Can a form be uncontrolled or excluded from the QMS ?

LesPiles

Starting to get Involved
Hello !

We, the quality department, noticed by hovering over a disk in our network that a document in the quotation process was uncontrolled.

We therefore asked the process owner to ensure that this form was included in the QMS.

He told us that he did not believe it was relevant to add this form to an documented process.

The reasons he gives are as follows:
- It only affects one business line,
- It is not always completed,
- Iit is only mandatory when a customer asks us to buy from a particular type of supplier,
- Purchases with this type of supplier (or external service provider I should say) are increasingly rare, so the form is not used often.

In short, as the use is not permanent but more on a case-by-case basis and is increasingly rare, they would be inclined not to include it in the ISO procedures.

What do you think ? Can documents be excluded from control or QMS?

LesPiles
 

Randy

Super Moderator
Hello !

We, the quality department, noticed by hovering over a disk in our network that a document in the quotation process was uncontrolled.

We therefore asked the process owner to ensure that this form was included in the QMS.

He told us that he did not believe it was relevant to add this form to an documented process.

The reasons he gives are as follows:
- It only affects one business line,
- It is not always completed,
- Iit is only mandatory when a customer asks us to buy from a particular type of supplier,
- Purchases with this type of supplier (or external service provider I should say) are increasingly rare, so the form is not used often.

In short, as the use is not permanent but more on a case-by-case basis and is increasingly rare, they would be inclined not to include it in the ISO procedures.

What do you think ? Can documents be excluded from control or QMS?

LesPiles
There is only one question as an auditor I would start off with .... If it's not needed and the use is not required then why have it? Your "process owner" is chumming the water and I'm a very old, large shark.
 

Quality-Nation

On Holiday
What do you think ? Can documents be excluded from control or QMS?
What is it about “control” that people are avoiding it - by making excuses? Control of any documentation which is part of the QMS should be approved for use, available, change controlled. Why isn’t this form “controlled”?
 

Golfman25

Trusted Information Resource
Hello !

We, the quality department, noticed by hovering over a disk in our network that a document in the quotation process was uncontrolled.

We therefore asked the process owner to ensure that this form was included in the QMS.

He told us that he did not believe it was relevant to add this form to an documented process.

The reasons he gives are as follows:
- It only affects one business line,
- It is not always completed,
- Iit is only mandatory when a customer asks us to buy from a particular type of supplier,
- Purchases with this type of supplier (or external service provider I should say) are increasingly rare, so the form is not used often.

In short, as the use is not permanent but more on a case-by-case basis and is increasingly rare, they would be inclined not to include it in the ISO procedures.

What do you think ? Can documents be excluded from control or QMS?

LesPiles
What is the form. How is it different from any other form? Can its contents be included on another form, thus reducing the number of forms.

Even if it isn’t used that often, if it’s an important form it should be part of the QMS. Your procedure would simply refer to the forms use when necessary.
 

John Broomfield

Leader
Super Moderator
Forms specify data to be collected for the effective functioning of the management system. Right up to the time when the data are no longer required; even occasionally.

Ask the process owner to bring the form under revision control or come up with a better plan for ensuring requirements are fulfilled.

Then issue your corrective action request so this system weakness is not forgotten.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Its possible to have uncontrolled documents but not for the reasons listed. I had a few at my old company. We had a form to submit another employee for employee of the month. Not Controlled. If it can affect product quality it should be controlled.
 

UncleFester

Involved In Discussions
I'd just question why you wouldn't want the document - used in the quotation process - to be controlled. Regardless of how seldom it's used, if it's used as part of a process then it should be controlled.
 

qusys

Trusted Information Resource
Hello !

We, the quality department, noticed by hovering over a disk in our network that a document in the quotation process was uncontrolled.

We therefore asked the process owner to ensure that this form was included in the QMS.

He told us that he did not believe it was relevant to add this form to an documented process.

The reasons he gives are as follows:
- It only affects one business line,
- It is not always completed,
- Iit is only mandatory when a customer asks us to buy from a particular type of supplier,
- Purchases with this type of supplier (or external service provider I should say) are increasingly rare, so the form is not used often.

In short, as the use is not permanent but more on a case-by-case basis and is increasingly rare, they would be inclined not to include it in the ISO procedures.

What do you think ? Can documents be excluded from control or QMS?

LesPiles
Question: do you a documented procedure or process where you established the criteria to control the documented information? I think that this could be the approach. In a second way, then you can perform a risk assessment to applied to your process of documented information control.
Consider in addtion that some document are relevant to legal standpoint, so also in this sense you shall conform in retaining these documents. Did you have consider this aspect too?
 
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