The best way to manage changes to the documentation of PCB files & BOM

[Bunny]

We design our PCBs but do not manufacturer them. Our PCB BOMs are under document control. Sometimes, once orders for PCBs are placed with the board house, they call and say a component is obsolete or has a long lead time and they located an alternate. We approve the alternate part. My question is what is the best way to manage the change to the documentation of the PCB files? Should we add the alternate to the BOM and revise the BOM? The engineering department is suggesting that they should only have to add the part to the database and not touch the BOM.

 

[Le Chiffre]

I've done both in the past. If the alternative is likely to be the long-term substitute then the BOM would be revised and signed-off again once the performance of the part is validated. However, if it's just a temporary sub, then it can be handled by an Engineering Order. In either case, The important thing is to record which product was assembed with the substitute part or BOM revision level.

 

[Jeff Frost]

If you are certified to ISO 9001 of one of the other quality management systems you must manage your configuration and should document the deviation to the BOM requirements that you have approved to your supplier. This protects you, your customer and your supplier should an issue come up with the PCB.

 

[somashekar]

We design our PCBs but do not manufacturer them. Our PCB BOMs are under document control. Sometimes, once orders for PCBs are placed with the board house, they call and say a component is obsolete or has a long lead time and they located an alternate. We approve the alternate part. My question is what is the best way to manage the change to the documentation of the PCB files? Should we add the alternate to the BOM and revise the BOM? The engineering department is suggesting that they should only have to add the part to the database and not touch the BOM.

You are talking about the PCBA (Printed Circuit Board Assembly) and not just the PCB.
Your typical BOM can have suggested sources against each component. This will help the board house to source with greater flexibility. You can plan well to make your BOM versatile.

 

[Bunny]

We are ISO 9001 and 13485. We also must comply with FDA and CE regulations.

I am referring to populated boards (Printed Circuit Board Assembly).

Talk to me about using the engineering change order in lieu of running BOM changes through the change process? How is the change order used? Who approves it? Who maintains the record?

 

[Le Chiffre]

Your system must allow for a temporary deviation from the BOM for reasons such as supply deficiency, etc. So this isn't a change to the BOM but a special variance that is controlled by an Engineering Change Notice for a specific period or batch size. You need to determine who can originate this and who need to authorize it.
For 13485 compliance you need to ensure that this deviation is well documented for traceability purposes.

 

[sowmya]

The alternates has to be updated in BOM if it is for long term. if it is for short term, it can be managed with TDO.

If you are adding only in database, you are allowing the procurement but traceability of when change is implemented, who apporved it and when it was bought...etc will be a problem.

Normally the cross functional team reviews and approves the change.

 

[Bunny]

We have decided to implement an ECO process to manage the temporary BOM changes. The regular document control process will continue to manage the permanent BOM changes. I do not have experience with an ECO process to handle temporary changes. Can someone please share advise and their procedure? I would like to get a clear understanding of how the documents are managed and retained.

 

[BethP]

We have decided to implement an ECO process to manage the temporary BOM changes. The regular document control process will continue to manage the permanent BOM changes. I do not have experience with an ECO process to handle temporary changes. Can someone please share advise and their procedure? I would like to get a clear understanding of how the documents are managed and retained.

For a temporary change, our engineering team follows a Deviation Request process. This is similar to an ECO process, but has fewer reviews and approvers. The Deviation Request provides information on PO / date range that change is effective for, description of the change, and number of products that are impacted. It is to provide some trace back to the products if any issues later on. Additionally, it provides the supplier permission to do the temporary change. The documents are retained like any other product related document, e.g. BOM.