How to meet traceability requirements in an AS9100D-based QMS
The AS9100 Rev D includes requirements for the aerospace quality management system (QMS) with regards to identification and traceability. These requirements include not only the standard requirements of ISO 9001:2015, but also supplementary requirements for the aerospace industry. So, exactly how are you supposed to implement the AS9100 traceability requirements in your company?
What does AS9100 Rev D say about traceability?
AS9100 Rev D has five statements about identification and traceability, and a clarifying note in clause 8.5.2, which also mentions identification and traceability. These short requirements include:
Suitable identification. To know if a product has been tested or not, you need to know the identification of a product (such as a serial number and part number) to determine its conformity. You then you need a suitable way of marking this identification for the product.
Maintaining configuration. When it is necessary to know exactly what parts and processes went into a product or service so that it can be compared to the design configuration, this needs to be maintained. For instance, knowing what part numbers and parts revisions, and what revisions of processes were actually used allows you to compare to the design listing. For a better understanding of configuration management, see the article: Understanding configuration management in AS9100 Rev D.
Identifying status. You need to easily know if the unit has gone through specific monitoring or measurement activities, such as testing. You also need to know what stage of the build and test a product or service has successfully passed.
Acceptance media. If you are using stamps, passwords or electronic signatures to designate who performed a task or accepted a measurement, then these media need to be controlled so that you know they are properly used by the right people.
Identification & traceability. When you need to know traceability for outputs, you need to properly identify these outputs so that you can keep track of what went into them. This could be a serial number, batch, or other method of identification that allows you to trace what parts, processes, materials, etc. went into the product or service.
The note for clause 8.5.2 clarifies some possible aerospace requirements that could be included in traceability. These include identification throughout the life of the product, knowing all of the products made from one batch of material and what happened to them, ability to trace components of an assembly that becomes part of a larger assembly, and the ability to retrieve the sequential record of a product through manufacture, assembly, testing, inspection, etc. It is important to understand that these are not requirements, but examples of what could be imposed on a company.
What else must you consider?
It should come as no surprise that the AS9100 standard doesn’t explicitly tell you what to do for traceability, because the actual application of traceability is very different across the many differing companies of the aerospace industry. So, where should you turn to understand exactly what traceability requirements apply to you? There are two main places to find these requirements:
Legal requirements. Certain parts of the aerospace industry have legal requirements for traceability. For instance, the aircraft industry needs to be able to precisely track what serial numbers of each part are included on an aircraft at any given time. This traceability needs to extend right down to the raw materials used for each individual part. The reason for this is that, if it is found that a particular part is faulty and caused (or potentially could cause) an aircraft disaster, they need to be able to find out which parts on other aircraft could be affected. So, this requirement extends to knowing exactly which parts are made from the same batch of material.
Customer requirements. Whether a legal requirement exists or not, customers will very often tell you exactly what is needed in your contract. This will include the type of traceability needed, such as forward traceability (the ability to know the final units that contain everything from a batch of a certain product), backwards traceability (knowing all of the information such as batches and serial numbers for everything that is used in a product), or both. These customer requirements will also include additional information such as the delivery of the traceability information and the retention times for the traceability records.
It is important to know what level of traceability you need so that you can ensure compliance. For instance, if you do supply the aircraft industry and there is a plane crash, you could have a big problem if you did not know exactly which other products you made from the same batch of material. This could be a costly mistake as you might end up replacing every questionable product just because you don’t know for sure if it is suspect or not.
For more about product safety, read the article How to implement product safety requirements according to AS9100 Rev D.
Traceability can be critical
Knowing your traceability requirements is an important first step to ensuring you have adequate knowledge about your products. By identifying your required level of traceability, you can then decide if you need a simple traceability tracking system, or a more complex computer tool to ensure that traceability is not lost. Know your specific requirements so that you can adequately implement a system that is right for you.
For a better understanding of traceability requirements of AS9100 Rev D, download this free whitepaper: Clause-by-clause explanation of AS9100 Rev D.
About the author:
Mark Hammar is a Certiﬁed Manager of Quality / Organizational Excellence through the American Society for Quality, and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes and writing procedures for Quality, Environmental and Occupational Health & Safety Management Systems, and is certiﬁed as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.