察 CAPA 根因

為合規偏行結構根因察並設有效糾正與預防動（CAPA）。

用

• 審計所識需 CAPA
• 確認系統之偏或事件
• 監管察需正式應
• 數據完整異需察
• 重現問題示系統根因

入

• 必：偏、識或事件之述
• 必：嚴重歸（臨、主、次）
• 必：審計或察時集之證
• 可：前相關 CAPA 或察
• 可：相關 SOP、確認文件、系統日誌
• 可：涉員訪談記

行

一：起察

# Root Cause Investigation
## Document ID: RCA-[CAPA-ID]
## CAPA Reference: CAPA-[YYYY]-[NNN]

### 1. Trigger
| Field | Value |
|-------|-------|
| Source | [Audit finding / Deviation / Inspection observation / Monitoring alert] |
| Reference | [Finding ID, deviation ID, or observation number] |
| System | [Affected system name and version] |
| Date discovered | [YYYY-MM-DD] |
| Severity | [Critical / Major / Minor] |
| Investigator | [Name, Title] |
| Investigation deadline | [Date — per severity: Critical 15 days, Major 30 days, Minor 60 days] |

### 2. Problem Statement
[Objective, factual description of what happened, what should have happened, and the gap between the two. No blame, no assumptions.]

### 3. Immediate Containment (if required)
| Action | Owner | Completed |
|--------|-------|-----------|
| [e.g., Restrict system access pending investigation] | [Name] | [Date] |
| [e.g., Quarantine affected batch records] | [Name] | [Date] |
| [e.g., Implement manual workaround] | [Name] | [Date] |

得：察起，明問題述，臨識於 24 時內遏。 敗：遏不能即施→升 QA 總監並記延遏之風險。

二：擇察法

按問題複度擇：

### Investigation Method Selection

| Method | Best For | Complexity | Output |
|--------|----------|-----------|--------|
| **5-Why Analysis** | Single-cause problems, straightforward failures | Low | Linear cause chain |
| **Fishbone (Ishikawa)** | Multi-factor problems, process failures | Medium | Cause-and-effect diagram |
| **Fault Tree Analysis** | System failures, safety-critical events | High | Boolean logic tree |

**Selected method:** [5-Why / Fishbone / Fault Tree / Combination]
**Rationale:** [Why this method is appropriate for this problem]

得：法配問題複度——勿為簡程誤用故障樹，亦勿為複系統失用 5-Why。 敗：首法不達信服根因→用二法。多法收斂強結論。

三：行根因析

甲：5-Why

### 5-Why Analysis

| Level | Question | Answer | Evidence |
|-------|----------|--------|----------|
| Why 1 | Why did [the problem] occur? | [Immediate cause] | [Evidence reference] |
| Why 2 | Why did [immediate cause] occur? | [Contributing factor] | [Evidence reference] |
| Why 3 | Why did [contributing factor] occur? | [Deeper cause] | [Evidence reference] |
| Why 4 | Why did [deeper cause] occur? | [Systemic cause] | [Evidence reference] |
| Why 5 | Why did [systemic cause] occur? | [Root cause] | [Evidence reference] |

**Root cause:** [Clear statement of the fundamental cause]

乙：魚骨（石川）圖

### Fishbone Analysis

Analyse causes across six standard categories:

| Category | Potential Causes | Confirmed? | Evidence |
|----------|-----------------|------------|----------|
| **People** | Inadequate training, unfamiliarity with SOP, staffing shortage | [Y/N] | [Ref] |
| **Process** | SOP unclear, missing step, wrong sequence | [Y/N] | [Ref] |
| **Technology** | System misconfiguration, software bug, interface failure | [Y/N] | [Ref] |
| **Materials** | Incorrect input data, wrong version of reference document | [Y/N] | [Ref] |
| **Measurement** | Wrong metric, inadequate monitoring, missed threshold | [Y/N] | [Ref] |
| **Environment** | Organisational change, regulatory change, resource constraints | [Y/N] | [Ref] |

**Contributing causes:** [List confirmed causes]
**Root cause(s):** [The fundamental cause(s) — may be more than one]

丙：故障樹析

### Fault Tree Analysis

**Top event:** [The undesired event]

Level 1 (OR gate — any of these could cause the top event):
├── [Cause A]
│   Level 2 (AND gate — both needed):
│   ├── [Sub-cause A1]
│   └── [Sub-cause A2]
├── [Cause B]
│   Level 2 (OR gate):
│   ├── [Sub-cause B1]
│   └── [Sub-cause B2]
└── [Cause C]

**Minimal cut sets:** [Smallest combinations of events that cause the top event]
**Root cause(s):** [Fundamental failures identified in the tree]

得：根因析達根本因（非僅症），各步有證支持。 敗：僅生症（「用者誤」）→推深。問：「用者何能造此誤？何控當阻之？」

四：設糾正與預防動

明辨糾、糾正動、預防動：

### CAPA Plan

| Category | Definition | Action | Owner | Deadline |
|----------|-----------|--------|-------|----------|
| **Correction** | Fix the immediate problem | [e.g., Re-enable audit trail for batch module] | [Name] | [Date] |
| **Corrective Action** | Eliminate the root cause | [e.g., Remove admin ability to disable audit trail; require change control for all audit trail configuration changes] | [Name] | [Date] |
| **Preventive Action** | Prevent recurrence in other areas | [e.g., Audit all systems for audit trail disable capability; add monitoring alert for audit trail configuration changes] | [Name] | [Date] |

### CAPA Details

**CAPA-[YYYY]-[NNN]-CA1: [Corrective Action Title]**
- **Root cause addressed:** [Specific root cause from Step 3]
- **Action description:** [Detailed description of what will be done]
- **Success criteria:** [Measurable outcome that proves the action worked]
- **Verification method:** [How effectiveness will be checked]
- **Verification date:** [When effectiveness will be verified — typically 3-6 months after implementation]

**CAPA-[YYYY]-[NNN]-PA1: [Preventive Action Title]**
- **Risk addressed:** [What recurrence or spread this prevents]
- **Action description:** [Detailed description]
- **Success criteria:** [Measurable outcome]
- **Verification method:** [How effectiveness will be checked]
- **Verification date:** [Date]

得：各 CAPA 動可追至具體根因，有可量成準，含效驗計。 敗：成準模糊（「改善合規」）→重寫為具體可量（「6 連月內無變更管制外之審計跡配置變」）。

五：驗效

CAPA 施後驗動實有效：

### Effectiveness Verification

**CAPA-[YYYY]-[NNN] — Verification Record**

| CAPA Action | Verification Date | Method | Evidence | Result |
|-------------|------------------|--------|----------|--------|
| CA1: [Action] | [Date] | [Method: audit, sampling, metric review] | [Evidence reference] | [Effective / Not Effective] |
| PA1: [Action] | [Date] | [Method] | [Evidence reference] | [Effective / Not Effective] |

### Effectiveness Criteria Check
- [ ] The original problem has not recurred since CAPA implementation
- [ ] The corrective action eliminated the root cause (evidence: [reference])
- [ ] The preventive action has been applied to similar systems/processes
- [ ] No new issues were introduced by the CAPA actions

### CAPA Closure
| Field | Value |
|-------|-------|
| Closure decision | [Closed — Effective / Closed — Not Effective / Extended] |
| Closed by | [Name, Title] |
| Closure date | [YYYY-MM-DD] |
| Next review | [If recurring, when to re-check] |

得：效驗示根因實除，非僅動畢。 敗：驗示 CAPA 無效→重開察並設修訂動。勿閉無效 CAPA。

六：析 CAPA 趨勢

### CAPA Trend Analysis

| Period | Total CAPAs | By Source | Top 3 Root Cause Categories | Recurring? |
|--------|------------|-----------|---------------------------|------------|
| Q1 20XX | [N] | Audit: [n], Deviation: [n], Monitoring: [n] | [Cat1], [Cat2], [Cat3] | [Y/N] |
| Q2 20XX | [N] | Audit: [n], Deviation: [n], Monitoring: [n] | [Cat1], [Cat2], [Cat3] | [Y/N] |

### Systemic Issues
| Issue | Frequency | Systems Affected | Recommended Action |
|-------|-----------|-----------------|-------------------|
| [e.g., Training gaps] | [N occurrences in 12 months] | [Systems] | [Systemic programme improvement] |

得：趨勢析識單 CAPA 所失之系統問題。 敗：趨勢示 CAPA 仍有重現根因→CAPA 僅治症。升管理審以系統干預。

驗

• 察於時限內起（臨 24 時，主 72 時）
• 問題述據實無責
• 察法適問題複度
• 根因析達根本因（非僅症）
• 各根因步有證支持
• CAPA 辨糾、糾正動、預防動
• 各 CAPA 有可量成準與驗計
• 閉前以證驗效
• 至少季審趨勢

忌

• 止於症：「用者誤」非根因。根因乃系統或程何容此誤
• CAPA = 重訓：重訓僅治一可能根因（知）。若真根因為系統設計缺或 SOP 不清→重訓不阻重現
• 未驗閉：畢動 ≠ 驗效。未驗效之 CAPA 乃待發之監管引用
• 責向察：聚何人誤非何容誤→損質文化、抑報
• 無趨勢：單 CAPA 或似無關，趨勢常揭系統問題（如「訓」根因跨多系統→訓程損）

參

• conduct-gxp-audit — 審生需 CAPA 之識
• monitor-data-integrity — 監測異起察
• manage-change-control — CAPA 驅變入變更管制
• prepare-inspection-readiness — 開及逾期 CAPA 為監管首查
• design-training-program — 根因為訓相關時→改訓程