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Overview
Complete
RoughRoad Inc / 28 Mar 2019 / Jean Stahl
IATF 16949:2016 Audit
Inspection score
96.45%
Failed items
0
Created actions
2
Organization name
RoughRoad Inc
Location
9750 Maloney Rd Brownsburg, IN 46112 United States (39.89797081350416, -86.35255488515223)
Conducted on

28th Mar, 2019

12:22 PM +08

Prepared by
Jean Stahl
Actions
2
4 Context of the organization
92.68%
Introduction
Please complete all sections starting immediately below. This IATF audit checklist will evaluate the organization's compliance with the IATF 16949:2016 standard. Remember to attach evidence to items where required, and to sign off and complete this audit in the final section.
4.1 Understanding the organization and its context
100%
Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.
Meets requirement
Verify how these issues affect the ability to achieve the intended result of the QMS.
Meets requirement
Verify how the organization monitors and reviews information about these internal and external issues.
Meets requirement
4.2 Understanding the needs and expectations of interested parties
100%
Verify how organization determined relevant interested parties to QMS.
Meets requirement
Verify how the organization has determined the relevant needs and expectations of interested parties.
Meets requirement
Verify how the organization has determined the impact or potential impact of the interested parties.
Meets requirement
Verify how the organization monitors and reviews information about interested parties and their relevant requirements.
Meets requirement
4.3 Determining the scope of the quality management system
86.36%
Verify the QMS scope considers the following:
Improvement Opportunity
Notes
Improvement opportunity for us because of new supplier.

External and internal issues.

The requirements of relevant interested parties.

The products and services of the organization.

Verify how the organization has determined how the ISO 9001:2015 standard is applied within the organization.
Meets requirement
If the organization has determined any of the requirements of the ISO 9001:2015 standard not to be applicable, show me how conformity of products and services are not affected by this.
Meets requirement
Verify QMS scope is documented.
Meets requirement
Verify scope states what products and services are covered by the QMS and how it justifies instances where requirements cannot be applied.
Meets requirement
Verify support functions included in scope
Meets requirement
If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design.
Meets requirement
Verify customer-specific requirements evaluated and included in scope
Meets requirement
4.4 Quality management system and its processes
93.48%
Show me how the processes have been determined and how they interact.
Meets requirement
Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.
Meets requirement
Verify the sequence and interaction of of the processes.
Meets requirement
Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.
Meets requirement
Verify how resources are determined and allocated.
Meets requirement
Verify how responsibilities and authorities are determined.
Meets requirement
Verify how risks and opportunities are considered and what actions are taken to address them.
Improvement Opportunity
Notes
We have a new supplier and we are yet to have an updated risk assessment. Will meet with M tomorrow to discuss.
Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.
Improvement Opportunity
Verify how opportunities for improvement for the QMS and its processes are determined.
Meets requirement
Reviewed documented information created to support the operation of its processes.
Meets requirement
Verify conformance to all applicable customer, statutory and regulatory requirements
Meets requirement
Verify documented process
Improvement Opportunity
Notes
Opportunity for us because we are yet to document a new process to integrate the new supplier.
Where applicable, shall include:
Meets requirement

identification of statutory and regulatory product-safety requirements and customer notification

special approvals for design FMEA, process FMEAs and control plans

identification and controls of product safety-related characteristics (including at the point of manufacture)

reaction plans

definition of responsibilities, escalation process and flow of information, including top management and customer notification

training required

changes of product or process shall be approved prior to implementation

transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources

product traceability by manufactured lot (at a minimum) throughout the supply chain

lessons learned for new product introductions

5 Leadership
95.12%
5.1 Leadership and commitment
90.91%
Top management is identified
Meets requirement
Verify top management demonstrates leadership and commitment by:
Meets requirement

Taking accountability for QMS effectiveness

Ensuring the QMS policy and objectives are established and are compatible with strategic direction and context of organization

Ensuring the QMS is integrated into organization's business processes

Promoting the use of the process approach and risk-based thinking

Ensuring resources are available

Communicating the importance of effective QMS and of conforming to its requirements

Ensuring intended outcomes

Engaging, directing and supporting persons to contribute to the effectiveness of the QMS

Promoting continuous improvement

Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of respsonsibility

Verify how top management demonstrates leadership and commitment with respect to customer focus by ensuring that:
Meets requirement

customer and applicable statutory and regulatory requirements are determined, understood and consistently met.

the risks and opportunities that affect product and service conformity and the ability to enhance customer satisfaction are determined and addressed.

the focus of enhancing customer satisfaction is maintained.

Verify corporate responsibility policies are defined and implemented:
Non-conformance
Notes
There was an issue last month concerning the anonymous reporting system. Will meet M to discuss this whistle blowing policy because we need to set this properly and avoid retaliation from happening to whistle blowers.

Anti-bribery policy

Employee code of conduct

Ethics escalation policy ("whistle-blowing policy")

Verify top management reviews the product realization process for effectiveness and efficiency and is input to Management Review
Meets requirement
Verify top management has identified process owners and that the process owners understand their roles and are competent to perform those roles
Meets requirement
5.2 Policy
100%
Verify the quality policy:
Meets requirement

is appropriate to the purpose and context of the organization and supports its strategic direction.

provides a framework for setting quality objectives.

includes a commitment to satisfy applicable requirements.

includes a commitment to continual improvement of the QMS.

Verify QMS Policy is maintained as documented information.
Meets requirement
Verify QMS Policy is communicated, understood and applied within the organization.
Meets requirement
Verify QMS Policy is available to relevant interested parties.
Meets requirement
5.3 Organizational roles, responsibilities and authorities
100%
Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization
Meets requirement
Verify top management assigns responsibility and authority for:
Meets requirement

ensuring the QMS conforms to the ISO 9001:2015 and IATF 16949:2016 standards.

ensuring that processes are delivering their intended outputs.

reporting on the performance of the QMS and on opportunities for improvement, in particular to top management.

ensuring the promotion of customer focus throughout the organization.

ensuring the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

Verify personnel are assigned responsibility and authority to ensure that customer requirements are met and these assignments are documented.
Meets requirement
Verify personnel responsible for conformity have the authority to stop shipment and stop production to correct quality problems.
Meets requirement
Verify personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform
Meets requirement
Verify that personnel across all shifts have responsibility for ensuring conformity to product requirements.
Meets requirement
6 Planning
95.83%
6.1 Actions to address risks and opportunities
92.11%
Verify how the internal and external issues and interested parties are considered when planning for the QMS?
Meets requirement
Verify how risks and opportunities are determined and addressed so the QMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement
Meets requirement
Verify how actions are planned to address risks and opportunities.
Meets requirement
Verify how actions are integrated and implemented into the QMS processes.
Meets requirement
Verify how the organization evaluates the effectiveness of the actions.
Meets requirement
Verify how actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services.
Non-conformance
Notes
Will have this taken cared of tomorrow during meeting with M.
Verify risk analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.
Meets requirement
Verify retained documented information
Meets requirement
Verify preventive action process
Improvement Opportunity
Verify contingency plans are documented
Meets requirement
Verify contingency plans are prepared for continuity of supply in the event of:
Meets requirement

key equipment failures

interruption from externally provided products, processes and services

recurring natural disasters

fire

utility interruptions

labour shortages

infrastructure disruptions

Verify validation of manufactured product after re-start
Meets requirement
6.2 Quality objectives and planning to achieve them
100%
Verify top management ensures that quality objectives are defined, established and maintained at relevant functions, levels and processes.
Meets requirement
Verify the quality objectives are:
Meets requirement

consistent with the quality policy.

measurable.

taking into account applicable requirements.

relevant to the conformity of products and services and to the enhancement of customer satisfaction.

moinitored.

communicated.

updated as appropriate.

Verify objectives are documented.
Meets requirement
Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives.
Meets requirement
Verify annual quality objectives and related performance targets (internal and external) are established
Meets requirement
6.3 Planning of changes
100%
Verify how QMS changes are planned systematically.
Meets requirement
Verify how the organization demonstrates the purpose and potential consequences of changes.
Meets requirement
Verify how the organization considers the integrity of the QMS.
Meets requirement
Verify how resources are made available.
Meets requirement
Verify how responsibility and authority is allocated and reallocated.
Meets requirement
7 Support
97.16%
7.1 Resources
95.24%
Verify how resources are determined for the organization.
Meets requirement
Show me how the capabilities and constraints on internal resources are considered.
Meets requirement
Show me how needs from external providers are considered.
Non-conformance
Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.
Meets requirement
Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.
Meets requirement
Verify design layout optimizes material flow, material handling and value-added use of floor space
Meets requirement
Verify assessments of manufacturing feasibility and evaluation of capacity planning as inputs into Management Review
Meets requirement
Verify how the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity.
Meets requirement
Verify premises are in a state of order, cleanliness and repair
Non-conformance
Notes
I think we can do better on cleanliness. Will discuss this with M tomorrow. Perhaps reinforcing 5S across the board will solve the cleanliness issue.
Verify how resources are determined to ensure valid and reliable monitoring and measuring results.
Meets requirement
Verify how the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose.
Meets requirement
Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.
Meets requirement
Show me how measurement instruments are verified or calibrated at specific intervals against national or international standards. If no standards, show me documented information which is used as the basis for calibration or verification.
Meets requirement
Show me how measurement instruments are identified.
Meets requirement
Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.
Meets requirement
Verify how the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration. Verify any actions taken.
Meets requirement
Verify MSA
Meets requirement
Verify criteria used conforms to those in reference manuals on MSA
Meets requirement
Verify documented process for managing calibration/verification records
Meets requirement
Verify calibration/verification activities and records shall include:
Meets requirement

revisions following engineering changes that impact measurement systems

any out-of-spec readings as received for calibration/verification

risk assessment caused by out-of-spec condition

documented information on the validity of previous measurement results 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

customer notification if product or material has been shipped

statements of conformity to spec after calibration/verification

verification of software version

records of the calibration and maintenance activities for all gauging, including employee-owned, customer-owned or on-site supplier-owned equipment

production-related software verification used for product and process control

Verify defined scope for internal laboratory is documented
Meets requirement
Verify laboratory requirements for:
Meets requirement

adequacy of the laboratory technical procedures

competency of laboratory personnel

testing of the product

traceability to relevant process standard (such as ASTM, EN, etc.) or when no national standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability

customer requirements, if any

review of related records

Verify external laboratories are accredited to ISO/IEC 17025 or national equivalent and or is acceptable to the customer
Meets requirement
Verify scope incudes relevant inspection, test or calibration service and the certificate of calibration or test report includes the mark of a national accreditation body
Meets requirement
Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.
Meets requirement
Verify how knowledge is maintained and made available to the extent necessary.
Meets requirement
Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.
Meets requirement
7.2 Competence
100%
Show me how you determine the necessary competence of people doing work under your control that affects quality performance.
Meets requirement
Show me how you determine competence on the basis of appropriate education, training or experience.
Meets requirement
Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.
Meets requirement
Verify documented information as evidence of competence where appropriate.
Meets requirement
Verify documented process(es) for identifying training needs including awareness and achieving competence
Meets requirement
Verify on-the-job training process
Meets requirement
Verify documented process(es) to verify internal and second-party auditors are competent and can demonstrate:
Meets requirement

understanding of the automotive process approach for auditing, including risk-based thinking

understanding of applicable customer and organization specific requirements

understanding of applicable ISO 9001 and IATF 16949 requirements

applicable manufacturing process(es) to be audited, including PFMEA and control plan (second-party auditor only)

understanding of the applicable core tool requirements

understanding how to plan, conduct, report and close out audit findings

Verify how manufacturing process auditors demonstrate technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (PFMEA) and control plan
Meets requirement
Verify product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity
Meets requirement
Verify maintenance of and improvement in internal auditor competence by:
Meets requirement

executing minimum number of audits per year, as defined by organization

maintaining knowledge of relevant requirements based on internal or external changes

7.3 Awareness
100%
Verify people doing work under the organization's control are aware of:
Meets requirement

the quality policy.

the relevant quality objectives.

their contribution to the effectiveness of the QMS, including the benefits of improved performance.

the implications of not conforming with the QMS requirements.

Verify that the organization documents process for employee motivation and empowerment:
Meets requirement

to achieve quality objectives

to make continual improvements

to create an environment that promotes innovation

Verify that the organization promotes quality and technological awareness in the whole organization
Meets requirement
7.4 Communication
100%
Verify internal and external communication process (what, when, with whom and how to communicate).
Meets requirement
7.5 Documented information
97.06%
Verify documented information required by the ISO 9001:2015 standard.
Meets requirement
Verify documented information that shows the effectiveness of the QMS.
Meets requirement
Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).
Meets requirement
Show me how the documented information is reviewed and approved for suitability and adequacy.
Meets requirement
Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.
Meets requirement
Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
Meets requirement
Verify documented information of external origin is identified, as appropriate, and controlled.
Meets requirement
Verify quality manual and it includes, at a minimum:
Meets requirement

Scope of the QMS, including details of and justification for any exclusions

documented processes established for the QMS or reference to them

the organization's processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes

a document indicating where within the QMS their customer-specific requirements are addressed

Verify record retention policy
Meets requirement
Verify production part approvals, tooling records, product and process design records, purchase orders (if applicable) or contracts and amendments are maintained for the length of time that the product is active for production/service plus one calendar year
Improvement Opportunity
Notes
New supplier’s details and paperwork to be included.
Verify documented process describing the review, distribution and implementation of all customer engineering standards/specifications and related revisions
Meets requirement
Verify records of dates engineering standard/spec change implemented in production (implementation shall included updated documents)
Meets requirement
Verify review is completed within 10 working days of receipt of notification of engineering standards/spec changes
Meets requirement
8 Operation
1
95.81%
8.1 Operational planning and control
100%
Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.
Meets requirement
Verify how requirements for products and services are determined.
Meets requirement
Verify how criteria for processes and acceptance for products and services are determined.
Meets requirement
Verify how resources are determined.
Meets requirement
Verify how process control is implemented.
Meets requirement
Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.
Meets requirement
Determine how output from the planning process is suitable for operations.
Meets requirement
Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
Meets requirement
Verify how outsourced processes are controlled.
Meets requirement
Verify topics shall be included in planning for product realization:
Meets requirement

customer product requirements and technical specifications

logistics requirements

manufacturing feasibility

project planning

acceptance criteria

Verify organization ensures confidentiality
Meets requirement
8.2 Determination of requirements for products and services
100%
Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and specific requirements for contingency actions.
Meets requirement
Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained.
Meets requirement
Verify how product and service requirements including statutory and regulatory requirements are defined. Verify that the organization has the ability to meet the defined requirements and substantiate any claims for its products and services.
Meets requirement
Verify how the organization reviews:
Meets requirement

customer requirements for delivery and post-delivery.

requirements necessary for customer's specified or intended use, where known.

statutory and regulatory requirements applicable to the products and services.

other contract or order requirements.

Verify retained documented evidence of customer-authorized waiver of above requirements for a formal review
Meets requirement
Verify organization's manufacturing processes are capable (capability analysis, Cp, Cpk, Pp, Ppk)
Meets requirement
Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer.
Meets requirement
Verify how the organization resolves differences in the contract or order requirements from those previously defined.
Meets requirement
Verify how the organization confirms customer requirements where the customer doesn't provide a documented statement.
Meets requirement
Verify documented information of reviews describing new or changed requirements to products and services.
Meets requirement
Verify documented information of amended reviews and how relevant personnel are made aware of those changes.
Meets requirement
Verify written or verbal communication is in language agreed to with the customer
Meets requirement
8.3 Design and development of products and services
100%
Verify how the design and development process is established, implemented and maintained.
Meets requirement
Verify product and manufacturing design is focused on error prevention rather than detection
Meets requirement
Verify that the organization documents the design and development process
Meets requirement
In determining the stages and control for design and development, verify the organization considers:
Meets requirement

the nature, duration and complexity of the activities.

the requirements that specify particular process stages including applicable reviews.

required verification and validation.

responsibilities and authorities.

how interfaces are controlled between individuals and parties.

the need for involvement of customer and user groups.

Verify documented information that confirms design and development requirements have been met.
Meets requirement
Verify design and development planning includes a multidisciplinary approach of all affected stakeholders within its organization and its supply chain (as appropriate).
Meets requirement
Verify product design personnel are competent to achieve design requirements and are skilled in applicable product design tools and techniques.
Meets requirement
Verify process for quality assurance for their products with internally developed embedded software.
Meets requirement
In determining requirements essential for the type of products and services being designed and developed, the organization shall consider:
Meets requirement

functional and performance requirements.

information derived from previous similar design and development activities.

statutory and regulatory requirements.

standard or codes of practice that the organization has committed to implement.

potential consequences of failure due to the nature of the products and services.

Verify that the inputs are complete and unambiguous.
Meets requirement
Verify documented information on design and development inputs are retained.
Meets requirement
Verify design input requirements as a result of contract review:
Meets requirement

product specs including but not limited to special characteristics

boundary and interface requirements

identification, traceability and packaging

consideration of design alternatives

assessment of risks with the input requirements and the organization's ability to mitigate/manage the risks, including from the feasibility analysis

targets for conformity to product requirements

applicable statutory and regulatory requirements

embedded software requirements

Verify manufacturing process design inputs include (but not limited to):
Meets requirement

product design output data including special characteristics

targets for productivity, process capability, timing and cost

manufacturing technology alternatives

customer requirements

experience from previous developments

new materials

product handling and ergonomic requirements

design for manufacturing and design for assembly

Verify error-proofing included in manufacturing process design as appropriate
Meets requirement
Verify multi-disciplinary approach to identify special characteristics:
Meets requirement

documentation of all special characteristics in the drawings, risk analysis (FMEA), control plans and standard work/instructions

verify special characteristics are identified with specific markings and are cascaded through each of the documents

development of control and monitoring strategies

customer-specified approvals

compliance with customer-specified definitions and symbols (can be organization's equivalent as defined by conversion table)

Verify the organization includes 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
Meets requirement
Verify the organization applies controls to the design and development process to ensure that:
Meets requirement

the results to be achieved are defined.

reviews are conducted to evaluate the ability of the results of design and development to meet requirements.

verification activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use.

validation activities are conducted to ensure that the resulting products and services meet the requirements of the specified application or intended use.

any necessary actions are taken on problems determined during the reviews, or verification and validation activities.

Verify documented information of these activities are retained.
Meets requirement
Verify measurement results summary are an input to management review
Meets requirement
Verify measurements are reported to customer, if required
Meets requirement
Verify validation performed in accordance to customer requirements, including industry and government regulation standards.
Meets requirement
Verify interaction of organization's product, including embedded software, within the system of the final customer's product (if contractually agreed with customer)
Meets requirement
Verify prototype program and control plan (if required)
Meets requirement
Verify prototype performance testing is monitored for timely completion
Meets requirement
Verify product and manufacturing approval process conforming to customer requirements
Meets requirement
Verify approval of external provided parts and services prior to submission of part approval to customer
Meets requirement
Verify product approval is documented prior to shipment (if required) and retained.
Meets requirement
Verify the organization ensures the design and development outputs:
Meets requirement

meet the input requirements.

are adequate for the subsequent processes for the provision of products and services.

include or reference monitoring and measuring requirements, as appropriate , and acceptance criteria.

specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

design risk analysis (FMEA)

reliability study results

product special characteristics

results of product design error-proofing, such as DFSS, DFMA and FTA

product definition including 3D models, technical data packages, product manufacturing information and geometric dimensioning & tolerancing (GD&T)

product design review results

service diagnostic guidelines and repair and serviceability instructions

service part requirements

packaging and labeling requirements for shipping

Verify documented information on design and development outputs are retained.
Meets requirement
Verify manufacturing process design output is documented
Meets requirement
Verify manufacturing process design output versus input
Meets requirement
Verify manufacturing process design output includes:
Meets requirement

specifications and drawings

special characteristics for product and manufacturing process

identification of process input variables that impact characteristics

tooling and equipment for production and control, including capability studies of equipment and process(es)

manufacturing process flow charts/layout, including linkage of product, process and tooling

capacity analysis

manufacturing process FMEA

maintenance plans and instructions

control plan

standard work and work instructions

process approval acceptance criteria

data for quality, reliability, maintainability and measurability

results of error-proofing identification and verification, as appropriate

methods of rapid detection, feedback and correction of product/manufacturing process nonconformities

Verify the organization identifies, reviews and controls changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.
Meets requirement
Verify documented information on design and development changes, the result of reviews, the authorization of changes and the actions taken to prevent adverse impacts are retained.
Meets requirement
Verify organization evaluates design changes after initial product approval
Meets requirement
Verify documented approval or waiver from the customer prior to production implementation (if required)
Meets requirement
Verify revision level of embedded software and hardware
Meets requirement
8.4 Control of externally provided processes, products and services
1
72.09%
Verify the organization has a documented supplier selection process and it includes:
Non-conformance
Actions
To do
New supplier QMS

an assessment of the selected supplier's risk to product conformity and uninterrupted supply of the organization's product to their customers

relevant quality and delivery performance

an evaluation of the supplier's QMS

multidisciplinary decision making

an assessment of software development capabilities (if applicable)

Verify "Directed-Buy" external providers meet all requirement
Meets requirement
Verify how the organization ensures externally provided processes, products and services conform to specified requirements.
Meets requirement
Verify controls applied to externally provided processes, products and services when products and services are intended for incorporation into the organization's own products and services, products and services are provided directly to the customer or a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
Meets requirement
Verify how the organization determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.
Meets requirement
Verify documented information of activities and actions arising from the evaluations.
Meets requirement
Verify how the organization determines controls applied to the external provision of processes, products and services and the resulting output.
Meets requirement
Verify how the organization considers the potential impact of the external provided processes, products and services on its ability to meet customer and applicable statutory and regulatory requirements.
Meets requirement
Verify the effectiveness of the controls applied by the external provider.
Meets requirement
Verify how the organization determines the verification, or other activities, necessary to ensure the externally provided processes, products and services meet requirements.
Meets requirement
Verify the organization has a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity ( shall include criteria and actions to escalate or reduce controls based on supplier performance and assessment of product, material or service risk
Meets requirement
Verify the organization has a documented process that purchased products, processes and services conform to the current applicable statutory and regulatory requirements
Meets requirement
Verify the organization ensures special controls defined by the customer are implemented and maintained, including at suppliers
Meets requirement
Verify supplier's QMS is certified to ISO 9001 with the ultimate objective of becoming certified to IATF 16949
Non-conformance
Notes
Will verify this tomorrow during the meeting. Until then, tagging this as nonconformance.
Verify process for software quality assurance for suppliers of automotive product-related software or automotive products with embedded software
Meets requirement
Verify organization has documented process and criteria to evaluate supplier performance
Meets requirement
Verify organization monitors the following supplier performance indicators:
Meets requirement

delivered product conformity to requirements

customer disruptions at the receiving plant, including yard holds and stop ships

delivery schedule performance

number of occurrences of premium freight

special status customer notifications related to quality or delivery issues (if provided by customer)

dealer returns, warranty, field actions and recalls (if provided by customer)

Verify the organization has documented the criteria for determining the need, type, frequency and scope of second-party audit
Meets requirement
Verify second-party audit reports are retained
Meets requirement
Verify inputs to supplier development includes:
Non-conformance

performance issues

second-party audit findings

third-part quality management system certification status

risk analysis

Verify the organization communicates to external providers its requirements for:
Meets requirement

the processes, products and services to be provided.

the approval of product and services; methods, processes and equipment; and the release of products and services.

competence, including any required qualification of persons.

the external providers' interactions with the organization.

control and monitoring of the external providers' performance to be applied by the organization.

verification or validation activities that the organization, or its customer, intends to perform at the external providers' premises.

Verify all applicable statutory and regulatory requirements and special product and process characteristics are passed down to suppliers
Meets requirement
8.5 Production and service provision
100%
Verify the organization 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 results to be achieved.
Meets requirement
Verify the availability and use of suitable monitoring and measuring resources.
Meets requirement
Verify the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.
Meets requirement
Verify the use of suitable infrastructure and environment for the operation of processes.
Meets requirement
Verify the appointment of competent persons, including any required qualification.
Meets requirement
Verify the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.
Meets requirement
Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)
Meets requirement
Verify the implementation of release, delivery and post-delivery activities.
Meets requirement
Verify control plans (in accordance with Annex A) include:
Meets requirement

controls used for the manufacturing process control, including verification of job set-ups

first-off/last-off part validation (as applicable)

methods for monitoring of control exercised over special characteristics defined by both the customer and the organization

the customer-required information (if any)

specified reaction plan (see Annex A)

Verify the control plans shall be reviewed and updated:
Meets requirement

if the organization determines it has shipped nonconforming product to the customer

when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes or risk analysis (FMEA) (see Annex A)

after a customer complaint and implementation of the associated corrective action (as applicable)

at a set frequency based on a risk analysis

Verify if the customer requires approval of Control Plan after review or revision
Meets requirement
Verify standardized work documents are:
Meets requirement

communicated to and understood by the employees who are responsible for performing the work

legible

presented in language(s) understood by personnel who follow them

accessible for use at the designated work area(s)

Verify standardized work documents include rules for operator safety
Meets requirement
Verify organization verifies job setups
Meets requirement
Verify documentation is maintained for set-up personnel
Meets requirement
Verify organization uses statistical methods of verification, where applicable
Meets requirement
Verify first-off/last-off part validation
Meets requirement
Verify records are retained for process and product approval following set-up and first-off/last-off validations
Meets requirement
Verify organization ensure compliance with requirements after a planned or unplanned production shutdown period
Meets requirement
Verify total productive maintenance system is documented and includes:
Meets requirement

identification of process equipment

availability of replacement parts

provision of resource for machine, equipment and facility maintenance

packaging and preservation of equipment, tooling and gauging

applicable customer-specfic requirements

documented maintenance objectives (i.e. OEE, MTBF, MTTR and preventive maintenance compliance metrics)

regular review of maintenance plan and objectives and documented action plan to address corrective actions where objectives are not met

use of preventive maintenance methods

use of predictive maintenance methods (as applicable)

periodic overhaul

Verify production tooling management system (customer-owned or organization-owned) includes:
Meets requirement

maintenance and repair facilities and personnel

storage and recovery

set-up

tool-change programs for perishable tools

tool design modification documentation, including engineering change level of the product

tool modification and revision to documentation

tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location

Verify customer-owned tools and equipment are permanently marked in a visible location
Meets requirement
Verify system implemented to monitors these activities
Meets requirement
Verify production is scheduled to meet customer orders/demands such as JIT
Meets requirement
Verify production scheduling is supported by an information system
Meets requirement
Verify how organization identifies outputs from the process to ensure conformity.
Meets requirement
How does the organization identify the status of process outputs.
Meets requirement
Verify how the organization controls the unique identification of process outputs when traceability is required. Verify documented information of traceability, where required.
Meets requirement
Verify traceability plans:
Meets requirement

enable the organization to identify nonconforming and/or suspect product

enable the organization to segregate nonconforming and/or suspect product

ensure the ability to meet the customer and/or regulatory response time requirements

ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the organization to meet the response time requirements

ensure serialized identification of individual products, if specified by the customer or regulatory standards

ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics

What care is provided to customers' or external providers' property?
Meets requirement
Verify how the organization identifies, verifies, protects and safeguards customers' or external providers' property which is provided for use or incorporation into the organization's products or services.
Meets requirement
Verify retained documented information for property that is damaged or otherwise found to be unsuitable for use.
Meets requirement
Verify how the organization ensures preservation of the process outputs to ensure conformity to requirements.
Meets requirement
Verify organization assesses product in stock, the place/type of storage container and the storage environment at planned intervals
Meets requirement
Verify organization uses inventory management system to optimize inventory turns over time and ensure stock rotation (i.e. FIFO)
Meets requirement
Verify obsolete product is controlled similar to that of nonconforming product
Meets requirement
Verify organization complies with customer requirements for preservation, packaging, shipping and labeling
Meets requirement
Verify the organization considers the following to meet post-delivery activities:
Meets requirement

statutory and regulatory requirements

potential undesired consequences associated with its products and services

the nature, use and intended lifetime of its products and services

customer requirements

customer feedback

Verify organization has process for communication of information on service concerns to manufacturing, material handling, logistics, engineering and design
Meets requirement
Verify the following if a service agreement with the customer exists:
Meets requirement

relevant service centers comply with applicable requirements

effectiveness of any special purpose tools or measurement equipment

service personnel are trained in applicable requirements

Verify how the organization reviews and controls changes for production or service provision.
Meets requirement
Verify retained documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.
Meets requirement
Verify documented process
Meets requirement
Verify that the organization:
Meets requirement

defines verification and validation activities

validates changes before implementation

documents evidence of related risk analysis

retains records of verification and validation

notifies the customer of any planned product realization changes after the most recent product approval (if required)

obtains documented approval, prior to implementation of the change (if required)

completes additional verification or identification requirements, such as production trial run and new product validation (if required)

Verify production trial run for verification of changes made a supplier
Meets requirement
Verify organization has a list of primary and approved back-up/alternate process controls
Meets requirement
Verify alternate method is documented
Meets requirement
Verify alternate control method is approved internally prior to production implementation and by the customer (if required)
Meets requirement
Verify alternative control methods are identified in the Control Plan and are reviewed periodically
Meets requirement
Verify standard work instructions are created for alternative control methods
Meets requirement
Verify alternative process controls are reviewed on a daily basis (at a minimum)
Meets requirement
Verify restart verification is documented for a defined period
Meets requirement
Verify traceability of all product produced with alternative process control devices or processes
Meets requirement
8.6 Release of products and services
91.67%
Verify at appropriate stages product and service requirements have been met.
Meets requirement
Verify products and services are not released to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by relevant authority and, as applicable, by the customer.
Meets requirement
Verify retained documented information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.
Meets requirement
Verify verification of product and service requirements are documented as specified in the Control Plan
Meets requirement
Verify a layout inspection and functional inspection is performed per the Control Plan and are available for customer review
Meets requirement
For appearance items, verify the organizations provides:
Meets requirement

appropriate resources, including lighting, for evaluation

masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) and haptic technology, as appropriate

maintenance and control of appearance masters and evaluation equipment

verification that personnel making appearance evaluations are competent and qualified

For externally provided processes, products, services, verify the organization utilizes one or more of the following methds:
Improvement Opportunity

receipt and evaluation of statistical data

receiving inspection and/or testing, such as sampling based on performance

second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable delivered product conformance to requirements

part evaluation by a designated laboratory

another method agreed with the customer

Verify organization confirms and is 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
Meets requirement
Verify acceptance criteria defined by organization
Meets requirement
8.7 Control of nonconforming outputs
100%
Verify that outputs that do not conform to requirements are identified and controlled.
Meets requirement
Verify appropriate action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services):
Meets requirement

Correction

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Obtaining authorization for acceptance under concession

Verify conformity to the requirements when nonconforming outputs are corrected.
Meets requirement
Verify retained documented information that describes the nonconformity, describes actions taken, describes any concessions obtained and identifies the authority deciding the action in respect of the nonconformity.
Meets requirement
Verify concession or deviation permit approved by customer prior to further processing from what is currently approved
Meets requirement
Verify organization obtains customer authorization prior to further processing for "use as is" and rework dispositions of nonconforming product (including sub-components)
Meets requirement
Verify records are maintained of expiration date and quantity authorized under concession
Meets requirement
Verify material shipped under concession is appropriately identified
Meets requirement
Verify product with unidentified or suspect status is classified and controlled as nonconforming product
Meets requirement
Verify appropriate manufacturing personnel are trained for containment of suspect and nonconforming product
Meets requirement
Verify documented process for rework confirmation
Meets requirement
Verify instructions for disassembly or rework, including re-inspection and traceability requirements
Meets requirement
Verify documented process for repair confirmation
Meets requirement
Verify instructions for disassembly or repair, including re-inspection and traceability requirements
Meets requirement
Verify documented customer authorization for concession for the product to be repaired
Meets requirement
Verify retained documentation on the disposition of rework including quantity, disposition, disposition date and applicable traceability information
Meets requirement
Verify customer is immediately notified if nonconforming product is shipped
Meets requirement
Verify detailed documentation of the event followed initial communication
Meets requirement
Verify documented process for disposition of nonconforming product not subject to rework or repair
Meets requirement
Verify nonconforming product is rendered unusable prior to disposal
Meets requirement
9 Performance evaluation
100%
9.1 Monitoring, measurement, analysis and evaluation
100%
Verify the organization has determined what needs to be monitored and measured, the methods to be used, when it will be performed, analyzed and evaluated.
Meets requirement
Verify the organization evaluates the performance and effectiveness of its QMS.
Meets requirement
Review retained appropriate documented information
Meets requirement
Verify the organization performs process studies on all new manufacturing processes to verify process capability
Meets requirement
Verify the organization's adherence to:
Meets requirement

measurement techniques

sampling plans

acceptance criteria

records of actual measurement values and/or test results for variable data

reaction plans and escalation process when acceptance criterial are not met

Verify significant process events (i.e. tool change, machine repair) are retained documented information
Meets requirement
Verify reaction plans created for processes that are either not statistically capable or are unstable. Reaction plans shall include containment of product and 100% inspection (as appropriate)
Meets requirement
Verify records of effective dates of process changes
Meets requirement
Verify that organization has determined the appropriate use of statistical tools
Meets requirement
Verify statistical concepts are understood and used by employees involved in the collection, analysis and management of statistical data
Meets requirement
Verify the organization monitors customers' perceptions and satisfaction based on performance indicators that include but not limited to:
Meets requirement

delivered part quality performance

customer disruptions

field returns, recalls and warranty (where applicable)

delivery 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)
Meets requirement
Verify the organization analyzes and evaluates:
Meets requirement

conformity of products and services.

the degree of customer satisfaction.

the performance and effectiveness of the QMS.

if planning has been implemented effectively.

the effectiveness of actions taken to address risks and opportunities.

the performance of external providers.

the need for improvements the the QMS.

Verify organization compares trends in quality and operational performance with progress toward objectives and leads to improving customer satisfaction
Meets requirement
9.2 Internal audit
100%
Verify internal audit process is documented
Meets requirement
Verify audits are conducted at planned intervals
Meets requirement
Verify organization has established, implemented, and maintains an internal audit program
Meets requirement
Verify the importance of the process, changes affecting the organization and the results of previous audits are considered
Meets requirement
Verify audit criteria and scope are created for each audit
Meets requirement
Auditors are objective and impartial
Meets requirement
Audit results reported to relevant management
Meets requirement
Verify appropriate correction and corrective actions are taken without delay
Meets requirement
Review retained documented information
Meets requirement
Verify QMS processes are audited over three-year calendar period
Meets requirement
Verify manufacturing processes are audited over three-year calendar period
Meets requirement
Verify all shifts are audited
Meets requirement
Verify products are audited using customer-specific required approaches
Meets requirement
9.3 Management review (go through entire standard and add to inputs)
100%
Verify management reviews QMS at least annually
Meets requirement
Verify inputs to management review includes:
Meets requirement

status of actions from previous management reviews

changes in external and internal issues relevant to the QMS

customer satisfaction and feedback from relevant interested parties

the extent to which quality objectives have been met

process performance and conformity of products and services

nonconformities and corrective actions

monitoring and measurement results

audit results

effectiveness of the audit program

the performance of external providers

adequacy of resources

effectiveness of actions taken to address risks and opportunities

opportunities for improvement

cost of poor quality (cost of internal and external nonconformance)

measures of process effectiveness

measures of process efficiency

product conformity

assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product

review of performance against maintenance objectives

warranty 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:
Meets requirement

opportunities for improvement

any need for changes to the QMS

resource needs

action plan when customer performance targets are not met

Verify retained documented information
Meets requirement
10 Improvement
100%
10.1 General
100%
Verify the organization determines and selects opportunities for improvement to improve products and services, corrects, prevents or reduces undesired effects and improves the performance and effectiveness of the QMS.
Meets requirement
10.2 Nonconformity and corrective action
100%
Verify how organization reacts to nonconformity, including complaints, by evaluating how its takes action to control and correct it and how it deals with the consequences.
Meets requirement
Verify how the organization evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere.
Meets requirement
Verify how organization implements necessary actions.
Meets requirement
Verify how organization evaluates the effectiveness of actions taken.
Meets requirement
Verify the organization updates risks and opportunities determined during planning, if necessary.
Meets requirement
Verify any changes made to the QMS, if necessary.
Meets requirement
Verify retained documented information that provides evidence of the nature of the nonconformity and any subsequent actions taken and the results of any corrective actions
Meets requirement
Verify that the organization has documented process for problem solving including:
Meets requirement

defined approaches for various types and scales of problems

containment, interim actions and related activities necessary for controlling nonconforming outputs

root cause analysis, methodology used, analysis and results

implementation of systemic corrective actions, including consideration of the impact on similar processes and products

verification of the effectiveness of implemented corrective actions

reviewing and updating appropriate documented information (where necessary)

Verify documented process to determine the use of appropriate error-proofing methodologies
Meets requirement
Verify details of error-proofing method used is documented in the process risk analysis (PFMEA) and test frequencies documented in the Control Plan
Meets requirement
Verify records of testing of error-proofing devices
Meets requirement
Verify challenge parts are identified, controlled, verified and calibrated (where feasible)
Meets requirement
Verify reaction plans for error-proofing device failures
Meets requirement
Verify warranty management process (if required)
Meets requirement
Verify method for warranty part analysis, including NTF (no trouble found)
Meets requirement
Verify that the organization has performed analysis on customer complaints and field failures (include embedded software)
Meets requirement
Verify problem solving and corrective action initiated
Meets requirement
Verify the organization communicates the results of testing/analysis to the customer and also within the organization
Meets requirement
10.3 Continual improvement
100%
Verify how the organization continually improves. Does it consider the results of analysis and evaluation and the outputs from management review to determine if there are needs or opportunities that shall be addressed as part of continual improvement?
Meets requirement
Verify that the organization's documented process for continual improvement includes:
Meets requirement

identification of methodology used, objectives, measurement, effectiveness and documented information

a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste

risk analysis (such as FMEA)

Sign Off
Sign Off
I, the undersigned, have completed this IATF 16949:2016 audit in an accurate manner. I have attached evidence as required and declare this audit complete.
Full name and signature of auditor
Jean Stahl
28th Mar, 2019 1:31 PM +08