How Much Process Documentation is Required? We have 200+ products!

[luksha]

some questions

Hello, everyone!

I'm still performing this initial audit thing, and I have come across some questions:

1) The company I'm auditing is producing more than 200 different product types (all from wood, like chairs, tables, fences, log houses etc). Is it necessary to write an instruction about how every product is made? Right now they have design drawings for the products (but not all), and they know the production process by heart...

2) This company is using about 50 diferent machines for production. Half of these machines are bought used, so they have no instruction or anything. As far as I know there must be a list of all machines which are used for production, and they all have to be regulary checked. So is it necessary to have instructions for every machine? If yes - can we write these instructions by ourselves?

Thanks in advice! I guess there will be a LOT of questions when the audit will be finished

Normunds

 

[energy]

Yes

Hello, everyone!

I'm still performing this initial audit thing, and I have come across some questions:

1) The company I'm auditing is producing more than 200 different product types (all from wood, like chairs, tables, fences, log houses etc). Is it necessary to write an instruction about how every product is made? Right now they have design drawings for the products (but not all), and they know the production process by heart...
Normunds

What happens when these people leave, die, get injured, etc? I would, unless you use the "They are trained to do it" ruse and back that up with training records.

2) This company is using about 50 diferent machines for production. Half of these machines are bought used, so they have no instruction or anything. As far as I know there must be a list of all machines which are used for production, and they all have to be regulary checked. So is it necessary to have instructions for every machine?
Normunds

At least a Maintenance schedule and instructions, if needed, to perform the maintenance.

If yes - can we write these instructions by ourselves?
Normunds

Absolutely. Who else knows better than you? JMHO

 

[Bob_M]

1) The company I'm auditing is producing more than 200 different product types (all from wood, like chairs, tables, fences, log houses etc). Is it necessary to write an instruction about how every product is made? Right now they have design drawings for the products (but not all), and they know the production process by heart...

If the EXISTING drawings are detailed enough, could a NEW employee make the parts without WRITTEN work instructions? If yes, you may not need them. IF no, like Energy said, what happens when you lose people who know the stuff from memory? If possible, keep the instructions simple and include pictures and or flowcharts, to minimize the reading and increase the likelyhood of the Work Instructions actually being used/read.

2) This company is using about 50 diferent machines for production. Half of these machines are bought used, so they have no instruction or anything. As far as I know there must be a list of all machines which are used for production, and they all have to be regulary checked. So is it necessary to have instructions for every machine? If yes - can we write these instructions by ourselves?

Do you need a manual for most wood working machines? Try getting some from the internet!! Don't try to re-create the manual, just write the specific directions on how to use the machine for YOUR products. (Basic/complex setup instructions - See point 1 above). Do you need a list of machines? Do you need to regularly check/maintain them. For OSHA/safety reasons you DO! If you're not checking/maintaining them and OSHA were to visit, you'd end up with quite a bit of fines...

Thanks in advice! I guess there will be a LOT of questions when the audit will be finished

I'm not sure how you're questions relate to auditing alone, but bring all the questions you have! And welcome to the Cove!

 

[Wes Bucey]

The curse of being an auditor rather than a consultant is that you aren't supposed to tell the target "HOW" to do business.

Question is: "Are you auditing as internal auditor, customer or third party registrar?"

If internal auditor, you have a duty to also bring these items to the attention of someone who can remedy them as soon as possible.
Internal auditors have a primary duty to the survival of the organization. Same goes for consultants performing a "preliminary audit" which is often referred to as a "Gap Analysis."

If registrar, the answer is "write them up as nonconformities"
Without documentation, how do they train new employees to build products to the same standard of quality? How do they pursue a corrective action or root cause? In the discussion period that arises after the nonconformities are listed - you can explain that work instructions need not be elaborate, but there should be some uniformity of certain processes from operator to operator (what order of events is most efficient for producing a product? Are there some critical characteristics which need to be watched for form, fit, function?

Certain minimum maintenance and repair instructions ought to be written for machines to keep them in peak operating condition. What happens to quality of production if worker A resharpens tools every x cycles and worker B resharpens after X + 25 cycles? Which frequency is most efficient, if any? More frequent sharpening than necessary wastes time and shortens productive life of tool. Working with dull tools on the other hand, increases production time and results in poorer finish. It is in the company's best interest to document such processes to evaluate them for possible improvement in efficiency.

How are new employees trained? If by osmosis or informal training from fellow workers, how can you be sure they learn the most efficient method?

If you are a customer auditing, then proscriptions against consulting go out the window. Tell the folks in charge what you think so they can be a more productive Quality supplier for you. Otherwise, consider using another supplier if they refuse to consider your suggestions. Good finished products today does not give you confidence next month's production will have similar quality if there is no uniformity of process documented.

 

[db]

The important question is: "What information is needed to perform the task?"

It is that information that must be controlled. You do not need a work instruction for every task. And even then, there two types of work instructions process instruction tell you how to do the job. These are usually product specific. They might include prints, control plans, etc. Everything a trained operator will need.

Training work instructions also tell you how to do the job, but with more detail in the operation. They are not necessarily product specific.

An example. A process work instruction will tell a welder what two pieces are to be welded, what kind of weld (butt, angle, lap, etc), how often and what to inspect, etc. A training work instruction will give the instructions on how to set the welder, how to feed the wire, adjust the gas, etc. These things are "routine" for a trained welder, so he/she would not need them.

The same applies for maintenance. If all (or some) of the equipment is similar, and the maintenance person is experienced, then work instructions might not be necessary. If a major rebuild is in order, then you can always find the instruction (if needed) at that point.

 

[Al Rosen]

For OSHA/safety reasons you DO! If you're not checking/maintaining them and OSHA were to visit, you'd end up with quite a bit of fines...

Does OSHA go to Latvia? That should keep them busy and off our tails.

 

[luksha]

Well, first of all, thanks for Your replies! Now I have clearer vision about these instructions and machines!

Secondly, I got You all confused with this audit thing , actually the audit I'm performing is "initial gap analysis".

Thirdly, there is no OSHA in Latvia, at least I haven't heard about them

Normunds