Introduction to AS9100D

Maintaining superior product quality is always a constant challenge. Effective

quality management requires a robust quality system. The quality system has to
be designed to ensure not only good internal quality but supplier quality as well.
When the supplier is in a different country or continent managing product
quality can become even more challenging. To ensure quality of goods,
regardless of the supplier’s home country, there are ISO standards for
developing and maintaining quality systems. However, the risk of poor quality
differs from industry to industry. If a part fails on a home appliance, in most
cases it is likely a mere inconvenience to the customer. In contrast, if a part fails
on a piece of equipment in the aviation, space or defense industry the effect
could potentially cause severe injury or loss of life. The importance of quality
components within these industries cannot be overstated. To ensure adequate
levels of quality and customer satisfaction in the aviation, space and defense
industries, the SAE AS9100 standard was developed. This standard defines the
quality management system requirements to be used at all levels of the supply
chain by suppliers from around the globe.
What is AS9100D
The AS9100D standard specifies the Quality Management System requirements
for organizations that design, develop or manufacture aviation, space, and
defense products. The AS9100 standard is an SAE document developed by the
International Aerospace Quality Group (IAQG). The IAQG is comprised of
representatives from Europe, the Asia Pacific region and the Americas. The
standard is acknowledged worldwide. While some countries utilize various
numbering practices the standard remains the same around the world. The
AS9100 includes not only the ISO 9001:2015 requirements, but also identifies
additional requirements specifically for the aviation, space and defense
industries. Some of the changes to Revision D of the AS9100 standard include
the addition of information regarding the handling of counterfeit parts, attention
to the human factors of manufacturing quality, a focus on product safety, ethics
training, and the process approach including SIPOC and PDCA tools, Risk Based
Thinking, and monitoring supplier delivery performance. Organizations whose
Quality Management System meets the requirements of the AS9100 Rev.D
standard may apply for their AS9100 certificate of compliance.
To support the proper application of the AS9100 Rev. D standard, the IAQG have
produced the 9100:2016 Series Clarifications publication. This document
provides additional information intended to clear up any confusion or settle any
disputes regarding the application of the standard. The clarifications publication
includes information applicable to the 9100, 9110 and 9120 standards.
Why Implement AS9100D
Whether your organization is new to the aviation, space or defense industries or
a long-time manufacturer, gaining AS9100D certification will benefit your
organization. Achievement of an AS9100D certification indicates to your current
and potential customers that your organization is devoted to supplying the
highest level of quality and product safety. Maintaining the highest levels of
quality in any industry is fundamental to the survival and growth of an
organization. In order to not only achieve but also maintain consistent high
quality, an organization needs a robust, well maintained quality management
system QMS. Implementation of an AS9100D QMS will produce many benefits
including but not limited to:
 Improvement of quality processes and meeting your customer’s needs
 Promoting decision making based upon evidence and data
 Monitoring of processes to improve efficiency, and productivity
 A Reduction in the three forms of waste and scrap costs.
 Supporting and encouraging a culture of continuous improvement
 Active risk assessment of designs and processes and effective mitigation
practices
 Consistent compliance to regulatory, safety and reliability requirements.
 Enhancement of your corporate image in the global marketplace.
In addition to the many benefits to your organization, there is also the subject of
corporate responsibility to consider. These industries rely heavily on their
suppliers to provide material and components that not only meet their
functional requirements but also safety requirements. Failure to maintain the
highest levels of quality or properly identify and mitigate risk in the design of a
component or assembly could have a detrimental effect on your organization or
worse. Potential component or system failures could result in injuries or possible
fatalities. Organizations must be diligent in identification and evaluation of risk
in their designs and follow through with effective measures to reduce or
eliminate that risk. Development and implementation of an AS9100D compliant
QMS is an important step toward success and can have a huge effect on your
bottom line.
 How to Implement AS9100D
Implementation of any new management system requires dedication of
management to the success of the project along with time and resources to
accomplish the goal. It is the same with the successful development,
implementation and maintenance of an AS9100 D quality management system.
In this section, we will briefly cover the main requirements of the QMS
requirements. The standard includes the requirements of ISO 9001:2015 with
additional requirements unique to the aviation, space and defense industries.
The standard requires the process approach based on the PDCA (Plan, Do,
Check, Act) method for product and process improvements and problem
resolution. In addition, the standard advocates the practice of risk based
thinking. Proactive risk identification, assessment, and mitigation methodology
is required. Addressing of risk is one of many items included in the previously
mentioned clarification document.
The success of the QMS requires a commitment of time and resources from all
levels of the organization. Top management must lead the effort towards the
successful implementation and continued support of the QMS. The AS9100D
standard provides a model for the establishment and implementation of an
effective QMS. The following paragraphs provide brief descriptions of the main
sections that constitute the body of information within the standard.
Section 4 – Context of the Organization
The AS9100D standard requires evaluation of the internal and external
influences relevant to organization’s purpose or direction that could affect
meeting the requirements and goals of the QMS. The organization must also:
 Understand and take into account the needs and expectations of
interested parties.
 Determine and document the scope of the QMS
 Commit to the establishment, maintenance and continuous improvement
of the QMS.
Section 5 – Leadership
The AS9100D standard requires that all levels of management within the
organization embrace and commit to the success of the QMS. The leaders of the
organization must:
 Be accountable for the success and support of the QMS
 Integrate the QMS into the organizations regular business processes
  Ensure that all product, safety, and regulatory requirements are defined
and understood.
 Promote risk based thinking and use of the process approach
 Establish a quality policy and objectives aligned with corporate strategy
 Ensure that the quality policy is available for review and maintained
 Provide adequate resources for implementation and continued support of
the QMS
 Encourage associates to become engaged in the QMS and contribute to
its success
 Foster a culture of continual improvement within the organization.
Organizational Roles Responsibilities and Authority
Top management of the organization must assign responsibility and authority
for supporting, reporting and maintaining the QMS. Furthermore, leadership of
the organization is required to assign responsibility and authority for ensuring
that the QMS conforms to AS9100D requirements and for regularly reporting the
QMS performance results.
Section 6 – Planning
Just like any other endeavor, the development and implementation of an
AS9100 compliant QMS requires proper planning. During the planning phase,
top management must consider multiple factors. Management must consider
the context of the organization along with any and all interested parties. In
addition, management must determine the scope of the quality management
system, and take proactive measures to ensure the QMS is capable of achieving
its desired objectives. Plans must be developed and implemented to provide
sufficient support and resources necessary to achieve continual improvement of
the QMS. The AS9100 standard outlines many requirements to be met during
the planning phase including but not limited to the following:
Actions to address Risks and Opportunities
The organization must develop plans for identifying, and addressing potential
risks and opportunities for improvement. The plan must include methods for
addressing risks and taking full advantage of opportunities for improvement. In
addition, the organization must determine how to properly integrate these
methods into the heart of the QMS.
Addressing Risk
There are multiple options an organization can consider for addressing risk.
Many are spelled out in the standard for addressing risk. Some examples given
are as follows:
  Avoiding Risk
 Taking a risk in pursuit of an opportunity
 Determining and eliminating the cause of the risk
 Taking action to change the outcome or lower the severity of the risk
 Making an educated decision to live with the risk
Addressing Opportunities
Opportunities can present themselves in a myriad of ways or forms. Taking
action to seize these opportunities can have a profound impact on the
organization. Stepping up when opportunity presents itself can lead to:
 Adoption of new methods and practices to improve quality
 Development and introduction of new products or product lines
 Increased market share or moving into new markets
 Utilizing new technology within the organization
Addressing risks and opportunities can improve the organizations ability to meet
or exceed customer expectations of performance or quality. In addition,
proactively addressing risk and seizing opportunities for improvement can also
have a positive impact on your organization’s bottom line.
Establishing Quality Objectives and Plans for achieving them.
The establishment of quality objectives is vital if your QMS is going to
continually improve. Quality objectives are one type of KPI (Key process
indicator) that can be measured and monitored throughout the year. The quality
objectives must address what needs improvement. Do your due diligence,
collect and analyze data. Then let data speak for itself, not opinion or rhetoric.
Quality objectives should also align with your organization’s strategic long term
plans. In this section, we shall be using the terms objective and goal
interchangeably. When determining the goals or objectives for the QMS, be
certain that they are SMART goals.
 Specific – Define the goal as clearly as possible. Cover the why, what,
when, where, and who details when defining the objective. Make sure
everyone is on the same page.
 Measurable – Make certain that your goals are expressed in measurable
terms. Define the measurable in the how many, how much or how often
terms. Such as the goal of reducing customer shortages by 50%. A goal
must be measurable because what you cannot measure you cannot
improve.
 Attainable – Ensure that the goal is achievable. Make certain it is within
reach and not unattainable. In addition, the goal must be accomplished
by the person or persons assigned within their regular responsibilities
and authority.
  Relevant – Ask yourself questions such as “Does the goal fit the
organization’s needs?” “Will achievement of this goal contribute to the
short- and long-term strategy of the organization?” Make sure the goal is
relevant to your business.
 Time Based – Goals should have a defined timeline. For example,
achieving a reduction in customer shortages by 50% within the next 12
months. This will instill a sense of urgency and enable the responsible
parties to plan and manage their time accurately.
Once the goals or objectives have been determined, it is vital that they are well
communicated within the organization. They are not intended to be a secret
plan. In addition, the involvement of each team or individual should be clearly
communicated and understood. If the goal is to reduce customer shortages by
50% then the shipping department should be involved from the start. And each
associate working in the shipping department must fully understand their role in
achieving the objective. Associates that are well informed and actively involved
tend to take mental ownership of the process or objective. Proper
communication, employee involvement and empowerment at all levels of the
organization frequently results in increased employee morale and lower
turnover rates.
Section 7 – Support
Successful development, implementation and continued improvement of an
AS9100D compliant QMS is highly dependent upon the support received from
the management team of the organization. AS9100D compliance requires top
management within the organization to commit adequate resources for
establishing, implementing, maintaining and driving continual improvement of
the Quality Management System. The organization must consider the
capabilities of and any constraints of available, qualified internal resources. In
the same manner, the resources that will be acquired from external sources
must be considered as well. Some examples of the resources management is
required to supply are listed below. The list is not intended to be fully
comprehensive but includes information relating to the major requirements
needed to meet the standard.
 General Requirements – The organization must determine and meet the
personnel requirements mandatory to implement and manage the QMS,
and for the support of its processes. In addition, management must
determine and provide the proper infrastructure, environment,
monitoring and measurement resources, and measurement traceability
to support a robust QMS.
  Competence – The organization must determine the level of competence
required for each position supporting the QMS including the level of
education, training or experience required. It is not uncommon for
AS9100D compliant organizations to develop and maintain bios for each
of the key personnel responsible for the QMS and its adherence to the
standard.
 Awareness – Management must ensure that the persons performing work
are aware of the quality policy, the objectives as mentioned in section
six of the standard and roles and responsibilities to the success and
continuous improvement of the Quality Management system.
 Communication – Management of the organization shall determine and
establish the appropriate internal and external lines of communication
required for the success of the QMS. The organization must also define
the method of communication along with what will be communicated,
when to communicate, whom to communicate with and how often
communication will take place. Furthermore, communication should
include internal and external feedback pertaining to the Quality
Management System status and its objectives.
 Documentation – The organization must develop and maintain
documented information required by AS9100D standard. Along with any
information deemed necessary by the organization for the success of the
QMS. The required documentation shall have adequate protection of the
content and control revisions ensuring that any changes or updates are
identified and traceable. The proper documents must be available for
use where and when required. Furthermore, the document control
system must provide for proper access, distribution, storage, retention
and the eventual disposition of obsolete documents.
Section – 8 Operation
Top management of the organization must plan for the operation of the Quality
Management System. Once the QMS is developed and implemented, the day
to day operation of the QMS must be managed and monitored to ensure it is
fulfilling its intended purpose and pursuing the appropriate objectives. The
AS9100D standard outlines what the organization must do to ensure proper
operation of the QMS. In this section, we will briefly touch on the main points
contained within the standard.
 Operational Planning and Control – Plans shall be developed for the
implementation and control of the processes identifying and addressing
operational risk, product identity, traceability and product safety. One
additional requirement included in the AS9100D standard addresses the
requirements concerning the control of counterfeit parts. Proper training
of personnel including verification and testing, to identify counterfeit
parts, along with processes for the containment and disposition of said
parts is required by the standard.
 Requirements for Products and Services – The organization is required to
implement processes to ensure that all product and service
requirements are met on a consistent basis. The processes for
communication with customers and the criteria for acceptance of
products and services are among the requirements that must be defined
by the AS9100D standard.
 Design and Development of Products and Services – Compliant
organizations are required to establish and support a robust design and
development process to ensure product and service requirements are
met. This includes but is not limited to design inputs, development and
verification of the design and control of the outputs such as drawings,
part lists, the material and any special product or process requirements.
 Control of Externally Supplied Processes, Products and Services –
Externally sourced parts or services must be monitored and controlled.
The organization should have a robust supplier quality management
process with regular evaluation of supplier performance. The
organization shall determine and apply the appropriate criteria for
judging the quality of an external supplier’s parts or products and the
supplier’s performance.
 Production and Service Provision – Systems must be in place to
effectively monitor and control multiple aspects of the production
processes including but not limited to:
o Equipment, Tools and Software used for automation, monitoring,
measuring or controlling production processes must be validated
and properly maintained.
o Validation of special processes that cannot be monitored or
accurately measured
o Material or product traceability when required to assure the quality
and conformity of products or services.
o Control of process changes including documentation of the review
results and the associates authorizing the change in the process or
processes.
 Release of Products and Services – Systems must be in place to
document conformity prior to the release of a product to the customer.
The organization must be able to produce evidence of compliance
including the product acceptance criteria, the person authorizing the
release, and their qualifications.
 Control of Non-Conforming Outputs – The organization shall develop and
maintain systems and procedures for the containment and control of any
non-conforming process outputs. This would include proper
documentation of the non-conformity along with the segregation,
disposition and prevention of use or delivery to the customer.
Section – 9 Performance
Organizations pursuing AS9100 certification must develop and maintain
effective procedures for monitoring and evaluating the performance and
effectiveness of their Quality Management System. If it cannot be measured it
cannot be properly controlled. Therefore, the QMS must include the proper
tools, associate training and sufficient resources to monitor the progress of the
QMS and the achievement of planned objectives.
 Monitoring, Measurement, Analysis, and Evaluation – The organization
shall determine what needs to be monitored and measured, when it shall
be done, and the method of documentation.
 Internal Audit Process – Internal audits are required to be performed at
regular intervals to ensure that the QMS is meeting internal, customer
and any applicable regulatory requirements. Records of the audit results
shall be retained as evidence of compliance and shall be available for
review.
 Management Reviews – Management shall hold QMS review meetings at
regular intervals. The agenda or subject matter of the review meetings
are the decision of the organization. The subject matter may include but
is not limited to the following:
 Reviewing the status of actions from previous reviews
 Changes to any internal or external issues relevant to the management
system
 Information about the QMS performance including audit results and
progress of objectives.
 Potential risks to the QMS or opportunities for improvements.
 Review of the supplier performance KPIs
Any relevant information resulting from the meetings should be shared with
workers and other interested parties. The organization shall also retain
documented records of the results of the management reviews.
Section 10 – Improvement
In order for an organization’s Quality Management System to be most effective,
it must continually improve. Organizations must actively look for opportunities
to improve the effectivity of their QMS. They should continually work toward
achieving the QMS objectives while providing products and services tailored to
their customer requirements.
The AS9100 standard requires that organizations have plans in place to react to
non-conformities. This should include but not be limited to containment,
control, Root Cause Analysis (RCA) and Corrective Action Preventative
Action (CAPA). In order to prevent the problem from becoming a repeat
problem, the root cause must be identified.
  A good example is a weed in your garden. The goal of your garden is to
grow and supply you, the customer, with high quality fresh produce.
Weeds rob the soil of essential nutrients and moisture interfering or
possibly preventing the garden from achieving the planned objective. If
you merely cut down or pull the weed without identifying the root, it will
be back. The same can be said about quality problems. In many cases,
we end up addressing the symptom and not the true root cause. If the
root cause is not determined, the issues may re-occur within the same
process or elsewhere in the organization. The root cause is the true
underlying or fundamental cause of nonconformity.
An action plan should be developed for implementation of the appropriate
corrective actions and documenting their effectiveness. The standard also
requires that the organization document the incident including the corrective
actions and their effectiveness. The records must be properly maintained and
available for review by management or during a third party audit.
In Conclusion
As previously stated, AS9100D incorporates the PDCA cycle approach towards
building, maintaining and improving your QMS. The PDCA (Plan, Do, Check, Act)
cycle includes the Plan phase that covers the planning phase and beginning
stages of QMS development. The Do cycle deals with QMs implementation and
operation. The Check cycle is the evaluation of the QMS effectiveness. This
includes the management reviews of the QMS performance. Finally the Act
phase looks at ways to integrate improvements throughout the organization and
ensures the PDCA cycle never ends. Thus the depiction of the PDCA cycle as a
circle and not a straight line.
The initial development and implementation of an AS9100 compliant Quality
Management System may take several months and a large amount of
resources. One key to success is to have participation and buy-in from all levels
of the organization. Quality is everyone’s responsibility. The QMS must have
adequate resources and constant support from organizational leadership.
At any time during the planning, implementation or operation of the QMS
questions arise regarding the AS9100 standard. Be sure to reference the 9100-
2016 Series Clarification document provided by the IAQG. Referencing this
document may provide the information required to clear up any confusion
regarding the application of the standard. In some cases, further clarification is
needed or you may require the assistance of experienced, and highly qualified
subject matter experts. When additional resources or subject matter experts are
needed they are close at hand. At Quality-One we can meet your needs.
Therefore, if your organization is in need of additional resources or would like
more information regarding AS9100D implementation, please contact one of the
professionals at Quality-One.