IATF 16949:2016 Requirements Clause 7

7. Support

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:

1. the capabilities of, and constraints on, existing internal resources;
2. what needs to be obtained from external providers.

7.1.2 People

The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

7.1.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Note: Infrastructure can include:

a. buildings and associated utilities;

b. equipment, including hardware and software;

c. transportation resources;

d. information and communication technology.

7.1.3.1 Plant, facility, and equipment planning

The organization shall use a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. ln designing plant layouts, the organization shall:

• optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and
• facilitate synchronous material flow, as applicable.

Methods shall be developed and implemented 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.

The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance and verification on job set-ups. Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews.

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.

Note: A suitable environment can be a combination of human and physical factors, such as:

• social (e.g. non-discriminatory, calm, non-confrontational);
• psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
• physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

These factors can differ substantially depending on the products and services provided.

7.1.4.1 Environment for the operation of processes — supplemental

The organization shall maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organization shall ensure that the resources provided:

• are suitable for the specific type of monitoring and measurement activities being undertaken;
• are maintained to ensure their continuing fitness for their purpose.

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

7.1.5.1.1 Measurement system analysis

• Statistical studies shall be conducted to analyze 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 systems analysis.
• Other analytical methods and acceptance criteria may be used if approved by the customer.
• Records of customer acceptance of alternative methods shall be retained along with results from alternative measurement systems analysis 

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

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:

• calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
• identified in order to determine their status;
• safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.

7.1.5.2.1 Calibration/verification records

• The organization shall have a documented process for managing calibration/verification records. Records of the calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements shall be retained.
• The organization shall ensure that calibration/verification activities and records shall include the following details:

1. revisions following engineering changes that impact measurement systems;
2. any out-of-specification readings as received for calibration/verification;
3. an assessment of the risk of the intended use of the product caused by the out-of-specification    condition;
4. when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained, including the associated standard's last calibration date and the next due date on the calibration report;
5. notification to the customer if suspect product or material has been shipped;
6. statements of conformity to specification after calibration/verification;
7. verification that the software version used for product and process control is as specified;
8. records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
9. production-related software verification used for product and process control (including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment).

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, requirements for:

a. adequacy of the laboratory technical procedures;

b. competency of the laboratory personnel;

c. testing of the product;

d. capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.); when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability;

e. customer requirements, if any;

f. review of the related records.

Note: Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization's in-house laboratory conformity to this requirement.

7.1.5.3.2 External laboratory

• External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either:
• The laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or there shall be evidence that the external laboratory is acceptable to the customer.
• Note Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment.
• Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met.
• Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation, if required.

7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made 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 any necessary additional knowledge and required updates.

NOTE 1: Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

NOTE 2:  Organizational knowledge can be based on:

• internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
• external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers).

7.2 Competence

The organization shall:

• determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;
• ensure that these persons are competent on the basis of appropriate education, training, or experience;
• where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
• retain appropriate documented information as evidence of competence.

7.2.1 Competence — supplemental

The organization shall establish and maintain a documented process(es) for identifying training needs including awareness (see Section 7.3.1) and achieving 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 Competence — on-the-job training

The organization shall provide on-the-job training (which shall include customer requirements training) for personnel in any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements; this shall include contract or agency personnel.

The level of detail required for on-the-job training shall be commensurate with the level of education the personnel possess and the complexity of the task(s) they are required to perform for their daily work. Persons whose work can affect quality shall be informed about the consequences of nonconformity to customer requirements.

7.2.3 Internal auditor competency

• The organization shall have a documented process(es) to verify that internal auditors are competent, taking into account any customer-specific requirements. For additional guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a list of qualified internal auditors.
• Quality management system auditors, manufacturing process auditors, and product auditors shall all be able to demonstrate the following minimum competencies:

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

b. understanding of applicable customer-specific requirements;

c. understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;

d. understanding of applicable core tool requirements related to the scope of the audit;

e. understMaintenance of and improvement in internal auditor competence shall be demonstrated through: executing a minimum number of audits per year, as defined by the organization; and

g. maintaining knowledge of relevant requirements based on internal changes (e.g., process technology, product technology) and external changes (e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements).anding how to plan, conduct, report, and close out audit findings.

7.2.4 Second-party auditor competency

The organization shall demonstrate the competence of the auditors undertaking the second-party audits. Second-party auditors shall meet customer specific requirements for auditor qualification and demonstrate the minimum following core competencies, including understanding of:

a. the automotive process approach to auditing, including risk based thinking;

b. applicable customer and organization specific requirements;

c. applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;

d. applicable manufacturing process(es) to be audited, including PFMEA and control plan;

e. applicable core tool requirements related to the scope of the audit;

f. how to plan, conduct, prepare audit reports, and close out audit findings.

7.3 Awareness

The organization shall ensure that persons doing work under the organization’s control are 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 performance;

d) the implications of not conforming with the quality management system requirements.

7.3.1 Awareness — supplemental

The organization shall maintain documented information that demonstrates 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 requirements and the risks involved for the customer with non-conforming product

7.3.2 Employee motivation and empowerment

The organization shall maintain a documented process(es) to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.

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;

e. who communicates.

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.

Note: The extent of documented information for a quality management system can differ from one organization to another due to: the size of organization and its type of activities, processes, products and services;

7.5.1.1 Quality management system documentation

The organization's quality management system shall be documented and include a quality manual, which can be a series of documents (electronic or hard copy).

The format and structure of the quality manual is at the discretion of the organization and will depend on the organization's size, culture, and complexity. If a series of documents is used, then a list shall be retained of the documents that comprise the quality manual for the organization.

The quality manual shall include, at a minimum, the following:

• the scope of the quality management system, including details of and justification for any exclusions;
• documented processes established for the quality management system, or reference to them;
• the organization's processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes;
• a document (i.e., matrix) indicating where within the organization's quality management system their customer-specific requirements are addressed.

Note: A matrix of how the requirements of this Automotive QMS standard are addressed by the organization's processes may be used to assist with linkages of the organization's processes and this Automotive QMS.

7.5.2 Creating and updating

• When creating and updating documented information, the organization shall ensure appropriate:
• Identification and description (e.g. a title, date, author, or reference number); format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
• Review and approval 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:

• it is available and suitable for use, where and when it is needed;
• it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:

• distribution, access, retrieval and use;
• storage and preservation, including preservation of legibility;
• control of changes (e.g. version control);
• retention and disposition.

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 be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

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 Record retention

The organization shall define, document, and implement a record retention policy. The control of records shall satisfy statutory, regulatory, organizational, and customer requirements. 

Production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts 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 Engineering specifications

• The organization shall have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required.
• When an engineering standard/specification change results in a product design change, refer to the requirements in ISO 9001, Section 8.3.6. When an engineering standard/specification change results in a product realization process change, refer to the requirements in Section 8.5.6.1. The organization shall 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 an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs), etc.