Document Control of FMEAs and Control Plans

[Trence Myda]

Hello elsmar forum users, I hope to get inputs from you and help me with my current challenges at work.

How do you ensure that your FMEA, Control Plan and Work Instructions are aligned during revisions? I handle Document Control in our organization and we have difficulty having these 3 documents revised at the same time.

 

[yodon]

I'll toss out some thoughts with the hopes that others will chime in.

Changes to controlled artifacts (e.g., FMEA) should be reviewed and approved before implementation. The changes should be proposed, approved, implemented, verified, released. During the approval process, any other affected artifacts should be identified and tied to the change approval.

One way to do this is to use whatever change management system you're already using (ECN, DCO, Bug Tracking, etc.). Document the need for the change and that gets reviewed by a board of stakeholders who can identify the other artifacts affected. Make closure of the change contingent of getting all changes implemented and verified.

I hope that makes sense. I tried to be generic since change management has so many different "faces."

 

[Ron Rompen]

Part of the solution may be the way that you are creating the various documents. A system I implemented years ago at another company (still being used today) had ALL the documents related to a part on one excel spreadsheet - first tab was PFLOW, next tab PFMEA, next tab CTLPLAN, etc etc.

In front of all those (so the actual first tab, I guess) is a cover page - this lists the part number, revision level, date, etc. Those boxes are linked within the remainder of the document, so that a change on the cover page (say of the engineering level) is automatically cascaded down to all other affected documents. Its not a complete system, but at least having to open only one document makes it simpler to remember to make any necessary changes in all of them.

 

[J0anne]

Revise and update them one at a time and when you are ready to make an amendment. Don't try to align revisions.

 

[Trence Myda]

Thanks yodon and ron rompen for your inputs!

yodon, that is how we actually control revisions of our documents. we raise DCN, reviewed and approved by multidisciplinary team involved in the revision. however, the problem comes in the actual revision of the individual affected documents. it takes long time and they don't get to document control section at the same time so monitoring is somehow difficult.

ron rompen, i somehow find your implemented system to be of help in my problem. may i just clarify, is the revision in all thread of documents done by one person only? can you please present more how the system works from request to change or DCN, processing of change up to issuance of the revised/new document.

 

[Krocpok]

Apart from a process for change management, we use the same revision number for all relating documents: flowchart, FMEA, control plan and work instructions. Anytime one of these documents is changed, other documents must be reviewed and their revision number updated to the same level. Then, it's easy to notice nonconformity when you see that different documents with different revision numbers are in use.