4 Context of the organization

4.1 Understanding the organization and its context

  • Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.

  • Verify how these issues affect the ability to achieve the intended result of the QMS.

  • Verify how the organization monitors and reviews information about these internal and external issues.

4.2 Understanding the needs and expectations of interested parties

  • Verify how organization determined relevant interested parties to QMS.

  • Verify how the organization has determined the relevant needs and expectations of interested parties.

  • Verify how the organization has determined the impact or potential impact of the interested parties.

  • Verify how the organization monitors and reviews information about interested parties and their relevant requirements.

4.3 Determining the scope of the quality management system

  • Verify the QMS scope considers the following:

  • 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.

  • 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.

  • Verify QMS scope is documented.

  • Verify scope states what products and services are covered by the QMS and how it justifies instances where requirements cannot be applied.

4.3.1 Determining the scope of the quality management system - supplemental

  • Verify support functions included in scope

  • If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design.

4.3.2 Customer-specific requirements

  • Verify customer-specific requirements evaluated and included in scope

4.4 Quality management system and its processes

  • Show me how the processes have been determined and how they interact.

  • Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.

  • Verify the sequence and interaction of of the processes.

  • Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.

  • Verify how resources are determined and allocated.

  • Verify how responsibilities and authorities are determined.

  • Verify how risks and opportunities are considered and what actions are taken to address them.

  • Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.

  • Verify how opportunities for improvement for the QMS and its processes are determined.

  • Reviewed documented information created to support the operation of its processes.

4.4.1.1 Conformance of products and processes

  • Verify conformance to all applicable customer, statutory and regulatory requirements

4.4.1.2 Product Safety

  • Verify documented process

  • Where applicable, shall include:

  • 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

5.1 Leadership and commitment

  • Top management is identified

  • Verify top management demonstrates leadership and commitment by

  • 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

  • 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

  • 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

  • Verify top management has identified process owners and that the process owners understand their roles and are competent to perform those roles

5.2 Policy

  • Verify the quality policy ...

  • 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.

  • Verify QMS Policy is communicated, understood and applied within the organization.

  • Verify QMS Policy is available to relevant interested parties.

5.3 Organizational roles, responsibilities and authorities

  • Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization

  • Verify top management assigns responsibility and authority for..

  • 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.

  • Verify personnel responsible for conformity have the authority to stop shipment and stop production to correct quality problems.

  • Verify personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform

  • Verify that personnel across all shifts have responsibility for ensuring conformity to product requirements.

6 Planning

6.1 Actions to address risks and opportunities

  • Verify how the internal and external issues and interested parties are considered when planning for the QMS?

  • 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

  • Verify how actions are planned to address risks and opportunities.

  • Verify how actions are integrated and implemented into the QMS processes.

  • Verify how the organization evaluates the effectiveness of the actions.

  • 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.

  • Verify risk analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.

  • Verify retained documented information

  • Verify preventive action process

  • Verify contingency plans are documented

  • Verify contingency plans are prepared for continuity of supply in the event of:

  • key equipment failures

  • interruption from externally provided products, processes and services

  • recurring natural disasters

  • fire

  • utility interruptions

  • labour shortages

  • infrastructure disruptions

  • Verify validation of manufactured product after re-start

6.2 Quality objectives and planning to achieve them

  • Verify top management ensures that quality objectives are defined, established and maintained at relevant functions, levels and processes.

  • Verify the quality objectives are..

  • 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.

  • Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives.

  • Verify annual quality objectives and related performance targets (internal and external) are established

6.3 Planning of changes

  • Verify how QMS changes are planned systematically.

  • Verify how the organization demonstrates the purpose and potential consequences of changes.

  • Verify how the organization considers the integrity of the QMS.

  • Verify how resources are made available.

  • Verify how responsibility and authority is allocated and reallocated.

7 Support

7.1 Resources

7.1.1 General - 7.1.3 Infrastructure

  • Verify how resources are determined for the organization.

  • Show me how the capabilities and constraints on internal resources are considered.

  • Show me how needs from external providers are considered.

  • Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.

  • Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.

  • Verify design layout optimizes material flow, material handling and value-added use of floor space

  • Verify assessments of manufacturing 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 maintains the environment for the operation of processes to achieve products and service conformity.

  • Verify premises are in a state of order, cleanliness and repair

7.1.5 Monitoring and measuring resources

  • Verify how resources are determined to ensure valid and reliable monitoring and measuring results.

  • 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.

  • Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.

  • 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.

  • Show me how measurement instruments are identified.

  • Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.

  • 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.

  • Verify MSA

  • Verify criteria used conforms to those in reference manuals on MSA

  • Verify documented process for managing calibration/verification records

  • Verify calibration/verification activities and records shall include:

  • 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

  • Verify laboratory requirements for:

  • 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

  • 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

7.1.6 Organizational knowledge

  • Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.

  • Verify how knowledge is maintained and made available to the extent necessary.

  • Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.

7.2 Competence

  • Show me how you determine the necessary competence of people doing work under your control that affects quality performance.

  • Show me how you determine competence on the basis of appropriate education, training or experience.

  • Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.

  • Verify documented information as evidence of competence where appropriate.

  • Verify documented process(es) for identifying training needs including awareness and achieving competence

  • Verify on-the-job training process

  • Verify documented process(es) to verify internal and second-party auditors are competent and can demonstrate

  • 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

  • Verify product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity

  • Verify maintenance of and improvement in internal auditor competence by

  • 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

  • Verify people doing work under the organization's control are aware of

  • 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.

7.4 Communication

  • Verify internal and external communication process (what, when, with whom and how to communicate).

7.5 Documented information

  • Verify documented information required by the ISO 9001:2015 standard.

  • Verify documented information that shows the effectiveness of the QMS.

  • Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).

  • Show me how the documented information is reviewed and approved for suitability and adequacy.

  • Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.

  • Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.

  • Verify documented information of external origin is identified, as appropriate, and controlled.

  • Verify quality manual and it includes, at a minimum:

  • 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

  • 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

  • Verify documented process describing the review, distribution and implementation of all customer engineering standards/specifications and related revisions

  • Verify records of dates engineering standard/spec change implemented in production (implementation shall included updated documents)

  • Verify review is completed within 10 working days of receipt of notification of engineering standards/spec changes

8 Operation

8.1 Operational planning and control

  • Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.

  • Verify how requirements for products and services are determined.

  • Verify how criteria for processes and acceptance for products and services are determined.

  • Verify how resources are determined.

  • Verify how process control is implemented.

  • Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.

  • Determine how output from the planning process is suitable for operations.

  • Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.

  • Verify how outsourced processes are controlled.

  • Verify topics shall be included in planning for product realization:

  • customer product requirements and technical specifications

  • logistics requirements

  • manufacturing feasibility

  • project planning

  • acceptance criteria

  • Verify organization ensures confidentiality

8.2 Determination of requirements for products and services

  • 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.

  • 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.

  • 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.

  • Verify how the organization reviews..

  • 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

  • Verify organization's manufacturing processes are capable (capability analysis, Cp, Cpk, Pp, Ppk)

  • Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer.

  • Verify how the organization resolves differences in the contract or order requirements from those previously defined.

  • Verify how the organization confirms customer requirements where the customer doesn't provide a documented statement.

  • Verify documented information of reviews describing new or changed requirements to products and services.

  • Verify documented information of amended reviews and how relevant personnel are made aware of those changes.

  • Verify written or verbal communication is in language agreed to with the customer

8.3 Design and development of products and services

8.3.1 General

  • Verify how the design and development process is established, implemented and maintained.

  • Verify product and manufacturing design is focused on error prevention rather than detection

8.3.2 Design and development planning

  • In determining the stages and control for design and development, verify the organization considers..

  • 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.

  • Verify design and development planning includes a multidisciplinary approach of all affected stakeholders within its organization and its supply chain (as appropriate).

  • Verify product design personnel are competent to achieve design requirements and are skilled in applicable product design tools and techniques.

  • Verify process for quality assurance for their products with internally developed embedded software.

8.3.3 Design and development inputs

  • In determining requirements essential for the type of products and services being designed and developed, the organization shall consider..

  • 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.

  • Verify documented information on design and development inputs are retained.

  • Verify design input requirements as a result of contract review

  • 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

  • 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

  • Verify multi-disciplinary approach to identify special characteristics

  • 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)

8.3.4 Design and development controls

  • Verify the organization applies controls to the design and development process to ensure that..

  • 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.

  • Verify measurement results summary are an input to management review

  • Verify measurements are reported to customer, if required

  • Verify validation performed in accordance to customer requirements, including industry and government regulation standards.

  • Verify interaction of organization's product, including embedded software, within the system of the final customer's product (if contractually agreed with customer)

  • Verify prototype program and control plan (if required)

  • Verify prototype performance testing is monitored for timely completion

  • Verify product and manufacturing approval process conforming to customer requirements

  • Verify approval of external provided parts and services prior to submission of part approval to customer

  • Verify product approval is documented prior to shipment (if required) and retained.

8.3.5 Design and development outputs

  • Verify the organization ensures the design and development outputs..

  • 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.

  • Verify manufacturing process design output is documented

  • Verify manufacturing process design output versus input

  • Verify manufacturing process design output includes..

  • 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

8.3.6 Design and development changes

  • 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.

  • 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.

  • Verify organization evaluates design changes after initial product approval

  • Verify documented approval or waiver from the customer prior to production implementation (if required)

  • Verify revision level of embedded software and hardware

8.4 Control of externally provided processes, products and services

  • Verify the organization has a documented supplier selection process and it includes..

  • 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

  • Verify how the organization ensures externally provided processes, products and services conform to specified requirements.

  • 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.

  • Verify how the organization determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.

  • Verify documented information of activities and actions arising from the evaluations.

  • Verify how the organization determines controls applied to the external provision of processes, products and services and the resulting output.

  • 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.

  • Verify the effectiveness of the controls applied by the external provider.

  • Verify how the organization determines the verification, or other activities, necessary to ensure the externally provided processes, products and services meet requirements.

  • 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

  • Verify the organization has a documented process that purchased products, processes and services conform to the current applicable statutory and regulatory requirements

  • Verify the organization ensures special controls defined by the customer are implemented and maintained, including at suppliers

  • Verify supplier's QMS is certified to ISO 9001 with the ultimate objective of becoming certified to IATF 16949

  • Verify process for software quality assurance for suppliers of automotive product-related software or automotive products with embedded software

  • Verify organization has documented process and criteria to evaluate supplier performance

  • Verify organization monitors the following supplier performance indicators

  • 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

  • Verify second-party audit reports are retained

  • Verify inputs to supplier development includes..

  • 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..

  • 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

8.5 Production and service provision

8.5.1 Control of production and service provision

  • 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.

  • Verify the availability and use of suitable monitoring and measuring resources.

  • 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.

  • Verify the use of suitable infrastructure and environment for the operation of processes.

  • Verify the appointment of competent persons, including any required qualification.

  • 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.

  • Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)

  • Verify the implementation of release, delivery and post-delivery activities.

8.5.1.1 Control Plan

  • Verify control plans (in accordance with Annex A) include..

  • 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..

  • 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

8.5.1.2 Standardized work - operator instructions and visual standards

  • Verify standardized work documents are..

  • 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

8.5.1.3 Verification of job set-ups / 8.5.1.4 Verification after shutdown

  • Verify organization verifies job setups

  • Verify documentation is maintained for set-up personnel

  • Verify organization uses statistical methods of verification, where applicable

  • Verify first-off/last-off part validation

  • Verify records are retained for process and product approval following set-up and first-off/last-off validations

  • Verify organization ensure compliance with requirements after a planned or unplanned production shutdown period

8.5.1.5 Total productive maintenance

  • Verify total productive maintenance system is documented and includes..

  • 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

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment

  • Verify production tooling management system (customer-owned or organization-owned) includes..

  • 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

  • Verify system implemented to monitors these activities

8.5.1.7 Production scheduling

  • Verify production is scheduled to meet customer orders/demands such as JIT

  • Verify production scheduling is supported by an information system

8.5.2 Identification and traceability

  • Verify how organization identifies outputs from the process to ensure conformity.

  • How does the organization identify the status of process outputs.

  • Verify how the organization controls the unique identification of process outputs when traceability is required. Verify documented information of traceability, where required.

  • Verify traceability plans..

  • 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

8.5.3 Property belonging to customers or external providers

  • What care is provided to customers' or external providers' property?

  • 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.

  • Verify retained documented information for property that is damaged or otherwise found to be unsuitable for use.

8.5.4 Preservation

  • Verify how the organization ensures preservation of the process outputs to ensure conformity to requirements.

  • Verify organization assesses product in stock, the place/type of storage container and the storage environment at planned intervals

  • Verify organization uses inventory management system to optimize inventory turns over time and ensure stock rotation (i.e. FIFO)

  • Verify obsolete product is controlled similar to that of nonconforming product

  • Verify organization complies with customer requirements for preservation, packaging, shipping and labeling

8.5.5 Post-delivery activities

  • Verify the organization considers the following to meet post-delivery activities.

  • 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

  • Verify the following if a service agreement with the customer exists:

  • relevant service centers comply with applicable requirements

  • effectiveness of any special purpose tools or measurement equipment

  • service personnel are trained in applicable requirements

8.5.6 Control of changes

  • Verify how the organization reviews and controls changes for production or service provision.

  • 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.

8.5.6.1 Control of changes - supplemental

  • Verify documented process

  • Verify organization...

  • 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

8.5.6.1.1 Temporary change of process controls

  • Verify organization has a list of primary and approved back-up/alternate process controls

  • Verify alternate method is documented

  • Verify alternate control method is approved internally prior to production implementation and by the customer (if required)

  • Verify alternative control methods are identified in the Control Plan and are reviewed periodically

  • Verify standard work instructions are created for alternative control methods

  • Verify alternative process controls are reviewed on a daily basis (at a minimum)

  • Verify restart verification is documented for a defined period

  • Verify traceability of all product produced with alternative process control devices or processes

8.6 Release of products and services

  • Verify at appropriate stages product and service requirements have been met.

  • 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.

  • Verify retained documented information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.

  • Verify verification of product and service requirements are documented as specified in the Control Plan

  • Verify a layout inspection and functional inspection is performed per the Control Plan and are available for customer review

  • For appearance items, verify the organizations provides..

  • 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

  • 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

  • Verify acceptance criteria defined by organization

8.7 Control of nonconforming outputs

  • Verify that outputs that do not conform to requirements are identified and controlled.

  • Verify appropriate action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services).

  • 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.

  • 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.

8.7.1.1 Customer authorization for concession - 8.7.1.3 Control of suspect product

  • Verify concession or deviation permit approved by customer prior to further processing from what is currently approved

  • Verify organization obtains customer authorization prior to further processing for "use as is" and rework dispositions of nonconforming product (including sub-components)

  • Verify records are maintained of expiration date and quantity authorized under concession

  • Verify material shipped under concession is appropriately identified

  • Verify product with unidentified or suspect status is classified and controlled as nonconforming product

  • Verify appropriate manufacturing personnel are trained for containment of suspect and nonconforming product

8.7.1.4 Control of reworked product - 8.7.1.5 Control of repaired product

  • Verify documented process for rework confirmation

  • Verify instructions for disassembly or rework, including re-inspection and traceability requirements

  • Verify documented process for repair confirmation

  • Verify instructions for disassembly or repair, including re-inspection and traceability requirements

  • Verify documented customer authorization for concession for the product to be repaired

  • Verify retained documentation on the disposition of rework including quantity, disposition, disposition date and applicable traceability information

8.7.1.6 Customer notification - 8.7.1.7 Nonconforming product disposition

  • Verify customer is immediately notified if nonconforming product is shipped

  • Verify detailed documentation 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 disposal

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

  • 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.

  • Verify the organization evaluates the performance and effectiveness of its QMS.

  • Review retained appropriate documented information

  • Verify the organization performs process studies on all new manufacturing processes to verify process capability

  • Verify adherence to..

  • 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

  • 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)

  • Verify records of effective dates of process changes

  • Verify that organization has determined the appropriate use of statistical tools

  • Verify statistical concepts are understood and used by employees involved in the collection, analysis and management of statistical data

  • Verify the organization monitors customers' perceptions and satisfaction based on performance indicators that include but not limited to ..

  • 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)

  • Verify the organization analyzes and evaluates:

  • 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

9.2 Internal audit

  • Verify internal audit process is documented

  • Verify audits are conducted at planned intervals

  • Verify organization has established, implemented, and maintains an internal audit program

  • Verify the importance of the process, changes affecting the organization and the results of previous audits are considered

  • Verify audit criteria and scope are created for each audit

  • Auditors are objective and impartial

  • Audit results reported to relevant management

  • Verify appropriate correction and corrective actions are taken without delay

  • Review retained documented information

  • Verify QMS processes are audited over three-year calendar period

  • Verify manufacturing processes are audited over three-year calendar period

  • Verify all shifts are audited

  • Verify products are audited using customer-specific required approaches

9.3 Management review (go through entire standard and add to inputs)

  • Verify management reviews QMS at least annually

  • Verify inputs to management review includes:

  • 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:

  • 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

10 Improvement

10.1 General

  • 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.

10.2 Nonconformity and corrective action

  • 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.

  • 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.

  • Verify how organization implements necessary actions.

  • Verify how organization evaluates the effectiveness of actions taken.

  • Verify the organization updates risks and opportunities determined during planning, if necessary.

  • Verify any changes made to the QMS, if necessary.

  • 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

10.2.3 Problem solving

  • Verify document process that includes..

  • 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)

10.2.4 Error-proofing

  • Verify documented process to determine the use of appropriate error-proofing methodologies

  • Verify details of error-proofing method used is documented in the process risk analysis (PFMEA) and test frequencies documented in the Control Plan

  • Verify records of testing of error-proofing devices

  • Verify challenge parts are identified, controlled, verified and calibrated (where feasible)

  • 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 warranty 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 communicates the results of testing/analysis to the customer and also within the organization

10.3 Continual improvement

  • 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?

  • Verify documented process for continual improvement includes..

  • 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)

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