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.