AS9110:2016 has been Published!
There are not only new requirements in this standard above and beyond those found in ISO 9001:2015 and AS9110B but also areas of emphasis that will enable your company to adapt to an ever changing business environment. The significant additions and changes are outlined below but first, it is important to understand the rationale for the publication of this standard:
Since it is based on the ISO 9001 standard, the publication of the new AS9001:2015 standard necessitates this new revision.
Input from stakeholders on the shortcomings of the current revision and a need for clarification and revision define the changes to this standard.
Before addressing the aerospace specific changes to the AS9110C standard, it is important first to understand the changes in both its structure and the terminology used. Be advised though that you are not required to revise the terminology in your aerospace quality management system or the structure itself to coincide with the terminology and structure of this new standard.
High level structure (HLS) & Terminology
Products are now referred to as products and services
Documentation, records and documented procedures are now collectively referred to as documented information
Purchased product is now referred to as externally provided products and services
Suppliers are now referred to as external suppliers
The high level structure change now more closely follows the Plan-Do-Check-Act model in that sections 4, 5, 6 and 7 fall under “Plan”, section 8 falls under “Do”, section 9 falls under “Plan” and section 10 falls under “Act”.
Relevant Interested Parties
AS9110C requires that you identify interested parties or any entity or even personnel that would have an interest in your organization, products or services. A common mistake people make is assuming an interested party is only one who has a financial stake or would be impacted financially by your organization. In fact, an interested party could even be a local municipality with an interest in how your company interacts with the community. In other words, they are interested in the goings-on at your company.
New Key Requirements
Design and Development (8.3)
A new requirement was added for organizations authorized by competent authorities to perform Design & Development Repairs. For approved or accepted Maintenance, Repair, Overhaul Organizations, i.e., a Certificated Repair Station by a National Aviation Authority, this is already defined; just follow the regulatory guidance.
For MRO activities performed for a Department of Defense organization on the other hand, repair activities not published in approved and defined technical manuals must receive approval from the competent authority. Additionally, continuous airworthiness requirements must be evaluated to ensure outputs are incorporated into work orders when developing aircraft maintenance programs.
Working closely with your Customer, National Aviation Authority or Department of Defense (or equivalent) agency will provide the best opportunity for success for your design and development process.
Human Factors (7.2(f), 7.3, 10.2.1(b)
Consideration of Human Factors Analysis plays a key role when assessing potential solutions to non-conformances to include continuous improvement projects. While not new to AS9110 or Maintenance, Repair, Overhaul organizations, AS9110C expands the application to recognize the importance of identifying potential human factors when considering all nonconformities and not limit it to just the corrective action process.
The products/service, workplace, equipment and personnel at a company must all be taken into consideration when determining the effects of Human Factors. Within the aerospace community, the increased awareness of human factors and their impact on non-conformances have been noted by the authors of and now included in the AS9100:2016 standard.
That’s the good news. The bad news is that organizations normally take a superficial look at how human factors may have influenced the nonconformity. Therefore it is often understated or a misunderstood aspect of AS9110 on how it may affect the organization, quality of product/services provided and ultimately the end user.
In the United States, the Federal Aviation Administration (FAA) provides information on Human Factors that can be invaluable to an organization. They have identified a “Dirty Dozen” that are recognized as potential culprits and having contributed to incidents and accidents.
- More information on human factors can be found here.
- Human factors specific to aviation maintenance can be found here.
- Lastly, it’s not just about MRO activities; human factors incorporated into product lifecyle/design can be found here.
Counterfeit Parts (3.7, 3.15, 8.1.4, 8.7.1(a-d)
Counterfeit parts are not new to any industry. Counterfeit parts awareness/risks are now inclusive in all Aerospace Standards prompting an organizations need to examine potential risks of counterfeit parts becoming part of the delivered product. Consideration for counterfeit parts may include nonconformance control, reporting, and training. Good counterfeit parts programs not only address/mitigate internal activities of the organization, but activities regarding external providers as well.
Process Approach and Risk Based Thinking
Aerospace Standards have a way of stimulating an organizations processes to provide a quality/safe product on time while meeting the customer expectations and applicable National Aviation Authority Requirements. These standards provide guidance; however, the organization has the responsibility to manage the life cycle of the product. A proven method/tool to achieve that is managing using of the Plan, Do, Check Act cycle, something we should all be familiar with.
This organizational approach to systematically manage processes and interactions necessary to achieve the intended results can be highly effective. The process relies on activities/processes being identified, inputs getting transformed into outputs, establishment of appropriate checks, the results of which are monitored to see if they are meeting objectives, and finally the implementation of continuous improvement activities which may be implemented as a result of the monitoring process.
For the management function of many organizations, using a process approach while utilizing risk based thinking is already in place and has proven to be highly effective. A key aspect of this though for any organization is to identify its processes, interactions and any associated risks. Some processes are descriptive and other may take the form of Value Stream Maps, Process Flow Charts or possibly Turtle Diagrams.
Whatever method the organization chooses, those processes should be monitored for effectiveness. Appropriate key performance indicators/metrics and risk identification are important when determining what action is required when the organization is not meeting internal or external expectations.
Additional information to include support material for the AS9110:2016 standard can be found here.
Written by Merlyn O’Hara-NQA Aerospace experienced AS9110 auditor.