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Quality Managers use this IATF audit checklist to evaluate if the company’s QMS is aligned with the IATF 16949:2016 standard. It assists you to assure that an automotive supplier or manufacturer’s QMS promotes continuous development, defect prevention, and waste reduction in the automotive equipment chain. Use this checklist with Lumiform on mobile devices to attach photos and make notes of nonconformance found important to the question item. Use all sections of this checklist to make an internal evaluation of compliance with the IATF 16949:2016 standard.
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Complete all sections starting below. This IATF audit checklist will assess the organization's compliance with the IATF 16949:2016 standard. Don't forget to attach proof to items where needed, and to sign off and complete this audit in the last section.
4.1 Understanding the organization and its context
Check how the organization has determined external and internal issues important to its purpose and strategic direction.
Check how these issues influence the ability to achieve the intended result of the QMS.
Check how the organization monitors and reviews data about these internal and external issues.
4.2 Understanding the needs and expectations of interested parties
Document how the organization determined important interested parties to QMS.
Document how the organization has determined the important demands and expectations of interested parties.
Document how the organization has determined the influence or potential impact of the interested parties.
Check how the organization monitors and reviews information about interested parties and their relevant demands.
4.3 Determining the scope of the quality management system
Verify how the QMS scope considers the following:
The demands of relevant interested parties.
External and internal issues.
The products and services of the company.
If the organization has determined any of the demands of the ISO 9001:2015 standard not to be suitable, show how conformity of products and services are not affected by this.
Document how the organization has determined how the ISO 9001:2015 standard is applied within the company.
Verify that QMS scope is documented.
Verify scope states which products and services are covered by the QMS and how it supports instances where demands cannot be applied.
4.3.1 Determining the scope of the quality management system - supplemental
Verify support functions contained in scope
If an exemption is taken, verify that it is for ISO 9001, Section 8.3. Also, verify that permitted exclusion does not include production process design.
4.3.2 Customer-specific requirements
Verify customer-specific demands evaluated and included in scope
4.4 Quality management system and its processes
Show how the processes have been determined and how they interact.
Verify how the methods for the QMS were determined. Verify the inputs and outputs to the methods.
Verify the sequence and interaction of the processes.
Verify the rules, methods, measurement and related performance indicators needed to operate and control the processes.
Verify how equipment is determined and allocated.
Verify how responsibilities and authorities are established.
Verify how risks and opportunities are considered and what actions are considered to address them.
Verify what methods are practised to monitor, measure and evaluate processes. Verify changes, if required, are implemented to achieve intended results.
Verify how opportunities for change for the QMS and its methods are determined.
Reviewed documented information made to support the operation of its methods.
18.104.22.168 Conformance of products and processes
Verify conformance to all applicable buyer, statutory and regulatory demands
22.214.171.124 Product Safety
Verify documented process
Where applicable, shall include:
Identification of statutory and regulatory product safety demands and customer notification
Special permissions for design FMEA, process FMEAs and control plans
Identification and checks of product safety-related characteristics (including at the point of manufacture)
Definition of responsibilities, escalation method and flow of information, including top management and customer notification
Changes of product or method shall be approved prior to implementation
Lessons learned for new product introductions
Transfer of demands with regard to product safety during the supply chain, including customer-designated sources
Product traceability by accomplished lot (at a minimum) throughout the supply chain
5.1 Leadership and commitment
Top management is defined.
Document top management demonstrates leadership and commitment by:
Assuring the QMS is integrated into the organization's business processes
Assisting other important management roles to demonstrate their leadership as it refers to their areas of respsonsibility
Taking accountability for QMS effectiveness
Assuring the QMS policy and objectives are established and are cooperative with strategic direction and context of organization
Promoting the usage of the process approach and risk-based thinking
Assuring resources are available.
Communicating the relevance of effective QMS and of conforming to its requirements
Assuring intended outcomes.
Engaging, directing and supporting people to contribute to the effectiveness of the QMS
Promoting continuous development
Document how top management demonstrates leadership and commitment with respect to customer focus by assuring that:
Customer and applicable statutory and regulatory demands are determined, understood and consistently met.
The dangers and opportunities that affect product and service conformity and the ability to enhance customer satisfaction are determined and addressed.
The focus on enhancing customer satisfaction is sustained.
Document corporate responsibility policies are defined and implemented:
Document top management reviews the product realization method for effectiveness and efficiency and is input to Management Review
Document if top management has identified process owners and that the process owners know their roles and are competent to perform those roles
Verify the quality policy:
Is appropriate to the purpose and meaning of the organization and supports its strategic direction.
Provides a framework for setting quality objectives.
Includes a commitment to satisfy applicable demands.
Includes a commitment to continual improvement of the QMS.
Verify QMS Policy is sustained as documented information.
Verify QMS Policy is communicated, understood and applied within the whole organisation.
Verify QMS Policy is accessible to relevant interested parties.
5.3 Organizational roles, responsibilities and authorities
Verify responsibilities and authorities for relevant roles are allocated and communicated within the organization
Verify top management assigns duty and authority for:
assuring the QMS conforms to the ISO 9001:2015 and IATF 16949:2016 standards.
guaranteeing that processes are delivering their intended outputs.
reporting on the performance of the QMS and on opportunities for development, in particular to top management.
ensuring the improvement of customer focus throughout the organization.
assuring the integrity of the QMS is maintained when changes to the QMS are prepared and implemented.
Verify personnel are authorised responsibility and authority to ensure that customer demands are met and these assignments are documented.
Verify personnel qualified for conformity have the authority to stop shipment and stop production to improve quality problems.
Verify personnel with authority and responsibility for improving action are promptly informed of products or methods that do not conform
Verify that personnel in all shifts have responsibility for assuring the conformity to product requirements.
6.1 Actions to address risks and opportunities
Verify how the internal and external issues and affected parties are considered when preparing for the QMS?
Verify how dangers and opportunities are determined and addressed so the QMS can achieve its intended results, limit and reduce undesired effects and achieve continual improvement
Verify how actions are designed to address risks and opportunities.
Verify how actions are united and implemented into the QMS processes.
Verify how the company evaluates the effectiveness of the actions.
Verify how actions are taken to address dangers and opportunities determined as being appropriate to the possible impact on the conformity of products and services.
Verify danger analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.
Verify preventive action process
Verify retained documented information
Verify contingency plans are documented
Verify contingency plans are prepared for continuity of supply in the event of:
interruption from externally provided products, processes and services
recurring natural disasters
key equipment failures
Verify validation of fabricated product after re-start
6.2 Quality objectives and planning to achieve them
Verify top management assures that quality objectives are defined, established and kept at relevant functions, levels and processes.
Verify that the quality objectives are:
taking into account applicable requirements.
consistent with the quality policy.
relevant to the conformity of products and services and to the enhancement of customer satisfaction.
updated as appropriate.
Verify objectives are reported.
Verify how the organization determines what will be done, with what sources, when completed and how the results will be assessed for quality objectives.
Verify annual quality objectives and related performance goals (internal and external) are established
6.3 Planning of changes
Verify how QMS developments are planned systematically.
Verify how the organization shows the purpose and potential outcomes of changes.
Verify how the organization views the integrity of the QMS.
Verify how resources are made possible.
Verify how responsibility and authority are allocated and reallocated.
7.1.1 General - 7.1.3 Infrastructure
Show how the capabilities and constraints on internal resources are thought about.
Show how requirements from external providers are considered.
Verify design layout improves material flow, material handling and value-added use of floor space
Verify how resources are determined for the company.
Verify how the organization implements persons necessary to consistently meet customer, applicable statutory and regulatory demands for the QMS including the necessary processes.
Verify how the organization determines, provides and sustains the infrastructure for the operation of methods to achieve products and services conformity.
Verify assessments of producing feasibility and evaluation of capacity planning as inputs into Management Review
7.1.4 Environment for the operation of processes
Verify how the organization determines, provides and sustains the environment for the operation of methods to achieve products and service conformity.
Verify premises are in a state of order, tidiness and repair
7.1.5 Monitoring and measuring resources
Verify how sources are determined to secure valid and reliable monitoring and measuring outcomes.
Verify how the organization guarantees that the resources provided are proper for the specific type of monitoring and measurement activities being undertaken and that they are supported to ensure continued fitness of purpose.
Verify documented information that shows proof of fitness for the purpose of monitoring and measurement resources.
Show how measurement instruments are classified.
Show how measurement instruments are safeguarded from adjustments, destruction and deterioration.
Verify how the company determines the validity of previous measurements if you find an instrument to be inadequate during verification or calibration. Verify any actions taken.
Show how measurement instruments are established or calibrated at specific intervals against national or international standards. If no standards, show any documented information which is taken as the basis for calibration or verification.
Verify criteria used conforms to those in reference manuals on MSA
Verify documented methods for managing calibration/verification records
Verify calibration/verification activities and records shall contain:
revisions following engineering changes that have an influence on measurement systems
risk evaluation caused by out-of-spec condition
Documents of the calibration and maintenance activities for all gauging, including employee-owned, customer-owned or on-site supplier-owned tools
any out-of-spec readings as received for calibration/verification
documented information on the legality of previous measurement results when a piece of inspection measurement and test devices is found to be out of calibration or defective during its outlined verification or calibration or during its usage
customer notification if product or material has been delivered
comments of conformity to spec after calibration/verification
verification of software version
production-related software verification taken for product and process control
Verify defined scope for an internal laboratory is reported
Verify laboratory needs for:
sufficiency of the laboratory technical procedures
competency of laboratory personnel
testing of the outcome
traceability to relevant method standard (such as ASTM, EN, etc.) or when no national standard(s) is available, the company shall define and implement a methodology to verify measurement system capability
customer needs, if there are any
review of related documents
Verify scope contains relevant inspection, test or calibration service and the certificate of calibration or test report contains the mark of a national accreditation body
Verify external laboratories are accredited to ISO/IEC 17025 or national equivalent and or is agreeable to the customer
7.1.6 Organizational knowledge
Verify how the business determines the required knowledge for the operation of processes and achieves conformity of products and services.
Verify how knowledge is sustained and made available to the extent needed.
Verify how the organization determines current knowledge and how it acquires additional knowledge when speaking about changing needs and trends.
Show how you determine the required competence of people doing work under your control that influences quality performance.
Show how you determine competence on the basis of relevant education, training or experience.
Show how you take actions to obtain important competence where applicable and how do you assess the effectiveness of those actions.
Verify documented information as proof of competence where appropriate.
Verify documented process(es) for identifying training demands including awareness and achieving competence
Verify on-the-job training method
Verify documented process(es) to verify internal and second-party auditors are skilled and can demonstrate:
knowledge of the automotive process approach for auditing, including risk-based thinking
knowledge of the applicable customer and organization-specific requirements
knowledge of applicable ISO 9001 and IATF 16949 demands
the applicable producing process(es) to be audited, including PFMEA and control plan (second-party auditor only)
understanding of the applicable core tool needs
knowledge how to plan, conduct, report and close out audit findings
Verify how production process auditors demonstrate technical understanding of the relevant production process(es) to be audited, containing process risk analysis (PFMEA) and control plan
Verify how product auditors show competence in understanding product requirements and use of important measuring and test equipment to verify product conformity
Verify maintenance of and changes in internal auditor competence by:
executing a minimum number of audits per year, as determined by organization
sustaining knowledge of relevant demands based on internal or external changes
Verify people doing business under the organization's control are aware of:
the quality policy.
the relevant quality objectives.
their contribution to the effectiveness of the QMS, containing the benefits of changed performance.
the implications of not conforming with the QMS demands.
Verify that the company documents the process for employee motivation and empowerment:
to make continual improvements
to achieve quality objectives
to create an environment that promotes innovation
Verify that the organization promotes quality and technological consciousness in the whole organization
Verify internal and external communication methods (what, when, with whom and how to communicate).
7.5 Documented information
Verify documented information demanded by the ISO 9001:2015 standard.
Verify documented information that determines the effectiveness of the QMS.
Show that your documented information contains proper identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).
Show how the reported information is reviewed and approved for suitability and adequacy.
Show how you control documented information and make it possible and suitable for use. Explain how you protect your documented information.
Verify how the organization controls the distribution, entrance, retrieval, use, storage, preservation, legibility, control of changes, retention and disposal of documented information.
Verify documented information of external origin is identified, as suitable, and controlled.
Verify quality manual and it contains, at a minimum:
Scope of the QMS, including details of and justification for any exclusions
documented methods established for the QMS or reference to them
the organization's methods and their sequence and interactions (inputs and outputs), containing type and extent of control of any outsourced processes
a document indicating where within the QMS their customer-specific demands are addressed
Verify record retention policy
Verify production part approvals, tooling records, product and process design records, obtaining orders (if applicable) or contracts and amendments are sustained for the length of time that the product is active for production/service plus one calendar year
Verify documented plans describing the review, distribution and implementation of all client engineering standards/specifications and related revisions
Verify records of dates engineering standard/spec change performed in production (implementation shall involve updated documents)
Verify review is completed within 10 working days of the bill of notification of engineering standards/spec changes
8.1 Operational planning and control
Verify how the company has organised, implemented and controlled processes required to meet the needs of products and services.
Verify how demands for products and services are determined.
Verify how criteria for plans and acceptance for products and services are determined.
Verify how resources are determined.
Verify how process control is implemented.
Show documented information that illustrates processes have been carried out as planned and can demonstrate the conformity of products and services.
Determine how the output from the planning process is appropriate for operations.
Verify how scheduled changes are controlled. Verify how unintended changes are reviewed and what procedures are taken to mitigate any adverse effects, as needed.
Verify how outsourced methods are controlled.
Verify topics shall be included in preparing for product realization:
customer product needs and technical specifications
Verify organization assures confidentiality
8.2 Determination of requirements for products and services
Verify methods created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or handling of customer property and specific requirements for contingency actions.
Verify process to determine the demands for products and services to be submitted to potential customers and how the method is established, implemented and maintained.
Verify how product and service needs including statutory and regulatory requirements are defined. Verify that the organization has the possibility to meet the defined needs and substantiate any claims for its products and services.
Verify how the organization reviews:
customer demands for delivery and post-delivery.
demands necessary for customer's specified or intended use, where known.
statutory and regulatory demands applicable to the products and services.
other contract or order demands.
Verify retained documented proof of customer-authorized waiver of above demands for a formal review
Verify the organisation's producing processes are capable (capability analysis, Cp, Cpk, Pp, Ppk)
Show that the review is administered prior to the organization's commitment to supply products and services to the buyer.
Verify how the company resolves differences in the contract or order needs from those previously defined.
Verify how the company confirms customer needs where the customer doesn't provide a documented announcement.
Verify documented information of reviews explaining new or changed needs to products and services.
Verify documented information of amended reviews and how important staff are made aware of those changes.
Verify written or verbal communication is in language agreed to with the buyer
8.3 Design and development of products and services
Verify how the design and development process is organised, implemented and sustained.
Verify product and producing design is focused on error prevention rather than detection
Verify that the company documents the design and development process
8.3.2 Design and development planning
In determining the stages and control for design and improvement, verify the organization considers:
the nature, duration and complexity of the activities.
the demands that specify particular process stages including applicable reviews.
necessary verification and validation.
responsibilities and authorities.
how interfaces are regulated between individuals and parties.
the need for involvement of the buyer and user groups.
Verify reported information that confirms the design and development demands have been met.
Verify design and development planning contains a multidisciplinary approach of all affected stakeholders within its business and its supply chain (as appropriate).
Verify product design personnel are competent to achieve design demands and are skilled in applicable product design equipment and techniques.
Verify process for quality assurance for their products with internally revealed embedded software.
8.3.3 Design and development inputs
In determining conditions essential for the type of products and services being designed and developed, the company shall consider:
functional and performance demands.
information derived from the previous similar design and establishing activities.
statutory and regulatory demands.
standard or codes of practice that the business has committed to implement.
potential risks of failure due to the nature of the products and services.
Verify that the inputs are fulfilled and unambiguous.
Verify documented information on design and development inputs are engaged.
Verify design input terms as a result of contract review:
product specs involving but not limited to special characteristics
boundary and interface demands
identification, traceability and packaging
consideration of design alternatives
evaluation of risks with the input requirements and the organization's ability to mitigate/manage the dangers, including from the feasibility analysis
targets for conformity to product demands.
applicable statutory and regulatory demands.
embedded software demands
Verify manufacturing process design inputs contain (but not limited to):
product design output data involving special characteristics
targets for productivity, method capability, timing and cost
producing technology alternatives
experience from previous improvements
product handling and ergonomic requirements
design for producing and design for assembly
Verify error-proofing included in production process design as appropriate
Verify a multi-disciplinary approach to identify special characteristics:
documentation of all special characteristics in the drawings, risk analysis (FMEA), check plans and standard work/instructions
verify special characteristics that are identified with specific markings and are cascaded within each of the documents
improvement of control and monitoring strategies
agreement with customer-specified definitions and symbols (can be an organization's equivalent as defined by conversion table)
8.3.4 Design and development controls
Verify the organization contains all products and services that affect customer demands such as sub- assembly, sequencing, sorting, rework, and calibration services in the scope of their description of externally provided products, processes, and services
Verify the company applies controls to the design and development process to ensure that:
the outcomes to be achieved are defined.
reviews are conducted to assess the ability of the results of design and development to meet demands.
verification activities are conducted to assure that the resulting products and services meet the demands for the specified application or intended use.
validation activities are conducted to assure that the resulting products and services meet the demands of the specified application or intended use.
any important actions are taken on problems determined during the reviews, or verification and validation activities.
Verify documented information of these activities is maintained.
Verify measurement results report are input to management review
Verify measurements are reported to the customer, if needed
Verify validation performed in accordance with customer demands, including industry and government regulation standards.
Verify interaction of an organization's product, containing embedded software, within the system of the final customer's product (if contractually agreed with customer)
Verify prototype program and control plan (if necessary)
Verify prototype performance testing is monitored for timely completion
Verify product and production approval process conforming to customer requirements
Verify approval of external provided parts and services prior to submission of part approval to buyer
Verify product approval is reported prior to shipment (if required) and retained.
8.3.5 Design and development outputs
Verify the organization assures the design and development outputs:
meet the input demands.
are sufficient for the subsequent processes for the provision of products and services.
contain or reference monitoring and measuring requirements, as appropriate , and acceptance criteria.
specify the characteristics of the products and services that are important for their intended purpose and their safe and proper provision.
design danger analysis (FMEA)
product special characteristics
results of product design error-proofing, such as DFSS, DFMA and FTA
reliability study results
product definition including 3D models, technical data packages, product production information and geometric dimensioning & tolerancing (GD&T)
product design review results
service diagnostic guidelines and repair and serviceability directions
service part demands
packaging and labeling demands for shipping
Verify reported information on design and development outputs are retained.
Verify production process design output is documented
Verify production process design output versus input
Verify production process design output includes:
specifications and drawings
identification of process input variables that impact characteristics
special characteristics for product and production process
tooling and equipment for production and control, containing capability studies of equipment and process(es)
production process flow charts/layout, including linkage of product, process and tooling
production process FMEA
maintenance plans and instructions
data for quality, reliability, maintainability and measurability
standard work and work instructions
process approval acceptance criteria
outcomes of error-proofing identification and verification, as appropriate
processes of rapid detection, feedback and correction of product/manufacturing process nonconformities
8.3.6 Design and development changes
Verify the company identifies, reviews and controls changes made during, or subsequent to, the design and development of products and services, to the extent required to ensure that there is no adverse impact on conformity to demands.
Verify documented information on design and development changes, the result of reviews, the authorization of differences and the actions taken to prevent adverse impacts are retained.
Verify revision level of embedded software and hardware
Verify the organization assesses design changes after initial product approval
Verify reported approval or waiver from the customer prior to manufacturing implementation (if required)
8.4 Control of externally provided processes, products and services
Verify the company has a documented supplier selection method and it includes:
an evaluation of the selected supplier's risk to product conformity and uninterrupted supply of the organization's product to their buyers?
an assessment of software development capabilities (if applicable)
relevant quality and delivery performance
an assessment of the supplier's QMS
multidisciplinary decision making
Verify "Directed-Buy" external providers meet all demands
Verify how the company ensures externally provided processes, products and services conform to specified demands.
Verify controls applied to externally provided methods, products and services when products and services are intended for incorporation into the organization's own outcomes, products and services are provided directly to the customer or a process, or part of a method is provided by an external provider as a result of a decision by the organization.
Verify how the company determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.
Verify reported information of activities and actions arising from the evaluations.
Verify how the organization determines controls applied to the external provision of methods, products and services and the resulting output.
Verify how the company considers the potential impact of the external provided processes, products and services on its possibility to meet customer and applicable statutory and regulatory demands.
Verify the effectiveness of the controls applied by the external provider.
Verify how the company determines the verification, or other activities, required to ensure the externally provided processes, products and services meet requirements.
Verify the company has a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity ( shall contain criteria and actions to escalate or reduce controls based on supplier performance and evaluation of product, material or service risk)
Verify the organization has a reported process that purchased products, processes and services conform to the current applicable statutory and regulatory demands
Verify the organization assures special controls defined by the customer are implemented and sustained, including at suppliers
Verify supplier's QMS is certified to ISO 9001 with the ultimate objective of being certified to IATF 16949
Verify process for software quality support for suppliers of automotive product-related software or automotive products with embedded software
Verify company has documented process and criteria to assess supplier performance
Verify the organization monitors the following supplier performance indicators:
delivery schedule performance
shipped product conformity to requirements
customer complaints at the receiving plant, including yard holds and stop ships
number of occurrences of premium freight
special status buyer notifications related to quality or delivery issues (if provided by customer)
dealer returns, warranty, field actions and recalls (if provided by customer)
Verify the company has documented the criteria for determining the need, type, frequency and scope of second-party audit
Verify second-party audit reports are retained
Verify inputs to supplier improvement includes:
second-party audit findings
third-part quality management system certification status
Verify the organization communicates to external providers its demands for:
the methods, products and services to be provided.
competence, including any needed qualification of persons.
the external providers' interactions with the organization.
control of the external providers' performance to be applied by the organization.
the approval of product and services; methods, processes and tools; and the release of products and services.
verification or validation activities that the organization, or its buyer, intends to perform at the external providers' premises.
Verify all applicable statutory and regulatory demands and special product and process characteristics are passed down to suppliers
8.5 Production and service provision
8.5.1 Control of production and service provision
Verify the company has documented information that defines the characteristics of the products to be produced, the services to be provided or the activities to be performed and the outcomes to be achieved.
Verify the availability and use of suitable controlling and measuring resources.
Verify the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of methods or outputs, and acceptance criteria for products and services, have been met.
Verify the use of suitable infrastructure and environment for the operation of methods.
Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)
Verify the appointment of competent persons, including any necessary qualification.
Verify the validation, and periodic revalidation, of the ability to achieve planned results of the methods for production and service provision, where the resulting output cannot be verified by subsequent controlling or measurement.
Verify the implementation of release, shipping and post-delivery activities.
126.96.36.199 Control Plan
Verify control plans (in accordance with Annex A) include:
controls used for the production process monitoring, including verification of job set-ups
methods for controlling of control exercised over special characteristics defined by both the customer and the organization
the customer-needed information (if any)
first-off/last-off part validation (as applicable)
specified reaction plan (see Annex A)
Verify the control plans shall be reviewed and updated:
if the organization determines it has delivered nonconforming product to the customer
when any change occurs affecting product, production process, measurement, logistics, supply sources, production volume improvements or risk analysis (FMEA) (see Annex A)
after a buyers complaint and implementation of the associated corrective action (as applicable)
at a set frequency based on a risk analysis
Verify if the customer demands approval of Control Plan after review or revision
188.8.131.52 Standardized work - operator instructions and visual standards
Verify standardized work documents are:
communicated to and understood by the staff who are responsible for performing the work
presented in language(s) understood by staff who follow them
approachable for use at the designated work area(s)
Verify standardized work reports include rules for operator safety
184.108.40.206 Verification of job set-ups / 220.127.116.11 Verification after shutdown
Verify company's verifies job setups
Verify documentation is sustained for set-up personnel
Verify organization uses statistical processes of verification, where applicable
Verify first-off/last-off part validation
Verify documents are retained for process and product approval following set-up and first-off/last-off validations
Verify organization assure compliance with requirements after a planned or unplanned production shutdown period
18.104.22.168 Total productive maintenance
Verify the total productive sustainance system is documented and includes:
identification of process tools
availability of replacement parts
provision of resource for machine, equipment and facility maintenance
applicable customer-specfic requirements
packaging and preservation of equipment, tooling and gauging
regular review of maintenance plan and objectives and reported action plan to address corrective actions where objectives are not met
use of preventive maintenance processes
use of predictive maintenance methods (as applicable)
22.214.171.124 Management of production tooling and manufacturing, test, inspection tooling and equipment
Verify production tooling management system (customer-owned or organization-owned) that includes:
maintenance and repair plants and personnel
storage and recovery
tool-change programs for perishable tools
tool design modification report, including engineering change level of the product
tool modification and revision to report
tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and place
Verify system implemented to monitors these activities
Verify customer-owned tools and equipment are permanently marked in a visible place
126.96.36.199 Production scheduling
Verify production that is scheduled to meet customer orders/demands such as JIT
Verify production schedule that is supported by an information system
8.5.2 Identification and traceability
Verify how the organization identifies outcomes from the process to ensure conformity.
How does the organization defines the status of process outputs?
Verify how the organization controls the individual identification of process outputs when traceability is required. Verify reported information of traceability, where required.
Verify traceability plans:
enable the organization to identify nonconforming and/or suspect product
ensure the identification and traceability demands are extended to externally provided products with safety/regulatory characteristics
ensure the ability to meet the buyer and/or regulatory response time requirements
assure documented information is retained in the format (electronic, hardcopy, archive) that enables the company to meet the response time requirements
guarantee serialized identification of individual products if specified by the customer or regulatory standards
enable the company to segregate non-conforming and/or suspect product
8.5.3 Property belonging to customers or external providers
What care is given to customers' or external providers' property?
Verify how the company identifies, verifies, protects and safeguards customers' or external providers' property which is presented for use or incorporation into the organization's products or services.
Verify retained documented information for the property that is destroyed or otherwise found to be unsuitable for use.
Verify how the company ensures preservation of the process outputs to guarantee conformity to requirements.
Verify organization evaluates product in stock, the place/type of storage container and the storage environment at planned intervals
Verify organization uses an inventory management system to optimize inventory turns over time and assure stock rotation (i.e. FIFO)
Verify obsolete product is managed similar to that of nonconforming product
Verify organization complies with customer demands for preservation, packaging, shipping and marking
8.5.5 Post-delivery activities
Verify the company that considers the following to meet post-delivery activities:
the nature, use and intended lifetime of its products and services
statutory and regulatory demands
potential undesired consequences associated with its products and services
Verify that the company has a process for communication of information on service concerns to production, material handling, logistics, engineering and design
Verify the following if a service agreement with the customer is in place:
effectiveness of any special purpose tools or measurement tools
service personnel are trained in applicable demands
relevant service centres comply with applicable demands
8.5.6 Control of changes
Verify how the organization reviews and controls improvements for production or service provision.
Verify retained reported information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.
188.8.131.52 Control of changes - Supplemental
Verify reported process
Verify that the organization:
defines verification and validation activities
validates changes before implementation
documents proof of related risk analysis
retains records of verification and validation
notifies the buyer/client of any planned product realization changes after the most recent product approval (if required)
gets documented approval, prior to the implementation of the change (if required)
completes additional verification or identification demands, such as production trial run and new product validation (if required)
Verify production trial run for verification of changes made by a supplier
184.108.40.206.1 Temporary change of process controls
Verify organization has a document of primary and approved back-up/alternate process controls
Verify alternate method is reported
Verify an alternate control method is approved internally prior to production implementation and by the client/buyer (if required)
Verify alternative control methods are identified in the Control Plan and are reviewed periodically
Verify standard work instructions are designed for alternative control methods
Verify alternative process controls are analysed on a daily basis (at a minimum)
Verify restart verification is reported for a defined period
Verify traceability of all product manufactured with alternative process control devices or processes
8.6 Release of products and services
Verify at appropriate stages product and service demands have been met.
Verify products and services are not released to the consumer until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer.
Verify retained reported information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.
Verify verification of product and service demands are documented as specified in the Control Plan
Verify a layout inspection and functional inspection is performed per the Control Plan and are accessible for customer review
For appearance objects, verify the organizations provides:
appropriate resources, including lighting, for assessment
masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) and haptic technology, as appropriate
maintenance and control of appearance masters and assessment equipment
verification that staff making appearance evaluations are competent and qualified
For externally provided processes, products, services, verify the organization used one or more of the following methods:
receipt and assessment of statistical data
receiving inspection and/or testing, such as sampling based on performance
second-party or third-party evaluation or audits of supplier sites when coupled with records of acceptable delivered product conformance to demands
part assessment by a designated laboratory
another method agreed with the customer
Verify organization approves and is able to provide evidence that externally provided processes, products and services conform to the latest suitable statutory, regulatory and other requirements in the countries where they are manufactured and in the customer-identified countries of destination if provided
Verify acceptance criteria defined by the organization
8.7 Control of nonconforming outputs
Verify that outputs that do not conform to demands are identified and controlled.
Verify proper action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services):
Informing the customer
Segregation, containment, return or suspension of provision of products and services
Obtaining authorization for acceptance under concession
Verify conformity to the demands when nonconforming outputs are corrected.
Verify retained reported information that describes the nonconformity, describes actions taken, explaining any concessions obtained and identifies the authority deciding the action in respect of the nonconformity.
220.127.116.11 Customer authorization for concession - 18.104.22.168 Control of suspect product
Verify concession or deviation permit approved by the buyer prior to further processing from what is currently approved
Verify organization concerns customer authorization prior to further processing for "use as is" and rework dispositions of nonconforming product (including sub-components)
Verify documentation are maintained of expiration date and quantity authorized under concession
Verify material delivered under concession is appropriately identified
Verify product with unidentified or suspect status is classified and controlled as nonconforming product
Verify proper manufacturing personnel are trained for containment of suspect and nonconforming product
22.214.171.124 Control of reworked product - 126.96.36.199 Control of repaired product
Verify reported process for rework confirmation
Verify instructions for disassembly or rework, containing re-inspection and traceability demands
Verify reported process for repair confirmation
Verify instructions for disassembly or repair, including re-inspection and traceability demands
Verify reported customer authorization for concession for the product to be repaired
Verify retained report on the disposition of rework including quantity, disposition, disposition date and applicable traceability information
Verify customer is instantly notified if the nonconforming product is shipped
Verify detailed report of the event followed initial communication
Verify documented process for disposition of nonconforming product not subject to rework or repair
Verify nonconforming product is rendered unusable prior to control
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
Verify the organization has determined what needs to be controlled and measured, the methods to be utilised, when it will be performed, analyzed and evaluated.
Verify the organization assesses the performance and effectiveness of its QMS.
Review retained properly documented information
Verify the organization performs process studies on all new production processes to verify process capability
Verify the organization's adherence to:
reaction plans and escalation process when acceptance criterial are not met
records of actual measurement values and/or test results for variable data
Verify important process events (i.e. tool change, machine repair) that are retained documented information
Verify reaction plans designed for processes that are either not statistically capable or are unstable. Reaction systems shall include containment of product and 100% inspection (as appropriate)
Verify documents of effective dates of process changes
Verify that the organization has determined the appropriate use of statistical euqipment
Verify statistical concepts are recognised and used by employees involved in the collection, analysis and management of statistical data
Verify the business monitors customers' perceptions and satisfaction based on performance indicators that include but not restricted to:
delivered part quality performance
field returns, recalls and warranty (where applicable)
transfer schedule performance (including incidents of premium freight)
customer notifications related to quality or delivery issues, including special status
Verify organization monitors customer portals and customer scorecards (where provided)
Verify the organization analyzes and evaluates:
the degree of customer satisfaction.
the need for improvements the the QMS.
the performance and effectiveness of the QMS.
if planning has been implemented effectively.
the effectiveness of actions taken to address risks and opportunities.
conformity of products and services.
the performance of external providers.
Verify organization connects trends in quality and operational performance with progress toward objectives and leads to improving customer happiness
9.2 Internal audit
Verify internal audit process is reported
Verify audits are conducted at planned intervals
Verify organization has established, implemented, and maintains an internal audit program
Verify the value of the process, changes affecting the organization and the results of previous audits are considered
Verify audit criteria and scope are designed for each audit
Auditors are objective and impartial
Audit results documented to relevant management
Verify appropriate correction and corrective actions are taken without delay
Review retained reported information
Verify QMS methods are audited over three-year calendar period
Verify production processes are audited over three-year calendar period
Verify all shifts are inspected
Verify products are audited using customer-specific needed approaches
9.3 Management review (go through entire standard and add to inputs)
Verify management reviews QMS at least every year
Verify inputs to management review contains:
changes in external and internal issues are relevant to the QMS
customer satisfaction and feedback from important interested parties
the extent to which quality objectives have been met
Improvement performance and conformity of products and services
nonconformities and corrective actions
controlling and measurement results
status of actions from previous management reviews
effectiveness of the audit program
the performance of external providers
sufficiency of resources
effectiveness of actions taken to address risks and opportunities
opportunities for changes
cost of poor quality (cost of internal and external nonconformance)
measures of process effectiveness
measures of process efficiency
evaluation of manufacturing feasibility made for changes to existing operations and for new facilities or new product
review of performance against maintenance objectives
guarantee performance (where applicable)
review of customer scorecards (where applicable)
identification of potential field failures identified through risk analysis (such as FMEA)
actual field failures and their impact on safety or the environment
Verify outputs to management review includes:
any need for changes to the QMS
opportunities for improvement
action plan when customer performance targets are not met
Verify retained documented information
Verify that the organization determines and selects opportunities for improvement to improve products and services, corrects, prevents or decreases undesired effects and improves the performance and effectiveness of the QMS.
10.2 Nonconformity and corrective action
Verify how the organization reacts to nonconformity, including complaints, by evaluating how it takes action to monitor and correct it and how it deals with the consequences.
Verify how the organization assesses the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere.
Verify how the organization implements the required actions.
Verify how the organization evaluates the effectiveness of actions taken.
Verify the organization updates dangers and opportunities determined during planning, if necessary.
Verify any improvements made to the QMS, if necessary.
Verify retained reported information that provides evidence of the nature of the nonconformity and any subsequent actions taken and the results of any corrective actions
10.2.3 Problem solving
Verify that the organization has reported process for problem solving including:
defined approaches for different types and scales of problems
containment, interim actions and related activities required for controlling nonconforming outputs
root cause analysis, the methodology used, analysis and results
implementation of systemic corrective actions, including consideration of the influence on similar processes and products
verification of the effectiveness of implemented corrective actions
reviewing and updating appropriate reported information (where necessary)
Verify reported process to determine the use of appropriate error-proofing methodologies
Verify challenge parts are identified, controlled, verified and calibrated (where feasible)
Verify details of error-proofing method used is reported in the process risk analysis (PFMEA) and test frequencies documented in the Control Plan
Verify documents of testing of error-proofing devices
Verify reaction plans for error-proofing device failures
10.2.5 Warranty management systems - 10.2.6 Customer complaints and field failure test analysis
Verify guarantee management process (if required)
Verify method for warranty part analysis, including NTF (no trouble found)
Verify that the organization has performed analysis on customer complaints and field failures (include embedded software)
Verify problem solving and corrective action initiated
Verify the organization talks about the results of testing/analysis to the customer and also within the organization
10.3 Continual improvement
Verify how the organization regularly improves. Does it consider the results of analysis and evaluation and the outputs from management review to determine if there are requirements or opportunities that shall be addressed as part of the continual change?
Verify that the organization's reported process for continual improvement includes:
identification of methodology used, objectives, measurement, effectiveness and reported information
a production process improvement action plan with emphasis on the reduction of process variation and waste
risk analysis (such as FMEA)
I, the undersigned, have completed this IATF 16949:2016 audit in a proper manner. I have attached proof as required and declare this audit complete.
Full name and signature of auditor:
Please note that this checklist template is a hypothetical example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
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