When we set out to make changes to systems there are a few things we need to take into consideration. They are...
1. Is this an entire system overhaul?
2. Is only a small portion of the system being revised?
3. Is the person who initially created the system still working at the company and responsible for the change?
4. Is the current system being revised to effect efficiency?
5. Is the system currently compliant? Has the FDA ever cited the system? If yes, when?
History is very important to review when seeking to make a change to any quality system. We need to be aware that mature systems have evolved over time for reasons we may not be aware of. A solid review of the change control system related to the procedure(s) of any process is very important. A good change control system will record the rational for historical revisions. When we do not review this history there are things that can happen such as the following.
1. Change Control system being revised is now reverting back to a past practice. I remember seeing this once. It just so happened that there was someone at the company involved in removing the practice that a staff member was now trying to reimplement. Thank God this employee was there and was a signature on the change control record. This person was able to tell the staff member initiating the change why they removed the practice. It was a bit embarrassing for this change initiator and the record was canceled. The change that this staff member was attempting to reinstate was an older industry practice and something they were just used to working with. But, it was outdated and didn't collect all of the necessary information. This staff member thought it would just be easier and that the information lost wasn't really needed. The potentially lost information was actually critical to another department.
2. An eager legislative law leader started efforts to require Plastic Trash bags to be illegal. This change leader did not do their homework. This effort was implemented years ago. The result was that law was passed requiring plastic bags to be highly biodegradable but not illegal to use. Have you ever noticed how quickly plastic bags degrade? They will degrade just as fast as food you bury in your backyard. The effort was retracted and one legislator was a bit embarrassed.
Check change history before you initiate change. We evolve for a reason.
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