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IATF 16949:2016 GAP ANALYSIS TOOLS

IATF 16949:2016 GAP ANALYSIS TOOLS

 The following checklist can be used for both internal audit as well as  a Gap Analysis tools.The checklist given below has the requirements as given in standard IATF 16949:2016 and has to be used along with the requirements as given in Standard ISO 9001:2015. Please click here for ISO 9001:2015 GAP Analysis Tools
Gap analysis

 

IATF 16949:2016 Checklist
Clause 4  Context of the organization
4.3 – Determining the Scope of the Quality Management System
4.3.1 – Determining the Scope of the Quality Management System-Supplemental
1 Are supporting functions, whether on-site or remote (such as design centres, corporate headquarters, and distribution centres), included in the scope of the Quality Management System (QMS)?
2 Have you taken the only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3 (Design and development of product and services)? Is the exclusion justified and maintained as documented information? Please note Permitted exclusions do not include manufacturing process design
4.3.2 Customer – Specific Requirements
1 Are customer – specific requirements evaluated and included in the scope of the organization’s quality management system?
4.4 – Quality Management System and its Processes
4.4.1.1 – Conformance of Products and Processes
1 Has the organization ensured conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements?
4.4.1.2 – Product Safety
1 Does the organization have documented processes for the management of product-safety related products and manufacturing processes?
2 Does the organization have documented processes for identification of  statutory and regulatory product – safety requirements?
3 Does the organization have documented processes for customer notification of requirements in identification of  statutory and regulatory product – safety requirements?
4 Does the organization have documented processes for special approvals for design FMEA?

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

5 Does the organization have documented processes for identification of product safety – related characteristics?
6 Does the organization have documented processes for identification and controls of safety – related characteristics of product and at the point of manufacture?
7 Does the organization have documented processes for  special approval of control plans and process FMEAs?
8 Does the organization have documented processes for  reaction plans?
9 Does the organization have documented processes for  defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification?
10 Does the organization have documented processes for training identified by the organization or customer for personnel involved in product – safety related products and associated manufacturing processes?
11 Does the organization have documented processes for changes of product or process shall be approved prior to implementation, including evaluation of potential effects on product safety from process and product changes?
12 Does the organization have documented processes for  transfer of requirements with regard to product safety throughout the supply chain, including customer – designated sources?
13 Does the organization have documented processes for product traceability by manufactured lot (at a minimum) throughout the supply chain?
14 Does the organization have documented processes for lessons learned for new product introduction?
Clause 5 Leadership
Clause 5.1 Leadership and Commitments
Clause 5.1.1 General
5.1.1.1 Leadership and Commitment – Corporate Responsibility
1 Has the organization defined and implemented corporate responsibility policies, including at a minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation policy (“whistle – blowing policy”)?
5.1.1.2 Process Effectiveness and Efficiency
1 Has top management reviewed the product realization processes and support processes to evaluate and improve their effectiveness and efficiency? Are the results of the process review activities included as input to the management review?
5.1.1.3 Process owners
1 Has top management identified process owners who are responsible for managing the organization’s processes and related outputs?
2 Do process owners understand their roles and are they competent to perform those roles?
5.3 Organizational Roles, Responsibilities, and Authorities
5.3.1 Organizational Roles, Responsibilities, and Authorities – Supplemental
1 Has top management assigned personnel with the responsibility and authority to ensure that customer requirements are met?  
2 Have these assignments been documented?  
3 Does this includes but is not limited to the selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development, capacity analysis, logistics information, customer scorecards, and customer portals?  
5.3.2 Responsibility and Authority for Product Requirements and Corrective Actions
 1 Has top management ensured that personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems?
 2 In case it is not possible to stop production immediately, has top management ensured that the affected batch is contained and shipment to the customer prevented?
 3 Has top management ensured that personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all potential nonconforming product is identified and contained?
 4 Has top management ensured that  production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements?
6 Planning
6.1 Action to address risks and opportunities
6.1.2.1 Risk Analysis
1 Has the organization included in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework?  
2 Has the organization retained documented information as evidence of the results of risk analysis??  
6.1.2.2 Preventive Actions
1 Has the organization determined and implemented action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence?  
2 Are preventive actions appropriate to the severity of the potential issues?  
3 Has the organization established a process to lessen the impact of negative effects of risk?  
4 Has the organization established a process to  determining potential nonconformities and their causes?  
5 Has the organization established a process to evaluating the need for action to prevent occurrence of nonconformities?  
6 Has the organization established a process to determining and implementing action needed?  
7 Has the organization established a process to documented information of action taken?  
8 Has the organization established a process to  reviewing the effectiveness of the preventive action taken?  
9 Has the organization established a process to  utilizing lessons learned to prevent recurrence in similar processes?  
6.1.2.3 Contingency Plans
1 Has the organization  identified and evaluated internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met?  
2 Has the organization defined contingency plans according to risk and impact to the customer?  
3 Has the organization prepared contingency plans for continuity of supply in the event of  key equipment failures, interruption from externally provided products, processes, and services, recurring natural disasters, fire, utility interruptions, labor shortages or infrastructure disruptions?  
4 Has the organization  included, as a supplement to the contingency plans, a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations?  
5 Has the organization periodically tested the contingency plans for effectiveness (e.g. simulations, as appropriate) ?  
6 Has the organization conducted contingency plan reviews at a minimum annually using a multidisciplinary team including top management, and updated as required?  
7 Has the organization documented the contingency plans and retained documented information describing any revisions, including the person who authorized the change?  
8 Do the contingency plans include provisions to validate that the manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the regular shutdown processes were not followed?  
6.2 Quality Objectives and Planning to Achieve Them
6.2.2.1 Quality Objectives and Planning to Achieve Them – Supplemental
1 Has top management ensured that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization?  
2 Are the results of the organization’s review regarding interested parties and their relevant requirements considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and external)?  
7 Support
7.1 Resources
7.1.3 Infrastructure
7.1.3.1 Plant, Facility, and Equipment Planning
1 Has the organization used a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans?  
2 In designing plant layouts has the organization optimized material flow, material handling, and value-added use of floor space including control of nonconforming product?  
3 In designing plant layouts  facilitated synchronous material flow?  
4 Are methods developed and implemented to evaluate manufacturing feasibility for new product or new operations?  
5 Do manufacturing feasibility assessments include capacity planning?  
6 Are these methods also applicable for evaluating proposed changes to existing operations?  
7 Has the organization maintained process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance , and verification of job set-ups ?  
8 Are assessments of manufacturing feasibility and evaluation of capacity planning inputs to management reviews?  
9 As applicable does these requirements should include the application of lean manufacturing principles and apply to on-site supplier activities?  
7.1.4 Environment for the Operation of Processes
7.1.4.1 Environment for the Operation of Processes – Supplemental
1 Has the organization maintained its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs?  
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.1.1 Measurement Systems Analysis
1 Have statistical studies been conducted to analyse the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan?  
2 Do the analytical methods and acceptance criteria used conform to those in reference manuals on measurement systems analysis? Other analytical methods and acceptance criteria may be used if approved by the customer.  
3 Are records of customer acceptance of alternative methods retained along with results from alternative measurement systems analysis?  
4  Is prioritization of MSA studies focused on critical or special product or process characteristics?  
7.1.5.2 Measurement traceability
7.1.5.2.1 Calibration / Verification Records
1 Does the organization have a documented process for managing calibration / verification records?  
2 Are records of the calibration / verification activity for all gauges and measuring and test equipment (including employee – owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer -defined requirements retained?  
3 Has the organization ensured that calibration / verification activities and records include  revisions following engineering changes that impact measurement systems?  
4 Has the organization ensured that calibration / verification activities and records include any out-of-specification readings as received for calibration / verification?  
5 Has the organization ensured that calibration / verification activities and records include an assessment of the risk of the intended use of the product caused by the out-of-specification condition?  
6 Has the organization ensured that when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment is retained, including the associated standard’s last calibration date and the next due date on the calibration report?  
7 Has the organization ensured that notification is sent to the customer if suspect product or material has been shipped?  
8 Has the organization ensured that calibration / verification activities and records include statements of conformity to specification after calibration / verification?  
9 Has the organization ensured that calibration / verification activities and records include verification that the software version used for product and process controls is as specified?  
10 Has the organization ensured that calibration / verification activities and records include  records of the calibration and maintenance activities for all gauging including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment?  
11 Has the organization ensured that calibration / verification activities and records include production-related software verification used for product and process control including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment?  
7.1.5.3.1 Laboratory Requirements: Internal Laboratory
1 Does the organization’s internal laboratory facility have a defined scope that includes its capability to perform the required inspection, test, or calibration services?  
2 Is this laboratory scope included in the quality management system documentation?  
3 Has the laboratory specified and implemented requirements for adequacy of the laboratory technical  procedures?  
4 Has the laboratory specified and implemented requirements for competency of the laboratory personnel?  
5 Has the laboratory specified and implemented requirements for  testing of the product?  
6 Does the laboratory have the capability to perform these services correctly, traceable to the relevant process standard such as ASTM, EN, etc.?  
7 When no national or international standard(s) is available, has the organization defined and implemented a methodology to verify measurement system capability?  
8 Has the laboratory specified and implemented requirements for customer requirements?  
9 Has the laboratory specified and implemented requirements for  review of the related records?  
10 Does the Laboratory have a third-party accreditation to ISO / IEC 17025 (or equivalent)  to demonstrate the organization’s in-house laboratory conformity to the above mentioned requirements?  
7.1.5.3.2 Laboratory Requirements: External Laboratory
1 Do external/ commercial/ independent laboratory facilities used for inspection, test, or calibration services by the organization have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration?  
2 Is the external laboratory accredited to ISO / IEC 17025 or national equivalent and includes the relevant inspection, test, or calibration service in the scope of the accreditation (certificate) where  the certificate of calibration or test report includes the mark of a national accreditation body; or  there is evidence that the external laboratory is acceptable to the customer?  
NOTE: 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. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. Calibration services mayb be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met. Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation, if required.
7.2 Competence
7.2.1 Competence – Supplemental
1 Has the organization established and maintained a documented process for identifying training needs including awareness and achieving competence of all personnel performing activities affecting conformity to product and process requirements?  
2 Are personnel performing specific assigned tasks qualified, as required, with particular attention to the satisfaction of customer requirements?  
7.2.2 Competence – On-The-Job Training
1 Does the organization provide on-the-job training, which includes customer requirements training, for personnel in any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements?  
2 Does this includes contract or agency personnel?  
3 Is the level of detail required for on-the-job training commensurate with the level of education the personnel possess and the complexity of the task they are required to perform for their daily work?  
4 Are persons whose work can affect quality informed about the consequences of nonconformity to customer requirements?  
7.2.3 Internal Auditor Competency
 
1
Does the organization have a documented process to verify that internal auditors are competent, taking into account any customer-specific requirements?  
 
2
Does the organization maintain a list of qualified internal auditors?  
 
3
Are quality management system auditors, manufacturing process auditors, and product auditors all able to demonstrate the  understanding of the automotive process approach for auditing, including risk-based thinking?  
 
4
Are the auditors able to demonstrate the  understanding of applicable customer-specific requirements?  
 
5
Are the  auditors able to demonstrate the  understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit?  
 
6
Are the  auditors able to demonstrate the understanding of applicable core tool requirements related to the scope of the audit?  
 
7
Are the  auditors able to demonstrate the   understanding how to plan, conduct, report, and close out audit findings?  
 
8
Do manufacturing process auditors demonstrate technical understanding of the relevant manufacturing process to be audited, including process risk analysis such as PFMEA and control plan?  
 
9
Do product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity?  
 
10
Where training is provided to achieve competency, is documented information retained to demonstrate the trainer’s competency with the above requirements?  
 
11
Is maintenance of and improvement in internal auditor competence demonstrated through executing a minimum number of audits per year, as defined by the organization?  
 
12
Is maintenance of and improvement in internal auditor competence demonstrated through maintaining knowledge of relevant requirements based on internal changes (e.g. process technology, product technology) and external changes (e.g. ISO 9001, IATF 16949, core tools, and customer specific requirements)?  
7.2.4 Second-Party Auditor Competency
 
1
Does the organization demonstrate the competence of the auditors undertaking the second-party audits?  
 
2
Do second-party auditors meet customer specific requirements for auditor qualification and demonstrate the understanding of the automotive process approach to auditing, including risk based thinking?  
 
3
Do second-party auditors demonstrate the understanding of applicable customer and organization specific requirements?  
 
4
Do second-party auditors demonstrate the understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit?  
 
5
Do second-party auditors demonstrate the understanding of applicable manufacturing process to be audited, including PFMEA and control plan?  
 
6
Do second-party auditors demonstrate the understanding of applicable core tool requirements related to the scope of the audit?  
 
7
Do second-party auditors demonstrate the understanding of how to plan, conduct, prepare audit reports, and close out audit findings?  
7.3 Awareness
7.3.1 Awareness – Supplemental
 
1
Does the organization maintain documented information that demonstrates that all employees are aware of their impact on product quality and the importance of the activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with non-conforming product?  
7.3.2 Awareness – Employee Motivation and Empowerment
1 Does the organization maintain a documented process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation?  
2 Does the process include the promotion of quality and technological awareness throughout the whole organization?  
7.5 Documented Information
7.5.1 General
7.5.1.1 Documented Information: Quality Management System Documentation
1 Is the organization’s quality management system documented and includes a quality manual, which can be a series of documents (electronic or hard copy)?  
2 Is the format and structure of the quality manual at the discretion of the organization and does it depend on the organization’s size, culture, and complexity?  
3 If a series of documents is used, is a list retained of the documents that comprise the quality manual for the organization?  
4 Does the quality manual include the scope of the quality management system, including details of and justification for any exclusions?  
5 Does the quality manual include documented processes established for the quality management system, or reference to them?  
6 Does the quality manual include the organization’s processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes?  
7 Does the quality manual include  a document (ie. matrix) indicating where within the organization’s quality management system their customer-specific requirements are addressed?  
NOTE: A matrix of how the requirements of this Automotive QMS standard are addressed by the organization’s processes may be used to assist with linkages of the organization’s processes and this Automotive QMS.
7.5.3 Control of Documented Information
7.5.3.2.1 Record Retention
1 Does the organization define, document, and implement a record retention policy?  
2 Do the control of records satisfy statutory, regulatory, organizational, and customer requirements?  
3 Are production part approvals, tooling records including maintenance and ownership, product and process design records, purchase orders (if applicable), or contracts and amendments retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency?  
4 Does Production part approval documented information include approved product, applicable test equipment records, or approved test data?  
7.5.3.2.2 Control of Documented Information: Engineering Specifications
1 Does the organization have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required?  
2  Does the organization retain a record of the date on which each change is implemented in production?  
3 Does implementation include updated documents?  
4 Is review completed within 10 working days of receipt of notification of engineering standards/specification changes?  
NOTE: A change in these standards / specifications may require an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs), etc.
8 Operations
8.1 Operational Planning and Control
8.1.1 Operational Planning and Control – Supplemental
1 When planning for product realization, are the following topics included: a) customer product requirements and technical specifications b) logistics requirements c) manufacturing feasibility d) project planning  e) acceptance criteria?  
8.1.2 Confidentiality
1 Has the organization ensured the confidentiality of customer-contracted products and projects under development, including related product information?  
8.2 Requirements for Products and Services
8.2.1 Customer Communication
8.2.1.1 Customer Communication – Supplemental
1 Is written or verbal communication in the language agreed with the customer?  
2 Does the organization have the ability to communicate necessary information, including data in a customer-specified computer language and format e.g. computer-aided design data, electronic data interchange?  
8.2.2 Determining the Requirements for Products and Services
8.2.2.1 Determining the Requirements for Products and Services – Supplemental
1 Do these requirements include recycling, environmental impact, and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes?  
2 Does compliance to any statutory and Regulatory requirement related to product include all applicable government, safety, and environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material?  
8.2.3 Review of the Requirements for Products and Services
8.2.3.1.1 Review of the Requirements for Products and Services – Supplemental
1 Does the organization retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001, Section 8.2.3.1, for a formal review?  
8.2.3.1.2  Customer-Designated Special Characteristics
1 Does the organization conform to customer requirements for designation, approval documentation, and control of special characteristics?  
8.2.3.1.3 Requirements for Products and Services: Organization Manufacturing Feasibility
1 Does the organization utilize a multidisciplinary approach to conduct an analysis to determine if it is feasible that the organization’s manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer?  
2 Does the organization conduct this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design?  
3 Additionally, does the organization validate through production runs, bench marking studies, or other appropriate methods, their ability to make product to specifications at the required rate?  
8.3 Design and development of products and services
8.3.1 General
8.3.1.1 Design and development of products and services – supplement
1 Does the requirement of product and manufacturing process design and development focusses on error prevention rather on detection ?  
1 Does the organization documents its design and development processes?  
8.3.2 Design and Development Planning 
8.3.2.1 Design and Development Planning – Supplemental
1 Does the organization ensure that design and development planning includes all affected stakeholders within the organization and, as appropriate, its supply chain?  
2 While doing the Design and development planning, does the organization uses as  a multidisciplinary approach which includes  a) project management (for example, APQP or VDA – RGA); b) product and manufacturing process design activities (for example, DFM and DFA), such as consideration of the use of alternative designs and manufacturing processes; c) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks; d) development and review of manufacturing process risk analysis (for example, FMEAs, process flows, control plans, and standard work instructions)?  
NOTE: A multidisciplinary approach typically includes the organization’s design, manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions.
8.3.2.2 Product Design Skills
1 Does the organization ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques?  
2 Are applicable tools and techniques identified by the organization?  
8.3.2.3 Development of Products with Embedded Software
1

 

Does the organization use a process for quality assurance for their products with internally developed embedded software?  
2 Is a software development assessment methodology utilized to assess the organization’s software development process?  
3 Using prioritization based on risk and potential impact to the customer, does the organization retain documented information of a software development capability self-assessment?  
4 Does the organization include software development within the scope of their internal audit programme?  
8.3.3 Design and Development Inputs
8.3.3.1 Product Design Input
1 Does the organization identify, document, and review product design input requirements as a result of contract review?  
2 Do product design input requirements include product specifications including but not limited to special characteristics?  
3 Do product design input requirements include boundary and interface requirements?  
4 Do product design input requirements include  identification, traceability, and packaging?  
5 Do product design input requirements include consideration of design alternatives?

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

 
6 Do product design input requirements include assessment of risks with the input requirements and the organization’s ability to mitigate / manage the risks, including from the feasibility analysis?  
7 Do product design input requirements include targets for conformity to product requirements including preservation, reliability, durability, serviceability, health, safety, environmental, development timing, and cost?  
8 Do product design input requirements include applicable statutory and regulatory requirements of the customer-identified country of destination, if provided?  
9 Do product design input requirements include embedded software requirements?  
10 Does the organization have a process to deploy information gained from previous design projects, competitive product analysis (benchmarking), supplier feedback, internal input, field data, and other relevant sources for current and future projects of a similar nature?  
8.3.3.2 Manufacturing Process Design Input
 1 Does the organization identify, document, and review manufacturing process design input requirements?  
 2 Does the manufacturing process design input requirements including but not limited to the following: a) product design output data including special characteristics; b) targets for productivity, process capability, timing, and cost; c) manufacturing technology alternatives; d) customer requirements, if any; e) experience from previous developments; f) new materials; g) product handling and ergonomic requirements; and h) design for manufacturing and design for assembly?  
3 Does the manufacturing process design include the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered?  
8.3.3.3 Special Characteristics
 1  Does the organization use a multidisciplinary approach to establish, document, and implement its process to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization?  
 2  Does it includes  documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standard work/operator instructions; special characteristics identified with specific markings and cascaded through each of these documents?  
 3  Does identification of special characteristics includes development of control and monitoring strategies for special characteristics of products and production processes?  
 4 Does identification of special characteristics includes customer-specified approvals, when required?  
 5 Does identification of special characteristics includes compliance with customer-specified definitions and symbols or the organization’s equivalent symbols or notations, as defined in a symbol conversion table?  
 6  Is the symbol conversion table submitted to the customer, if required?  
8.3.4 Design and Development Controls
8.3.4.1 Monitoring
 1 Are measurements at specified stages during the design and development of products and processes defined, analyzed, and reported with summary results as an input to management review?  
 2  When required by the customer, are measurements of the product and process development activity reported to the customer at stages specified, or agreed to, by the customer?  
 3 When appropriate, does these measurements include quality risks, costs, lead times, critical paths, and other measurements?  
8.3.4.2 Design and Development Validation
1 Is design and development validation performed in accordance with customer requirements, including any applicable industry and governmental agency-issued regulatory standards?  
2 Is the timing of design and development validation planned in alignment with customer-specified timing, as applicable?  
3 Where contractually agreed with the customer, does this include evaluation of the interaction of the organization’s product, including embedded software, within the system of the final customer’s product?  
8.3.4.3 Prototype Programme
1 When required by the customer, does the organization have a prototype programme and control plan?  
2 Does the organization use, whenever possible, the same suppliers, tooling, and manufacturing processes as used in production?  
3 Are all performance-testing activities monitored for timely completion and conformity to requirements?  
4 When services are outsourced, does the organization include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to requirements?  
8.3.4.4 Product Approval Process
1 Does the organization establish, implement, and maintain a product and manufacturing approval process conforming to requirements defined by the customer?  
2 Does the organization approve externally provided products and services per ISO 9001, Section 8.4.3 (Information for external provider), prior to submission of their part approval to the customer?  
3 Does the organization obtain documented product approval prior to shipment, if required by the customer? Are records of such approval retained?  
4 Are records of such approval retained?  
NOTE: Product approval should be subsequent to the verification of the manufacturing process.
8.3.5 Design and Development Outputs
8.3.5.1 Design and Development Outputs – Supplemental
1 Is the product design output expressed in terms that can be verified and validated against product design input requirements?  
2 Does the product design output include design risk analysis (Design FMEA)?  
 3  Does the product design output include reliability study results?
 4  Does the product design output include product special characteristics?  
 5  Does the product design output include  results of product design error-proofing, such as DFSS, DFMA and FTA?
 6  Does the product design output include product definition including 2D drawing, 3D models, technical data packages, product manufacturing information, and geometric dimensioning & tolerancing (GD & T)?
 7  Does the product design output include product design review results?
 8  Does the product design output include service diagnostic guidelines and repair and serviceability instructions?
 9 Does the product design output include service part requirements?
 10 Does the product design output include packaging and labeling requirements for shipping?
 11 Does the Interim design outputs include any engineering problems being resolved through a trade-off process?
8.3.5.2 Manufacturing Process Design Output
 1 Does the organization document the manufacturing process design output in a manner that enables verification against the manufacturing process design inputs?
 2 Does the organization verify the outputs against manufacturing process design input requirements?
 3 Does the manufacturing process design output include specifications and drawings?
 4 Does the manufacturing process design output include  special characteristics for product and manufacturing process?
 5  Does the manufacturing process design output include  identification of process input variables that impact characteristics?
 6 Does the manufacturing process design output include tooling and equipment for production and control, including capability studies of equipment and process?
 7 Does the manufacturing process design output include manufacturing process flowcharts / layout, including linkage of product, process, and tooling?
 8 Does the manufacturing process design output include capacity analysis?
 9  Does the manufacturing process design output include manufacturing process FMEA?
 10  Does the manufacturing process design output include  maintenance plans and instructions?
 11  Does the manufacturing process design output include  control plan?
12 Does the manufacturing process design output include standard work and work instructions?  
13 Does the manufacturing process design output include process approval acceptance criteria?  
14 Does the manufacturing process design output include  data for quality, reliability, maintainability, and measurability?  
15 Does the manufacturing process design output include  results of error-proofing identification and verification, as appropriate?  
16 Does the manufacturing process design output include  methods of rapid detection, feedback, and correction of product/manufacturing process nonconformities?  
8.3.6 Design and Development Changes
8.3.6.1 Design and Development Changes – Supplemental
1 Does the organization evaluate all design changes after initial product approval, including those proposed by the organization or its suppliers, for potential impact on fit, form, function, performance, and/or durability?  
2 Are these changes validated against customer requirements and approved internally, prior to production implementation?  
3 If required by the customer, does the organization obtain documented approval, or a documented waiver, from the customer prior to production implementation?  
4 For products with embedded software, does the organization document the revision level of software and hardware as part of the change record?  
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.1.1 General – Supplemental
1 Does the organization include all products and services that affect customer requirements such as sub- assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services?  
8.4.1.2 Supplier Selection Process
 1 Does the organization have a documented supplier selection process?
 2 Does the selection process include an assessment of the selected supplier’s risk to product conformity and uninterrupted supply of the organization’s product to the customers?
 3 Does the selection process include relevant quality and delivery performance?
 4 Does the selection process include an evaluation of the supplier’s quality management system?
 5  Does the selection process include multidisciplinary decision making?
 6 Does the selection process include an assessment of software development capabilities, if applicable?  
 7 Are other supplier selection criteria considered including the following: volume of automotive business (absolute and as a percentage of total business); financial stability; purchased product, material, or service complexity; required technology (product or process); adequacy of available resources (e.g. people, infrastructure); design and development capabilities (including project management);  manufacturing capability; change management process; business continuity planning (e.g. disaster preparedness, contingency planning); logistics process; customer service  
8.4.1.3 Customer-Directed Sources (also known as “Directed-Buy”)
1 When specified by the customer, does the organization purchase products, materials, or services from customer-directed sources?  
 2  Are all requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) applicable to the organization’s control of customer-directed sources unless specific agreements are otherwise defined by the contract between the organization and the customer?  
8.4.2 Type and Extent of Control
8.4.2.1 Type and Extent of Control – Supplemental
1 Does the organization have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements?  
2 Does the process include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks?  
8.4.2.2 Statutory and Regulatory Requirements
1 Does the organization document their process to ensure that purchased products, processes, and services conform to the current applicable statutory and regulatory requirements in the country of receipt, the country of shipment, and the customer-identified country of destination, if provided?  
2 If the customer defines special controls for certain products with statutory and regulatory requirements, does the organization ensure they are implemented and maintained as defined, including at suppliers?  
8.4.2.3 Supplier Quality Management System Development
1 Does the organization require their suppliers of automotive products and services to develop, implement, and improve a quality management system certified to ISO 9001, unless otherwise authorized by the customer, with the ultimate objective of becoming certified to this Automotive QMS Standard?  
2 Unless otherwise specified by the customer, is the following sequence applied to achieve this requirement:

  1. compliance to ISO 9001 through second-party audits;
  2. certification to ISO 9001 through third-party audits; unless otherwise specified by the customer, do suppliers to the organization demonstrate conformity to ISO 9001 by maintaining a third-party certification issued by a certification body bearing the accreditation mark of a recognized IAF MLA (International Accreditation Forum Multilateral Recognition Arrangement) member and where the accreditation body’s main scope includes management system certification to ISO / IEC 17021;
  3. certification to ISO 9001 with compliance to other customer-defined QMS requirements (such as Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers [MAQMSR] or equivalent) through second-party audits;
  4. certification to ISO 9001 with compliance to IATF 16949 through second-party audits;
  5. certification to 16949 through third-party audits (valid third-party certification of the supplier to IATF 16949 by an IATF-recognized certification body)?
 
8.4.2.3.1 Automotive product-related software or automotive products with embedded software
1 Does the organization require their suppliers of automotive product-related software, or automotive products with embedded software, to implement and maintain a process for software quality assurance for their products?  
2 Is a software development assessment methodology utilized to assess the supplier’s software development process?  
3 Using prioritization based on risk and potential impact to the customer, does the organization require the supplier to retain documented information of a software development capability self-assessment?  
8.4.2.4 Supplier Monitoring
1 Does the organization have a documented process and criteria to evaluate supplier performance in order to ensure conformity of externally provided products, processes, and services to internal and external customer requirements?  
2 At a minimum, are the following supplier performance indicators monitored:

  1. delivered product conformity to requirements;
  2. customer disruptions at the receiving plant, including yard holds and stop ships;
  3. delivery schedule performance;
  4. number of occurrences of premium freight?
 
3 If provided by the customer, does the organization also include the following, as appropriate, in their supplier performance monitoring:

  1. special status customer notifications related to quality or delivery issues;
  2. dealer returns, warranty, field actions, and recalls?
 
8.4.2.4.1 Second-party audits
1 Does the organization include a second-party audit process in their supplier management approach?
Second-party audits may be used for the following: a) supplier risk assessment; b) supplier monitoring; c) supplier QMS development; d) product audits; e) process audits.
 
2 Based on a risk analysis, including product safety/regulatory requirements, performance of the supplier, and QMS certification level, at a minimum, does the organization document the criteria for determining the need, type, frequency, and scope of second-party audits? Does the organization retain records of the second-party audit reports?  
3 If the scope of the second-party audit is to assess the supplier’s quality management system, is the approach consistent with the automotive process approach?  
8.4.2.5 Supplier Development
1 Does the organization determine the priority, type, extent, and timing of required supplier development actions for its active suppliers?  
2 Do determination inputs include performance issues identified through supplier monitoring?  
3 Do determination inputs include second-party audit findings?  
4 Do determination inputs include  third-party quality management system certification status?  
5 Do determination inputs include risk analysis?  
6 Does the organization implement actions necessary to resolve open (unsatisfactory) performance issues and pursue opportunities for continual improvement?  
8.4.3 Information for External Providers 
8.4.3.1 Information for External Providers – Supplemental
1 Does the organization pass down all applicable statutory and regulatory requirements and special product and process characteristics to their suppliers and require the suppliers to cascade all applicable requirements down the supply chain to the point of manufacture?  
8.5 Production and Service provision
8.5.1 Control of Production and Service provision
8.5.1.1 Control Plan
1 Does the organization develop control plans at the system, subsystem, component, and / or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts?  
2 Are family control plans acceptable for bulk material and similar parts using a common manufacturing process?  
3 Does the organization have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk analysis outputs (such as FMEA)?  
4 Does the organization, if required by the customer, provide measurement and conformity data collected during execution of either the pre-launch or production control plans?  
5 Does Control plan includes controls used for the manufacturing process control, including verification of job set-ups?  
6 Does Control plan includes first-off / last-off part validation, as applicable?  
7 Does Control plan includes  methods for monitoring of control exercised over special characteristics, defined by both the customer and the organization?  
8 Does Control plan includes  the customer-required information, if any?  
9 Does Control plan includes specified reaction plan when nonconforming product is detected, the process becomes statistically unstable or not statistically capable?  
10 Does the organization review control plans and update when it has shipped nonconforming product to the customer?  
11 Does the organization review control plans and update when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)?  
12 Does the organization review control plans and update  after a customer complaint and implementation of the associated corrective action, when applicable?  
13 Does the organization review control plans and update at a set frequency based on a risk analysis?  
14 If required by the customer, does the organization obtain customer approval after review or revision of the control plan?  
8.5.1.2 Standardised Work – Operator Instructions and Visual Standards
1 Does the organization ensure that standardised work documents are communicated to and understood by the employees who are responsible for performing the work?  
2 Is it  legible and presented in the language understood by the personnel responsible to follow them?  
3 Is it accessible for use at the designated work area?  
4  Do the standardised work documents also include rules for operator safety?  
8.5.1.3 Verification of Job Set-Ups
1 Does the organization verify job set-ups when performed, such as an initial run of a job, material changeover, or job change that requires a new set-up?  
2 Does the organization maintain documented information for set-up personnel?  
3 Does the organization use statistical methods of verification, where applicable?  
4 Does the organization  perform first-off/last-off part validation, as applicable; where appropriate, are first-off parts retained for comparison with the last-off parts; where appropriate, are last-off parts retained for comparison with first-off parts in subsequent runs?  
5 Does the organization retain records of process and product approval following set-up and first-off/last-off part validations?  
8.5.1.4 Verification After Shutdown
1 Does the organization define and implement the necessary actions to ensure product compliance with requirements after a planned or unplanned production shutdown period?  
8.5.1.5 Total Productive Maintenance
 1 Does the organization develop, implement, and maintain a documented total productive maintenance system?  
 2 Does the system include identification of process equipment necessary to produce conforming product at the required volume?  
 3 Does the system include availability of replacement parts for the equipment identified?  
 4 Does the system include provision of resource for machine, equipment, and facility maintenance?  
 5 Does the system include packaging and preservation of equipment, tooling, and gauging?  
 6 Does the system include applicable customer-specific requirements?  
 7 Does the system include documented maintenance objectives, for example: OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure), and MTTR (Mean Time To Repair), and Preventive Maintenance compliance metrics?  
 8 Does performance to the maintenance objectives form an input into management review ?  
 9 Does the system include regular review of maintenance plan and objectives and a documented action plan to address corrective actions where objectives are not achieved?  
 10  Does the system include use of preventive maintenance methods?
 11  Does the system include  use of predictive maintenance methods, as applicable?  
 12  Does the system include  periodic overhaul?  
8.5.1.6 Management of Production Tooling and Manufacturing, Test, Inspection Tooling and Equipment
 1  Does the organization provide resources for tool and gauge design, fabrication, and verification activities for production and service materials and for bulk materials, as applicable?  
 2 Does the organization establish and implement a system for production tooling management, whether owned by the organization or the customer?  
 3 Does the Production tooling management includes maintenance and repair facilities and personnel?  
 4 Does the Production tooling management includes storage and recovery?  
 5 Does the Production tooling management includes set-up and tool-change programmes for perishable tools?  
 6 Does the Production tooling management includes tool design modification documentation, including engineering change level of the product?  
 7 Does the Production tooling management includes tool modification and revision to documentation?  
 8 Does the Production tooling management includes tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location?  
 9  Does the organization verify that customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined?  
 10  Does the organization implement a system to monitor these activities if any work is outsourced?  
8.5.1.7 Production Scheduling
1 Does the organization ensure that production is scheduled in order to meet customer orders/demands such as Just-In-Time (JIT) and is supported by an information system that permits access to production information at key stages of the process and is order driven?  
2 Does the organization include relevant planning information during production scheduling, e.g. customer orders, supplier on-time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration?  
8.5.2 Identification and Traceability 
8.5.2.1 Identification and Traceability – Supplemental
1 Does the organization implement identification and traceability processes to support identification of clear start and stop points for product received by the customer or in the field that may contain quality and/or safety-related nonconformities?  
2 Does the organization conduct an analysis of internal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers, and consumers?  
3 Do these plans define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location?  
4 Do these plans  enable the organization to identify nonconforming and/or suspect product?  
5 Do these plans enable the organization to segregate nonconforming and/or suspect product?  
6 Do these plans ensure the ability to meet the customer and/or regulatory response time requirements?  
7  Do these plans  ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the organization to meet the response time requirements?  
8  Do these plans ensure serialized identification of individual products, if specified by the customer or regulatory standards?  
9 Do these plans ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics?  
8.5.4 Preservation
8.5.4.1 Preservation – Supplemental
1 Does preservation include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection?  
2 Does preservation apply to materials and components from external and/or internal providers from receipt through processing, including shipment and until delivery to/acceptance by the customer?  
3 In order to detect deterioration, does the organization assess at appropriate planned intervals the condition of product in stock, the place/type of storage container, and the storage environment?  
4 Does the organization use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out” (FIFO)?  
5 Does the organization ensure that obsolete product is controlled in a manner similar to that of nonconforming product?  
6 Do organizations comply with preservation, packaging, shipping, and labeling requirements as provided by their customers?  
8.5.5 Post Delivery activities
8.5.5.1 Feedback of Information from Service
1 Does the organization ensure that a process for communication of information on service concerns to manufacturing, material handling, logistics, engineering, and design activities is established, implemented, and maintained?  
2

 

Is  the organization  aware of nonconforming products and materials that may be identified at the customer location or in the field. ?  
3 Where applicable does “Service Concerns” include the results of field failure test analysis?  
8.5.5.2 Service Agreement with Customer
1 When there is a service agreement with the customer, does the organization verify that the relevant service centres comply with applicable requirements?  
2 Does the organization verify the effectiveness of any special purpose tools or measurement equipment?
3 Does the organization ensure that all service personnel are trained in applicable requirements?  
8.5.6 Control of Changes
8.5.6.1 Control of Changes – Supplemental
1 Does the organization have a documented process to control and react to changes that impact product realization?  
2 Are the effects of any change, including those changes caused by the organization, the customer, or any supplier, assessed?
3 Does the organization define verification and validation activities to ensure compliance with customer requirements?  
4 Does the organization validate changes before implementation?  
5 Does the organization document the evidence of related risk analysis?
6 Does the organization retain records of verification and validation?  
7 Do changes, including those made at suppliers, require a production trial run for verification of changes such as changes to part design, manufacturing location, or manufacturing process to validate the impact of any changes on the manufacturing process?  
8 When required by the customer, does the organization notify the customer of any planned product realization changes after the most recent product approval?
9 When required by the customer, does the organization obtain documented approval, prior to implementation of the change?  
10 When required by the customer, does the organization complete additional verification or identification requirements, such as production trial run and new product validation?  
8.5.6.1.1 Temporary Change of Process Controls
1 Does the organization identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices, that includes the primary process control and the approved back-up or alternate methods?  
2 Does the organization document the process that manages the use of alternate control methods?
3 Does the organization include in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implementation of the alternate control method?  
4 Before shipping product that was inspected or tested using the alternate method, if required, does the organization obtain approval from the customer(s)?  
5 Does the organization maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan?
6 Are standard work instructions available for each alternate process control method?  
7 Does the organization review the operation of alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the goal to return to the standard process as defined by the control plan as soon as possible? Example methods include but are not limited to the following:

  1. daily quality focused audits (e.g. layered process audits, as applicable)
  2. daily leadership meetings.
 
8 Is restart verification documented for a defined period based on severity and confirmation that all features of the error-proofing device or process are effectively reinstated?
9 Does the organization implement traceability of all product produced while any alternate process control devices or processes are being used (e.g. verification and retention of first piece and last piece from every shift)?  
8.6 Release of Products and Services
8.6.1 Release of Products and Services – Supplemental
 1 Does the organization ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan?  
 2 Does the organization ensure that the planned arrangements for the initial release of products and services encompass product or service approval?  
 3 Does the organization ensure that product or service approval is accomplished after changes following initial release, according to ISO 9001, Section 8.5.6?  
8.6.2 Layout Inspection and Functional Testing
 1 Is a layout inspection and a functional verification to applicable customer engineering material and performance standards performed for each product as specified in the control plans?  
 2 Are results available for customer review?  
NOTE 1: Layout inspection is the complete measurement of all product dimensions shown on the design record(s). NOTE 2: The frequency of layout inspection is determined by the customer.
8.6.3 Appearance Items
 1 For organizations manufacturing parts designated by the customer as “appearance items”, does the organization provide appropriate resources, including lighting, for evaluation?
 2 Does the organization provide masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), and haptic technology, as appropriate?
 3 Does the organization provide maintenance and control of appearance masters and evaluation equipment?
 4 Does the organization provide verification that personnel making appearance evaluations are competent and qualified to do so?
8.6.4 Verification and Acceptance of Conformity of Externally Provided Products and Services
 1 Does the organization have a process to ensure the quality of externally provided processes, products, and services utilizing one or more of the following methods:

  1. receipt and evaluation of statistical data provided by the supplier to the organization;
  2. receiving inspection and/or testing, such as sampling based on performance;
  3. second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable delivered product conformance to requirements;
  4. part evaluation by a designated laboratory;
  5.  another method agreed with the customer?
8.6.5 Statutory and Regulatory Conformity
 1 Prior to release of externally provided products into its production flow, does the organization confirm and is it able to provide evidence that externally provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requirements in the countries where they are manufactured and in the customer-identified countries of destination, if provided?
8.6.6 Acceptance Criteria
 1 Is acceptance criteria defined by the organization and, where appropriate or required, approved by the customer?
 2  For attributed data sampling, is the acceptance level zero defects?
8.7 Control of Non conforming outputs
8.7.1.1 Customer Authorization for Concession
1 Does the organization 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?  
2 Does the organization obtain customer authorization prior to further processing for “use as is” and rework dispositions of nonconforming product?
3  If sub-components are reused in the manufacturing process, is that sub-component reuse clearly communicated to the customer in the concession or deviation permit?  
4 Does the organization maintain a record of the expiration date or quantity authorized under concession?  
5 Does the organization also ensure compliance with the original or superseding specifications and requirements when the authorization expires?
6 Is material shipped under concession properly identified on each shipping container (this applies equally to purchased product)?  
7 Does the organization approve any requests from suppliers before submission to the customer?  
8.7.1.2 Control of Nonconforming Product – Customer – Specified Process
 1 Does the organization comply with applicable customer-specified controls for nonconforming product(s)?
8.7.1.3 Control of Suspect Product
 1 Does the organization ensure that product with unidentified or suspect status is classified and controlled as nonconforming product?
 2 Does the organization ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconforming product?
8.7.1.4 Control of Reworked Product
1 Does the organization utilize risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a decision to rework the product?  
2 If required by the customer, does the organization obtain approval from the customer prior to commencing rework of the product?
3 Does the organization have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications?  
4  Are instructions for disassembly or rework, including re-inspection and traceability requirements, accessible to and utilized by the appropriate personnel?  
5 Does the organization retain documented information on the disposition of reworked product including quantity, disposition, disposition date, and applicable traceability information?
8.7.1.5 Control of Repaired Product
1 Does the organization utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a decision to repair the product?  
2 Does the organization obtain approval from the customer before commencing repair of the product?
3 Does the organization have a documented process for repair confirmation in accordance with the control plan or other relevant documented information?  
4 Are instructions for disassembly or repair, including re-inspection and traceability requirements, accessible to and utilized by the appropriate personnel?  
5 Does the organization obtain a documented customer authorization for concession for the product to be repaired?
6 Does the organization retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information?
8.7.1.6 Customer Notification
 1 Does the organization immediately notify the customers in the event that nonconforming product has been shipped?
 2 Is initial communication followed with detailed documentation of the event?
8.7.1.7 Nonconforming Product Disposition
1 Does the organization have a documented process for disposition of nonconforming product not subject to rework or repair?  
2 For product not meeting requirements, does the organization verify that the product to be scrapped is rendered unusable prior to disposal?
3 The organization shall not divert nonconforming product to service or other use without prior customer approval.  
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.1.1 Monitoring and Measurement of Manufacturing Processes
1 Does the organization perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control, including those for special characteristics?
2 For  manufacturing processes where  it may not be possible to demonstrate product compliance through process capability, are  alternate methods such as batch conformance to specification  used?
3 Does the organization maintain manufacturing process capability or performance results as specified by the customer’s part approval process requirements?
4 Does the organization verify that the process flow diagram, PFMEA, and control plan are implemented?  
5 Does the organization adherence to the following:

  1. measurement techniques;
  2. sampling plans;
  3. acceptance criteria;
  4. records of actual measurement values and/or test results for variable data;
  5. reaction plans and escalation process when acceptance criteria are not met
 
6 Are significant process events, such as tool change or machine repair, recorded and retained as documented information?  
7 Does the he organization initiate a reaction plan indicated on the control plan and evaluated for impact on compliance to specifications for characteristics that are either not statistically capable or are unstable?  
8 Does these reaction plans include containment of product and 100 percent inspection, as appropriate?  
9 Is a corrective action plan developed and implemented by the organization indicating specific actions, timing, and assigned responsibilities to ensure that the process becomes stable and statistically capable.?  
10 Do the organization review the plans  with and approved by the customer, when required. ?  
11 Does the organization  maintain records of effective dates of process changes.?  
9.1.1.2 Identification of Statistical Tools
1 Does the organization determine the appropriate use of statistical tools?  
2 Does the organization verify that appropriate statistical tools are included as part of the advanced product quality planning (or equivalent) process and included in the design risk analysis (such as DFMEA) (where applicable), the process risk analysis (such as PFMEA), and the control plan?  
9.1.1.3 Application of Statistical Concepts
1 Are statistical concepts, such as variation, control (stability), process capability, and the consequences of over-adjustment, understood and used by employees involved in the collection, analysis, and management of statistical data?  
9.1.2. Customer satisfaction
9.1.2.1 Customer Satisfaction – Supplemental
1 Is customer satisfaction with the organization monitored through continual evaluation of internal and external performance indicators to ensure compliance to the product and process specifications and other customer requirements?  
2 Are performance indicators based on objective evidence and include but not limited to the following: a) delivered part quality performance?  
3 Does performance indicators include customer disruptions?  
4 Does performance indicators include field returns, recalls, and warranty (where applicable)?  
5 Does performance indicators include delivery schedule performance (including incidents of premium freight)?  
6 Does performance indicators include  customer notifications related to quality or delivery issues, including special status?  
7 Does the organization monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?  
8 Does the organization monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?  
9 Does the organization monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?  
10 Do the organization record analytical results and do the organization retain and control these records?  
9.1.3. Analysis and evaluation
9.1.3.1 Prioritization
1 Are trends in quality and operational performance compared with progress toward objectives and lead to action to support prioritization of actions for improving customer satisfaction?  
9.2 Internal Audit
9.2.2.1 Internal Audit Programme
1 Does the organization have a documented internal audit process?  
2 Does the process include the development and implementation of an internal audit programme that covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits?  
3 Is the audit programme prioritized based upon risk, internal and external performance trends, and criticality of the processes?  
4 Where the organization is responsible for software development, does the organization include software development capability assessments in their internal audit programme?  
5 Is the frequency of audits reviewed and, where appropriate, adjusted based on occurrence of process changes, internal and external nonconformities, and/or customer complaints?  
6  Is the effectiveness of the audit programme reviewed as a part of management review?  
9.2.2.2 Quality Management System Audit
1 Does the organization audit all quality management system processes over each three-year calendar period, according to an annual programme, using the process approach to verify compliance with this Automotive QMS Standard?  
2 Integrated with these audits, does the organization sample customer-specific quality management system requirements for effective implementation?  
9.2.2.3 Manufacturing Process Audit
1 Does the organization audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency using customer-specified required approaches for process audits?  
2 Where not defined by the customer, does the organization determine the approach to be used?  
3 Within each individual audit plan, is each manufacturer process audited on all shifts where it occurs, including the appropriate sampling of the shift handover?  
4 Does the manufacturing process audit include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents?  
9.2.2.4 Product Audit
1 Does the organization audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements?  
2 Where not defined by the customer, does the organization define the approach to be used?  
9.3 Management review
9.3.1 General
9.3.1.1 Management Review – Supplemental
1 Is management review conducted at least annually?  
2 Is the frequency of management review(s) increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality management system and performance-related issues?  
9.3.2 Management review inputs
9.3.2.1 Management Review Inputs – Supplemental
1 Does input to management review include cost of poor quality (cost of internal and external nonconformance)?  
2 Does input to management review include measures of process effectiveness?  
3 Does input to management review include measures of process efficiency?  
4 Does input to management review include product conformance?  
5 Does input to management review include assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product?  
6 Does input to management review include  customer satisfaction?  
7 Does input to management review include  review of performance against maintenance objectives?  
8 Does input to management review include warranty performance where applicable?  
9 Does input to management review include  review of customer scorecards where applicable?  
10 Does input to management review include identification of potential field failures identified through risk analysis (such as FMEA)?  
11 Does input to management review include actual field failures and their impact on safety or the environment?  
9.3.3 Management review outputs
9.3.3.1 Management Review Outputs – Supplemental
1 Does top management document and implement an action plan when customer performance targets are not met?  
10 Improvement
10.2 Non conformity and corrective action
10.2.3 Problem Solving
1 Does the organization have a documented processes for problem solving?  
2 Has the organization defined approaches for various types and scale of problems (e.g. new product development, current manufacturing issues, field failures, audit findings)?  
3 Does the process includes containment, interim actions, and related activities necessary for control of nonconforming outputs?  
4 Does it includes root cause analysis, methodology used, analysis, and results?  
5 Does it includes implementation of systemic corrective actions, including consideration of the impact on similar processes and products?  
6 Does the organization  verifies of the effectiveness of implemented corrective actions?  
7  Does the organization reviews and, where necessary, update the appropriate documented information (e.g. PFMEA, control plan)?  
8 Where the customer has specified prescribed processes, tools, or systems for problem solving, does the organization use those processes, tools, or systems, unless otherwise approved by the customer?  
10.2.4 Error-Proofing
1 Does the organization have a documented process to determine the use of appropriate error-proofing methodologies?  
2 Are details of the method used documented in the process risk analysis (such as PFMEA) and are test frequencies documented in the control plan?  
3 Does the process include the testing of error-proofing devices for failure or simulated failure?  
4 Are records maintained?  
5 Are challenge parts, when used, identified, controlled, verified, and calibrated where feasible?  
6 Do error-proofing device failures have a reaction plan?  
10.2.5 Warranty Management Systems
1 When the organization is required to provide warranty for their products, does the organization implement a warranty management process?  
2 Does the organization include in the process a method for warranty part analysis, including NTF (no trouble found)?  
3 When specified by the customer, does the organization implement the required warranty management process?  
10.2.6 Customer Complaints and Field Failure Test Analysis
1 Does the organization perform analysis on customer complaints and field failures, including any returned parts, and does it initiate problem solving and corrective action to prevent recurrence?  
2 Where requested by the customer, does this include analysis of the interaction of embedded software of the organization’s product within the system of the final customer’s product?  
3 Does the organization communicate the results of testing/analysis to the customer and also within the organization?  
10.3 Continual improvement
10.3.1 Continual Improvement – Supplemental
1 Does the organization have a documented process for continual improvement?  
2 Does it includes identification of the methodology used, objectives, measurement, effectiveness, and documented information?  
3 Does it includes  a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste?  
4 Does it includes risk analysis (such as FMEA)?  
NOTE: Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product characteristics are predictable and meet customer requirements.

pdf Template for IATF GAP  Analysis tools
  Example of  IATF GAP  Analysis

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