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Change Control Systems - How much is too much?

Should a small company with a single product have multiple Change Control Systems?


  • Total voters
    9
4

4LeanDocs

#1
How many Change Control systems are too Many?

My company is starting to put together the quality system for an FDA regulated device. The current plan is for 3 different change control systems, meaning 3 different forms, 3 different rule sets, 3 different procedures, 3 different databases (we have also established 2 different part number schemes):

1. Quality System
2. Minor part changes
3. Design changes

From my user name you can deduce that I might have a problem with this. I've found with previous experiences that more generally leads to confusion and un-needed bureaucracy. Have any other forum users dealt with this issue and if yes, what has been the outcome?

Too much? Just right? :confused:
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Change Control - How much is too much?

How many Change Control systems are too Many?

My company is starting to put together the quality system for an FDA regulated device. The current plan is for 3 different change control systems, meaning 3 different forms, 3 different rule sets, 3 different procedures, 3 different databases (we have also established 2 different part number schemes):

1. Quality System
2. Minor part changes
3. Design changes

From my user name you can deduce that I might have a problem with this. I've found with previous experiences that more generally leads to confusion and un-needed bureaucracy. Have any other forum users dealt with this issue and if yes, what has been the outcome?

Too much? Just right? :confused:
One question: Have you brought this to the attention of your Management Team?

What needs to be done in my opinion, is to use what works best for the Organization. If the organization wants this many, then so be it. But, you could argue the facts exactly how you have stated in your post with Top Management.
 
T

tomvehoski

#3
Re: Change Control - How much is too much?

I typically agree with keeping QMS changes under a different process than design changes. In a small place, QMS changes should be pretty quick and may only need one approval after an easy review. Design changes may need much more review, testing, simulation, customer approval, tool design, tool approval, process approval, .........

I don't understand how a "minor part change" is different than a "design change". A minor change can mess things up big time if you don't do the right planning and reviews.
 

Ajit Basrur

Staff member
Admin
#4
Re: Change Control - How much is too much?

4LeanDocs,

Change Control is required but how many is your organization's call - but by the examples that you cited, one "good" system should be able to address all :)

BTW, I feel the poll is not required for this required
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Re: Change Control - How much is too much?

4LeanDocs,

Change Control is required but how many is your organization's call - but by the examples that you cited, one "good" system should be able to address all :)

BTW, I feel the poll is not required for this required
I agree. One system can handle different types and "levels" of change. You can have "Level 1/2/3" for the purpose of identifying how much and what type of supporting data is required, as well as groups/authoruty levels of approvers. Make a complex system and people will find reasons not to use it.
 
A

arios

#6
Re: Change Control - How much is too much?

4LeanDocs,

Change Control is required but how many is your organization's call - but by the examples that you cited, one "good" system should be able to address all :)

BTW, I feel the poll is not required for this required
I agree with Shirley and Ajit

BTW, it does not have to be electronic, even a paper based system with change forms and section for approvals would work
 
M

MIREGMGR

#7
Re: Change Control - How much is too much?

We have a complex mostly-medical-device environment...~2700 active products, products under our name+private name manufacturing+contract manufacturing, Class I & Class II, kit packing, various types of suppliers, subject to three major and several other medical device regulatory systems...and we get by with one change control system.
 

Ajit Basrur

Staff member
Admin
#8
Re: Change Control - How much is too much?

We have a complex mostly-medical-device environment...~2700 active products, products under our name+private name manufacturing+contract manufacturing, Class I & Class II, kit packing, various types of suppliers, subject to three major and several other medical device regulatory systems...and we get by with one change control system.
A single system explains the beauty of handling such a complex system :)
 
G

George Weiss

#9
Since this is an FDA item, I would pull out my only tool here, the FDA QMS and say, look at them and how they do it. Some big companies stumble when not dealing with changes correctly, and get dinged by the FDA. Different rules for different events.
Likely different forms, and completely different issues, maybe. I suggest you give them a look.
http://www.fda.gov/ScienceResearch/FieldScience/default.htm
sellect volume I II II or IV
 
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