I have a question about work instuctions. I know that they are a required part of ISO but no where that I can find states where and what departments should have them. I read that there are usually more work instuctions than procedures which is not the case at my place of employment. I have recently taken over the M.R. position. Two departments currently have work instuctions. Are all department required to have them? I know if they are not required there is a likely chance that they won't be written.

I hear two things about work instructions:

1. Every job needs them. This is mostly true.
2. Work instructions need to be simple enough for anyone off the street to follow. This is absolutely true ....... if your intent is to have anyone off the street follow them. Let me explain.

7.5.1 b) states:

"the availability of work instructions, as necessary,"

There are essentially two types of work instructions. One is the work instruction that says things like "push the red button at the end of the process". The second type give specifics related to the product.

I have to go in for knee surgery (not really). I really hope the Surgeon doesn’t need work instruction to tell him/her HOW to perform surgery on a knee. I do expect a work instruction to tell the Dr. WHICH knee on WHICH patient. See the difference?

What work instruction do you need? Only YOU can tell!

Good analogy, db!

good job db. better than i would have said it and saved me from typing !

welcome tracey- you will find some very useful goodies here on the cove. i'll give you my 2 sense worth on work instructions

1) only put them in place where you absolutely need 'em. your process will tell you where there are gaps. you get no extra points for having a ream of them in place
2) nix extravagant lexis ! i.e. none of them big words. choose words that you would understand if you were the operator for that process--always try to keep them to one page and maximize font size for easy reading in poor light.
3) visual, visual, visual---pictures, flow charts, more pictures, arrows, highlights, ---whatever you can use to see it--not just read about it.
4) have someone unfamiliar with the process use a draft work instruction to prove or disprove it's effectiveness and modify accordingly
5) good luck and let us know how you made out

:agree: :D :smokin:

db -

So a work instruction for knee surgury wouldn't include HOW it's done? This seems a little odd to me - I have tasks here that I'm very familiar with, and yet I like to have my notes (which I'm currently turning into Work Instructions) nearby while I do the work so I can ensure I don't forget anything. Even surgeons can forget and leave a sponge in the wrong place or something. Remember the old joke about the doctor who tries to write a prescription for a patient and discovers he is holding a thermometer; he says "oh no, some a-hole has my pen!"

db said:
Work instructions need to be simple enough for anyone off the street to follow.


Not true in all cases (by a long stretch).
(And onther topic where there have been numerous threads)

If you hire someone to perform knee surgery, I'd be hoping it wasn't a person off the street!

THE QUESTION IS, when do you need a work instruction?
THE ANSWER IS, when the expected qualifications and experience of a new incumbent in the position don't provide them with the knowledge to perform the task with the desired outcome on a consistent basis AND you're not going to provide them with the training required to achieve competency before they start.

Good ole WIs, to have or not to have, is that the question??? There will be several points for and not. The 00 standard in 7.5.1 says as applicable and as necessary, so it is up to the organization!!! I believe that one of the keys to this standard as in the past is training,training, training. WIs should not be designed for some one to walk in off the street and start working. WIs should be based in part on the skills and knowledge of the workforce (training). If it is not being done properly a WI will not make a difference. WIs if created should be created with the person using them in mind., in understandable language, as brief as possible(skills and knowledge in mind)(training)and with flexability in mind. We use WIs for complicated processes with multi tasks. One good point for is that when trainers train, they have notes that they use so why not turn them into WIs. Why create more paper or use up more computer space? WIs should not be department based, but manufacturing process based.
An interesting story, a company I worked for in 95 Work Instructed everything. We were trained to say and the records showed that we were trained to WIs. During the registration audit a woker was asked how he knew how to operate the mqachine, " I was trained to WI 258.". The auditor just laughed and said now tell me how you really learned how to run that machine. TRAINING OJT. WIs will always be a sticking point. Use only as applicable and as necessary.

As I am implementing a QMS here, the idea of work instructions has reared its ugly head. I am currently using the following guidelines, which have pointed out enough requirements for work instructions to keep everybody busy here.

1. If there have been indications of quality problems in the past which could have been prevented through the use of a work instruction. Old way, yell at the operator until he does it right.

2. Interviews of operators indicate confusion on their part. Old way, yell at them until they do it right.

3. When interviews of two or more operators result in two or more ways of doing the same thing.

I have recieved an amazing amount of buy in from the operators regarding WI's. Initial experience has already shown them that the old way can be replaced by working on the system. Alas, some Managers find it less satisfactory to yell at a procedure. :biglaugh:

I thank everyone for their help. In our quality system there are few work intructions. Each department has the own folder with their related documentation which includes W.I. Only the engineer department and EDM department have W.I. . I was considering creating work instuction for the shop floor but have decided, with everyones help, that I shall wait until we feel they are needed. An example maybe if we see a trend after reviewing nonconformaning product that W.I. will eliminate.

We are currently ISO 9001-1994 ceritfied and I will be responsible for switching us over to 9001-2000. I look forward to having everyones help.

Thanks

I agree WI's are an as needed thing, not mandatory. And, as others have pointed out, should consider the needs of the user, education, experience, complexity if the operation, all that important stuff. The "KISS principle" should apply.

But, another reason for WI's may be to preserve a record of the correct/baseline way of doing something. Even if operators are trained in the baseline method by OJT and they don't need a WI for daily operation, a simple WI documenting this baseline method can be valuable in some cases to record this baseline method as sometimes people drift from the baseline method into doing things a different way. And, if the only operator with the knowledge leaves quickly that could be trouble, too. Over time, the baseline method may be lost if not documented.

Letting the operators write, or at the very least review and comment on or approve, the WI's is important in my experience.

Jim,

The manufacturing work instructions, which are what I'm primarily involved in, are available at the work station. For the most part we have instituted, along with the WI's, a sort of work cell setup. The WI's that concern sub-assemblies are in a binder in the work cell. Copies are available on the server. WI's concerning final assembly are in the System Logbook which is at the final assembly site and follows the tool throughout.

Let me try to get these straight.

David Mullins:
If you read my post again, you will see I finished the statement with :
if your intent is to have anyone off the street follow them


Mickeyman:
Even surgeons can forget and leave a sponge in the wrong place or something.
Surgeons do indeed have Work instructions (usually checklists) where they count devices and such. My comment was more like having a work instruction that gives step-by-step instructions on how to cut into a knee.

noboxwine
only put them in place where you absolutely need 'em. your process will tell you where there are gaps. you get no extra points for having a ream of them in place
This is a really good piece of advice. Normally all the 'extra' documentation will do is hang you!

Db,

Respectfully, I would not want to cut into anybody no matter what instructions I had available. Should work instruction be written in accordance with the training level of the participant?

As an addendum, there is one person with whom I would enjoy cutting without instruction, and he/she is not a member of this board!

I like the type of work instructions that are checklists. Doesn't tell you how to do each step, but leads you through the process. We used them for almost everything at my previous company. Initial and date beside each step. It verified that something was done, by whom, and when. So after completion you had a record of the activity.

I would make a checklist for almost every task in this company if they'd let me!

You Go Lucinda and Jim !

Checklist style Work Instructions not only can be effective for achieving an objective, you then have a record of it as well with minimal effort. Simple, simple. Yippie !!!!!!!!!

;)

Al -

Good point - as I understand it, WIs are not supposed to replace training, rather they are supposed to support trained personnel. Although we are not certified yet, I've been turning my notes into WIs and I find them very helpful, especially since I had to turn my scribble into english to write them.

One point remains unclear to me: I've been told the WIs are not auditable, but the auditor may in fact verify the WIs exist. Is this true?

Not auditable? No, I don't think so. Guess it depends on the semantics you use. A work instruction is simply a more detailed procedure. Would you say that procedures are not auditable?

Although,....there was some discussion in this cove regarding calling WI's "training aids", and thereby removing them from scope of audit. Removal as in "is the person doing it exactly like the work instruction calls for?", and not removal from document control issues. If you removed these "training aids" from doc control then an auditor could argue that you aren't controlling the administration of training by ensuring that the info is current, etc."

I always write a WI assuming it is auditable. My customers have surely audited to them in the past, and I would assume a registrar's auditor would as well, at least a few. Our WI's are actually used in the making and testing of the product, so why not? The only area that gets hairy for me sometimes is making sure they aren't written too "tightly" that they get me in trouble. For example, if some steps can be done in any order without having any effect on the outcome, I don't want to say/insinuate in the WI that things MUST be done in that order if it is no big deal. Just my take on things...

It's becoming increasingly clear to me that the so-called "expert" our company hired isn't completely clear on what is auditable and what isn't. In fact, I suspect he is unclear on several concepts, but that remains to be seen. In the mean time, I will write my WIs as if god himself will audit them and hopefully this will have two results:

1: I won't be caught short if they do get audited, and
2: I'll have really good WIs.

Thanks for the information, everyone!

Your 'expert' may have a point, although misguided. Six procedures are required, but no work instructions. So, to that extent he/she has a point. However, the standard requires you to control required documents. If the WI is required "to ensure the effective planning, operation and control of its processes" (4.2.1d), then they are auditable.

Lucinda's comment:

A work instruction is simply a more detailed procedure

is a good thing to remember. A procedure is normally processed-based, and a work instruction is normally task-based. However, I have seen dozens of cases where documents that one comany calls a procedure would be called a work instruction by another (and the other way around).

The key is, IMNSHO, if someone uses the doucment/data to do their job, then the document/data is auditable.

first...Aussie Bloke and Kens.....great response back on page 1 as to when a WI is needed. (Needed where the absence of one would affect quality.)

What is a WI? I always go back to the document pyramid, not cause I use "4 tiers", but because the guideance is there. Teir 1 is where we state "YUP>>>>>we address all the shalls and answer WHO, why/why not" Tier 2 is where we detail what process we use to address the shalls and answer WHAT (and maybe more who stuff), where, when. Teir 3 is where we answer How and provide the Show me trail.....YES they are all auditable. Teir 4 is the evidence that all of the above has happenned. Call them procedures, call them manuals, WI, flow charts, process maps, forms, records, dinner menus or what ever you like...as long as the information is there when its needed/suppose to be.......you are OK.

I guess the safe thing to do is to assume everything can be audited and that way I won't be waffle-stomped by the auditor or anyone else...

I also have a question about work instructions. The machine shop I work for will make 1 piece of prototype/production tooling for a customer, or we may get a job to machine at most 150 castings. Since alot of our jobs are prototype and our production is low, what types of work instructions would we need in this environment, especially when we have skilled tradesman working for us and every job is different. If anyone in this type of environment has a suggestion it would be appreciated.

I also have a question about work instructions. The machine shop I work for will make 1 piece of prototype/production tooling for a customer, or we may get a job to machine at most 150 castings. Since alot of our jobs are prototype and our production is low, what types of work instructions would we need in this environment, especially when we have skilled tradesman working for us and every job is different. If anyone in this type of environment has a suggestion it would be appreciated.

Well, here's my take
You have a process for handling the prototypes....make that your work instruction...if you doing short run production...just jot down what you do. Do you use any type of job router? That can serve as your work instruction. Just working off of prints? Maybe that can serve as your work instruction.

Just a few ideas.

CarolX

I also have a question about work instructions. The machine shop I work for will make 1 piece of prototype/production tooling for a customer, or we may get a job to machine at most 150 castings. Since alot of our jobs are prototype and our production is low, what types of work instructions would we need in this environment, especially when we have skilled tradesman working for us and every job is different. If anyone in this type of environment has a suggestion it would be appreciated.

This is a quite common question, and it help to consider that documentation can be in any form of medium. I really had hoped they would have moved away from the word "documentation" and used the word "information" instead. If you really think about it information is what we want to control.

Having said that, the question is what type of information do your skilled trademan need? I would think they know how to operate the equipment, and perform checks, but what information do they need? How about dimensions? Or how about the grade of steel they are using?

I worked closely with a fabrication shop that made equipment bases. Their welders didn't need a work instruction that told them how to weld. What they needed was information that told them what to weld, and where the parts would be positioned. Prints, control plans, BOMs and inspection sheets can all provide the necessary info. They, then become your work instructions.

Hope that helps

Muck like Carol said, I would have a map that shows your basic process and you can add notes/directions for how you handle specials/small orders. The big thing would be to keep it simple.