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IATF 16949 Webinar Slides 3.7.17 Final PDF
IATF 16949 Webinar Slides 3.7.17 Final PDF
IATF 16949:2016
According to the IATF Rules (Table 5.2), the transition audit shall
take as much time as a re-certification audit. However, the
document review that is required prior to the audit may be
conducted by the auditor on or off site. To this end, the
organization needs to make available to the auditor at least their
quality management documentation (e.g. manual, process map
and processes), and evidence of their conformity with the IATF
16949 requirements (e.g. via internal audit reports and gap
analyses). Depending on the organizations level of maturity, size
and complexity, document review will take at least four hours. If
documentation has not been submitted in advance, the
Transition Audit shall commence with an additional 0.5 days
minimum on site.
This means that the supplier would need some sort of process
to evaluate each of their customers customer-specific
requirements and determine exactly how (and where) it
applies to their organization's QMS, as applicable
The software development process must also be included within the scope of
the internal audit program; the internal auditor should be able to understand and
assess the effectiveness of the software development assessment methodology
chosen by the organization.
VDA QMC has a document available: Automotive SPICE, which may be helpful.
Software Process Improvement and Capability determination
This new section aligns customer-specific requirements into the IATF 16949
standard. See Section 7.2.4 for details of 2nd Party Auditor Qualifications.
Examples of situations that could trigger a second-party audit include: input from
supplier performance indicators; risk assessment results and follow-up of open
issues from process and product audits; and new development launch
readiness.
The organization's criteria for determining the need, type, frequency, and scope
of second-party audits must be based on a risk analysis including product
safety/regulatory, performance, etc. This criteria needs to be documented.
Short term efforts would generally focus on supplier products, and would
require defining suitable methods to assure the quality of purchased product
from each supplier.
Long term efforts would generally focus on supplier QMS and manufacturing
processes on the whole, and consider audits, training, and enhancement
efforts that implement and enhance quality assurance agreements between
suppliers and the organization, and further reduce risk.
If the gage used for measurement gives variable data, the actual
measurement must be recorded.
The process needs to identify and evaluate the level of risk related to
each QMS process, internal and external performance trends, and
process criticality.
Strengthen the quality management system audit and the use of process
approach, which further drives process improvements organization-wide.
There is a 3 year window to audit all of the QMS processes, but the schedule
should be based on risk.
The audit program is continuously monitoring information that could trigger the
need for an unplanned internal audit.
The internal audit must also sample customer-specific QMS requirements for
effective implementation.
There are customers who specify the use of VDA 6.3 for
Manufacturing audits. If not specified by a customer, an
internal process must be defined. This could be the
currently defined process based on the IATF2016
Requirements.
Mike Brannock
Director Automotive SBU
Phone: (317) 379-6277
E-Mail: mike.brannock@dqsus.com
Charles Blair
Regional Automotive Program Manager
Phone: (812) 866-8068
E-Mail: charles.blair@dqsus.com