Skills › Scientific Agent Skills › iso-standards-readiness › capa-record-template.json
capa-record-template.json
99 lines · skills/iso-standards-readiness/assets/templates/capa-record-template.json at 5f2bc03
1{
2 "_notice": "DRAFT EXAMPLE ONLY. A script cannot approve, close, or determine the effectiveness or regulatory adequacy of a CAPA.",
3 "metadata": {
4 "register_id": "<controlled CAPA register ID>",
5 "review_date": "<YYYY-MM-DD>",
6 "owner": "<CAPA system owner>",
7 "status": "draft",
8 "evidence": [],
9 "approval": {
10 "status": "pending",
11 "by": "",
12 "date": ""
13 },
14 "source_refs": []
15 },
16 "capas": [
17 {
18 "id": "<CAPA ID>",
19 "owner": "<CAPA owner>",
20 "status": "open",
21 "source_event": "<complaint/audit/nonconformity/supplier/risk signal ID>",
22 "problem_statement": "<factual problem statement>",
23 "scope": "<known and potential systemic extent>",
24 "correction_or_containment": "<immediate action and evidence>",
25 "evidence": [],
26 "source_refs": [],
27 "approval": {
28 "status": "pending",
29 "by": "",
30 "date": ""
31 },
32 "risk_assessment": {
33 "patient_and_user_impact": "<assessment>",
34 "product_and_process_impact": "<assessment>",
35 "reportability_review": "<authorized reportability/vigilance decision reference>",
36 "decision": "escalate",
37 "decision_rationale": "<rationale>",
38 "owner": "<risk/RAQA owner>",
39 "evidence": [],
40 "approval": {
41 "status": "pending",
42 "by": "",
43 "date": ""
44 }
45 },
46 "investigation": {
47 "method": "<selected method and rationale>",
48 "root_cause_or_justified_conclusion": "<supported conclusion>",
49 "systemic_extent_review": "<similar products/processes/sites review>",
50 "owner": "<investigation owner>",
51 "evidence": [],
52 "approval": {
53 "status": "pending",
54 "by": "",
55 "date": ""
56 }
57 },
58 "actions": [
59 {
60 "id": "<action ID>",
61 "description": "<action tied to supported cause/risk>",
62 "owner": "<action owner>",
63 "due_date": "<YYYY-MM-DD>",
64 "implemented_date": "",
65 "evidence": [],
66 "approval": {
67 "status": "pending",
68 "by": "",
69 "date": ""
70 }
71 }
72 ],
73 "change_control_refs": [
74 "<change record ID>"
75 ],
76 "effectiveness": {
77 "plan": "<planned check>",
78 "objective_acceptance_criteria": "<measurable criteria>",
79 "baseline": "<baseline/comparator>",
80 "sample_or_observation_window": "<risk-based sample/window>",
81 "due_date": "<YYYY-MM-DD>",
82 "owner": "<effectiveness owner>",
83 "independent_reviewer": "<independent reviewer>",
84 "result": "pending",
85 "conclusion": "",
86 "review_date": "",
87 "evidence": [],
88 "approval": {
89 "status": "pending",
90 "by": "",
91 "date": ""
92 }
93 },
94 "closure_date": "",
95 "closure_summary": "",
96 "cancellation_rationale": ""
97 }
98 ]
99}