Informational Please help this newbie understand ISO 9001 Work Instructions

[Marc]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

Coming from clinical research which is under an entirely different set of regulations I would argue that having work instructions ensures that everyone does things in a consistent manner so that the work is reproducible.

It's understood that everyone has the necessary training and experience to do the job, but if you leave everything up to each person's professional judgment you won't necessary get the same product in the end with the required quality attributes.

Absolutely agree that WIs shouldn't be the sole training tool.

Welcome to the Cove - and to a controversial discussion!

I disagree. You're assuming the WI is actually any good - and we are surrounded by ineffective WIs in our everyday lives. Secondly, writing it down doesn't make things happen. Thirdly, if you don't get a consistent result, it may be nothing to do with the WI - if you don't know process capability and cause/effect, a WI won't help!

I think the point here is that for every operation/process the company has to decide where work instructions are necessary. And, they must have a justification for each. Sometimes the same operation in different companies "require" a work instruction in one company whilst in the other company a work instruction isn't needed. This can be due to many things such as different company hiring practices/requirements for specific positions, whether the company cross trains its employees, the complexity of the operation/process/equipment, and more.

Doing implementations over the years one of the things I got a lot of client feedback on was how they were happy to have reduced paperwork including when and when not to use work instructions. The key to me is asking "Why do you need this?" Their answers were key to me. Sometimes they had a very good reason why. Other times they didn't. The important part, in short, was whether the company personnel could give a good reason for the need for one, including the level of detail needed (content).

I remember one company which has a piece of process equipment which had a very good instruction manual. They also had a long work instruction of considerable detail. When asked why they said their understanding was each process had to have one. Upon questioning, they explained the instruction wasn't used because they had a list of people who had been trained/qualified on the machine and it was simple to use. Machine setup was in the machine manual, as were other instructions specific to the machine. They also had criteria as to who they would allow to be trained to use it. There was simply no need for a work instruction. That was one less document to maintain and control.

Another example is where there was a complex assembly operation at a station. When asked why they had a work instruction they said their internal corrective action system showed that without one mis-assembly (assembly errors) was significant. The work instruction significantly reduced assembly errors which is why they introduced a work instruction in the first place. Obviously this company was wise in using internal metrics for many decisions.

My point is, there are no set rules on what specific process(es) need work instructions. I think this is an interesting discussion. One of the things I have not seen addressed (maybe it's here and I missed it) is the use of internal metrics (and external ones such as customer returns) for decision making. Andy somewhat addresses this with his statement "...process capability and cause/effect...", but there is much more than those 2 aspects.

Andy is right, there are many useless work instructions. None the less, there are also many extremely important work instructions.

And JJ_FDA is right in that, especially in his field work instructions are more important than in many other industries.

Take note of Miner's post, too. Work instruction content, when a work instruction is of value, the question is why it is of value (necessary?). What is the content of the work instruction? Does it include parameters or other criteria, or is it just "...take part A, place part B on it..."?
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In part I think this discussion is bouncing around a lot is because each of us work in different industries with different processes so we have our own paradigm as to what work instructions are necessary and why (or why not) for our particular processes.

 

[Shannon S]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

It's the end of my work day and I just wanted to offer one more thank you to everyone for all of the feedback. There hasn't been a single day since stepping into my new position that I haven't opened this forum. Along with the comments posted here, I had some emails and private messages and even a phone call with a few of you. You all have so much wisdom, but the willingness to help is what is most impressive! Maybe one day, I won't be posting as the newbie, and I'll be able to share some great advice with the next person who is as confused as I was/am!

Hope you all have a great evening, I'm sure you'll see me again real soon with my next stumbling block!

Shannon

 

[Big Jim]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

I know I'm late to the party, but I wish to stress that there is no requirement to have work instructions.

The closest the standard comes is in 7.5.1 b concerning control of production where it says: "The organization shall plan and carry out production under controlled conditions. Controlled conditions include, as appropriate . . . b) the availability of work instructions, as necessary . . . "

Two things to point out here. First, the list that is presented in 7.5.1 is "as appropriate", indicating that any item in the list may not always be required, including work instructions. Second, at the end of b) it specifies that work instructions be available "as necessary".

About the most you can make of this is that if the organization has determined that work instructions are needed, they need to be readily available at the point of use.

So who gets to determine if work instructions are needed? For the most part, the organization, allowing for the somewhat rare occasion that a customer may require them.

 

[Marc]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

Another thought. There is the aspect of work instructions and their "availability" which many take to mean at the work station. While this is typical, it is not always necessary. For example, in a wafer fab I worked in they had one computer with all the work instructions (including setup instructions, parameters and so on) on it in the fab. Employees were given OJT for their station (or any station they worked at as people became cross trained). I have also seen this in some general manufacturing companies. The person doing their job could look up any work instruction at any time at a "local" computer shared by employees of a specific area. This method is, of course, cheaper than where I have seen a computer at every work station. Then again, a computer at every work station is rarely a realistic option for a variety of reasons.

Just throwing that out as food for thought.

 

[sitapaty]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

In my experiance an SOP displayed at each work station/machine/processin (in local language) will serve as a work instruction.All operators/workmen are not used to computors.

 

[Big Jim]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

Another thought. There is the aspect of work instructions and their "availability" which many take to mean at the work station. While this is typical, it is not always necessary. For example, in a wafer fab I worked in they had one computer with all the work instructions (including setup instructions, parameters and so on) on it in the fab. Employees were given OJT for their station (or any station they worked at as people became cross trained). I have also seen this in some general manufacturing companies. The person doing their job could look up any work instruction at any time at a "local" computer shared by employees of a specific area. This method is, of course, cheaper than where I have seen a computer at every work station. Then again, a computer at every work station is rarely a realistic option for a variety of reasons.

Just throwing that out as food for thought.

Good point Marc. I would consider this as an acceptable method of "availibility".

 

[Marc]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

In my experiance an SOP displayed at each work station/machine/processin (in local language) will serve as a work instruction.All operators/workmen are not used to computors.

I don't expect paper to go away any time soon. The same can be done with a paper binder in a "central" location. The example of a wafer fab was a place you can not even have paper in unless it is a special paper.

Yes - I know that the typical way is through work instructions at each "applicable" station. What ever works. And as has been mentioned, some places have no work instructions per se in the traditional sense. I have also seen where "work instructions" were part of the router which accompanied each lot. It all depends upon the processes the company has, how they train their employees, and the specific job requirements.

To take it to an extreme, several call centers I have worked with had no paper at all. Everything is available on their computers. Others had a book shelf in each cubical with all the information they need.

 

[AndyN]

Re: Pls help this newbie understanding ISO 9001 Work Instructions

I don't expect paper to go away any time soon.

When I joined Xerox in 1973, the "buzz" was the paperless office...

 

[Chuck.Phillips]

I’m a Salesman turned Business owner turned CNC operator to now Quailty Tech.
I am new to this position (2 Mo.) I have a Audit coming in just 30 days so expect several post from me

Question for today.
Who is responsible (required) to train machine operators on the WI’s? QM, QT or can a floor supervisor or the operator who has a Technician/Leader Role?

 

[AndyN]

I’m a Salesman turned Business owner turned CNC operator to now Quailty Tech.
I am new to this position (2 Mo.) I have a Audit coming in just 30 days so expect several post from me

Question for today.
Who is responsible (required) to train machine operators on the WI’s? QM, QT or can a floor supervisor or the operator who has a Technician/Leader Role?

Firstly, Chuck, welcome. Secondly, as an ex-machine operator myself, what WI's do you have? Most machine operators I know don't need instructions, other than a router to plan out each operation in sequence. Training, btw, can be done by anyone who is a competent trainer.