality management. By selecting the appropriate method based on different product characteristics and non-conforming situations, the overall quality of products can be effectively improved.