My company has put all of our Levels 1,2 and 3 documents into read only PDF files. The problem I have is with the Work Instructions. Each area has access to a computer to view these, but they are not connected to a printer and those of us who are, are denied printing rights. This limits an operator in using these instructions because they have to refer back to their computer when trying to follow something step-by-step. Most of the operators do not work close to their computers. We are not ISO certified yet and I am concerned that this could be an issue with the Registrar, in addition to the concern of new employees not being able to walk through the processing steps easily. Any suggestions?

Recommendations:


Connect them to a printer and give them printing rights.
Make someone else responsible for printing and distributing the work instructions.
Provide LCD monitors at each workstation and provide electronically the work instructions to them.
Don't use work instructions and let the operators do whatever they want.

;)

There are several good threads on this subject here on the Cove.

One option, let everyone who needs to print the WI and then put a header or footer that states something like, "Expires 24 hours from printing date"

They need to have the most recent revision accessible to them to perform the work, but they also need to control the copies that are available and "out there" we are doing this some thing right now. Everyone can print whatever they want, however all our SOPs are stamped by the printer as UNCONTROLLED COPY - FOR REFERENCE ONLY and our WI are stamped by the printer as CONTROLLED COPY - EXPIRES 24 HOURS FROM DATE AND TIME OF PRINTING and our operators are trained to the fact that they are allowed to print up their WI in the morning and they have to shred them on their way out the door at night or at the end of the run. It works for us.

Good Luck

This is certainly a difficult spot to be in. I have seen different ways of using 'on-line' methods to control access to documents. There are several sections in the ISO standard to keep in mind: 1. how does the company meet the requirement 4.1 d, which says the organization shall ensure the availability of resources and information necessary to support the operation and monitoring of these processes (can your organization convince itself and the registrar that the computer docs are 'available' enough for operators?) 2. 4.2.3 d, which says the procedure for doc control defines how relevant versions of applicable documents are available at points of use (how do the employees feel about the on-line system and its features?). 3. 7.5.1b, which says the controlled conditions for production and service will include the availability of work instructions, as necessary (are the instructions available in a way that the registrar or another outside party is comfortable that they can be used to control production or service operations?).

If your management and your workforce all think this system as you described it works, and they can use it to effectively control the operations (this includes training new folks), your organization might be able to convince an auditor from a registrar. Here are a few of the ways I have seen on-line doc control sub-systems augmented for the improved use by workers:

A. when someone is in training, a copy of the instruction is printed and stamped FOR TRAINING or some similar statement. The training instructions say how long the document is good for.
B. a company bought enough monitors to place at work stations. The operator went to the main CPU, called up the instruction they needed at the monitor where they were working, and then had an accessible and controlled copy at the point of use. (I think there was some way to select the monitor for the document)
C. a company revised its forms to include critical process steps in a checklist format. That way the operator just filled out the checklist and successfully completed the operation. The instruction became a reference document or to be used in training.
D. a central document control center had laminated and controlled copies of instructions. These were called out on job routers, and were part of a kit that went out to workers with the job to be assembled. They came back at the end of the order and were re-filed for later use.
E. a company allowed instruction pages to be printed, but a time/date stamp also printed. The document was only good for 24 hours.
F. one company moved all its instructions onto its production routers. The copy is printed for the job, and all the information is at the worker's immediate disposal. Workers signed off on each step, so they also created a record from the instruction (yes, although slick, it uses a lot of paper).
G. the same company as stated in B eventually bought computer touch screens. Now operators access the instructions and the records on-line. They fill out records and sign them right on the screen. It's all saved to a database. (yes, very slick and limited use of paper).

Good luck!

--QG

Ask your users (operators) what works best for them, and give it to them. If hard copies is what they prefer, then accomodate them. Unless you're changing these instructions fairly regularly, what's the harm in letting them keep their copies (or laminating and posting them - whatever). Look at risk vs. benefit.

I've found, however, that once the average worker has followed an instruction for some time, they don't need to read the instructions over and over (in fact, very often, visual / pictorial aids at point of use work best), and therefore do not need direct access to them.

When revisions are made, as Dave points out, make someone responsible for ensuring the latest are available and obsolete are destroyed.

I personally think terms like "reference only" should be stricken from the english language. Documents are either valid or not.

I personally think terms like "reference only" should be stricken from the english language. Documents are either valid or not.
Yes, it is kind of dumb when you think about it--all documents are for reference, aren't they? :bonk: The question is whether a document is subject to control; i.e., subject to recall when changes occur. A document can be valid and not subject to recall.

And then, just posted in this thread http://elsmar.com/Forums/showthread.php?p=121705#post121705 is this little gem: Uncontrolled Document--Not for Referencehttp://elsmar.com/Forums/images/smilies/frustrated.gif http://elsmar.com/Forums/images/smilies/bonk.gif http://elsmar.com/Forums/images/smilies/surrender.gif

We use electronic documents in our facility with a computer located in each department. Our operators do not have to refer to their work instructions often as their operations are the same for each part however, they do have to review their specification daily to determine unique part dimensions/requirements. They simply copy the vital information down on the specification board located beside each machine and perform the work as required. We are ISO Certified and our auditor did not have a problem with our electronic system.

"Just posted... uncontrolled document - not for reference"

Ohh my. I just made the mistake of referring to it! What shall I do? :mg:

While I agree in theory to what you are referring to, "Uncontrolled - For Reference Only" and I agree to an extent. Let me throw a scenario at you...

You have a corporate campus that encompasses 4 buildings and 3 of the 4 have manufacturing or assembly in them. Similar processes happen in each of the 3 buildings. You and your illustrious Quality team have created some Work Instructions and Standard Operating Procedures. They need to be accessible to each of the cells that are performing the functions. Let's say 8 just for fun. SO each one of the eight cell leaders prints up and trains all the cell team members to the new Work Instruction and Standard Operating Procedure. The training is documented and retained per your ISO requirements. :applause:

Later that week....

A studious engineer discovers while reviewing the SOP that the designer misspelled two words (calclaute & calpiers) so like a good engineer, he fixes it (although, not many engineers would notice the misspelling :biglaugh: ) He also notices that the SOP/ WI states that an operator must cut the flash on both ends prior to placing in the box. Sometimes there is not flash on both ends so like a good engineer, he adds, "if flash is present"

Now there is no need to redistribute all those SOPs and Work Instructions to the cells again, but technically this is a new version and needs to become Rev. B (or 2 or whatever)

Now according to your system and theory, he (or the Quality Coordinator) must go around to all 3 buildings and 8 cells and retreive the obsolete documents (per the ISO standard as it relates to obsolete documents). It is pretty much guaranteed that they will miss one and that will be the one that the auditor will find. Who knows the cell leader may have printed up 20 copies for all members of the cell to review during the training, maybe he only printed it once. Who knows.

This way he can gather all the required copies and make sure that only the most current revision is being used.

Just some thoughts.....

A studious engineer discovers while reviewing the SOP that the designer misspelled two words (calclaute & calpiers) so like a good engineer, he fixes it (although, not many engineers would notice the misspelling :biglaugh: ) He also notices that the SOP/ WI states that an operator must cut the flash on both ends prior to placing in the box. Sometimes there is not flash on both ends so like a good engineer, he adds, "if flash is present"

Now there is no need to redistribute all those SOPs and Work Instructions to the cells again, but technically this is a new version and needs to become Rev. B (or 2 or whatever)

Now according to your system and theory, he (or the Quality Coordinator) must go around to all 3 buildings and 8 cells and retreive the obsolete documents (per the ISO standard as it relates to obsolete documents). It is pretty much guaranteed that they will miss one and that will be the one that the auditor will find. Who knows the cell leader may have printed up 20 copies for all members of the cell to review during the training, maybe he only printed it once. Who knows.

This way he can gather all the required copies and make sure that only the most current revision is being used.

Just some thoughts.....
There should be no need for a formal revision when documents are cleaned up--typos, spelling, grammar, etc. corrections. There should be a notation made on the controlled, "master copy," but that's all. It's important, however, to limit the authority to make such changes, so that everyone in the building isn't doing it.

A word of caution: It's best to make sure that documentation is written correctly in the first place. If there's no one in the building who can write (and you're right, most engineers can't) then someone should be brought in to proofread before release. Be ever mindful of changes in punctuation and grammar that can alter meaning.