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배경
ISO 13485:2016 ISO-5.6.2(MR 입력 9개 항목)·ISO-5.6.3(출력) 둘 다 PARTIAL. SOP-MR-001(v0.1, 327 lines) 절차서는 충실하나 실제 입력/출력
양식(F-MR-001/002)·실증 기록 샘플 부재 — 심사 시 「실제 수행 증거」가 약하다.
갭 내용
| 조항 | 요구사항 | 현재 상태 |
| --- ...
prio:P1
qms
risk:high
source:plan
type:depth
배경
ISO 13485:2016 ISO-7.5.1b(배치/로트별 제조 기록) PARTIAL. SOP-MFG-001(제조공정관리)은 절차를 다루지만, DHR(Device History Record) 양식·배치 트레이서빌리티
항목이 명시적으로 정의되지 않음. FDA QMSR §820.184(DHR 신설) 합치성 위해 필수.
갭 내용
| 조항 | 요구사항 | ...
prio:P1
risk:high
source:plan
type:clause
배경
ISO 13485:2016 §7.4.1·§7.4.2·§7.4.3 그리고 ISO-7.4.1a(공급자 재평가) 모두 CHK-ISO13485-001에서 PARTIAL. 09_공급자_관리/SOP-SUP-001(공급자
감사·재평가)·F-SUP-001(초기평가)만 존재 — 구매 요구사항 명확화(7.4.2) 및 구매 제품 검증 활동 정의(7.4.3)를 다루는 별도 ...
prio:P1
qms
risk:high
source:plan
type:clause
Parent
#1 — Milestone 1: Earth 1960 → First Moon Landing (Godot 4)
What to build
Implement the full lunar sequence: Lunar Transit research, probe launch with ETA countdown, probe arrival with survey ...
ready-for-agent
Idea
Context seeding (watchdog context / /watchdog-context) currently shells out to Claude Code: cmd_context
(cmd/ingest.py:265-307) calls _launch_claude(vault, /watchdog-context , model=...), handing ...
enhancement
When trying to select a model for an agent, there is no way to return back to Choose Agent View.
img width= 886 height= 370 alt= Image src=
https://github.com/user-attachments/assets/8a39b626-8af6-415b-a69e-81cead54ea95 ...
loop
Idea
Treat the bare watchdog command (no args, run from inside a project) as a do whatever makes sense next orchestrator that
walks the user through the pipeline in order, offering each stage interactively: ...
enhancement
enhancement
hello,
artifacts are not generated since 1.1.4
Describe the bug I have a resource pack that adds custom models for skeletons with specific names, who I want to use as
NPCs. Just on its own the pack works fine - skeletons with specified name do receive ...
bug

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