Hi all, I'm in desperate need of help.
I am trying to build a quality system in my company. It is a very small start up company.
The problem is that the processes and machines are very unstable, and we are having difficult time controlling them.
I was trying to implement working instructions which includes all the specifications for the product as well as forms for the production floor to use. But because there are so many problems during production it makes it impossible to handle them as controlled documents. What am I suppose to do? revise the edition every time there's a change in parameters? Which is all the time?
Can you also clarify two more things for me?
1. The working instructions - do we have to control them as procedures (SOP's) meaning edition no., change control, signatures, effective date and so on?
2. How do we control forms (not records)?

I hope I am clear enough.

Thanks a million.

Hello!

1. It sounds to me that you have an out of control process. Have you ever worked with control charts?

2. Do you have a quality assurance individual? Do you have an inspector?

Just some thoughts:

1. I would start mapping out all the different variables that enter your process, from start to finish. Get as many people in your company to help. Many times we get so close to something we become oblivious to things.

2. Once you get all your variables identified, then figure out how to get better control. Work with your suppliers on raw materials, get your folks doing the job to help with work instructions,etc.

Once you identify what your real issues are, it will become very clear where you need work instructions, forms, and the like, and where control is needed.

Getting everyone to help is important. They will feel they were part of this operation. More importantly, you will have a better quality system that will minimize unneeded forms/policies/procedures.

Brad is right. Until you know what you should be doing, you cannot create a documented process. You are in the start up phase, you need to learn how to control the process before you document how to control the process.

Hi all, I'm in desperate need of help.
I am trying to build a quality system in my company. It is a very small start up company.
The problem is that the processes and machines are very unstable, and we are having difficult time controlling them.
I was trying to implement working instructions which includes all the specifications for the product as well as forms for the production floor to use. But because there are so many problems during production it makes it impossible to handle them as controlled documents. What am I suppose to do? revise the edition every time there's a change in parameters? Which is all the time?
Can you also clarify two more things for me?
1. The working instructions - do we have to control them as procedures (SOP's) meaning edition no., change control, signatures, effective date and so on?
2. How do we control forms (not records)?

I hope I am clear enough.

Thanks a million.

To answer your questions directly:

1) If you are striving to become ISO compliant / certified and these instructions affect product quality (7.5.1) then, "Yes" you must control them and all provisions of 4.2.3 apply.

2) In any manner that makes sense for your business. We use a master document list and assign form numbers based upon ISO clause # with a running numerical suffix i.e. forms related to calibration would be labeled in the footer as F(for Form)-76-01 /02 /03 /04 etc. This works for us; what can work for you? Our master list tab for forms shows current revision level and a brief revision history; we don't put the history on the forms because most forms take the full page for their content.

Comment: We use, and you could also, a temporary process deviation form/ methodology which would allow for a change to any processing parameter that is approved by appropriate personnel. This form can capture therefore, changes that are truely temporary (one-time material substitution) or changes that may be analyzed to determine permanence (Oven # 1 temps for product X123). It's nice to talk about establishing capable processes but you need to have tools to do so. Establishing baseline process specifications and then controlling changes through a deviation process will highlight the areas / processes that need improvement.:2cents:

Hello

Do you use route/job cards? if so could you put the work instructions against the operations so that each time you change the process on the route card you are also reminded to change the operations.
And each time the job comes around you print a new one off.
One sheet two functions.

Hello

Do you use route/job cards? if so could you put the work instructions against the operations so that each time you change the process on the route card you are also reminded to change the operations.
And each time the job comes around you print a new one off.
One sheet two functions.

Thank you guys for your replies.

We don't use a route card, could you pls explain some more about it? is it like a traveler? If you can post an example I would appreciate it.

Thank you guys for your replies.

We don't use a route card, could you pls explain some more about it? is it like a traveler? If you can post an example I would appreciate it.

At least in our organization the Route Card and Traveler are synonymous (the same).

Find attached a copy of route card you can change to suit your requirements.