Significant element here around design and development.
Depending upon whether your organisation is involved in design and development, and that could be:-
· designing products associated to manufacturing,
· designing your processes where you manufacturing take place that may be very specific to a specification,
· to do with temperature
· to do with gases, chemical volumes, etc.
It's a process that is designed so that you get the outputs of your products aligned to the specification and requirements.
It could also be a design and development of a service that you provide, it might be bespoke to what you do and the methods and how you do it.
There are quite a lot of detailed elements within design, so if design is an area that you do, or you're involved in, or part of your organisation is, it's important to recognize that there are certain general requirements around design, and they generally fall into the development of the planning of design i.e.
· what information you need that are the inputs into your design process?
· what controls you have in place around those inputs, and how are they managed?
· what the expected outputs are and how are they controlled?
And importantly with design, around the changes. Design management has a whole section on its own around changes, and revision controls and so on.
It is also important to recognize, that you can't simply just exclude yourself from design, like the previous standards used to allow you to do. You have to be able to explain why you're excluded from it. In the past, it was quite common for organisations just to say in their systems that they are excluded from design. When even in some cases, they did actually undertake an element of design and development, that's no longer the case, you have to be able to give your reasons and justifications around that.
Design and development in general, is looked upon what it is you do? How you handle inquiries and survey what those needs are, and then how you actually design the requirements so that you've got a contracted review and design verification process that meets what those inputs are.
The key elements that come into that in terms of planning is,
· What is it you're planning to do?
· How long is it going to take?
· What are the requirements and jurisdictions around what you have to control in terms of: customer statutory and regulatory requirements?
· Is there any specific requirements that are very much essential for the types of goods and services that you're developing - whether that’s something specific to the industry that you work in that must be a certain standard or code of practice?
They may also be other internal and external issues associated to your design for example, your actual manufacturing process, maybe associated to the chemicals you use, the method and how they are used, the ovens and so on.
It could be that your design relies heavily upon a subcontracted service.
It could be that you undertake a design, and part of that process is the elements of the design are done by an external source. What controls do you demonstrate that you have to ensure that that design, when issued out to an external resource is controlled?
Likewise, you can flip it around the other way. It's possible actually, that you use an external design resource, it may be that you understand what the specifications are, what the criteria is, but you may need to rely on the engineering design house to do the calculations to undertake the method and how the design is completed and signed off upon. In that situation, you've got to be able to look at, ‘that's an external resource that we're using, how do we ensure that that resource is meeting the requirements that we expect?’ It could be that they have some sort of independent certification that they comply with.
You also have to think about under the design and development planning, what involvement do others need to have? And how do you control that within your process?
Is it that your contracts state that your customers have to sign off on design?
Could it be that other interested parties have to verify a design?
It’s about what other interfaces that you plan and measure, and all along this, you have to think about risks.
As part of the inputs for your design, you have to think about functional and performance requirements.
If it's a fairly straightforward product the functional performance requirements could be very simple. If it's a very detailed design of a piece of kit, or an installation of a piece of kit to do a particular function, you've got to think about how do we demonstrate those functional and performance requirements at an input stage.
And what we have to think about is information from previous design activities, lessons learned from previous designs are we ensuring that we bring them forward.
You started doing regulated appliance codes of practice, and at this stage, you’ve got to think about the inputs of the consequences of failure. If that design does not meet the requirements, how do you control it, so that it doesn't go any farther? When you see this failure occur, how you control and step back?
The controls you have to have in place are around if problems arise during the development of a process, you've taken a design, you've got controls in place, you want to manage that before you're committing to further develop work or setting priorities. Often there are not controls that are put in place associated to this, but regularly, when there's a design that's very specific to a customer, you may have to put a test run in place, or you may go so far, and then there’s a requirement for it to be inspected.
We take for example, a design associated to construction, putting an extension on your house, it may be at certain stages, there are controls along the way of that activity happening. It may be someone from the local authority planning or building control may come to your home and do an inspection and a verification before you can commence any further.
These are things I'm thinking about, but they're going to be specific to your business, so you want to think about what methods you can audit against to see that, if there's been issues associated to design and development, how can we plan out internal audit around capturing lessons learned and improvements from that?
The output, of course, is relative to the input and the controls.
Did we meet the requirements of what we expected to achieve?
Do we have adequate and subsequent processes for the provisions?
Do we have to make adjustments and changes?
Is an additional monitoring and measurement that we have to do to meet the acceptance criteria?
Are they fit for the intended purpose?
Are they safe and proper for use?
These are all going to be based on the input elements of came in.
If there has been significant requirements around control associated to safety or anything like that, we have to be able to look at that input and show that we can demonstrate, on the output we have the controls in place.
Design and development changes.
When a change occurs in a design, we have to look at how that moves from an initial change request into an item that gets moved into full production or full-service provision.
· It could be that your organisation is simply changing how they deliver their services.
· It could be their changing the method and how those services are designed.
· It could be a significant design changes and a manufacturing process.
Often these design changes will be developed and reviewed and maybe signed off upon.
But what's the method on how you move them from that stage into full production?
What about if there are any outstanding actions that's required?
When something is signed off, how do you ensure that any additional actions coming out of that have been completed and managed effectively?