Re: Pls help this newbie understanding ISO 9001 Work Instructions
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.
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.
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.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!
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..."?
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. 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..."?