AS9100D, Terms & Definitions and the Context of the Organisation
When you read through AS9100 D you will notice that where ISO9001:2015 may hint at something or assume you understand what it means, AS9100D is far better at being explicit in what it's talking about.
Right off the bat in the scope of the standard for example it states "If there is a conflict between the requirements of this standard and customer or applicable statutory or regulatory requirements, the latter shall take precedence." Which makes perfect sense considering the regulatory and customer requirements will change and accelerate faster than the standard will.
In the Terms & Definitions section of the standard it gives very clear information:
3.1 Counterfeit Part - An unauthorized copy, imitation, substitute, or modified part (e.g., material, part, component), which is knowingly misrepresented as a specified genuine part of an original or authorized manufacturer
3.2 Critical Items - Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the provision and use of the products and services; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.
3.3 Key Characteristic - An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life, or producibility, that requires specific actions for the purpose of controlling variation.
3.4 Product Safety - The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.
3.5 Special Requirements - Those requirements identified by the customer, or determined by the organization, which have high risks of not being met, thus requiring their inclusion in the operational risk management process. Factors used in the determination of special requirements include product or process complexity, past experience, and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of the industry's capability, or requirements determined by the organization to be at the limit of its technical or process capabilities.
It may be tempting to just gloss over these but it's important that you understand what these terms mean because they will come up again later in the standard and should form some of the basis for the risk-based approach you are going to take when applying the standard. They are also terms that you should be using throughout the day to day activities in your business. At goods inwards or even when specifying parts for example, the need to tick off all 4 of the items listed above is going to be important so everyone from the design team to goods inwards to despatch needs to know what they mean and what their part of the puzzle is with respect to understanding and controlling them.
Clause 4 Context of the Organisation
There are not too many changes when it comes to the context of the organisation with respect to AS9100D vs ISO9001:2015 so we will just cover the few additional lines. You should however check out the post on the Context of the Organisation with respect to ISO9001 to get a good understanding of it we have linked the previous articles covering that in ISO9001:2015 below. We actually advise you not to follow the clauses 4.1, 4.2, 4.3 and finally 4.4 but instead it's best work through the clauses in this order: 4.2, 4.1, 4.4 and finally 4.3 because it actually makes mores sense when you are done:
AS9100D Clause 4.4. Quality Management system and its processes
In line with AS9100's approach of clarification or upscaling a requirement they have added a great additional line (in bold) to clause 4.4.1:
The organization shall establish, implement, maintain, and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization's quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.
Once again, the standard is stressing that while you need to create a quality management system that works for your organisation it is critical that you work with your customers and the regulatory authorities to ensure that what you do also meets what they need. What that means is you need to be having clear communication with both your customers and regulatory bodies to understand what their needs are. They are not looking for lip service here they really want you to fully understand what they need and why.
Those requirements will then turn into the inputs for your QMS, your product design methodology, the actual design and of course your risk based approach within the business. For example, if your customers are very risk adverse, which would be understandable if you are flying 300 people at 600mph then you should reflect that in your systems as well.
Clause 4.4.2 has some additional clarification as well over the usual two lines from ISO9001
To the extent necessary, the organization shall:
- maintain documented information to support the operation of its processes;
- retain documented information to have confidence that the processes are being carried out as planned.
The organization shall establish and maintain documented information that includes:
- a general description of relevant interested parties (see 4.2 a);
- the scope of the quality management system, including boundaries and applicability (see 4.3);
- a description of the processes needed for the quality management system and their application throughout the organization;
- the sequence and interaction of these processes;
- assignment of the responsibilities and authorities for these processes.
NOTE: The above description of the quality management system can be compiled into a single source of documented information and referred to as a quality manual.
Most of what the AS9100D additional requirements are asking for are things you really should be doing in your ISO9001 system anyway, it just makes sense. ISO9001 doesn't actually mandate you document your interested parties, you have to know who they are but it's not actually a requirement to write them down, it's dumb if you don't but it's not a requirement. AS9100D takes a different approach and says you WILL write them down along with your scope and processes and so on which means that again, everyone is clear on what we are talking about in the QMS.
The assignment of responsibilities and authorities is not something directly covered in 9001 however you are likely to cover these things via your position descriptions and I know a few organisations that have a document outlining who gets to make what decisions in their processes and under what circumstances it needs to be elevated already which really helps things. Think about it in the same way as financial sign off authorities, someone may be able to sign off up to $500 but there after they need to go up the ladder, it will be the same with your QMS authorities, especially around risk and design.
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