Are Machine and Equipment Manuals Controlled Documents?

[Howard Atkins]

I received this question by E-Mail from frank napoli
"We are starting the process for TS and are evaluating documents to identify under document control. Since preventative maintaince is required, do companies consider identifying machine maintenance manuals as controlled?"

Do you mean your internal maintenance manual or that supplied by the manufacturer.
Your manual yes, IMO it is the equivalent of a work instruction

The manufacturers manual, yes also, you need to update the maintenance information that you use.

What do others do?

 

[Marc]

I typically see them as locally controlled documents by maintenance or whoever is responsible for maintaining the equipment.

 

[CarolX]

I see it as this, like Marc said, controlled locally. In other words, the document should be identified and accesable (sp), but updating to "current revision" isn't required unless issued and delivered by the manufacture. You would not be required to actively search for updates.


JMHO

 

[Wes Bucey]

I see it as this, like Marc said, controlled locally. In other words, the document should be identified and accesable (sp), but updating to "current revision" isn't required unless issued and delivered by the manufacture. You would not be required to actively search for updates.


JMHO

I dealt with a lot of machines in a high tech machining environment. Most of them were so complex, I wouldn't have been able to turn one on, let alone use it to make something, without a short (sometimes a LONG) session with the operating manual, which we kept in a heavy duty plastic pouch chained to the machine.

For the most part, manufacturers do not update or revise the manuals except when bringing out a new model. (You only need the update if you have the new model or upgrade the machine itself.) Occasionally, there will be bulletins about new attachments or accessories available, which we added to the plastic pouch. Operators would often refer to these manuals for tips in working out a new setup.

In the last five years, manufacturers of complex CNC machines have made their machines internet accessible and the entire manual applicable to the machine is downloaded into the machine memory and routinely updated via internet. Some manufacturers even allow for remote programming of the machine from the manufacturer's engineering department.

We extracted information from these machine manuals to create our own maintenance Work Instruction to cover all machines in a department, which we "normalized" to allow setting up a routine for maintenance to mesh with our work load (so no machine was scheduled for a long run if routine maintenance would have interrupted the run - a business decision might be made to complete the maintenance early BEFORE the work run.)

TIP: When you spend $250,000 on a machine, it's OK to put the arm on the manufacturer to supply a couple of backup copies of the manual to keep in storage for replacement if the one at the machine is damaged beyond legibility.

Bottom line: We considered the manufacturer's manual a REFERENCE DOCUMENT - our employees might highlight passages or add margin notes - we did not CONTROL any of the copies. We considered our Work Instruction a CONTROLLED DOCUMENT. We sealed (laminated) it in plastic to prevent notes and highlighting and to prevent deterioration from dirt, grime, and oil.

 

[Marc]

Let's not neglect manuals for areas such as metrology. Different departments typically have documents which are specific to them that are (or should be) controlled locally. The degree of 'formal' control is relative to the importance of the document. For example, I know calibration laboratories that calibrate in accordance with the manufacturers manual and do not go through the motions of deriving a specific work instruction.

As always (sigh), it's sitution specific.

 

[KIDDO]

What about information printed from a CD-ROM?

Our maintenance manager has recently printed Lock Out procedures from the manufacturer. He's laminated them and put them out on each machine on the plant floor... nothing approved, dated, revision level..... ugh!!

IMHO I believe he needs to control these documents.. but now they're laminated and I know he'll hum and haw about destroying these and reprinting them, re-laminate etc. etc.

Before I go and "set him straight", do you agree that these need to be controlled?

thanks
KIDDO

 

[Al Rosen]

Control them like any external document. Can you label the lamination so they don't have to be redone?

 

[CarolX]

Before I go and "set him straight", do you agree that these need to be controlled?

IMHO, no they do not. These are safety procedures and instructions issued by the manufacture. Do you require any other type of safety or warning signs to be approved?

Look at it this way....does the operator need to know how to do this to make good parts?

 

[Helmut Jilling]

We extracted information from these machine manuals to create our own maintenance Work Instruction to cover all machines in a department...

Bottom line: We considered the manufacturer's manual a REFERENCE DOCUMENT - our employees might highlight passages or add margin notes - we did not CONTROL any of the copies. We considered our Work Instruction a CONTROLLED DOCUMENT. We sealed (laminated) it in plastic to prevent notes and highlighting and to prevent deterioration from dirt, grime, and oil.

These two ideas are the most comon approach I see. The auditors I know have not required owners manuals to be officially controlled. They generally do not change.

 

[Jim Wynne]

These two ideas are the most comon approach I see. The auditors I know have not required owners manuals to be officially controlled. They generally do not change.

In most instances, confusion results from not understanding what actually needs to be controlled. Processes need to be controlled, and one of the elements of process control is the control of related documentation. If a document is necessary (or potentially necessary) to the efficacious operation of a process, the document should be controlled to the extent that the document will be changed when a process change renders the document obsolete.

Equipment manuals (issued by the equipment manufacturers) may or may not be necessary to the operation of a process. (Note that operation of a machine and maintenance of it are two different processes.) If they are, they should be controlled in a manner that ensures they remain current and relevant.