AS9120:2016 has been Published!
There are not only new requirements in this standard above and beyond those found in ISO 9001:2015 and AS9120A 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. The basis for the publication of this standard is actually two-fold:
Since it is based on the ISO 9001 standard, the publication of the new 9001:2015 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 AS9120B 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
AS9120B 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 be the local water quality organization responsible for the cleanliness of the water exiting that facility.
Two new requirements in the standard not only require that you ensure that employees performing work under your control are aware of both their contribution to product safety and the importance of ethical behavior but additionally requires that your suppliers be aware of these aspects as well. The key thing to understand regarding product safety is that it is referring to the ability of the product to perform to its designed or intended purpose. In other words, it is to be manufactured in such a way as to not harm the end user.
Project management requires that you give consideration to how you will plan and manage product and service provision in a structured and controlled manner to include scheduled events performed in a planned sequence. A requirement of AS9100C since its inception, project management has long been a misunderstood and mis-applied concept. For the most part, companies have long associated it with an actual project like purchasing and installing a new air handling system. In actuality, a project management approach could be applied to any new product, customer, industry or any other undertaking needing a structured approach to realize your intended goals.
Design and Development
Undoubtedly the most controversial and least understood new requirement of the AS9120B standard is the introduction of design and development. Long considered outside the scope of a distributor since they do not manufacture product, many distributors do in fact design their processes in order to provide products or services. Though the requirements of the standard are relatively straightforward, what is less clear is the fundamental question “does this apply to my organization?”. In short, if your company has a process that is needed to ensure the provision of products and service and therefore has an effect on customer satisfaction, the design of that process would fall under this requirement.
Notification of Change
A long held concern voiced throughout the aerospace industry is the fact that suppliers make changes to processes, products, services, location of manufacture or sub-suppliers without notifying their customers. AS9120B now requires that suppliers identify criteria for when they are to notify their customers when they make changes. In addition, it requires suppliers to pass along requirements for their suppliers (sub-tier suppliers) to also notify them when a change is made.
This process should be defined in such a way that when a change is made, you have clearly defined criteria either requiring you to notify your customer or allowing you to make the change without further notification. The same holds true for your supplier. There should be no ambiguity as to when they do and do not have to notify you of a change to their processes, products etc.
Validating Test Reports
Though similar to a requirement in the obsolete AS9100B standard, AS9120B now requires that you implement a process to evaluate the data in test reports to confirm that the product meets requirements. Additionally it requires your company to validate the accuracy of test reports if raw material is seen as a significant risk. The first part has always been a given; evaluating the data in test reports (C of C’s, C of A’s, 2nd or 3rd party test labs etc.). Evaluation often takes the form of comparing the test report against a known set of criteria or values.
Validation on the other hand denotes a deeper understanding of the information found in the test report and is often, but not required to be conducted by a 2nd or 3rd party organization using comparative analysis or alternate test methods. Please remember that validation of information in the test report is only required when you have identified raw material as a significant risk.
Suspected, Unapproved and Counterfeit Parts
The AS9100B not only requires your company to have a process to control suspect or counterfeit parts but it also requires that you communicate to your suppliers a need to implement an aerospace quality management system that will prevent the use of counterfeit parts.
A fully realized counterfeit parts program considers CP not only at the planning phase but also at design input. It includes a training and obsolescence monitoring program, the procurement of externally provided product from OEM’s and authorized distributors and appropriate traceability, testing, quarantine and reporting processes. Lastly, you must have a process to ensure that CP does not make its way back into the supply chain.
This new standard now requires companies to consider both product/service and equipment related obsolescence. This begins at the planning phase and requires the user to ensure that they are not building obsolescence into the product they are delivering or requiring the use of equipment or software whose availability will be limited in the future. A robust program to prevent the introduction of obsolescence in any form is one of many ways to help prevent the introduction of counterfeit parts.
Validation/Maintenance of Equipment, Tools and Software Programs
This requirement of AS9100C has now made its way into the world of aerospace distribution. It requires that equipment, tools and software programs used to automate; control, monitor, or measure processes shall be validated and maintained. In addition, storage requirements must be defined for production equipment or tooling in storage to include periodic preservation or condition checks.
A good example of this would be cut-off saws used to cut raw stock into smaller pieces to meet customer requirements. Using that example, the saws, blades and any associated equipment has to be validated to ensure it is capable of the intended task, maintained to safeguard against failure and if stored, periodically checked for deterioration, damage or missing components. Needless to say, equipment that is not capable of answering the bell when the need arises could adversely affect customer satisfaction.
Borrowing from the AS9110 standard, AS9120B now requires an organization to consider human factors when determining the cause of non-conformances. We have all witnessed a nonconformance related to a human factor where the root cause has been relegated to “human error” and the corrective action merely states “retrain”. In actuality, the majority of those “human errors” are caused by, to name just a few:
- Lack of concentration
- Pressure and stress
All of these causal factors are human factors and should be identified. The hesitancy to call it like you see it prevents an accurate corrective action. It is important to look at your most recent corrective actions to see if you have in fact fallen into the trap of classifying human factors superficially as training issues.
Additional information on the AS9120B standard can be found here.