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获取原文件assets/templates/procedures/CAPA-procedure-template.md
STATUS: DRAFT EXAMPLE — NOT APPROVED — NOT EVIDENCE OF CONFORMITY
Adapt this structure to approved processes, applicable requirements, product risk, and authorized roles. A completed template or passing script cannot establish compliance, close a CAPA, or replace RA/QA, management, legal, regulatory, auditor, or certification-body judgment.
Controlled-document metadata
| Field | Entry |
|---|---|
| Document ID/revision | <ID> / <revision> |
| Owner | <accountable role> |
| Status | draft / in-review / approved |
| Effective date | <YYYY-MM-DD after approval> |
| Evidence repository | <controlled location> |
| Supersedes/change record | <IDs> |
| Approval role | Named approver | Status | Date | Approval evidence |
|---|---|---|---|---|
| Process owner | <name/role> |
pending |
<date> |
<ID> |
| RA/QA | <name/role> |
pending |
<date> |
<ID> |
| Authorized management | <name/role> |
pending |
<date> |
<ID> |
1. Purpose and scope
- Controlled purpose:
<organization-specific statement> - Products, sites, processes, and records covered:
<scope> - Interfaces: complaints, audit, suppliers, nonconformity, risk, vigilance, design/production change, validation, training, and management review.
- Exclusions or interfaces outside this procedure:
<approved rationale/evidence>
2. Roles and authority
| Role | Responsibility and decision authority | Escalation | Competence evidence | Approval |
|---|---|---|---|---|
| CAPA system owner | <entry> |
<entry> |
<ID> |
<ID> |
| CAPA owner | <entry> |
<entry> |
<ID> |
<ID> |
| Independent effectiveness reviewer | <entry> |
<entry> |
<ID> |
<ID> |
| RA/QA reviewer | <entry> |
<entry> |
<ID> |
<ID> |
| Closure approver | <entry> |
<entry> |
<ID> |
<ID> |
3. CAPA intake and decision
Define controlled inputs and the approved criteria for opening, escalating, linking, combining, or declining a CAPA. Do not use an arbitrary priority label as a substitute for product/process risk and reportability review.
| Input | Owner | Decision method | Evidence | Status | Approval |
|---|---|---|---|---|---|
| Complaint/feedback | <role> |
<method> |
<ID> |
draft |
<ID> |
| Audit/nonconformity | <role> |
<method> |
<ID> |
draft |
<ID> |
| Supplier issue | <role> |
<method> |
<ID> |
draft |
<ID> |
| Trend/risk/postmarket signal | <role> |
<method> |
<ID> |
draft |
<ID> |
Each decision record must include:
- unique CAPA ID and source-event links;
- factual problem statement and known scope;
- correction/containment and evidence;
- product, patient/user, process, and regulatory/reportability impact review;
- decision owner, status, rationale, evidence, and approval.
4. Investigation and systemic extent
The record must define the method before drawing a conclusion and preserve the evidence reviewed.
| Field | Required entry |
|---|---|
| Investigation owner/status | <role> / draft |
| Scope and plan | <entry> |
| Data and evidence IDs | <IDs> |
| Analysis method and rationale | <entry> |
| Root cause or justified conclusion | <entry> |
| Similar/systemic issue review | <entry> |
| Risk-file/design/supplier/process impacts | <entry> |
| Reviewer and approval evidence | <role/ID> |
Do not force a preferred root-cause method. Select and approve a method appropriate to the evidence, complexity, and risk.
5. Action planning and change control
| Action ID | Description | Owner | Due date | Change/validation/training links | Implementation evidence | Status | Approval |
|---|---|---|---|---|---|---|---|
<ID> |
<entry> |
<role> |
<date> |
<IDs> |
<IDs> |
planned |
<ID> |
Actions must address the supported cause or risk, include objective acceptance criteria, and route affected documents, software, validation, suppliers, products, training, risk files, and postmarket controls through approved change control.
6. Effectiveness plan and review
Define the effectiveness plan before closure.
| Field | Required entry |
|---|---|
| Effectiveness owner | <role> |
| Independent reviewer | <role> |
| Objective acceptance criteria | <measurable criteria> |
| Baseline/comparator | <entry> |
| Data source and evidence IDs | <IDs> |
| Sample or observation window | <risk-based rationale> |
| Review date | <YYYY-MM-DD> |
| Result | pending / effective / ineffective |
| Conclusion and evidence | <entry/IDs> |
| Approval | <approver/date/record ID> |
Fail-closed gate: pending, insufficient data, or ineffective cannot support
closure. Re-open the investigation/action cycle or document authorized escalation.
7. Closure, cancellation, and extension
Closure requires:
- all actions implemented with evidence;
- approved effectiveness result of
effective; - linked risk, design, production, supplier, postmarket, document, validation, and training changes completed or explicitly dispositioned;
- complete source/version references;
- closure summary, date, owner, status, evidence, and authorized approval.
Cancellation or due-date changes require a documented rationale, risk/reportability impact review, owner, status, evidence, and approval. Neither changes the need for immediate safety or regulatory action when applicable.
8. Records, metrics, and management visibility
| Record/measure | Owner | Retention basis | Location | Review method | Evidence | Approval |
|---|---|---|---|---|---|---|
| CAPA record set | <role> |
<approved basis> |
<location> |
<method> |
<ID> |
<ID> |
| Aging/overdue status | <role> |
<basis> |
<location> |
<method> |
<ID> |
<ID> |
| Recurrence/effectiveness trend | <role> |
<basis> |
<location> |
<method> |
<ID> |
<ID> |
| Management-review input | <role> |
<basis> |
<location> |
<method> |
<ID> |
<ID> |
Release checklist
- Placeholders are resolved.
- Interfaces to risk, complaints/vigilance, suppliers, design, production, validation, software, training, and change control are explicit.
- No fixed timeline is used without an approved risk/process basis.
- Effectiveness criteria are objective and approved before closure.
- Records carry owner, status, evidence, source/version, and approval fields.
- Authorized human approvers released the procedure.
- The procedure makes no compliance or certification claim.