Control of Electronic Forms and Documents Embedded in Software

J

JRKH

So what your are saying Michel is that you are concerned about who has access to the system for making changes.

What Steel Maiden proposes seems ideal. (depending on company size) The department proposes the changes, it is run by a "systems specialist" to make sure it doesn't mess something els up, and that person either enters it into the system, or takes to the IT person to get it done.
So now you have the control. The deparment requesting the change, the person reviewing and approving the change, and the person who manages the database (maybe the reviewer)

As long as it is spelled out that way in the procedure it should be fine.

James
 

Marc

Fully vaccinated are you?
Leader
Originally posted by Michel Saad
Good try Marc.

You are still talking about the mechanics of changing the form on the system and access control. My question pertains more to the management of the content of the form. If I am the only person authorised to change the CAR form, should I be allowed to get rid of 3 steps (from an 8D) without anyone else approving the change? Of course not ! Then if no one approves the form itself, how do you show that changes were warranted? Through a document change control form (or ECN system) maybe? Thats what seems to be proposed in your chart.

I am simply looking for best praticises.
You do have to look at the size / complexity of the company and such (my One Size Does NOT Fit All), but there is a basic assumption that when the contents of a document or form are changed that someone reviews and approves the changes and that the person is competent to do so. Many of my clients have IS set up directories which have specif access restrictions so that (for example) purchsing has a directory which only the purchasing manager can write to and delete from. That is the control. Neither IS (IT, whatever) or anyone else has to be involved once directory permissions are set.

Many companies allow departments to control their own documentation like this. Many times a document change only affects 'local' systems in which case it may only be a matter of one person reviewing and approving its release. In your 8-D case, it would probably be 'owned' by the quality manager or someone who understands the effect(s) of the changes on the system as a whole. I can't, for example, see an argument for the purchasing manager 'owning' the 8-D form. And I would expect, particularly with respect to an 8-D form, that the 'owner' would have the 'good sense' to call in others to discuss the proposed change as almost everyone is potentially affected by a change to such a major system.

As you mention, many companies do have a defined review and approval cycle with a change form and such - which is fine. In many companies this isn't necessary but (especially in bigger ones) it is.

The bigger the company the more complex the procedure will become. It may be in many cases that a team approach is appropriate and necessary for many document and forms. I'm not trying to say that a document change will always be one person making a decision on his/her own without consulting others. But the bottom line is one person typically 'owns' a document or form (such as a departmental manager). This does not preclude the person from consutling other appropriate parties (other managers, etc.) if the change will affect them.

The type of document is also part of what you should consider. In the case of an engineering change to a print, for example, you would (well, I would) expect a well defined review and approval system including an appropriate cross functional team review. But do you need a cross functional team if the purchasing manager wants to change a departmental procedure which does not affect anyone or any department outside of purchasing?

One argument for a change form is so that people can propose changes from the 'outside'. Another is where you have a centralized document control procedure or where you run changes through a single 'gate' (this is what JRKH described above). I have seen companies where the quality manager had to review and approve changes to any document from any department. Their premise was that they wanted to preclude any changes from impacting their compliance to ISO 9001. You have a document administrator or other focal point for putting things on or taking things off the server. This to me is typically, particularly in smaller companies, a useless extra requirement.

Look closely at your company and ask yourself how complex the system should be for your individual company. To me the goal is Keep is Simple.

As to 'Best Practices', the reality is that what is 'Best Practice' in one company is not always so for another company.

Just some thoughts. :thedeal:
 

Ettore

Quite Involved in Discussions
I take your same approach Marc. Forms are controlled here when they are created on a computer and filled out by hand. .......................................the "record" is filled out within the computer, anything you print becomes a report, not a form.
organization.

........the time pass Away.

Today, If we have only electronics registrations we can abandon the term "forms" from our procedures?
How many here are using to take care only to "registrations" and forget the old term "forms"?
I remember tath last non conformity about the use of the forms was issued by the oldest auditors .
:(
 
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