14. Clause 7.1.5.3.2 External laboratory

QUESTION:

 

Do calibration certification or reporting (testing) requirements by an external laboratory bearing the mark (or logo or symbol) of the relevant national accreditation body that accredited the laboratory under ISO/IEC 17025?

ANSWER:

Yes, only a calibration certificate or test report that includes a mark from a national accreditation body will be accepted.

Accreditation mark (commonly referred to as the accreditation symbol and corporate logo identification) Certification and endorsement by a national accreditation body provides documentary evidence that inspection, testing or calibrations are provided under accreditation and they comply with the requirements of ISO/IEC 17025.

 

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15. Clause 8.3.2.3 Product development with embedded software

QUESTION:

Acceptable methods for evaluation development

ANSWER:

The purpose of IATF 16949, Section 8.3.2.3 is to apply the same level of rigor to software development as is intended inHardware product development Just like products, software must have defined performance, operating conditions, known inputs, specified outputs, environment parameters (e.g. size) of the file), specified requirements (if any), known failure modes, usage configuration, changing operating conditions, etc.

The phases of planning, design, writing, testing, Validation and production in software development is not much different in concept from developing hardware components.

IATF 16949 provides a robust framework to confirm that all necessary steps have been taken to design, verify, and manufacture hardware parts that continue to meet specification in manufacturing. series. Although similar in concept, those steps are not the same for the development of software. Therefore, a different set of criteria is used to evaluate the methods used for software development.

These criteria are not included in IATF 16949; so other methods are mentioned, like Automotive SPICE and CMMI. There may be other acceptable methods available as determined by some customers. Each customer may have a preferred tool for evaluating a vendor's software development capabilities. Organizations should require their customer(s) to endorse the acceptability assessment tool. Each customer can also specify a different approach to be used (e.g. customer site audits, supplier self-assessments, or a combination of the two).

The role of the IATF 16949 internal or external auditor is not knowledgeable to perform Automotive SPICE or CMMI assessments. However, internal or external auditors should be familiar enough with audits to be able to recognize when a requirement for software evaluation has not been met and to have corrective action plans in place, with appropriate resources are assigned. IATF 16949 internal and external auditors should also know if the client is involved in the software development review and how that is documented.

 

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16. Clause 8.4.2.4.1 Second-party audits

QUESTION:

If the organization has low-risk suppliers, is a second-party audit necessary? What is the intention/purpose?

ANSWER:

Risk-based thinking, driven by ISO 9001:2015, should be incorporated into supplier management. The risk analysis should be completed and, depending on the results of the risk assessment (see below), then a 2nd party audit may not be required.

To support the risk analysis, the organization should consider criteria such as: supplier certification status, merchandise complexity, new product implementation, revenue, product quality issues, delivery issues, customer-specific requirements, and other risks to the organization or to its customers.

 

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17. Clause 8.5.6.1.1 Temporary change of process controls

QUESTION:

Is there a need for an alternative process control for each key control specified in the control plan?

ANSWER:

No, a replacement process control is not required for every primary control. When implementing a new product, an organization should consider the risk of a key control potentially failing and, based on the risk and severity of the failure mode, decide where to control the replacement process. position. When redundant or alternative process controls are needed, both primary and alternative process controls should be defined in the process flow, PFMEA, control plan and work standard available.

For existing processes where there is a defect in the primary process control and no alternative process control is identified, the organization should consider the risk, (e.g. FMEA) and, if approved, develop Develop work standards for replacement process controls, implement controls, verify effectiveness through day-to-day management, and then reconfirm when primary control is restored.

The organization will periodically review the use cases of alternative process controls and use this as input to update the process flowchart, FMEA and control plan. (See SI 11)

 

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18. (deleted) Quality management system audits Clause 9.2.2.2

See SI 14, issued November 2018, effective January 2019.

 

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19. Clause 9.2. 2.3 Manufacturing Process Assessment

QUESTION:

For the assessment of each production process, must the audit be performed at all production shifts?

ANSWER:

Each audit is not required to cover all shifts in an audit (for example, an audit of the stamping process could be performed in shifts 1 and 2, sampling shift change in year 1, and then in year 2 or 3, an assessment is performed on the third shift for stamping). However, all manufacturing processes must be evaluated on all shifts over a three-year cycle, frequency depending on risk, performance, variability, etc.

 

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20. Clause 9.2.2.4 Product Evaluation Product

QUESTION:

Why not specify a review frequency for product reviews?

ANSWER:

The audit frequency should be determined based on the risk and complexity of the product (See ISO 9001, Section 9.2.2). If an organization has high risk and high product complexity, the frequency of product reviews should be increased.

 

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21. Clause 8.6.2 Layout testing and functional testing

QUESTION:

Is layout testing different from a product or functional test?

ANSWER:

Yes, as stated in Note 1 of 8.6.2 of IATF 16949, [Layout test is the complete measurement of all product dimensions shown on the profile(s) design sketch]; Layout testing is limited in size measurement and requirements. Performance or material measurements are not included in the layout test.

Product certification typically involves full validation of all product approval requirements (e.g. PPAP or PPA) and is therefore beyond the scope of layout testing.

Functional testing/verification will typically be limited to performance and material measurements such as strength or tensile strength and will not include dimensional measurements.

Where the frequency is not defined by the customer, it is the responsibility of the organization to determine the frequency of layout checks.

Layout testing is part of the product evaluation, if requested by the customer.

Layout testing and ongoing functional testing requirements are defined in the control plan. If specific customer requirements exist, those requirements (including layout testing and functional testing requirements) are also included in the control plan.

 

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22. Clause 9.2.2.4 Product Evaluation

QUESTION:

How is product evaluation different from layout testing?

ANSWER:

As defined in section 3 of IATF 16949, the term product is used to represent any expected output of a production process.

Products often have dimensional, performance (functional) and material requirements, so product reviews may contain verifications for size, performance (function), or material requirements. As stated in FAQ 21 above, layout checking is limited to size requirements.

Product evaluation can be performed on finished or semi-finished products, according to customer-specified approaches (e.g. VDA 6.5 Product Evaluation), where applicable. Product reviews may include packaging and labeling requirements.

Product reviews, like other types of reviews, are an independent verification of compliance with requirements. As such, product audits have a defined frequency and scope specified in the audit program and are risk-based.

 

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23. Clause 8.5.1.3 Verification of Work Setup

QUESTION:

If first-off/last-off product validation is not performed or is appropriate for a production process type specific export, are such records maintained in accordance with 8.5.1.3 e)?

ANSWER:

As stated in 8.5.1.3 d), first/last product validation is performed only where applicable and appropriate. Where validation is not made because it is not applicable or inappropriate, there is no requirement to maintain records.

 

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24. Clause 8.4.2.2 Statutory and Regulatory Requirements

QUESTION 1:

If an organization is not responsible for the design of the product and therefore only manufactures the product according to the customer's design, then can the organization be exempt from the requirements in 8.4.2.2?

ANSWER:

No, all organizations regardless of their responsibility for product design must meet the applicable requirements in 8.4.2.2. The applicable requirements address purchased products, processes and services for which the organization is responsible.

QUESTION 2:

Is the organization required to request a complete list of destination countries from the customer if such list is not provided by the customer?

ANSWER:

Yes, the organization is required to request a complete list of destination countries from the customer if such list is not provided by the customer.

NOTE:

• “Country of receipt” is where the organization is located at the manufacturing plant. (Country of shipment)

• “Country of shipment” is the customer's receiving location. (Country to which the product is manufactured)

• “Country of destination” is the country where the vehicle is sold. (Country where the final product is sold)

QUESTION 3:

What are the consequences if the customer does not provide information about the destination countries to the organization? What is the need for the organization to recognize this situation?

ANSWER:

If the organization claims that the customer has not provided the necessary information about the country of destination, the organization will be able to provide written evidence (e.g. letter, email, meeting minutes, etc.) ) about their efforts to obtain that information.

QUESTION 4:

What level of detail is provided by the customer regarding the destination countries? Could such a general statement as on a per-country basis across the globe be an appropriate response?

ANSWER:

No, such a general statement as per country across the globe, is not acceptable. Customers are expected to provide the organization with a specific list of the countries where the vehicle was originally sold.

QUESTION 5:

Applicable statutory and regulatory requirements are generally related to the use of the product concerned. Some parts may become a safety related product, depending on its use. Based on the previous statement, is the customer required to provide the organization with detailed information about the intended use?

ANSWER:

It is expected that the customer will provide the organization with information on relevant characteristics to determine the controls necessary to meet applicable statutory and regulatory requirements ( e.g. special characteristics).

 

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25. Clause 8.3 Product and Service Design and Development

QUESTIONS

What constitutes product design responsibility for an organization?

ANSWER

If an organization receives from its customer a fully defined specification for the parts it is working on (make-to-print), the organization will not be responsible for the design. product.

In the event that the organization does not receive a fully defined specification for the products it is working on, the organization is responsible for the design of the product.

In all cases, the organization is responsible for the design of the manufacturing process

 

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26. Clause 8.5.1.5 Maintaining overall productivity

QUESTION What

Is the purpose of including the term periodic overhaul in the requirements for maintaining overall productivity?

ANSWERING

The purpose of all of the content in section 8.5.1.5 is to include the minimum steps to maintain production equipment over a long period of use so that it can continuously produce products according to specifications. technical number.

A routine overhaul is a tool and equipment remanufacturing that is needed when routine maintenance steps are no longer sufficient to keep tools and equipment in a condition that can continue to produce products to specifications. technique, as detected using Mean Time Between Repairs (MTBF) or other similar metrics.

Routine overhauls are defined in part 3 of the standard: Maintenance methods to prevent unexpected major failures, based on the history of failures or interruptions, of a device or its subsystem, are proactively stop the machine and disassemble, repair, replace parts, reassemble, and then return to service.

Perhaps periodic overhaul does not apply to certain types of tools and equipment. Perhaps some tools are simply replaced with a new one at the end of its useful life. However, all tools and equipment have limited lifespans based on use, time, or other known factors. Tool and equipment manufacturers will be a good source for determining which elements and estimating when that major work needs to be completed. Periodic overhaul or appropriate equivalent (e.g. replacement) will need to be included in the steps of the organizational maintenance plan.

 

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