BC medical-device-risk-management
医疗器械风险管理（ISO 14971:2019 / GB/T 42062-2022）专题技能——六步风险流程实操（风险分析→评价→控制→综合剩余风险→报告→生产后反馈）+ 危害识别清单 + 风险矩阵与可接受准则 + 风险管理报告框架。每份医械注册案卷的必备文件，审评首先看的"风险是否识别评价控制"，一站拿到可落地的模板与全球标准对照（含 FDA 认可共识标准、EU 协调标准、日本 JIS T 0304）。
医疗器械风险管理（ISO 14971:2019 / GB/T 42062-2022）专题技能——六步风险流程实操（风险分析→评价→控制→综合剩余风险→报告→生产后反馈）+ 危害识别清单 + 风险矩阵与可接受准则 +…
As a process C 53/100 · Has gaps — weak spots: result and completion, when it triggers, inputs and preconditions
What is at stake
Medium-severity findings: the skill is probably honest, but read what alarmed the scanner.
Below is the worst case for this category. The finding here is medium: the guard saw a sign, not a proof.
The skill contains commands that delete files, rewrite disks or execute code fetched from the network. The agent may run them without asking if it believes the instructions require it.
Replace destructive commands with safe equivalents that ask for confirmation, scope them to one folder, and stop piping curl into a shell: pin a version and a checksum.
How to improve
- Say in the description WHEN to use the skill ("use when…", example requests): that is the agent's main cue.
- For Hermes the description must be one sentence under 60 characters; move the conditions to a "When to Use" section.
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 1
✓ No critical or high findings
Medium and low: 1
-
medium Dangerous commands
cmd-pipe-to-shell安全审计报告.md:28Downloads and executes remote code from an unrecognised host (pipe to shell) (documentation table row)| 远程脚本下载执行 | 无 `curl \| bash`、base64 解码执行等模式 | ✅ 无风险 |
table
Files scanned: 9. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
- warning
description-long-hermesdescription is 204 chars; the Hermes authoring standard requires ≤ 60 (one sentence, ending with a period) - warning
description-no-whenneither description nor a "## When to Use" section says when to use the skill - note
frontmatter-keyunknown frontmatter key "displayName" - note
frontmatter-keyunknown frontmatter key "description_zh" - note
frontmatter-keyunknown frontmatter key "description_en" - note
frontmatter-keyunknown frontmatter key "xiaping_category" - note
frontmatter-keyunknown frontmatter key "xiaping_tags" - note
frontmatter-keyunknown frontmatter key "agent_created" - note
frontmatter-keyunknown frontmatter key "slug" - note
frontmatter-keyunknown frontmatter key "display_name" - note
frontmatter-keyunknown frontmatter key "title"
Process rating: all ten parameters 53/100
- 0Result and completion. Does not say what the result is
- 0Inputs and preconditions. Does not say what the process needs to start
- 0Failures and branches. Linear process with no failure handling
- 0Progress reporting. Says nothing while it works
- 20When it triggers. No condition that starts the skill
- 100Tools and files. No external tools needed
- 100Steps. 22 steps
- 100Consistency. Name and required fields are in place
- 100Execution cost. Instruction body is 490 tokens
- 100Running it twice. No mutating operations
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +3Output format is not stated: the model decides each time
- +4No input/output examples
- +2Single-language instructions
- +3Description length 204: enough signal without eating the budget
- +4Structure: 9 headings
- +3Step-by-step instructions: 22 items
- +4Reference files are cited in the instructions (1 of 1)
- +1License stated
Quality base 70; lint remarks subtract, signals add up to 100. Result: 64.