Are we an outlier for so many variations of Change Management?

[Puck81]

While conducting a desk audit of our change management procedure, I realized we do not have a MOC form for quality system changes...I.E. If I were to revise a procedure.

We have separate MOC forms for Machinery Moves/Purchases, Process Deviation Requests for our machining processes, Personnel Change Requests, and Supplier Change Requests. From the forms we have, I cannot see how i could use one of the existing forms for a QMS change request. I was thinking of making a simple form and adding it to the system.

Are we an outlier for so many variations of change management? Do most of you have a general change management form?

 

[Mark Meer]

Are we an outlier for so many variations of change management? Do most of you have a general change management form?

I can't speak for others, so I don't know if you are an outlier. Could very well be that we are the outlier, but we've gone out of our way to issue generic forms whenever possible to cut down on the number of controlled documents, and reduce documentation control burden.

Our approach involves specifying general requirements (e.g. in a system procedure) that apply to ANY change. For example:
- Description & reason
- List of documents/product/inventory/etc. affected
- Risk assessment
- Required activities (e.g. notifications, training, verification/validation, dispositions)
- Approvals & effective date

You can then create a general form with fields for all the required info above, and perhaps an additional "Category" field to indicate if the change applies to QMS, Personnel, Suppliers, Assembly Processes..etc.).

Just a suggestion as to what works for us.
Cheers!
MM.

 

[Ronen E]

I can't speak for others, so I don't know if you are an outlier. Could very well be that we are the outlier, but we've gone out of our way to issue generic forms whenever possible to cut down on the number of controlled documents, and reduce documentation control burden.

Our approach involves specifying general requirements (e.g. in a system procedure) that apply to ANY change. For example:
- Description & reason
- List of documents/product/inventory/etc. affected
- Risk assessment
- Required activities (e.g. notifications, training, verification/validation, dispositions)
- Approvals & effective date

You can then create a general form with fields for all the required info above, and perhaps an additional "Category" field to indicate if the change applies to QMS, Personnel, Suppliers, Assembly Processes..etc.)....

The above is along the lines of what I've seen in almost all orgs in/with which I worked.

 

[Puck81]

Thank you both. I had acquired the ISO 9001/API Q1 QMS on top of my ISO 14001 & Safety management systems late last summer. Down time is definitely not a luxury anymore.

I spent some time making a generic MOC form which we should be able to use for all change management, not just documentation. We may need to revise later on, but hey...that is what continual improvement is all about.

 

[dsanabria]

While conducting a desk audit of our change management procedure, I realized we do not have a MOC form for quality system changes...I.E. If I were to revise a procedure.

We have separate MOC forms for Machinery Moves/Purchases, Process Deviation Requests for our machining processes, Personnel Change Requests, and Supplier Change Requests. From the forms we have, I cannot see how i could use one of the existing forms for a QMS change request. I was thinking of making a simple form and adding it to the system.

Are we an outlier for so many variations of change management? Do most of you have a general change management form?

Use the 7.3.7 ECN concept (from AS 9100C) or 8.3.6 in AS 9100D which is being highly encouraged for changes to any processes or documentation.

You are not an outlier, you are an example of a company that has not done a lean exercise in your documentation - maybe it is time and stop the duplication and bureaucracy in your processes.