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§110.10 现行良好操作规范的操作人员(Personnel)

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放大字体  缩小字体 2011-04-19 09:28:39  来源:GPO  浏览次数:5665
核心提示:生产加工企业管理机构必须采取合理的措施和预防方法确保做到下列几点:疾病控制、清洁卫生、教育与培训、监督。
发布单位
FDA
FDA
发布文号 51 FR 24475
发布日期 1986-06-18 生效日期 暂无
有效性状态 废止日期 暂无
备注 生产加工企业管理机构必须采取合理的措施和预防方法确保做到下列几点:疾病控制、清洁卫生、教育与培训、监督。

  原文后附带中文翻译,由食品伙伴网食品论坛网友gaoketian提供,食品伙伴网在此表示感谢!

     § 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 员工

  生产加工企业管理机构必须采取合理的措施和预防方法确保做到下列几点:

  a.疾病控制:经体检或监督人员观察,凡是患有或疑似患有疾病、创伤,包括疖、疮或感染性的创伤,或可成为食品、食品接触面或食品包装材料的微生物污染源的员工,直至上述病症消除之前,均不得参与食品生产加工,否则会造成污染。必须要求员工在发现上述疾病时向上级报告。

  b.清洁卫生:凡是在工作中直接接触食品、食品接触面及食品包装材料的员工必须严格遵守卫生操作规范,使食品免受到污染。保持清洁的方法包括,但不仅限于:

  (1) 穿戴适合生产加工的工作衣,防止食品、食品接触面或食品包装材料受污染。

  (2) 保持良好的个人卫生。

  (3) 开始工作之前、每次离开工作台之后、以及手被污染或其他任何情况下受到污染时,应在合适的洗手设施上彻底洗净双手(如要防止有害微生物的污染,则应进行消毒)。

  (4) 除去不牢靠的,可能掉入食品、设备或容器中的珠宝饰品和其他饰物,除去在手工操作食品时无法彻底消毒的首饰。如果无法除去首饰,可以用一块完整无损的、清洁卫生的、并能有效地防止食品、食品接触面或食品包装材料受污染的物料将首饰包套起来。

  (5) 使用的手套(如果用它们处理食品)应完整无损、清洁卫生。手套应当用不渗透的材料制作。

  (6) 在适当的场合,应戴发网、束发带、帽子、胡须套,或其他有效的须发约束物。

  (7) 将衣物或其他个人物品应存放在不与食品接触或被清洗设备用具之外的场所。

  (8) 将以下行为限制在不与食品接触或被清洗设备及用具之外的区域:吃东西、咀嚼口香糖、喝饮料或吸烟。

  (9) 采取其他必要的预防措施,防止食品、食品接触面或食品包装材料受到微生物或异物(包括,但不仅限于:汗水、头发、化妆品、烟草、化学物及皮肤用药物)的污染。

  c.教育与培训:负责检查评定卫生不良或食品污染的人员应当受过教育培训或具有经验,或两者皆具备,这样才能保证生产出干净和安全的食品。食品加工和监督人员应当接受食品加工技术及食品保护原理的适当培训,而且应当认识到不良的个人卫生及不卫生操作的危险性。

  d.监督:必须明确地指定由符合要求的监督人员监管全体员工。务必使员工遵守本章的一切规定(51 FR24475,1986年 6月 19日发布实施;1989年 6月 12日修改为 54FR24892)。

  更多关于美国FDA 21 CFR 第110部分的内容,请详见美国FDA 21 CFR 第110部分关于食品生产企业现行良好操作规范(GMP)法规汇总

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