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IATF 16949:2016

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Quality Managers use this IATF audit checklist to evaluate if the company’s QMS is aligned with the IATF 16949:2016 standard. It assists you to assure that an automotive supplier or manufacturer’s QMS promotes continuous development, defect prevention, and waste reduction in the automotive equipment chain. Use this checklist with Lumiform on mobile devices to attach photos and make notes of nonconformance found important to the question item. Use all sections of this checklist to make an internal evaluation of compliance with the IATF 16949:2016 standard.
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IATF 16949:2016

4 Context of the Organisation

Introduction

Complete all sections starting below. This IATF audit checklist will assess the organization's compliance with the IATF 16949:2016 standard. Don't forget to attach proof to items where needed, and to sign off and complete this audit in the last section.

4.1 Understanding the Organisation and its Context

NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local. NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

Check how these issues influence the ability to achieve the intended result of the QMS.

Check how the organization monitors and reviews data about these internal and external issues.

4.2 Understanding the needs and expectations of interested parties

Has the company conducted a study to determine the impact or potential impact on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:a)The interested parties that are relevant to the quality management system;b)The requirements of these interested parties that are relevant to the quality management system.

Document how the organization determined important interested parties to QMS.

Document how the organization has determined the important demands and expectations of interested parties.

Document how the organization has determined the influence or potential impact of the interested parties.

Check how the organization monitors and reviews information about interested parties and their relevant demands.

4.3 Determining the scope of the quality management system

Verify how the QMS scope considers the following:

The demands of relevant interested parties.

External and internal issues.

The products and services of the company.

If the organization has determined any of the demands of the ISO 9001:2015 standard not to be suitable, show how conformity of products and services are not affected by this.

Document how the organization has determined how the ISO 9001:2015 standard is applied within the company.

Verify that QMS scope is documented.

Verify scope states which products and services are covered by the QMS and how it supports instances where demands cannot be applied.

4.3.1 (TS) Determining the scope of the QMS - Supplementary

Verify support functions contained in scope

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

4.3.2 (TS) Customer Specific Requirements

Verify customer-specific demands evaluated and included in scope

4.4 Quality management system and its processes

4.4.1

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

Verify how the methods for the QMS were determined. Verify the inputs and outputs to the methods.

Verify the sequence and interaction of the processes.

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

Verify how equipment is determined and allocated.

Verify how responsibilities and authorities are established.

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

Verify what methods are practised to monitor, measure and evaluate processes. Verify changes, if required, are implemented to achieve intended results.

Verify how opportunities for change for the QMS and its methods are determined.

Reviewed documented information made to support the operation of its methods.

4.4.1.1 (TS) Conformance of products and processes

The organisation shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customers, statutory requirements (See Sections 8.4.2.2)

Verify conformance to all applicable buyer, statutory and regulatory demands

4.4.1.2 (TS) Product Safety

The organisation shall have documented processes for the Management of Product Safety related products and manufacturing processes which shall include but not limited to the following, where applicable:

Verify documented process

Where applicable, shall include:

Identification of statutory and regulatory product safety demands and customer notification

Special permissions for design FMEA, process FMEAs and control plans

Identification and checks of product safety-related characteristics (including at the point of manufacture)

Definition of responsibilities, escalation method and flow of information, including top management and customer notification

Training necessary

Changes of product or method shall be approved prior to implementation

Lessons learned for new product introductions

Reaction plans

Transfer of demands with regard to product safety during the supply chain, including customer-designated sources

Product traceability by accomplished lot (at a minimum) throughout the supply chain

Lessons learned for new product introduction

5 Leadership

5.1 Leadership and commitment

5.1.1 Leadership and commitment for the quality management system

Top management shall demonstrate leadership and commitment with respect to the quality management system by:a) taking accountability of the effectiveness of the quality management system;b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the strategic direction and the context of the organization;c) ensuring that the quality policy is communicated, understood and applied within the organization;d) ensuring the integration of the quality management system requirements into the organization’s business processes;e) promoting awareness of the process approach;f) ensuring that the resources needed for the quality management system are available;g) communicating the importance of effective quality management and of conforming to the quality management system requirements;h) ensuring that the quality management system achieves its intended results;i) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;j) promoting continual improvement;k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence; whether the organization is public, private, for profit or not for profit.

Does Best Bars top management demonstrates leadership and commitment w.r.t. the QMS by taking accountability of the effectiveness of the QMS.

Does Best Bars make use of the quality policy and objectives established for the QMS and are they compatible with the strategic direction and the organizational context?

Does Best Bars communicate the quality policy within the organization?

Are Best Bars requirements of the QMS integrated into the business processes?

Does Best Bars communicate the importance of effective quality management?

Does Best Bars ensure that the QMS achieves its intended results?

Does Best Bars engage, direct and support people to contribute to the effectiveness of the QMS?

Does Best Bars promote continual improvement?

Does Best Bars support other relevant management roles to demonstrate leadership in their areas of responsibility?

5.1.1.1 (TS) Corporate responsibility

Does Best Bars define and implement corporate responsibility policies, including at a minimum abd anti-bribery policy, an employee code of conduct, and an ethics escalation policy (Whistle blowing policy)

5.1.1.2 (TS) Process effectiveness and efficiency

Does Best Bars Top Management review product realisation processes and support processes to evaluate and improve their effectiveness and efficiency?The results of the process review activities shall be included as a input into the Management Review (See Section 9.3.2.1)

5.1.1.3 (TS) Process owners

Does Best Bars top management identify process owners who are responsible for managing the organisations processes and related outputs? The process owners shall understand their roles and competent to perform those roles (See ISO 9001, Section 9.3.2.1)

5.1.2 Customer focus

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:a) customer requirements and applicable statutory and regulatory requirements are determined and met;b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;d) the focus on enhancing customer satisfaction is maintained.

Does Best Bars top management demonstrates leadership and commitment w.r.t. customer focus ensuring requirements and applicable statutory and regulatory requirements are determined and met.

Does Best Bars determine the risks and opportunities that can affect conformity of products and services?

Does Best Bars consistently provide products and services that meet customer and applicable statutory and regulatory requirements?

Does Best Bars provide customer satisfaction?

5.2 Quality policy

5.2.1

Top management shall establish, review and maintain a quality policy that:a) is appropriate to the purpose and context of the organization;b) provides a framework for setting and reviewing quality objectives;c) includes a commitment to satisfy applicable requirements;d) includes a commitment to continual improvement of the quality management system.

Does Best Bars top management establish, review and maintain a quality policy?

Does Best Bars determine the Quality Policy to be appropriate to the purpose and context of the organization?

Does it provide a framework for setting and reviewing quality objectives?

Does it contain a commitment to satisfy applicable requirements?

Does it include a commitment to continual improvement of the QMS?

5.2.2

The quality policy shall:a) be available as documented information;b) be communicated, understood and applied within the organization;c) be available to relevant interested parties, as appropriate.

Is the quality policy available as documented information?

Is it communicated?

Is the Policy available to relevant interested parties?

5.3 Organisational roles, responsibility and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.Top management shall assign the responsibility and authority for:a) ensuring that the quality management system conforms to the requirements of this International Standard;b) ensuring that the processes are delivering their intended outputs;c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management; d) ensuring the promotion of customer focus throughout the organization;e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Does top management ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?

Does top management assign the responsibility and authority for ensuring that the QMS conforms to the International standard?

Does top management assign the responsibility and authority for ensuring processes are delivering their intended outputs?

Is the performance of the QMS, opportunities for improvement and the need for change or innovation reported to top management?

Does top management promote customer focus within the organization?

Is the integrity of the QMS maintained when changes to the QMS are planned and implemented?

5.3.1 (TS) Organisational roles, responsibilities and authorities

Does Best Bars top Management assign personnel with the responsibility and authority to ensure that customer requirements are met? These assignments shall be documented. This includes but is not limited to the selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development, capacity analysis, logistics information, customer scorecards and customer portals.

5.3.2 (TS) Responsibility and authority for product requirements and corrective actions

Does Best Bars top Management ensure:Personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems?

Does Best Bars production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements?

Does Best Bars personnel with authority and responsibility for corrective actions are promptly informed of products or processes that do not conform to requirements to ensure that nonconforming products is not shipped to the customers and that all potential nonconforming product is identified and contained?

6 Planning for the Quality Management System

6.1 Actions to address risks and opportunities

6.1.1

When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities thatneed to be addressed to:a) give assurance that the quality management system can achieve its intended result(s);b) prevent, or reduce, undesired effects; c) Achieve continual improvement.

Are the internal and external issues and interested parties considered when planning for the QMS?

Are risks and opportunities determined and addressed so that the QMS can achieve its intended results?

Are risks and opportunities determined and addressed so that the QMS can prevent or reduce undesired effects?

Are risks and opportunities determined and addressed so that the QMS can achieve continual improvement?

6.1.2

NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.Applicable tools and techniques shall be identified by the organization.

Are actions planned to address risks and opportunities?

Are actions integrated and implemented into the QMS processes?

Does Best Bars evaluate the effectiveness of the actions?

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

Does Best Bars take actions to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services?

Product design skills

The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.Applicable tools and techniques shall be identified by the organization.

Does Best Bars determine that personnel with product design responsibility are competent to achieve design requirements?

Does Best Bars determine skills required in applicable tools and techniques?

Does Best Bars identify applicable tools and techniques?

NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

6.1.2.1 (TS) Risk Analysis

Does Best Bars at a minimum include in its risk analysis lessons learned from product recalls, product audits, field returns and repairs, complaints and scrap and rework?

6.1.2.2 (TS) Preventive action

Does Best Bars determine and implement actions to eliminate the causes of potential non conformity in order to prevent their occurrences? Preventive actions shall be appropriate to the severity of the potential issues?

Does Best Bars establish a process to lessen the impact of negative effects of risk which includes the following:Determining potential non-conformity and their causes?

Evaluating the need for action to prevent occurrences of non-conformity?

Determining and implementing actions needed?

Documented information of action taken?

Reviewing the effectiveness of the preventive action taken?

Utilising lessons learned to prevent re-occurrences in similar processes (See ISO 9001. Section 7.1.6)

6.1.2.3 (TS) Contingency Plans

Does Best Bars

Identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met?

Define contingency plans according to risk and impact to the customer?

Prepare contingency plans for continuity of supply in the event of any of the following key equipment failures (Also see section 8.5.6.1.1), interruption from externally provided products, processes and services, recurring natural disasters, fire, utility interruptions, labor shortages and infrastructure disruptions?

Include, as a supplement to the contingency plans, a notification process to the customer and other interested parties for the extent and duration of any situation impacting customers operations?

Periodically test the contingency plans, a notification process to the customer and other interested parties for the extent and duration of any situation impacting customers operations?

Conduct contingency plan reviews (At a minimum Annually) using multidisciplinary team including top Management, and update as required?

Document the contingency plans and retain documented information describing and revision, including the person who authorised the change?

The contingency plan shall include provisions to validate that the manufactured product continues to meet customer specifications after the restart of production following and emergency in which production was stopped and if the regular shutdown processes were not followed?

6.2 Quality objectives and planning to achieve them

6.2.1

The organization shall establish quality objectives at relevant functions, levels and processes.The quality objectives shall: a) be consistent with the quality policy,b) be measurable;c) take into account applicable requirements;d) be relevant to conformity of products and services and the enhancement of customer satisfaction;e) be monitored;f) be communicated;g) be updated as appropriate.The organization shall retain documented information on the quality objectives.

Does Best Bars have quality objectives and are these at all relevant functions, levels and processes?

Are they consistent with the quality policy?

Do they consider applicable requirements?

Are they relevant to the conformity of products and services and do they enhance customer satisfaction?

Are they monitored? How? How often?

Are they communicated?

Are they updated?

Are there documented information on the quality objectives?

6.2.2

When planning how to achieve its quality objectives, the organization shall determine: a) what will be done;b) what resources will be required;c) who will be responsible;d) when it will be completed;e) how the results will be evaluated

Does Best Bars determine what will be done, with what resources, when completed and how will results be evaluated for quality objectives?

6.2.2.1 (TS) Quality Objectives and planning to achieve them

Does Best Bars top Management ensure that quality objectives to meet customer requirements are defined, established and maintained for relevant functions, processes and levels throughout the organisation?The results of the organisations review regarding interested parties and their relevant requirements shall be considered when Best Bars establishes its annual (At a minimum) quality objectives and related performance targets (Internal and External)

6.3 Planning of changes

Where the organization determines the need for change to the quality management system (see 4.4) the change shall be carried out in a planned and systematic manner.The organization shall consider:a) the purpose of the change and any of its potential consequences;b) the integrity of the quality management system;c) the availability of resources;d) the allocation or reallocation of responsibilities and authorities.

Are changes to the QMS planned systematically?

Can Best Bars demonstrate the purpose and potential consequences of changes?

Can Best Bars demonstrate the integrity of the QMS?

Can Best Bars demonstrate how resources are made available?

Can Best Bars demonstrate how responsibility and authority is allocated or reallocated?

7 Support

7.1 Resources

7.1.1 General

The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.The organization shall consider:a) the capabilities of, and constraints on, existing internal resources;b) what needs to be obtained from external providers.

Can Best Bars demonstrate how resources are determined for the establishment, implementation, maintenance and continual improvement of the QMS?

Can Best Bars demonstrate how the capabilities and constraints on internal resources are considered?

Can Best Bars demonstrate how needs from external providers are considered.

7.1.2 People

To ensure that the organization can consistently meet customer and applicable statutory and regulatory requirements, the organization shall provide the persons necessary for the effective operation of the quality management system, including the processes needed.

Does Best Bars provide persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes?

7.1.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure for the operation of its processes to achieve conformity of products and services

Does Best Bars determine, provide and maintain the infrastructure for the operation of processes to achieve products and service conformity?

7.1.3.1 (TS) Plant, facility and equipment planning

Does Best Bars use a multidisciplinary approach including a risk identification and risk mitigation methods when developing and improving plant, facility and equipment plans

In designing plant layouts, Does Best Bars optimise material flow, material handling, and value added use of floor space including control of nonconforming products?

Does Best Bars facilitate synchronous material flow, as applicable?

Does Best Bars develop and implement methods to evaluate manufacturing feasibility for new product or new operations?Manufacturing feasibility assessments shall include capacity planning. These methods shall also be applicable for evaluating proposed changes to existing operations.

Does Best Bars maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance (See section 8.5.1.1) and verification of job set-ups (see section 8.5.1.3)

Note 1: These requirements should include the application of lean manufacturing principles.

Note 2: These requirements should apply to on-site supplier activities, as applicable.

Health and Safety

Where third party certification to ISO 45001 (or equivalent) is recognised, it may be used to demonstrate the organisations conformity to the personnel safety aspects of this requirement.

7.1.4 Environment for the operation of processes

The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

Does Best Bars determine, provide and maintain the environment for the operation of processes to achieve products and service conformity?

NOTE Environment for the operation of processes can include physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).

7.1.4.1 (TS) Environment for the operation of processes

Does Best Bars maintain its premises is a state of order, cleanliness and repair that is consistent with the product and manufacturing process needs?

7.1.5 Monitoring and measuring resources

Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organization shall determine the resources needed to ensure valid and reliable monitoring and measuring results.

Are the resources determined for ensuring valid and reliable monitoring and measuring results, where used?

The organization shall ensure that the resources provided:a) are suitable for the specific type of monitoring and measurement activities being undertaken;b) are maintained to ensure their continued fitness for their purpose.

Does Best Bars ensure that resources provided are suitable for the specific monitoring and measurement activities and are maintained to ensure continued fitness for purpose?

The organization shall retain appropriate documented information as evidence of fitness for purpose of monitoring and measurement resources.

Does Best Bars have documented information which is evidence of fitness for purpose of monitoring and measurement resources.

Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectation; or considered by the organization to be an essential part of providing confidence in the validity of measurement results; measuring instruments shall be:-verified or calibrated at specified intervals or prior to use against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification shall be retained as documented information;-identified in order to determine their calibration status;-safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

Does Best Bars Verify or calibrate at specified intervals against national or international measurement standards;

If there are no standards does Best Bars document information which is used as the basis used for calibration or verification

Are Best Bars measurement instruments identified to determine their calibration status.

Are safeguarded from adjustments

Are they safeguarded from damage and deterioration

7.1.5.1.1 (TS) Measurement System Analysis

Does Best Bars conduct statistical studies to analyse the variation present in the results of each type of inspection, measurement and test equipment system identified in the control plan? The analytical methods and acceptance criteria used shall conform to those in reference manuals on measurement system analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.

Note: Prioritisation of MSA studies should focus on critical or special product or process characteristics.

7.1.5.2.1 (TS) Calibration/Verification records

Does Best Bars have a documented process for managing calibration/verification records?Records for the calibration/verification activity for all gauges and measuring and test equipment (including employee owned equipment relevant for measuring, customer owned equipment, or on-site supplier owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements and customer defined requirements shall be retained.

Does Best Bars ensure that calibration /verification activities and records shall include the following details:Revisions following engineering changes that impact measuring systems?

Any out of specification readings received for calibration/verification?

An assessment of the risk of the intended use of the product caused by the out of spec condition?

When a piece of inspection measurement and test equipment is found to be out of calibration or defective during planned verification or calibration or during use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained, including associated standards last calibration date and the next due date on the calibration report.

Notification to the customer if suspect product or material is shipped

Statements of conformity to specification after calibration/verification

Verification that software version used for product and process control is specified

Records of the calibration and maintenance activities for all gauging

Production related software verification used for product and process control

7.1.5.3 (TS) Laboratory Requirements

7.1.5.3.1 (TS) Internal Laboratory

Does Best Bars internal laboratory facility have a defined scope that includes its capacity to perform the required inspection, test or calibrated service?

The laboratory shall specify and implement as a minimum, requirements for:Adequacy of the laboratory technical procedures

Competency of the laboratory personnel

Testing of the product

Capability to perform these services correctly, traceable to the relevant process standard (ASTM etc.)

Customer requirements, if any

Review of the related records

Note: Third party accreditation to ISO 17025 may be used to demonstrate the organisations in-house laboratory conformity to this requirement.

7.1.5.3.2 (TS) External Laboratory

Does Best Bars define the scope used for inspections, test and calibration services used for external laboratory facilities that includes the capacity to perform the required inspection, test, calibration?

Does Best Bars ensure that the laboratory is ISO 17025 accredited or national equivalent and includes the relevant inspections, tests and calibration services in the scope of the accreditation Certificate?

Does Best Bars ensure that the external laboratory is accredited by the customer?

Note, Such evidence may be demonstrated by customer assessment, for example, or by the customer approved third party assessment that the laboratory meets the intent of ISO 17025 or national equivalent. The second party assessment may be performed by the organisation assessing the laboratory using a customer approved method of assessment.

Use of calibration services, other than qualified (Or customer accepted) laboratories may be subject to government regulatory confirmation, if required.

7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

Does Best Bars determine necessary knowledge for the operation of processes?

Does Best Bars determine necessary knowledge to achieve conformity of products and services?

This knowledge shall be maintained, and made available to the extent necessary.

Does Best Bars maintain this knowledge and how do you make it available to the extent necessary?

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge

How does Best Bars consider current knowledge

How does Best Bars acquire additional knowledge when addressing changing needs and trends?

NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned. NOTE 2 To obtain the knowledge required, the organization can consider:a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the organization); b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).

7.2 Competence

The organization shall:a) determine the necessary competence of person(s) doing work under its control that affects its quality performance;b) ensure that these persons are competent on the basis of appropriate education, training, or experience;c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;d) retain appropriate documented information as evidence of competence

Does Best Bars determine the necessary competence of people doing work under your control that affects quality performance;

Does Best Bars determine competence on the basis of appropriate education, training or experience?

Does Best Bars take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions?

Does Best Bars have documented information where appropriate of competence

NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring or contracting of competent persons.

7.2.1 (TS) Competence

Does Best Bars establish and maintain a documented process for identifying training need including awareness (See section 7.3.1) and achieve competence of all personnel performing activities affecting conformity to product and process requirements? Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.

7.2.2 (TS) Competence - On the jib training

Does Best Bars provide on the job training (Which shall include customer requirements training) for personnel new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements which include contract or agency personnel?

Does Best Bars administer the level of detail required for on-the-job training with the level of education the personnel posses and the complexity of the tasks they are required to perform for their daily work? Persons who can effect quality shall be informed about the consequences of non-conformity to customer requirements.

7.2.3 (TS) Internal auditor competency

Does Best Bars have a documented process to verify that the internal auditors are competent, taking into account any customer specific requirements? For additional guidance on auditor competencies, refer to ISO 19011.

Does Best Bars maintain a list of qualified internal auditor?

Does Best Bars QMS auditors, manufacturing process auditors and product auditors able to demonstrate the following minimum competencies:Understanding of the automotive process approach for auditing, including risk thinking?

Understanding of applicable customer specific requirement?

Understanding of the ISO 9001 and IATF 16949 requirements related to the scope of the auditing?

Understanding applicable core tools requirements related to the scope of the audit?

Understanding how to plan, conduct, report and close out audit findings?

Does Best Bars auditors demonstrate manufacturing process technical understanding of the relevant manufacturing process to be audited, including process risk analysis (PFMEA) and control plan.

Does Best Bars product auditors demonstrate competence in the understanding of product requirements and use the relevant measuring and test equipment to verify product conformity?

Does Best Bars provide training to achieve competency, documented information shall be retained to demonstrate the trainers competency with the above requirements?

Does Best Bars auditors execute a minimum number of audits per year as defined by the organisation?

Does Best Bars maintain knowledge of relevant requirements based on internal changes (e.g Process technology, product technology) and external changes (E.g ISO 9001, IATF 16949, Core tools and customer specific requirements)?

7.2.4 (TS) Second Part auditor competency

Does Best Bars demonstrate the competencies of the auditors undertaking second party audits?

Second part auditors shall meet customer specific requirements for auditing qualification and demonstrate at a minimum the following core competencies, including understanding of the following:The automotive process approach to auditing, including risk base thinking?

Understanding of applicable customer specific requirement?

Understanding of the ISO 9001 and IATF 16949 requirements related to the scope of the auditing?

Understanding applicable core tools requirements related to the scope of the audit?

Understanding how to plan, conduct, report and close out audit findings?

7.3 Awareness

Persons doing work under the organization’s control shall be aware of: a) the quality policy;b) relevant quality objectives;c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance;d) the implications of not conforming with the quality management system requirements.

Does Best Bars make their workers aware of their quality policy?

Does Best Bars make their employees aware of their relevant quality objectives?

Does Best Bars make their employees aware of their contribution to the effectiveness of the QMS?

Does Best Bars make their employees aware of the benefits of improved performance?

Does Best Bars make their employees aware of the implications of not conforming with the QMS requirements?

7.3.1 (TS) Awareness

Does Best Bars maintain documented information that demonstrate that all employees are aware of their impact on product quality and the importance of their activities in achieving, maintaining and improving quality, including customer specific requirements and the risks involved for the customer with non-conforming product?

7.3.2 (TS) Employee motivated and empowerment

Does Best Bars maintain a documented process to motivate employees to achieving quality objectives, to make continual improvements and to create an environment that promotes innovation? The process shall include the promotion of quality and technology awareness throughout the entire organisation

7.4 Communication

The organization shall determine the internal and external communications relevant to the quality management system including:a) on what it will communicate;b) when to communicate;c) with whom to communicate;d) how to communicate.

Does Best Bars show you how to determine internal and external communications relevant to the QMS?

Does Best Bars show you how to determine What?

Does Best Bars show you how to determine When?

Does Best Bars show you how to determine With Whom?

Does Best Bars show you how to determine How?

7.5 Documented information

7.5.1 General

The organization’s quality management system shall include:a) documented information required by this International Standard;b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.

What documented information does Best Bars have as required by this standard?

What documented information does Best Bars have as being necessary for the effectiveness of your QMS?

NOTE The extent of documented information for a quality management system can differ from one organization to another due to:a) the size of organization and its type of activities, processes, products and services;b) the complexity of processes and their interactions;c) the competence of persons.

7.5.1 (TS) Quality Management System Documentation

Is Best Bars QMS documented and includes a quality manual which can be a series of documents (Electronic or hard copy)?

Does the quality manual include, at a minimum, the scope of the quality management system, including details of and justification for any exclusions?

Does the quality manual include, at a minimum, documented processes established for the QMS or reference them?

Does the quality manual include, at a minimum, the organisations processes and their sequence and interactions (inputs and outputs) including type and extent of control of any outsourced processes?

Does the quality manual include, at a minimum, a document (i.e Matrix) indicating where within the organisations QMS their customer specific requirements are addressed?

Note: A matrix of how the requirements of this QMS standard are addressed by the organisations processes may be used to assist the linkages of the organisations processes and this automotive QMS.

7.5.2 Creating and updating

When creating and updating documented information the organization shall ensure appropriate:a) identification and description (e.g. a title, date, author, or reference number); b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);c) review and approval for suitability and adequacy.

Does Best Bars have documented information that contains:Identification;Description;and in what media format?

Does Best Bars have documented information that can be reviewed and approved for suitability and adequacy.

7.5.3 Control of documented information

7.5.3.1

Documented information required by the quality management system and by this International Standard shall be controlled to ensure:a) it is available and suitable for use, where and when it is needed;b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

Does Best Bars show how to control documented information.

Does Best Bars show how to make it available and suitable for use.

How does Best Bars protect their documented information?

7.5.3.2

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled.

How does Best Bars identify as appropriate and control documented information of external origin which has been determined as necessary for the QMS

NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.

7.5.3.2.1 (TS) Record Retention

Does Best Bars define, document and implement a record retention policy? The control of records shall satisfy statutory, regulatory, organisational and customer requirements.

Does the record retention policy include production part approvals, tooling records (Including maintenance and ownership), product and process design records, purchase ordeers (if applicable), or controls and amendments shall be retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency?

Note: Production Part Approval documented information may include approved product, applicable test equipment records or approved test data.

7.5.3.2.2 (TS) Engineering Specifications

Does Best Bars have a documented process describing the review, distribution and implementation of all customer engineering standards/specifications and related revisions based upon customer schedules as required?

When an engineering standard/specification change results in a product design change, refer to the requirements in ISO 9001, section 8.3.6. When and engineering standard/specification change results in a product realisation process change, refer to the requirements in Section 8.5.6.1.

Does Best Bars retain a record of the date on which each change is implemented in production? Implementation shall include updated documents.

Review should be completed within 10 working days of receipt of notification of engineering standards/specifications changes.

Note: A change in these standards/specifications may require and update record of customer product part approval when these specifications are referenced on the design record or if they effect documents of the PPAP, such as controls, risk analysis (Such as FMEAs) etc.

8 Operation

8.1 Operational planning and control

The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1, by:a) determining requirements for the product and services;b) establishing criteria for the processes and for the acceptance of products and services;c) determining the resources needed to achieve conformity to product and service requirements;d) implementing control of the processes in accordance with the criteria;e) retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements.

Are there processes at Best Bars needed to meet requirements for provision of products and services planned, implemented and controlled?

Does Best Bars have requirements for products and services determined?

At Best Bars is there a criteria for processes and acceptance for products and services determined?

Does Best Bars have a way of determining resources

At Best Bars is process control implemented?

At Best Bars can you show the documented information that shows confidence in that the processes have been carried out as planned and can demonstrate conformity of products and services.

The output of this planning shall be suitable for the organization's operations.

At Best Bars have you determined that the output from the planning process is suitable for your operations?

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

Does Best Bars have a way to control planned changes?

Does Best Bars review the consequences of unintended changes?

Does Best Bars have an action that is taken to mitigate any adverse effects?

The organization shall ensure that outsourced processes are controlled in accordance with 8.4.

At Best Bars can you show how you control outsourced processes?

8.1.1 (TS) Operational Planning and Control

When planning product realisation, is the topic included, with regards to, customer product requirements and technical specifications?

When planning product realisation, is the topic included, with regards to, logistics requirements?

When planning product realisation, is the topic included, with regards to, manufacturing feasibility?

When planning product realisation, is the topic included, with regards to, project planning (Refer to ISO 9001, section 8.3.2)?

When planning product realisation, is the topic included, with regards to, acceptance criteria?

The resources identified is ISO 9001, section 8.1 C refer to the required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance.

8.1.2 (TS) Confidentiality

Does Best Bars ensure confidentiality of customer contracted products anbd projects under development, including related product information?

8.2 Determination of requirements for products and services

8.2.1 Customer communication

The organization shall establish the processes for communicating with customers in relation to:a) information relating to products and services;b) enquiries, contracts or order handling, including changes;c) obtaining customer views and perceptions, including customer complaints; d) the handling or treatment of customer property, if applicable;e) specific requirements for contingency actions, when relevant.

Does Best Bars have processes for communicating with customers?

Does Best Bars communicate information relating to:Products;Services;Enquiries;Contracts;Order handling;Customer views, perceptions and complaints;Handling or treatment of customer property;

Does Best Bars have specific requirements for contingency actions?

8.2.1.1 (TS) Customer communication

Does Best Bars ensure that the written and verbal communication shall be in the language agreed by the customer? The organisation shall have the ability to communicate necessary information, including data in a customer specified computer language and format (e.g. Computer aided design data, electronic data interchange)

8.2.2 Determination of requirements related to products and services

The organization shall establish, implement and maintain a process to determine the requirements for the products and services to be offered to potential customers.

Does Best Bars have a process to determine the requirements for products and services to be offered to potential customers?

Does Best Bars establish, implement and maintain this process?

The organization shall ensure that:a) product and service requirements (including those considered necessary by the organization), and applicable statutory and regulatory requirements, are defined;b) it has the ability to meet the defined requirements and substantiate the claims for the products and services it offers.

Does Best Bars show how to define product and service requirements including statutory and regulatory requirements?

8.2.2.1 (TS) Determining the requirements for product and services

Does Best Bars include recycling, environmental impact, and characteristics identified as a result of the organisations knowledge of the product and manufacturing processes?

Does Best Bars compliance to ISO 9001, section 8.2.2 item A 1 include applicable government, safety and environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal or material?

8.2.3.1.1 (TS) Review of the requirements for products and services

Does Best Bars retain documented evidence of a customer authorised waiver for the requirements stated in ISO 9001 section 8.2.3.1 for a formal review?

8.2.3.1.2 (TS) Customer designated special characteristics

Does Best Bars conform to customer requirements for designation, approval documentation and control of special characteristics?

8.2.3.1.3 (TS) Organisational Manufacturing feasibility

Does Best Bars utilise a multidisciplinary approach to conduct an analysis if it is feasible that the organisation's manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer?

Does Best Bars conduct this feasibility analysis for all manufacturing or product technology new to the organisation and for any changed manufacturing process or product design?

Does Best Bars validate through production runs, bench-marking studies or other appropriate methods their ability to make product to specifications at the required rate?

8.2.3 Review of requirements related to products and services

The organization shall review, as applicable:a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;b) requirements not stated by the customer, but necessary for the customers' specified or intended use, when known;c) additional statutory and regulatory requirements applicable to the products and services;d) contract or order requirements differing from those previously expressed.

Does Best Bars have in place a review of Customer requirements for delivery and post-delivery?Requirements necessary for customers’ specified or intended use, where known;Additional statutory and regulatory requirements applicable to products and services;Any other contract or order requirements.

NOTE Requirements can also include those arising from relevant interested parties.

This review shall be conducted prior to the organization’s commitment to supply products and services to the customer and shall ensure contract or order requirements differing from those previously defined are resolved.

Does Best Bars show that the review is conducted prior to their commitment to supply products and services to their customers.

Does Best Bars show how they resolve contract or order requirements which differ from those previously defined?

Where the customer does not provide a documented statement of their requirements, the customer requirements shall be confirmed by the organization before acceptance.

Does Best Bars confirm customer requirements where the customer does not provide a documented statement?

Documented information describing the results of the review, including any new or changed requirements for the products and services, shall be retained.

Can Best Bars show where they retain documented information which describes results of the review including any new or changed requirements.

Where requirements for products and services are changed, the organization shall ensure that relevant documented information is amended and that relevant personnel are made aware of the changed requirements.

Does Best Bars show the documented information containing changes to products and services

Does Best Bars ensure that relevant personnel are made aware of those changes?

8.3 Design and development of products and services

8.3.1 General

Where the detailed requirements of the organization’s products and services are not already established or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the organization shall establish, implement and maintain a design and development process.

Does Best Bars establish, implement and maintain a design and development process (where detailed requirements of their products and services are not already established or defined by the customer or other parties).

NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for production and services provision.NOTE 2 For services, design and development planning can address the whole service delivery process. The organization can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.

8.3.1.1 (TS) Design development of products and services

The requirements of ISO 9001, section 8.3.1 shall apply to product and manufacturing process design and development and shall focus on error proofing prevention rather than detection. Does Best bars conduct error proofing studies?

Does Best Bars document the design and development process?

8.3.2 Design and development planning

In determining the stages and controls for design and development, the organization shall consider:a) the nature, duration and complexity of the design and development activities;b) requirements that specify particular process stages, including applicable design and development reviews; c) the required design and development verification and validation;d) the responsibilities and authorities involved in the design and development process;e) the need to control interfaces between individuals and parties involved in the design and development process; f) the need for involvement of customer and user groups in the design and development process; g) the necessary documented information to confirm that design and development requirements have been met.

Does Best Bars determine the stages and control for design and development and show how they consider:The nature, duration and complexity of the activities;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.

Does Best Bars show documented information that confirms design and development requirements have been met.

8.3.2.1 (TS) Design and development planning

Does Best Bars ensure that the design and development planning includes all effected stakeholders within the organisation and, as appropriate, its supply chain?

Examples of areas for using such a multidisciplinary approach include but are not limited to the following:Project management (APQP of VDA-RGA)Product and manufacturing process design activities (DFM and DFA), such consideration of the use of alternative designs and manufacturing processesDevelopment and review of product design risk analysis (FMEAs) including actions to reduce potential risksDevelopment and review of manufacturing process risk analysis (E.g, FMEAs, Process flows, control plans and standardised work instructions)

8.3.2.2 (TS) Product design skills

Does Best Bars ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques? Applicable design techniques and tools shall be identified by the organisation

Note: An example of product design skills is the application of digitised mathematically based data.

8.3.2.3 (TS) Development of products with embedded software

Does Best Bars ensure the use of a process for quality assurance for their products with internally developed embedded software?

Does Best Bars conduct a software development assessment methodology use to assess the organisations software development process?

Does Best Bars include software development within the scope of their internal audit program (See section 9.2.2.1)

8.3.3 Design and development inputs

The organization shall determine:a) requirements essential for the specific type of products and services being designed and developed, including, as applicable, functional and performance requirements;b) applicable statutory and regulatory requirements;c) standards or codes of practice that the organization has committed to implement; d) internal and external resource needs for the design and development of products and services;e) the potential consequences of failure due to the nature of the products and services; f) the level of control expected of the design and development process by customers and other relevant interested parties.

Does Best Bars show how they determine:Requirements essential for the type of products and services being designed and developed, including as applicable:Functional & performance requirements;Statutory and regulatory requirements;Standards or codes of practice where there is a commitment to implement;Internal and external resources needed for the design and development of products and services;Potential consequences of failure;Level of control expected of the design and development process by customers and other relevant parties.

Inputs shall be adequate for design and development purposes, complete, and unambiguous. Conflicts among inputs shall be resolved.

Does Best Bars determine that inputs are adequate, complete and unambiguous for design and development?

Does Best Bars resolve conflicts among inputs?

8.3.3.1 (TS) Product design inputs

Does Best Bars identify, document and review product design input requirements as a result of contract reviews?

Product design input requirements include, but not limited to the following:Product specifications including but not limited to special characteristics (See Section 8.3.3.3)Boundary and interface requirementsIdentification, trace-ability and packagingConsideration of design alternativesAssessment of risks with the input requirements and the organisations ability to mitigate/manage the risks, including a feasibility analysisTargets for conformity to product requirements including preservation, reliability, durability, serviceability, health and safety, environmental, development timing and costApplicable statutory and regulatory requirements of the customer identified country of destination, if approvedEmbedded software requirements

Best Bars shall have a process to deploy information gained from previous design projects, competitive product analysis (Bench-marking), supplier feedback, internal input, field data and othe relevant sources for current and future projects of a similar nature.

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

8.3.3.2 (TS) Manufacturing process design input

Does Best Bars identify, document and review manufacturing process design inputs with regards to product design output data including special characteristics?

Does Best Bars identify, document and review manufacturing process design inputs with regards to targets for productivity, process capability, timing and cost?

Does Best Bars identify, document and review manufacturing process design inputs with regards to manufacturing technology alternatives

Does Best Bars identify, document and review manufacturing process design inputs with regards to customer requirements, if any?

Does Best Bars identify, document and review manufacturing process design inputs with regards to experience from previous developments ?

Does Best Bars identify, document and review manufacturing process design inputs with regards to raw materials?

Does Best Bars identify, document and review manufacturing process design inputs with regards to product handling and ergonomic requirements?

Does Best Bars identify, document and review manufacturing process design inputs with regards to design for manufacturing and design assembly?

Does the manufacturing process design include the use of error proofing methods to a degree appropriate to the magnitude of the problem and commensurate with the risks encountered?

8.3.3.3 (TS) Special Characteristics

Does Best Bars make use of a multidisciplinary approach to establish and implement its processes to identify special characteristics, including those determined by the customers and the risk analysis performed by the organisation?

Does the risk analysis include a documentation of all special characteristics in the drawing (as required), risk analysis (Such as a FMEA), control plans, and standardised work/operator instructions, special characteristics are identified with special markings and are cascaded through each of these documents?

Does the risk analysis include a development of control and monitoring strategies for special characteristics of products and product processes?

Does the risk analysis include customer specified approval, when required?

Does the risk analysis include compliance with customer specified definitions and symbols or the organisations equivalent symbols or notations, as defined in a symbol table? The symbol conversion table shall be submitted to the customer, if required.

8.3.4 Design and development controls

The controls applied to the design and development process shall ensure that: a) the results to be achieved by the design and development activities are clearly defined;b) design and development reviews are conducted as planned;c) verification is conducted to ensure that the design and development outputs have met the design and development input requirements;d) validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known).

Does Best Bars have controls that are applied to the design and development process to ensure:Results achieved by design and development activities are clearly defined?

Does Best Bars have Design and development reviews that are conducted as planned?

Does Best Bars outputs meet the input requirements by verification/validation is conducted to ensure that the resulting products and services are capable of meeting the requirements for the specified application or intended use (when known)?

8.3.4.1 (TS) Monitoring

Does Best Bars make use of measurements at specified stages during the design and development of products and processes that are defined, analysed and reported with summary results as an input to Management review (See section 9.3.2.1)?

When required by the customer, measurements of the product and process development activity shall be reported to the customer at stages specified by the customer.

Note: When appropriate, these measurements may include quality risks, costs, lead times, critical paths and other measurements.

8.3.4.2 (TS) Design and development validation

Does Best Bars ensure design and development validation is performed according to customer requirements, including any applicable industry and governmental agency issued regulatory standards?

Does Best Bars ensure timing of the design and development validation shall be planned in alignment with customer specified timing, as applicable?

Does Best Bars, where contractually agreed with the customer, include evaluation of the interaction of the organisations product, including embedded software, within the system of the final customers product?

8.3.4.3 (TS) Prototype Program

Does Best Bars, when required by the customer, have a prototype program and control plan?

Does Best Bars make use of all the same suppliers, tooling and manufacturing processes as will be used in product when developing the prototype?

Does Best Bars monitor all performance testing activities for timely completion and conformity to requirements?

Does Best Bars ensure when services are outsourced, the organisation includes the type and extent of control in the scope of its QMS to ensure that outsourced services conform to requirements (See ISO 9001 section 8.4)?

8.3.4.4 (TS) Product approval process

Does Best Bars establish, implement and maintain product and manufacturing approval process conforming to requirements as defined by the customer?

Does Best Bars approve externally provided product approval prior to shipment, if required by the customer? Records of their part approval shall be retained.

Note: Product approval should be subsequent to the validation of the manufacturing process.

8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:a) meet the input requirements for design and development;b) are adequate for the subsequent processes for the provision of products and services; c) include or reference monitoring and measuring requirements, and acceptance criteria, as applicable;d) ensure products to be produced, or services to be provided, are fit for intended purpose and their safe and proper use.

Does Best Bars ensure that design and development outputs:Meet the input requirements for design and development?

Does Best Bars ensure they are adequate for the subsequent processes for the provision of products and services?

Does Best Bars include or reference monitoring and measuring requirements, and acceptance criteria, as applicable?

Does Best Bars ensure products to be produced, or services to be provided, are fit for intended purpose and their safe and proper use?

The organization shall retain the documented information resulting from the design and development process.

8.3.5.1 (TS) Design and development outputs

Does Best Bars ensure that the product design output shall be expressed in terms that can be verified and validated against product design input requirements?

Does Best Bars product design output include design risk analysis (FMEA)?

Does Best Bars product design output include reliability study results?

Does Best Bars product design output include product special characteristics?

Does Best Bars product design output include results of product design error proofing, such as DFSS, DFMA and FTA?

Does Best Bars product design output include product definition including 3D models, technical data packages, product manufacturing information, and geometric dimension and tolerance (GD&T)?

Does Best Bars product design output include product design review results

Does Best Bars product design output include service diagnostics guidelines and repair and serviceability instructions?

Does Best Bars product design output include service parts requirements?

Does Best Bars product design output include packaging and rebelling requirements for shipping?

Note: Interim design outputs should include any engineering problems being resolved through a trade-off process.

8.3.5.2 (TS) Manufacturing process design output

Does Best Bars document the manufacturing process design output in a manner that enables verification against the manufacturing process design outputs?

Does Best Bars verify the outputs against manufacturing process design input requirements?

Does Best Bars manufacturing design output include specifications and drawing?

Does Best Bars manufacturing design output include special characteristics for product and manufacturing process?

Does Best Bars manufacturing design output include identification of process input variables that impact characteristics?

Does Best Bars manufacturing design output include tooling and equipment for production and control, including capability studies of equipment and processes?

Does Best Bars manufacturing design output include manufacturing process flow charts/layout, including linkage of product, process and tooling?

Does Best Bars manufacturing design output include capacity analysis?

Does Best Bars manufacturing design output include manufacturing process FMEA?

Does Best Bars manufacturing design output include maintenance plans and instructions?

Does Best Bars manufacturing design output include control plan?

Does Best Bars manufacturing design output include standardised work and work instructions?

Does Best Bars manufacturing design output include process approval acceptance criteria?

Does Best Bars manufacturing design output include data for quality, reliability, maintainability and measure-ability?

Does Best Bars manufacturing design output include results of error proofing identification and verification, as appropriate?

Does Best Bars manufacturing design output include methods of rapid detection, feedback and corrections of product.manufacturing process non-conformity?

8.3.6 Design and development changes

The organization shall review, control and identify changes made to design inputs and design outputs during the design and development of products and services or subsequently, to the extent that there is no adverse impact on conformity to requirements.

Does Best Bars review, control and identify changes made to the design inputs and outputs during design and development of products and services ensuring no impact on conformity to requirements?

Documented information on design and development changes shall be retained.

Does Best Bars show the documented information for design and development changes.

8.3.6.1 (TS) Design and development changes

Does Best Bars evaluate all design changes after initial product approval, including those proposed by the organisation or its suppliers for the potetial impact on fit, form, function, performance and/or durability?These changes shall be validated against customer requirements and approved internally from the customer prior to production implementation.

If required by the customer, does Best Bars, obtain documented approval, or a documented waiver from the customer prior to production implementation?

For products with embedded software, does Best Bars document the revision level of the software and hardware as part of the change record?

8.4 Control of externally provided products and services

8.4.1 General

The organization shall ensure that externally provided processes, products, and services conform to specified requirements.

Does Best Bars ensure externally provided processes, products and services conform to specified requirements?

The organization shall apply the specified requirements for the control of externally provided products and services when:a) products and services are provided by external providers for incorporation into the organization’s own products and services; b) products and services are provided directly to the customer(s) by external providers on behalf of the organization; c) a process or part of a process is provided by an external provider as a result of a decision by the organization to outsource a process or function.

Does Best Bars show how they apply specified requirements for the control of externally provided products and services when:Products and services are provided by external providers for incorporation into your own products and services;You provide products and services directly to customers by external providers on your behalf;A process or part-process is provided by an external provider as a result of a decision to outsource a process or function.

The organization shall establish and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with specified requirements.

Does Best Bars show how to establish and apply criteria for evaluation, selection, monitoring of performance and re-evaluation of external providers.

Does Best Bars assess their ability to provide processes or products and services in accordance with specified requirements?

The organization shall retain appropriate documented information of the results of the evaluations, monitoring of the performance and re-evaluations of the external providers.

Does Best Bars have documented information with the results of evaluations, monitoring of performance and re-evaluations of external providers?

8.4.1.1 (TS) General

Does Best Bars include all products and services that effect customer requirements such as sub-assembly, sequencing, sorting, rework and calibration services in the scope of their definition of externally provided products, processes and services?

8.4.1.2 (TS) Supplier selection process

Does Best Bars have a documented supplier selection process?

Does the supplier selection process include an assessment of the selected suppliers risk to product conformity and uninterrupted supply of the organisations product to their customers?

Does the supplier selection process include relevant quality and delivery performance?

Does the supplier selection process include an evaluation of the suppliers QMS?

Does the supplier selection process include multidisciplinary decision making?

Does the supplier selection process include an assessment of software development capabilities?

Other suppliers selection criteria that should be considered includes the following:Financial stabilityPurchased product, material or service complexityRequired technology (product and process)Adequacy of available resource. people, infrastructure)Design and development capabilitiesChange management processBusiness continuity planningLogistic processcustomer service

8.4.1.3 Customer direct sources (Direct buy)

When specified by the customer, does Best bars purchase products, materials or services from customer directed sources?

All requirements of section 8.4 (except for the requirements in IATF 16949 Section 8.4.1.2) are applicable to the organisations control of customer directed sources unless specific agreements are otherwise defined by the contract between the organisation and the customer.

8.4.2 Type and extent of control of external provision

In determining the type and extent of controls to be applied to the external provision of processes, products and services, the organization shall take into consideration:a) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;b) the perceived effectiveness of the controls applied by the external provider.

Does Best Bars determine the controls applied to the external provision of processes, products and services and take into consideration the following:a) The potential impact of the externally provided processes, products and services on the ability to consistently meet customer and applicable statutory and regulatory requirements?

Does Best Bars determine the controls applied to the external provision of processes, products and services and take into consideration the following:

The organization shall establish and implement verification or other activities necessary to ensure the externally provided processes, products and services do not adversely affect the organization's ability to consistently deliver conforming products and services to its customers.

Can Best Bars show what verification or other activities they have to ensure externally provided processes, products and services do not adversely affect your ability to consistently deliver conforming products and services to your customers?

Processes or functions of the organization which have been outsourced to an external provider remain within the scope of the organization’s quality management system; accordingly, the organization shall consider a) and b) above and define both the controls it intends to apply to the external provider and those it intends to apply to the resulting process output.

When Best Bars processes or functions have been outsourced to external providers, how do Best Bars consider a) and b) in 8.4.1 and how does Best Bars define the controls intended to be applied to the external provider and to the resulting process output?

8.4.2.1 (TS) Type and extent of control

Does Best Bars have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes and the service to internal and external customer requirements?

Does the process include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product material or service risks?

8.4.2.2 Statutory and regulatory requirements

Does Best Bars have a documented process to ensure that purchased products, processes and services conform to the current applicable statutory and regulatory requirements in the country of receipt, the country of shipment and the customer identified country of destination, if provided?

If the customer defines special controls for certain products with statutory and regulatory requirements, does the Best Bars ensure they are implemented and maintained as defined, including at suppliers?

8.4.2.3 Supplier QMS development

Does Best Bars require their suppliers of automotive products and services to develop, implement and improve a QMS certified to ISO 9001, unless otherwise authorised by the customer, with a ultimate objective of becoming certified to the IATF 16949:2016 QMS standard.

Unless otherwise specified by the customer, the following sequence should be applied to achieve this requirement:Compliance to ISO 9001 through second party auditsCertification to ISO 9001 through third party audits, unless otherwise specified by the customers, suppliers to Best Bars shall demonstrate conformity to ISO 9001 by maintaining q third party certification issued a certification body bearing the accreditation mark of a recognised IAF MLA member and where the accreditation body main scope include management system certification to ISO 17021Certification to ISO 9001 with compliance to other customer defined QMS requirementsCertification to IATF 16949 by an IATF recognised certification body

8.4.2.3.1 Automotive product related software or automotive products with embedded software

Does Best Bars require their suppliers of automated product related software or automotive products with embedded software, to implement and maintain a process for software quality assurance for their products?

Does Best Bars ensure that a software development assessment methodology shall be utilised to assess the suppliers software development process? Using a prioritisation based risk and potential impact to the customer, Best Bars shall require the supplier to retain documented information of a software development capability self-assessment.

8.4.2.4 (TS) Supplier Monitoring

Does Best Bars have a documented process and criteria to evaluate supplier performance in order to ensure conformity to externally provided products, processes and services to internal and external requirements?

Does Best Bars monitor supplier performance indicators in terms of delivered product conformity to requirements?

Does Best Bars monitor supplier performance indicators in terms of customer disruptions at the receiving plant, including yard holds and stop ships?

Does Best Bars monitor supplier performance indicators in terms of delivery schedule performance?

Does Best Bars monitor supplier performance indicators in terms of number of premium freight?

Does Best Bars monitor supplier performance indicators in terms of special status customer notifications related to quality or delivery issues?

Does Best Bars monitor supplier performance indicators in terms of dealer returns, warranty, field actions and recalls?

8.4.2.4.1 (TS) Second Party Audits

Does Best Bars include a second party audit process in their supplier management process?

Second party audits may be used for the following:Supplier risk assessmentSupplier monitoringSupplier QMS developmentProduct auditsProcess audits

Based on a risk assessment analysis, including product safety/regulatory requirements, performance of the supplier and QMS certification level, at a minimum, does Best Bars document the criteria for determining the need, type, frequency and scope of second party audits?

Does Best Bars retain records of the second party audit reports?

Note: Guidance may be found in the IATF Auditor Guide and ISO 19011

8.4.2.5 (TS) Supplier Development

The organisation shall determine the priority, type, extent and timing of required supplier development actions for its active suppliers.

Do the determination inputs include performance issues identification through supplier monitoring?

Do the determination inputs include second party audit findings?

Do the determination inputs include third party QMS certification status?

Do the determination inputs include risk analysis?

8.4.3 Information for external providers

The organization shall communicate to external providers applicable requirements for the following:a) the products and services to be provided or the processes to be performed on behalf of the organization;b) approval or release of products and services, methods, processes or equipment; c) competence of personnel, including necessary qualification;d) their interactions with the organization's quality management system; e) the control and monitoring of the external provider’s performance to be applied by the organization;f) verification activities that the organization, or its customer, intends to perform at the external provider’s premises.

Does Best Bars show how they communicate to external providers, applicable requirements for:Products and services to be provided or the processes to be performed on behalf of the organization;Approval or release of products and services, methods, processes or equipment; Competence of personnel, including necessary qualification;Their interactions with the organization's quality management system; The control and monitoring of the external provider’s performance to be applied by the organization;Verification activities that the organization, or its customer, intends to perform at the external provider’s premises.

The organization shall ensure the adequacy of specified requirements prior to their communication to the external provider.

Before Best Bars communicates with external providers, do they ensure the adequacy of specified requirements?

8.4.3.1 Information for external providers

Does Best Bars pass down all applicable statutory and regulatory requirements and special product and process characteristics to their suppliers and require the suppliers to cascade all applicable requirements down the supply chain to the point of manufacturing?

8.5 Production and service provision

8.5.1 Control of production and service provision

The organization shall implement controlled conditions for production and service provision, including delivery and post-delivery activities.

Controlled conditions shall include, as applicable:a) the availability of documented information that defines the characteristics of the products and services;b) the availability of documented information that defines the activities to be performed and the results to be achieved;c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met. d) the use, and control of suitable infrastructure and process environment;e) the availability and use of suitable monitoring and measuring resources;f) the competence and, where applicable, required qualification of persons;g) the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement;h) the implementation of products and services release, delivery and post-delivery activities.

Can Best Bars show me controlled conditions for:a) the availability of documented information defining the characteristics of the products and services;b) the availability of documented information defining the activities to be performed and the results to be achieved;c) monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met. d) the use, and control of suitable infrastructure and process environment;e) the availability and use of suitable monitoring and measuring resources;f) the competence and, where applicable, required qualification of persons;g) the validation, and periodic revalidation, of the ability to achieve planned results of any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement;h) the implementation of products and services release, delivery and post-delivery activities.

8.5.1.1 (TS) Control Plan

Does Best Bars develop control plans at the system, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those processes producing bulk materials as well as parts?"Family" control plans are acceptable for bulk material and similar parts using a common manufacturing process.

Does Best Bars have a control plan for pre-launch and production that shows linkage and incorporates information from design risk analysis, process flow diagram and manufacturing process risk analysis outputs (Such as FMEAs)

Does Best Bars, if required by the customer, provide measurement and conformity data collected during execution of either the pre-launch or production control plans?

Does the control plans include controls used for the manufacturing process control, including verification of job set ups?

Does the control plans include first off/last off part validation, as applicable?

Does the control plans include methods for monitoring or control exercised over special characteristics defined in both the customer and the organisation?

Does the control plans include the customer required information?

Does the control plans include specified reaction plan, when non-conforming product is detected, the process becomes statistically unstable or not statistically capable?

Does Best Bars review the Control plans for determining it has shipped non conforming product to the customer?

Does Best Bars review the Control plans for when change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes or risk analysis (FMEA)?

Does Best Bars review the Control plans after a customer complaint and implementation of the associated corrective actions, when applicable?

Does Best Bars review the Control plans at a set frequency based on a risk analysis?

8.5.1.2 (TS) Standardised work - Operator instructions and visual standards

Does Best Bars ensure that standardised work documents are communicated to and understood by the employees who are responsible for performing the work?

Does Best Bars ensure that standardised work documents are legible?

Does Best Bars ensure that standardised work documents are presented in the language understood by the personnel responsible to follow them?

Does Best Bars ensure that standardised work documents are accessible for use at the designated work area?

The standardised work documents shall also include rules for operator safety

8.5.1.3 (TS) Verification of job set ups

Does Best Bars verify job set-ups when performed, such as initial run of a job, material changeover, or job change that requires a new sett-up?

Does Best Bars maintain documented information for set-up personnel?

Does Best Bars use statistical methods of verification, where applicable?

Does Best Bars perform first off/last off part validation, as applicable, where appropriate, first off parts should be retained for comparison with the last off parts, where appropriate, last off parts should be retained for comparison with first off parts in subsequent runs?

Does Best Bars retain records of process and product approval following set-up and first off/last off part validation?

8.5.1.4 (TS) Verification after shut down

Does Best Bars define and implement the necessary actions to ensure product compliance with requirements after planned or unplanned production shutdown period?

8.5.1.5 Total productive maintenance

Has Best Bars developed, implemented and maintained a document a total productive maintenance system?

At a minimum, does the system include identification of process equipment necessary to produce conforming product at the required volume?

At a minimum, does the system include availability of replacement parts for the equipment and facility maintenance?

At a minimum, does the system include provision of resources for machine, equipment and facility maintenance?

At a minimum, does the system include packaging and preservation of equipment, tooling and gauging?

At a minimum, does the system include applicable customer specific requirements?

At a minimum, does the system include documented maintenance objectives?

At a minimum, does the system include regular review of maintenance plan and objectives and a documented action plan to address corrective actions where objectives are not achieved?

At a minimum, does the system include the use of preventive maintenance methods?

At a minimum, does the system include a predictive maintenance methods, as applicable?

At a minimum, does the system include periodic overhauling?

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

Does Best Bars provide resources for tool and gauge design, fabrication, and verification activities for production and service materials and for bulk materials, as applicable?

Has Best Bars established and implemented a system for production tooling management whether owned by the organisation or the customer?Including:Maintenance and repair facilities and personnelStorage and recoveryset-upTool change programs for perishable toolsTool design modifications documentationTool modification and revision to documentationTool identification, such as serial or asset number etc

The organisation shall verify that customer owned tools, manufacturing equipment and test/inspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined

8.5.1.7 (TS) Production Scheduling

Does Best Bars ensure that production is scheduled in order to meet customer order/demands such as Just In Time and is supported by an information system that permits access to production information at key stages of the process and is order driven?

Does Best Bars include relevant planning information during production scheduling e.g customer orders, capacity etc?

8.5.2 Identification and trace-ability

Where necessary to ensure conformity of products and services, the organization shall use suitable means to identify process outputs.

Does Best Bars show ways they use to identify process outputs to ensure conformity of products and services?

Does Best Bars have a way of identifying the status of process outputs?

Where traceability is a requirement, the organization shall control the unique identification of the process outputs, and retain any documented information necessary to maintain traceability.

Does Best Bars have a way to control the unique identification of process outputs, where applicable?

Can Best Bars show the type of documented information that it retains?

NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include products, services, intermediate parts, components, etc.

8.5.2.1 Identification and Traceability

The purpose of traceability is to support identification of clear start and stop points for product received by the customers or in the field that may contain quality and/or safety related non-conformities.

Has Best Bars implemented identification and traceability processes?

Has Best Bars conducted and analysis of internal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers and consumers?

8.5.3 Property belonging to customers or external providers

The organization shall exercise care with property belonging to the customer or external providers while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard the customer’s or external provider’s property provided for use or incorporation into the products and services.

Does Best Bars provide care for customer or external provider’s property while under their control?

Does Best Bars identify, verify, protect and safeguard that property which is provided for use or incorporation into their products or services?

When property of the customer or external provider is incorrectly used, lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider.

Does Best Bars have means they use to report to the customer or external provider if their property is incorrectly used, lost, damaged or found to be unsuitable for use?

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8.5.4 Preservation

The organization shall ensure preservation of process outputs during production and service provision, to the extent necessary to maintain conformity to requirements.

Does Best Bars ensure preservation of process outputs during production and service provision to maintain conformity to product requirements?

NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation, and protection.

8.5.4.1 (TS) Preservation

Does Best Bars ensure preservation that includes handling, identification contamination control, packaging, storage, transmission or transportation and protection?

8.5.5 Post-delivery activities

As applicable, the organization shall meet requirements for post-delivery activities associated with the products and services.

Does Best Bars meet the requirements for post-delivery activities associated with products and services?

In determining the extent of post-delivery activities that are required, the organization shall consider:a) the risks associated with the products and services;b) the nature, use and intended lifetime of the products and services;c) customer feedback;d) statutory and regulatory requirements.

Can Best Bars determine:Risk;Nature, use and intended lifetime;Customer feedback;Statutory and Regulatory requirements, when determining the extent of post-delivery activities required with products and services?

NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

8.5.5.1 (TS) Feedback of information from service

Does Best Bars ensure that there is a process for communication of information on service concerns to manufacturing, material handling, logistics, engineering and design activities is established, implemented and maintained?

8.5.5.2 (TS) Service agreements with customers

When there is a service agreement with the customer, Best Bars shall:

Verify that the relevant service centers comply with applicable requirements?

Verify the effectiveness of any special purpose tools or measuring equipment?

Ensure that all service personnel are trained in applicable requirements?

8.5.6 Control of changes

The organization shall review and control unplanned changes essential for production or service provision to the extent necessary to ensure continuing conformity with specified requirements.

Does Best Bars review and control unplanned changes to ensure continuing conformity with specified requirements?

The organization shall retain documented information describing the results of the review of changes, the personnel authorizing the change, and any necessary actions.

Does Best Bars have documented information that can be shown which describes the results of reviews of changes, the personnel authorizing change and any necessary actions?

8.5.6.1 (TS) Control of changes

Does Best Bars have a documented process to control and react to changes that impact product realisation?The effects of any change, including those changes caused by the organisation, by the customer or any supplier shall be addressed.

Does Best Bars define verification and validation activities to ensure compliance with customer requirements?

Does Best Bars validate changes before implementation?

Does Best Bars document the evidence of related risk analysis?

Does Best Bars retain records of verification and validation?

Changes, including those made at suppliers, should require a production trail run for verification of changes to validate the impact of any changes on the manufacturing process.

When required by the customer, does Best Bars notify the customer of any planned product realisation changes after the most recent product approval?

When required by the customer, does Best Bars obtain documented approval prior to implementation of the changes?

When required by the customer, does Best Bars complete additional verification or identification requirements, such as production trail run and new product validation?

8.5.6.1.1 (TS) Temporary change of process controls

Has Best Bars identified, documented and maintained a list of the process controls, including inspection, measuring, test and error proofing devices, that includes the primary process control and the approved back-up or alternative methods?

Has Best Bars a document for the process that mages the use of alternative control methods?

8.6 Release of products and services

The organization shall implement the planned arrangements at appropriate stages to verify that product and service requirements have been met. Evidence of conformity with the acceptance criteria shall be retained.

Can Best Bars show how planned arrangements have been implemented at appropriate stages to verify product and service requirements have been met.

Can Best Bars show what evidence they retain?

The release of products and services to the customer shall not proceed until the planned arrangements for verification of conformity have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. Documented information shall provide traceability to the person(s) authorizing release of products and services for delivery to the customer.

Can Best Bars show how the release of products and services is held until planned arrangements for verification of conformity have been satisfactorily completed, unless approved by a relevant authority, or the customer if applicable.

Does Best Bars have documented information which shows traceability to the person authorizing release of products and services?

8.6.1 (TS) Release of products and services

Does Best Bars ensure that the planned arrangements to verify that the product and services requirements have been met encompass the control plan and are documented as specified in the control plan?

Does Best Bars ensure that the planned arrangements for initial release of products and services encompass product or service approval?

Does Best Bars ensure that product or service approval is accomplished after changes following initial release, according to ISO 9001, section 8.5.6.

8.6.2 (TS) Layout inspection and functional testing

A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans.

Are the results available for customer review?

8.6.3 (TS) Appearance Items

Does Best Bars manufacture parts designated by the customers as "appearance Items" and if so, then this section will apply? Refer to the IATF 16949:2016 standard.

8.6.4 (TS) Verification and acceptance of conformity of externally provided products and services.

Does Best Bars have a process to ensure the quality of externally provided processes, products and services utilizing one or more of the following methods?:Receipt and evaluation of statistical data provided by the supplier to the organisationReceiving inspection and/or testing, such as sampling based on performanceSecond party or third party assessments or audits of suppliers sites when coupled with records or acceptable delivered product conformance to requirementsPart evaluation by a designated laboratoryAnother method agreed by the customer

8.6.5 (TS) Acceptance criteria

Does Best Bars have a acceptance criteria that is defined by the organisation and, where appropriate or required, approved by the customer? For attribute data sampling, the acceptance shall be zero defects (See section 9.1.1.1)

8.7 Control of non-conforming process outputs, products and services

The organization shall ensure process outputs, products and services that do not conform to requirements are identified and controlled to prevent their unintended use or delivery.

Does Best Bars identify and control process outputs, products and services that do not conform to requirements and prevent their unintended use or delivery?

The organization shall take appropriate corrective action based on the nature of the nonconformity and its impact on the conformity of products and services. This applies also to nonconforming products and services detected after delivery of the products or during the provision of the service.

Does Best Bars have appropriate corrective actions that are taken based on the nature of the nonconformity and its impact on the conformity of products and services?

Does Best Bars have away of applying this to nonconformity detected after delivery?

As applicable, the organization shall deal with nonconforming process outputs, products and services in one or more of the following ways:a) correction; b) segregation, containment, return or suspension of provision of products and services; c) informing the customer; d) obtaining authorization for: - use “as-is’; - release, continuation or re-provision of the products and services; - acceptance under concession.

Does Best Bars have a way to deal with nonconforming process outputs, products and services in terms of:Correction;Segregation, containment, return or suspension of provision of products and services?Informing the customer?Obtaining authorization for use as-is?Release, continuation or re-provision of the products and service?Acceptance under concession?

Where nonconforming process outputs, products and services are corrected, conformity to the requirements shall be verified.

Does Best Bars have a way of verifying conformance where process outputs, products and services are corrected following nonconformance?

The organization shall retain documented information of actions taken on nonconforming process outputs, products and services, including on any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformity.

Does Best Bars have documented information they keep following actions taken to address nonconformities, including any concessions obtained and on the person or authority that made the decision regarding dealing with the nonconformance.

8.7.1.1 (TS) Customer authorisation for concession

Does Best Bars obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved?

Does Best Bars obtain customer authorisation prior to further processing for "use as is" and rework dispositions of non-conforming product?

Does Best Bars maintain a record of the expiration date authorised under concession?

8.7.1.2 (TS) Control of non-conforming product - Customer specified process

Does Best Bars comply with applicable customer-specified controls of nonconforming products?

8.7.1.3 (TS) Control of suspect product

Does Best Bars ensure that all appropriate manufacturing personnel receive training for containment of suspect and non-conforming product?

Does Best Bars ensure that product with unidentified or suspect status is classified and controlled as non conforming product?

8.7.1.4 (TS) Control of rework product

Does Best Bars utilise risk analysis (Such as FMEA) methodology to asses risks in the rework process prior to decision to rework the product? If required, Best Bars shall obtain approval from the customer prior to commencing rework of the product.

Does Best Bars have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications?

Are the instructions for disassembly or rework, including re-inspection and traceability requirements accessible to and utilised by the appropriate personnel?

8.7.1.5 (TS) Control of repaired product

Does Best Bars utilise risk analysis *Such as FMEA) methodology to assess risks in the repairs process prior to a decision to repair the product? The organisation shall obtain approval from the customer before commencing repair of the product.

Does Best Bars have a documented process for repair confirmation in accordance with the control plan or other relevant documented information?

Does Best Bars have a instructions for disassemble or repair, including re-inspection and traceability requirements that is accessible to and utilised by the appropriate personnel?

Does Best Bars obtain documented customer authorisation for concession for the product to be repaired?

Does Best Bars obtain documented information on the disposition of repaired product including quantity, disposition, disposition date and applicable traceability information?

8.7.1.6 (TS) Customer notification

Does Best Bars immediately notify the customer in the event that nonconforming product has been shipped? Initial communication shall be followed with detailed documentation of the event

8.7.1.7 (TS) Non-conforming product disposition

Does Best Bars have a documented process for disposition of non conforming product not subject to rework or repair?

Does Best Bars verify that product not meeting requirements that a verification process is in place to be scrapped if rendered unusable prior to disposal?

The organisation shall not divert nonconforming product to service or other use without prior customer approval.

9 Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

The organization shall determine:a) what needs to be monitored and measured;b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results;c) when the monitoring and measuring shall be performed; d) when the results from monitoring and measurement shall be analysed and evaluated.

Does Best Bars show how to determine what needs to be monitored and measured?

Does Best Bars show how they determine methods for monitoring, measurement, analysis and evaluation to ensure valid results?

Does Best Bars show how they determine when to perform monitoring and measuring?

Does Best Bars show how they determine when results shall be analysed and evaluated?

The organization shall ensure that monitoring and measurement activities are implemented in accordance with the determined requirements and shall retain appropriate documented information asevidence of the results.

Has Best Bars got documented information that can be shown that monitoring and measurement activities have been implemented in accordance with determined requirements?

The organization shall evaluate the quality performance and the effectiveness of the quality management system.

Does Best Bars show how they evaluate the quality performance and the effectiveness of the QMS.

9.1.1.1 (TS) Monitoring and measurement of manufacturing process

Does Best Bars perform process studies on all new manufacturing processes to verify process capability and to provide additional input for process control, including those for special characteristics?

Note: For some manufacturing processes, it may not be possible to demonstrate product compliance through process capability. For those processes, alternative methods such as batch conformance to specification may be used.

Does Best Bars maintain manufacturing capability or performance results as specified by the customer?

Does Best Bars verify that the process flow diagram, PFMEA and control plan are implemented, including adherence to the following:1) Measurement techniques2) Sample plans3) Acceptance criteria4) Records of actual measurement values and/or test results for variable data5) Reaction plans and escalation process when acceptance criteria are not met?

Does Best Bars document significant process events, such as tool change or machine repair? This shall be recorded and retained as documented information

Does Best Bars initiate a reaction plan indicated on the control plan and evaluated impact on compliance to specifications for characteristics that are either not statistically capable or are unstable?These reaction plans shall include containment of product and 100% inspection, as appropriate.

Is Best Bars corrective action plan developed and implemented by the organisation indicating specific actions, timing plan, and assigned responsibility to ensure that the process becomes stable and statistically capable?

Does Best Bars review corrective action plans with and approved by the customer, when required?

Does Best Bars maintain records of effective dates of process changes?

9.1.1.2 (TS) Identification of statistical tools

Does Best Bars determine the appropriate use of statistical tools?

Does Best Bars verify that appropriate statistical tools are included as part of the advanced product quality planning (or equivalent) process and include in the design risk analysis (Such as DFMEA) (Where applicable), the process risk analysis (Such as PFMEA), and control plan?

9.1.1.3 (TS) Application of statistical concepts

Are Best Bars statistical statistical concepts, such as variation, control (Stability), process capability, and the consequences of over-adjustment, understood and used by employees involved in the collection, analysis and management of statistical data?

9.1.2 Customer satisfaction

The organization shall monitor customer perceptions of the degree to which requirements have been met.The organization shall monitor customer perceptions of the degree to which requirements have been met.

Does Best Bars show how they monitor customer perception of the degree to which requirements have been met?

Does Best Bars show how they obtain information relating to customer views and opinions of their products and services?

The methods for obtaining and using this information shall be determined.

Does Best Bars show what methods for obtaining and using this information they have?

NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer data on delivered products or services quality, market-share analysis, compliments, warranty claims and dealer reports.

9.1.2.1 (TS) Customer satisfaction

Does Best Bars monitor customer satisfaction through continual evaluation of internal and external performance indicators to ensure compliance to the product and process specifications and other customer requirements?

Are performance indicators based on objective evidence and include, but not limited to the following:1) Delivered part quality performance2) Customer disruptions3) Field returns, and warranty4) Delivery schedule performance (Including incidents or premium freight)5) Customer notifications related to quality or delivery issues, including special status?

Does Best Bars monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?

Does Best Bars monitoring include the review of customer performance data including on-line customer portals and customer scorecards, where provided?

9.1.3 Analysis and evaluation

The organization shall analyse and evaluate appropriate data and information arising from monitoring, measurement and other sources.

Does Best Bars show how they analyse and evaluate data and information arising from monitoring, measurement and other sources.

The output of analysis and evaluation shall be used to:a) demonstrate conformity of products and services to requirements;b) assess and enhance customer satisfaction; c) ensure conformity and effectiveness of the quality management system;d) demonstrate that planning has been successfully implemented;e) assess the performance of processes; f) assess the performance of external provider(s); g) determine the need or opportunities for improvements within the quality management system.

Can Best Bars show how the output of analysis and evaluation is used to:Demonstrate conformity of products and services to requirements?

Can Best Bars show how the output of analysis and evaluation is used to:Demonstrate conformity of products and services to requirements?Assess and enhance customer satisfaction?

Can Best Bars show how the output of analysis and evaluation is used to:Ensure conformity and effectiveness of the QMS?

Can Best Bars show how the output of analysis and evaluation is used to:Demonstrate that planning has been successfully implemented?

Can Best Bars show how the output of analysis and evaluation is used to:Assess process performance?

Can Best Bars show how the output of analysis and evaluation is used to:Assess performance of external providers?

Can Best Bars show how the output of analysis and evaluation is used to:Determine the need or opportunities for improvements within the QMS?

The results of analysis and evaluation shall also be used to provide inputs to management review.

Does Best bars show where the results of analysis and evaluation are used to provide inputs to management review.

9.1.3.1 (TS) Prioritisation

Does Best Bars compare operational trends in quality and operational performance with progress towards objectives and lead to action support prioritisation of actions for improving customer satisfaction?

9.2 Internal audit

9.2.1

The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system; a) conforms to: 1) the organization’s own requirements for its quality management system;2) the requirements of this International Standard; b) is effectively implemented and maintained.

Does Best Bars have internal audits being conducted at planned intervals?

Does Best Bars have a way they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance)

Does Best Bars have a way they determine whether the QMS is effectively implemented and maintained? (Review records)

9.2.2

The organization shall:a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization, and the results of previous audits;b) define the audit criteria and scope for each audit;c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;d) ensure that the results of the audits are reported to relevant management;e) take necessary correction and corrective actions without undue delay; f) retain documented information as evidence of the implementation of the audit programme and the audit results.

Can Best Bars show audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization and the results of previous audits?

Does Best Bars show where are the audit criteria and scope for each audit?

Can Best Bars demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t audit their own work?

Can Best Bars sow how the audit results are reported to relevant management?

Can Best Bars demonstrate that necessary correction and corrective actions are taken without undue delay?

Can Best Bars show the documented information of the audit programme and the audit results?

NOTE See ISO 19011 for guidance.

9.2.2.1 (TS) Internal audit program

Does Best Bars have a documented internal audit process?

Does the internal audit process include the development and implementation of an internal audit program that covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits?

Does Best Bars prioritise the program based on risk, internal and external performance trends and criticality of the processes?

Where the organisation is responsible for software development, the organisation shall include software development capability assessments in their internal audit program.

Does Best bars review the audit frequency and, where appropriate, adjust based on occurrence or process changes, internal and external non conformities, and/or customer complaints?

Does Best Bars review the effectiveness of the audit program as part of the management review?

9.2.2.2 (TS) QMS Audit

Does Best Bars audit all QMS processes over each three year period, according to a annual plan?

Does Best Bars, according to an annual program, using the process approach to verify compliance with the IATF 16949 QMS standard, sample customer specific QMS requirements for effective implementation?

9.2.2.3 (TS) Manufacturing process audit

Does Best Bars audit all manufacturing processes over a three year calendar period to determine the effectiveness and efficiency using customer specific approaches for process audit?Where not defined by the customer, the organisation shall determine the approach to be used.

Within each individual audit plan, does Best Bars audit each manufacturing process, on all shifts where it occurs, including the appropriate sampling of the shift handover?

Does Best Bars ensure that the manufacturing process audits the effective implementation of the process risk analysis (Such as PFMEA), control plan and associated documentation?

9.2.2.4 (TS) Product audit

Does Best Bars audit products using customer specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements?Where not defined by the customer, the organisation shall define the approach to be used.

9.3 Management Review

9.3.1

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness.

Does Best Bars show the frequency that top management reviews the organization's QMS?

Does Best Bars show how the QMS is deemed suitable, adequate and effective?

The management review shall be planned and carried out taking into consideration the status of actions from previous management reviews?

The management review shall be planned and carried out taking into consideration changes in external and internal issues that are relevant to the quality management system including its strategic direction?

The management review shall be planned and carried out taking into consideration information on the quality performance, including trends and indicators for: 1) nonconformities and corrective actions; 2) monitoring and measurement results; 3) audit results; 4) customer satisfaction; 5) issues concerning external providers and other relevant interested parties;6) adequacy of resources required for maintaining an effective quality management system;7) process performance and conformity of products and services?

The management review shall be planned and carried out taking into consideration the effectiveness of actions taken to address risks and opportunities (see clause 6.1)?

The management review shall be planned and carried out taking into consideration new potential opportunities for continual improvement?

Does Best Bars show what kinds of information are reviewed in management reviews?

Do the Management reviews include actions status of previous reviews?

Do the Management reviews include changes to internal/external issues relevant to the QMS?

Do the Management reviews include issues that affect strategy?

Do the Management reviews include KPIs for non-conformities and corrective actions?

Do the Management reviews include monitor and measurement of results?

Do the Management reviews include audit results?

Do the Management reviews include customer satisfaction?

Do the Management reviews include issues concerning external providers?

Do the Management reviews include issues concerning other relevant parties?

Do the Management reviews include adequacy of resources and effectiveness of QMS?

Do the Management reviews include process performance?

Do the Management reviews include actions taken to address risks and opportunities and their effectiveness?

Do the Management reviews include conformity of products and services?

Do the Management reviews include opportunities for continual improvement?

9.3.2 Management review inputs

The management review frequency shall be increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the QMS and performance related issues

The outputs of the management review shall include decisions and actions related to:a) continual improvement opportunities;b) any need for changes to the quality management system, including resource needs.

Does Best Bars show that their management reviews include decisions and actions relating to:Continual improvement opportunities;The need for changes to the QMS including resource needs.

The organization shall retain documented information as evidence of the results of management reviews.

Can Best Bars show what documented information they have as evidence of management reviews?

9.3.2.1 (TS) Management review inputs

Does the inputs to management review include cost of poor quality (Cost of internal and external non conformance)?

Does the inputs to management review include measures of process effectiveness?

Does the inputs to management review include measures of process efficiency?

Does the inputs to management review include product conformance?

Does the inputs to management review include assessments of manufacturing feasibility made of changes to existing operations and for new facilities or new product (See Section 7.1.3.1)?

Does the inputs to management review include customer satisfaction (See ISO 9001, Section 9.1.2)?

Does the inputs to management review include review of performance against maintenance objectives?

Does the inputs to management review include warranty performance (Where applicable)?

Does the inputs to management review include review of customer scorecards (Where applicable)?

Does the inputs to management review include identification of potential field failures identified through risk analysis (Such as FMEA)?

Does the inputs to management review include actual field failures and their impact on safety or the environment?

9.3.3 Management review outputs

Does Best Bars Management review outputs include decisions and actions related to opportunities for improvement?

Does Best Bars Management review outputs include decisions and actions related to any need for changes to the QMS?

Does Best Bars Management review outputs include decisions and actions related to resources needed?

9.3.3.1 (TS) Management review - Supplement

Does Best Bars conduct a Management Review at least annually?

10 Improvement

10 Improvement

10.1 General

The organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction.

Does Best Bars show how they determine and select opportunities for improvement?

Can Best Bars show what necessary actions they have implemented so that they have met customer requirements and enhanced customer satisfaction?

This shall include, as appropriate: a) improving processes to prevent nonconformities; b) improving products and services to meet known and predicted requirements;c) improving quality management system results.

Can Best Bars show how they have:Improved processes to prevent nonconformities;Improved products and services to meet known and predicted requirements;Improved QMS results.

NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization (e.g. transformation).

10.2 Nonconformity and corrective action

10.2.1

When a nonconformity occurs, including those arising from complaints, the organization shall:a) react to the nonconformity, and as applicable:1) take action to control and correct it; 2) deal with the consequences; b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: 1) reviewing the nonconformity; 2) determining the causes of the nonconformity; 3) determining if similar nonconformities exist, or could potentially occur; c) implement any action needed; d) review the effectiveness of any corrective action taken; e) make changes to the quality management system, if necessary.

When nonconformities occur can Best Bars show how;they react;Take action to control and correct it;Deal with the consequences;Evaluate the need for action to eliminate the cause so that it does not recur or occur elsewhere by:Reviewing the nonconformity;Determining the cause of the nonconformity;Determining if similar nonconformities exist or could potentially occur;Actions needed are implemented;Review the effectiveness of corrective actions taken, if any;Make necessary changes to the QMS.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Does Best Bars show me how correction actions were appropriate to the effects of the nonconformities encountered.

NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.

10.2.2

The organization shall retain documented information as evidence of: a) the nature of the nonconformities and any subsequent actions taken;b) the results of any corrective action.

Does Best Bars have documented information that they can show as evidence of:The nature of the nonconformities and subsequent actions taken;

Does Best Bars have documented information that they can show as evidence of:The results of any corrective action.

10.2.3 (TS) Problem solving

Does Best Bars have a documented process for problem solving that includes a defined approach for various types and scales of problems (e.g new product development, current manufacturing issues, field failures, audit findings)?

Does Best Bars have a documented process for problem solving that includes containment, interim actions, and related activities necessary for control of nonconforming outputs (See ISO 9001, Section 8.7)

Does Best Bars have a documented process for problem solving that includes root cause analysis, methodology used, analysis and results?

Does Best Bars have a documented process for problem solving that includes implementation of systemic corrective actions, including correspondence of the impact on similar processes and products?

Does Best Bars have a documented process for problem solving that includes verification of the effectiveness of implemented corrective actions?

Does Best Bars have a documented process for problem solving that includes reviewing and, where necessary, updating the appropriate documented information (E.g FMEA, Control plan)?

Where the organisation has specified prescribed processes, tools, or systems for problem solving, the organisation shall use those processes, tools, or systems unless otherwise approved by the customer.

10.2.4 (TS) Error Proofing

Does Best Bars have a documented process to determine the use of appropriate error-proofing methodologies?Details of the method used shall be documented in the process risk analysis (Such as a PFMEA) and test frequencies shall be documented in the control plan.

Does Best Bars include the testing of error proofing devices for failure or simulated failure?

Does Best Bars maintain records?

"Challenged" parts, when used, shall be identified, controlled, verified, and calibrated were feasible.

Do error proofing device failures shall have a action plan.

10.2.5 (TS) Warranty management systems

Does Best Bars perform an analysis on customer complaints and field failures, including any return parts, and shall initiate problem solving and corrective action to prevent re-occurrence?

When requested by the customer, this shall include analysis of the interaction of embedded software of the organisations product within the system of the final customers product.

Does Best Bars communicate the results of testing/analysis to the customer and also within the organisation.

10.3 Continual improvement

The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.

Can Best Bars demonstrate that they continually improve the suitability, adequacy and effectiveness of the QMS.

The organization shall consider the outputs of analysis and evaluation, and the outputs from management review, to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.

Does Best Bars demonstrate that the outputs of analysis and evaluation and the outputs from management review are considered to confirm if there are areas of underperformance or opportunities that shall be addressed as part of continual improvement.

Where applicable, the organization shall select and utilise applicable tools and methodologies for investigation of the causes of underperformance and for supporting continual improvement.

Can Best Bars show what applicable tools and methodologies for investigation of the causes of underperformance and to support continual improvement are selected?

10.3.1 (TS) Continual Improvement - Supplemental

Does Best Bars have a documented process for continual improvement?

Does the process include identification of the methodology used, objectives, measurement, effectiveness and documented information?

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

Does the process include risk analysis (FMEA)?

Note: Continual improvement is implemented once manufacturing processes are statistically capable and stable or when product characteristics are predictable and meet customer requirements.