Risk management lead
- Sees
- Open chains, the usability question and the overall residual risk facts
- Signs
- Decides acceptability under the plan and approves the review
One change order, one missing warning
A risk management file re-check, and the staple line warning a reformat lost
A powered linear cutter's file holds 318 chains, 1,906 links and 11 IFU language versions. One change order launches a 60 mm reload and reformats the IFU into two columns.
demoThe device, its risk file, the people and every figure on the screens are sample data.
- 01Before the re-check
One change order runs through 103 of 318 chains and clears her signature
Risk management leadThe rack draws the file as 318 chains on eight shelves, one per hazardous situation. The change order for the 60 mm reloads brought IFU rev F, a new design FMEA revision, and a verification report, drawing and label for the new size. 103 chains pass through a changed passage, and the other 215 keep their last check. Her earlier approval is cleared until someone signs again.
- 02Re-check
102 chains stay whole, and the one that opens is a staple line crossed
Risk management leadShe starts the re-check and watches the agents work through it. Controls: 102 of 103 implemented and matched to the current revision of their report. Disclosure: 75 chains across 11 language versions, 825 sentence places, 814 found and 11 not found, all of them in the same chain. That chain is a staple line crossed with a later firing, severity 4.
- 03Re-check
Four links open at once, because the warning was the control
Risk management leadNo design or protective measure can stop a surgeon choosing to cross a staple line, so this hazard's control is information for safety: the IFU warning itself. With the sentence gone, the control is not implemented in rev F, its verification fails, the residual estimate that assumed it no longer stands, and the disclosure is missing. Each open link names its document, revision and page.
- 04Re-check
Rev E carried the sentence as item 9, and rev F's warnings stop at 11
Risk management leadShe opens the source behind the disclosure link. English page 14 of rev E sits beside pages 12 and 13 of rev F. Item 9 warned that crossing an existing staple line can increase the risk of leaks. The reformat for the 60 mm reload dropped it, and the list now holds 11 items where rev E held 12. Her reading is recorded with her session.
- 05Labeling
The approved sentence goes back into all 11 versions from translation memory
Labeling specialistThe labeling specialist signs in as herself, opens rev E and rev F, and restores warnings item 9 word for word into draft 3, in all 11 language versions, signed as author. Only this chain is re-checked, and the warning is found in 11 of 11. The usability evidence ran on the single-column rev E layout, so that question waits for the lead.
- 06Sampled check
A second person opens 3 chains the agents called whole, link by link
Design quality engineerThe design quality engineer signs in as himself. The rule in settings draws 3 of the 102 whole chains at random: a titanium clip caught in the 60 mm jaws, a staple line not inspected in lung tissue, an opened reload kept for a later case. He opens all six links of each beside its source and signs the sampled check, meaning Review.
- 07Sign-off
She rules the rev E usability evidence still holds for the two-column IFU
Risk management leadThe warning's effectiveness evidence, task 14 with 15 of 15 surgeons, was run on the old layout. She reads the review packet and decides it applies to rev F, reason UL-1: the same wording, order and place in the warnings list. She signs that decision as a review. Only her conclusion on overall residual risk is still open.
- 08Sign-off
317 risks sit in the acceptable region, and one was accepted on benefit-risk
Risk management leadThe agents set out the overall residual risk facts and draw no conclusion: 317 of 318 in the plan's acceptable region, one accepted after benefit-risk analysis, none unacceptable. She chooses acceptable under the plan's criteria herself and approves review rev 9 over IFU rev F draft 3. A later draft of the IFU would reopen it.
- 09Release
The change order may now release, and the release stays in the quality system
Risk management leadThe change page lists what the order touched: the IFU, the design FMEA, the 60 mm verification report, drawing and label, 103 chains in all. It now reads can release, review signed. The quality release lead at the stapler plant does the release in the quality management system. Before anyone edits a document, its reach shows the chains it would touch.