8 Operation 8.1 Operational planning and control ‘See ISO 9001:2015 requirements. 8.1.1 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; ©) manufacturing feasibility; d) project planning (refer to ISO 9001, Section 8.3.2); e) acceptance criteria. ‘The resources identified in ISO 3001, 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. 8.1.2 Confidentiality The organization shall ensure the confidentiality of customer-contracted products and projects under development, including related product information. 8.2 Requirements for products and services 82.1 Customer communication See ISO 9001:2015 requirements. 82.1.1 Customer communication — supplemental Written or verbal communication shall be in the language agreed with the customer. The organization shall have the ability to communicate necessary information, including data in a customer-specified computer language and format (¢.g., computer-aided design data, electronic data interchange) 8.2.2 Determining the requirements for products and services See ISO 9001:2015 requirements. 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 to ISO 9001, Section 8.2.2 item a) 1), shall include but not be limited to the following: all applicable government, safety, and environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material 8.2.3 Review of the requirements for products and services 8231 See ISO 9001:2015 requirements. AIG, © ANFIA, © FIEV, © SMMT, © VDA 2016 — Al rights reserved a8.2.3.1.1 Review of the requirements for products and services — supplemental The organization shail retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001, Section 8.2.3.1, for a formal review. 8.2.3.1.2 Customer-designated special characteristics ‘The organization shall conform to customer requirements for designation, approval documentation, and control of special characteristics, 8.2.3.1.3 Organization manufacturing feasibility ‘The organization shall utilize a multidisciplinary approach to conduct an analysis to determine if it {s feasible that the organization's manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. The organization shall conduct this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design, ‘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. 8.2.3.2 See ISO 9001:2015 requirements. 8.2.4 Changes to requirements for products and services See ISO 9001:2015 requirements. 8.3 Design and development of products and services 8.3.1 General See ISO 9001:2015 requirements. 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. 8.3.2 Design and development planning See ISO 9001:2015 requirements. 8.3.2.1 Design and development planning — supplemental ‘The organization shall ensure that design and development planning includes all affected stakeholders within the organization and, as appropriate, its supply chain. Examples of areas for using such a multidisciplinary approach include but are not limited to the following: @) project management (for example, APQP or VDA-RGA); b) product and manufacturing process design activities (for example, DFM and DFA), such as consideration of the use of altemative designs and manufacturing processes; ©) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks; ~ AIAG, @ANFIA, © FIEV, © SMMT, © VDA. 2016 Allright reservedd) development and review of manufacturing process risk analysis (for example, FMEAS, process flows, control plans, and standardised work instructions). NOTE A multidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions. 8.3.2.2 Product design skills The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques shall 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 shall use a process for quality assurance for their products with internally developed embedded software. A software development assessment methodology shall be utilized to assess the organization's software development process. Using prioritization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment ‘The organization shall include software development within the scope of their internal audit programme (see Section 9.2.2.1), 8.3.3 Design and development inputs See ISO 9001:2015 requirements. 8.3.3.1 Product design input The organization shall identity, document, and review product design input requirements as a result of contract review. Product design input requirements include but are not limited to the following a) _ product specifications including but not limited to special characteristics (see Section 6.3.3.3); b) boundary and interface requirements; ©) identification, traceability, and packaging: ) consideration of design alternatives; ) assessment of risks with the input requirements and the organization's abilty to mitigatey manage the risks, including from the feasibility analysis; f) targets for conformity to product requirements including preservation, reliability, durability, serviceability, health, safety, environmental, development timing, and cost; 9) applicable statutory and regulatory requirements of the customer-identified country of destination, if provided; h) embedded software requirements. The organization shall have a process to deploy information gained from previous design projects, competitive product analysis (benchmarking), supplier feedback, internal input, field data, and other relevant sources for current and future projects of a similar nature. NOTE One approach for considering design alternatives is the use of trade-off curves, AIAG, © ANFIA, © FIEV, © SMMT, © VDA~ 2016 — All rights reserved 28.3.3.2, Manufacturing process design input The organization shall identify, document, and review manufacturing process design input requirements including but not limited to the following: a) _ product design output data including special characteristics; b) _ targets for productivity, process capability, timing, and cost; ©) manufacturing technology alternatives: @) customer requirements, if any; ) experience from previous developments; ) new materials; 9) product handling and ergonomic requirements; and h) design for manufacturing and design for assembly. The manufacturing process design shall include the use of error-proofing methods to a degree appropriate to the magnitude of the problem(s) and commensurate with the risks encountered. 8.3.3.3 Special characteristics The organization shall use a muttidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standardised work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents; b) development of contro! and monitoring strategies for special characteristics of products and production processes; ©) customer-specified approvals, when required; a) compliance with customer-specified definitions and symbols or the organization's equivalent ‘symbols or notations, as defined in a symbol conversion table. The symbol conversion table shall be submitted to the customer, if required 8.3.4 Design and development controls See ISO 9001:2015 requirements. 8.3.4.1 Monitoring Measurements at specified stages during the design and development of products and processes shall be defined, analysed, and reported with summary results as an input to management review (see Section 9.3.2.1) 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, 8.3.4.2 Design and development validation Design and development validation shall be performed in accordance with customer requirements, including any applicable industry and governmental agency-issued regulatory standards. The timing of 0 G AIAG, OANFIA, © FIEV, @ SMMT, @ VDA~ 2016 ~All rights reserveddesign and development validation shall be planned in alignment with customer-specified timing, as applicable, ‘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 8.3.4.3 Prototype programme When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production. All performance-testing activities shall be monitored for timely completion and conformity to requirements, When services are outsourced, the organization shall include the type and extent of control in the ‘scope of its quality management system to ensure that outsourced services conform to requirements {see ISO 9001, Section 8.4), 8.3.4.4 Product approval process 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. 8.3.5 Design and development outputs See ISO 9001:2015 requirements. 8.3.5.1 Design and development outputs — supplemental The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include but is not limited to the following, as applicable: a) design risk analysis (FMEA); b) reliability study results; ©) product special characteristics; 4) _ results of product design error-proofing, such as DFSS, DFMA, and FTA; €) product definition including 3D models, technical data packages, product manufacturing information, and geometric dimensioning & tolerancing (GD&T); f) 2D drawings, product manufacturing information, and geometric dimensioning & tolerancing (Gpat); 9) product design review results; h) service diagnostic guidelines and repair and serviceability instructions; i) service part requirements, ji) _ packaging and labeling requirements for shipping. (AIAG, © ANFIA, © FIEV, © SMMT, © VDA 2016 ~ Al rights reserved a”NOTE Interim design outputs should include any engineering problems being resolved through @ trade-off process. 8.3.5.2 Manufacturing process design output ‘The organization shall document the manufacturing process design output in a manner that enables verification against the manufacturing process design inputs. The organization shall verify the outputs against manufacturing process design input requirements. The manufacturing process design output shall include but is not limited to the following: a) specifications and drawings; b) special characteristics for product and manufacturing process, c) _ identification of process input variables that impact characteristics; d) tooling and equipment for production and control, including capability studies of equipment and process(es) e) manufacturing process flow charts/layout, including linkage of product, process, and tooling: f) capacity analysis; @) manufacturing process FMEA; fh) maintenance plans and instructions; i) control plan (see Annex A): j) _ standardised work and work instructions; k) process approval acceptance criteria; |) data for quality, reliability, maintainability, and measurabilty m) results of error-proofing identification and verification, as appropriate nl) methods of rapid detection, feedback, and correction of productmanuracturing process nonconformities. 8.3.6 Design and development changes See ISO 9001:2015 requirements. 8.3.6.1 Design and development changes — supplemental ‘The organization shall evaluate all design changes after initial product approval, including those proposed by the organization or its suppliers, for potential impact on ft, form, function, performance, ‘and/or durability. These changes shall be validated against customer requirements and approved internally, prior to production implementation 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. 8.4 Control of externally provided processes, products and services 8.4.1 General See ISO 9001:2015 requirements. 8.4.1.1 General — supplemental ‘The organization shall include all products and services that affect customer requirements such as 32 AIAG. @ ANFIA, © FIEV, © SMMT, © VDA 2016 ~All rights reservedsub-assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services. 8.4.1.2 Supplier selection process ‘The organization shall have a documented supplier selection process. The selection process shall include: a) _ an assessment of the selected supplier's risk to product conformity and uninterrupted supply of the organization's product to their customers; b) relevant quality and delivery performance: c) an evaluation of the supplier's quality management system; d) _muttidisciplinary decision making: and e) _ an assessment of software development capabilities, if applicable. Other supplier selection criteria that should be considered include the following: volume of automotive business (absolute and as a percentage of total business); ~ financial stability; - purchased product, material, or service complexity; - required technology (product or process); - adequacy of available resources (e.g., people, infrastructure); - design and development capabilities (including project management); - manufacturing capability; - change management process; - business continuity planning (e.., disaster preparedness, contingency planning) - logistics process; = customer service, 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. All requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) are applicable to the organization's control of customer-directed sources unless specific agreements are otherwise defined by the contract between the organization and the customer. 8.4.2 Type and extent of control See ISO 9001:2015 requirements. 8.4.2.1 Type and extent of control — supplemental The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verily conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements. The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks AIAG, @ ANFIA, © FIEV, © SMMT, © VDA 2016 — Al ights reserved 38.4.2.2 Statutory and regulatory requirements The organization shall document their process to ensure that purchased products, processes, and services conform to the current applicable statutory and regulatory requirements in the country of receipt, the country of shipment, and the customer-identified country of destination, if provided. Ifthe 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 shall require their suppliers of automotive products and services to develop, implement, and improve a quality management system certified to ISO 9001, unless otherwise authorized by the customer [e.g., iter a) below}, with the ultimate objective of becoming certified to this Automotive QMS Standard. Unless othenwise specified by the customer, the following sequence ‘should be applied to achieve this requirement: a) compliance to ISO 9001 through second: party audits; b) certification to ISO 9001 through third-party audits; unless otherwise specified by the customer, suppliers to the organization shall demonstrate conformity to ISO 9001 by maintaining a third- party certification issued by a certification body bearing the accreditation mark of a recognized JAF MLA (International Accreditation Forum Multilateral Recognition Arrangement) member and where the accreditation body's main scope includes management system certification to ISOMEC 17021: ©) certification to ISO 9001 with compliance to other customer-defined QMS requirements (such ‘as Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers. [MAQMSR] or equivalent) through second-party audits; d) certification to ISO 9001 with compliance to IATF 16949 through second-party audits; ) _ certification to IATF 16949 through third-party audits (valid third-party certification of the supplier to IATF 16949 by 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. A software development assessment methodology shall be utilized to assess the supplier's software development process. Using prioritization based on risk and potential impact to the customer, the organization shall require the supplier to retain documented information of a software development capability self-assessment. 8.4.2.4 Supplier monitoring The organization shall have a documented process and criteria to evaluate supplier performance in order to ensure conformity of externally provided products, processes, and services to internal and external customer requirements. Ata minimum, the following supplier performance indicators shall be monitored: a) delivered product conformity to requirements; b) customer disruptions at the receiving plant, including yard holds and stop ships; ey AIAG, © ANFIA, © FIEV, © SMMT, © VDA ~ 2016 ~All rights reserved©) delivery schedule performance: d) number of occurrences of premium freight. If provided by the customer, the organization shall also include the following, as appropriate, in their supplier performance monitoring €) special status customer notifications related to quality or delivery issues; ) dealer returns, warranty, field actions, and recalls. 4.2.4.1 Second-party audits The organization shall include @ second-party audit process in their supplier management approach ‘Second-party audits may be used for the following: a) supplier risk assessment; ») supplier monitoring; ©) supplier QMS development; d) product audits; e) process audits. Based on a risk analysis, including product safetyiregulatory requirements, performance of the supplier, and QMS certification level, at a minimum, the organization shall document the criteria for determining the need, 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. NOTE Guidance may be found in the IATF Auditor Guide and ISO 19011 8.4.2.5 Supplier development The organization shall determine the priority, type, extent, and timing of required supplier development actions for its active suppliers. Determination inputs shall include but are not limited to the following a) performance issues identified through supplier monitoring (see Section 8.4.2.4); b) _second-party audit findings (see Section 8.4.2.4.1), ©) _ third-party quality management system certification status; @) risk analysis. The organization shall implement actions necessary to resolve open (unsatisfactory) performance issues and pursue opportunities for continual improvement. 8.4.3 Information for external providers ‘See ISO 9001:2015 requirements. 8.4.3.1 Information for external providers — supplemental ‘The organization shall pass down all applicable statutory and regulatory requirements and special product and process characteristics to their suppliers and require the suppliers to cascade all applicable requirements down the supply chain to the point of manufacture. AIAG, @ ANFIA, © FIEV, © SMMT, © VDA 2016 - All rights reserved 358.5 Production and service provision 8.5.1 Control of production and service provision See ISO 9001:2015 requirements. NOTE Suitable infrastructure includes appropriate manufacturing equipment required to ensure product compliance. Monitoring and measuring resources include appropriate monitoring and measuring equipment required to ensure effective control of manufacturing processes. 8.5.1.1 Control plan ‘The organization shall develop control plans (in accordance with Annex A) at the system, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a common manufacturing process. ‘The organization shail have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk analysis outputs (such as FMEA), ‘The organization shall if required by the customer, provide measurement and conformity data collected during execution of either the pre-launch or production control plans. The organization shall include in the control plan: a) controls used for the manufacturing process control, including verification of job set-ups: b) _ first-offiast-off part validation, as applicable; ¢) methods for monitoring of control exercised over special characteristics (see Annex A) defined by both the customer and the organization; ) the customer-required information, if any; ) specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statistically unstable or not statistically capable, The organization shall review control plans, and update as required, for any of the following: )_ the organization determines it has shipped nonconforming product to the customer; 9) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) (see Annex A), h) after a customer complaint and implementation of the associated corrective action, when applicable; i) ataset frequency based on a risk analysis. If required by the customer, the organization shall obtain customer approval after review or revision of the control plan. 8.5.1.2 Standardised work — operator instructions and visual standards The organization shall ensure that standardised work documents are: a) communicated to and understood by the employees who are responsible for performing the work: b) legible; ¢) presented in the language(s) understood by the personnel responsible to follow them; 4) accessible for use al the designated work area(s). 6 AIAG, @ANFIA, © FIEV, © SMMT, © VDA 2016 ~All rghts reserved‘The standardised work documents shall also include rules for operator safety. 8.5. .3 Verification of job set-ups ‘The organization shall a) _ verify job set-ups when performed, such as an initial run of a job, material changeover, or job change that requires a new set-up; b)_ maintain documented information for set-up personnel, ©) _ use statistical methods of verification, where applicable; 4) _ perform first-offfast-off part validation, as applicable; where appropriate, first-off parts should be retained for comparison with the last-off parts; where appropriate, last-off-parts should be retained for comparison with first-off parts in subsequent runs; e) retain records of process and product approval following set-up and first-offlast-off part validations. 8.5.1.4 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. 8.5.1.5 Total productive maintenance The organization shall develop, implement, and maintain a documented total productive maintenance system Ata minimum, the system shall include the following: @) _ identification of process equipment necessary to produce conforming product at the required volume; b) availability of replacement parts for the equipment identified in item a) ©) provision of resource for machine, equipment, and facility maintenance; d) packaging and preservation of equipment, tooling, and gauging; ©) applicable customer-specific requirements; f) documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure), and MTTR (Mean Time To Repair), and Preventive Maintenance compliance metrics. Performance to the maintenance objectives shall form an input into management review (see ISO 9001, Section 9.3); 9) regular review of maintenance pian and objectives and a documented action plan to address corrective actions where objectives are not achieved: h) _ use of preventive maintenance methods; ji) _ use of predictive maintenance methods, as applicable; i) periodic overhaul. 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. @AIAG, @ ANFIA, © FIEV, © SMMT, © VDA 2016 ~ All:ights reserved 7‘The organization shall establish and implement a system for production tooling management, whether owned by the organization or the customer, including: a) maintenance and repair facilities and personnel, b) storage and recovery: ) setup; 4) tool-change programmes for perishable tools: ) _ tool design modification documentation, including engineering change level of the product; ) tool modification and revision to documentation; @) tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location The organization shall verify that customer-owned tools, manufacturing equipment, and testfinspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined. ‘The organization shall implement a system to monitor these activities if any work is outsourced. 8.5.1.7 Production scheduling ‘The organization shall ensure that production is scheduled in order to meet customer orders/ demands such as Just-In-Time (JIT) and is supported by an information system that permits access to production information at key stages of the process and is order driven, ‘The organization shall include relevant planning information during production scheduling, €.g., customer orders, supplier on-time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration. 8.5.2 Identification and traceability ‘See ISO 9001:2015 requirements. NOTE Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious, such as material in an automated production transfer process. Alternatives are permitted if the status is clearly identified, documented, and achieves the designated purpose. 8.5.2.1 Identification and traceability — supplemental The purpose of traceability is to support identification of clear start and stop points for product received by the customer or in the field that may contain quality and/or safety-related nonconformites. Therefore, the organization shall implement identification and traceability processes as described below. The organization shall conduct an analysis of intemal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers, and consumers. These plans shall define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location that: a) enable the organization to identity nonconforming and/or suspect product; b) enable the organization to segregate nonconforming and/or suspect product; ©) ensure the ability to meet the customer and/or regulatory response time requirements; 3 © AIAG, © ANFIA, © FIEV, © SMMT, © VDA ~ 2016 ~All rights reservedd) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the organization to meet the response time requirements; €) ensure serialized identification of individual products, if specified by the customer or regulatory standards, ) ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics. 8.5.3 Property belonging to customers or external providers See ISO 9001:2015 requirements. 8.5.4 Preservation See ISO 9001:2015 requirements. 8.5.4.1 Preservation — supplemental Preservation shall inciude identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. Preservation shall apply to materials and components from extemal and/or internal providers from receipt through processing, including shipment and until delivery tofacceptance by the customer. \n 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 tums over time and ensure stock rotation, such as “first-in-first-out" (FIFO). ‘The Uryanization shall ensure that obsolete product is controlled in a manner similar to that of nonconforming product Organizations shall comply with preservation, pack provided by their customers. 19, shipping, and labeling requirements as 8.5.5 Post-delivery activities See ISO 9001:2015 requirements. 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 concems” 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 focation or in the field. NOTE 2 “Service concerns” should include the results of field failure test analysis (see Section 10.2.6) where applicable. 8.5.5.2 Service agreement with customer When there is a service agreement with the customer, the organization shall a) verify that the relevant service centres comply with applicable requirements; AIAG, © ANFIA, © FIEV, © SMMT, © VOA~ 2016 ~All rights reserved 39b) _ verify the effectiveness of any special purpose tools or measurement equipment, ¢) ensure that all service personnel are trained in applicable requirements 8.5.6 Control of changes See ISO 9001:2015 requirements. 8.5.6.1 Control of changes — supplemental The organization shall have a documented process to control and react to changes that impact product realization. The effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be assessed. The organization shalt ) define verification and validation activities to ensure compliance with customer requirements; b) validate changes before implementation ©) document the evidence of related risk analysis; d) retain records of verification and validation. Changes. including those made at suppliers, should require a production trial run for verification of changes (such as changes to part design, manufacturing location, or manufacturing process) to validate the impact of any changes on the manufacturing process. When required by the customer, the organization shal! ) _nofify the customer of any planned product realization changes after the most recent product approval ) obtain documented approval, prior to implementation of the change; 9) complete additional verification or identification requirements, such as production trial run and new product validation 8.5.6.1.1 Temporary change of process controls The organization shall identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices, that includes the primary process control and the approved back-up or alternate methods. The organization shall document the process that manages the use of alternate control methods. The ‘organization shall include in this process, based on risk analysis (such as FMEA), severity, and the intemal approvals to be obtained prior to production implementation of the altemate contro! method. Before shipping product that was inspected or tested using the alternate method, if required, the ‘organization shall obtain approval from the customer(s). The organization shall maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan. Standardised work instructions shalll be available for each alternate process control method. The organization shall review the operation of alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the goal to return to the standard process as defined by the control plan as soon as possible. Example methods include but are not limited to the following a) daily quality focused audits (e.9., layered process audits, as applicable); b) daily leadership meetings. « @AIAG, © ANFIA, © FIEV, © SMMT, © VDA~2016 — Al rights reserved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 shall implement traceability of all product produced while any altemate process control devices or processes are being used (e.g., verification and retention of first piece and last piece from every shift) &6 Release of products and services See ISO 9001:2015 requirements, 8.6.1 Release of products and services — supplemental ‘The organization shall ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan (see 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 intial release, according to ISO 9001, Section 8.5.6 8.6.2 Layout inspection and functional testing Alayout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review. NOTE 1 Layout inspection is the complete measurement of all product dimensions shown on the design records). NOTE 2 The frequency of layout inspection is determined by the customer. 8.6.3 Appearance items For organizations manufacturing parts designated by the customer as "appearance items,” the organization shall provide the following a) appropriate resources, including lighting, for evaluation: b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), and haptic technology, as appropriate; ©) maintenance and control of appearance masters and evaluation equipment; 4) _ Verification that personnel making appearance evaluations are competent and qualified to do so. 8.6.4 Verification and acceptance of conformity of externally provided products and services ‘The organization shall have a process to ensure the quality of externally provided processes, products, and services utilizing one or more of the following methods: a) receipt and evaluation of statistical data provided by the supplier to the organization; b) receiving inspection and/or testing, such as sampling based on performance; ‘c) _second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable delivered product conformance to requirements; d) part evaluation by a designated laboratory; ) another method agreed with the customer. AIAG, @ANFIA, © FIEV, © SMMT, @ VDA 2016 ~All rights reserved “18.6.5 Statutory and regulatory conformity Prior to release of extemally provided products into its production flow, the organization shall confirm and be able to provide evidence that externally provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requirements in the countries where they are manufactured and in the customer-identified countries of destination, if provided 8.6.6 Acceptance criteria ‘Acceptance criteria shall be defined by the organization and, where appropriate or required, approved by the customer. For attribute data sampling, the acceptance level shall be zero defects (see Section 9.1.1.1). 8.7 Control of nonconforming outputs a7 ‘See ISO 9001:2015 requirements. 8.7.1.1 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. ‘The organization shall obtain customer authorization prior to further processing for “use as is” and rework dispositions of nonconforming product. If sub-components are reused in the manufacturing process, that sub-component reuse shall be clearly communicated to the customer in the concession or deviation permit. The organization shall maintain a record of the expiration date or quantity authorized under concession. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires, Material shipped under concession shall be properly identified on each shipping container (this applies equally to purchased product) ‘The organization shall approve any requests from suppliers before submission to the customer. 8.7.1.2 Control of nonconforming product — customer-specified process The organization shall comply with applicable customer-specified controls for nonconforming product(s). 8.7.1.3 Control of suspect product ‘The organization shall ensure that product with unidentified or suspect status is classified and controlled as nonconforming product. The organization shall ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconforming product 8.7.1.4 Control of reworked product ‘The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a decision to rework the product. If required by the customer, the organization shall obtain approval from the customer prior to commencing rework of 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, a AIAG, © ANFIA. © FIEV, © SMMT, © VDA~ 2016 ~All rights reserved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 8.7.1.5 Control of repaired product ‘The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a decision to repair the product. The organization shall obtain approval from the customer before commencing repair of 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, 8.7.1.6 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. 87.1.7 Nonconforming product disposition ‘The organization shall have a documented process for disposition of nonconforming product not subject to rework or repair. For product not meeting requirements, the organization shall verify that the product to be scrapped is rendered unusable prior to disposal. The organization shall not divert nonconforming product to service or other use without prior customer approval 872 ‘See ISO 9001:2015 requirements. OAIAG, @ANFIA, © FIEV, © SMMT, © VDA - 2016 - Allrights reserved “a‘9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General See ISO 9001:2015 requirements. 9.1.1.1 Monitoring and measurement of manufacturing processes ‘The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control, including those for special characteristics. NOTE For some manufacturing processes, it may not be possible to demonstrate product compliance through process capability. For those processes, alternate methods such as batch conformance to specification may be used. The organization shall maintain manufacturing process capability or performance results as specified by the customer's part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented, including adherence to the following, a) _ measurement techniques: b) sampling plans; ©) acceptance criteria; d) records of actual measurement values and/or test results for variable data; ) _ reaction plans and escalation process 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 shall initiate a reaction plan indicated on the control plan and evaluated for impact on compliance to specifications for characteristics that are either not statistically capable or are unstable. ‘These reaction plans shall include containment of product and 100 percent inspection, as appropriate. ‘A corrective action plan shall be developed and implemented by the organization indicating specific ‘actions, timing, and assigned responsibilities to ensure that the process becomes stable and statistically capable. The plans shall be reviewed with and approved by the customer, when required The organization shall maintain records of effective dates of process changes. 9.1.1.2 Identification of statistical tools The organization shall determine the appropriate use of statistical tools. The organization shall verify that appropriate statistical tools are included as part of the advanced product quality planning (or equivalent) process and included in the design risk analysis (such as DFMEA) (where applicable), the process risk analysis (such as PFMEA), and the control plan, 9.1.1.3 Application of statistical concepts Statistical concepts, such as variation, control (stability), process capability, and the consequences of over-adjustment, shall be understood and used by employees involved in the collection, analysis, and management of statistical data “ AIAG, OANFIA, © FIEV, © SMMT, © VDA. 2016 — All rights reserved