ISO 10007 - Configuration Management Requirements

[Lorenzo]

Looking for quick help in understanding "Configuration Management", what in general is required. We are being required as a supplier to have an AS 9100 compliant system, at this time. I am ordering the ISO 10007 for future reference, but don't yet have.

[BadgerMan]

The requirement states that the config mgmt system must be "appropriate to the product" which seems to be somewhat open to interpretation by the auditor. Our system is quite complex as are our products. We also develop software for airborne systems so the config mgmt of that process is done in accordance with RTCA DO-178B. We use some fairly elaborate software tools to manage configuration during the software development/lifecycle because the task is so complex. We have never had a registrar/auditor write an observation against our system so I must conclude that it is somewhere in the adequacy ballpark relative to our products.

I don't have much knowledge of other systems and have not read 10007 so maybe somebody who is more "worldly" can enlighten us.

[ARUMPLE]

Reference - 4.3 Config. management.
When you receive the guide ISO 10007, you will find the "key elements", to document within your QMS manual. I don't remember exactly how many, but you should see them in several areas.

Best regards

[Raptorwild]

Hello All!

Would anyone out there like to share how they meet the requirement for clause 4.3 Configuration Management?

I ask this because our QM has a section stating the following below, and would like some feedback on wether you all feel it is adequate.

4.3 Configuration Management
Maricopa Controls Inc. has established, documented and maintains a Configuration Management process to ensure that our products continue to function safely and reliably when individual components are changed.
This is achieved through the use of a Product Matrix, located on the Server and in the Blue Books listed by Part Number.

We have no seperate process for CM at this time, our CM is broken down by part number.

Thanks Paula

[QualityPhD]

When looking at configuration management the standard defines configuration as the functional and physical characterisitcs of a product as defined in technical documents and is achieved on the product.

Looking at the configuration of the product first identify the configuration item, whether it is a part or an assembly. From that point, usually an engineering drawing, look to how the organization documents and justifies changes to the product, evaluates the risk of the change, shows evidence that the change of the configuration has been approved (usu. and ECN) and that the change has been implemented (changed production orders) or a process deviation or waiver has been received.

Structure of CM is normally acheived in the project design phase and includes all the functional or performance characteristics of the product that are to be maintained throughout the life cycle of the product.

Configuration identification should include such things as a listing of the technical specifications used, the numbering system that will identify the specification, drawing or any changes, how serial numbers or other traceability will be addresses and the proper procedure or tech. specs required for release of the product.

Hope this is of some assistance to you.

Ann Morgan

[Raptorwild]

Originally Posted by QualityPhD

When looking at configuration management the standard defines configuration as the functional and physical characterisitcs of a product as defined in technical documents and is achieved on the product.

Looking at the configuration of the product first identify the configuration item, whether it is a part or an assembly. From that point, usually an engineering drawing, look to how the organization documents and justifies changes to the product, evaluates the risk of the change, shows evidence that the change of the configuration has been approved (usu. and ECN) and that the change has been implemented (changed production orders) or a process deviation or waiver has been received.

Structure of CM is normally acheived in the project design phase and includes all the functional or performance characteristics of the product that are to be maintained throughout the life cycle of the product.

Configuration identification should include such things as a listing of the technical specifications used, the numbering system that will identify the specification, drawing or any changes, how serial numbers or other traceability will be addresses and the proper procedure or tech. specs required for release of the product.

Hope this is of some assistance to you.

Ann Morgan

Ann,
This is right on with what I was thinking and is verifiable during an audit and also during everyday operations. Great Response! Paula

[Cari Spears]

Originally Posted by Raptorwild

...Would anyone out there like to share how they meet the requirement for clause 4.3 Configuration Management?...

This is something I've been wondering about for us. We manufacture products in accordance with someone else's configuration management plan - we're not design responsible. So I think our procedures need to address cmp's as they pertain to us - like change control/contract review and document control, etc. In the same manner that we control and use technical orders and repair manuals given to us by some of our customers (customer specific requirements).

I'm also not sure about configuration audits - who does them? The design responsible function who created the CMP? Or is it our final product inspection? 10007 says "A CA may be required for the formal acceptance of a configuration item."

What do you guys think?

[Marc]

I got this in my personal e-mail so I guess someone pushed the wrong button:

The organization shall establish, document and maintain a configuration "management process", "appropriate to the product":.
****
Sounds a little confusing, almost describes why we need a change process.

I do not see the whole, so its inadequate. looking for something in other processes. What's the QMS scope, and its exclusions, if any?

Phillip