AS9100. 7.1.3 Configuration Management. PCB production. ECN. Revision Control.

[AlexanderS]

Hello Experts,
I am working on AS9100 implementation and I need your constructive criticism. I would greatly appreciate if you find the time to read my post and comment on it.


We are small (40 people) contract manufacturer of Printed Circuit Boards, PCBs. No design/development work, no New Product Introduction. No Project Management for Product Realization, we operate under Standard Operating Procedures for each Order, because the process is standard each time from receiving customer requirements to shipping.

So, we have this requirement for 7.1.3 Configuration Management, CM.
To comply with CM requirement I have decided to write CM Procedure and implement the following activities:

a) Control of Changes to Product. Against each Quote/Order we already have Production Planning process where we review Customer Requirements and perform Revision control of our PCBs. Each unique batch of PCBs is associated with Customer Product Revision and can be tracked this way. Any change of the Product will result in changing the Revision.

b) Control of Changes to Quality Management System. Any change to QMS, be that production process change, or change to any QMS document, is processed via Engineering Change Notice, ECN. In the ECN we record what is changed, why, and which other documents within QMS are affected. Other QMS documents are Quality Manual, Standard Operating Procedures, Work Instructions, Control Plan and PFMEA.

c) Let everybody know. During ECN review we figure out if we need to let the Customer(s) know about this change. If yes, then we issue Notification Of Change and send it to Customer. On ECN we also state which departments within the company need to know about this change and distribute the document accordingly.

And that is all I can think of, and I am not sure it is sufficient. I don?t see any other sensible interpretation of CM in our case...

Please help,

Thank you,

Alexander.

 

[Mikishots]

Changes to your QMS don't need to be part of the configuration management process. The intent of CM is to plan, identify and control configuration as appropriate to the product.

Some points to consider for Planning:

Planning scope and objectives
Identification of significant documents and how they are related
The means used to accomplish it (we use IT as an example)

Some points to consider for Config Identification:

Evidence of the existence of the tree of product, spec and other configuration
Identification method of the product and documentation, and identification of the change.
Evidence of traceability
Communication method to know the config status of the product.

You can refer to a document like ISO 10007 for detailed guidance on how to do this.

 

[Big Jim]

In the simplest of terms, Configuration Management is revision level control to ensure that the configuration (totality of the specifications) of what you deliver matches the configuration of what your customer ordered.

One of the main things here is to ensure you used the correct revision level of the drawings to make the parts.

 

[AlexanderS]

I think I found application for Configuration Management in our company. We are in PCB manufacturing and after we receive ODB++(industry standard) files from Customer we take that data and generate several hard and soft tools to produce the actual board: copper layer files; drill files; router program files; legend files; Electrical Tester design files; solder mask film.
Configuration Management should take care of that configuration set up, so if the Customer decides to make a change and rev. the part, we know exactly which files to use and how to prevent any mixing in the future.

Does that sound right, dear Experts?

 

[Big Jim]

I think I found application for Configuration Management in our company. We are in PCB manufacturing and after we receive ODB++(industry standard) files from Customer we take that data and generate several hard and soft tools to produce the actual board: copper layer files; drill files; router program files; legend files; Electrical Tester design files; solder mask film.
Configuration Management should take care of that configuration set up, so if the Customer decides to make a change and rev. the part, we know exactly which files to use and how to prevent any mixing in the future.

Does that sound right, dear Experts?

That's the essence of it. The devil is in the details.