DHF File Change Control Requirements

[snoopy2017]

Hi everyone,

When we implement a DHF for the first time , does it have to through change control? I have noticed in a couple of companies, that the first version of the DHF (including all the necessary docs) are not assigned a change control number. But subsequent changes to the DHFs are assigned an ECO number and a change control number. Can somebody please clarify for me when change control is required for DHF? Does the first version of DHF need change control #?

Thank you!

 

[Sam Lazzara]

My opinions...

The design control procedure (SOP) should describe the document control requirements for the deliverables (documents) required at each design review. It could require the deliverables at each design review to be controlled via the formal change order process or it could describe alternative controls or exceptions.

Each deliverable should either be approved/released in the formal change order system (e.g. DCO) or should be somehow approved/condoned by the appropriate team member(s) (in memo-style for example).

Furthermore, all document deliverables should be subject to review by all design review participants even if some of those participants have not previously reviewed/approved the deliverables in advance of each design review.

I have attached an example of a Design Review Checklist that shows "Review/Approval" requirements for each deliverable at each design review.