ISO13485:2016 7.3.9 design and development change

#1
Hi
I need a bit more help again.
ISO13485:2016 7.3.9 design and development change

7.3.9 i am assuming relates to changes after design transfer to manufacturing.

My question is:
Small design changes before transfer to manufacturing can simply be dealt with at the scheduled design reviews. However, changes that have a major impact should be raised and an unscheduled design review called to discuss any requirements.

Also, can anyone give me an example of how do other design companies control design and development changes prior to transfer to manufacture?

Thanks
 
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#2
Hi
I need a bit more help again.
ISO13485:2016 7.3.9 design and development change

7.3.9 i am assuming relates to changes after design transfer to manufacturing.

My question is:
Small design changes before transfer to manufacturing can simply be dealt with at the scheduled design reviews. However, changes that have a major impact should be raised and an unscheduled design review called to discuss any requirements.

Also, can anyone give me an example of how do other design companies control design and development changes prior to transfer to manufacture?

Thanks
Good question/topic @SteveChallinor ;
Here are some considerations
1. Clause l7.3) is , as you are aware "design and development"
2- The change control specified in clause 7.3 is stated separate from control of changes to the management system and documentation. (i.e. it is
specific to "design and development".
3- You utilize the subjective term "small design changes..."...
a) 7.3.9 does indeed indicate..."(...organization shall determine the significance of the change...)", but then goes on to state (almost contradictory)...
b)" Design and development changes shall be identified. Before implementation,....(and so on/so forth).
c) As a point of clarity, 7.3.9 closes with a paragraph that reminds us that this design change process must ALSO include...
"...product in process or already delivered"...(the inference is that this is in ADDITION to those changes made prior to transfer to manufacturing).

Summary:
The standards only reference to the "level" of change is the statement ..."...determine the significance". While this statement seems a bit random and out of place with the balance of the verbiage, it is consistent with the "risk based approach.." as referenced in 4.1.2.

In addition, the clause specifically includes the term "development". This implies that all changes even PRIOR to transfer to manufacturing shall follow the guidelines stated. And, as stated previously, the last paragraph of 7.3.9 goes out of its way to state "...product in process or already delivered"...(the inference is that this is in ADDITION to those changes made prior to transfer to manufacturing).
Therefore, your assumption that this clause ONLY "relates to changes after design transfer to manufacturing" is incorrect.

Pragmatism:
In one organization I worked for, we specifically identified PRE production and POST production design changes in our change point control procedure. That particular organization was not medical device, however, we successfully managed our PRE production changes in a specified/truncated manner due to, as you are aware, the frequency and, sometimes, insignificance of early development "design changes".

Counsel:
CLEARLY delineate procedurally (no subjectivity) as to what constitutes a PRE production transfer design change vs POST production transfer. Ensure that the change is indeed included during gate reviews at each stage of design and development and are recorded accordingly.

NOTE:
Be careful and CRITICALLY determine risks to your customer and your organization if pre production release design changes are managed in a truncated manner...minimalized vs post production release changes.

Hope this helps.

Be well.
 
Last edited:

Mhalik

Starting to get Involved
#4
Here is another example of how another company (start up) handles design changes before transfer to production if it can help. Note that, this may not be at all compliant with you own procedure (ex: design management or change control) or not be compatible with your own project/industrialization.

At a very early stage (during the « research » part of the developement), changes are not submitted to the change control process, as it would slow the engineers and discourage them to find innovative solutions. Evolution of the prototypes are just traced with different “prototype versions” that go along the “research” phase.

After a while, it reaches a kind of « pre-design freeze » state, which means the device features are ok and it is ready for the industrialization. The manufacturing tools are designed (internal) or bought if necessary (external). Here sometimes the device has to be adjusted a tiny little bit to works properly with the tools, and it is when it is time to think “do I need to go through the change control process”. There is no easy reply, as it depends several things. I’ll try to keep it simple for a general overview, here is the idea :

  • If at least one of the manufacturing process is undergoing, or already underwent process qualification (OQ/PQ), then the change control process is used to trace the impact analysis
  • If at least one validated document is impacted (ex: drawing, device specification, etc) then the change control process is used to trace the impact analysis. Mainly because it means that other studies were probably based on initial first document revision, so a change may impact something else and invalidate the results
  • If a validation test was already performed/is ongoing (analytical method, functional, whatever), then the change control process is used to trace the impact analysis
  • Otherwise, most of the time it means it is an early industrialization stage and nothing was yet “settled” so the change control process is not used. Only traced with “prototype version”
The design freeze was acted after QP.

Here is the idea, even though there are always exceptions that depend on the process complexity of each specific project. These rules may not be applicable to each type of project/company. I would say it really depends on what is mentioned in your design procedure (how far are settled the different things when you start to transfer to production, when does it starts to get “serious”). The important thing is to visualize the big picture to determine what would be the consequences (first for the patient, and second for your regulatory approval) if the impact analysis of your change is not well performed.

If your change control process is efficient, it should guide you through the impact analysis so you are sure to overview everything and you will highlight what needs to be. It can be a powerfull and handy tool.

There is no risk to start using your change control process too soon (only loss of time, which is still important), but not using it when you should have can be dangerous for the patient.

Hope it helped somehow.
 
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