Quality management and quality assurance STANDARDs—Part 2:Generic guidelines for the application of GB/T 19001,GB/T 19002 and GB/T 19003
Some standard content:
National Standard of the People's Republic of China
GB/T 19000.21998
idt 1S0 9000-2:1997
Quality management and quality assurance standards-Part 2:Generic guidelines for the application ufGB/T 19001,GB/T 19002 and GB/T 19003Published on November 13, 1998
Implemented on May 1, 1999
Published by the State Administration of Quality and Technical Supervision
GB/T 19000.2—1998
150 years ago
ISo cited
referenced standards
quality system requirements
general management
distribution system
contract review
design control
document and data control
control of products provided by SCS
product identification and traceability
process control
aging and test environment
control of inspection, measurement and test equipment.
inspection and test status
control of non-conformity and
correction and prevention of errors
replacement, installation, maintenance and delivery
control of quality order requirements
internal quality audit
system expansion Technical
Appendix A (Indicative Appendix)
Safety Documents
GB/T19000.2—1998
This standard is equivalent to the international standard SOS0C0-2:1997 Quality Management and Quality Assurance Standard Part 2:159M1IS092 and IS03 series general instructions for use (R/I9 family marked group sense part) and is consistent with it. This standard makes technical adjustments to GB/T19CDD.2—1994 (idtTS0) 9000-2, 1993) and replaces the technical standard Appendix A of this version. This standard is the indicative appendix
This standard is proposed and managed by the National Technical Committee for Quality Management and Quality Assurance Standardization (C3BTS/1Y:151). This standard is drafted by the China Institute of Standardization and Information Classification and Coding. The main contributors of this standard are: China Institute of Standardization and Information Classification, China New Era Quality System Certification Center, National Science and Technology Commission Nuclear Safety Center, Beijing Institute of Technology, China Aerospace Industry Corporation 18th Institute. The main drafters of this standard are: Wei Jun, Li Renliang, Xu Youbie, Chun, Mao Liuping, Yan Shengwu, Fei Xiuling. GB/T19000.2—1998
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually completed by ISO's technical committees. If each member body is interested in the work established by the collective technical committee, it has the right to participate in the work of the committee. International organizations (official or unofficial) that maintain contact with IS may also participate in the relevant work: In the field of electrotechnical standardization, IS maintains a planned cooperative relationship with the International Electrotechnical Commission (ISO), and submits the draft international standards passed by the technical committee to the member groups for voting. A draft international standard must be approved by at least 75% of the member groups voting before it can be officially released as an international standard. The international standard TSOS000-2 was formulated by the Quality Management and Quality Assurance Technical Requirements Committee of the IS/TC176/SC2 International Standardization Group.
IS09000-2 Second Edition (Rate Release) is a technical revision of the first edition and replaces the first edition (1S0900C-2,193). The general title of IS09000-2 is <Quality Management and Quality Assurance Standard 3. It includes the following parts: Part 1: Operation and Cost Indicators
- Part 2: I509001. General Guide for the Implementation of IS09002 and IS09003 - Part 3: Guide for the Application of IS09001 in the Development, Application and Maintenance of Products - Part 4: Guide for Availability Management
Appendix A to this standard is for special purposes only:
GE/T 19000.21998
ISO introduced
cloud standard provides the implementation guidelines of GB/TI, GB/TI2 and GB/TIG3. This standard adopts the clause features of GB/E19001G0/9002G/1900: for comparison, generally speaking, the quality system required by the quality assurance should be consistent with the number and scope of procedures, the largest in B/1900 and the smallest in GBT9003. The scope and requirements of the clauses in the standard are consistent with the corresponding clauses in the model standard (GB/T19001B/T15C2 or GB/T19303). The appropriate content and degree of verification should refer to the guidance given in Section 8.3 of GR/T1904.1. GB/T1904.1 provides an overview of the GB/T19000 series of standards and explains how to use these standards. GBT19004.1 provides guidance on the design of an integrated quality management system. This standard does not repeat other donated national standards, but adds the guidance provided for users in GH/19000.1, GH13000.3, GR/T1904.1 and GB/T19004.2. 1 Scope
National Standard of the People's Republic of China
Quality and quality assurance standards
Part 2: General guidance for the implementation of GB/T 19001, B/T 19002 and GB/T 19003
General guidance for the implementation of GA/T 19001, GR/T 19002, GA/T 19003 and GB/T 19000.2—1998
tdt sO 9D00-2:1997
Replaces GB 1000.2—1994
This standard provides the implementation of GB/T 19001, GB/T 19002 and GB/T 19003 (1994 revised edition). This standard does not add to or modify the requirements of GB/T 19001, GB/T 19002 or GB/T 19003. If the elaboration of this standard is inconsistent with the content of GB/T 19001, GB/T 19002 or GB/T 19003, priority shall be given to the content of GB/T 19901, GB/T 19002 or GB/T 19003. The requirements of this standard do not reduce the requirements of GB/T 19001, GB/T 19002 and GB/T 19003.
This standard provides guidance for the following users:
a) Application of GB/T19001, GB/T19002 or GB/T19003 15) The principles and third points,
2 Referenced standards
The following standards contain provisions that are replaced by reference in this standard as the content of this standard. At the time of publication, the versions shown are valid. All standards are subject to revision. Those who use this standard should consider the possibility of using the latest version of the following markings GB/T6583-1999 Quality Management and Quality Assessment Specifications (idt1SO8402:1994) GB/T19001-1994 Quality Assurance Model for Quality System Design, Development, Production, Installation and Service (idtTSSCC11964)
Quality System Quality Assurance Model for Production, Installation and Service (idtIS09002:199 4) GB/T19002-1994
Quality system quality assurance model for inspection and testing (IDT1509003:1994) GB/T:9003-1994
3 Definitions
This standard adopts the text of GR/T6583 and the following definitions. 3.1 Contract
The requirements for the contract between the supplier and the customer that have been modified in any way before [GB/T19001-1991 3.33-2 Product Product
The result of an activity or process,
1. It can include components, materials, or combinations of components. 2. Products can be tangible (such as components or process materials), or intangible (such as cognitive or conceptual) or a combination of them. National Quality and Technical Supervision Bureau 199811-13 approved 199905·01 implementation
GB/T 19000.2-1998
3. "Product\This technical class, the area applies to the products provided in the next period, not some undesirable\by-products\ of the southern environment. If it does not comply with the provisions of the company's 6563, [G319001-1291+3-33 standard pet infant igrns
=) Requirements for products proposed by the customer and agreed by the supplier!) Requirements put forward by the supplier to meet the requirements. 3. Award rende
The supplier is invited to make a proposal to provide products that meet the contract requirements: [GB/19001-1994 3.2] 1 Quality system requirements
4.1 Responsibilities
4-1.1 The quality party
is responsible for execution 1.1.2.1 The supplier management must have a written quality policy, quality targets and commitments to quality that are consistent with the organization's goals and customer expectations and needs. The quality policy, quality targets and commitments to quality should be clearly stated within the organization and receive the full support of management. All employees, including full-time, part-time and temporary employees, should be trained to understand the organization's goals and the commitments made to achieve them. The quality policy should be stated in easy-to-understand language. Quality targets should be achievable through planning and regular review.
Managers can ensure the organization's understanding of the goals by continually implementing their commitments to quality that are achievable through the following activities (but not limited to these): These and other quality objectives include: 1. ensuring that team members are aligned with the overall quality objectives; 2. promoting and managing the implementation of quality plans, including the implementation and maintenance of the quality system; 3. not allowing any department in the organization to deviate from quality in any way; 4. providing the necessary resources and training to ensure the construction and implementation of the quality system (4, 1.2.2). 4.1.2 Group
4.1.2.1 Responsibilities and authorities
The manager responsible for executive management is the individual or group of people with the necessary authority within the organization who is responsible for formulating quality plans and establishing quality objectives, monitoring the implementation of objectives and targets, reviewing the effectiveness of implementation, and taking corrective action. These should be clearly defined. 4.2.2 Resources
To implement the objectives, goals and requirements of the customer and the planned supply chain, the management shall determine and provide the appropriate resources required. To this end, management shall consider the following two aspects: - define the required standards, procedures and other documents required for planning, controlling and performing activities; - train and qualify (see 4.18):
: - plan design, development and production activities to allow adequate time for implementation; - prepare and document the implementation of new services or new technologies; and - provide quality records.
4.1.2.3 Management Representative
In the organization, a management representative shall be appointed and authorized to supervise the operation of the quality management system. The management representative shall be responsible for the implementation of the management measures. The management representative may also have other functions and responsibilities within the organization, such as management C8/19000.2·—1998
The management representative shall be responsible for other functions and responsibilities within the organization, but these functions shall not conflict with the management system functions. The management representative shall have sufficient knowledge to ensure that the requirements of GB/T19001, GB/T19002 or GB/T19003 are met and maintained. At the same time, he shall be responsible for implementing these requirements within the organization.
The management representative's responsibilities also include reporting on the suitability and effectiveness of the quality system as a basis for quality approval and management reviews. When necessary, the management representative should also maintain contact with customers, subcontractors and other external parties regarding quality management. 4.1.3 Annual review
The supplier management responsible for implementation shall conduct an audit of the quality system. The review may include the following aspects (but not limited to): the suitability of the organizational structure (including personnel and other resources) and the degree of conformity with GB/T19002/F1SCC1(B/T19002/GB19003) and the effectiveness of the quality system; the implementation of the quality policy
- information on customer feedback, internal feedback (such as the results of internal audits), process and product status, and the corrective and preventive measures taken.
The supplier management responsible for implementation shall conduct an audit of the quality system. The audit may include the following aspects (but not limited to): the suitability of the organizational structure (including personnel and other resources) and the degree of conformity with GB/T19002/F1SCC1(B/T19002/GB19003) and the effectiveness of the quality system; the implementation of the quality policy
- information on customer feedback, internal feedback (such as the results of internal audits), process and product status, and the corrective and preventive measures taken.
The review should be conducted regularly to ensure the continued suitability and effectiveness of the quality system. The frequency of the management review process shall be determined according to the actual situation. The management shall pay attention to the trend of problems that may occur: in particular, pay attention to the areas that occur frequently. In the joint review, the management shall pay attention to the trend of problems that may occur: in particular, pay attention to the areas that occur frequently. Corrective action should be taken promptly to correct the quality system. The effectiveness of the corrections should be evaluated and records of the review should be collected (see 4.1). 4.2 Quality system
4.2.1 General
The quality system can only be implemented most effectively when the members of the organization understand the role of the quality system and how it works, especially the role of quality at the interface with other parts of the system within their area of responsibility and how it works. The quality manual plays an important role both internally and externally in this regard. In order to clearly describe the quality system, the quality manual should include the quality policy, a detailed description of the organization and the order of the quality system, and a cross-reference table of more detailed documents. For example, the manual can be composed of several documents, each of which is more detailed than the next: there can also be a general quality manual, several specific procedure manuals, work instructions and referenced documents, which together define the entire quality system. GH/191232 Resources
To achieve the objectives, base and requirements of the customer and the schedule, the supplier manager shall determine and provide the appropriate resources required. To this end, management shall consider the following two aspects: - Define the required standards, procedures and other documents required for personnel planning, controlling, executing and verifying activities. For example: - Training and qualification assessment (see 4.18):
: Plan design, development and production activities to allow adequate time for implementation, - Prepare and record the implementation of new services or technologies, including the implementation of new equipment or technology: The quality of the results of the implementation.
4.1.2.3 Resource management representative
In the supplier organization, a representative shall be appointed and authorized to supervise the operation of the product. The representative shall be responsible for the implementation of the management measures. The position of the management representative may also be related to the quality system activities and may also include other functions and responsibilities within the organization, such as management. The management representative should be responsible for other functions, but these functions should not conflict with the management system functions. The management representative should have sufficient responsibility to ensure that the requirements of GB/T19001, GB/T19002 or GB/T19003 are met and maintained. At the same time, he should also be responsible for implementing these requirements within the organization. The responsibilities of the management representative also include reporting on the suitability and effectiveness of the quality system as a basis for quality review and management. When necessary, the management representative should also maintain contact with customers, subcontractors and other external parties on quality management. 4.1.3 Annual review
The supplier management responsible for implementation shall conduct an audit of the quality system. The review may include the following aspects (but not limited to): the suitability of the organizational structure (including personnel and other resources) and the degree of conformity with GB/T19002/F1SCC1(B/T19002/GB19003) and the effectiveness of the quality system; the implementation of the quality policy
- information on customer feedback, internal feedback (such as the results of internal audits), process and product status, and the corrective and preventive measures taken.
The supplier management responsible for implementation shall conduct an audit of the quality system. The audit may include the following aspects (but not limited to): the suitability of the organizational structure (including personnel and other resources) and the degree of conformity with GB/T19002/F1SCC1(B/T19002/GB19003) and the effectiveness of the quality system; the implementation of the quality policy
- information on customer feedback, internal feedback (such as the results of internal audits), process and product status, and the corrective and preventive measures taken.
The review should be conducted regularly to ensure the continued suitability and effectiveness of the quality system. The frequency of the management review process shall be determined according to the actual situation. The management shall pay attention to the trend of problems that may occur: in particular, pay attention to the areas that occur frequently. In the joint review, the management shall pay attention to the trend of problems that may occur: in particular, pay attention to the areas that occur frequently. Corrective action should be taken promptly to correct the quality system. The effectiveness of the corrections should be evaluated and records of the review should be collected (see 4.1). 4.2 Quality system
4.2.1 General
The quality system can only be implemented most effectively when the members of the organization understand the role of the quality system and how it works, especially the role of quality at the interface with other parts of the system within their area of responsibility and how it works. The quality manual plays an important role both internally and externally in this regard. In order to clearly describe the quality system, the quality manual should include the quality policy, a detailed description of the organization and the order of the quality system, and a cross-reference table of more detailed documents. For example, the manual can be composed of several documents, each of which is more detailed than the next: there can also be a general quality manual, several specific procedure manuals, work instructions and referenced documents, which together define the entire quality system. GH/191232 Resources
To achieve the objectives, base and requirements of the customer and the schedule, the supplier manager shall determine and provide the appropriate resources required. To this end, management shall consider the following two aspects: - Define the required standards, procedures and other documents required for personnel planning, controlling, executing and verifying activities. For example: - Training and qualification assessment (see 4.18):
: Plan design, development and production activities to allow adequate time for implementation, - Prepare and record the implementation of new services or technologies, including the implementation of new equipment or technology: The quality of the results of the implementation.
4.1.2.3 Resource management representative
In the supplier organization, a representative shall be appointed and authorized to supervise the operation of the product. The representative shall be responsible for the implementation of the management measures. The position of the management representative may also be related to the quality system activities and may also include other functions and responsibilities within the organization, such as management. The management representative should be responsible for other functions, but these functions should not conflict with the management system functions. The management representative should have sufficient responsibility to ensure that the requirements of GB/T19001, GB/T19002 or GB/T19003 are met and maintained. At the same time, he should also be responsible for implementing these requirements within the organization. The responsibilities of the management representative also include reporting on the suitability and effectiveness of the quality system as a basis for quality review and management. When necessary, the management representative should also maintain contact with customers, subcontractors and other external parties on quality management. 4.1.3 Annual review
The supplier management responsible for implementation shall conduct an audit of the quality system. The review may include the following aspects (but not limited to): the suitability of the organizational structure (including personnel and other resources) and the degree of conformity with GB/T19002/F1SCC1(B/T19002/GB19003) and the effectiveness of the quality system; the implementation of the quality policy
- information on customer feedback, internal feedback (such as the results of internal audits), process and product status, and the corrective and preventive measures taken.
The supplier management responsible for implementation shall conduct an audit of the quality system. The audit may include the following aspects (but not limited to): the suitability of the organizational structure (including personnel and other resources) and the degree of conformity with GB/T19002/F1SCC1(B/T19002/GB19003) and the effectiveness of the quality system; the implementation of the quality policy
- information on customer feedback, internal feedback (such as the results of internal audits), process and product status, and the corrective and preventive measures taken.
The review should be conducted regularly to ensure the continued suitability and effectiveness of the quality system. The frequency of the management review process shall be determined according to the actual situation. The management shall pay attention to the trend of problems that may occur: in particular, pay attention to the areas that occur frequently. In the joint review, the management shall pay attention to the trend of problems that may occur: in particular, pay attention to the areas that occur frequently. Corrective action should be taken promptly to correct the quality system. The effectiveness of the corrections should be evaluated and records of the review should be collected (see 4.1). 4.2 Quality system
4.2.1 General
The quality system can only be implemented most effectively when the members of the organization understand the role of the quality system and how it works, especially the role of quality at the interface with other parts of the system within their area of responsibility and how it works. The quality manual plays an important role both internally and externally in this regard. In order to clearly describe the quality system, the quality manual should include the quality policy, a detailed description of the organization and the order of the quality system, and a cross-reference table of more detailed documents. For example, the manual can be composed of several documents, each of which is more detailed than the next: there can also be a general quality manual, several specific procedure manuals, work instructions and referenced documents, which together define the entire quality system. GH/19123This chapter provides guidance for the preparation of a quality manual.
4.2.2 Quality Management System
The documented quality management system shall meet the relevant requirements of T19001, T19002 or G9, T190C3 and be consistent with the organization's quality management system. It is important to recognize that the level of detail in the documented structure should be tailored to the organization's members, which will depend on the methods used and training requirements, as well as the competences and qualifications of members, as described in 4.18. Documented procedures follow the day and scope of defined activities: what to do, by whom:
... when, where and how to do it;
what materials, equipment and documents should be used, how to control and record the activities
The documented procedures can provide instructions for how to carry out a particular activity. 4.2.3 Quality planning
The supplier needs to indicate that the quality planning activities have been selected and the methods to achieve the requirements have been determined. The contents of the plan include the application of the quality system and how to meet the product quality requirements. It may be necessary to
) For management and operation planning to prepare for the implementation of the quality system: b) For product planning, for specific products, it may be necessary to determine the quality plan or other documented process for the quality measures, resources and activities. GB/15015 (idtSO1005) provides two guidelines for the preparation of quality plans. 4.3 Joint review
4.3. 1 General Principles
GB/T19000.2-199B
When a supplier and a customer enter into a bidding, contract or ordering relationship, the key factor in whether both parties can be satisfied is the contract review process. Contract review is one of the primary interfaces between suppliers and customers. The documented contract review process should include the review of customer requirements (written or verbal in the bid, contract or order) and how to conduct the review and communicate it within the team. The review process should be conducted before the contract or order is accepted. 4.3.2 Review
From the initial contact, bid setting or receipt of a verbal order, until the contract is formed and the order is completed. In all subsequent stages, it is important to fully understand the importance of customer needs. In order to correctly understand the customer's requirements for products, delivery dates and other important matters, the supplier must conduct regular discussions. If the supplier receives a verbal order from the customer, the supplier can ensure that the content of the order (the details of the requirements) is correctly understood, well-documented and agreed to by the customer. Contract review is a process that includes the following: a) Detailed review of the requirements, which is usually carried out at various stages before bidding or receiving an order and before accepting a contract or order 6) Agree on the following within the supplier organization: - Requirements have been clarified: - Requirements have been processed!
The supplier is able to meet the requirements of the contract. This can be done through a specified inspection and verification process. The supplier has the necessary resources and facilities to meet the requirements of the contract.
(:) Any discrepancies with the customer can be resolved by arbitration. +d) For standard products (such as ready-made products or products listed in the product specification with corresponding public cabinets), the review can be simplified to verify whether the content in the order is accurate. +e) When appropriate, the requirements of the contract can be converted into terms, tolerances and other necessary information suitable for design, procurement and process control! When appropriate, in order to understand how to successfully implement the contract, the supplier can develop a preliminary quality plan to support the contract review process.
A review procedure for a contract or order with the following features will be beneficial to the supplier: First, all interested parties have the opportunity and sufficient time to review the contract; Second, a checklist or other document (such as a standard form) is provided to verify that the reviewer has reviewed and understood the contract or order and its requirements; Third, a method is provided to enable the reviewer to raise questions about the requirements of the contract or order and to study them, and to reach agreement on any differences with other interested parties.
4.3.3 Joint review
When customer requirements change, the supplier shall establish a procedure to review the original contract or order and shall have specific procedures to ensure that the affected departments are notified of the changes before they take effect. 4.3.4 Records
In all cases, records of completed or accepted contracts shall be kept (see 1.165). However, in order to meet the requirements of the department, In some cases, it may be necessary to keep records of contract evaluations such as urgent or critical requirements. These records will provide evidence for audits and will be useful for: a review after delivery; a review of future changes; and a review of future differences. 4.4 Design control The quality characteristics and regulatory requirements of product costs, such as safety, quality and feasibility, are determined during the design and development phase. Defective design is a major cause of manufacturing or quality problems. GB/T 19000. 2 -1998
When considering design controls, it is important to note that the design process can be used for a variety of activities of different types and time periods, which are related to the product and the process of product design. Therefore, the supplier should consider all design stages related to product design and all stages of the design process, which must have controlled procedures. 4.4.2. Design and concurrent planning
The supplier shall establish a sequence of stage planning and development planning, which shall include the following: Name, model and objectives:
Sequential and concurrent work schedule; Timing, amount and nature of design verification and design validation activities: Evaluation of safety, performance and feasibility of product design; Product measurement test methods and acceptance criteria; Allocation of responsibilities
The design and development plan shall be integrated into other plans or verification procedures related to the product, and the plan shall be updated as needed. The supplier's leadership responsibilities for specific design and the responsibilities for other design tasks are clearly assigned to qualified personnel, who shall The personnel should be able to list the information and resources necessary to complete the task. The detailed scope of the design activities should be based on the needs of implementing the design process. 4.4.3 Technical Interface When there are multiple design inputs, the supplier should determine, coordinate and control the relationships and interfaces as well as the corresponding positions and authorities, and form documents. Many internal and external organizational departments are related to the design process, such as research and development: marketing and sales, tt||Quantity management
- Engineering,
- Material technology:
Production/Consolidation:
Service team,
Facility management,
Warehousing/Transportation/Post-production:
Information system,
These departments1 should determine (but not limited to): What information should be received and transmitted,
- The information should be received by the issuing party1
- The month when the information is transmitted!
Identification of the transmission method:
- Transmission of documents and maintenance of records:wwW.bzxz.Net
4.4.4 Design axis
The user requirements (also through market research) or customer requirements (through contract) determined during the contract review (see 4, 3), as well as the relevant legal requirements, together constitute the requirements for design input. The design input is in the form of product requirement description and/or specification document on the technical status, structure, composition and other design features of the product. The supplier shall confirm, review and record all relevant design inputs (such as performance requirements, energy requirements, specification requirements, environmental requirements, safety requirements and legal requirements). The design input shall describe all requirements as detailed as possible to provide a systematic approach to the design. The design input shall include the details agreed upon between the client and the supplier on how to meet the requirements of the client and the regulations. The design input record shall also include any discrepancies or inconsistencies found during the design review and/or design verification stage or in the relevant design control activities.
The design input should clearly identify the design criteria, materials and processes that need to be developed and analyzed, including prototype tests to verify their suitability. The design input should be compiled in a way that allows for regular updates. The design input should clearly state "when" "what" is updated, who is responsible for re-reading, and who will receive the updated copy in the event of an upgrade. In the design process, the design input compiled in the above manner is undoubtedly the latest reference document. 4.4.5 Design output
Throughout the design process, the supplier converts the requirements in the design specification into design output. The design output should be documented and can be verified and confirmed based on the requirements of the input, and should also include or cite acceptance criteria. For example, - drawings and parts color;
- specifications (also process and calibration specifications) + a guide book:
Obtain service department.
Design is the product requirements for production, installation, inspection and testing, and service. The impact of the following design on the subsequent activities is important for the review before the release of the design. 4.4.6 The design review
The supplier shall plan the design review. To ensure its objectivity, the design review shall be attended by all external and internal functional departments related to the design stage being reviewed. When necessary, designers and other experts shall also participate. For some types of products, the design review may consider regulatory requirements. The frequency of design review shall be based on the complexity of the product to be designed. The design review records shall be kept (see 4.16).
The people involved in the design review shall be prepared to review the design and its safety content: The design review may focus on the following issues: a) Is the design consistent with the requirements of the product: b) Is the product design compatible with the capabilities of the process? Is safety considered:
) Does the design meet the functional and operational requirements, such as performance and reliability indicators? ) Have appropriate materials and/or components been selected? ) Are the material and component specifications/documents in place? ) Does the design meet all expected environmental and load conditions? 5) Are the parts or service requirements standardized? Do they specify the requirements for availability, availability and maintainability? Are the technical status and/or technical conditions specified to ensure exchangeability and replacement? Is the design plan technically feasible (such as procurement, production, installation, inspection and testing)? k) Have the computer models used in the design calculations, construction models or analyses been appropriately recognized, approved, verified and configured?
Have the inputs and outputs of the design been appropriately verified when used? m) Are the assumptions made in the design process valid? n) Consider the more recent type or prototype test
4.4.7 Design Verification
GD/T1001 describes the design control means (such as design review, testing and verification, alternative calculation, comparison with proven instruments), and the parties may discuss design verification. Design verification is an additional inspection method to ensure that the design output meets the specified requirements (GD/T19000.2--1998). Since design verification is a daily activity, it may be necessary to combine this with other activities in some cases. The design verification report of the stage is completed to record (see 4.16).
In the planning and evaluation stage of design verification, the time and personnel responsibilities of verification should be considered. If the design verification adopts alternative calculation or comparison with the proven design cabinet, it should be based on When new products are to be used, the suitability of the methods of alternative calculations and/or the designs that have been implemented shall be reviewed. If the design verification adopts the test and verification method, the safety and performance of the product shall be verified under the full range of conditions that represent actual use. Products used for testing and implementation shall be produced under expected production conditions. If the design verification adopts the method of design output being evaluated at any stage before development, it shall be reviewed in accordance with the relevant standards and acceptance criteria specified in advance. 4.4.8 Design Confirmation
Design confirmation is a necessary step to confirm that the final product meets the specified intended use requirements. Design confirmation may require the participation of the customer. After successful design verification, the final product is tested under specified application conditions. If this is not possible or is difficult to achieve, the final stage of the design verification will be completed. To confirm these characteristics, it is necessary to conduct design confirmation in the early stages of product development. On the contrary, in other cases, design confirmation can only be carried out by observing the product during its initial use. The results of the inspections, tests and verifications carried out during design confirmation should be included in the design records. 4.4.9 Design Changes
The design of the product may need to be changed or modified for the following reasons: - defects or errors in the design found in the subsequent stages (due to calculations, material selection, etc.); - difficulties in manufacturing, installation and/or service found after the design stage, and the original equipment manufacturer or subcontractor requires changes;
- the function or performance of the product needs to be improved; - safety, performance, or other requirements have changed! Design review (see 4.4.6), design verification ( 4.1.7) or design validation (see 1.4.8) requires a change - a corrective action or preventive action requires a change (see 4.14). The supplier shall identify and verify any changes in the design input to determine whether they will affect the previously approved design review, acceptance or verification results. When a design change occurs in a component of a product, its impact on the entire product shall be evaluated. A certain improvement may have a noticeable adverse effect on other features. When a major design change occurs, it may also be compensated during the review of the verification process at an appropriate time. The supplier shall have a corresponding procedure to notify all interested parties of the new design output and record all design changes. It shall also ensure that all design changes are annotated as document changes. Only approved changes are implemented (see 4.5.3). 4.5 Document and Data Control
4.5.1 General
Document and data control should include documents and data related to the project, procurement, engineering, quality standards, material inspection and quality assurance system documents. Suppliers can use various media forms (such as hard disk, disk or tape) to record, transmit or receive information and/or instructions from documents and materials: Documents should describe or stipulate how to carry out activities and should be modified as the situation changes. Materials include the basis for conducting flow strategies. The information may include changes in the form of documents and other documents. 4.5.2 Approval and release of documents and materials
The supplier's system should clearly define the procedures and responsibilities for the approval, release, distribution and management of standard documents and materials, including the cancellation or marking of obsolete documents (to prevent reuse): For example, this can be done by establishing a non-channel shareholding information form or equivalent certification or data control procedures, and the level of return, distribution (issuing department) and order status. The supplier's internal document should describe the following when describing the delivery of documents that violate this responsibility: 1. Disclaimer:
Control the content;16)
During the planning and evaluation of design verification, the time and personnel for verification should be considered. If design verification is achieved by alternative calculation or comparison with a previously verified design, the suitability of the alternative calculation method and/or the verified design should be reviewed in light of the new use scenario. If design verification is achieved by testing and verification, the safety and performance of the product should be verified under full range conditions representative of actual use. Products used for testing and verification should be produced under expected production conditions. If design verification is achieved by the method whereby the design output is evaluated at any stage before development, it should be reviewed in accordance with the relevant standards, practices and acceptance criteria specified in the specification. 4.4.8 Design Verification
Design verification is the necessary means to verify that the product meets the specified intended use requirements. Design verification may require the participation of the customer. After successful design verification, the final product is subjected to design validation under specified use conditions. If it is not possible or difficult to validate these features at the final stage, design validation is required at an early stage of product development. On the contrary, in other cases, design validation can only be performed by observing the product during its initial use. The results of the inspections, tests and verifications performed during design validation should be included in the design records. 4.4.9 Design Changes
The design of the product may need to be changed or modified for the following reasons: - defects or errors in the design found at a later stage (due to calculations, material selection, etc.); - difficulties in manufacturing, installation and/or service found after the design stage, and the original equipment manufacturer or subcontractor requires changes;
- the function or performance of the product needs to be improved; - safety, performance, or other requirements have changed! Design review (see 4.4.6), design verification (see 4.1.7) or design validation (see 4.1.4.8) requires changes to corrective actions or preventive actions (see 4.14). The supplier shall identify and verify any changes in the design to determine whether they will affect the results of the previously approved design review, acceptance or verification. When a design change occurs in a component of a product, its impact on the entire product shall be evaluated. A certain improvement may cause noticeable changes to other features. When a major design change occurs, the supplier shall establish procedures to notify all interested parties of the new design output and record all design changes. The supplier shall ensure that all design changes are annotated as document changes. Only approved changes are implemented (see 4.5.3). 4.5 Document and information control
4.5.1 General
Document and information control shall include the control of the design, procurement, and import and export of the design. Suppliers may use various media (such as hard disk, disk or tape) to record, transmit or receive information and/or instructions from documents and materials: The document should describe or stipulate how to carry out activities and should be modified as the situation changes. The information should include the information on which the process flow is based: The registration information may include changes in the document or other forms. 4.5.2 Approval and release of documents and materials
Supplier's system Clearly defined procedures and responsibilities should be defined for the approval, release, and distribution of internal documents and materials, including the cancellation or marking of obsolete documents (to prevent reuse): for example, this can be accomplished by establishing a non-channel ownership information sheet or equivalent documentation or data control procedures, which can be used to determine the level of compliance, distribution (issuing department), and order status. The supplier's internal document should describe the following when describing the delivery of documents that violate this obligation: 1. Disclaimer:
Control the content of the document;16)
During the planning and evaluation of design verification, the time and personnel for verification should be considered. If design verification is achieved by alternative calculation or comparison with a previously verified design, the suitability of the alternative calculation method and/or the verified design should be reviewed in light of the new use scenario. If design verification is achieved by testing and verification, the safety and performance of the product should be verified under full range conditions representative of actual use. Products used for testing and verification should be produced under expected production conditions. If design verification is achieved by the method whereby the design output is evaluated at any stage before development, it should be reviewed in accordance with the relevant standards, practices and acceptance criteria specified in the specification. 4.4.8 Design Verification
Design verification is the necessary means to verify that the product meets the specified intended use requirements. Design verification may require the participation of the customer. After successful design verification, the final product is subjected to design validation under specified use conditions. If it is not possible or difficult to validate these features at the final stage, design validation is required at an early stage of product development. On the contrary, in other cases, design validation can only be performed by observing the product during its initial use. The results of the inspections, tests and verifications performed during design validation should be included in the design records. 4.4.9 Design Changes
The design of the product may need to be changed or modified for the following reasons: - defects or errors in the design found at a later stage (due to calculations, material selection, etc.); - difficulties in manufacturing, installation and/or service found after the design stage, and the original equipment manufacturer or subcontractor requires changes;
- the function or performance of the product needs to be improved; - safety, performance, or other requirements have changed! Design review (see 4.4.6), design verification (see 4.1.7) or design validation (see 4.1.4.8) requires changes to corrective actions or preventive actions (see 4.14). The supplier shall identify and verify any changes in the design to determine whether they will affect the results of the previously approved design review, acceptance or verification. When a design change occurs in a component of a product, its impact on the entire product shall be evaluated. A certain improvement may cause noticeable changes to other features. When a major design change occurs, the supplier shall establish procedures to notify all interested parties of the new design output and record all design changes. The supplier shall ensure that all design changes are annotated as document changes. Only approved changes are implemented (see 4.5.3). 4.5 Document and information control
4.5.1 General
Document and information control shall include the control of the design, procurement, and import and export of the design. Suppliers may use various media (such as hard disk, disk or tape) to record, transmit or receive information and/or instructions from documents and materials: The document should describe or stipulate how to carry out activities and should be modified as the situation changes. The information should include the information on which the process flow is based: The registration information may include changes in the document or other forms. 4.5.2 Approval and release of documents and materials
Supplier's system Clearly defined procedures and responsibilities should be defined for the approval, release, and distribution of internal documents and materials, including the cancellation or marking of obsolete documents (to prevent reuse): for example, this can be accomplished by establishing a non-channel ownership information sheet or equivalent documentation or data control procedures, which can be used to determine the level of compliance, distribution (issuing department), and order status. The supplier's internal document should describe the following when describing the delivery of documents that violate this obligation: 1. Disclaimer:
Control the content of the document;
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