Work Instructions 4.9.1 - Work instructions must be readily accessible



We have recently incorporated a "paperless" system for our QS program. Element 4.9.1 states that the work instructions must be readily accessible at the work station without interrupting the work. Would we meet this requirement by having our work instructions available through our paperless system with the supervisor of each department able to print the work instructions if the employee requested them? We still have the hard copy of the work instruction for each department on the information board within each department. The employee must go to that board and get the hardcopy if they want to read them. What does the phrase "work station" actually mean? Can we define the work station as the computer that the supervisor uses to cover this issue and remove all hard copies of work instructions from our facility? Will we meet the intent of "at the work station" if we don't have individual copies of the work instruction at each machine? Your comments are welcome!!

Tom Goetzinger

Our auditor indicated that if the employee had to leave his workstation (the place he performed his work), to view a work instruction, it did not meet the standard.
His feelings were that going to another location, no matter how close, would negatively affect productivity and be in violation of the standard.

Christian Lupo

Tom is correct, this issue is more than just the auditor's interpretation. This topic was defined in a (one of the first) Sanctioned Interpretation. The auditor made the right call.


Fully vaccinated are you?
If you are currently not keeping 'work instructions' at the work station, there must be a reason. Often companies train their employees such that work instructions are not always necessary - employees only reference them if they have a question. I have done several implementations where there were no work instructions at any station. None were necesasary.

I suggest you take a step back and ask yourself what you are defining as work instructions and when operators use them.

I went thru an ISO (!) registration back in 1997 where the auditor complained because work instructions were not 'readily' available because the operator had to turn around to see them. The operators faced an assembly line standing up. Assemblers were on either side of the line. The auditor said it would be acceptable if they posted work instructions on the opposite side of the line so the assemblers didn't have to turn around.... Never mind the fact they would have to walk across the line to the other side to be able to read them, that people were working opposite them who blocked the view from time to time, etc.

Before you run out and change your system, ask why you don't currently have them at the individual work stations. Apparently the operators do not use them all the time. Why not? When do they use them? How often?

This is not a black-and-white issue. But - the 'work station' is where the work actually takes place.

More info about the process (Assembly? Lathe? Paint? Metal forming press?) would help a lot if you want more detail.

[This message has been edited by Marc Smith (edited 01 August 2000).]

Martijn TVM

The company I am currently working for has there operator instructions, machine settings, packing plan etc. all printed out automatically with the workorder. so when the workorder is taken into production there is a instruction readily available.

Thing is that those few pages don't weight up to having someone leaving his workspace, communicating his/her problem, retrieving the operator instruction and than walk back. This would take so much time on the long run.

I must say that a automatic process that doesn't need a operator maybe shouldn't have all instructions but what could those 4-8 pages matter in a facility. For instance if a Workorder runs for 6 days and has a 6 page workinstruction we utilize 10 machines that is 10 pages a day. one copy screw-up takes more than 10 pages and if it helps the product quality.... I would just post them on a clipboard or have them readily available on a MES terminal.

Dan De Yarman

Tom, what did you do with your Work Instructions? I know you have a paperless system for the Procedures, are you using the same system for your Work Instructions? What software are you now using? Perhaps these questions belongs in the 'Quality Assurance Software' forum instead of this one, oh well.

Tom Goetzinger

We actually have very few formal work instruction documents. Those that we do have are located at the work station where they are used.
We rely on the training and skills of our employees as they build our product from the drawings, wiring diagrams, schematics, etc. These documents, which are delivered with the shop paper to the floor, are the "work instructions" which the floor uses.
Our "paperless" system is nothing more that a read only set of files on our computer network. I did have them in an Outlook folder, but a drive on the network which everyone has access to proved to be more accessible. There are terminals scattered throughout the shop from which all employees have access should they need to access the documents, and I am out on the floor everyday, so I am available to answer questions that might come up.

Tom Goetzinger

Jim Evans

We use a system similar to Tom's in that we have very few written work instructions. We use blueprints to the latest revision level and the approved first piece sample as our basic work instructions in our processing, welding, paint and assembly departments.


[This message has been edited by Jim Evans (edited 04 August 2000).]

Montserrat P

We count on with an electronic document system. But we count on with electronic document system station in every area of manufacturing. Therefore, if our employees have any doubt about their procedures, they can consult that information. The PC is only used for it.
On the other hand we have included visual aids or synopis (Tables,parameters, everything that is difficult to remember) that are attached or posted near of the machines or workstation tables.
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