Informational Please help this newbie understand ISO 9001 Work Instructions

[Bjourne]

Re: Pls help this newbie understanding ISO 9001 work instructions

It's done but I have issues in attaching this to you for your reference as it's 5mb. Above the 3 mb limit.

Do send me a PM and I'll send you it via email.

Again this is an old document(Process Instruction). I am in fact one of the reviewers for it way back then. The new doc (done with Excel) we have has images per work station - instruction and is approved by our customers in the electronics field. Start simple but the details of this ref tackles all about the process, the supplementary docs used in this process etc etc.

Goodluck

 

[Colin]

Re: Pls help this newbie understanding ISO 9001 work instructions

To add to the answers already provided, I will go back to an earlier version of ISO 9001, I believe it was the 1994 version. There was a statement in there that I really liked regarding the use of work instructions. It said "provide work instructions where the absence of such would adversely affect quality".

In other words, you only need them if not having them would cause a problem. I agree with Andy's statement that competent people often mean that we don't need work instructions.

Oh and I am not a believer that we need work instructions so detailed that you could pick someone from the street and say "here you go, read the and start work" - non-one would do that would they?

It is worth looking at what ISO/DIS 9001:2015 currently says on the matter - clause 7.5.1 b)
'documented information determined by the organization as being necessary for the effectiveness of the quality management system'

 

[JJ_FDA]

Re: Can you help a newbie?

But the manual is written this way because the car makers have no control over the competency of the driver! Frankly, if I were given a work instruction written like this, I'd throw it back at the supervisor! What about the people who all ready know how to drive? Don't organizations employ people who have "been there, done that"? I think this proposal is exactly what ISO 9001 ISN'T about. Some people don't need a work instruction at all - skills, experience and knowledge replace the need. Even if you do write it down, that's NOT how people get trained. Believe me, it isn't effective to teach people how to use a car from reading the manual!

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.

 

[AndyN]

Re: Can you help a newbie?

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!

 

[JLyt207]

Re: Pls help this newbie understanding ISO 9001 work instructions

I think this thread shows how difficult it must be to draft the standard that is appropriate to the different types of manufacturing plants there are and also include services. This is why the person in charge of the QMS must have a brain. When I was in high volume production for the auto industry WI were critical. Now I am with a prototype aerospace tooling company. The workers are talented and highly skilled. WI are few and a lot less specific.
So my advice to the OP is to assume every sample they look at will need to be changed to be appropriate to their company.

 

[RoxaneB]

Re: Pls help this newbie understanding ISO 9001 work instructions

The intent behind documenting processes is to support/enable the ability to consistently achieve desired results. Your external auditor gave you a hint by saying that s/he would wonder how you control production without work instructions. Think about your current processes...What are you currently doing to meet customer requirements? Are you even meeting requirements? What are you doing well? How do you know you are meeting requirements? Consider your defects...Are they high? Does a high volume of defects indicate something about your processes?

I used to be all about documenting every activity...now I'm more about documenting where it adds value. If your small organization is able to demonstrate a controlled process and consistently meet customer requirements, perhaps work instructions are not the way to go.

I also try to focus on documenting only that which is critical (of course, defining 'critical' is a whole separate discussion! ). To use the car example, however, working with the presumption that we hire people who have valid driver licenses, the work instruction on driving from Point A to Point B would look like:

1. Get in car.
2. Start car. (Safety Note - Do not start car remotely.)
3. Drive car.
4. Try to not hit anything.

Do we need to include where folks much change lanes or to come to a complete stop at a stop sign? Not necessarily - If your industry is not regulation-nuts, repeating the law in the work instruction may add little value, but you can include safety notes (as I did in step 2). If, however, you're in an industry where FDA or automotive or pharmaceutical regulations drive your business, you may need to be very, very detailed in your work instructions, no matter the level of competency of your employees.

Another point to consider...we don't know how detailed your procedures are. For all we know, you have "work instructions" buried in your procedures.

 

[Shannon S]

Re: Pls help this newbie understanding ISO 9001 work instructions

Bjourne, Thank you so much! I tried to send a PM but it says I do not have enough posts to do so. Can you send one to me that I can reply to?

 

[JJ_FDA]

Re: Pls help this newbie understanding ISO 9001 work instructions

I also try to focus on documenting only that which is critical (of course, defining 'critical' is a whole separate discussion! ). To use the car example, however, working with the presumption that we hire people who have valid driver licenses, the work instruction on driving from Point A to Point B would look like:

1. Get in car.
2. Start car. (Safety Note - Do not start car remotely.)
3. Drive car.
4. Try to not hit anything.

Don't forget to put on your seatbelt

 

[Shannon S]

Re: Pls help this newbie understanding ISO 9001 work instructions

Goodness gracious! How fabulous it was to turn on my computer this morning and see all of the wonderful input! I can't stress enough how thankful I am to have found this forum!
A few thoughts as I read all of your comments. The owner doesn't believe I need WI because he was told that during the certification to the 1994 standards. He was told that IF he puts them in black and white and someone does it in a different order, than it could lead to a finding during an audit, even if it didn't affect the outcome. Aside from that, he does seem to be very supportive in allowing me the freedom to put a quality system in place and implement. He's held a company wide meeting to inform everyone of my new position, the importance of it, and that he wants and expects everyone to give me complete cooperation with it. That makes me hopeful that we are actually doing this for more than the piece of paper, because I believe we can truly benefit from it!
Secondly, 98% of the employees have been here for 30+ years. To mean, that has it pros and cons. They are all very knowledgeable and need very little, if any, instruction on their job. However, having it done the same way for so long, doesn't mean that there isn't room for improvement. There definitely is and I am hoping to that this quality system will help bring some of those areas to light.
I believe that what I've gained from your comments so far, is my starting point is to sit down with each department head, have them take me through their process, and make a broad (not to specific) instruction? I definitely agree with keeping it simple, but my thought behind doing this may be that, together, we may see more efficient ways to do things.

 

[Ninja]

Re: Pls help this newbie understanding ISO 9001 work instructions

Goodness gracious! How fabulous it was to turn on my computer this morning and see all of the wonderful input! I can't stress enough how thankful I am to have found this forum!
A few thoughts as I read all of your comments. The owner doesn't believe I need WI because he was told that during the certification to the 1994 standards. He was told that IF he puts them in black and white and someone does it in a different order, than it could lead to a finding during an audit, even if it didn't affect the outcome. Aside from that, he does seem to be very supportive in allowing me the freedom to put a quality system in place and implement. He's held a company wide meeting to inform everyone of my new position, the importance of it, and that he wants and expects everyone to give me complete cooperation with it. That makes me hopeful that we are actually doing this for more than the piece of paper, because I believe we can truly benefit from it!
Secondly, 98% of the employees have been here for 30+ years. To mean, that has it pros and cons. They are all very knowledgeable and need very little, if any, instruction on their job. However, having it done the same way for so long, doesn't mean that there isn't room for improvement. There definitely is and I am hoping to that this quality system will help bring some of those areas to light.
I believe that what I've gained from your comments so far, is my starting point is to sit down with each department head, have them take me through their process, and make a broad (not to specific) instruction? I definitely agree with keeping it simple, but my thought behind doing this may be that, together, we may see more efficient ways to do things.

Hi Shannon,

You've brushed a number of things in this post:

1. Establishing a formal QMS, getting certified and improving are three different things (though certainly related). Handle them one at a time.

2. Boss is behind it...breathe a sigh of relief.

3. "He was told that IF he puts them in black and white and someone does it in a different order, than it could lead to a finding during an audit, even if it didn't affect the outcome."
---The WI can state specifically that order does not matter.
---If the WI is not necessary in the first place to get the job done right, then the boss is right...you don't need it. (others have already posted above the pertinent clause in ISO saying so)

Establish the formal QMS around what you've got right now...don't try to use the QMS creation to change things. You'll just annoy people.
Once your job goals have been met (as defined by the boss), then start down the road of improvement.

If improvement were so very drastically needed, you would have been hired to improve things. Improvement is always a good thing...but don't take your eyes off of the goal set for you.