Work Instructions for ALL Processes Effecting Quality??

[SteelWoman]

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"?

 

[Sam]

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.

 

[mshell]

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.

 

[SteelWoman]

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....."

 

[Tom W]

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.

 

[Greg B]

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

 

[Howard Atkins]

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.

 

[Randy Stewart]

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.

 

[Tom W]

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.

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.

 

[mshell]

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.