Design/Change Control Procedure - How to cope with Changes during Development?

sagai

Quite Involved in Discussions
#11
Actually, you do not have to release a zero defect product, so you can decide that you change the design later in order to comply with your product related requirement, so it is not mandatory to correct every deviation found during the design verification/validation.
But the remaining defect should not effect patient safety and shall be rationalized why are they can be solved later. Actually the remaining defects shall be in line with the quality goals defined in a planning stage very earlier. (I am in a software MD area)

The exact implementation of the change depends on the documentation hierarchy used in your requirement engineering.
In case you have:
1., User Requirement
2., System Requirement
3., Detailed Design Reguirements,

than

I. during to course of the correction of the deviation found in validation, than:
a., someone did not completed the required work as defined in the requriement -> 3., shall be reworked
b., the 2., was not properly defined based on the corresponding 1., -> 2., 3., shall be reworked plus the impact of this change shall be evaluated, if any safety related function interfered, the correction can be even more overkill.

II. during to course of the correction of the deviation found in verification, than:
a., someone did not completed the required work as defined in the requriement -> 3., shall be reworked
b., the 3., was not properly defined based on the corresponding 2., -> 3., shall be reworked plus the impact of this change shall be evaluated, if any safety related function interfered, the correction can be exhausting.

br
Sz.
 
Elsmar Forum Sponsor

Aphel

Involved In Discussions
#12
Hello,

Thank you for your guesses.

To be practical - how are you documenting a necessary design loop during the development of a medical device?

Do you have procedures to be followed? In the QSIT you find the hint, that the procedures for design changes has to cover pre-production design changes and post-production design changes...


Thank you very much for your support!

Best regards,
Aphel
 
T

The Specialist

#13
Hello,

o.k., i will try to explain it another way.

During design verification you are doing a lot of tests.
Sometimes you have situations, when a test fails for example due to
incorrrect product design. Then you must change the product design to
pass the test.
Or during design validation you have a problem that shows, you are not able meet certain customer requirements. This problem also may lead to a design change, so that you are conform to customer requirements.
I was talking about these kind of design changes.

Are my guesses too theoratically - then i will try bring up an example...

Again, thank you very much for your help...

Best regards,
Aphel

In my view, this all just comes under a simple change control procedure...

Failed tests from verification/validation studies are recorded as 'failed' and a 'deviation' (or such-like) is raised to address the failure, the impact of the failure, the reasons for the failure and the resolution to the failure. This, in its-self, is one level of control.

If, as in the instaces you describe, it is the output of the deviation assessment that there must be a design change then a Change Control shall be raised, as-per your change control procedure, and the change implemented following requirements of the change... which may include updates to drawings/documents that make up your design history file.
 

sagai

Quite Involved in Discussions
#14
:D

Thank you for your guesses.
It is even worst, it is reality in the daily life of the two biggest MD manufacturer ww. :tg:


how are you documenting a necessary design loop during the development of a medical device?
There is always a change management system (luckily integrated with a configuration management system) and it is documented with a change request ticket, we can call it charm, defect, incident, anything. Typical implementation is in ClearCase or JIRA I have seen. Be aware, in case you use change management system and you subject to 21CFR820, you shall validate that system also according to the requirements defined in 21CFR11.
But you can have a change management on paper based documentation of course.

Do you have procedures to be followed?
Yes, but it is confidential, I can not share.
It is really depends on your business, I would only check not to create more than required (based on regulation or company need) control.

Further reading I would suggest:
http://www.sei.cmu.edu/library/abstracts/reports/10tr033.cfm
Page 144.

br
Sz.
 
K

KamakshiKariya

#15
Alphel,

Follow the simple steps given below for change control
1. Rev A freezed and relesed for Verification.
2. Issues during verification observed, log the issue (Issue could be in design, requiremets..etc)
3. Identify the resoultion and do the impact analysis to identify where and all needs changes (could be a change in the design or in requirements)
4. Open change request in your configuration management tool, get the change approved from your change control board.
5. Revise the documents referencing the change request >>> Rev B.
 
T

treesei

#16
We established a change control procedure for post-production changes, but not for changes during the development. Management is of the opinion, during the development of a product we have to stay "flexible" without strong rules for changes... At the moment i have no idea, how i can create a simple and effective, but also correct procedure for that issue.

What are your experiences with changes during development, how do you cope with the daily problems? How do you meet this requirement of §820.20?

Aphel
--------------------------------------------
Below is directly from the FDA:

"Manufacturers are not expected to maintain records of all changes proposed during the very early stages of the design process. However, all design changes made after the design review that approves the initial design inputs for incorporation into the design, and those changes made to correct design deficiencies once the design has been released to production, must be documented....The evaluation and documentation should be in direct proportion to the significance of the change. Procedures must ensure that after the design requirements are established and approved, changes to the design, both pre-production and post-production are also reviewed, validated (or verified where appropriate), and approved."

So here is the requirement. Each firm may write a procedure that covers the requirement but practically fits its own situation.
 
#17
--------------------------------------------
Below is directly from the FDA:

"Manufacturers are not expected ....................................................................and approved."

So here is the requirement. Each firm may write a procedure that covers the requirement but practically fits its own situation.
Thanks Treesai, that is a good quote.

Can you tell me which guidance document it comes from?
 
T

treesei

#20
Can you tell me which guidance document it comes from?
--------------------------------------------------
Dear Pads38,

Certainly. It comes from the preamble of the US FDA's medical device cGMP final rule published in Federal Register Vol 65 No 195:52602-52654; 1996, available from the FDA's website. The particular quote is on page 52621.

The cGMP rules (21 CFR 820) are purposely vague. However, a lot of info that explains the rules can be found in the preamble which I recommend my colleagues to spend some time on reading. It is not formally written in the regulation but it shows how the FDA interprets the regulation.

Regards,
treesei
 
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