Change Order Admin Check
Medical DeviceQuality & Regulatory
7,500 change orders a year. The same 19 mistakes kept sending them back.
A medical device manufacturer put its known rejection checks at the moment a change order is created. Document Control still makes the final call, and the PLM stayed exactly as it was.
- Organization
- Medical device manufacturer
- Industry
- Medical Device
- Team
- Quality & Regulatory
- Problem
- Rework & verification
The operating problem
The same mistakes came back after every submission.
The company was on track to process more than 7,500 change orders a year. Every one passed through document control, where the same wrong file names, missed fields, and mismatches between the documents and the PLM record kept sending work back to whoever created it.
Document Control caught them, but only after submission. Each preventable rejection cut first-pass yield and added another round of correction, resubmission, and review before the change could move.
The catch moved from document control's desk to the change creator's screen.
Before and after path
Before
Change order submitted
Document Control reviews
One of the known issues found
Work sent back to its creator
Another review round
Back through review
After
Check for the 19 known issues
Show the creator what to fix
Clean work for document control
Document Control decides
Cleaner work
Before
Back through review
- 01
Change order submitted
- 02
Document Control reviews
- 03
One of the known issues found
- 04
Work sent back to its creator
- 05
Another review round
After
Cleaner work
- 01
Check for the 19 known issues
- 02
Show the creator what to fix
- 03
Clean work for document control
Document Control decides
What Botable built
The check now happens when the change order is created, not after it is submitted.
It catches the mistakes before submission. Document Control still reviews the change.
- 01
Check for the 19 known issues
The creator enters the change order number. The system checks the attached documents and the PLM record against the team's list of known rejection reasons.
- 02
Show the creator what to fix
The creator gets a list of what is wrong and fixes it before submitting.
- 03
Document Control reviews clean work
Reviewers make the same call they always did. They just stop finding the same fixable mistakes.
Evidence
The review starts with cleaner work.
- 7,500+
- Change orders a year checked
- 19
- Known issues checked on every change order
- Before submission
- When mistakes are now caught
- 0
- Systems replaced. Built on the existing PLM.
After go-live
The list started at 10 issues. It is now 19.
The first version checked 10 known rejection reasons. As document control found new ones, Botable added them. Nobody on the quality team maintains the list, files a ticket, or waits on IT. It keeps up with the process because keeping up with it is Botable's job.
Start with one gapHave a review step that keeps catching the same mistakes?
We will build the check that catches them earlier, and keep it current as the process changes.
Start with one gap