ISO 9001:2008

ISO/TS 16949:2009

Added Requirement

Introduction 0.1 General 0.2 Process approach 0.3 Relationship with ISO 9004

Introduction 0.1 General 0.2 Process approach 0.3 Relationship with ISO 9004 0.4 Compatibility with other management systems

0.5 Goal of this Technical Specification

1. Scope

1 Scope1

1.1 General

1.1 General1

The goal of this Technical Specification is a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. This Technical Specification, in conjunction with ISO9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification. This Technical Specification can be

1.2 Application

1.2 Application

2 Normative references ISO 9000:2005 3 Terms and definitions

2 Normative references ISO 9000:2005 3 Terms and definitions 3.1 Terms and definitions for the automotive industry 3.1.1 Control Plan

Header Header

3.1.2 Design Responsible Organization 3.1.3 Error Proofing

A documented description of the systems and processes required for controlling the product see Appendix A of the standard. The organization responsible for establishing new or changing existing product specifications Product and manufacturing process design and development to prevent manufacturing of nonconforming product. Facility for inspection, test or calibration that may include but is not limited to chemical, metalilurgical, dimensional, physical, electrical or reliability testing. A control document is required that contains - Specific tests, evaluations, calibrations that a Lab is qualifified to perform - A list of the equipment, which it uses to perform the above, and - a list of methods and standards to which it performs the above. The process of making or fabricating - Production material - Production or service parts - Assemblies, or - Heat treating, welding, painting, plating, or other finishing services Activities based on process data aimed at the avoidance of maintanance problems by prediction of likely failure modes. Planned action to eliminate causes of equipment failure and unscheduled interruptions in production. Extra costs incurred in additional to contracted delivery.

3.1.4 Laboratory

3.1.5 Laboratory Scope

3.1.6 Manufacturing

3.1.7 Predictive Maintenance 3.1.8 Preventive Maintenance 3.1.9 Premium Freight

3.1.10 Remote Location 3.1.11 Site

Location that supports sites and at which non-production processes occur. Location at which value-added processes occur.

4 Quality management system 4.1 General requirements

3.1.12 Special Characteristic Product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance, or subsequent processing. 4 Quality management Header system 4.1 General requirements 4.1.1 General requirements Ensuring control over outsourced Supplemental processes shall not absolve the organization of responsibility for conformity for all customer requirements. 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual Header

4.2 Documentation requirements 4.2.1 General 4.2.2 Quality Manual

4.2.3 Control of Documents 4.2.3 Control of documents

4.2.3.1 Engineering specifications

Required to review, distribute, and implement customer engineering specs and changes w/in 2 weeks, and maintain documents and records of same, with customer approvals.

4.2.4 Control of Records

4.2.4 Control of records

4.2.4.1 Records retention

The control of records shall satisfy, statutory, regulatory, and customer retention requirements.

5 Management responsibility 5 Management responsibility Header 5.1 Management commitment 5.1 Management commitment 5.1.1 Process efficiency

Top management required to review product realization and support processes and assure their efficiency.

5.2 Customer focus 5.3 Quality policy

5.2 Customer focus 5.3 Quality policy

5.4 Planning 5.4.1 Quality Objectives

5.4 Planning Header 5.4.1 Quality objectives 5.4.1.1 Quality objectives Top management required to define Supplemental quality objectives and measurements to be included in business plan and used to deploy quality policy.

5.4.2 Quality Management System Planning

5.4.2 Quality management system planning

5.5 Responsibility, authority 5.5 Responsibility, authority and communication and communication 5.5.1 Responsibility and Authority 5.5.1 Responsibility and authority 5.5.1.1 Responsibility for quality

5.5.2 Management Representative

5.5.2 Management representative

Managers promptly notified of nonconformance; personnel responsible for conformity to have authority to stop production; all shifts staffed with personnel responsible for conformity.

5.5.2.1 Customer representative

T op management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.

5.5.3 Internal Communication 5.6 Management Review

5.5.3 Internal communication 5.6 Management review

Header

5.6.1 General

5.6.1 General 5.6.1.1 Quality management These reviews shall include all system performance requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1). These results shall be recorded to provide, as a minimum, evidence of the achievement of -the quality objectives specified in business plan, and -customer satisfaction with product supplied. Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment. Header

5.6.2 Review Input

5.6.2 Review input 5.6.2.1 Review input Supplemental

5.6.3 Review Output 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, Training and Awareness

5.6.3 Review output 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, training and awareness

Header

6.2.2.1 Product design skills The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques. 6.2.2.2 Training The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting conformity to product requirements. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements. NOTE 1 This applies to all employees having an effect on quality at all levels of the organization. NOTE 2 An example of the customerspecific requirements is the application of digitized mathematically based data. The organization shall provide on-thejob training for personnel in any new or modified job affecting conformity to product requirements, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.

6.2.2.3 Training on the job

6.2.2.4 Employee motivation and empowerment

6.3 Infrastructure

6.3 Infrastructure

The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d)].

6.3.1 Plant, facility and equipment planning

6.3.2 Contingency plans

The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations. NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system. The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.

6.4 Work environment

6.4 Work environment 6.4.1 Personnel safety to achieve conformity to product requirements

Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities. The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs. Header

6.4.2 Cleanliness of premises

7 Product realization 7.1 Planning of product realization

7 Product realization 7.1 Planning of product realization 7.1.1 Planning of product realization Supplemental

Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan. Acceptance criteria shall be defined by the organization and, where required, approved by the customer. For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1).

7.1.2 Acceptance criteria

7.1.3 Confidentiality

7.1.4 Change control

7.2 Customer-related processes 7.2.1 Determination of requirements related to the product

7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.1.1 Customerdesignated special characteristics

The organization shall ensure the confidentiality of customer-contracted products and projects under development, and related product information. The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed and verificaiton and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation. For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated. When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met. NOTE 1: Any product realization change affecting customer requirements requires notification to, and agreement from, the customer. NOTE 2: The above requirement applies to product and manufacturing Header

The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

7.2.2 Review of requirements related to the product

7.2.2 Review of requirements related to the product 7.2.2.1 Review of requirements related to the product Supplemental

Waiving formal reviews shall require customer authorization.

7.2.2.2 Organization manufacturing feasibility

The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.

7.2.3 Customer Communication

7.2.3 Customer communication 7.2.3.1 Customer communication Supplemental

7.3 Design and development 7.3 Design and development 7.3.1 Design and Development Planning 7.3.1 Design and development planning 7.3.1.1 Multidisciplinary approach

The organization shall have the ability to communicate necessary information, including data, in a customer- specified language and format (e.g. computer-aided design data, electronic data exchange).

The organization shall use a multidisciplinary approach to prepare for product realization, including development/finalization and monitoring of special characteristics -development and review of FMEAs, including actions to reduce potential risks, and -development and review of control plans.

7.3.2 Design and Development Inputs

7.3.2 Design and development inputs 7.3.2.1 Product design input The organization shall identify, document, and review product design input requirements, including the following: -customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability, and packaging; -use of information: the organization shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature; -targets for conformity to product requirements, life, reliability,

7.3.2.2 Manufacturing process design input

The organization shall identify, document, and review manufacturing process design input requirements, including: -product design output data, -targets for productivity, process capability, and cost, -customer requirements,if any, and -experience from previous developments. NOTE The manufacturing process design includes the use of errorproofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered. The organization shall identify special characteristics, such as product characteristics and process parameters, and: include them in the control plan, comply with customerspecified definitions and symbols, & identify process control documents with the customer's special symbol to include the steps affecting special characteristics. NOTE Special characteristics can include product characteristics and process parameters.

7.3.2.3 Special characteristics

7.3.3 Design and Development Outputs

7.3.3 Design and development outputs 7.3.3.1 Product design outputs Supplemental

Product design outputs shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include: -design FMEA, reliability results; -product special characteristics and specifications; -product error-proofing as appropriate; -product definition, incuding drawings or mathematically based data; -product design review results; and -diagnostic guidelines where applicable.

7.3.3.2 Manufacturing process design output

7.3.4 Design and Development Review

7.3.4 Design and development review 7.3.4.1 Monitoring

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include: -specifications and drawings -manufacturing process flow chart/layout, -manufacturing process FMEAs, -control plan (see 7.5.1.1), -work instructions, -process approval acceptance criteria, -data for quality, reliability, maintainability, and measurability, -results of error-proofing activities, as appropriate, and -methods of rapid detection and feedback of product/manufacturing process nonconformities. Management review input shall include measurements at specified stages of design and development, including quality risks, costs, lead times, critical paths, and others.

7.3.5 Design and Development Verification 7.3.6 Design and Development Validation

7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.6.1 Design and development validation Supplemental

Design and development validation shall be performed in accordance with customer requirements, including program timing. When required, the organization shall have a prototype program and control plan. The organization shall use, wherever possible, the same suppliers, tooling, and manufacturing processes as used in production. All performance testing activities shall be monitored for timely completion and conformity to requirements. While services may be outsourced, the organization shall be reponsible for the outsourced services, including technical leadership.

7.3.6.2 Prototype program

7.3.6.3 Product approval process

The organization shall conform to a product and manufacturing process approval procedure recognized by the customer. NOTE Product approval should be subsequent to the verification of the manufacturing process. The product and manufacturing rocess approval procedure shall also be applied to suppliers. Design and development changes include all changes during the product program life. (see 7.1.4) Header

7.3.7 Control of Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process

7.3.7 Control of design and development changes 7.4 Purchasing 7.4.1 Purchasing process 7.4.1.1 Statutory and regulatory conformity

7.4.1.2 Supplier quality management system development

All purchased products or materials used in product shall conform to applicable statutory and regulatory requirements. The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2008 is the first step in achieving this goal. NOTE The priortization of suppliers for development depends on, for example the supplier's quality performance and the importance of the product supplied.

Unless otherwise specified by the customer, suppliers to the organization shall be third party, registered to ISO 9001:2008 by an accredited third7.4.1.3 Customer-approved When specified by the contract (e.g. sources customer engineering drawing, specification), the organization shall purchase products, materials, or services from approved sources. The use of customer-designated sources, including tool/gauge suppliers, does not relieve The organization of responsibility for quality of the purchased products.

7.4.2 Purchasing Information

7.4.2 Purchasing information

7.4.3 Verification of Purchased Product

7.4.3 Verification of purchased product 7.4.3.1 Incoming product conformity to requirements

7.4.3.2 Supplier monitoring

The organization shall have a process to assure the quality of purchased product (see 7.4.3), utilizing one or more of the following methods: -receipt of, and evaluation of, statistical data by the organization, -receiving inspection and/or testing, such as sampling based on performance; -second or third party assessements or audits of supplier sites, when coupled with records of acceptable delivered product conformity to requirements; -part evaluation by a designated laboratory; -another method agreed with the customer. Suppliers shall be monitored through the following indicators: -product conformity; -customer disruptions, including field returns; -delivery schedule performanc (including incidents of premium freight); -special status customer notifications related to quality or delivery issues. The organization shall promote supplier monitoring of the performance of their manufacturing processses. Header

7.5 Production and service provision 7.5.1 Control of Production and Service Provision

7.5 Production and service provision 7.5.1 Control of production and service provision

7.5.1.1 Control plan

The organization shall: -develop control plans (see Annex A) at the system, subsystem, component, and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and -have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs. The control plan shall: -list the controls used for the manufacturing process control, -include the methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organization, -include the customer-required information, if any, and -initiate the specified reaction plan (8.2.3.1) when the process becomes unstable or not statistically capable. Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact conformity to product requirements. These instructions shall be accessible for use at the work station. These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process. Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or job change. W ork instructions shall be available for set-up personnel. The organization shall use statistical methods of verification, where applicable. NOTE Last-off-part comparisons are recommended.

7.5.1.2 Work instructions

7.5.1.3 Verification of job set-ups

7.5.1.4 Preventive and predictive maintenance

The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the following: -planned maintenance activities; -packaging and preservation of equipment, tooling and gauging; -availability of replacement parts for key manufacturing equipment; -documenting, evaluating and improving maintenance objectives. The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of the production equipment.

7.5.1.5 Management of production tooling

The organization shall provide resources for tool and gauge design, fabrication and verification activities. The organization shall establish and implement a system for production tooling management including: -maintenance and repair facilities and personnel; -storage and recovery; -set-up; -tool-change programmes for perishable tools; -tool design modification documentation, including engineering change level; -tool modification and revision to documentation; -tool identification, defining the status, such as production, repair or disposal. The organization shall implement a system to monitor these activities if any work is outsourced. NOTE This requirement also applies to the availability of tools for vehicle service parts.

7.5.1.6 Production scheduling

7.5.1.7 Feedback of information from service

Production shall be scheduled in order to meet customer requirements, such as just-in-time supported by an information system that permits access to production information at key stages of the process and is order driven. A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained. NOTE The intent of the addition of service concerns to this subclause is to ensure that the organization is aware of nonconformities that occur outside of its organization.

7.5.1.8 Service agreement with customer

When there is a service agreement with the customer, the organization shall verify the effectiveness of -any organization service centres, -any special-purpose tools or measurement equipment, and -the training of service personnel.

7.5.2 Validation of Processes 7.5.2 Validation of for Production and Service processes for production Provision and service provision 7.5.2.1 Validation of processes for production and service provision Supplemental 7.5.3 Identification and 7.5.3 Identification and Traceability traceability

The requirements of 7.5.2 shall apply to all processes for production and service provision.

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. 7.5.3.1 Identification and The words Where appropriate in traceability Supplemental 7.5.3 shall not apply. 7.5.4 Customer property

7.5.4 Customer Property

7.5.4.1 Customer-owned production tooling

Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined.

7.5.5 Preservation of Product

7.5.5 Preservation of product 7.5.5.1 Storage and inventory

In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals. The organization shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as first-in-firstout (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product. NOTE A number or other identifier traceable to the device calibration record meets the intent of requirement c) above. Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may

7.6 Control of monitoring and measuring Equipment

7.6 Control of monitoring and measuring equipment 7.6.1 Measurement system analysis

7.6.2 Calibration/verification Records of the calibration/verification records activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include -equipment identification, including the measurement standard against which the equipment is calibrated. -revisions following engineering changes. -any out-of-specification readins as received for calibration/verification -an assessment of th eimpact of out-ofspecification condition. -statements of conformity to specification after calibration/verification, and -notification to the customer if suspect product or material has been shipped.

7.6.3 Laboratory requirements 7.6.3.1 Internal laboratory

Header An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for -adequancy of the laboratory procedures. -competency of the laboratory personnel, testing of the product. -capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.) and -review of the related records. NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory copnformity to this requirement, but is

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either -there shall be evidence tha thte extenal laboratory is acceptable to the customer, or -the laboratory shall be accredited to ISO/IEC 17025 or national equivalent. NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second- party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. NOTE2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met. Header

8 Measurement, analysis and improvement 8.1 General

8 Measurement, analysis and improvement 8.1 General 8.1.1 Identification of statistical tools

Appropriate statistical tools shall be determined during advanced quality planning and included in the control plan.

8.1.2 Knowledge of basic statistical concepts 8.2 Monitoring and 8.2 Monitoring and measurement measurement 8.2.1 Customer Satisfaction 8.2.1 Customer satisfaction

Basic statistical concepts shall be understood and utilized throughout the organization.

NOTE Consideration should be given to both internal and external customers.

8.2.1.1 Customer Customer satisfaction with the satisfaction Supplemental organization shall be monitored through continual evaluation of performance of the realization processes. Performance indicators shall be based on objective data and include, but not be limited to: -delivered part quality performance, -customer disruptions, -delivery schedule performance (including incidents of premium freight), and -customer notifications about quality or delivery issues. The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for

8.2.2 Internal Audit

8.2.2 Internal audit

8.2.2.1 Quality management The organization shall audit its quality system audit management system to verify compliance with this Technical Specification and any additional quality management system requirements. 8.2.2.2 Manufacturing process audit The organization shall audit each manufacturing process to determine its effectiveness.

8.2.2.3 Product audit

The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency.

8.2.2.4 Internal audit plans

Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan. When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased. NOTE Specific checklists should be used for each audit.

8.2.2.5 Internal auditor qualification

The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification( see 6.2.2.2).

8.2.3 Monitoring and Measurement of Processes

8.2.3 Monitoring and measurement of processes 8.2.3.1 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. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified -measurement techniques, -sampling plans -acceptance critieria -reaction plans when acceptance criteria are not met.

8.2.4 Monitoring and Measurement of Product

8.2.4 Monitoring and measurement of product

8.2.4.1 Layout inspection and functional testing

8.2.4.2 Appearance items

8.3 Control of nonconforming product

8.3 Control of nonconforming product 8.3.1 Control of nonconforming product Supplemental 8.3.2 Control of reworked product

NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determines the types of product characteristics, leading to -the types of measurements, -suitable measurement means, and -the capability and skills required. A layout 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 Layout inspection is the complete measurement of all product dimensions shown on the design records. For organizations manufacturing parts designated by the customer as appearance items, the organization shall provide -appropriate resources, including lighting, for evaluation -masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate, -maintenance and control of appearance masters and evaluation equipment, and -verification that personnel making appearance evaluations are competent and qualified to do so. Parts with unidentified or suspect status shall be classified as nonconforming (see 7.5.3) Instructions for rework, including reinspection requirements, shall be accessible to and utilized by the appropriate personnel.

8.3.3 Customer information Customers shall be informed promptly in the event that nonconforming product has been shipped.

8.3.4 Customer waiver

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 maintain a record of the expiration date or quantity authorized. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization 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. Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following: -development of priorities for prompt solutions, -determination of key customerrelated trends and correlation for decision-making and long term planning, -an information system for timely reporting of product information arising from usage. NOTE Data should be compared with those of competitors and/or appropriate benchmarks.

8.4 Analysis of data

8.4 Analysis of data 8.4.1 Analysis and use of data

8.5 Improvement 8.5.1 Continual Improvement

8.5 Improvement 8.5.1 Continual improvement 8.5.1.1 Continual improvement of the organization

Header

The organization shall define a process for continual improvement.

8.5.1.2 Manufacturing process improvement

Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters. NOTE 1 Controlled characteristics are documented in the control plan. NOTE2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.

8.5.2 Corrective Action

8.5.2 Corrective action 8.5.2.1 Problem solving

8.5.2.2 Error-proofing

8.5.2.3 Corrective action impact

The organization shall have a defined process for problem solving leading to root cause identification and elimination. The organization shall use errorproofing methods in their corrective action process. The organization shall apply to other similar processes and products the corrective action, and controls implemented, in order to eliminate the cause of a nonconformity. The organization shall analyse parts rejected by the customer's manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and initiate corrective action to prevent recurrence. NOTE Cycle time related to rejected product analysis should be consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation. Heading

8.5.2.4 Rejected product test/analysis

8.5.3 Preventive Action

8.5.3 Preventive action Annex A (normative) Control plan

A.1 Phases of the control plan

A.2 Elements of the control plan

The control plan shall cover three distinct phases, as appropriate. a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during building of the prototype. The organization shall have a prototype control plan, if required by the customer. b) Pre-launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production. Pre-launch is defined as a production phase in the process of product realization which may be required after prototype build. c) Production: documentation of product/process characteristics, process controls, tests and measurement systems that occur during mass production. Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts The organization shall develop a control plan that includes, as a minimum, the following contents. a)General data -control plan number -issue date and revision date, if any -customer information (see customer's requirements) -part numbers part name/description -engineering change level -phase covered (prototype, prelaunch, production) -key contact -part/process step number -process name/operation description b)Product control -product-related special characteristics, -other characteristics for control

A.2 Elements of the control plan (cont'd)

c)Process control -process parameters -process-related special characteristics -machines, jigs, fixtures, tools for manufacturing d)Methods -evaluation and measurmenet technique -error-proofing -sample size and frequency -control method e)Reaction plan and corrective actions -reaction plan (include or reference) -corrective action

Compliance with TS16949

Rating 1= no compliance 2= partial 3= full 4= via subcon NA=not applicable N/A N/A N/A N/A N/A

Rationale/Evidence

Assesso r

ESD = Chip design OK, Board design to be verified. Refer to clause 7.

Some manufacturing sites are TS-certified; others need to be verified. This means that NV, even if it outsourcs the manufacture of parts, is subject to site audits.

N/A

N/A

N/A N/A N/A N/A

Definition only

Definition only

Definition only

Definition only

Definition only

Definition only

Definition only

Definition only

Definition only

Definition only Definition only Definition only

N/A 3 2 UL 9001 Certified Outsourcing controls exist; Evidence of NV acknowledgement of responsibility for adherence to customer requirements needs to be verified.

N/A 3 3 UL 9001 Certified UL 9001 Certified

UL 9001 Certified

Change review infrastructure exists; evidence needed to demonstrate compliance with customer time frames and record of approval. UL 9001 Certified

Not known that this is happening, but the infrastructure exists to meet this requirement, if identified during Contract Review.

N/A 3 2 UL 9001 Certified Reportedly product realization and distribution efficiencies are reviewed in MR; need to verify review of design for efficiency. UL 9001 Certified

3 N/A

N/A 3 2

UL 9001 Certified Top management concerned with quality; need to verify objectives, measurements, inclusion in business plan, and use in deploying quality policy. UL 9001 Certified

UL 9001 Certified

3 2

UL 9001 Certified "Hold" practices in place, a process is documented, but needs to be reviewed. SiOps managers receive a weekly digest of CARs created. UL 9001 Certified

Marketing, CPMs, and CQEs are assigned to address customer requirements, but documented understandings of roles and responsibilities are not clear across functions.

3 N/A

UL 9001 Certified

3 2

UL 9001 Certified Some quality objectives and customer satisfaction data reviewed; cost of good/poor quality requires review.

3 2

UL 9001 Certified Not enough information to form definite opinion; needs to be reviewed. UL 9001 Certified UL 9001 Certified

3 N/A 3 N/A 3 3

UL 9001 Certified UL 9001 Certified

Evidenced by successful, timely product introductions.

Training procedure exists; verify if it addresses automotive requirements.

Further definition of OJT per TS required. Evidence of OJT apparently available at least for some functions. Need to validate that consequences of nonconformity are being communicated.

Recognition for technical accomplishments; on-site technical symposia; presently no measurement of awareness level. (Employee survey)

UL 9001 Certified

2/3

Support functions include design for manufacturing and quality principles. (Larry Sladewski and Bob Jafari)

Supply chain resiliency plans are being developed with each supplier.

3 2

UL 9001 Certified ISO 14K certified, plus EHS and safety programs; need to verify safety status at CMs.

Needs work in some areas.

N/A 3 2

UL 9001 Certified Current MRD process needs to be verified. POR = technical spec; controls need to be verified. Verify Contract Review includes customer acceptance criteria.

Emptoris database and controls need to be verified.

CRB, PCN, ECO processes seem to be under control; customer communication process is questionable.

N/A N/A 3

UL 9001 Certified

Need to research how to address special characteristics.

UL 9001 Certified

NV has a product waiver process, but it does not apply to documentation.

1/2

Reportedly Contract Review partially addresses feasibility; requires confirmation. Status of risk analysis unknown. UL 9001 Certified Appears technically feasible.

3 2/3

3 3 1/2

UL 9001 Certified UL 9001 Certified Multidisciplinary approach frequently utilized; application to special characteristics, FMEAs, and control plans unknown. (Forward-looking lessons learned)

3 2

UL 9001 Certified Part of regular practices, but capture of lessons learned may be informal; needs to become formalized as deliverables within the PD/NPI processes.

Part of regular practices, but capture of lessons learned may be informal; needs to become formalized as deliverables within the manufacturing process design phase.

Infrastructure and procedures for marking and traceability exist; ability to extend to processes, and to specialize to ind

3 1

UL 9001 Certified Some currently in practice, some not; need to insert all deliverables in the formal NPI/PD process.

Some currently in practice, some not; need to insert all deliverables in the formal NPI/PD process.

3 1

UL 9001 Certified Some currently in practice, some not; need to insert all deliverables in the formal NPI/PD process. UL 9001 Certified UL 9001 Certified Validation processes currently exist and will most likely satisfy the standard. However field return data is not currently formalized. Evidenced through the ES, QS, and PS sample production that parallels developmental phases. Additional samples are produced outside of the ES, QS, and PS flow.

3 3 2

A product approval by customer exists, but not known if it meets TS. Status with suppliers unknown.

UL 9001 Certified, but gaps need to be reviewed.

N/A 3 3 UL 9001 Certified Already part of corporate product and environmental compliance program. Capability to determine ISO status of suppliers exists. Many already ISO-registered, except 2 substrate suppliers and SLT/warehouse at JSI. Developing TS-compliant supplier base can be done in time.

2/3

NV can agree to use customerspecified sources; acknowledgement of responsibility for quality when using customer-specified sources needs to be verified.

UL 9001 Certified

3 3

UL 9001 Certified Warehouse procedures address conformity of incoming product.

Suppliers are monitored; exact metrics used need to be verified.

3 3

UL 9001 Certified UL 9001 Certified

Systems for controlling prelaunch production exist. Review needed to determine if it accounts for FMEA outputs.

Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification.

Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification.

Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification.

Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification.

Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification. Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification.

Assumed to exist within production environments at SiOps suppliers that are TS certified, but needs to be verified. Where applicable at NV support sites, need verification. UL 9001 Certified

Validation processes exist; need to verify scope and reporting. UL 9001 Certified

Identification and traceability practices are already uniform. UL 9001 Certified

Need to verify that product validation boards are identified and controlled.

3 2

UL 9001 Certified Inventory management already covered by spec.

UL 9001 Certified

Formalizing NV's GR&R on all process and test metrology needs to be done.

Calibration by SE Labs is in place for all NV equipment. Need to verify that this process exists for all suppliers, and meets the TS requirements.

TBD 1 Engineering laboratories are considered out of scope. Controls are limited, not subject to audit. Gold standards and reference units are used in production environments; need to verify use of standards and compliance to ASTM in laboratories. Accreditation to ISO/IEC 17025 may serve as a guide for engineering labs.

External labs practices need to be verified to be in compliance with TS; e.g. REL test labs.

N/A 3 2 UL 9001 Certified Statistical tools used in quality planning e.g. JMP; control plans apply to actual production sites, but advance quality planning practices are questionable. Evidenced by use in analyses and presentations across spectrum of support site activities. UL 9001 Certified UL 9001 Certified

3 3

Continual evaluation of customer satisfaction evidenced by records of surveys and analyses.

UL 9001 Certified

Internal audit process established in accordance with ISO 9001.

Representatives gather and analyze data on effectiveness of CMs; need to verify coverage of actual manufacturing processes. Representatives conduct supplier audits; need to review audit of specific products at stages of production.

Internal audit plan covers appropriate scope with annual plan.

Trained and experienced ISO auditors available for any special training required for this TS. UL 9001 Certified

Representatives oversee CMs in fulfillment of this requirement; need to verify scope of their activities.

UL 9001 Certified

N/A

Not applicable to support site; need to check application to manufacturing site.

N/A

Not applicable to support site; need to check application to manufacturing site.

3 2

UL 9001 Certified Consistent with NV practice, although need to check for documentation of same. Extent of rework documentation needs to be reviewed.

Consistent with NV policy and practice.

Consistent with NV policy and practice.

3 3

UL 9001 Certified Weekly digest of quality and operational data available to support planning and decisionmaking.

N/A 3 2

UL 9001 Certified Company practices Plan-DoCheck-Act cycle of ISO.

Representatives oversee CMs to improve manufacturing processes.

3 3

UL 9001 Certified 8D process is institutionalized as part of the CAR system.

Practice philosophy of eliminating the root cause of errors. Need to globalize corrective actions is documented; review for examples.

Established RMA procedure and Failure Analysis capabilitiy, along with relevant records.

3 TBD

UL 9001 Certified

Implemented through the X, V, and P staged release program.

N/A

Applicable to production environment.