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§ 110.10 Personnel.
The plant management shall take all reasonable measures and precautions to ensure the following:
(a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.
(b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to:
(1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials.
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.
(4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.
(5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material.
(6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.
(7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.
(8) Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.
(9) Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.
(c) Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.
(d) Supervision. Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to competent supervisory personnel.
[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]
110.10 員工
生產加工企業管理機構必須采取合理的措施和預防方法確保做到下列幾點:
a.疾病控制:經體檢或監督人員觀察,凡是患有或疑似患有疾病、創傷,包括癤、瘡或感染性的創傷,或可成為食品、食品接觸面或食品包裝材料的微生物污染源的員工,直至上述病癥消除之前,均不得參與食品生產加工,否則會造成污染。必須要求員工在發現上述疾病時向上級報告。
b.清潔衛生:凡是在工作中直接接觸食品、食品接觸面及食品包裝材料的員工必須嚴格遵守衛生操作規范,使食品免受到污染。保持清潔的方法包括,但不僅限于:
(1) 穿戴適合生產加工的工作衣,防止食品、食品接觸面或食品包裝材料受污染。
(2) 保持良好的個人衛生。
(3) 開始工作之前、每次離開工作臺之后、以及手被污染或其他任何情況下受到污染時,應在合適的洗手設施上徹底洗凈雙手(如要防止有害微生物的污染,則應進行消毒)。
(4) 除去不牢靠的,可能掉入食品、設備或容器中的珠寶飾品和其他飾物,除去在手工操作食品時無法徹底消毒的首飾。如果無法除去首飾,可以用一塊完整無損的、清潔衛生的、并能有效地防止食品、食品接觸面或食品包裝材料受污染的物料將首飾包套起來。
(5) 使用的手套(如果用它們處理食品)應完整無損、清潔衛生。手套應當用不滲透的材料制作。
(6) 在適當的場合,應戴發網、束發帶、帽子、胡須套,或其他有效的須發約束物。
(7) 將衣物或其他個人物品應存放在不與食品接觸或被清洗設備用具之外的場所。
(8) 將以下行為限制在不與食品接觸或被清洗設備及用具之外的區域:吃東西、咀嚼口香糖、喝飲料或吸煙。
(9) 采取其他必要的預防措施,防止食品、食品接觸面或食品包裝材料受到微生物或異物(包括,但不僅限于:汗水、頭發、化妝品、煙草、化學物及皮膚用藥物)的污染。
c.教育與培訓:負責檢查評定衛生不良或食品污染的人員應當受過教育培訓或具有經驗,或兩者皆具備,這樣才能保證生產出干凈和安全的食品。食品加工和監督人員應當接受食品加工技術及食品保護原理的適當培訓,而且應當認識到不良的個人衛生及不衛生操作的危險性。
d.監督:必須明確地指定由符合要求的監督人員監管全體員工。務必使員工遵守本章的一切規定(51 FR24475,1986年 6月 19日發布實施;1989年 6月 12日修改為 54FR24892)。
更多關于美國FDA 21 CFR 第110部分的內容,請詳見美國FDA 21 CFR 第110部分關于食品生產企業現行良好操作規范(GMP)法規匯總