Archive note: this article follows the FAQs dated 7 March 2019 and is not the current edition. Before implementation or audit preparation, consult the latest official IATF publications.
ITVC GLOBAL · BUSINESS SERVICES
ITVC Global presents the following IATF 16949:2016 frequently asked questions, based on the document IATF-16949-Frequently-Asked-Questions_7March2019.
This historical collection contains 26 numbered FAQ entries and was updated on 7 March 2019.
Download the English source document here: IATF-16949-Frequently-Asked-Questions_7March2019
Contents: 26 FAQ entries (March 2019 edition)
ANSWER:
IATF and ISO did not reach a licensing agreement for publishing IATF 16949 as an integrated document. To avoid delaying the new standard’s release, IATF chose to publish it in a two-manual format.
Before publication, IATF checked with international accreditation organizations that other industries also use two manuals to define their sector-specific requirements. Auditing against two manuals is not ideal, but it works.
IATF continues to cooperate closely with ISO through its liaison committee status so that alignment with ISO 9001 is maintained.
ANSWER:
Without a joint licensing agreement for an integrated IATF 16949 publication, IATF could not negotiate a discounted price for ISO 9001:2015.
IATF kept the price of its automotive-specific content in line with earlier pricing.
The difference largely reflects the full list price charged by ISO for the ISO 9001 publication.
ANSWER:
IATF follows a defined translation management process, including cross-checks for accuracy. If an organization or certification body suspects a translation error, it should contact an IATF member industry association or the Oversight Office responsible for its certification body.
ANSWER:
The clause concerns product and manufacturing process characteristics that affect the safe operation of the final assembled product. A customer may identify these characteristics even when legislation or regulations do not address them directly.
ANSWER:
Assign responsibilities to roles or positions in the organization, such as Quality Director. The person holding the role carries out those responsibilities, but the responsibilities remain attached to the position. Top management therefore assigns authority and responsibility to roles rather than to individuals by name.
ANSWER:
No. Each individual device does not need a separate, complete statistical study. Devices with matching characteristics — such as measurement range, resolution and repeatability — may be grouped, and a representative instrument from that family may be used for the statistical study.
If an accredited laboratory is distant or expensive, may a nearby manufacturer of the equipment perform the calibration even if that manufacturer is not accredited to ISO/IEC 17025?
ANSWER 1:
As part of designing and manufacturing inspection or test equipment, its original manufacturer develops methods to maintain and adjust it to meet calibration requirements. The manufacturer is therefore qualified to calibrate the equipment it designed and produced.
The organization must obtain its customer’s approval before using an original equipment manufacturer for calibration services.
ANSWER 2:
No. In-line measurement and test equipment used during manufacturing or assembly is not treated as an internal laboratory.
ANSWER:
Under clause 4.3.2, the organization must evaluate customer requirements, including customer-specific requirements, and incorporate applicable requirements into the scope of its quality management system.
Clause 7.5.1.1 d) requires a document, such as a table, list or matrix, within the quality manual. It must cover all direct customers of the certified organization, which may include IATF OEMs, non-IATF OEMs and other automotive customers, such as Tier 1 and Tier 2 companies.
For example, a Tier 2 organization considers the requirements, including customer-specific requirements, of every direct customer. It need not consider an automotive OEM’s requirements where that OEM is not its direct customer.
Non-IATF OEMs and other automotive customers may communicate their requirements through internal documents shared with suppliers, such as a supplier quality manual, or through documents made publicly available online.
Identifying customer-specific requirements can be difficult when a customer’s documents do not clearly relate them to IATF 16949 clauses. One approach is to check clauses containing wording such as “if required by the customer”, then look for corresponding requirements in the customer’s documents. Where such requirements exist, add that customer and its requirements to the table, list or matrix in the quality manual.
An organization does not have to reformat its customers’ requirements and CSRs into a clause-by-clause CSR document matching the format used by IATF OEMs.
ANSWER 1:
Clauses 8.3.3.1 g) and 8.3.4.2 require an approach for researching, identifying, obtaining, reviewing and understanding applicable legal and regulatory requirements, and ensuring conformity. This covers the product, the country of manufacture and the destination country to which the product is shipped.
Clause 8.4.2.2 expects the organization to build methods into product development and supplier management for obtaining supplier confirmation and evidence of compliance. These methods address the countries where the supplier manufactures the products or services, where the organization uses them, and where the organization ships its products when the customer has provided that information.
Clause 8.6.5 requires the organization to examine supplier conformity records and check that the evidence covers the received product’s lot code, batch number or equivalent traceability identifier. This check may take place on receipt or while the product is held in stock, but it must occur before release into the organization’s production flow.
ANSWER 2:
No. ISO/TS 16949 already required purchased products to comply with applicable legislation and regulations. IATF considered the earlier passive wording insufficiently clear. The new wording specifies more clearly what must be done, when it must happen and what supporting evidence is needed.
ANSWER 3:
Clause 8.6.5 does not require the organization to know or maintain a list of every international legal and regulatory requirement for all externally provided processes, products and services it purchases.
The organization must review results and periodically assess or verify that its suppliers have robust processes for ensuring compliance with current legislation, regulations and other requirements in the countries of manufacture and the destination countries identified by the customer.
ANSWER 4:
The clause expects the customer to tell the organization where the products will be shipped. Changes in applicable legislation or regulations arising from changed destinations become requirements for the organization when the customer communicates those destinations.
Refer to SI 15, issued in November 2018 and effective from January 2019.
ANSWER 1:
The purpose is to prevent nonconforming products from reaching an unofficial aftermarket, being fitted to road vehicles or being shipped to a customer by mistake.
Products do not have to be made unusable within the production area, provided that this is completed before their final disposal.
ANSWER 2:
The organization is responsible for establishing and implementing a process for disposing of nonconforming products and for verifying that the process works.
ANSWER 3:
Yes. This work may be outsourced. The organization must approve the provider’s method and periodically verify how the provider makes the products unusable before disposal.
ANSWER 4:
It applies to products that have passed through the product approval process and are supplied by the organization to its customers.
ANSWER 5:
The product must be made unusable and incapable of repair. There is no requirement to crush it or break it into small pieces.
ANSWER:
Yes. An organization may group several documented processes within one or more procedures. Each process does not need to be a stand-alone document. Documentation should be arranged in a way that suits the organization and its individual activities.
ANSWER:
As with other competence requirements, people assigned particular tasks must be competent to perform them. Their competence should include the rules and regulations relevant to the task.
The product safety requirements in clause 4.4.1.2 are specific. Consider the following parts of that clause:
a) Suppliers are expected to understand the legal and regulatory requirements in the product’s markets of use, as identified by the customer. They should know where to research the regulations for each affected country or region.
b) Customer-specific requirements identify any required customer notifications. Personnel therefore need to understand those requirements; a designated internal subject-matter expert may provide this training.
c) Any special approval requirements for design FMEAs are identified in customer-specific requirements; see point b).
d) and e) Customers define product safety characteristics and the required controls through their special-characteristic requirements. Personnel developing PFMEAs and Control Plans need knowledge of the areas addressed in their customers’ documents.
The same analysis can be applied to items f) through m) to identify the training level and suitable training source for each safety requirement.
Because many requirements depend on the customer, no single course covers every aspect of this subject. The organization must examine the customer and regulatory requirements for each product, its countries of use and its safety-related characteristics.
Some customers specify particular expectations for product safety, training, knowledge and personnel. The organization must understand the product safety requirements specific to its own customers.
ANSWER:
Yes. According to this historical FAQ, acceptable calibration certificates and test reports must carry the relevant national accreditation body’s mark.
The accreditation mark and identification provide documented evidence that the inspection, testing or calibration services fall within the laboratory’s accredited scope and meet ISO/IEC 17025 requirements.
ANSWER:
Clause 8.3.2.3 expects software development to receive the same rigour as hardware product development. Software therefore needs defined performance, operating conditions, known inputs, specified outputs, environmental parameters such as file size, applicable regulatory requirements, known failure modes, usage profiles and changing operating conditions.
Planning, designing, writing, testing, validating and releasing software are conceptually comparable to the stages of developing hardware components.
IATF 16949 provides a strong framework for verifying that hardware has been designed, verified and manufactured through the necessary steps and continues to meet specifications in serial production. Software development follows a similar concept, but its individual activities differ, so different assessment criteria are needed.
Those software assessment criteria are not set out in IATF 16949. Methods such as Automotive SPICE and CMMI are therefore referenced. Customers may accept other methods or prefer particular assessment tools. The organization should confirm acceptable tools with each customer. Customers may also specify different assessment approaches, such as an on-site customer assessment, supplier self-assessment or a combination.
IATF 16949 internal and external auditors are not expected to be qualified to perform Automotive SPICE or CMMI assessments. However, they should understand the assessments well enough to recognize an unmet software assessment requirement and verify that corrective action plans have appropriate resources. They should also understand whether and how the customer participated in the software development assessment and how that participation was documented.
ANSWER:
Supplier management should incorporate the risk-based thinking promoted by ISO 9001:2015. Complete a risk analysis; depending on its results, a second-party audit may not be necessary.
The risk analysis should consider factors such as the supplier’s certification status, the complexity of the supplied commodity, new product introductions, business turnover, product quality and delivery problems, customer-specific requirements, and other risks to the organization or its customers.
ANSWER:
No. During new product introduction, the organization should assess the possibility of a primary control failing and the severity of the associated failure mode. This risk assessment determines where alternative controls are needed. Where backup or alternative controls are required, identify both primary and alternative controls in the process flow, PFMEA and Control Plan, and provide standardized work.
If a primary control fails in an existing process and no alternative has been defined, review the risk, for example through FMEA. If an alternative is approved, develop standardized work, implement the control, check its effectiveness through daily management, and revalidate the process when the primary control is restored.
Periodically review occasions when alternative controls were used and use that information to update process flow diagrams, FMEAs and Control Plans. See SI 11.
Refer to SI 14, issued in November 2018 and effective from January 2019.
ANSWER:
An individual audit does not have to cover every shift. For example, a stamping process audit might cover shifts 1 and 2 and a shift change in year 1, then cover shift 3 in year 2 or 3. However, every manufacturing process must be audited across all shifts within the three-year cycle, with frequency determined by risk, performance, changes and other relevant factors.
ANSWER:
Set the frequency according to product risk and complexity, referring to ISO 9001 clause 9.2.2. Higher-risk and more complex products warrant more frequent product audits.
ANSWER:
As explained in note 1 to IATF 16949 clause 8.6.2, layout inspection measures every product dimension shown in the design records. Its scope is dimensional requirements; it does not include performance or material testing.
Product requalification generally verifies the complete set of product approval requirements, such as PPAP or PPA, and therefore extends beyond layout inspection.
Functional testing or verification normally addresses performance and material properties, such as strength or tensile strength, and excludes dimensional measurements.
If the customer has not specified the frequency of layout inspection, the organization must determine it.
Layout inspection is included in a product audit when the customer requires it.
Ongoing layout inspection and functional testing requirements belong in the Control Plan. Where customer-specific requirements exist for these activities, include them in the Control Plan as well.
ANSWER:
In section 3 of IATF 16949, “product” means an intended output of the manufacturing process.
Products typically have dimensional, performance or functional, and material requirements. A product audit may verify any of these. By contrast, as FAQ 21 explains, layout inspection addresses dimensional requirements only.
Product audits may examine finished or partly finished products using a customer-specified approach, such as VDA 6.5, where applicable. Packaging and labelling requirements may also be included.
Like other audits, a product audit independently checks conformity with requirements. Its defined scope and frequency form part of the audit programme and are based on risk.
ANSWER:
Clause 8.5.1.3 d) requires first-off/last-off validation only where it is applicable and appropriate. Where validation is not performed for those reasons, there is no requirement to retain records of it.
ANSWER:
No. Every organization must meet the applicable requirements of clause 8.4.2.2, regardless of product design responsibility. These requirements address purchased products, processes and services for which the organization is responsible.
ANSWER:
Yes. The organization must ask its customer for a complete list of destination countries if none has been provided.
NOTE:
ANSWER:
If the organization states that its customer has not supplied the necessary information, it should retain written evidence of its attempts to obtain it, such as letters, emails or meeting minutes.
ANSWER:
No. A general statement covering the whole world is insufficient. The customer is expected to identify the particular countries where the vehicle is initially sold.
ANSWER:
The customer is expected to provide information on relevant characteristics so that the organization can determine controls needed to meet applicable legal and regulatory requirements, for example controls for special characteristics.
ANSWER:
If the customer provides a fully defined specification for the parts to be manufactured — a build-to-print arrangement — the organization does not have product design responsibility.
If a fully defined product specification is not provided, the organization is responsible for product design.
The organization remains responsible for manufacturing process design in every case.
ANSWER:
Clause 8.5.1.5 sets out minimum activities for keeping manufacturing equipment in service over its useful life so that it can continue producing products that meet specifications.
Periodic overhaul involves rebuilding tools or equipment when routine maintenance can no longer keep them capable of producing conforming products. Measures such as mean time between failures (MTBF), or comparable indicators, can reveal this need.
Section 3 describes periodic overhaul as a preventive maintenance approach based on failure or interruption history. Equipment or a subsystem is deliberately taken out of service, dismantled, repaired, fitted with replacement parts as necessary, reassembled and returned to operation to avoid an unexpected major failure.
Some tools and equipment may not require overhaul; a tool may simply be replaced at the end of its useful life. However, all tools and equipment have limits determined by use, age or other known factors. Their manufacturers can help identify those factors and estimate when major work is needed. The organization’s maintenance plan should account for periodic overhaul or an appropriate equivalent, such as replacement.
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