As of July 2017, a total of 63 certifications have been
issued worldwide to the revision D of AS9100. Audit data gathered from the OASIS NextGen database show the clauses of
the standard were non-conformances are being documented against. This data list the number of minor and major
non-conformances by clause.
While this information is
important for any certified organization pending performance of a transition
audit, it should be noted that these clauses are not the only area where a
non-conformance may be issued during your audit. It is imperative an organization effectively
plans, executes and monitors the implementation of the AS9100D revision in its
quality management system. ASACB
recommends that an organization utilize its internal audits program to monitor
the implementation of all new requirements of new revision to ensure that the
output realized is the expected output. This will provide a better outcome for a successful implementation of
the new requirements.
ASACB has posted a gap assessment
tool on its website which can be downloaded for free by any organization. This can be accessed by clicking on the
following link, http://www.aviationsuppliers.org/AQMS-2016-Transition
then download the file titled "Gap Assessment 9100D". An organization will be able to see immediate
results of how successful it was on implementing the standards new and/or
clarified requirements when this tool is used in conjunction during your
internal audits. It will also show our
auditor's the efforts deployed to manage an effective and monitor deployment of
the requirements into an organizations quality management system.
To further assist in the
successful transition of currently certified organizations, the International
Aerospace Quality Group (IAQG) has created and made available deployment
material which can be accessed through its web-site www.iaqg.org. The following is a quick visual on how to navigate to this information.
To promulgate a lesson's learned environment industry
developed a list of frequently asked questions (FAQ's) for the AS9100:2016
series revision. This information was
obtained from experts and users of the standard from around the world. This information will be updated as new data
becomes available. The FAQ's can also be
accessed via the IAQG website under its deployment material section.
ASACB would like to provide some clarification to a few of
the requirements of AS9100D. These
clarifications have been approved by industry and were presented to
certification body personnel during the recent Registration Management
Committee and Americas Aerospace Quality Group Meeting held in Minneapolis, MN
in July 2017.
Clause 4.3 Scope Applicability
Clarification Requested: Can a build to print sheet metal
manufacturer exclude clause 8.3 for tooling if they accept customer tool POs,
design tools, make tools, and deliver them to the customer?
- No, the tooling is considered a product since it
is procured and delivered to the customer.
- If the tooling Is not contracted or sold to the
customer, then the development of tooling is an enabler to product build making
of tooling is covered under clause 8.5.1d and 18.104.22.168.
Clause 4.3 Scope Applicability
A organization must develop and validate a complex manufacturing process
to achieve the results (special processes, control software, automated
measuring equipment). Are they required
to use design and development processes?
- No, 9100 requirements is for design and development of
products and services, not of processes. An organization can use clause 8.3 for process development but it is not
Clause 4.4 Process Measures
Can an organization just have a top-level process to evaluate
effectiveness of QMS processes?
- No, 9100 requires the organization to determine if the
identified processes are effective and achieving planned results (see clause
4.4.1c). Each process measure should
evaluate the effectiveness of that process and be value-added. This is the measure that would be included in
a Process Effectiveness Assessment Report (PEAR) as the key performance
indicator for that process.
Transition to the new AS9100D requirements to say the least
should not be taken lightly. The
expiration date of September 15, 2018 of ISO 9001:2008 and
AS9100C/AS9110B/AS9120B is fast approaching. If your organization finds itself unprepared or needs the standards new
requirements clarified please do not hesitate to contact ASACB's Accreditation
Manager, George Ringger at George@aviationsuppliers.org
or Vice President Technical Services, Sam O'Connor at Sam@aviationsuppliers.org. We are here to assist you and we promise to
get the correct answer to your question if we are unable to provide it.