Work Instructions for ALL Processes Effecting Quality??

[Rob Nix]

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.

 

[Howard Atkins]

additional thoughts

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
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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.
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These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process (my emphasis)
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mean that this is only for production processes. ​

IATF Guidance to ISO/TS 16949:2002 ​

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7.5.1.2 Work instructions​

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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.

Any one want to add first hand experience?
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[Tom W]

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
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mean that this is only for production processes. ​

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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.

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.

 

[db]

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.

 

[Randy Stewart]

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?

I'm just kidding, honest!

 

[Howard Atkins]

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.

 

[db]

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.

 

[Sam]

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.

 

[Howard Atkins]

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 ***.