Change Control Numbering system

[Quality Specialist]

Hello, I recently got hired for a small company (12 employees) where I am in control of documents and most of the other QMS system aspects. I do not have much experience regarding Change Control (or whatever you choose to call it i.e., ECO) as far as how to keep track of CO #'s so that no number is reused and doesn't create a filing nightmare. We do not have any software for any QMS processes such as for internal audits, CA's, doc. control and the likes.
How do any of you manage to keep track of CO#'s past a doc/form # and rev? Is it necessary to have an individual number issued for every CO that comes across my desk? If so, what is the best way to do this, say in an excel spreadsheet or other method?

 

[John C. Abnet]

Welcome to the site and the world of QMS @Quality Specialist. There are numerous expert resources on here that will prove helpful to you I'm sure.

Before I/we respond, can you help me understand what you mean by "CO" ??

Thank you.

 

[Quality Specialist]

Thank you for the welcome! I actually have been here a long time - went through the loss of Elsmar a bit back in time. I was then called Audit Coordinator. Lost my handle when Elsmar came back and got a new job as well.
Depending on where one works (I'm finding out) it is sometimes called ECO, Engineering Change Order, ECC - Engineering Change Control, CO - Change Order and such. In this case we are using the CO.
Quote from above:

 

[Thee Bouyyy]

how to keep track of CO #'s so that no number is reused and doesn't create a filing nightmare. We do not have any software for any QMS processes

Simply create one excel sheet for all the engineering change orders. Make that as documented information.

Is it necessary to have an individual number issued for every CO that comes across my desk? If so, what is the best way to do this, say in an excel spreadsheet or other method?

Of course, you have to assign individual number issued for every change order. Excel spreadsheet is the best solution if you don't have any other QMS software.

 

[John C. Abnet]

Thank you for the welcome! I actually have been here a long time - went through the loss of Elsmar a bit back in time. I was then called Audit Coordinator. Lost my handle when Elsmar came back and got a new job as well.
Depending on where one works (I'm finding out) it is sometimes called ECO, Engineering Change Order, ECC - Engineering Change Control, CO - Change Order and such. In this case we are using the CO.
Quote from above: View attachment 28380

This can be a complex data base that allows circulation, records signatures, etc...or....as @Thee Bouyyy stated, just a centralized Excel document, or , depending on the size of your organization, it may be as simple as a "revision record" section at the back of each document identifying the rev, approval, description of change, et.c....

There are even options for revision tracking. For example, it is common for organizations to give an original document no revision, and then each subsequent revision an -A; -B, etc...

Or, from my experience, I prefer a change point control tracking/serial number . For example, each change point request is assigned a unique sequential number (e.g. CP-0001; CP-0002; etc..etc....) This way there can be a record maintained per that number even if the change request is rejected. The history, description, approvals can then be kept centrally and the only information that needs applied to the "document" is the relevant change point tracking number (e.g. CP-0002, etc...). Since this number is unique it can also be referenced in regard to action/change taken on corrective actions, as results of audits, etc...

Remember, change control is often more complex than organizations give credit. Consider the following...

My counsel:
Map out (process flow) the entire change point control system, including all potential inputs...
a) If customer requests change. Does finance/sales need involved?? Does engineering need to approve?
b) If supplier requests change, does customer need notified? Does finance/sales need involved? Is a drawing impacted?
c) If someone internal to the organization requests a change. Does it impact a supplier? Does customer need notified? Is a drawing impacted?

Food for thought.

Hope this helps.
Be well.

 

[Quality Specialist]

John, you make so many good points here about, really, how complex change control is! You just made me add a few more columns to my new spreadsheet

 

[Mikey324]

I say make this as complex as needed to provide value for you. I personally love excel spreadsheets. I have a MOC spreadsheet (management of change). Make columns as you need them. If this is for IATF, there are certain things you need to consider, but they are easy to document if laid out in a simple spreadsheet.

 

[abublitz]

I have an ECO (engineering change order) log for my company in an excel workbook. I have conditional formatting to make sure there are no duplicate numbers assigned.

Our numbering scheme is EC(YY)-001, example: EC21-001. That way each change order has a unique number that can be referenced for additional information. The log has top-level information that is contained in more detail on the ECO form.

• ECO#
• Status
• Request Date
• Approval Date
• Training Required
• CAPA#/Deviation#/Validation#, etc (the document number if the ECO was generated or linked to another QMS process)
• Description
• Originator
• Originator Dept
• Reason for Change

To build on what John said here:

My counsel:
Map out (process flow) the entire change point control system, including all potential inputs...
a) If customer requests change. Does finance/sales need involved?? Does engineering need to approve?
b) If supplier requests change, does customer need notified? Does finance/sales need involved? Is a drawing impacted?
c) If someone internal to the organization requests a change. Does it impact a supplier? Does customer need notified? Is a drawing impacted?

We use a matrix to determine who needs to sign off for approval, its quite helpful.