This form is a template for entities or individuals to use if they are being audited. It allows for optimal user customization by including standard clauses as well as giving the user the opportunity to add any additional clauses as they see fit. This form should be used by entities or individuals that are being audited to organize and expedite the process.
This form is a template for entities or individuals to use if they are being audited. It allows for optimal user customization by including standard clauses as well as giving the user the opportunity to add any additional clauses as they see fit. This form should be used by entities or individuals that are being audited to organize and expedite the process. North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY 1.1 Has the supplier's management with Documented policy statement with clearly executive responsibility defined and defined measurable quality objectives documented its quality policy objectives for approved by CEO quality, and its commitment to quality? (18.104.22.168) 1.2 Is the quality policy relevant to Defined objectives organizational goals expectations and needs of the customer? company goals stated in the business plan (22.214.171.124) and their alignment with the quality policy statement 1.3 Is the quality policy implemented, Direct interviews with randomly selected understood and maintained throughout the people of the organization and top organization? (126.96.36.199) management 1.4 Are the goals, objectives and measurements to deploy the quality policy defined? (188.8.131.52) 1.5 Are the objectives for achieving quality Quality objectives linked to the business objectives included in the business plan? plan. (184.108.40.206) Scope of the quality objectives 1.6 Does the supplier have an objective Description of an objective process process for determining customer Methodology used for surveys satisfaction, including frequency of Original customer data and scope such as determination and how objectivity and validity customer satisfaction feedback (surveys, are assured? (220.127.116.11) scorecards, awards etc.) 1.7 Are trends in customer satisfaction and dissatisfaction documented and supported by objective information? (18.104.22.168) 1.8 Does the quality policy intent include Quality policy document continuous improvement in quality, service, Records of improvement cost and technology? (22.214.171.124) 1.9 Has the supplier identified opportunities Examples and status of quality and and implemented appropriate projects for productivity improvements projects. quality and productivity improvement? Management review results (126.96.36.199) 1 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 1.10 Has the supplier used appropriate Training records for continuous continuous improvement measures and improvement methodologies methodologies? (188.8.131.52) Examples of use of DOE, SPC, value analysis, benchmarking, etc. FMEA RPN reduction Quality Indices, e.g. Cpk showing improvement over 1.33 overtime 1.11 Has the responsibility, authority, Responsibilities and authority as defined in interrelationship of personnel who manage, job descriptions, responsibilities matrices, perform, and verify work affecting quality been procedures, accountabilities documents defined and documented? (184.108.40.206) 1.12 Is authority delegated to personnel who Responsibilities and authority as defined have the organizational freedom to: in job descriptions, responsibilities a) Initiate action to prevent nonconformity matrices, procedures, accountabilities occurrence? documents b) Identify and record quality problems? Quality records c) Initiate, implement and verify corrective action? d) Control further processing? (220.127.116.11) 1.13 Has the supplier assigned the responsibility to Quality function representative in project represent the needs of the customer in teams internal functions? (18.104.22.168.1) Quality function participation in milestones decision points (Production release, Engineering release,...) Responsibilities and job description of the customer representative (ex. Quality function) 1.14 Is management with responsibility and Select examples of non-compliance from authority for corrective action promptly informed suitable sources such as internal or of products/processes that become non- external concerns/complaints, etc. compliant? (22.214.171.124.2) Communication channels and timeliness 2 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 1.15 Do the personnel responsible for quality Who is responsible for quality in the have the authority to stop production in order to production process correct quality problems? (126.96.36.199.2) How the authority is defined Recent examples 1.16 Has the supplier identified the resource Job Training records descriptions requirements, and provided Quality Plans adequate resources including the assignment of Shift staffing trained personnel for management, Personnel workload performance of work and verification activities, including internal audits? (188.8.131.52.1) 1.17 Are all shifts staffed with personnel with Quality Assurance responsible quality assurance responsibility? (184.108.40.206.2) personnel in all shifts 1.18 Is there a clearly identified management Who is the person in charge of this representative with authority and responsibility responsibilities to ensure TS compliance, and to report on the Evidence of activities performing including performance of the performed including empowerment for all applicable system quality system? (220.127.116.11) elements including design, sales, manufacturing, delivery, etc. Management review minutes 1.19 Does the supplier have a system in place to Product planning process conforming to ensure management of appropriate activities customer specific requirements during concept development, prototype and Specific project management requirements production, according to customer requirements (Contract Review) (see Bibliography)? (18.104.22.168) 1.20 Does the supplier use a multi-disciplinary Project records such as milestones decision approach for decision making? (22.214.171.124) points during product and process realization Contract Review 1.21 Does the supplier have the ability to Common language at the interface level communicate necessary information and data in Common language for technical the customer prescribed language? (126.96.36.199) specifications and important document Customer/supplier EDI system requirements and supplier capabilities 3 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 1 22 Does the management review include all Review of all the elements of the quality the elements of the quality system and its system to ensure its continuing suitability and performance, as well as the monitoring of effectiveness strategic quality objectives and regular Review of quality cost indicators evaluation and reporting of the cost of poor Management review meeting minutes, attendance and adequate frequency Action quality? (188.8.131.52; 184.108.40.206; 4.1 4.3.d) (4.1.4) plans and follow-up 1 23 Does the supplier utilize a controlled and Business plan comprehensive business plan that includes Evidence of top executive approval. short-term and longer-term goals and plan(s)? Document Control procedure Master List - reference to Business Plan Comprehensive, e.g. all business aspects, not just quality Goals and Objective 1.24 Are goals and plans based on analysis of Benchmarking reports and analysis of data competitive products and benchmarking inside Marketing and competitor analysis data and outside the automotive industry? (4.1.4) 1.25 Are there methods in place to determine Methodology employed, such as, surveys, current and future customer expectations? meetings, etc. (4.1.4) Evidence that this is an ongoing activity 1.26 Does the Supplier use an objective process to Data collection and analysis system define the scope, collection and analysis of availability information, including the frequency and method of Planning collection? (4.1.4) 1.27 Are there documented methods to track, Evidence of verification that it is followed update, revise and review the business plan to (e.g. records of periodical management ensure it is communicated and followed meetings) throughout the organization, as appropriate? (4.1.4) 1 28 Does the supplier document trends in the Internal performance data such as: quality, operational performance, and current Poor quality cost indicators quality levels for key product and service Effectiveness and efficiency of features? (4.1.5) production processes Test results Process capability data Quality audits 4 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence Results of product inspections Internal and external quality data Subcontractors rating Customer reports Employees information - 1.29 Are trends in data and information Customer problem resolution compared with progress toward business Comparison of trends to objectives, to lead to appropriate action to objectives (goals) support: Specific actions to trend developing priorities for resolving analysis customer problems Prioritization of action determination of key customer-related trends an information system for timely reporting of product information? (4.1.5) 1 30 Does the supplier have a process for Incentive systems used motivating the employees to achieve quality objectives and continuous improvement? (4.1.6) 1.31 Does the supplier have a process for Personnel interview promoting quality awareness at all levels of the Activities such as company? (4.1.6) Formalized programs which are approved by Top Management Structured training Quality circles Use of visual aids 1.32 Does the supplier have a process for Measurement of employee satisfaction measurement of employee satisfaction and employee understanding of appropriate quality objectives? (4.1.6) 5 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 1 33 Does the supplier's quality policy and Preventive activities in design and process practices address due care regarding product control safety and means to minimize potential risks to Knowledge and application of legislation employees, customers, users and the Risk analysis such as FMEA environment? (220.127.116.11) Results of internal/external audits including: - System certifications - Corrective actions Records of accidents Safety-related customer complaints 1.34 Does the supplier promote internal Personnel training Warning related to the awareness of safety considerations relative to potential consequences of product defects its own product? (18.104.22.168) (e.g. Movies, pictures, posters, samples) 1.35 Does the supplier have a process to Process for government, safety and ensure compliance with all applicable environmental regulations compliance government, safety and environmental Internal audit results Design/Process Quality regulations, including those concerning storage, Records Product descriptions (e.g. manuals) handling, recycling, eliminating or disposing of Appropriate product identification materials? (22.214.171.124) 6 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.2 - Quality System 2.0 Has the supplier implemented a quality Quality manual according to ISO/TS 16949 or system described in a Quality Manual that one with a conversion matrix. covers the requirements of ISO/TS 16949 with related procedures? (4.2.1 ;126.96.36.199) 2 1 Are there adequate supporting Adequacy of the procedures to the .procedures (Level 2) for each element of the complexity of the organization quality manual, and are they effectively Procedure Manual and master document list implemented? (4.2.2; 4.4.1; 4.9.la; 188.8.131.52,. Key personnel interview Examples of effective implementation 411.1.1; 4.12; 184.108.40.206; 220.127.116.11; 18.104.22.168, 4.15.1;4. 16. 1;4. 17. 1;4.20.2) 2.2 Is the quality planning process consistent with Development of Quality plan(s) all other requirements of the quality system, Link between quality plan and Design documented in a suitable format, and does it Record, Control Plan, Operator Instructions, consider as appropriate, the elements of the quality Product Approval records, resources facilities system that address: and any plans to enhance them o Preparation of quality plans? Design validation at the various stages of the o Identification and acquisition of all design inspection & production/service resources? Link between process changes and updates in o Conducting design and process feasibility the quality plan(s) studies? o Updating and maintenance of all quality control and inspection methodology? o Identification of suitable verification at appropriate stages? o Production, installation and servicing processes which directly affect quality (22.214.171.124) 2.3 Does the quality plan include the customer Quality plans requirements and references to appropriate Customer specifications technical specifications? (126.96.36.199) Technical specifications 7 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 2.4 Does the supplier have a process for Quality Planning process developing product and/or service that meets Project Planning process the customer requirements for timing, quality, Quality Plans for new products cost, and delivery, product design for design responsible suppliers? (4.2.4) 2.5 For project management is there evidence of Job descriptions dedicated project manager and project team with Team composition has to be cross-functional appropriate resources and defined Organization charts special responsibilities and organizational Documentation for project management interfaces? process. (4.2.4; 188.8.131.52; 184.108.40.206; 220.127.116.11) 2.6 Does the supplier ensure confidentiality of Information access security customer contracted product under Security for product development. development, and related product information? (4.2.4) 2.7 Is there a process to define, analyze and Indicators and records report to management measurements of the Reporting process product realization? Does it include at a minimum quality risks, costs, lead-times, and critical paths? (18.104.22.168) 2.8 Is there evidence of status review and Product design and development status appropriate corrective action at the appropriate reviews stages in the product realization? (22.214.171.124) Link of corrective action to status reviews 2.9 Does the supplier convene multi-disciplinary . Functions represented in product teams for planning the production of new or development teams changed products including special Personnel involved in definition of special characteristics, FMEA, and Control Plan? characteristics, FMEA, and Control Plan (126.96.36.199; 188.8.131.52) 2.10 Does the supplier use in the product Knowledge of customer advanced product development process appropriate tools and quality plan and control plan manuals, or techniques as referenced in customer manuals similar Implementation of the appropriate or similar? (184.108.40.206) techniques in the different product development steps 2.11 Does the supplier perform potential Use of risk analysis nonconformity analysis and implement Product and process FMEA's 8 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence appropriate corrective action, including all Special characteristics list special characteristics in process, FMEA's and conforming to customers requirements, if any, regarding review and approval of FMEA and Control Plans? (220.127.116.11) 2.12 Are mistake proofing techniques utilized, Examples of mistake proofing where appropriate, which includes but is not limited to planning of process, facilities, equipment and tooling, and in problem resolution? (18.104.22.168; 4.10.3; 22.214.171.124,126.96.36.199) 2.13 Does the supplier perform process studies Process capability measurements results as and verity process capability for all new appropriate for all new processes processes? (188.8.131.52) Related actions based on the results 2.14 Do these studies result in documented Basis for production, measurement and test, specifications for means of production, and maintenance specifications measurement and test, and maintenance instructions? Defined acceptance criteria based on Do they include the objectives for process objectives capability, reliability, maintainability, availability and the acceptance criteria? (184.108.40.206) 2.15 When specified in the contract, does the Job description supplier have. Specific training records - Appropriate resources and facilities to use Services sub-contractor management system computer-aided design, engineering and (choice, evaluation and control) if analysis compatible with the customer subcontracted. systems? Evidence of compatibility with customer - Computer-aided methods to use numerical systems. design and drawing data for production tooling and prototypes? - If any of these functions is/are sub-contracted, has the supplier provided technical leadership? (220.127.116.11) 9 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 2.16 Are all special characteristics appropriately Process to establish special Characteristics identified, complying with specific customer Design Record definition and included in the control plan? Review customer requirements for special (18.104.22.168) characteristics, definitions and symbol identification. Control plans 2.17 Are process control documents marked Use of symbol to identity special with the appropriate special characteristic characteristics in the process control symbol to indicate the steps that affect the documents for each process step special characteristics? (22.214.171.124) 2.18 Is manufacturing feasibility investigated, Feasibility studies confirmed, and documented, prior to contracting proposed products? (126.96.36.199; 4.3) 2 19 Are process design input requirements Design FMEA identified, documented and reviewed? Productivity, process capability, costs targets (188.8.131.52.2) Customer requirements, if any Experience from previous development 2.20 Are the process design output data Process specifications and drawings expressed in terms that can be verified and Process FMEA's validated against the design input, and are Job instructions records maintained to evidence the verification? Process approval acceptance criteria (184.108.40.206.3; 220.127.116.11.4) Quality, reliability, maintainability data Mistake-proofing activities results Nonconformity detection methods Product/Process verification plans 2 21 Are control plans developed by multi- Control plan team composition disciplinary approach to the system, subsystem, Control plans for different product levels component, and/or material level, and list all controls used for process control and verifications? (18.104.22.168;4.l0.4.l) 2.22 Do control plans include the customer Control Plans for applicable Stages required information, reaction plan, and Control Plan framework with data does it cover prototype (if applicable), pre- launch and production phases? Annex B (22.214.171.124) 2.23 Are control plans reviewed and updated Matching between product/process changes, 10 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence as appropriate when any of the following occurs: instability/non capability process results, and Product or process changes control plans updating Processes are found to be unstable or non- capable Inspection method, frequency, etc. is revised? (126.96.36.199) 2 24 Does the supplier fully comply with all Compliance with requirements regarding requirements set forth in the customer product customer product approval process approval process? (188.8.131.52) 2.25 Does the supplier utilize a product Product approval process documentation approval process for subcontractors? (184.108.40.206) and records for subcontractors 2.26 Is there evidence that product changes Product change validation records are properly validated? (220.127.116.11) Subcontractor product change validation records 2.27 Is the customer notified of all changes, Customer change notification and is there approval for the change as process/records applicable? (18.104.22.168) Customer approval, as applicable 2 28 Does the supplier use a multidisciplinary Team composition has to be cross-functional approach to developing plant, facility and equipment plans? (4.2.5) 2.29 Does the plant layout minimize material Process flow analysis Plant layout (current travel and handling, facilitate synchronous and planned) material flow, and maximize value-added use of floor space9 (4.2.5) 2.30 Are methods developed for evaluating the Metrics for ergonomics, automation, line effectiveness of existing operations and balance, inventory levels processes? (4.2.5) 2.31Are appropriate technical resources Tool/gage design staffing and qualification available for tool and gage design, fabrication and full dimensional inspection? (4.2.6) 11 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 2.32 Has the supplier established and Tool management process implemented a system for tool management that includes maintenance and repair facilities and personnel, storage and recovery, set-up, and tool change programs for perishable tools, tool modification including tool design modification? (4.2.6) 2.33 If tooling management is sub-contracted, is Sub-contractor management system (choice, there a system to track and follow-up these evaluation and control) activities? (4.2.6) 2 34 Does continuous improvement extend to Records showing improvement in special product characteristics and process parameters characteristics with the highest priority on special Reduction in process parameter variation characteristics? (4.2.7) 2.35 Does the supplier have a prioritized action Continuous improvement plans, initiatives plan for continuous improvement? (4.2.7) 2.36 Do records evidence the measurement of Policy, business plan and customer the quality system effectiveness in meeting the satisfaction metrics Reports objectives of the quality policy, business plan Product results (quality, cost, time) against and the customer satisfaction with the product? quality policy goals and customer specified (4.2.8) targets 2 37 Is there evidence that quality system Trends in metrics (business and customer performance results are used for continuous satisfaction) improvement or corrective action? (4.2.8) Basis for continuous improvement projects 12 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.3 - Contract Review 3.1 Does the supplier review a tender, contract or Resolutions of differences order, to ensure that the requirements are Feasibility assessments understood and can be met, and if any Customer contracts misunderstanding arises that the differences are resolved prior to contract or order acceptance? (4.3.2.]) 3.2 Does the supplier have a process to identify Process for determining cost elements the appropriate cost elements when developing quotations? (22.214.171.124) 3.3 Does the customer ensure that all customer Process used to ensure that customer specific requirements are met? (126.96.36.199; specific requirements are met 188.8.131.52; 184.108.40.206) 3 4 Are there provisions that document and Change control process Contract deploy contract amendments to the functions amendments concerned? (4.3.3) 3.5 Are records of contract reviews maintained Records of contract review (4.3.4; 4.16) 13 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.4 - Design Control 4.1 Have design plans for each project been Examples of design plans and responsibility established, updated and responsibilities assignment assigned? 4.2 Are responsible personnel qualified in the Training records complementing the type of “required Skills” and equipped with adequate design activity resources as appropriate? Personnel records Interviews with design personnel 4.3 Does the supplier have access to research Appropriate facilities and equipment and development facilities? (internal or external) 4.4 Are the organizational interfaces between Defined organizational interfaces with roles groups defined and is there evidence of the and communication processes necessary information being documented, transmitted and regularly reviewed? (4.4.3) 4 5 Are design input requirements including the Design input Records & Documents applicable statutory and regulatory requirements, Records of supplier review product life, reliability, durability and maintainability objectives identified documented and reviewed? (220.127.116.11; 18.104.22.168) 4.6 Are incomplete, ambiguous or conflicting Customer specification analysis requirements resolved? (22.214.171.124) Feasibility contract review minutes. 4 8 Has the design output been documented and Design output records expressed in terms that can be verified and matching criteria established validated against design input requirements.' in design input requirements Meet the design input requirements? Contain or reference acceptance criteria? Identify' Special Characteristics? Include a review of design output documents before release? (126.96.36.199) 14 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.9 Was the design output a result of a process that Techniques / tools used in the design included: process Efforts to simplify, optimize, innovate, and reduce waste such as QFD, DFM, DFA, VE, DOE or appropriate alternatives? GDT (as applicable)? Analysis of cost/performance/risk trade- offs? Feedback from testing, production and the field? Analysis of design failure mode and effects (DFMEA)? (188.8.131.52) 4 10 Are there records of formal documented Design review planning and records design reviews by the appropriate functions Design review extended to all functions conducted at appropriate stages of design per the affected by it design plan? (4.4.6) 4 11 Are there records to demonstrate that Design verification done in accordance to design verification has been performed at plan appropriate stages to ensure that design output Comparison between outputs and meets design input requirements? (4.4.7) design requirements Corrective actions based on results- 4 12 Has design validation been performed to Design validation against user requirements ensure that product conforms to defined user / needs needs and/or requirements including customer Comparison between customer plan timing requirements (184.108.40.206;220.127.116.11) and internal development plans Design validation records Documented failure 4,13 Are design failures addressed through the Corrective action process for the design designated corrective and preventive action activity procedures? (18.104.22.168) Corrective Action Records 4.14 When required by the customer, does the Prototype facilities supplier have a comprehensive prototype Prototype records program? (22.214.171.124) 15 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.15 Wherever possible, are the subcontractor's Design/prototype /production tooling and process for prototype the same as the Tooling Prototype realization and test ones that will be used in production? (126.96.36.199) conditions must be known and controlled . 4.16 Is the performance testing tracked for timely Test records completion and conformance? (188.8.131.52) 4.17 If prototype activities have been sub- Sub-contractor management as appropriate contracted has the supplier provided technical leadership? (184.108.40.206) 418 Are design changes identified, documented, Design change approval reviewed and approved by authorized personnel Process Change records before implementation? (220.127.116.11) 4.19 Does the supplier consider the impact of Impact study including proprietary design changes on the system in which the design product is used, the customer process and other Change management process related products and systems, including proprietary design? (18.104.22.168;4.2.4. I) 16 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.5- DOCUMENT AND DATA CONTROL 5 1 Are all documents and data under document Master List control including appropriate external Documents? (4.5.1) 5 2 Are all documents and data reviewed and Document approval authority approved by authorized personnel prior to use? Document approval records (22.214.171.124) 5 3 Is there a master list (or equivalent) Master list or equivalent identifying document revision status readily available? (126.96.36.199) 5.4 Has the supplier established a process to Availability of documents in various locations ensure that pertinent issues of appropriate Knowledge of documents location documents are available at all locations where Document accessibility operations essential to the effective functioning of the quality system are performed? (188.8.131.52.a) 5.5 Has the supplier established a process to Storage and disposal of obsolete documents ensure that invalid and/or obsolete documents are promptly removed from all points of use, or otherwise assured against unintended use? (184.108.40.206.b) 5.6 Is there timely review, distribution and Process for notification distribution of implementation of customer engineering customer engineering standards changes standards/specifications and changes? (220.127.116.11) 5.7 Does the supplier maintain a record of the Records of engineering changes date on which engineering changes are implemented implemented in production? (18.104.22.168; 4.16) 5 8 Does implementation of changes include Document changes triggered by engineering updates to all appropriate documents? (22.214.171.124) changes 5 9 Are changes in documents and data Review and approval of revised documents reviewed and approved by the same functions/ organizations that originally performed the review and approval, (unless specifically designated otherwise)? (4.5.3) 17 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 5.10 Do the designated functions or Interview key personnel organizations have access to pertinent background information upon which to base the review and approval? (4.5.3) 5.11 Are all changes in documents identified Method to identify changes to either in the (4.5.3) document or in documents attachments? 18 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.6- PURCHASING, 6 1 Where specified by the contract does the Approved suppliers list if applicable supplier use materials and services from the How are these lists used approved subcontractor list? (126.96.36.199; 4.3) 6.2 Do all materials used in part manufacture Audit results from government and conform to all applicable governmental, safety environment organizations and environmental regulations as they apply to Supplier Internal Audits the country of manufacture and sale? (188.8.131.52) Warrants or certificates of compliance Audits of subcontractors 6 3 Are sub-contractors evaluated and selected Selection system based on their ability to meet quality system and Performance rating system quality assurance requirements? (4.6.2. Ia) 6.4 Does the supplier define the appropriate Subcontractor records type and extent of control over subcontractors? Subcontractor monitoring system (4.6.1b) 6.5 Are quality records of acceptable Approved subcontractor records subcontractors established and maintained? (4.6.2.lc; 4.16) 6.6 Is subcontractor quality system development Supplier development process Evidence of being conducted with the goal of subcontractor subcontract or development compliance to TS 16949 or existing customer quality system requirements? (184.108.40.206) 6.7 Is 100% on time delivery a requirement of Purchase Order/Contract or Amendment the subcontractors and does the supplier Purchasing planning communication with convey all the necessary information to achieve sub-contractors that? (220.127.116.11) 6.8 Is there evidence of a system to monitor the Subcontractor performance Records delivery performance of subcontractors, Subcontractor corrective action including all premium freight, and evidence of appropriate corrective action? (18.104.22.168) 6 9 Do the purchasing documents contain - Purchase order / release data clearly service being ordered? (4.6.3) describing the product or 6.10 Is there evidence of supplier review and Purchase order/release review approval of purchasing documents for adequacy process to the specified requirements prior to release? 19 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence (4.6.3) 6.11 When applicable, do purchasing Supplier and subcontractor purchase orders documents specify verification arrangements and contracts and method of product release for purchased product at the subcontractors premises? (4.6.41) 6.12 Where specified in the contract (4.3), is the Contract review for customer right to verify customer (or their designated representative), afforded the right to verify product conformance to the requirements at the supplier’s subcontractors premises? (22.214.171.124) 20 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.7- CONTROL OF CUSTOMER-SUPPLIED PRODUCT 7 1 Is there evidence that product that is lost, Damage to customer supplied product damaged or otherwise unsuitable for use is reports recorded and reported to the customer? What happened to customer owned (4.7.1, 4.16) returnable packaging? How was it accounted for? 7.2 Are customer-owned tools and equipment Permanent identification of tooling and permanently marked so that ownership of each equipment ownership item is visually apparent? (4.7.2) 4.8 - PRODUCT IDENTIFICATION AND TRACEABILITY 8.1 Is product identification maintained through all Check for positive recall Suitable product stages of production, delivery and identification throughout the facility installation? (4.8; 126.96.36.199, 4.10.3b) Traceability from raw materials to delivered product. 8.2 How is traceability maintained and recorded Integration of customer traceability when required by the customer? (4.8; 4.16) requirements 21 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.9 PROCESS CONTROL 9.1 Does the supplier identify and plan the Quality plan production; installation and servicing processes Control plan which directly affect quality ensure that these processes are carried out under controlled conditions? (188.8.131.52) 9.2 Do controlled conditions include use of Tour of plant and facilities suitable production, installation and servicing equipment, and suitable working environment? (4.9.1.b) 9.3 Do controlled conditions include compliance Adherence to referenced standards, quality with reference standards/ codes, quality plans plans and/or documented procedures and/or documented procedures? (184.108.40.206.c) Tour of plant and facilities 9.4 Do controlled conditions include the moni- Control Charts and SPC Tools toring and control of suitable process para- Evidence of effective control meters and product characteristics? 220.127.116.11.d) 9.5 Do controlled conditions include the Process approval records approval of processes and equipment, as appropriate? (4.9.1. i.e.) 9.6 Do controlled conditions include criteria for Acceptance Criteria workmanship stipulated in the clearest practical Visual aids manner? (18.104.22.168) Work instructions 9.7 Are qualified operators and/or continuous Operator qualification Training Records monitoring and process control used where the Process parameters monitoring and control results of the processes cannot fully be verified evidence by subsequent inspection and testing? (22.214.171.124) 9.8 Are qualification requirements for special Requirement specification for operations, process operations and associated equipment equipment and personnel Related records of and personnel spec fled and are records qualification maintained? (126.96.36.199) 9.9 Are the premises maintained in a state of Tour of plant order, cleanliness and repair appropriate to the product manufactured? (188.8.131.52) 22 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 9.10 Does the supplier have contingency plans Contingency plans Identification of Key to reasonably protect the customer's supply of Equipment product in the event of emergency? (184.108.40.206) 9.11 Are customer requirements for designation, Designation and control of special documentation and control of Special characteristics Quality documents: control Characteristics in compliance? Is documentation plan, specifications, drawings, etc. shall available? (220.127.116.11) report the special characteristics designation 9.12 Is there an effective planned preventive System effectiveness demonstrated by maintenance system that identifies key process specifics measurement indicator equipment, provides appropriate resources, and Key equipment list includes at a minimum: Maintenance records o Planned maintenance activities? Predictive maintenance examples o Predictive maintenance methods? Plant tour o Packaging and preservation of equipment, tooling, and gages? o Availability of replacement parts for key manufacturing equipment? o Documenting, evaluating and improving maintenance objectives? (18.104.22.168; 4.9.l.l.g) 9 13 Have documented job instructions Availability of job instructions at the prepared and derived from appropriate sources workstation been prepared for all employees having Link between job instructions and source responsibilities for operation of processes and documents, e.g. Control Plan, Design are they accessible at the workstation? (4.9.2) Record, FMEA 23 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 9.14 Do process monitoring and job instructions Job instructions contents include or reference, as appropriate: Predetermined reaction plan Operation name and number keyed to process flow diagram? Part name and part number? Current engineering level/date? Required tools, gages and other equipment? Material identification and disposition instructions? Customer and supplier designated Special Characteristics? SPC requirements? Relevant engineering and manufacturing standards? Inspections and test instructions? Reaction plan? Revision date and approvals? Visual aids? Tool change intervals and set-up instructions? (4.9.2) 9.15 Does the supplier maintain or exceed the Current Cpk/Ppk versus customer approved process capability or performance as approved Cpk/Ppk via customer part approval process through the Existing reaction plan implementation and adherence to the Control Verifying the accuracy of Cpk/ Ppk Plan, Process Flow Diagram, measurement calculations technique, sampling plans, and reaction plans when acceptance criteria are not met? (4.9.3) 9.16 Are significant process events recorded on Process events recorded the control charts? (4.9.3) 9.17 Does the supplier initiate the appropriate reaction plan from the control plan for unstable or non-capable characteristics? (4.9.3) 9.18 Does the reaction plan include as Contents of reaction plan appropriate: Containment and 100% inspection? Processes Specific corrective action timing? 24 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 9.19 Does the supplier maintain record(s) of . Records Process change records process change - Responsibility assignment? effective dates? (4.9.3) - Customer approval? 9 20 Does the supplier verify job set-ups, and Job set-up records and Approval use statistical methods where applicable? (4.9.4) 9.21 Are job instructions available for set-up Set-up instructions personnel? (4.9.4) 9.22 For customer designated appearance Maintenance/Control and storage conditions of items: masters Is there appropriate lighting for the Visual aids evaluation area(s)? Personnel quantification / training records Are all appropriate masters available? Tour of facility Are the masters and evaluation equipment adequately maintained and controlled? Is there verification that personnel making appearance evaluation are qualified? (4.9.5) 25 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.10- INSPECTION AND TESTING 10.1 Are the required inspection and testing, Control Plans and the records established, and detailed .in the Inspection Instructions quality plan or documented procedures? (22.214.171.124) 10.2 Is appropriate acceptance criteria for all Inspection instruction/records situations documented and zero defects for Acceptance Criteria attribute data? (126.96.36.199) Control Plans 10.3 Does the supplier ensure that incoming Material certifications product is not used or processed (except for Subcontractor Data urgent production purposes), until it has been Inspection records inspected or otherwise verified as conforming to Receipt and evaluation of statistical data by specified requirements? (4.10.21, 188.8.131.52; supplier 184.108.40.206) Receiving inspection and/or testing Second or third party assessments or audits of subcontractor sites when coupled with records of acceptable performance Evaluations by accredited laboratories 10.4 Does the Supplier inspect and test product In-process inspection instructions as required by the quality plan (Control Plan) Control Plans and/or the documented procedures? (4.10.3.a) Records 10.5 Does the supplier carry out final inspection Control Plans and testing in accordance with the quality plan Final inspection records (Control Plan) and/or documented procedures? (220.127.116.11) 10.6 Does the supplier assure that no product is Inspection records and Approvals Label/tag of dispatched until all activities specified in the identification of inspection and test status in documented procedures have been various area of the operation. satisfactorily completed and that the associated data and documentation is available and authorized? (18.104.22.168) 26 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 10.7 Are layout inspection and functional Layout inspection reports verification performed for all products at Control plan frequencies established by control plan? (22.214.171.124) 10.8 Does the supplier maintain records which Inspection records that include acceptance provide evidence that the product has been criteria inspected and/or tested clearly showing whether Inspector performing the test, test status and, the product has passed or failed inspection testing date based on the defined acceptance criteria and identifying the authority responsible for the product release? (4.10.5) 10.9 Is product that fails any inspection and/or Identification tag test addressed under control of non- conforming Area non conforming material product? (4.10.5) 10.10 Do inspection records identify the Release of product by authorized personnel inspection authority responsible for the release of product? (4.10.5)- 10.11 Does the laboratory have a scope and Laboratory Scope does it comply with ISO/IEC Guide 17025? (See TS Glossary) (4.10.6) 10.12 When the supplier uses independent/ Commercial Laboratory commercial laboratories are they accredited to Accreditation records ISO/IEC Guide 17025 or a national equivalent? (4.10.6) 27 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.11- CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT 11.1 Inspection, measuring, and test equipment Management system analysis studies used in a manner which ensures that the including Gage Repeatability & measurement uncertainty is known and is Reproducibility consistent with the required measurement capability? (4.11.1) 11.2 Where test software or comparative Test software/comparative references references such as test hardware are used as verification suitable forms of inspection, are they checked to prove that they are capable of verifying the acceptability of the product prior to release for use during production, installation, or servicing? (126.96.36.199) 11.3 Does the supplier establish the extent and Verification schedule and records frequency of such checks and maintain records as evidence of control? (188.8.131.52) 11.4 For measurement systems referenced in Study results the Control Plan is there evidence that appropriate statistical studies have been conducted to analyze the variation present in the results of each type of measuring and test equipment system? (184.108.40.206) 11.5 Do analytical methods and acceptance Check methods against customer criteria used conform to those in the customer measurement system analysis requirements. reference manuals on measurement system analysis (see bibliography) as appropriate, Customer approval records, for other including bias, linearity, stability and analytical methods used measurement repeatability and reproducibility studies? When other methods are used are they approved by the customer? (220.127.116.11) 11.6 Has the supplier determined the Test equipment accuracy and precision measurements to be made and the accuracy capability related to the required required and selected the appropriate measurement inspection, measuring and test equipment that is capable of the required accuracy and precision? (4.11.2.a) 28 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 11.7 Has the supplier identified, and maintained Test equipment inventory calibration records for all inspection, measuring Certifications for calibration masters and their and test equipment that can affect product traceability to international national quality and calibrated and adjusted them at recognized standard prescribed intervals, against certified equipment having a known valid relationship to Calibration results records internationally or nationally recognized standards. Where no such standard exists is the basis for calibration documented? (4.11.2.b; 4.ll.2e) 11.8 Does the process for calibration of Calibration instructions that Include method, inspection, measuring and test equipment frequency, acceptance criteria and corrective include the following.' action, - Type of equipment? - Unique identification? - Location? - Frequency of checks? - Check method? - Acceptance criteria? - Corrective actions? (4.11.2.c) 11.9 Has the supplier identified inspection, Calibration status identification measuring and test equipment with a suitable indicator or approved identification record to show the calibration status? (4.11.2.d) 11.10 Does the supplier assess and document Records of re-inspected product the validity of previous inspection and test results when inspection, measuring and test equipment is found out of calibration? (4.11j) 11.11 Has the supplier ensured that the Facility tour environmental conditions are suitable for inspections, measurements and tests being carried out?_(4.ll.2.g; 4.16) 29 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 11.12 Has the supplier ensured that the Handling and storage of equipment at work handling, preservation and storage of inspection station and warehouse measuring and test equipment is such that the Facility tour accuracy for fitness for use is maintained? (4.11.2.h) 11.13 Has the supplier safeguarded the Test premises access and Security Method of inspection, measuring and test facilities, control of calibration settings including both hardware and test software, from adjustments which would invalidate the calibration setting? (4. 11. 2.i) 11.14 Do records of the calibration/ Measuring. Measurement equipment verification activity for and test equipment measurement equipment all gages, records include: Original specification of (including employee Revisions following engineering changes (if owned gages) appropriate)? Any out of specification readings as received for calibration/verification? Statements of conformance to specification after calibration Verification Notification to customer if suspect material or product has been shipped? (4.ll.3) 4.12 - INSPECTION AND TEST STATUS 12.1 Are the inspection and test status of Inspection records product identified by suitable means so that the conformance status of the product with regard to inspection and tests performed is recognizable and understood? (4.12) 30 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.13 CONTROL OF NONCONFORMING PRODUCT 13.1 Does the control of nonconforming product Follow one or more or product and suspect material provide for identification, nonconforming case and verify the flow documentation, evaluation, segregation (when (identification, segregation, etc.) practical, disposition, and for obsolete products notification of all appropriate functions? (18.104.22.168.15.3.2) 13 2 Does the supplier provide for visual Follow one or more non-conforming case identification of nonconforming or suspect and verify segregation area. product, and for quarantine the visual identification and areas? (22.214.171.124) 13.3 Does the supplier quantify and analyze prioritized reduction plan and track of nonconforming product, establish a product nonconforming material reduction monitoring system progress? (126.96.36.199) 13.4 Is the customer promptly informed when Method to communicate with the customer, nonconforming material has been shipped? for non-conforming products. (188.8.131.52) Records 13.5 Is the responsibility for review and authority for Procedures the disposition of non-conforming product Work instructions defined? (4.13.2) 13.6 Are nonconforming and suspect products Follow one or more non-conforming case and reviewed in accordance with documented verify in the plant, the flow (identification, procedures, and, reworked to meet the specified segregation, etc.) requirements - Accepted with or without repair by concession - Regarded for alternative applications, or - rejected or scrapped? (4.13.2) 13.7 When required, is the proposed use or Records of concessions repair of product, which does not conform to specified requirements, reported for concession to the customer? (4.13.2) 31 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 13.8 Is the description of nonconformity that has Records of customer acceptance of non been accepted, and of repairs, recorded to conforming material denote the actual condition? (4.13.2) 13.9 Are repaired and/or reworked/products re- Reworked product flow must guarantee the inspected and/or tested according to the quality re-inspection in accordance to control plan. plan (Control plan) and/or documented Inspection/testing records for procedures? (4.13.2) reworked/repaired product 13.10 Are the rework instructions accessible and Plant Tour utilized by the appropriate personnel in their work areas? (4.13.3) 13.11 Does the suppler obtain customer Records of subcontractor authorization authorization prior to shipment whenever product or process is different from the one currently approved? (4.13.4) 13.12 Does the supplier concur with any Records requests from a subcontractor before submission to the customer? (4.13.4) 13.13 Does the supplier maintain records of the Records expiration dates and quantities authorized? (4.13.4) 13.14 Is compliance with the original or Shipping container labeling specific and clear superseding specification and requirements identification ensured when authorization expires? (4.13.4) 13 15 Is material shipped on an authorization Shipping container labeling specific and clear properly identified on each shipping container? identification (4.13.4) 32 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.14 -Corrective and Preventive Action 14.1 Are appropriate corrective or preventive Coherence between action and document actions developed to eliminate the causes of change actual or potential non-conformances?(184.108.40.206) Records of changes 14.2 Are changes to the documented Coherence between action and document procedures resulting from corrective or change preventive action implemented and recorded? Records of changes (220.127.116.11) 14.3 Does the supplier use a disciplined Responses to customer complaints problem solving method to address internal or external non-conformances used? (18.104.22.168) 14.4 Does the supplier respond to external non- Responses to customer complaints conformances in the customer prescribed Customer formats manner? (22.214.171.124) 14.5 Does the supplier use mistake-proofing Examples methodology, as appropriate, in their corrective and preventive action process? (126.96.36.199) 14.6 Do procedures for corrective action List of customer complaints include: Effective handling of customer complaints Root Cause Analysis and records and reports of non-conformances; investigation of the causes of non- Determination of corrective action needed conformances relating to product, process and quality system and recording of Corrective action taken the results; determination of corrective action Corrective action effectiveness needed to eliminate the cause of non- conformance; application of controls to ensure that corrective action is taken and that it is effective? (4.14.2.a-b-c-d) 33 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 14.7 apply the corrective actions and controls Where applicable, does the supplier Review of implemented to similar products and processes? documents related to similar products and (188.8.131.52) processes 14.8 Are returned parts from Customer List of returned parts manufacturing plants, engineering facilities, and Records of analysis dealerships analyzed in minimum time, and are Minimalization of cycle time Examples records of this analysis kept and made available upon request? (184.108.40.206) 14.9 Where appropriate, does the supplier initiate corrective action and process changes to prevent recurrence? (220.127.116.11) 14.10 Do procedures for preventive action Sources of information used for preventive include: the use of appropriate sources of action information, e.g., product quality, deviation, Root cause determination (FMEA, FTA, etc.) audit result, quality records, etc., to develop Records and result analysis preventive actions; determination of steps needed to deal with problems requiring preventive action; initiation of preventive action and application of controls to ensure that it is effective (4.14.3.a-b-c) 34 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.15-Handling, Storage, Packaging, Preservation and Delivery 15 1 Does the supplier have documented and Procedure development and documentation established procedures for handling, storage, packaging, preservation and deliveries of product? (4.15.1) 15.2 Have methods for the handling of product to Facilities appropriate prevent damage or product deterioration been provided? (4.15.2) 15.3 Are designated storage areas or stock of all Plant Tour storage and rooms used to prevent damage or stock rooms deterioration of the product pending use or delivery? (18.104.22.168) 15.4 Have appropriate methods for authorized Process and facilities to authorizing receipt to movement of product from one area to another and dispatch from designated storage areas or areas been stipulated? (22.214.171.124) stock rooms 15.5 Is the condition of product in stock/storage Inspection records assessed at appropriate intervals to specifications detects deterioration? (126.96.36.199) 15.6 Does the supplier use an inventory Inventory management system management system to optimize inventory Evidence of FIFO turns, assure stock rotation and minimize Control of obsolete product inventory levels? (188.8.131.52) 15.7 Does the supplier control the packaging Internal process and marking processes so as to ensure product Packaging audit conformance to specifications? (184.108.40.206) 15.8 Does the supplier comply with all customer Customer requirements packaging requirements, including those for Packaging sample audit service parts? (220.127.116.11) 15.9 Does the supplier have a system to ensure Product labeling system that all materials shipped are labeled according to Customer requirements customer requirements? (18.104.22.168) Labeling audit 15.10 Have appropriate methods for Procedure preservation and segregation of product been Plant tour applied when the product is under the suppliers' control? (4.15.5) 35 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 15.11 Does the supplier arrange for the Procedures Plant tour protection of the quality of the product after final Returned material records inspection and test and does it extend to include Customer complaints delivery to destination when specified? (22.214.171.124) 15.12 Has the supplier established a system to Customer production and service support 100% on-time shipments to meet requirements vs. delivery history customer production and service requirements? (126.96.36.199) 15.13 If the supplier's delivery performance is Delivery problem records not 100% to schedule, is there evidence of Corrective actions plan and realization implemented corrective actions, and of communication regarding delivery problem information to the customer? (188.8.131.52) 15.14 Does the supplier have a systematic Delivery monitoring system with closed loops approach to develop, evaluate and monitor adherence to established lead-time requirements? (184.108.40.206) 15.15 Has the supplier implemented a system to Delivery performance monitoring track performance to customer delivery requirements and premium freight? (220.127.116.11) 15.16 Does the supplier maintain records of Premium freight records supplier responsible premium freight? (18.104.22.168) 15.17 Are materials shipped in conformance Customer Requirements Specifications with the customer requirements, adhering to up- Delivery records to-date customer specified transportation mode, routings and containers? (22.214.171.124) 15.18 Is supplier's production scheduling activity Process for production scheduling The order driven and based on a system to meet the scheduling system should be based on a customer requirements for delivery? (126.96.36.199) "pull" and not on a "push" system. 15.19 Does the supplier have a computerized System for receiving customer planning System to receive computerized customer information information and ship schedules, unless other method is agreed with the customer? (188.8.131.52) 36 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 15 20 Does the supplier have a computerized Advance Shipment Notice (ASN) system system for transmitting advanced ship notices to the customer, unless other method is agreed with the customer? (184.108.40.206) 15.21 Does the supplier have a back-up method Alternate method of a ASNs failure in the event the on-line system fails? (220.127.116.11) 15.22 Has the supplier verified that all ASNs Verification match shipping documents and labels? (18.104.22.168) 4.16-Control of Quality Records 16.1 Are records maintained to demonstrate Records maintenance system, including conformance to specified requirements and the disposal of records effective operation of the quality system? (4.16.1) 16.2 Does the control of quality records include Subcontractor quality performance records pertinent subcontractor quality records? (4.16.1) 16.3 Where agreed contractually are quality Defined record retention time compared to records available to the customer for evaluation customer regulatory requirements for an agreed period? (4.16.1) 16.4 Are all quality records legible readily Environment and storage conditions must be retrievable and stored in a suitable environment compatible with the file storage medium (ex: to prevent deterioration, damage, and loss? hard copy, floppy disk, etc.) (4.16.1) 16.5 Has the supplier defined the quality system Defined record retention time compared to related document and record retention periods to customer/ regulatory requirements satisfy as a minimum regulatory and Record disposal after retention period customer requirements? (4. 16.2; 4.16.1 ;4.5.2. expires Ic) Including identification of obsolescence documents Identification of invalid obsolete documents 37 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.17- INTERNAL QUALITY AUDITS 17.1 Are the audits scheduled and carried out Audit schedule on the basis of the status and importance of the Records of performed audits activity? (4.171) Appropriate prioritization 17.2 Are personnel conducting the audit Organization chart independent of the function being audited? (4.17.1) 17.3 Are the audit results recorded and brought Auditreport to the attention of the responsible personnel? (4.17.1) 17,4 Are corrective actions carried out on a Closure time for audit findings timely based (4.17.1) 17.5 Are there follow-up audit activities Records for recording verifying the effectiveness of the corrective actions taken? (4.17.1) 17.6 Does the audit frequency increase based on Audit frequency internal/ external nonconformities and/or customer r complaints? (4 17 2 1) 17.7 Does internal auditing cover all shifts? Interview with the different area managers (22.214.171.124) Audit reports Audit plan activities and 17.8 Is there an annual plan for scheduled Auditplans and schedule system audits? (126.96.36.199) 17.9 Are product realization and production Audit plans processes audited to determine the Audit reports effectiveness of process performance? (188.8.131.52) 17.10 Does the supplier perform product audits at Auditplan, process flow chart and schedule various stages of production and delivery, at an Product-audit procedure and reports appropriate frequency? (184.108.40.206) 17.11 Does the supplier comply with the Compliance to customer requirements customer requirements for internal auditor qualification? (4.17.3) 38 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence 4.18- Training 18.1 Are personnel qualified based upon Training plan appropriate education, training requirements, Employees previous experience and/or experience as required and have the Training requirements training needs for all personnel performing Training records activities affecting quality been met? (4.1.1; Job descriptions 4.16.2) 18.2 Is training periodically evaluated for Audit/appraisal of training performance effectiveness? (4.18.2) Surveys / questionnaires Performance reviews Pre and post testing 18.3 Are customer specific requirements given Comparison between content customer ( special attention in the training program? needs and training programs (4.18.2) 18.4 When appropriate, does the supplier Training records for personnel in new provide on the job training for personnel in any assignments new or modified job affecting quality, and does it Training records for contract personnel include contract or agency personnel. (4.18.3) 18.5 Is the personnel affecting quality, informed Training contents about the consequences for the customer of nonconformities with quality standards? (4.18.3) 4.19- SERVICING 19.1 Is there documented evidence that a Service reports servicing meets the specified requirements? (4.19.1) 19.2 Is there a procedure to communicate Meeting reports, follow up and corrective information on service concerns to supplier actions/ responsibility/dates Product service manufacturing, engineering and design data activities? (4.19.2) 19.3 If applicable, does the supplier verify the Planning of periodical audits effectiveness of: Reports and follow up any supplier service centers, special purpose tools, training of servicing personnel(4.19.3) 39 of 40 North America Audit Question List ISO 16949:1999 Requirements What to Look For Objective evidence ELEMENT 4.20- Statistical TECHNIQUES 20.1 Has the supplier identified the need for Review of control plan statistical techniques for establishing; Review of Plant tour of process parameters and product quality plan controlling and verifying the characteristics? capability (4.20.2) 20 2 Are the statistical tools for each process Advanced product quality planning records determined during advance quality planning and Control Plan Quality plan are they included in the control plan? (4.20.3) 20.3 Are basic statistical concepts understood Interview with personnel including management demonstrating the knowledge of at all levels of the organization, as appropriate? major statistical concepts like variation and (4.20.4) distribution, process control, cause and effect relationship, common and special causes. Statistical techniques training records( 40 of 40
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