3. D-3
還是來點正能量,引用愛爾蘭食品安全單位的說明
Benefits of HACCP ( 導入 HACCP 的好處,阿原翻譯如下 )
https://www.fsai.ie/food_businesses/haccp/benefits_of_haccp.html
Saves your business money in the long run
長期來看,為企業省錢
Avoids you poisoning your customers
避免顧客食品中毒
Food safety standards increase
食品安全標準會提升
Ensures you are compliant with the law
確定您符合法規之要求
Food quality standards increase
食品品質標準會提升
Organises your process to produce safe food
讓您生產的流程更有組織
Organises your staff promoting teamwork and efficiency
組織您的成員使提升團隊合作與效率
Due diligence defence in court.
法庭上的正當勤勞的辯護
就是沒有提到可以增
加收益 (revenue)
https://publicdomainvectors.org/en/
free-clipart/Vector-image-of-wooden-
treasure-chest-with-gold-frame/
21150.html
5. D-5
國外案例
Patulin levels in juice, filth at plant prompts FDA warning letter
By News Desk on May 14, 2018
https://www.foodsafetynews.com/2018/05/patulin-levels-in-juice-filth-at-plant-prompts-fda-warning-letter/
FDA 警告信 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hood-river-juice-company-inc-544482-04252018
棒麴毒素 (patulin)
Hood River Juice Company Inc. in Hood River, OR, was inspected by the U.S.
Food and Drug Administration Nov. 27 through Dec. 6 2017, and the results were
not good.
After the inspections, an FDA Form 483, listing the deviations was left with the
company. Hood River Juice Company responded on Dec. 18, 2017…One of the
most severe violations by the firm includes the failure to list all food safety
hazards that are reasonably likely to occur, and specifically, their HACCP plan
does not identify the food hazard of patulin.
▼ fair use 合理使用
7. D-7
對美國 FDA Form 483 ( 現場觀察報告 ) 及 Warning letter ( 警告信 )
有興趣的伙伴,可以
美國食品藥物管理局境外查核我國食品加工廠
衛生安全管理之流程分析 食品藥物研究年報 8: 234-241 2017
https://www.google.com.tw/url?sa=t&rct=j&q=&esrc=/slideshow/20200328-haccp-dmod/230971761/s&source=web&cd=9&cad=rja&uact=8&ved=2ahUKEwjgk_Ta9O7mAhUSvZQKHcCbCuUQFjAIegQIBhAC&url=https%3A%2F%2Finfo.fda.gov.tw
%2Ftc%2Fincludes%2FGetFile.ashx%3Fid%3Df636694170580551819&usg=AOvVaw1-pO7HBbJVlWQswtxX1d3P
Inspection Observations
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-
observations
FDA 提供的 Form 483 範本
https://www.fda.gov/media/101860/download
https://www.fda.gov/media/87761/download
FDA Form 483 Frequently Asked Questions | FDA
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-
frequently-asked-questions
Form FDA 483 - Wikipedia
https://en.wikipedia.org ? wiki ? Form_FDA_483
8. D-8
國外案例
Warning Letter says juice maker fails to pass FDA inspection
https://www.foodsafetynews.com/2017/05/warning-letter-says-juice-maker-fails-to-pass-fda-inspection/
By News Desk on May 1, 2017
Stoney Ridge Farm LLC in Everson, WA, was inspected by the U.S. Food and Drug Administration
Dec. 21 and 22, 2016, and again on Jan. 5 this year and the results were not good.
FDA closeout letter
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stoney-ridge-farm-llc-517412-04182017
*Failure to document the monitoring of critical control points by
not recording actual times and temperatures and other
measurements described in the HACCP plan.
*Failure to document continuous recording thermometer and
flow rate for apple cider in order to ensure control of biological
hazards identified in HACCP plan. ▼ fair use 合理使用
9. D-9
國外案例
▼ fair use 合理使用
*Failure to monitor conditions and practices during processing
with sufficient frequency to ensure conformance with current
Good Manufacturing Practice regulations. This included failure
to monitor the condition and cleanliness of food contact
surfaces, protection of food, food packaging material and food
contact surfaces from adulertion. [adulteration]
*Failure to exclude pests from inside the juice facility. This is
due to accumulated debris and flies in the production room.
*Failure to maintain sanitation control records.