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HACCP 基礎班
1. 實務演練 -Ⅲ
2. HACCP 監控 、矯正措施及確認系統之建立
(monitoring, corrective actions, and establishing verification procedures)
2019-04-02 南亞技術學院
講師:江易原
社會關懷者 / 準創業家
iychiang1809@gmail.com
下載課程講義及補充資料
https://iychiang1809.blogspot.com/
2019/04/20190420-haccp-haccp.html
2
1. 阿原個人創作與編輯的部份,放棄著作權保護,歡迎任何人進行任何用途,不需要事先取得
阿原同意。 引用的資料可能沒有版權或自由授權。
2. 但部分所引用資料有其原始授權或版權,阿原僅能合理使用或非商業用途。在著作權保護期
限內阿原無權改變其版權。若您預計將本簡報進行商業用途或再次散布時,請先移除標示有倒三角
標示的資料 『▼』 ( 如合理使用或原作者限制商業用途 )
3. 本簡報使用 行政院建議之 LibreOffice 6.1.5.2 ,在 Linux Mint 19 MATE 上進行編輯。
建議使用合法免費的國發會工具或是 Libreoffice 編輯本簡報之原始檔。
4. 阿原的講義資料等,若經他人修改,或非從阿原提供的下載點之資料,其正確性與阿原無
關。阿原喜歡讀資料、編講義,並無償公開,但難免有錯字或錯誤,歡迎來信指正。
阿原開放式課程及教學影片
本講義版權沒有,歡迎使用
下載阿原歷年 HACCP 報或食品衛生講義
https://iychiang1809.blogspot.tw/
2016/04/blog-post_15.html
3
為何 HACCP 這麼難懂?
---- 看阿原改編的漫畫
學 HACCP 的困難點之一
1. 是無法理解大架構,
2. 小細節多如牛毛 ( 都要背下來,多數人不情願,阿原當年也是,現在
也是 )
阿原走過那段時間,印象深刻,事實上,對餐飲或是食品系的學生,最難
的不是細節,是大架構 --- 驗證系統的概念,違反台灣教育的內涵
( 這才是根本原因 )
4
而各位在學校的東西,非常有用,但是,缺乏大架構的視角,所以不易體
會自己已經學到、已經帶在身上的武器。 等有了大架構的高度,就會知道
自己想要如何發展,還缺少什麼武器,以有限的資源 ( 時間、金錢、注意
力 )  自己在特定時間內,可以抓到多少武器。
阿原希望透過這樣的提示,讓大家可以快速抓到大架構。
今天第二單元的主題,監控 、矯正措施及確認,也是大架構的一部份,而
大架構如阿原整理的數張 A3 大表格,希望用簡單的方式把大架構列出
來,方便大家對照。
5
今天的主題,是大架
構之下的一部份。
細節迷路了,回頭看
大架構
有一顆星記號的 A3 大表格
~~~~~~~~~~ 略 ~~~~~~~~~~
6
1. 成立 HACCP 系統小組
2. 描述產品
3. 決定產品預計使用方式
4. 建立製造流程圖
5. 現場流程圖之確認 (confirmation)
6. 列出所有潛在危險 / 執行危害分析
/ 考慮控制方法
7. 決定 CCPs
8. 對每個 CCP 建立管制界限
9. 對每個 CCP 建立監控系統
10. 建立矯正措施
11. 建立確認 (verification) 程序
12. 建立文件與紀錄保存
雖然今天主題是
第 9, 10, 11 步驟,但還需要看
全面的,尤其是流程圖、危害分
析、 CCP
7
依照《中央廚房式餐飲製造業建立 HACCP 系統參考手冊》找出與 CCP 點相關的單元,並說明其連動關係
阿原製圖,版權沒有,歡迎使用
初學者經常不易了解 CCP 點之觀念,阿原以中央廚房 HACCP 手冊為例子說明,
幫大家打通任督二脈
9-1
9-2 製程與品質 p18, 19
9-3
危害分析
p46, 47
流程圖
p45
決定 CCP 點
P49 - 51
9-4
9-5
9-6
9-7
9-8
9-9
內稽
HACCP 計畫書 GHP 作業程序書 紀錄表單
CCP
執
行
方
法
管制介限
矯正措施
異常處理
p52
食品中心溫度紀錄表
G-4-2-02
p71
異常處理紀錄表
G-4-1-02
p56
執行後記錄
執
行
後
記
錄
超過管制介限未達設定溫度異常處理
執行後記錄
8
稽核時,從哪些文件開始?
1. 現場環境是否落實 GHP
2. 文件與紀錄也很重要。阿原在輔導或稽查時,一定先看 CCP 點相
關的文件與紀錄
9-2 製程與品質
危害分析 流程圖
決定 CCP 點
HACCP 計畫書 GHP 作業程序書 紀錄表單
管制介限
矯正措施
異常處理
食品中心溫度紀錄表
異常處理紀錄表
阿原
阿原查核業者執行 CCP 相關的文件與紀錄表單之過程
9
從四階文件的角度,看今天的內容
有兩個三角記號的 A3 大表格
~~~~~~~~~~ 略 ~~~~~~~~~~
10
監控 (monitoring)
Who: 誰來監控 ( 廚師 / 衛管 / 組長 /)
What: 監控項目 ( 溫度 / 水活性 /pH--- 儀器校正與操作 )
How: 如何執行監控
When: 監控頻率 ( 依照過去的統計資料之變異 )( 看阿原手上的包子 )
7. 決定 CCPs
8. 對每個 CCP 建立管制界限
9. 對每個 CCP 建立監控系統
10. 建立矯正措施
11. 建立確認 (verification) 程序
12. 建立文件與紀錄保存
今天要談監控,表示已經確定 CCP ,以及
管制界限。
我們使用衛福部出版的《中央廚房式餐飲製
造業建立 HACCP 系統參考手冊》,阿原快
速幫大家複習前面的觀念,再來看監控。
11
直接監控 ( 需要驗效 )
微生物:食物的中心溫度 ( 校正過的溫度計 )
微生物:檢測水活性 ( 標準品 )
微生物:檢測 pH 值 ( 標準緩衝溶液 )
物理 -- 異物:金檢機 ( 標準測試片 )
化學:殘留量檢測
間接監控 ( 需要驗效。需要與原始數據比對 )
油炸鍋或烘箱設定的溫度與時間
醃漬食品的可滴定酸
冷凍的溫度與時間
監控的結果,需要可以對應到 CCP
監控 (monitoring)
參考資料: Establishing Food Safety Monitoring Procedures: HACCP Principle #4. NC State
University. https://www.youtube.com/watch?v=T2Zak_hFXEA
12
監控的執行,需要是可以即時 (real-time) 測量的方式
例如監控微生物的危害,
若是烹煮的結果,進行取樣後檢驗微生物或病原,一般需要 48 小時後
才會知道微生物檢驗結果,因此不適合用來作為監控的方式。所以經常
監控溫度。但是對於台灣法規要求特定食品需要進行特定病原菌檢測,
合格後才能出貨,就是另一個品管的方式 。
( 例如法規要求飲料要檢驗沙門氏菌等微生物,嬰兒食品要檢驗阪崎腸
桿菌等病原菌 )
例如對牛乳或果汁進行巴斯德殺菌,因為殺菌設備的管子長度與流速可
以固定,經過測試後,設定儀器,找出有效的殺菌溫度與時間
監控 (monitoring)
13
溫度與殺菌的歷史
而對溫度進行監控,就變得簡單又快速。從可信的科學紀錄,知道加熱
溫度與殺菌的情況,在近代拿破崙主政者時期,為了東西徵求保存食物
的方法, Nicolas Appert 於 1804 年發明罐頭,後人稱這種消毒法為
Appertization 。
1864 年,路易巴斯德 (Louis Pasteur) 提出巴斯德滅菌法
(Pasteurization, 又稱為巴斯德殺菌 / 巴斯德消毒 ) ,是相對溫和的殺
菌法,主要殺掉腐敗菌疾病原菌,但會有耐熱性的微生物與其孢子殘
留,例如造成台灣食品中毒主要病原菌之一的仙人掌桿菌,就是產孢
子,巴斯德殺菌的條件無法殺掉其孢子。
為何監控溫度,就可以知道殺菌效果?
14
在前方已經建立管制點,設定管制界限 ( 這個例子是中心
溫度達 80℃) ,接下來就是監控。
15
資料來源:
Safe Minimum Cooking Temperatures, Foodsafety.gov (USDA)
https://www.foodsafety.gov/keep/charts/mintemp.html
使用 google 翻譯後,阿原人工校正,並把華氏溫度改成攝氏。
各類食材最低安全烹調溫度
16
提醒,國內有些學者認為美國對加熱安全溫度的設定是相對寬鬆
17
矯正措施
(corrective actions)
例如烹飪或加工,食物中心未達設定的溫度,可以繼續加熱。
某些情況無法進行矯正措施,則該產品需要丟棄。
7. 決定 CCPs
8. 對每個 CCP 建立管制界限
9. 對每個 CCP 建立監控系統
10. 建立矯正措施
11. 建立確認 (verification) 程序
12. 建立文件與紀錄保存
參考資料: Food safety. British Columbia, Canada
https://www2.gov.bc.ca/gov/content/industry/agriculture-seafood/fisheries-and-aquaculture/seafood-safety
當監控對象,超過管制界限,我們視同不
安全, 此時需要進行矯正措施。
18
矯正措施
2009-01-15 全美航空 1549 號班
機,與到鳥擊,兩個引擎同時失去
動力,機長駕駛,請副機長查詢操
作手冊,及後續應變措施。
Plane Hits the Birds | Sully (2016) |
https://www.youtube.com/watch?v=JSlbHK07fkY
影片 1:50 遭到鳥擊, 3:10 查手冊
Author Greg L, CC_BY-2.0
https://en.wikipedia.org/wiki/US_Airways_Flight_1549
我們在餐飲業或食品製造,超過管制界限,不會墜機,只要依照手冊
上,已經擬定好的矯正措施,進行矯正。
阿原想說,連開飛機遇到問題,都需要查手冊,各位在食品餐飲上,
監控 CCP ,遇到問題,可以不查手冊嗎?
( 據說該事件之後,當局開始簡化手冊及查詢的方式。 )
各位會不會問,現在科技發達,飛機卻躲不過飛鳥?
19
20
桃園市
範圍的大小
就像南亞技術學院位在 龍昌里 -- 中壢區 -- 桃園市
談 Verification ( 確認 ) 前,這概念
非常抽象,我們先暖身
中壢區龍昌里
21
這三者的範圍大小,以食品業為例子
抽驗與檢驗 -- 品管 (QC) -- 品保 (QA)
品保 (QA)品管 (QC)抽樣檢驗
需要的知識能力也不同
抽樣檢驗:統計學、檢驗技術
品管:法規標準、儀器保養與校正
品保:驗證系統、客訴、統計分析等
22
Verification
確認
Validation
驗效
Calibration
校正
這也是 HACCP 初學者常混淆的地方 ( 阿原當年也是 )
23
法規要求
Verification
確認
Validation
驗效
Calibration
校正
校正
法規: GHP (20180621 草案 )
第 11 條
三、測定、控制或記錄之測 量器
或記錄儀 , 應定期校正其準確性。
驗效
法規:食品安全管制系統準則 (2018-05-01 修正 )
第 7 條 管制小組應對每一重要管制點建立管制界限,
並進行驗效 (validation)
確認
法規:食品安全管制系統準則 (2018-05-01 修正 )
第二條
七、 確認本系統執行之有效性 (Confirm the
effectiveness of the system implementation)
24
Verification
確認
Validation
驗效
Calibration
校正
校正
溫度計、 pH 計
水活性測定儀
( 工欲善其事,必先利其器
,而且要校正 )
驗效
這樣的管制點,是否有效 ( 科學文獻、實測 )
例如一般餐飲加熱型,管制介限設定 80℃ ,這樣的條件,是否則夠達
到殺滅微生物到可接受的範圍。若是加熱到 65℃ ,是否可行?
確認
除監控外,從 CCP 設定是否合理、驗效方式、設計的
流程、人員操作、廠區衛生、各類執行紀錄、產品是
否檢驗合格才出場等方式,確認整個 HACCP 系統是
否能有要運作。
參考資料:
MyHACCP, Food Standard Agency, UK
https://myhaccp.food.gov.uk/help/guidance/principle-6-verification
25
建立確認程序
(Establishing Verification Procedures)
7. 決定 CCPs
8. 對每個 CCP 建立管制界限
9. 對每個 CCP 建立監控系統
10. 建立矯正措施
11. 建立確認 (verification) 程序
12. 建立文件與紀錄保存
1. 是否適當的執行監控與矯正措施
2. 是否適當的記錄監控與矯正措施
3. 人員是否經過適當的教育訓練,而且有效
4. HACCP 計畫是合理且有效
26
確認 (Verification)
建立確認程序
1. What: 確認哪些項目
2. How: 如何確認
3. Who: 誰來確認 ( 避免由執行監控的人來進行確認 )
4. When: 何時確認
5. 確認後之矯正措施:進行確認,若發現問題,該採取之動作
27
一般寫在後面欄,由主管每週檢查。尤其是對異常的紀
錄,找出問題之原因,找出解法。
( 例如阿原經常遇到記錄的溫度低於設定值,卻沒有進行矯正 )
28
openclipart.org/detail/182876/
sun-under-clouds
openclipart.org/detail/192996/red-crab
openclipart.org/detail/19896/beach

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