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AS9100 Clause 8.1 - The Operational, Planning & Control Requirements

If you think about the first 7 clauses of the AS9100 REV D as building the framework of your Quality Management System, then section 8 - Operation is very much about putting some substance on that framework and as a result it's quite in depth in its requirements.

Section 8.1 - Operational Planning and Control, that we will discuss here, gives the requirements for the organisation to put into place the processes, procedures and controls needed to ensure their products and services meets the requirements of their quality management system (see our post in section 4.4) and also to address the risks and change management elements that they have previously identified in section 6.

a. Determining the Requirements for Products & Services  

Meeting the requirements for part (a) of this section should be simple for most organisations, after all you know what products and services you are providing, you know what:

  1. Your customers want from your products and services
  2. You understand what shape, size, colour or functional requirements there are for your product
  3. You understand any legal or safety requirements
  4. You know about the statutory requirements of you

In addition to this, AS9100D wants you to consider the following as well:

  • personal and product safety;
  • producibility and inspectability;
  • reliability, availability, and maintainability;
  • suitability of parts and materials used in the product;
  • selection and development of embedded software;
  • product obsolescence;
  • prevention, detection, and removal of foreign objects;
  • handling, packaging, and preservation;
  • recycling or final disposal of the product at the end of its life.

Knowing these things then lets you move on to the next stage, (b) Establishing criteria for the processes & acceptance of your products.

b. Establishing Criteria  

While there is no requirement of within AS9100 REV D to document the processes or procedures you need to create your product or service let's face it you really must, it would be madness not to do it. By documenting the steps and processes required to produce your products or services you not only make it simple to determine that you are complying to the standard, but you create the groundwork for your continuous improvement processes as well.

The other element is to determine the acceptance criteria of your products or service, i.e. how will you know that it works as intended and meets the applicable standards and expectations of your clients. This may require simple go / no testing, colour charts, electronic test systems or simulations. Whatever you determine it should be repeatable and provide clarity that it meets expectation, grey areas are not your friend here. Also, remember that the entire process should be centred around what your customer needs.

AS9100D encourages you to use statistical technics to support things like design verification (e.g., reliability, maintainability, product safety); process capability measurements, design of experiments or failure mode, effects, and criticality analysis as an example. It's good practice to do this and really important that you keep track of the information in controlled documentation.

c. Determine Your Resources 

Just as you did previously you need to ensure that you have the resources required to implement your processes, procedures, and controls, after all, what's the point of coming up with a process that needs 100 people to comply with it when you have only 12 people in your organisations? Remember when we talk about resources it's people, equipment, training, power, lighting, facilities and so forth. Once again, your resources don't need to be all within your organisation, they can be external experts or organisations, but your organisations need to maintain control over how they work. That means you need to be able to verify what they provide you meets all your (and your customers) requirements. Importantly, the requirement is about determining the resources to be able to meet the on time delivery of your products and services, so by implication you need to think about tracking your delivery performance as a KPI.  

d. Implement Your Controls 

In the standard this section is actually listed after determining your resources, my view is how do you determine your resources if you don't know what your controls are going to be? So here is my tip, figure out first what your controls are, then figure out the resources needed. As mentioned it doesn't matter if your organisation directly is creating the product or service, or you have contracted another organisation the requirement if for you ensure that you or your supplier have implemented processes in accordance with the criteria you have set out for your product or service to meet.

Also, think about the fact you have opted to document this process or procedure, this would pull it into the requirement for say version control and change control documentation.

e. Maintaining and Retaining Documented Information  

As an organisation you should determine what type of documented information, (processes, procedures, records etc) are needed to show that the processes you documented have occurred and the output from those processes has been a product or service that meets your acceptability criteria. A key point here is that you want to make sure that you are not creating mountains or paperwork or 74 hoops that people have to jump through to comply, they won't, in fact, to be fair they can't! So you will make it impossible to comply. You need to make sure anything you come up with is suitable for your organisation.  

f. Determining the processes and controls needed to manage critical items 

As part of operational planning & control for AS9100D, you need to think about what exactly you're critical items within your product or service and the processes that are needed to provide them. That must include the process controls and what key characteristics you have identified as important within your controls. Again this means discussing them as a team, recording them, monitoring them and where it makes sense creating a KPI to manage them.  

g. Engaging representatives in planning & control

You need to engage a range of people into the organisational planning and control process. i.e. it's expected to be a team sport, not a one-person job. For those functions that are impacted by any planning and control process, that function must be engaged in the process. That means it's a 2-way discussion not a 1 way command and control approach, people need to be able to weigh into the options. Doing this means you will have a far better and more realistic outcome that is going to support your objectives, not create barriers.  

h. Determining the process and resources to support the use and maintenance of products & services

As part of the planning and control of the organisation, you are going to need to consider what resources you need, or your client, needs to have in place to ensure that your product or service operates as intended. That includes people, equipment, skills and documentation.  

i. Determining the products and services to be obtained from external providers.

Under what products or services, you will get from external providers is important. It would be unusual in today's world for a company to be able to manufacturer absolutely everything or provide all services without any help. Being clear about what you will do yourself and what someone else will do allows you to ensure you have the right systems in place for each option.

Once you understand those you then must start thinking about how you will manage them, what information they will need, what supervision or documentation

j. Establishing the controls needed to prevent the delivery of nonconforming products

Of course, you are going to ensure that you can't deliver a bad product to someone, but how exactly are you going to do that? Will you use 100% inspection, it will be manual or automated, will you use measuring equipment, or will you contract parts out? What if your supplier sends the product to the final customer, who will you control that? Also don't forget that you have an internal customer, so how do you ensure you don't pass on non-conforming product to them?  

Keeping Control  

Again, the organisations need to ensure that changes to their processes are controlled. This is especially important for the operational planning and control of your products and services. These changes, intentional or unintentional, need to be adequately controlled and reviewed to ensure that they don't have any unintended consequences for your delivered product or service with respect to your earlier defined criteria. That may be through project planning activities, a set of step by step sequences taking into account the various risks involved at each stage.  

Ready To Start Your AS9100D Journey?

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Ready To Start Your AS9100D Journey?

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Tuesday, 29 November 2022

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