ISO 8402:1986、ISO 8402:1994 為設計審查 (design review)，是一種品質管理手法，一種活動。ISO 9000:2000 第 3.8 節、ISO 9000:2005 第 3.8 節，檢查相關名詞 (Terms related to examination)。ISO 9000:2015 第 3.11 節決定相關名詞 (Terms related to determination)，是一種找出一項或多項特性及其特性價值的活動，此類活動包括：審查 (review)、監視 (monitoring)、量測 (measurement)、檢查 (inspection)、試驗 (test)、進度評估 (progress evaluation)。
審查定義：
ISO 9000:2015, 3.11.2 review
determination of the suitability, adequacy, or effectiveness of an object to achieve established objectives
EXAMPLE. Management review, design and development review, review of customer requirements, review of corrective action, and peer review.
NOTE 1 to entry. Review can also include the deternination of efficiency.
ISO 9000:2005, 3.8.7, review
activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives
NOTE. Review can also include the determination of efficiency.
EXAMPLE. Management review, design and development review, review of customer requirements, and non-conformity review.
ISO 9000:2000, 3.8.7, review
activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives
NOTE. Review can also include the determination of efficiency.
EXAMPLE. Management review, design and development review, review of customer requirements, and nonconformity review.
設計審查定義
IEC 61160:2005, 3.4 design review
planned, dccumented independent review of an existing or proposed design
NOTE 1. Objectives include evaluation of the design's capability to fulfil the specified requirements, identify any actural or potential deficiencies, proposing enhancements.
NOTE 2. Design review by itself is not sufficient to ensure proper design.
NOTE 3. The design can be for a product or process.
NOTE 4. The design review can be achieved by means of a meeting or other documented process.
ISO 8402:1994, 3.11 design review
documented, comprehensive and systematic examination of a design to evaluate its capability to fulfil the requirements for quality, identify problems, if any, and propose the development of solutions.
NOTE. A design review can be conducted at any stage of the design process, but should in any case be conducted at the complation of this process.
IEC 61160:1992, 3.1 (formal) design review
A formal and independent examination of an existing or proposed design for the purpose of detection and remedy of deficiencies in the requirements and design which could affect such things as reliability performance, maintainability performance, maintenance support performance requirement, fitness for the purpose and the identification of potential improvements.
NOTE. Design review by itself is not sufficient to ensure proper design. [IEV 191-17-13]
ISO 8402:1986, 3.13 design review
a formal, documented, comprehenisve and systematic examination of a design to evaluate the design requirements and the capability of the design to meet these requirements and to identify problems and process solution.
NOTE 1. Design review by itself is not sufficient to ensure proper design.
NOTE 2. A design review can be conducted at any stage of the design process.
ISO 9000:2015, 3.13.1 audit (3.13 terms related to audit)
systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
NOTE 1 to entry. The fundamental elements of an audit include the determination of the conformity of an object according to a procedure carried out by personnel not being responsible for the object audited.
NOTE 2 to entry. An audit can be an internal audit (first party), or an external audit (second-party or third-party), and it can be a combined audit or a joint audit.
NOTE 3 to entry. Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization iteself for management review and other internal purposes, and can form the basis for an organization's declaration of conformity independence can be demonstrated by the freedom from responsibility for the activity being audited.
NOTE 4 to entry. External audits include those generally called second and third- party audits. Second party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Thied-party audits are conducted by external, independent auditing organizations such as those providing certifiction / registration of conformity or governmental agencies.
NOTE 5 to entry. This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition and NOTE to entry have been modified to remove effect of circulairty between audit critieria and audit evidence term entries, and NOTE 3 and 4 to entry have been added.
ISO 9000:2005, 3.9.1 audit (3.9 Terms relating to audit)
systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
NOTE 1 to entry. Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and othr internal purposes, and may form the basis for an organization declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsiblity for the activity being audited.
NOTE 2 to entry. External audits include those generally termed second- and third-party audits. Second-party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. Third-party audits are conducted by external, independent auditing organizations, such as those providing certification / registration of conformity to ISO 9001 or ISO 14001.
NOTE 3 to entry. When two or more management systems are audited together, this is termed a combined audit.
NOTE 4 to entry. When two or more auditing organizations cooperate to audit a single auditee, this is termed a joint audit.
ISO 9000:2000, 3.9.1 audit (3.9 Terms relating to audit)
systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
NOTE. Internal audit, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization's self-declaration of conformity.
External audits include what are generally termed "second-" or "third-party audits".
Second-partty audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf.
Third-party audites are conducted by external independent organizations. Such organizations provide certification or registration of conformity with requirements such as those ISO 9001 and ISO 14001:1996.
When quality and environmental management systems are audited together, this is termed a "combined audit".
When two or more auditing organizations cooperate to audit a single auditee jointly, this is termed "joint audit".
ISO 8402:1994, 4.9 quality audit
systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
NOTE 1. The quality audit typically applies to, but is not limited to, a quality system or elements thereof, to processes, to products or to services. Such audits are often called "quality system audit", "process quality audit", "product quality audit", or "service quality audit".
NOTE 2. Quality audits are carried out by staff not having direct responsibility in the area being audited but, preferably, working in cooperation with the relevant personnel.
NOTE 3. One purposes of a quality audit is to evaluate the need for improvement or corrective actions. An audit should not be confused with quality surveillance or inspection activities performed for the purposes of process control or product acceptance.
NOTE 4. Quality audits can be conducted for internal or external purposes.
ISO 8402:1986, 3.10 quality audit
A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangement are implemented effectively and are suitable to achieve objectives.
NOTE 1. The quality audit typically applies, but is not limited, to a quality system or elements thereof, to processes, to products, or to services. Such audits are often called "quality system audit", "process quality audit", "product quality audit", "service quality audit".
NOTE 2. Quality audits are carried out by staff not having direct responsibility in the areas being audited but, preferably, working in cooperation with the relevant personnel.
NOTE 3. One purpose of a quality audit is to evaluate the need for improvement or corrective action. An audit should not be confused with "surveillance" or "inspection" activiites performed for the sole purpose of process control or product acceptance.
NOTE 4. Quality audits can be conducted for internal or external purposes.
德國車輛協會 (VDA) 產品稽核 (product audit)
A product audit assesses the effectiveness of quality assurance through the examination of a small number of product and/or parts and confirms their quality capability based on the quality of the product.
型態管理的型態稽核 (configuration audit)
EIA-STD-649B:2011, 5.5 Configuration Verification and Audit, 5.5.3 Configuration audit
configuration audit: review of processes, product definition information, documented verification of compliance with requirements, and a inspection of products, to confirm that products have achieved their required attributes and conform to released product configuration definition information.
a means to assure that configuration verifications have been accomplished and to establish baselines at key points in the product life cycle.
audits are a summation of the configuration verification activity to assure ...
configuration audits include performance verification (fiunctional configuration audit) and design verification (physical configuration audit).
CVA-3. Configuration audits are a summation of the configuration verification process, where necessary to establish baselines at key points in the product life cycle.
MIL-HDBK-61B:2002, 8 Configuration Verification and Audit
functional configuration audit (FCA): examination of functional characteristics to verify ... has achieved ...
physical configuration audit (PCA): examination ... to establish or verify ...
configuration audit of configuration verification records and physical product to validate that a ...
to establish ... and support ...
EIA-STD-649:1998, 5.5.2 Configuration audit
product configuration verification accomplished by inspecting document, products and recrods; and reviewing procedures, processes, and systems of operation to verify that the product has achieved its required attributes (performance requirements and functional constraints) and the product's design is accurately documented. Sometimes divided into separate functional and physical configuration audits.
audits may be conducted by the organization responsible for the product development, by the customer, or by a third party designated by the customer.
ISO 10007:1995, 5.5 Configuration audit (CA)
to assure the product complies with its contracted or specified requirements and to assure the product is accurately reflected by its configuration documents.
normally there are two types of configuration audits: functional configuration audit and physical configuration audit
functional configuration audit: verify performance and functional characteristics
physical configuration audit: examination to verify
interrelated functional and physical characteristics of a product defined in production configuration information
型態物件 (configuration item)：設計，設計與開發、設計與發展的產品
ISO 10007:2003 3.5
entity within a configuration that satisfies an end use function
型態管理 (configuration management)：
ISO 10007:2003, 3.6
coordinated activities to direct and control configuration.
NOTE. Configuration management generally concentrates on technical and organizational activities that establish and maintain control of a product and its product configuration information throughout the life cycle of the product.
產品型態資訊 (product configuration information)
ISO 10007:2003, 3.9
requirements for product design, realization, verification, operation, and support
工程變更 (engineering change)：
型態管理 (configuration management, CM) 相關文件：
ISO 10007:1995, CNS 14238:2000, ISO 10007:2003, CNS 14238:2006
activity to find out one or more characteristics and their characteristic values.
檢驗 (inspection)
ISO 9000:2015, 3.11.7 檢驗 (inspection)
determination of conformity to specified requirements.
NOTE 1 to entry: If the result of an inspection shows conformity, it can be used for purposes of verification.
NOTE 2 to entry: The result of an inspection can show conformity or nonconformity or a degree of conformity.
ISO 9000:2005, 3.8.2 檢驗 (inspection)
conformity evaluation by observation and judgement accompanied as approproate by measurement, testing or gauging
[ISO/IEC Guide 2]
ISO 9000:2000, 3.8.2 檢驗 (inspection)
試驗 (test)
ISO 9000:2015, 3.11.8 試驗 (test)
determination according to requirements for a specific intended use or application.
NOTE 1 to entry: If the result of a test shows conformity, it can be used for purpose of validation.
ISO 9000:2005, 3.8.3 試驗 (test)
determination of one or more characteristics according to a procedure
ISO 9000:2000, 3.8.3 試驗 (test)
監視 (monitoring)
ISO 9000:2015, 3.11.3 監視 (monitoring)
determining the status of a system, a process, a product, a service, or an activity.
NOTE 1 to entry: For the determination of the status there can be a need to check, supervise or critically observe.
NOTE 2 to entry: Monitoring is generally a determination of the status of an object, carried out at different stages or at different times.
NOTE 3 to entry: This constitutes one the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition and NOTE 1 to entry have been modified, and NOTE 2 to entry has been added.
ISO 9000:2015, 3.11.4 量測 (measurement)
process to determine a value.
NOTE 1 to entry: According to ISO 3534-2, the value determined is generally the value of a quantity.
NOTE 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 11. The original definition has been modified by adding NOTE 1 to entry.
ISO 9000:2015, 3.11.5 量測過程 (measurement process)
set of operations to determine the value of a quantity.
ISO 9000:2015, 3.11.6 量測設備 (measuring equipment)
measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process.
驗證 (verification)
ISO 9000:2015, 3.8.12 驗證 (verification)
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
NOTE 1 to entry. The objective evidence needed for a verification can be the result of an inspection or of other form of determination such as performing alternative calculations or reviewing documents.
NOTE 2 to entry. The activities carried out for verification are sometimes called a qualification process.
NOTE 3 to entry. The word "verified" is used to designate the corresponding status.
ISO 9000:2005, 3.8.4 驗證 (verification)
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
NOTE 1. The term "verified" is used to designate the corresponding status.
NOTE 2. Confirmation can comprise activities such as
performing alternative calculations,
comparing a new design specification with a similar proven design specification,
undertaking tests and demonstrations, and
reviewing documents prior to issue.
ISO 9000:2000, 3.8.4 驗證 (verification)
查證 (validation)
ISO 9000:2015, 3.8.13 查證 (validation)
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
NOTE 1 to entry. The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.
NOTE 2 to entry. The word "validated" is used to designate the corresponding status.
NOTE 3 to entry. The use conditions for validation can be real or simulated.
ISO 9000:2005, 3.8.5 查證 (validation)
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
NOTE 1. The term "validated" is used to designate the corresponding status.
NOTE 2. The use conditions for validation can be real or simulated.
ISO 9000:2000, 3.8.5 查證 (validation)
審查 (review)
ISO 9000:2015, 3.11.2 審查 (review)
determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Example: Management review, design and development review, review of customer.
NOTE 1 to entry: Review can also include the determination of efficiency.
ISO 9000:2005, 3.8.7 審查 (review)
activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives
NOTE. Review can also include the determination of efficiency.
EXAMPLE. Management review, design and development review, review of customer requirements, and nonconformity review.
ISO 9000:2000, 3.8.7 審查 (review)
ISO 9000:2015, 3.11.9 進度評估 (progress evaluation)
<project management> assessment of progress made on achievement of the project objectives.
NOTE 1 to entry: This assessment should be carried out at appropriate points in the project life cycle across project processes, based on criteria for project processes and product or service.
NOTE 2 to entry: The results of progress evaluations can lead to revision of the project management plan.
[SOURCE: ISO 10006:2003, 3.4, modified - NOTE to entry have been modified]
ISO 9000:2005, 3.8 Terms relating to examination
ISO 9000:2005, 3.8.1 客觀證據 (objective evidence)
data supporting the existence or verify of something
NOTE. Objective evidence may be obtained through observation, measurement, test, or other means.
ISO 9000:2005, 3.8.6 鑑定過程 (qualification process)
process to demonstrate the ability to fulfill specified requirements
NOTE 1. The term "qualified" is used to designate the corresponding status.
NOTE 2. Qualification can concern persons, products, processes, or systems.
EXAMPLE. Auditor qualification process, material qualification process.
ISO 9000:2000, 3.8 檢查相關名詞 (Terms relating to examination)
ISO 9000:2000, 3.8.1 客觀證據 (objective evidence)
ISO 9000:2000, 3.8.6 鑑定過程 (qualification process)
國際專業實務架構 (international professional practices framework, IPPF)
Internal auditing is an indenpendent, objective assurance and consulting activity designed to add value and improve an organization's operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control, and governance processes.
determine whether the management and the board are effective in promoting an ethical culture
determine whether the compliance and/or ethics programs provide reasonable assurance of compliance with organizational policies, applicable laws and regulations, and whether the incentive system is properly fomulated
determine if the compliance and ethics program's management framework is documented, in place, and appropriately resourced to meet the organization's needs.
determine whether the organization has implemented the compliance and ethics program effectively, and whether the program's performance reporting system accurately presents the results of the program's effort.
access the costs/benefits of the governance, risk, and complance program.
ensure that the program is in keeping with current practices based on the size and complexity of the organization.
內部稽核員學會 (The Institute of Internal Auditors, IIA)
Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization's operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control, and governance processes.
內部稽核的 Quality Assurance and Improvement Program (QAIP) [vs. 品質管理系統的內部稽查]
a means to systematically improve internal audit practices and results.
enable an evaluation of the internal audit activity's conformance to the "Definition of Internal Auditing," "International Standards for the Professional Practice of Internal Auditing," and an evaluation of whether or not internal auditors apply the "Code of Ethics."
assess the efficiency and effectiveness of the internal audit activity.
identify opportunities for improvement to add value to the audit activity.
improve operational operations.
內部稽核是展示公司治理與內部控制成果的手法
internal audit separately evaluates control environment, considering employee behaviours and whistleblower hotline results and reports thereon.
內部稽核報告為公司治理的外部非財務報告 (non-financial reports)
內部稽核人員親赴現場，看、聽，根據觀察的結果提出報告。
財務盡職調查 (financial due diligence) 與財務稽核 (financial audit) 的比較
2012 年豐田汽車公司檢討認為設計開發過程有太多的篩選程序，決議改變設計方式，減少設計審查參與人數。當太多人參與設計時，只是減少缺點的觀點進行設計，沒有導入創新的優點，因而針對已經驗證過的設計進行變更時，提出失效模式為基設計審查 (Design Review Based on Failure Mode, DRBFM) 的設計審查機制。
豐田汽車總設計師福市篤雄 (Tokuo Fukuichi) 認為，產品設計靠民主決定是不再存在的。「如果遵循持續改進原則，你可能會成為一名身材良好的模特兒，卻成不了一名演員，一個身材容貌都不算好卻令人難以忘卻的演員。」(By doing kaizen, you might be able to be a fashion model with a good figure, but not an actress - unforgettable even if she has a less attractive figure and an unusual face.)
GD[sup]3[/sup] = Good Design + Good Discusion (DRBFM) + Good Dissection (DRBTR)
GD[sup]3[/sup] = Good Design + Good Discussion + Good Design Review
其中：
Good Design = Design for Reliability (DfR) + Robust Design (System Design, Parameter Design, Tolearance Design) + DFSS (Design for Six Sigma)
Good Design Review = DRBFM + DRBTR
Delphi 公司 Lisa Allan 建議在產品發展過程推動設計審查時，在設計階段導入 DRBFM，雛型製造與試驗查證階段完成試驗之後執行 DRBTR，量產階段的生產物品執行 DRBD&P (design review based on design and process)，這些運用預防問題手法的時機如下圖所示：
研發過程導入預防問題手法的時機 (source: ReliaSoft website)
針對設計修改或設計變更 (design modification or design change)，所提出將 FMEA 與新產品導入 (NPD) 整合在一起的問題預防過程稱為「修改用失效模式與效應分析」 (Failure Modes and Effects Analysis of Modification, FMEAM) 。
