FACT or FICTION IATF 16949:2016
Initiate by Paul Herdiman. Answer by cisca.
FACT OR FICTION
1. Rework risks must be undertaken using PFMEA methodology before performing any
rework
2. Requirement 10.2.4 relates to error prevention and error detection devices
3. Personnel undertaking product audits must understand the automotive process
approach and risk-based thinking
4. Calibrations performed externally do not always have to be performed by an
ISO/IEC17025 accredited lab.
5. Personnel undertaking manufacturing process audits must have attended training in the
automotive core tools
6. Rework must always be approved by the customer prior to shipment
7. An organization must use first-in-first-out (FIFO) storage controls
8. Where a manufacturing process is unstable, 100% inspection must always be
implemented
9. Gauge R&R studies must be undertaken for each type of measuring equipment
specified on the control plan
10. Due the issue of the AIAG control plan manual, all organization must have safe launch
control plans
FACT OR FICTION
No. 1. Rework risks must be undertaken using PFMEA methodology before performing any
rework.
FALSE
8.7.1.4 Control of reworked products
The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in
the rework process prior to a decision to rework the product.
https://www.linkedin.com/feed/update/urn:li:activity:7255037104093605889?utm_source=shar
e&utm_medium=member_desktop
FACT OR FICTION
No. 2. Requirement 10.2.4 relates to error prevention and error detection devices.
FALSE
3.1 Terms and definitions for the automotive industry
error proofing
product and manufacturing process design and development to prevent manufacture of
nonconforming products.
In this context, error-proofing defect prevention.
FACT OR FICTION
No. 3. Personnel undertaking product audits must understand the automotive process
approach and risk-based thinking.
FALSE
7.2.3 Internal auditor competency
Product auditors shall demonstrate competence in understanding product requirements
and use of relevant measuring and test equipment to verify product conformity.
SANCTIONED INTERPRETATION
At a minimum, product auditors shall demonstrate competence in understanding product
requirements and use of relevant measuring and test equipment to verify product
conformity.
FACT OR FICTION
No. 4. Calibrations performed externally do not always have to be performed by an
ISO/IEC17025 accredited lab.
TRUE
SANCTIONED INTERPRETATION
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 its national equivalent (e.g., CNAS-CL01
in China) by an accreditation body (Signatory) of the ILAC MRA (International Laboratory
Accreditation Forum Mutual Recognition Arrangement – www.ilac.org) 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
• where an non-accredited laboratory is utilized for example, but not limited to: specialist or
integrated equipment, parameters with no international traceable standard reference, or
original equipment manufacturers), the organization is responsible to ensure that there is
evidence that the laboratory has been evaluated and meets the requirements of Section
7.1.5.3.1 of IATF 16949.
FACT OR FICTION
No. 5. Personnel undertaking manufacturing process audits must have attended training in
the automotive core tools
FALSE
7.2.3 Internal auditor competency
Additionally, manufacturing process auditors shall demonstrate technical understanding of
the relevant manufacturing process(es) to be audited, including process risk analysis (such
as PFMEA) and control plan.
SANCTIONED INTERPRETATION
At a minimum, manufacturing process auditors shall demonstrate technical understanding
of the relevant manufacturing process(es) to be audited, including process risk analysis
(such as PFMEA) and control plan.
shall demonstrate training
FACT OR FICTION
No. 6. Rework must always be approved by the customer prior to shipment.
FALSE
8.7.1.4 Control of reworked products
If required by the customer, the organization shall obtain approval from the customer
prior to commencing rework of the product.
FACT OR FICTION
No. 7. An organization must use first-in-first-out (FIFO) storage controls.
FALSE
8.5.4.1 Preservation – supplemental
The organization shall use an inventory management system to optimize inventory turns
over time and ensure stock rotation, such as “first-in-first-out” (FIFO).
Sometimes we should use FEFO, First Expired First Out, for product with expiry date.
FACT OR FICTION
No. 8. Where a manufacturing process is unstable, 100% inspection must always be
implemented
FALSE
9.1.1.1 Monitoring and measurement of manufacturing processes
The organization shall initiate a reaction plan indicated on the control plan and evaluated
for 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 percent inspection, as appropriate. A corrective action plan shall be
developed and implemented by the organization indicating specific actions, timing, and
assigned responsibilities to ensure that the process becomes stable and statistically
capable. The plans shall be reviewed with and approved by the customer, when
required.
FACT OR FICTION
No. 9. Gauge R&R studies must be undertaken for each type of measuring equipment
specified on the control plan
FALSE
7.1.5.1.1 Measurement System Analysis
Statistical studies shall be conducted 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 systems analysis. Other analytical methods and acceptance
criteria may be used if approved by the customer.
Statistical studies Gage R&R, Linearity, Stability, Bias, others.
Follow the Customer Specific Requirement.
FACT OR FICTION
No. 10. Due the issue of the AIAG control plan manual, all organization must have safe
launch control plans.
FALSE
8.5.1.1 Control Plan
The organization shall have a control plan for pre-launch and production that shows
linkage and incorporates information from the design risk analysis (if provided by the
customer), process flow diagram, and manufacturing process risk analysis outputs (such as
FMEA).
Follow the Customer Specific Requirement.
