Control of equipment instruction manuals

[John Mann]

At present, our control of instruction manuals is bad to non-existant. Many are out of date and this needs to be addressed. I see two possibilities:

(1) Treat them exactly the same as controlled company documents.
(2) Treat them as products in their own right and control them that way.

In both cases a mechanism would be needed to ensure the manual gets updated with the product to which it refers.

A third suggestion has come from the software developers who say that manuals could be controlled under the software versioning system they use, however management don't like this suggestion.

I would be interested to hear how others approach this.

Thanks,
John.

 

[qusys]

At present, our control of instruction manuals is bad to non-existant. Many are out of date and this needs to be addressed. I see two possibilities:

(1) Treat them exactly the same as controlled company documents.
(2) Treat them as products in their own right and control them that way.

In both cases a mechanism would be needed to ensure the manual gets updated with the product to which it refers.

A third suggestion has come from the software developers who say that manuals could be controlled under the software versioning system they use, however management don't like this suggestion.

I would be interested to hear how others approach this.

Thanks,
John.

I think that approach number 1 is good. Remember that it is up to the organization to define how to control the documents of "external origin" and states it in the document control procedure as per 4.2.3 of ISO 9001.
They can be considered as " controlled document" at all effects.

 

[John Mann]

I think that approach number 1 is good. Remember that it is up to the organization to define how to control the documents of "external origin" and states it in the document control procedure as per 4.2.3 of ISO 9001.
They can be considered as " controlled document" at all effects.

I should have explained that these are the instruction manuals we produce relating to the products we make, so they are not external origin.

 

[qusys]

I should have explained that these are the instruction manuals we produce relating to the products we make, so they are not external origin.

Yes, I was wrong in the interpretation. I had understood.

However I think that you should put in place activities to meet clause 7.2.3 of ISO 9001. They can fall under communication with customer.

 

[Jen Kirley]

My experience with equipment manuals is that they usually don't change once they are published for a given piece of equipment. Therefore, some of the controls in the various standards' document control elements may seem overmuch. Maybe that is why the requirement for them tends to be more specific, as in know what you have and make a plan to control the distribution. My guess is that is for readiness more than anything else; the manuals need to be where people require them to be in order to use them for their work, to the extent they do so.

 

[steve hussain]

They should be treated as your other documents; that is changed when required with the necessary records to prove when such changes occured. these updated versions must be in use with the old one removed completely (normal system used for clause 4.2.3). It is good if you have a list of all documents (including the equipment instruction manuals) to display your current documents.
i hope is helps.

 

[qusys]

They should be treated as your other documents; that is changed when required with the necessary records to prove when such changes occured. these updated versions must be in use with the old one removed completely (normal system used for clause 4.2.3). It is good if you have a list of all documents (including the equipment instruction manuals) to display your current documents.
i hope is helps.

Hi to all.
Probably there was a misunderstanding. The original poster refers to the instruction manuals that the organization prepares together their software products, not the manual for equipment.

 

[steve hussain]

My interpretations of what you have are written instructions develop my the company for a particular equipment making a specific product. What you need to do is first have identification codes for each one of them (say this under clause 4.2.3) and list them under a master list of control documents. Whenever they are changes necessary, go through a document change procedure and update the revision number and date ensuring all outdated ones are removed. These work instructions should be at the station where they are used (you need to state the storage areas).
I do hope this helps

 

[somashekar]

I should have explained that these are the instruction manuals we produce relating to the products we make, so they are not external origin.

Your equipment instructions manual is not a document under any document control. It is a part of your Bill Of Material (BOM)
It will have a revision level and will be in control as long as your BOM is in control.
The revision level of this manual as appearing in your BOM must also appear somewhere on the manual, printed in small font at the right bottom of your page 1 or page last or anywhere else for identification (your convenience)

 

[Wes Bucey]

To recap:
OP's company

1. creates software for others
2. creates operating/instruction manuals to accompany software
3. has question related to updating manual as either software version changes or additional info related to original version becomes available form ANY source (in-house, customer, third party critic.)

When I was part of an aerospace company, we were required to include detailed manuals with each installation of equipment. If some new information became available on an existing installation, we were required to either issue a supplement detailing that info or to withdraw the original manual and replace with new.

Sometimes, because of the configuration of an aircraft, each individual installation could be completely unique despite the underlying equipment being the same. In those cases, a unique manual was compiled for the unique installation.

In simple terms, this ALL comes under Configuration Management - the basis of which is to avoid confusion between documents and the versions to which they pertain. It would be kind of silly, for example, if a trucking company changed its entire fleet from "stick" [standard] shift transmissions to automatic transmissions, but did not update the operating manuals to reflect the change. It would be even sillier if the manufacturer of those trucks did not supply manuals for automatic transmissions, but kept on supplying manuals for standard transmissions with vehicles equipped with automatic.