AS9100 7.5.1.2 and 7.5.1.3 - Control of Production requirements

[Mr. K]

Hi! This is my first post on the forum. I?m excited to be a part of this community.

So I have a question regarding some of the sub clauses of 7.5.1 (Control of Production and Service Provision). Particularly sub clauses 7.5.1.2 (Control of Production Process Changes) and 7.5.1.3 (Control of Production Equipment, Tools and Software Programs).

So I work for a small business that has been highly successful with regards to quality, which is due in no small part to our experienced machinists. Our machinists are very skilled; they aren?t button pushers. However I?m worried that our methods of operation might get us into trouble with an auditor. We have a plan of manufacturing for every part that we produce, but often times the plan isn?t followed. Management has chosen to give our machinists the freedom to be creative in their approach to making parts. Now we don?t manufacture very complicated items, nor do we have any fully automated production lines. Rather we get orders for small quantities of parts, so they?re constantly changing set ups on our machines throughout the week.

The problem isn?t that we are making bad parts. Every machinist inspects the required characteristics/dimensions of the product after each operation is performed. After the full lot of parts have been produced the parts are bought off by an inspection authority. We check to make sure that no matter the methods or means by which the product is made, all dimensions are accounted for and are within tolerance before verified for release to customer. However I?m afraid an auditor wouldn't be satisfied with our methods.

The standard states?

"7.5.1.2 Control of Production Process Changes
Personnel authorized to approve changes to production processes shall be identified.
The organization shall control and DOCUMENT changes affecting processes, production equipment, tools or
software programs.

The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product conformity.

7.5.1.3 Control of Production Equipment, Tools and Software Programs
Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained.

Storage requirements, including periodic preservation/condition checks, shall be defined for production
equipment or tooling in storage."

I interpret this to mean that any time our machinists make a change to an operation or a CNC program/setup, they have to record the changes. Now it?s rather redundant for our machinists to record any changes for the purposes of confirming product conformity because they always check for product conformity, no matter how they make the part.

Also, is the standard implying that a First Article Inspection be performed for every change so that our organization can, ??confirm that the desired effect has been achieved without adverse effects to product conformity.?

And yet another question. Where is the line drawn for tooling, equipment, and software maintenance? Do we have to define how basic CNC tools are stored and maintained? Like I said our machinists aren?t button pushers. They know when a tool is no longer suitable for use.

I?m sorry that this post is so long. Could anyone help clarify some of my questions/concerns? Also, if anyone could share ideas or examples of how we might meet these requirements without generating a bunch of paperwork that would be greatly appreciated. Our machinists aren?t too keen on the idea of more paperwork.
Thanks

 

[Michael_M]

Hi! This is my first post on the forum. I’m excited to be a part of this community.

Welcome

The main point of this part of the standard is to assure consistent results, however so long a you have documented who can make changes, what those changes are, and the changes had the desired outcome you are fine.

Remember, you can use job titles to define who can make changes, for example this is from our procedure:

a) The General Manager, Quality Manager, or Planner has the authority to approve all changes to production processes. If hand written changes are made to the traveler, the authorized individual must sign/date all changes.
b) Applicable personnel are notified when processes are changed.
c) Customer or statutory and regulatory authority approvals are obtained as required by contracts or regulations.
d) Changes are recorded in production documentation and documented in procedures as appropriate.

You can use whatever job titles you desired within your organization based on how your organization works. You do want to be somewhat careful not to say 'anyone' or 'everyone' because then a janitor can make changes. Also, what happens if you hire an apprentice type person, will they be able to make whatever changes they desire? If one of the machinists decides to change the process by drilling a hole first then performing the lathe operation, he/she would need to document that they did this (on a traveler maybe?).

I may be incorrect on this as I am still fairly new to the standard, but I believe you could have an operation that states:

1. Purchase material
2. Machine part complete
3. Inspect part
4. Outside processing
5. Inspect part
6. Ship part.

This is a very basic process and one that I would not use, but it is a defined process.

 

[Mikishots]

Where you're going to have an issue is through Sec. 7.5.1. You are required to carry out production under controlled conditions, which includes showing that production and inspection/verification operations have been completed as planned (which means that you have to have the production steps planned). If you give the operators authority to do whatever they like as long as they end up with a conforming product, this clause is not satisfied.

7.5.1.2 means that you need to identify personnel who are allowed to make changes to your planned production processes. This does not mean the operator; this is referring to staff such as methods engineers or production managers. When a process is changed, the company has to ensure that the change hasn't adversely affected product conformity. Examples of this type of change might be changing the sequence of operations, moving the jigs or tooling to another location, or requiring the job be done in half the time.

7.5.1.3 means that you have to validate equipment tools or software for automating production or controlling/monitoring production BEFORE you start your production run. For CNC, this means to run the program and verify that it actually produces what you want it to. It also means that the validated program needs to be protected from unauthorized change.

 

[Mr. K]

Thank you Mikishots and Michael_M for your responses.

So in either of your opinions, would it satisfy the intent of the standard if a work order/traveler included a general plan for the measurement of the part's dimensions throughout product realization but left out the details pertaining to the equipment, tooling, fixtures/jigs, and/or CNC programs used? Couldn't I just include on the work order/traveler a place for authorized personnel to sign as verification that "Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained."
I understand that the above procedure wouldn't satisfy the requirement for maintenance, but it seems reasonable to me that a separate program/procedure could be implemented for maintaining CNCs, CNC programs, tooling, fixtures, etc.

If I had my way I would err on the side of caution by documenting all details relating to product specific jigs/fixtures, equipment, programs, etc. for each job, however I know that it would upset our machinists. I've expressed ideas similar to what you two have stated, but it has been met with opposition.

I'm trying to do my best to meet the requirements of the standard in a way that makes sense for our organization and relieves our machinists from generating a bunch of records. I believe there is a way, but I think it's going to require more record keeping than people will like.

 

[SmallBizDave]

I would say that 4.2.1, Note 2 (c) is worth looking at. The documentation can vary from company to company based on the competency of the personnel. If you define which machinists can make changes to the machining steps and use a router as proposed by Michael_M then I think you're fine. You also need to prove their competence with appropriate training, records, etc.

I frequently use varying levels of detail to allow for variation where it is appropriate. I recently completed a system for a shop that sends blank routers to the floor the first time the part is made. The machinists create the router on the fly. So long as they are approved for changing the process they're legal.

 

[Michael_M]

This does not mean the operator; this is referring to staff such as methods engineers or production managers.

Why not? If the operator is qualified why can he/she not alter the process? The standard only says:

Personnel authorized to approve changes to production processes shall be identified.

The organization shall control and document changes affecting processes, production equipment, tools or software programs

The results of changes to production process shall be assessed to confirm that the desired effect has been achieved without adverse effects to product conformity.

I understand they want qualified personal making the changes but specifically the standard does not say this. It only says authorized personal shall be identified, changes shall be documented, and the changes shall be confirmed.

If I am missing something, please let me know. I am still learning (and I hope I will still be learning 30 years from now).