IATF 16949 tiêu chuẩn

Automotive Quality Management System Standard Quality managment system requirements for automotive production and relevant service parts organizations Quality management system requirements for automotive production and relevant service parts organizations

PROCESS APPROACH

SCOPE -AUTOMOTIVE SUPPLEMENTAL TO ISO 9001:2015

The Automotive QMS Standard outlines the essential quality management system requirements for the design, development, production, assembly, installation, and servicing of automotive-related products, including those featuring embedded software.

This Automotive QMS Standard is applicable to sites of the organization where manufacturing of customer-specified production parts, service parts, and/or accessory parts occur

NORMATIVE AND INFORMATIVE REFERENCES

Annex A (Control Plan) is a normative part of this Automotive QMS standard

Annex B (Bibliography - automotive supplemental) is informative, which provides additional information intended to assist the understanding or use of this Automotive QMS standard

TERMS AND DEFINITIONS FOR THE AUTOMOTIVE INDUSTRY

Accessory parts refer to customer-specified components added to a vehicle or powertrain, either before or after delivery, such as custom floor mats, truck bed liners, and sound system enhancements Advanced Product Quality Planning (APQP) is a structured process aimed at ensuring product quality meets customer requirements, guiding development, and facilitating communication between organizations and customers APQP encompasses various aspects, including design robustness, testing, compliance, production process design, quality standards, and operator training Aftermarket parts are replacement components not sourced from the Original Equipment Manufacturer (OEM) and may vary in adherence to original specifications Authorization denotes the documented permission that outlines rights and responsibilities for granting or denying permissions within an organization.

The challenge involves a master part that adheres to a known specification, which is calibrated and traceable to established standards This process is essential for validating the functionality of error-proofing devices or check fixtures, ensuring reliable results that indicate whether the device passes or fails.

A control plan is a documented description of the systems and processes necessary for managing product manufacturing, ensuring compliance with customer requirements, which include technical, commercial, and specific manufacturing criteria Customer-specific requirements (CSRs) provide interpretations or additional stipulations related to particular clauses of the Automotive Quality Management System (QMS) standard Design for Assembly (DFA) emphasizes designing products with ease of assembly in mind, reducing the number of parts to lower assembly time and costs Design for Manufacturing (DFM) integrates product design with process planning to facilitate economical production The combined approach, Design for Manufacturing and Assembly (DFMA), enhances production efficiency and quality while minimizing assembly errors and costs Design for Six Sigma (DFSS) employs systematic methodologies and tools to create robust designs that meet customer expectations and achieve six sigma quality levels A design-responsible organization holds the authority to establish or modify product specifications.

The responsibility of ensuring design performance includes rigorous testing and verification within the customer's specified application This involves implementing error-proofing measures in product and manufacturing process design to prevent the production of nonconforming products An escalation process is utilized to flag issues within an organization, enabling appropriate personnel to address and monitor resolutions effectively Fault Tree Analysis (FTA) serves as a deductive failure analysis methodology, mapping the relationship between faults and subsystems through a logic diagram to analyze undesired states A laboratory is essential for conducting inspections, tests, and calibrations, which may encompass chemical, metallurgical, dimensional, physical, electrical, or reliability testing The laboratory scope is a controlled document that outlines specific tests, evaluations, and calibrations the laboratory is qualified to perform, including a comprehensive list of equipment and methods adhering to established standards.

Manufacturing feasibility involves analyzing a proposed project to determine its technical viability in meeting customer requirements while staying within estimated costs This includes assessing the availability of necessary resources, facilities, tooling, capacity, software, and skilled personnel Manufacturing services encompass companies that test, manufacture, distribute, and repair components and assemblies A multi-disciplinary approach is essential for gathering input from all stakeholders, including internal teams and external representatives, to effectively manage processes The term "No Trouble Found" (NTF) refers to parts replaced during service events that meet all quality standards upon analysis Outsourced processes involve functions performed by external organizations, while periodic overhaul is a maintenance strategy aimed at preventing unplanned breakdowns through proactive equipment servicing Predictive maintenance techniques monitor equipment conditions to forecast when maintenance should occur, and premium freight refers to additional costs incurred beyond contracted delivery terms.

Preventive maintenance involves planned activities at regular intervals, such as time-based inspections and overhauls, aimed at eliminating equipment failures and minimizing unscheduled production interruptions The manufacturing process design focuses on the intended output of the product realization process, ensuring that products meet safety standards to prevent harm or hazards to customers A production shutdown occurs when manufacturing processes become idle, which can last from a few hours to several months In case of abnormal or nonconforming events, a reaction plan outlines the necessary actions or steps to be taken as part of a control plan.

The article discusses various key concepts related to manufacturing and quality assurance, including the definition of a remote location where non-production processes support manufacturing sites, and the importance of service parts that meet OEM specifications for replacement needs It highlights the significance of special characteristics in products that can impact safety, compliance, and performance, as well as the notion of special status, which indicates when customer requirements are not met due to quality or delivery issues Additionally, it addresses support functions that enhance manufacturing operations, total productive maintenance for improving production integrity, and the use of trade-off curves as a tool to analyze the relationship between different design characteristics and product performance Finally, it emphasizes the trade-off process as a methodology for evaluating design alternatives based on customer, technical, and economic factors.

UNDERSTANDI NG THE ORGANIZATION AND ITS CONTEXT

UNDERSTANDI NG THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM

Determining the scope of the quality management system - supplemental

Supporting functions,whether on-site or remote (such as design centres, corporate headquarters, and distribution centres), shall be included in the scope of the Quality Management System (QMS)

The sole allowable exclusion for the Automotive Quality Management System (QMS) Standard pertains to the product design and development requirements outlined in ISO 9001, Section 8.3 This exclusion must be justified and documented as per the guidelines in ISO 9001, Section 7.5.

Permitted exclusions do not include manufacturing process design.

Customer-specific requirements

Customer-specific requirements shall be evaluated and included in the scope of the organization 's quality management system.

QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

Conformance of products and processes

The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8.4.2.2).

Product safety

The organization must establish documented processes for managing product-safety-related products and manufacturing processes, encompassing the identification of statutory and regulatory product-safety requirements, customer notifications, and special approvals for design FMEA It should also identify and control safety-related characteristics during manufacturing, obtain special approval for control plans and process FMEAs, and develop reaction plans Clear responsibilities, an escalation process, and effective communication with top management and customers are essential Additionally, training for personnel involved in product safety is necessary, and any changes to products or processes must be approved in advance, assessing their potential impact on product safety Finally, requirements regarding product safety should be communicated throughout the supply chain, including customer-designated sources.

I) product traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8.5.2.1); m) lessons learned for new product introduction

NOTE: Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety-related content

LEADERSHIP AND COMMITMENT

GENERAL

The organization shall define and implement corporate responsibility policies, including at a minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation policy ("whistle-blowing policy")

Top management must assess both product realization and support processes to enhance their effectiveness and efficiency The outcomes of these evaluations will be incorporated as input for the management review, as outlined in Section 9.3.2.1.

Top management must designate process owners accountable for overseeing the organization's processes and outcomes These process owners should fully comprehend their responsibilities and possess the necessary skills to execute their roles effectively, in accordance with ISO 9001, Section 7.2.

CUSTOMER FOCUS

POLICY ã

ESTABLISHING THE QUALITY POLICY

COMMUNICATING THE QUALITY POLICY

ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES

5.3 1 Organizational roles, responsibilities, and authorities -supplemental

Top management must designate personnel with the authority and responsibility to meet customer requirements, ensuring that these assignments are properly documented This encompasses selecting specific characteristics, establishing quality objectives, and providing necessary training and corrective actions.

18 © AIAG, © ANFIA, © FIEV, © SMMT, © VOA - 2016 - All rights reserved preventive actions, product design and development, capacity analysis, logistics information, customer scorecards, and customer portals

5.3.2 Responsibility and authority for product requirements and corrective actions

"Fop management shall ensure that: a) personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems;

In certain industries, immediate cessation of production may not be feasible due to process design; therefore, it is crucial to contain any affected batches and prevent shipment to customers Prompt communication with personnel authorized to take corrective action is essential to address nonconforming products or processes, ensuring that such products are not dispatched and that all potential nonconformities are identified and contained Additionally, all production shifts must be staffed with responsible personnel dedicated to maintaining conformity with product requirements.

ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

AND 6.1.2

The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework

The organization shall retain documented information as evidence of the results of risk analysis

The organization must identify and execute measures to eliminate the root causes of potential nonconformities, ensuring their prevention These preventive actions should be proportionate to the severity of the identified risks.

To mitigate the negative impacts of risks, the organization must implement a systematic process that includes identifying potential nonconformities and their root causes, assessing the need for preventive actions, executing necessary measures, and documenting the actions taken Additionally, it is crucial to review the effectiveness of these preventive actions and leverage lessons learned to avert recurrence in similar processes, in accordance with ISO 9001, Section 7.1.6.

The organization must identify and assess both internal and external risks that could affect manufacturing processes and essential infrastructure to ensure production output meets customer requirements It is crucial to establish contingency plans based on the risk level and potential impact on customers, preparing for scenarios such as equipment failures, supply interruptions, natural disasters, and labor shortages Additionally, the organization should implement a notification process to inform customers and stakeholders about the extent and duration of any disruptions Regular testing of these contingency plans through simulations is necessary to evaluate their effectiveness An annual review of the plans by a multidisciplinary team, including top management, should be conducted to ensure they remain up-to-date Finally, all contingency plans must be documented, with a record of any revisions and the individuals who authorized them.

Contingency plans must ensure that the manufactured product consistently meets customer specifications after production resumes following an emergency shutdown, particularly if standard shutdown procedures were not adhered to.

QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM

AND 6.2.2

6.2.2.1 Quality objectives and planning to achieve them -supplemental

Top management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization

The organization's review of interested parties and their requirements will inform the establishment of its annual quality objectives and performance targets, both internal and external.

PLANNING OF CHANGES

RESOURCES

GENERAL

PEOPLE

7.1.3.1 Plant, facility, and equipment planning

The organization will adopt a multidisciplinary approach that incorporates risk identification and mitigation strategies to enhance plant, facility, and equipment planning In designing plant layouts, the focus will be on optimizing material flow, efficient material handling, and maximizing the value-added use of floor space, while also managing nonconforming products Additionally, the design will aim to facilitate synchronous material flow wherever applicable.

To ensure successful new product development and operational changes, it is essential to establish and apply methods for assessing manufacturing feasibility These evaluations must encompass capacity planning and should also be adaptable for analyzing proposed modifications to current operations.

The organization will ensure the effectiveness of its processes through regular re-evaluation concerning risks, incorporating any modifications made during the approval phase, maintaining control plans, and verifying job set-ups.

Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews (see ISO 9001, Section 9.3)

NOTE 1 These requirements should include the application of lean manufacturing principles

ENVIRONMENT FOR THE OPERATION OF PROCESSES

NOTE Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the organization's conformity to the personnel safety aspects of this requirement

7 1.4.1 Environment for the operation of processes -supplemental

The organization shall maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs.

MONITORING AND MEASURING RESOURCES

Statistical studies will be performed to assess the variations in results from each inspection, measurement, and test equipment system outlined in the control plan The analytical methods and acceptance criteria must align with those specified in reference manuals on measurement systems analysis, although alternative methods may be utilized if they receive customer approval.

Records of customer acceptance of alternative methods shall be retained along with results from alternative measurement systems analysis (see Section 9.1.1.1)

NOTE Prioritization of MSA studies should focus on critical or special product or process characteristics

NOTE A number or another identifier traceable to the device calibration record meets the intent of the requirements in ISO 9001:2015

The organization shall have a documented process for managing calibration/verification records

Records of the calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-

All rights reserved by AIAG, ANFIA, FIEV, SMMT, and VOA (2016) It is essential to retain evidence of conformity to internal, legislative, regulatory, and customer-defined requirements for owned equipment.

The organization must ensure that calibration and verification activities are comprehensive, including revisions for engineering changes affecting measurement systems, documentation of any out-of-specification readings, and an assessment of risks associated with such conditions It is essential to retain documented information on the validity of previous measurements if inspection equipment is found to be out of calibration or defective, along with the last and next calibration dates Customers must be notified if suspect products or materials are shipped, and statements of conformity to specifications must be provided post-calibration Additionally, verification of the software version used in product and process control is necessary, along with maintaining records of calibration and maintenance activities for all gauging equipment, including that owned by employees, customers, or on-site suppliers Lastly, production-related software verification must be documented for all relevant equipment.

An organization's internal laboratory facility must define its scope, which includes the ability to perform necessary inspection, testing, or calibration services, and this scope should be documented within the quality management system The laboratory is required to establish and implement minimum standards for the adequacy of technical procedures, the competency of personnel, product testing, and the ability to conduct services accurately in accordance with relevant process standards like ASTM or EN In the absence of applicable national or international standards, the organization must create a methodology to assess measurement system capability Additionally, the laboratory should address customer requirements and conduct reviews of related records.

To demonstrate compliance with ISO/IEC 17025 standards, organizations can utilize third-party accreditation for their in-house laboratories This accreditation serves as evidence of conformity to the required quality and technical standards.

Organizations utilizing external, commercial, or independent laboratory facilities for inspection, testing, or calibration services must ensure that these laboratories have a defined scope of capabilities This includes accreditation to ISO/IEC 17025 or a national equivalent, which should encompass the relevant services within the accreditation certificate Additionally, calibration certificates or test reports must feature the mark of a recognized national accreditation body, or there must be proof of the laboratory's acceptability to the customer.

To demonstrate compliance with ISO/IEC 17025 or its national equivalent, laboratories can provide evidence through customer assessments or approved second-party evaluations These assessments, conducted by organizations using customer-sanctioned methods, validate that the laboratory meets the necessary standards.

When a qualified laboratory is unavailable for equipment calibration, the equipment manufacturer can perform the calibration services It is essential for the organization to ensure compliance with the requirements outlined in Section 7.1.5.3.1.

Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation, if required

COMPETENCE

Competence - on-the-job training

The organization will provide on-the-job training, including customer requirements training, for personnel with new or modified responsibilities that impact quality compliance, covering both internal and regulatory standards This training will also extend to contract or agency personnel The depth of the training will align with the employees' educational background and the complexity of their tasks Additionally, individuals whose roles influence quality will be made aware of the implications of failing to meet customer requirements.

Internal auditor competency

The organization must implement a documented process to ensure the competence of internal auditors, considering any specific requirements from customers For further information on auditor competencies, consult ISO 19011 Additionally, the organization is required to keep an updated list of qualified internal auditors.

Quality management system auditors, manufacturing process auditors, and product auditors must demonstrate key competencies, including a comprehensive understanding of the automotive process approach to auditing with an emphasis on risk-based thinking They should be well-versed in customer-specific requirements and the relevant ISO 9001 and IATF 16949 standards pertaining to the audit scope Additionally, auditors need to grasp the core tool requirements applicable to their audits and possess the skills necessary to effectively plan, conduct, report, and resolve audit findings.

Manufacturing process auditors must possess a strong technical understanding of the specific manufacturing processes being audited, which includes conducting process risk analyses like PFMEA and implementing control plans Meanwhile, product auditors need to demonstrate their competence in comprehending product requirements and effectively utilizing appropriate measuring and testing equipment to ensure product conformity.

Where training is provided to achieve competency, documented information shall be retained to demonstrate the trainer's competency with the above requirements

To ensure the competence of internal auditors, organizations must demonstrate that auditors conduct a specified minimum number of audits annually and stay updated on relevant internal changes, such as advancements in process and product technology, as well as external standards like ISO 9001, IATF 16949, core tools, and specific customer requirements.

Second- party auditor competency

Organizations must ensure that second-party auditors possess the necessary qualifications and competencies to conduct effective audits These auditors should have a strong understanding of the automotive process approach, including risk-based thinking, and must be familiar with both customer-specific and organizational requirements Additionally, they should be knowledgeable about relevant ISO 9001 and IATF 16949 standards, as well as the specific manufacturing processes being audited, including PFMEA and control plans Furthermore, auditors need to be aware of core tool requirements pertinent to the audit scope and should be skilled in planning, conducting audits, preparing reports, and addressing audit findings.

AWARENESS

Awareness - supplemental

The organization must keep documented evidence showing that all employees understand their influence on product quality and recognize the significance of their roles in achieving, maintaining, and enhancing quality This includes awareness of customer requirements and the potential risks to customers associated with non-conforming products.

Employee motivation and empowerment

The organization will implement a documented process aimed at motivating employees to meet quality objectives, foster continuous improvement, and cultivate an innovative environment This process will emphasize the importance of quality and technological awareness across the entire organization.

COMMUNICATION

GENERAL

The organization's quality management system shall be documented and include a quality manual, which can be a series of documents (electronic or hard copy)

The organization has the flexibility to determine the format and structure of its quality manual, which should align with its size, culture, and complexity If multiple documents are utilized, a comprehensive list of these documents must be maintained to ensure clarity and organization of the quality manual.

The quality manual must encompass the scope of the quality management system, detailing any exclusions with justifications It should document the established processes or provide references to them, outline the organization's processes along with their sequences and interactions, and specify the control measures for outsourced processes Additionally, it must include a matrix that highlights how customer-specific requirements are integrated within the quality management system.

A matrix outlining how the Automotive Quality Management System (QMS) requirements are met by the organization's processes can effectively illustrate the connections between these processes and the Automotive QMS.

CREATING AND UPDATING

CONTROL OF DOCUMENTED INFORMATION

The organization shall define, document , and implement a record retention policy The control of records shall satisfy statutory, regulatory, organizational, and customer requirements

Production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders, or contracts and amendments must be retained for the duration of the product's active production and service requirements, plus one additional calendar year, unless specified otherwise by the customer or regulatory agency This documentation may include approved product information and applicable test results.

\._, , equipment records, or approved test data

The organization shall have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required

When changes to engineering standards or specifications lead to modifications in product design, it is essential to adhere to ISO 9001, Section 8.3.6 Similarly, if such changes affect the product realization process, Section 8.5.6.1 must be followed Organizations are required to maintain a record of the implementation date for each change in production, ensuring that all relevant documents are updated accordingly.

Review should be completed within 10 working days of receipt of notification of engineering standards/specifications changes.

Changes to standards or specifications may necessitate an updated customer production part approval record if these changes are referenced in the design record or impact related documents in the production part approval process, including control plans and risk analyses like FMEAs.

OPERATIONAL PLANNING AND CONTROL

Operational planning and control - supplemental

When planning for product realization, the following topics shall be included: a) customer product requirements and technical specifications; b) logistics requirements; c) manufacturing feasibility; d) project planning (refer to ISO 9001, Section 8.3.2); e) acceptance criteria

The resources identified in ISO 9001, Section 8.1 c), refer to the required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance.

Confidentiality

The organization shall ensure the confidentiality of customer-contracted products and projects under development, including related product information.

REQUIREMENTS FOR PRODUCTS AND SERVICES

CUSTOMER COMMUNICATION

Effective communication, whether written or verbal, will be conducted in the language mutually agreed upon with the customer The organization is equipped to convey essential information, including data in formats specified by the customer, such as computer-aided design data and electronic data interchange.

DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.2.1 Determining the requirements for products and services -supplemental

These requirements shall include recycling, environmental impact, and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes.

Compliance with ISO 9001, Section 8.2.2 item a) 1) requires adherence to all relevant government, safety, and environmental regulations concerning the acquisition, storage, handling, recycling, elimination, and disposal of materials.

REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES

8.2.3.1.1 Review of the requirements for products and services -supplemental

The organization shall retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001, Section 8.2.3.1, for a formal review

The organization shall conform to customer requirements for designation, approval documentation, and control of special characteristics

The organization will employ a multidisciplinary approach to analyze the feasibility of its manufacturing processes, ensuring they consistently produce products that meet the engineering and capacity requirements set by customers This feasibility analysis will be conducted for any new manufacturing or product technology, as well as for any modifications to existing manufacturing processes or product designs.

Additionally, the organization should validate through production runs, benchmarking studies, or other appropriate methods, their ability to make product to specifications at the required rate

CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES

DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

GENERAL

8.3.1.1 Design and development of products and services - supplemental

The requirements of ISO 9001, Section 8.3.1 , shall apply to product and manufacturing process design and development and shall focus on error prevention rather than detection

The organization shall document the design and development process.

DESIGN AND DEVELOPMENT PLANNING

8.3.2.1 Design and development planning -supplemental

The organization must ensure that its design and development planning encompasses all relevant stakeholders within the organization and, where applicable, its supply chain This multidisciplinary approach is vital in various areas, including project management methodologies like APQP or VDA-RGA, product and manufacturing process design activities such as DFM and DFA that evaluate alternative designs and processes, and the development and review of product design risk analyses (FMEAs) aimed at mitigating potential risks Additionally, it is essential to conduct thorough manufacturing process risk analyses, which include FMEAs, process flows, control plans, and standard work instructions, to enhance overall project effectiveness.

NOTE A multidisciplinary approach typically includes the organization's design, manufacturing, engineering , quality, production, purchasing, supplier, maintenance , and other appropriate functions

The organization must ensure that its personnel responsible for product design possess the necessary competencies to meet design requirements and are proficient in relevant design tools and techniques, which will be identified by the organization.

NOTE An example of product design skills is the application of digitized mathematically based data

8.3.2.3 Development of products with embedded software

The organization will implement a quality assurance process for products featuring internally developed embedded software A software development assessment methodology will be employed to evaluate the organization's software development practices By prioritizing based on risk and potential customer impact, the organization will maintain documented evidence of a self-assessment of its software development capabilities.

The organization shall include software development within the scope of their internal audit programme (see Section 9.2.2.1).

DESIGN AND DEVELOPMENT INPUTS

The organization must identify, document, and review product design input requirements stemming from contract reviews These requirements encompass product specifications, including special characteristics, boundary and interface requirements, identification and traceability, and packaging considerations Additionally, the organization should evaluate design alternatives and assess risks associated with the input requirements, ensuring effective risk mitigation and management Furthermore, targets for conformity to product requirements should be established, addressing aspects such as preservation, reliability, durability, serviceability, health, safety, environmental impact, development timing, and cost Lastly, any applicable statutory and regulatory requirements from the customer's country of destination, as well as embedded software requirements, must also be considered.

The organization must implement a systematic approach to utilize insights from past design projects, competitive product analysis, supplier feedback, internal contributions, field data, and other pertinent sources to enhance current and future projects of a similar nature.

NOTE One approach for considering design alternatives is the use of trade-off curves

The organization must systematically identify, document, and evaluate the input requirements for manufacturing process design This includes analyzing product design output data, establishing productivity and cost targets, exploring manufacturing technology alternatives, considering customer requirements, leveraging insights from previous projects, incorporating new materials, addressing product handling and ergonomic needs, and applying principles of design for manufacturing and assembly.

The design of the manufacturing process must incorporate error-proofing techniques that align with the severity of the issues and the associated risks.

The organization will adopt a multidisciplinary approach to identify and document special characteristics, as determined by customer requirements and risk analysis This includes thorough documentation in drawings, risk assessments like FMEA, control plans, and standard operating procedures, with special characteristics clearly marked and communicated across all documents Additionally, the organization will develop control and monitoring strategies for these characteristics, ensure compliance with customer approvals when necessary, and adhere to customer-defined symbols or equivalent notations as outlined in a symbol conversion table, which will be provided to the customer upon request.

DESIGN AND DEVELOPMENT CONTROLS

Measurements at key stages in the design and development of products and processes must be clearly defined, analyzed, and reported, providing summarized results that serve as input for management review.

When required by the customer, measurements of the product and process development activity shall be reported to the customer at stages specified, or agreed to, by the customer

NOTE When appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other measurements

Design and development validation must align with customer requirements and adhere to relevant industry and regulatory standards The scheduling of this validation process should be coordinated with the timing specified by the customer.

Where contractually agreed with the customer, this shall include evaluation of the interaction of the organization's product, including embedded software , within the system of the final customer's product

To meet customer requirements, the organization must implement a prototype program and a control plan Additionally, it is essential to utilize the same suppliers, tooling, and manufacturing processes that will be employed during production whenever feasible.

All performance-testing activities shall be monitored for timely completion and conformity to requirements

When outsourcing services, organizations must define the level of control within their quality management system to guarantee that these services meet specified requirements, in accordance with ISO standards.

The organization shall establish, implement, and maintain a product and manufacturing approval process conforming to requirements defined by the customer(s)

The organization shall approve externally provided products and services per ISO 9001, Section 8.4.3 , prior to submission of their part approval to the customer

The organization shall obtain documented product approval prior to shipment, if required by the customer Records of such approval shall be retained

NOTE Product approval should be subsequent to the verification of the manufacturing process.

DESIGN AND DEVELOPMENT OUTPUTS

8.3.5.1 Design and development outputs - supplemental

The product design output must be articulated in verifiable terms that align with the specified design input requirements This output encompasses various elements, including but not limited to, detailed specifications, prototypes, and documentation that demonstrate compliance with the established criteria.

This article outlines essential components of product development, including design risk analysis (FMEA) and reliability study results, which ensure product robustness It highlights special characteristics of the product and the outcomes of error-proofing methodologies such as DFSS, DFMA, and FTA The product definition encompasses 30 models along with comprehensive technical data packages, manufacturing information, and geometric dimensioning & tolerancing (GD&T) Additionally, it includes 20 detailed drawings, product manufacturing information, and GD&T specifications The findings from product design reviews, service diagnostic guidelines, and repair instructions are also discussed, alongside service part requirements and packaging and labeling specifications for shipping.

NOTE Interim design outputs should include any engineering problems being resolved through a trade- off process

The organization must document the manufacturing process design output to ensure it can be verified against the design inputs Verification of these outputs against the specified input requirements is essential The manufacturing process design output should encompass specifications and drawings, special characteristics relevant to both the product and the manufacturing process, identification of process input variables that affect these characteristics, and tooling and equipment necessary for production and control, including capability studies of the equipment used.

The article outlines essential components of manufacturing processes, including flow charts that illustrate the relationships between products, processes, and tooling It emphasizes the importance of capacity analysis, manufacturing process Failure Mode and Effects Analysis (FMEA), and detailed maintenance plans and instructions Additionally, it highlights the need for a control plan, standard work procedures, work instructions, and established process approval acceptance criteria to ensure efficiency and quality in manufacturing operations.

I) data for quality, reliability, maintainability, and measurability; m) results of error-proofing identification and verification , as appropriate; n) methods of rapid detection , feedback, and correction of product/manufacturing process nonconformities

DESIGN AND DEVELOPMENT CHANGES

8.3.6.1 Design and development changes -supplemental

The organization will assess all design changes following initial product approval, whether suggested by the organization or its suppliers, to determine their potential effects on fit, form, function, performance, and durability These changes must be validated against customer requirements and receive internal approval before being implemented in production.

If required by the customer, the organization shall obtain documented approval, or a documented waiver, from the customer prior to production implementation

For products with embedded software, the organization shall document the revision level of software and hardware as part of the change record.

CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES

GENERAL

The organization must encompass all products and services that impact customer needs, including sub-assembly, sequencing, sorting, rework, and calibration services, within its definition of externally provided products, processes, and services.

The organization must implement a documented supplier selection process that assesses the supplier's risk to product conformity and the reliability of the supply chain This process includes evaluating the supplier's quality and delivery performance, examining their quality management system, engaging in multidisciplinary decision-making, and, where relevant, assessing their software development capabilities.

When selecting suppliers, it's crucial to evaluate several key criteria, including the volume of automotive business relative to their total operations, financial stability, and the complexity of the products or services offered Additionally, consider the required technology for both products and processes, the adequacy of available resources such as personnel and infrastructure, and their design and development capabilities, including project management skills Manufacturing capabilities, change management processes, and business continuity planning—encompassing disaster preparedness and contingency planning—should also be assessed, alongside their logistics processes and customer service quality.

8.4.1.3 Customer-directed sources (also known as "Directed-Buy")

When specified by the customer, the organization shall purchase products, materials, or services from customer-directed sources

The organization's management of customer-directed sources must adhere to all requirements outlined in Section 8.4, excluding those specified in IATF 16949, Section 8.4.1.2, unless alternative agreements are established in the contract with the customer.

TYPE AND EXTENT OF CONTROL

8.4.2.1 Type and extent of control -supplemental

The organization must establish a documented procedure for identifying outsourced processes and determining the types and extent of controls necessary to ensure that externally provided products, processes, and services meet both internal organizational standards and external customer requirements.

The process will outline the criteria and actions necessary to adjust the level of controls and development activities in response to supplier performance and the assessment of risks associated with products, materials, or services.

The organization must document its procedures to guarantee that all purchased products, processes, and services comply with the relevant statutory and regulatory requirements in the country of receipt, the country of shipment, and any customer-specified destination country.

If the customer defines special controls for certain products with statutory and regulatory requirements, the organization shall ensure they are implemented and maintained as defined, including at suppliers

8.4.2.3 Supplier quality management system development

The organization mandates that its automotive product and service suppliers develop, implement, and enhance a quality management system certified to ISO 9001, aiming for certification to the Automotive QMS Standard Unless specified otherwise by the customer, suppliers must achieve compliance through a sequence that includes: a) second-party audits for ISO 9001 compliance; b) obtaining ISO 9001 certification via third-party audits, with certification from an IAF MLA-accredited body; c) second-party audits for ISO 9001 certification that meets additional customer-defined QMS requirements; d) second-party audits for ISO 9001 certification in compliance with IATF 16949; and e) third-party certification to IATF 16949 from an IATF-recognized certification body.

8.4.2.3.1 Automotive product-related software or automotive products with embedded software

The organization shall require their suppliers of automotive product-related software, or automotive products with embedded software, to implement and maintain a process for software quality assurance for their products

To evaluate a supplier's software development process, a structured assessment methodology will be employed, focusing on risk prioritization and potential customer impact The organization will mandate that suppliers maintain documented evidence of their self-assessment regarding software development capabilities.

The organization must implement a documented process and criteria to assess supplier performance, ensuring that externally provided products, processes, and services meet both internal and external customer requirements.

To ensure optimal supplier performance, it is essential to monitor key indicators, including the conformity of delivered products to specified requirements, any customer disruptions at the receiving plant such as yard holds and stop ships, adherence to delivery schedules, and the frequency of premium freight occurrences.

To enhance supplier performance monitoring, the organization will incorporate customer-provided information, including special status notifications regarding quality or delivery issues, as well as details on dealer returns, warranty claims, field actions, and product recalls.

The organization shall include a second-party audit process in their supplier management approach

Second-party audits may be used for the following: a) supplier risk assessment; b) supplier monitoring; c) supplier QMS development; d) product audits; e) process audits

To ensure compliance with product safety and regulatory standards, organizations must conduct a thorough risk analysis that evaluates supplier performance and QMS certification levels This analysis should lead to the documentation of clear criteria for assessing the necessity, type, frequency, and scope of second-party audits.

The organization shall retain records of the second-party audit reports

If the scope of the second-party audit is to assess the supplier's quality management system, then the approach shall be consistent with the automotive process approach

S Supplier development

The organization will assess the priority, type, extent, and timing of necessary supplier development actions for its active suppliers, using inputs such as performance issues from supplier monitoring, findings from second-party audits, the certification status of third-party quality management systems, and risk analysis.

The organization shall implement actions necessary to resolve open (unsatisfactory) performance issues and pursue opportunities for continual improvement.

INFORMATION FOR EXTERNAL PROVIDERS

8.4.3.1 Information for external providers -supplemental

The organization must communicate all relevant statutory and regulatory requirements, along with specific product and process characteristics, to its suppliers Additionally, suppliers are required to ensure that these requirements are further communicated throughout the supply chain, extending all the way to the point of manufacture.

PRODUCTION AND SERVICE PROVISION

Control plan

The organization will create control plans as outlined in Annex A for the system, subsystem, component, and material levels relevant to the manufacturing site and all supplied products This includes processes for both bulk materials and individual parts Family control plans may be utilized for bulk materials and similar parts that share a common manufacturing process.

The organization must establish a comprehensive control plan for both pre-launch and production phases that integrates information from the design risk analysis, process flow diagram, and outputs from the manufacturing process risk analysis, such as FMEA, to ensure effective risk management.

The organization must provide measurement and conformity data during pre-launch or production control, if requested by the customer The control plan should encompass manufacturing process controls, including job setup verification, validation of first-off and last-off parts, and monitoring methods for special characteristics defined by both the customer and the organization Additionally, it should include any customer-required information and a specified reaction plan for addressing nonconforming products or when the process is deemed statistically unstable or incapable.

The organization is required to review and update control plans whenever it identifies the shipment of nonconforming products, experiences changes in product specifications, manufacturing processes, measurement systems, logistics, supply sources, production volume, or risk analysis (FMEA) Additionally, updates should occur following customer complaints and the implementation of corrective actions, as well as at predetermined intervals based on risk analysis.

If required by the customer, the organization shall obtain customer approval after review or revision of the control plan.

Standardised work - operator instructions and visual standards

The organization must ensure that standardized work documents are effectively communicated and comprehended by employees responsible for executing the tasks These documents should be clear and legible, presented in the languages understood by the personnel, and readily accessible in the designated work areas.

The standardised work documents shall also include rules for operator safety

8.5.1.3 Verification of job set-ups

The organization is responsible for verifying job set-ups during initial runs, material changeovers, or job changes that necessitate new setups It must maintain documented information for setup personnel and employ statistical methods for verification when applicable Additionally, first-off and last-off part validations are to be performed, with first-off parts retained for comparison with last-off parts and vice versa in subsequent runs Finally, the organization should keep records of process and product approvals following the setup and validations of first-off and last-off parts.

Verification after shutdown

The organization shall define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period.

Total productive maintenance

The organization shall develop, implement, and maintain a documented total productive maintenance system

The system must encompass the identification of essential process equipment to produce products that meet required volumes, along with ensuring the availability of replacement parts It should provide resources for the maintenance of machines, equipment, and facilities, as well as for the packaging and preservation of tools and gauging Customer-specific requirements must be incorporated, alongside documented maintenance objectives such as Overall Equipment Effectiveness (OEE), Mean Time Between Failure (MTBF), Mean Time To Repair (MTTR), and compliance metrics for preventive maintenance Performance against these objectives should be reviewed in management assessments as per ISO 9001, Section 9.3 Additionally, the maintenance plan and objectives require regular review, with a documented action plan for corrective measures if targets are not met The system should also implement preventive and predictive maintenance methods as applicable, along with periodic overhauls.

8.5.1.6 Management of production tooling and manufacturing , test , inspection tooling and equipment

The organization shall provide resources for tool and gauge design, fabrication, and verification activities for production and service materials and for bulk materials, as applicable

The organization must establish a comprehensive production tooling management system for both owned and customer tools, encompassing maintenance and repair facilities, storage and recovery solutions, and efficient set-up procedures It should include tool-change programs for perishable tools, documentation for tool design modifications, and revisions, as well as clear identification of tools through serial or asset numbers Additionally, the system should track the status of tools—whether in production, repair, or disposal—along with their ownership and location.

The organization must ensure that all customer-owned tools, manufacturing equipment, and test/inspection equipment are clearly marked in a visible location This permanent marking allows for easy identification of ownership and the specific application of each item.

The organization shall implement a system to monitor these activities if any work is outsourced.

Production scheduling

The organization will prioritize scheduling production to align with customer orders and demands, including Just-In-Time (JIT) requirements This approach will be underpinned by an information system that provides access to critical production data at essential stages of the process, ensuring an order-driven workflow.

Effective production scheduling requires the integration of essential planning information, including customer orders, supplier on-time delivery performance, capacity, shared loading at multi-part stations, lead times, inventory levels, preventive maintenance, and calibration.

IDENTIFICATION AND TRACEABILITY

Inspection and test status should not be inferred from a product's position in the production flow, unless it is clearly evident, like materials in an automated transfer Acceptable alternatives are allowed as long as the status is clearly marked, documented, and fulfills its intended purpose.

Traceability aims to establish clear start and stop points for products received by customers or in the field that may have quality or safety-related issues To achieve this, organizations must implement effective identification and traceability processes.

The organization will analyze internal, customer, and regulatory traceability requirements for all automotive products, creating and documenting traceability plans tailored to varying levels of risk or failure severity affecting employees, customers, and consumers These plans will outline the necessary measures for effective traceability.

To establish effective traceability systems, organizations must implement processes that allow for the identification and segregation of nonconforming or suspect products These systems should ensure compliance with customer and regulatory response time requirements and maintain documented information in accessible formats, whether electronic or hardcopy Additionally, if required by customers or regulatory standards, products should have serialized identification Furthermore, the traceability requirements must extend to externally provided products that possess safety or regulatory characteristics.

PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

PRESERVATION

Preservation shall include identification,handling, contamination control, packaging, storage, transmission or transportation, and protection

Preservation shall apply to materials and components from external and/or internal providers from receipt through processing, including shipment and until delivery to/acceptance by the customer

In order to detect deterioration, the organization shall assess at appropriate planned intervals the condition of product in stock, the place/type of storage container, and the storage environment

The organization shall use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as "first-in-first-out " (FIFO)

The organization shall ensure that obsolete product is controlled in a manner similar to that of nonconforming product

Organizations shall comply with preservation, packaging, shipping, and labeling requirements as provided by their customers.

POST-DELIVERY ACTIVITIES

r 8.5.5.1 Feedback of information from service

The organization shall ensure that a process for communication of information on service concerns to manufacturing, material handling, logistics, engineering, and design activities is established, implemented, and maintained

NOTE 1 The intent of the addition of "service concerns" to this sub-clause is to ensure that the organization is aware of nonconforming product(s) and material(s) that may be identified at the customer location or in the field

NOTE 2 "Service concerns" should include the results of field failure test analysis (see Section 10.2.6) where applicable.

When establishing a service agreement with customers, organizations must ensure that service centers meet all relevant compliance requirements, assess the effectiveness of specialized tools and measurement equipment, and confirm that all service personnel receive appropriate training on applicable standards.

CONTROL OF CHANGES

The organization must establish a documented procedure to manage and respond to changes affecting product realization It is essential to evaluate the impact of all changes, whether initiated by the organization, the customer, or suppliers.

The organization must establish verification and validation processes to ensure adherence to customer requirements, validate any changes prior to their implementation, document evidence from associated risk analyses, and maintain comprehensive records of all verification and validation activities.

Any modifications, particularly those initiated by suppliers, necessitate a production trial run to verify the changes This includes alterations in part design, manufacturing location, or manufacturing process, ensuring that the impact of these changes on the overall manufacturing process is thoroughly validated.

The organization must inform the customer of any planned changes to product realization following the latest product approval and secure documented approval before implementing these changes.

8.5.6.1.1 Temporary change of process controls

The organization must create and uphold a comprehensive list of process controls, encompassing inspection, measurement, testing, and error-proofing devices This list should feature the primary process control as well as any approved backup or alternative methods to ensure effective quality management.

The organization must document the process for managing alternate control methods, incorporating risk analysis techniques like FMEA This process should address the severity of potential risks and outline the necessary internal approvals required before implementing any alternate control methods in production.

Prior to shipping products that have undergone inspection or testing through alternate methods, organizations must secure customer approval Additionally, they are required to maintain and regularly review a list of approved alternate process control methods as outlined in the control plan.

Standard work instructions must be established for each alternative process control method The organization is required to conduct daily reviews of these alternate process controls to ensure adherence to standard work practices, aiming to revert to the standard process outlined in the control plan promptly Examples of these methods include daily quality-focused audits, such as layered process audits, and daily leadership meetings.

Restart verification is documented for a defined period based on severity and confirmation that all features of the error-proofing device or process are effectively reinstated

The organization will ensure traceability for all produced products, particularly when utilizing alternative process control devices or methods This includes the verification and retention of the first and last pieces from each production shift.

RELEASE OF PRODUCTS AND SERVICES

Release of products and services -supplemental

The organization must ensure that the verification of product and service requirements is effectively planned and documented in accordance with the control plan outlined in Annex A.

The organization shall ensure that the planned arrangements for initial release of products and services encompass product or service approval

The organization shall ensure that product or service approval is accomplished after changes following initial release, according to ISO 9001, Section 8.5.6.

Layout inspection and functional testing

Each product will undergo a layout inspection and functional verification to ensure compliance with customer engineering materials and performance standards as outlined in the control plans The results of these inspections will be made available for customer review.

NOTE 1 Layout inspection is the complete measurement of all product dimensions shown on the design record(s)

NOTE 2 The frequency of layout inspection is determined by the customer.

Appearance items

Organizations producing customer-designated "appearance items" must ensure proper resources, including adequate lighting, for evaluation They should provide masters for various attributes such as color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), and haptic technology as needed Additionally, maintaining and controlling the appearance masters and evaluation equipment is essential It's also crucial to verify that personnel responsible for appearance evaluations possess the necessary competence and qualifications.

Verification and acceptance of conformity of externally provided products and services

The organization must implement a process to guarantee the quality of externally sourced processes, products, and services by utilizing methods such as receiving and evaluating statistical data from suppliers.

Receiving inspection and testing, including performance-based sampling, are essential for ensuring product quality Additionally, conducting second-party or third-party assessments or audits at supplier sites, alongside records of acceptable product conformance, enhances reliability Evaluating parts through a designated laboratory and employing mutually agreed methods with customers further contribute to effective quality assurance.

Statutory and regulatory conformity

Before integrating externally sourced products into its production process, the organization must verify and provide evidence that these processes, products, and services meet the latest statutory, regulatory, and other relevant requirements in both the manufacturing countries and any customer-specified destination countries.

Acce ptance criteria

Acceptance criteria must be established by the organization and, when necessary, validated by the customer For attribute data sampling, the target acceptance level is zero defects.

CONTROL OF NONCONFORMING OUTPUTS

Customer authorization for concession

The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved

Before proceeding with "use as is" and rework dispositions of nonconforming products, the organization must secure customer authorization Additionally, if any sub-components are reused during manufacturing, this reuse must be explicitly communicated to the customer within the concession or deviation permit.

The organization must keep a record of the expiration date or authorized quantity under concession and ensure adherence to the original or updated specifications upon expiration All materials shipped under concession, including purchased products, must be clearly identified on each shipping container Additionally, any requests from suppliers require organizational approval prior to being submitted to the customer.

Control of nonconforming product - customer-specified process

The organization shall comply with applicable customer-specified controls for nonconforming product(s).

Control of suspect product

The organization must classify and control products with unidentified or suspect status as nonconforming Additionally, it is essential that all relevant manufacturing personnel receive training on how to manage and contain suspect and nonconforming products effectively.

Control of reworked product

The organization will employ risk analysis methods, like FMEA, to evaluate risks in the rework process before deciding to proceed with product rework Additionally, if requested by the customer, the organization will secure customer approval before initiating any rework on the product.

The organization shall have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications

Instructions for disassembly or rework, including re-inspection and traceability requirements, shall be accessible to and utilized by the appropriate personnel

The organization shall retain documented information on the disposition of reworked product including quantity, disposition, disposition date, and applicable traceability information.

Control of repaired product

The organization will employ risk analysis methodologies, like FMEA, to evaluate potential risks in the repair process before deciding to proceed with product repairs Additionally, customer approval is required prior to initiating any repair work on the product.

The organization shall have a documented process for repair confirmation in accordance with the control plan or other relevant documented information

Instructions for disassembly or repair, including re-inspection and traceability requirements, shall be accessible to and utilized by the appropriate personnel

The organization shall obtain a documented customer authorization for concession for the product to be repaired

The organization shall retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information.

Customer notification

The organization shall immediately notify the customer(s) in the event that nonconforming product has been shipped Initial communication shall be followed with detailed documentation of the event.

Nonconforming product disposition

The organization must maintain a documented procedure for handling nonconforming products that cannot be reworked or repaired It is essential that any product failing to meet requirements is verified to be rendered unusable before disposal.

The organization shall not divert nonconforming product to service or other use without prior customer approval

MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

GENERAL

9.1.1.1 Monitoring and measurement of manufacturing processes

The organization will conduct process studies on all new manufacturing processes, including assembly and sequencing, to assess process capability and gather essential data for process control, particularly concerning special characteristics.

In certain manufacturing processes, demonstrating product compliance through process capability may not be feasible In such cases, alternative methods like batch conformance to specifications can be utilized to ensure quality standards are met.

The organization must ensure that its manufacturing process capability aligns with the customer's part approval process requirements This includes verifying the implementation of the process flow diagram, PFMEA, and control plan while adhering to essential components such as measurement techniques, sampling plans, acceptance criteria, records of actual measurement values or test results for variable data, and established reaction plans for instances when acceptance criteria are not met.

Significant process events, such as tool change or machine repair, shall be recorded and retained as documented information

The organization will implement a reaction plan outlined in the control plan to address characteristics that are either unstable or not statistically capable, ensuring compliance with specifications This plan will involve product containment and thorough inspection as necessary A corrective action plan will also be created, detailing specific actions, timelines, and assigned responsibilities to stabilize the process and achieve statistical capability Additionally, these plans will be reviewed and approved by the customer when required.

The organization shall maintain records of effective dates of process changes

The organization must identify the suitable statistical tools for its processes It is essential to ensure that these tools are integrated into the advanced product quality planning process and utilized in design risk analysis (like DFMEA), process risk analysis (such as PFMEA), and the control plan where relevant.

Employees engaged in the collection, analysis, and management of statistical data must understand key statistical concepts, including variation, control (stability), process capability, and the risks associated with over-adjustment.

CUSTOMER SATISFACTION

To ensure compliance with product and process specifications, customer satisfaction will be continuously monitored by evaluating both internal and external performance indicators, addressing all customer requirements effectively.

Performance indicators must rely on objective evidence and encompass various metrics, including delivered part quality performance, customer disruptions, field returns, recalls, and warranty claims when applicable Additionally, they should assess delivery schedule performance, taking into account incidents of premium freight, as well as customer notifications regarding quality or delivery issues, including any special status updates.

The organization will track manufacturing process performance to ensure adherence to customer quality and efficiency standards This monitoring involves reviewing customer performance data, including information from online customer portals and scorecards, when available.

Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support prioritization of actions for improving customer satisfaction.

INTERNAL AUDIT

AND 9.2.2

The organization must establish a documented internal audit process that encompasses the creation and execution of a comprehensive internal audit program This program should address all aspects of the quality management system, including audits of the quality management system itself, manufacturing processes, and product evaluations.

The audit programme shall be prioritized based upon risk, internal and external performance trends, and criticality of the process(es)

Where the organization is responsible for software development , the organization shall include software development capability assessments in their internal audit programme

The frequency of audits will be evaluated and adjusted as necessary, taking into account process changes, internal and external nonconformities, and customer complaints Additionally, the effectiveness of the audit program will be assessed during management reviews.

The organization shall audit all quality management system processes over each three-year calendar period, according to an annual programme, using the process approach to verify compliance with this

Automotive QMS Standard Integrated with these audits, the organization shall sample customer-specific quality management system requirements for effective implementation

The organization will conduct audits of all manufacturing processes every three years to assess their effectiveness and efficiency, employing customer-specific methods for these process audits If the customer does not specify an approach, the organization will establish the appropriate method to use.

Within each individual audit plan, each manufacturing process shall be audited on all shifts where it occurs, including the appropriate sampling of the shift handover

The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents

The organization will conduct audits on products at key stages of production and delivery, utilizing customer-specific methods to ensure compliance with specified requirements If the customer does not provide a defined approach, the organization will establish its own auditing method.

MANAGEMENT REVIEW .SO

GENERAL SO

Management reviews must occur at least once a year, with the frequency increasing in response to risks affecting compliance with customer requirements due to internal or external changes that impact the quality management system and performance issues.

MANAGEMENT REVIEW INPUTS

Input to management review shall include: a) cost of poor quality (cost of internal and external nonconformance) ;

To ensure comprehensive evaluation in manufacturing, key measures include assessing process effectiveness and efficiency, verifying product conformance, and evaluating manufacturing feasibility for operational changes or new facilities Additionally, customer satisfaction metrics aligned with ISO 9001 standards, performance reviews against maintenance objectives, and warranty performance are crucial Regular analysis of customer scorecards and identification of potential field failures through risk analysis, such as FMEA, further enhance operational insights Finally, understanding actual field failures and their implications for safety and the environment is essential for continuous improvement.

MANAGEMENT REVIEW OUTPUTS

Top management shall document and implement an action plan when customer performance targets are not met

GENERAL

NONCONFORMITY AND CORRECTIVE ACTION

AND 10.2.2

Problem solving

The organization shall have a documented process(es) for problem solving including: a) defined approaches for various types and scale of problems (e.g., new product development,

To address current manufacturing issues and field failures, it is essential to conduct thorough audits and identify nonconforming outputs, as outlined in ISO 9001, Section 8.7 This involves implementing containment measures and interim actions to manage these outputs effectively A comprehensive root cause analysis should be performed, utilizing appropriate methodologies to analyze and document the results Following this, systemic corrective actions must be implemented, considering their impact on similar processes and products It is crucial to verify the effectiveness of these corrective actions and, when necessary, review and update relevant documented information, such as PFMEA and control plans, to ensure ongoing compliance and quality improvement.

Where the customer has specific prescribed processes, tools, or systems for problem solving, the organization shall use those processes, tools, or systems unless otherwise approved by the customer.

Error-proofing

The organization must establish a documented procedure for selecting suitable error-proofing methodologies This process should include a detailed description of the methods employed, as recorded in the process risk analysis, such as PFMEA, and specify the testing frequencies outlined in the control plan.

The testing of error-proofing devices will involve assessing them for actual or simulated failures, with comprehensive records maintained throughout the process Challenge parts must be properly identified, controlled, verified, and calibrated whenever possible In the event of error-proofing device failures, a proactive reaction plan will be implemented.

Warranty management systems

To ensure effective warranty management, organizations must implement a comprehensive warranty management process that includes warranty part analysis, addressing cases of no trouble found (NTF) Additionally, when requested by customers, organizations are required to adhere to the specified warranty management protocols.

Customer complaints and field failure test analysis

The organization shall perform analysis on customer complaints and field failures, including any returned parts, and shall initiate problem solving and corrective action to prevent recurrence

Where requested by the customer, this shall include analysis of the interaction of embedded software of the organization's product within the system of the final customer's product

The organization shall communicate the results of testing/analysis to the customer and also within the organization

CONTINUAL IMPROVEMENT

PHASES OF THE CONTROL PLAN

A control plan consists of three key phases: a) Prototype, which outlines the dimensional measurements, materials, and performance tests conducted during prototype development, required by the customer; b) Pre-launch, detailing the measurements and tests performed after the prototype and prior to full production, marking a crucial stage in product realization; and c) Production, which documents product and process characteristics, process controls, tests, and measurement systems utilized during mass production.

Control plans are developed for individual part numbers, although family control plans can also encompass multiple similar parts that are manufactured through a shared process These plans are a key component derived from the overall quality plan.

NOTE 1 It is recommended that the organization require its suppliers to meet the requirements of this Annex

NOTE 2 For some bulk materials, the control plans do not list most of the production information This information can be found in the corresponding batch formulation/recipe details.

ELEMENTS OF THE CONTROL PLAN

A control plan includes, as a minimum, the following contents:

The control plan must include essential information such as the control plan number, issue and revision dates, and customer details as per requirements It should identify the organization's name and site designation, along with the relevant part number(s) and part name or description Additionally, it is crucial to specify the engineering change level, the phase covered (whether prototype, pre-launch, or production), and the key contact person Lastly, the plan should outline the part or process step number and provide a detailed description of the process name or operation.

Product control a) product-related special characteristics ; b) other characteristics for control (number, product or process);

Process control a) process parameters (including process settings and tolerances) ; b) process-related special characteristics; c) machines, jigs , fixtures, tools for manufacturing (including identifiers , as appropriate)

Methods a) evaluation measurement technique ; b) error-proofing; c) sample size and frequency ; d) control method

CQl-9 Special Process: Heat Treatment System Assessment

CQl-11 Special Process: Plating System Assessment

CQl-12 Special Process: Coating System Assessment

CQl-15 Special Process: Welding System Assessment

CQl-17 Special Process: Soldering System Assessment

CQl-23 Special Process: Molding System Assessment

CQl-27 Special Process: Casting System Assessment

CQl-14 Automotive Warranty Management Guideline

CQl-20 Effective Problem Solving Practitioner Guide

Volume "Audit standard field failure analysis"

AQ 024 MSA Measurement Systems Analysis

Volume 5 "Capability of Measuring Systems"

Production Part Approval Process (PPAP)

Volume 2 Production process and product approval (PPA)

Volume 19 Part 1 ("Inspection of Technical Cleanliness - Particulate Contamination of

Volume 19 Part 2 ("Technical cleanliness in assembly - Environment, Logistics, Personnel and Assembly Equipment")

CQl-24 Design Review Based on Failure Modes (DRBFM Reference Guide)

Potential Failure Mode & Effects Analysis (FMEA)

AQ 014 Manual of Experimental Design

Volume 4 Chapter Product and Process FMEA

Volume VDA-RGA "Maturity Level Assurance for New Parts"

MMOG/LE Materials Management Operational Guidelines I Logistics Evaluation

AQ 026 Managing and improving the process

Rules for achieving and maintaining IATF recognition

Volume 4 "Ring-binder" (elementary aids, risk analyses, methods, and process models)

Capability Maturity Model Integration (CMMI)

Automotive SPICE® (Software Process Improvement and Capability Determination)

CQl-19 Sub-Tier Supplier Management Process Guideline

Minimum Automotive Quality Management System Requirements for

ISO 45001 Occupational health and safety management systems

Tiêu đề	IATF 16949 Quality Management System Requirements for Automotive Production and Relevant Service Parts Organizations
Tác giả	International Automotive Task Force
Trường học	International Automotive Task Force
Chuyên ngành	Quality Management
Thể loại	standard
Năm xuất bản	2016

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Số trang	62
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