Okay, go with me here while I ramble for a bit:

One of the first things we had to do for TS was decide what "processes effect quality" in our organization. That list of course includes non-machine processes, like purchasing, quality, etc.

Okay, now we get to 7.5.1.2 that says we need "documented work instructions for all employees having responsibilities for the operation of processes that impact product quality." Easy enough for machine processes - we all have those in place.

My question then is how are you guys handling this with NON-machine processes? Let's take my assistant, for instance. He is responsible for a wide variety of tasks (including bringing me coffee in the morning, though he isn't very good with THAT particular instruction!) but he is largely self-directed. He knows the "scope" of his duties, but with few exceptions he doesn't have any kind of report or anything that says okay, do this now. Take also the plant manager - same thing, he is responsible for a wide variety of tasks that inpact quality, but he has no "work instructions" per se. What are you folks doing with this? One guy here is suggesting 7.5.1.2 ONLY applies to machine processes, but I'm not sure where he's getting that interpretation - I don't see it.

Can I go so far as to say JOB DESCRIPTIONS = Work Instructions? If my job description, for instance, says I am responsible for the Quality System, for managing X number of people, for performing periodic reports, overseeing this and that, etc. Can I stretch to say that description IS my "work instruction"?

Okay, go with me here while I ramble for a bit:

One of the first things we had to do for TS was decide what "processes effect quality" in our organization. That list of course includes non-machine processes, like purchasing, quality, etc.

Okay, now we get to 7.5.1.2 that says we need "documented work instructions for all employees having responsibilities for the operation of processes that impact product quality." Easy enough for machine processes - we all have those in place.

My question then is how are you guys handling this with NON-machine processes? Let's take my assistant, for instance. He is responsible for a wide variety of tasks (including bringing me coffee in the morning, though he isn't very good with THAT particular instruction!) but he is largely self-directed. He knows the "scope" of his duties, but with few exceptions he doesn't have any kind of report or anything that says okay, do this now. Take also the plant manager - same thing, he is responsible for a wide variety of tasks that inpact quality, but he has no "work instructions" per se. What are you folks doing with this? One guy here is suggesting 7.5.1.2 ONLY applies to machine processes, but I'm not sure where he's getting that interpretation - I don't see it.

Can I go so far as to say JOB DESCRIPTIONS = Work Instructions? If my job description, for instance, says I am responsible for the Quality System, for managing X number of people, for performing periodic reports, overseeing this and that, etc. Can I stretch to say that description IS my "work instruction"?

Job instructions = work instructions; yes. And also include training. There aqre some jobs, such as yours, that only a job description can identify. However you may or may not also have a work instruction if you perform a specific task; such as how to gain access to the company MRP system.

You may however need a work instruction for your assistant since available of coffee in the morning has a direct impact on the quality of ones attitude. ;)

We have work instructions to perform tasks i.e. supplier evaluation for purchasing, receiving inspection for shipping clerk, project management for project managers but we do not have job specific work instructions other than individual job descriptions.

I guess in these cases if I say job description = work instruction I'm probably gonna' need to make sure people like me/my assistant, etc. KNOW what's in their job descriptions? I can't say for sure but if I had to guess I'd dare say the vast majority of folks here probably could NOT tell you what is contained in their job description.

Probably 'cause the only part of the job description for most of us that matters is the last line: "Other duties as assigned....." :ko:

You need a work instruction were the absence of one can lead to a nonconformity, not just to the customer product, but to your own internal product (purchase order, inspection processes, training, etc.). It is easy to over document activities within the company, but if it is a job being performed that you want consistant results that are improtant to business, then you might consider documenting it.

The intent is to show conformance to the requirements that you as a company establish to meet the standard. If you do not document how you achieve the results, you are leaving yourself open for inconsistant results through different ways of doing the same thing.

You need a work instruction were the absence of one can lead to a nonconformity, not just to the customer product, but to your own internal product (purchase order, inspection processes, training, etc.). It is easy to over document activities within the company, but if it is a job being performed that you want consistant results that are improtant to business, then you might consider documenting it.

The intent is to show conformance to the requirements that you as a company establish to meet the standard. If you do not document how you achieve the results, you are leaving yourself open for inconsistant results through different ways of doing the same thing.

Tom,

While I agree that some tasks do require work instructions, where do you draw the line? IMHO I think that more emphasis should be placed on training people and ensuring that they have the skills and knowledge to perform the task in a safe and competent manner. Whilst this is not always easy with turnover of perosnnel etc. I have been trying to improve my competenecy based training for employees and using more Checklists and flowcharts as opposed to full blown Work Instructions.

Greg B

One way around this need for more and more instructions etc is to add afew lines at the top of forms which explains what to do.

For example a company that backs up its data on CD once a week and records this can add to the top of the form:
"Weekly copy the data in folders XXX to the CD and write the date on the label.
Complete form."

This is a valid work instruction and has the advantage of being available when performing the action.

We rely on training and skill level. Like the example Howard used, the personnel know how to back it up so no instruction is needed on how to load the tape, turn machine on, etc. In the event that the person who is responsible for running the backup is out, the statement serves as a reminder of what needs to be accomplished.

Checklists, flowcharts and details on a form are all types of work instructions. You as the company have to decide what type of instructions you are going to use. I have seen companies that have no text type work instructions, just flowcharts. If a system works for you and your employees then it is no auditors place to state otherwise. Inovation in the area of work instructions is on-going and excuse me for saying this but can be exciting. :bonk:

Employee ownership in the system and the measureables that go along with evaluating the effectiveness of the system are key indicators to whether the system is effective down to the people that use it.

Again - over documenting a system can lead to nightmares but effectively documenting a system can make everyones day go easier. Do what works for you and ensure that you cover the requirements in a method that is effective for your workforce. THere is very little requirement for documentation in TS2, however success with a quality system can be measured in a vast number of different ways. :)

Howard has a great point about the forms. We have interactive forms in word/access and I have inserted Help Text for each field. This text guides the user through completion of the form without having a work instructions. We only create work instructions for activities that can not be clearly defined in the Operational Procedure.

SteelWoman's original thought was on whether work instructions are needed for everyone, or just "operators". I believe the context of 7.5.1.2 (control of production) suggests the focus IS operators.

Assuming that, Tom W makes some good suggestions. Laminated flowcharts or other visuals on the production line are satisfactory work instructions, as well as checklists or other forms with some basic instructions on them.

If referring to operators however, Howard's thoughts on interactive computer documents may not be practical if they do not have access to that media.

I do not believe an auditor should take 7.5.1.2 out of context and insist on physical work instructions for EVERYONE that may REMOTELY "impact product quality". The janitor may affect product quality. But the phrases "operation of processes" and "work station" allude to workers along the production line.

I think that in terms of processes despite the fact that the standard does not say specifically manufacturing process the position of the clause and the empasisied sentence


7.5.1.2 Work instructions
The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work station.

These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process (my emphasis)


mean that this is only for production processes.:evidence:

IATF Guidance to ISO/TS 16949:2002
7.5.1.2 Work instructions

These instructions may take the form of process sheets, inspection and laboratory test instructions, shop travelers, test procedures, standard operation sheets, drawings and visual aids or other documents normally used by the organization to provide the necessary information that impacts product quality. These instructions should include or reference, as appropriate:
· current engineering level/date,

· customer and organization designated special characteristics if any,

· inspection and test instructions with acceptance criteria (see 7.1.2),

· material identification and disposition instructions,

· operation name and number keyed to the process flow diagram,

· part name and part number, or part family,

· reaction plans,

· relevant engineering and manufacturing standards,

· required tools, gauges and other equipment,

· revision date and approvals,

· SPC and other process-monitoring requirements,

· tool-change intervals and set-up instructions,

· visual aids,


In my opinion this that the work instructions are just another way for the control plan to be "translated" into every day language.

I think we are over reacting to the standard.
:o
Any one want to add first hand experience?

I think that in terms of processes despite the fact that the standard does not say specifically manufacturing process the position of the clause and the empasisied sentence


mean that this is only for production processes.:evidence:

In my opinion this that the work instructions are just another way for the control plan to be "translated" into every day language.

I think we are over reacting to the standard.
:o
Any one want to add first hand experience?
[/size]


Were as I agree with Howard, however having just gone through our TS2 audit and refering to 7.3.3.2 under manufacturing process design output, it clearly states that the output to manufacturing design shall include;

- specifications and drawings,
- manufacturing process flowchart/layout,
- manufacturing process fmea,
- control plan,
- work instructions,
- process approval accetance criteria,
- data for quality, etc.,
- results from error proofing activities, etc.,
- methods of rapid detection, etc..

So in fact the standard does require documentation for manufacturing processes. The types are listed and the process should dictate what you have in terms of documentation. Good discussion, and I agree that it can be very easy to overdue the work instruction thing, however work instructions come in all shapes and sizes, find what works for your organization.

In my opinion this that the work instructions are just another way for the control plan to be "translated" into every day language. I think we are over reacting to the standard

Oh YES, YES, YES Howard.

I would add though that the work instruction might not be a "control plan". I break down the work instruction into two types. One type is product specific. This could be a control plan, it might be nothing more than a print. This type of work instruction is required so a trained and competent operator knows what the job entails.

The other work instruction is for training. It explains "how" to do the job.

The example I use, is I need surgery on my shoulder. Does the surgeon need a work instruction? Of course, after all which shoulder? What is the operation for? Which patient. Hopefully, the surgeon already knows "how to operate".

When looking at work instruction, consider this: What information is necessary to to the job correctly?

As far a job descriptions = work instructions, you would have to show me the information that would ensure the job is done correctly. Otherwise, I don't think so.

Hopefully, the surgeon already knows "how to operate".
Bing, Bing, Bing. Right on the nose db! Is it alright if I use that analogy?

This is especially true in skilled trades, you don't need a work instruction just a job line-up or something similar.

Hey Tom, is that your paint ball outfit in your avatar? :biglaugh:

I'm just kidding, honest!

Posted by SteelWoman
My question then is how are you guys handling this with NON-machine processes? Let's take my assistant, for instance. He is responsible for a wide variety of tasks (including bringing me coffee in the morning, though he isn't very good with THAT particular instruction!) but he is largely self-directed. He knows the "scope" of his duties, but with few exceptions he doesn't have any kind of report or anything that says okay, do this now. Take also the plant manager - same thing, he is responsible for a wide variety of tasks that inpact quality, but he has no "work instructions" per se. What are you folks doing with this? One guy here is suggesting 7.5.1.2 ONLY applies to machine processes, but I'm not sure where he's getting that interpretation - I don't see it.

This was the original discussion and I think that we have proved that 7.5.1.2 ONLY applies to MANUFACTURING processes.

In relation to work instructions etc, One of the favourite statements is that yoou need WI to ensure that the replacement can do the job. As in the surgeon above hr knows how to do the job but just needs to be pointed in the right direction.
As workers need to be qualified, and work validated 7.5.2 and trained on the job 6.2.1.3 then one doesent need a WI , in fact this could show that On the job training was NOT performed!!!

As db said The other work instruction is for training. It explains "how" to do the job.

This was the original discussion and I think that we have proved that 7.5.1.2 ONLY applies to MANUFACTURING processes.
I can't concur. "...of processes that impact product quality" can also apply to processes within 7.1, 7.2, 7.6, and some of the 8.2 stuff (at least in my opinion). I have found that the biggest customer complaints I've seen often go back to the sales process. What the customer wanted, and what the company thought the customer wanted were not the same. If my calibration, or inspection processes are not satisfactory, then they can easily affect product quality. I believe these areas require work instructions as well, only the form of these will be dependent on the reality.

I can't concur. "...of processes that impact product quality" can also apply to processes within 7.1, 7.2, 7.6, and some of the 8.2 stuff (at least in my opinion). I have found that the biggest customer complaints I've seen often go back to the sales process. What the customer wanted, and what the company thought the customer wanted were not the same. If my calibration, or inspection processes are not satisfactory, then they can easily affect product quality. I believe these areas require work instructions as well, only the form of these will be dependent on the reality.

I can agree with this statement. It has been my experience that the majority of customer complaints are traceable back to an administration error rather than a manufacturing operator.

db and sam
I agree with you and I did not say that other proceses should not have instructions.
My comment was more legalistic than any thing else.
In the letter of the law then
One guy here is suggesting 7.5.1.2 ONLY applies to machine processes,

But we all know the law is an ***.