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英语作文-环境风险评估与管控措施研究与案例分享Environmental risk assessment is a critical process in the management of environmental hazards. It involves identifying potential environmental threats and evaluating their possible impact on ecosystems and human health. The ultimate goal is to develop effective control measures to mitigate these risks. This essay delves into the methodologies of environmental risk assessment and shares case studies that highlight successful management strategies.The first step in environmental risk assessment is the identification of hazards. This involves a thorough analysis of the physical, chemical, and biological elements that could potentially cause harm. For instance, a chemical manufacturing plant may release toxic substances into the air and water, posing a threat to nearby communities and wildlife. By recognizing these hazards, stakeholders can prioritize which risks require immediate attention.Once hazards are identified, the next step is to evaluate the likelihood and severity of their impact. This is often done through quantitative methods, such as modeling the dispersion of pollutants or assessing the toxicity levels of chemicals. For example, researchers might use air quality models to predict the concentration of pollutants at various distances from a factory. These models help in understanding the potential exposure levels for humans and the environment.Risk characterization combines the information on hazard identification and impact evaluation to estimate the overall risk. This step considers both the probability of occurrence and the magnitude of consequences. It provides a comprehensive view of the potential environmental damage and forms the basis for developing control measures.Control measures are the actions taken to manage and reduce environmental risks. These can range from technological solutions, such as installing pollution control equipment, to policy interventions, like enforcing stricter emission standards. A casestudy that exemplifies effective control measures is the cleanup of the Hudson River in New York. After decades of pollution from PCBs, a combination of dredging and habitat restoration has significantly reduced the levels of contamination, leading to a healthier ecosystem.Monitoring and review are essential components of environmental risk management. They ensure that control measures are working as intended and allow for adjustments if necessary. Continuous monitoring of environmental indicators, such as water quality and biodiversity, provides data that can inform future decisions and policies.In conclusion, environmental risk assessment and control measures are indispensable tools in the pursuit of sustainable development. They enable us to understand and manage the complex interactions between human activities and the natural world. Through diligent application of these processes and learning from successful case studies, we can protect our environment and ensure a healthy planet for future generations.This essay has explored the intricate process of environmental risk assessment and the importance of implementing robust control measures. By examining real-world examples, it has demonstrated the positive outcomes that can be achieved when risks are managed effectively. The continuous evolution of assessment techniques and control strategies will play a pivotal role in safeguarding our environment against the myriad of risks it faces. 。
引言所有类型和规模的组织都面临内部和外部的、使组织不能确定是否及何时实现其目标的因素和影响。
这种不确定性所具有的对组织目标的影响就是“风险”。
组织的所有活动都涉及风险。
组织通过识别、分析和评定是否运用风险处理修正风险以满足它们的风险准则，来管理风险。
通过这个过程，它们与利益相关方进行沟通和协商，监测和评审风险，以及为确保不再进一步需求风险处理而修正风险的控制措施。
本国际标准详细描述了这一系统的和逻辑的过程。
尽管所有的组织在某种程度上都在管理风险，本国际标准建立了一些为使风险管理变得有效而需要满足的原则。
本国际标准建议，组织制定、实施和持续改进一个框架，其目的是将风险管理过程整合到组织的整体治理、战略和规划、管理、报告过程、方针、价值观和文化中。
风险管理可以在组织多个领域和层次、任何时间，应用到整个组织，以及具体职能、项目和活动。
尽管在过去一段时间在许多行业，为满足不同的需要，已经开展了风险管理实践，但在一个综合框架内采用一致性过程有助于确保在组织内有效、有效率和结合性地管理风险。
本国际标准中所描述的通用方法提供了在任何范围和状况下，以系统、清晰、可靠的方式管理风险的原则和指南。
每一个具体行业或风险管理的应用都产生了各自的需求、受众、观念和准则。
因此，本国际标准的主要特点是将所包含“确定状况”作为通用风险管理过程开始的活动。
确定状况将捕获组织的目标，组织所追求目标的环境，组织的利益相关方和风险准则的多样性，所有这些都将帮助揭示和评价风险的性质和复杂性。
本国际标准描述的风险管理原则、框架和风险管理过程之间的关系，如图1所示。
当依据本国际标准实施和保持风险管理时，能够使组织，例如：——提高实现目标的可能性；——鼓励主动性管理;——在整个组织意识到识别和处理风险的需求;——改进机会和威胁的识别能力；——符合相关法律法规要求和国际规范；——改进强制性和自愿性报告；——改善治理；——提高利益相关方的信心和信任；——为决策和规划建立可靠的根基；——加强控制；——有效地分配和利用风险处理的资源；——提高运营的效果和效率；——增强健康安全绩效，以及环境保护;——改善损失预防和事件管理；——减少损失；——提高组织的学习能力——提高组织的应变能力本国际标准旨在满足众多利益相关方的需求，包括：a）负责制定组织风险管理方针的人员;b）负责确保在组织整体、或者某一特定区域、项目或者活动内有效开展风险管理的人员;c）需要评定组织风险管理有效性的人员；d）整体或部分地实施风险管理的标准、指南、程序和操作规范的开发者。
健康安全环境风险评估总结汇报
为了确保员工和环境的安全，我们进行了一次健康安全环境风
险评估。
评估的目的是识别和评估工作场所可能存在的健康、安全
和环境风险，并采取相应的措施来减少或消除这些风险。
在评估过程中，我们首先对工作场所进行了全面的检查，包括
办公区域、生产车间、仓库和设施设备。
我们发现了一些潜在的健康、安全和环境风险，包括工作场所的通风不良、化学品泄漏的风险、设备操作不当的风险等。
针对这些风险，我们采取了一系列的措施来加以控制和管理。
首先，我们改善了工作场所的通风系统，确保空气质量达标。
其次，我们对化学品的存储和使用进行了规范，制定了详细的操作流程和
安全措施。
最后，我们对员工进行了安全培训，提高了他们对设备
操作和紧急情况处理的意识和技能。
通过这次健康安全环境风险评估，我们不仅找出了工作场所存
在的风险，也采取了有效的措施来加以控制和管理。
我们相信，这
些措施将有助于提高员工的健康和安全意识，减少工作场所的意外
事件发生，保护环境的健康和安全。
在未来，我们将继续定期进行健康安全环境风险评估，并不断改进和完善我们的管理措施，确保工作场所的健康、安全和环境风险得到有效控制和管理。
同时，我们也鼓励员工积极参与健康安全环境管理，共同营造一个安全、健康的工作环境。
Risk of Pathogenic Contamination1.Our facility is a dry environment. Water is not used in any part of our process including cleaning or processing.Our products are dry. Our dry edible beans have a water activity of ≤ 0.87 (source:.ca/agriculture/food-safety/at the food processor)Water Activity needed for these micros to reproduceBacillus cereus 0.93Clostridium botulinum 0.97C. perfringens 0.95Pathogenic E. coli 0.95Salmonella spp. 0.95Source: Cereal foods World 26:345-349, page 83, Beuchat, L.R.2.Microbiological hazards are not inherent in the product or the environment. It is possible, however, for externalpathogens (such as E Coli, Salmonella, etc.) to become attached to beans at the farm or, in some cases, at these facilities.Time and Temperature needed to kill these pathogens:Temp Time Where SourceBacillus cereus 203°F 2 minutes Internal Thermal Inactivation, Ashtown Research, Dublin (2005)Clostridium botulinum 180°F 10 minutes Internal Colorado State Univ. Botulism Fact SheetC. perfringens 212°F > 1.9 minutes Internal Thermal Inactivation, Ashtown Research, Dublin (2005)Pathogenic E. coli 194°F > 90 seconds Internal Internal Journal of food Protection, April 2008*Salmonella spp. 165°F <10 seconds Internal Science of Cooking, Important Temperatures*M. L. BARI, Y. INATSU, S. ISOBE, and S. KAWAMOTO (2008) Hot Water Treatments To Inactivate Escherichia coli O157:H7 and Salmonella in Mung Bean Seeds. Journal of Food Protection: April 2008, Vol. 71, No. 4, pp. 830-834.The University of Nebraska, Lancaster County Extension Education, states that to properly cook beans, the beans are to come to a boil (212°F) and then be simmered (defined by several publications as 185°F plus) for 1.5-2.0 hours. Such cooking will inactivate all the above-mentioned pathogens. Since all beans cleaned/sorted/packaged at this facility will be cooked after they leave these facilities, pathogens are not a concern.Risk of Spoilage Organisms in Beans1.Spoilage Organisms of potential concern for dry edible beans are molds. Molds require a combination of productmoisture, environmental relative humidity and environmental temperature to form.2.Mold growth occurs on beans stored at 70o F when the relative humidity is greater than 75% (which equates toabout 16% product moisture). (M. A. UEBERSAX and C. L. BEDFORD: Navy Bean Processing: Effects of Storage and Soaking methods on Quality of Canned Beans, Michigan State University Agricultural Experiment Station East Lansing, December 1980)3. At our facility, the average moisture of beans received in a normal year is 15%. The average moisture of beansshipped from our facility is about 12.5%.4.The table below shows the average temperature and relative humidity in North Dakota for months normallyassociated with storing dry edible beans and what the equilibrium moisture content for edible beans would be under these conditions. Note: The equilibrium moisture content is the moisture content at which the material is neither gaining nor losing moisture.(Table from K.J. HELLEVANG, Grain Moisture Content Effects and Management, NDSU Extension Service, March 1995)Based on the above data, mold will not form in our dry beans under normal conditions. Our beans average 15% moisture. The average temperature, relative humidity and moisture content of beans during the normal storage period will not support the formation of molds.。
环境风险评估分析英语作文Environmental Risk Assessment Analysis。
Introduction:Environmental risk assessment is a systematic process that evaluates the potential adverse effects of human activities on the environment. It helps in identifying and analyzing the risks associated with various activities and provides strategies to mitigate those risks. This essay aims to analyze the concept of environmental risk assessment and its significance in safeguarding the environment.Body:1. Definition of Environmental Risk Assessment:Environmental risk assessment involves the identification, evaluation, and estimation of the potentialadverse effects of human activities on the environment. It considers various factors such as pollution, climate change, habitat destruction, and resource depletion.2. Importance of Environmental Risk Assessment:a) Protection of the environment: By identifying potential risks, environmental risk assessment helps in developing strategies to prevent or minimize adverseeffects on the environment.b) Sustainable development: It enables decision-makersto make informed choices by considering the environmental risks associated with different activities.c) Public health: Environmental risk assessment helpsin evaluating the impact of pollutants and contaminants on human health, leading to the development of measures to protect public health.3. Steps involved in Environmental Risk Assessment:a) Hazard identification: This step involvesidentifying potential hazards or risks to the environment. It includes analyzing the nature and characteristics of the activity and its potential impact.b) Risk assessment: In this step, the identified hazards are evaluated to determine the likelihood and severity of the adverse effects on the environment. It involves collecting and analyzing data to estimate the potential risks.c) Risk management: Once the risks are assessed, appropriate measures are developed to manage and mitigate these risks. This step includes the implementation of preventive measures and monitoring the effectiveness ofrisk management strategies.d) Communication and decision-making: The findings of the risk assessment are communicated to stakeholders and decision-makers to facilitate informed decision-making. This step ensures that the risks are understood and appropriate actions are taken.4. Examples of Environmental Risk Assessment:a) Industrial activities: Environmental risk assessment helps in evaluating the potential risks associated with industrial processes, such as chemical spills, air pollution, and waste disposal.b) Construction projects: It enables the assessment of risks related to habitat destruction, soil erosion, and pollution caused by construction activities.c) Energy production: Environmental risk assessment plays a crucial role in assessing the impact of energy production methods, such as fossil fuel combustion, nuclear power, and renewable energy sources.Conclusion:Environmental risk assessment is a vital tool in safeguarding the environment and promoting sustainable development. It helps in identifying potential risks,evaluating their impact, and developing strategies to mitigate these risks. By incorporating environmental risk assessment into decision-making processes, we can ensure the protection of the environment and the well-being of future generations.。
环境监测评估总结汇报
尊敬的领导和各位同事：
我很荣幸能够向大家汇报我们的环境监测评估工作。
在过去的
一段时间里，我们团队致力于对环境进行全面的监测和评估，以确
保我们的生活和工作环境的安全和健康。
首先，我们对环境进行了全面的监测，包括空气质量、水质、
土壤污染等方面。
通过专业的设备和技术手段，我们成功地收集了
大量的数据，并对其进行了分析和评估。
在空气质量方面，我们发
现了一些污染源，并及时采取了措施进行治理，以保障人们的健康。
在水质和土壤污染方面，我们也发现了一些问题，并已经启动了相
应的整改计划。
其次，我们对环境进行了综合评估，包括环境风险评估和环境
影响评估。
我们根据收集的数据和现场调研，对环境风险进行了定
量和定性的评估，并制定了相应的应对措施。
同时，我们也对各种
活动和工程对环境的影响进行了评估，以确保它们符合环保标准和
法规要求。
最后，我们还进行了一些公众参与和社会影响评估工作，以了解公众对环境问题的关注和反馈，同时也提高了公众对环境保护的意识和参与度。
总的来说，我们的环境监测评估工作取得了一些成果，但也还存在一些问题和挑战。
我们将继续努力，加强监测和评估工作，为创造一个更加安全、健康和可持续的环境而努力奋斗。
谢谢大家的支持和合作！
此致。
敬礼。
二、环境的风险管理（一）环境污染事故分类（风险分析）1.根据事故的性质，污染事故可分为：水污染事故、大气污染事故、噪声与振动危害事故、固体废弃物污染事故、有毒化学物品污染事故和放射性污染事故等。
2.根据事故的污染程度，污染事故可分为：一般环境污染事故、较大环境污染事故、重大环境污染事故、特大环境污染事故。
(二)现场环境的有关规定（风险控制）1.施工单位应当遵守有关环境保护法律规定，采取措施控制施工现场各种粉尘、废气、废水、固体废弃物以及噪声、振动对环境的污染和危害。
2.施工单位应当采取下列防止环境污染的措施：（1）除设有符合规定的装置外，不得在施工现场溶融沥青或焚烧油毡、油漆以及其它会产生有毒有害烟尘和恶臭气体的物体；（2）使用密封式的圈筒或者采取其它措施处理高空废弃物；（3）采取有效措施控制施工过程中的扬尘；（4)禁止将有毒有害废弃物作土方回填，应及时将建筑施工工地产生的建筑垃圾自行清运到指定地点或委托环卫部门有偿清运处理；（5）对产生噪声、振动的施工机械，应当采取有效的控制措施，减轻噪声扰民。
3.尽量避免夜间施工，确需夜间作业的，必须向环保分局申请核发《夜间作业许可证》,经审批同意并发放夜间施工《通告》后方可进行施工。
4.设置各种防护设施，防止施工中产生扬尘及废弃物。
所有建筑工地必须设置围栏，施工道路要硬化，工地出入口有车轮清洗设备；装卸渣土严禁凌空抛散；有专人清扫路面，按规定使用商品混凝土，搅拌站有扬尘控制措施；楼层建筑垃圾严禁凌空抛散及乱倒乱卸，应垂直清运，禁止现场消化石灰、拌石灰土或其他有严重粉尘污染的作业。
道路、桥梁及河道整治施工工地应封闭进行并采取必要的防尘措施，施工弃土及时清运或采取覆盖措施，防止雨水冲刷。
5.施工单位不得向绿化带及绿化观察井排放施工废水，不得在绿化带及其周围一米范围内堆放施工废土和垃圾，及时清理建筑垃圾，控制建筑污染。
做好垃圾﹑工程渣土﹑黄沙等建筑材料运输的密闭化工作，控制扬尘污染。
报告编号：QRM2012-007洁净厂房环境监测风险评估报告第页共6页目录1.概述2.风险评估的目的和适用范围3.风险评估小组成员及职责4.风险评估4.1风险分析识别4.2风险判断标准4.3风险识别结果4.4风险评价结果第页共6页1.概述：我公司根据检测需要，严格按照GMP要求和产品要求，质量管理部和设备动力部负责对洁净区环境进行监测。
环境监控有悬浮粒子计数器、浮游菌采样器、照度仪、风速计、噪声仪、臭氧浓度检测仪、气体检测报警仪等检测检验设备，能够完成满足生产过程控制的要求。
同时根据区域或房间不同的设置和功能，具体分析每个区域或房间的风险来源，并制定相对应的监测措施，为在这些洁净区内进行的所有生产活动提供符合GMP的洁净级别要求。
2.风险评估的目的和适用范围：评估的目的：对影响生产过程控制的因素进行评价，对可能的危害进行判定,对于每种危害可能产生损害的严重程度、危害的发生概率和可检测性进行估计,在某一风险水平不可接受时，建议采取了降低风险的措施，在日常管理中进行控制。
适用范围：各车间洁净区的环境监控。
3. 风险评估小组成员及职责：第页共6页4.风险评估4.1风险分析识别：应用FMEA，识别潜在的失败模式，对风险的严重程度、发生几率和发现的可能性评分。
第页共6页4.2风险判断标准：4.3风险识别结果通过比对产品工艺规程、产品质量回顾与总结历史经验、查找资料、学习新版GMP及实施指南等方法，对环境监测中可能出现的质量风险进行了调查与分析。
现将查找并确认可能存在的质量风险与可能形成的危害统计如第页共6页下：第页共6页第页共6页这次评估共列举风险9项，其中高等风险0个，中等风险3个，低等风险6个。
4.4风险评价结果：第页共6页结论：通过对各生产车间生产过程各工序的调查、分析与评估，共查找列举了可能风险项目9项，分析评估判断中等级风险项目3项，高等级风险项目0项，其余6项低等级风险暂时予以忽略。
针对这2项中等级风险项目，风险管理小组逐一制订了控制措施，配套文件与规程已经修订完成，初步评估相应的控制措施将能够有效执行，将能够有效降低或控制生产过程中的质量风险。
环境风险分析范文环境风险分析(Environmental Risk Analysis) 是指对特定环境工程、项目或活动可能导致的环境风险进行评估和分析的过程。
环境风险是指在环境工程、项目或活动中可能发生的不利环境效应，包括污染、生态破坏、资源浪费和人类健康受影响等。
环境风险分析的目的是为了识别和评估潜在的风险，从而制定相应的管理和控制措施，以保护环境和人类健康。
1.问题定义和范围界定：确定研究的对象和目标，并明确分析的范围。
例如，选择一些环境工程、项目或活动进行风险评估。
2.风险识别：通过收集和分析相关的信息，确定可能导致环境风险的因素和过程。
这包括分析相关的环境因素、技术过程、社会经济条件和政策法规等。
3.风险评估：根据识别出的风险因素，对其可能的出现概率和影响程度进行评估。
常用的方法包括定性评估和定量评估。
定性评估是基于专家判断和经验来进行风险分析，而定量评估则需要进行数学建模和统计分析。
4.风险权衡和优先排序：根据风险评估的结果，对不同风险进行权衡和排序，确定哪些风险是最重要和紧迫的，需要优先处理。
这需要考虑到不同风险的可能性、影响程度和可控性等因素。
5.风险管理和控制：针对识别出的高风险问题，制定相应的管理和控制措施。
这可能包括技术改进、监测和检测、安全培训、风险传递和保险等。
6.风险沟通和参与：及时向相关利益相关方提供风险评估的结果，并鼓励他们积极参与风险管理和控制的过程。
风险沟通和参与是确保风险管理的有效性和可持续性的重要环节。
7.风险监督和评估：定期或不定期对已实施的风险管理和控制措施进行监督和评估，以确保其有效性和适应性。
如果发现问题，需要及时调整和改进。
环境风险分析的价值在于帮助决策者和利益相关方了解和评估可能的环境风险，并制定相应的管理和控制策略。
它有助于减少环境污染和生态破坏对人类健康和生态系统的影响，保护自然资源的可持续利用。
此外，环境风险分析还能帮助企业和项目运营者降低可能的环境责任和法律风险，提升企业形象和竞争力。
英语作文-环境风险评估与管控措施研究Environmental Risk Assessment and Management Measures。
Environmental risk assessment plays a pivotal role in safeguarding ecosystems, human health, and sustainable development. This process involves the systematic evaluation of potential hazards posed by various activities or pollutants to the environment. By identifying risks early on, effective management strategies can be implemented to mitigate adverse impacts and promote environmental sustainability.The assessment begins with the identification of potential hazards, which can range from industrial emissions and chemical spills to habitat destruction and climate change effects. Each hazard is evaluated based on its likelihood and potential consequences, taking into account factors such as toxicity, persistence, and the sensitivity of local ecosystems. This initial phase provides a foundation for understanding the scope and severity of potential environmental risks.Following hazard identification, the next critical step is exposure assessment. This involves determining how, where, and to what extent hazardous substances or activities may come into contact with environmental receptors, including air, water, soil, and biota. Through advanced modeling techniques and field measurements, exposure pathways are delineated to quantify the actual or potential exposure levels.Risk characterization integrates hazard and exposure data to assess the overall risk posed to the environment. This phase involves evaluating the likelihood and magnitude of adverse effects on ecosystems, biodiversity, and ecosystem services. By combining scientific data with risk assessment frameworks, decision-makers can prioritize risks and allocate resources effectively to prevent or minimize environmental harm.Effective risk management strategies are essential for controlling identified environmental risks. These strategies include engineering controls, administrative measures, and use of protective equipment to reduce exposure to hazardous substances.Implementing best practices and technologies, such as pollution prevention measures and sustainable practices, further mitigate risks and promote environmental stewardship.Continuous monitoring and reassessment are integral to adaptive risk management. Environmental conditions and risk factors can change over time due to factors such as climate variability, technological advancements, and regulatory updates. Regular monitoring ensures that risk management strategies remain effective and adaptive to evolving environmental challenges.Public engagement and stakeholder involvement are crucial components of effective environmental risk assessment and management. By fostering transparency, accountability, and community participation, stakeholders contribute valuable insights and support for sustainable decision-making processes. This inclusive approach enhances trust, promotes compliance with regulations, and fosters a shared responsibility for environmental protection.In conclusion, environmental risk assessment and management are fundamental practices for addressing and mitigating potential hazards to our natural environment. By systematically evaluating risks, implementing effective management strategies, and engaging stakeholders, we can safeguard ecosystems, protect biodiversity, and promote sustainable development. Through collaborative efforts and continuous improvement, we can ensure a resilient and healthy environment for current and future generations.This article highlights the importance of proactive risk assessment and management in achieving environmental sustainability. By adhering to rigorous methodologies and integrating scientific advancements, we can navigate complex environmental challenges and promote responsible stewardship of our natural resources.。
Environmental Monitoring Risk Assessment环境监测风险评估Wednesday, August 30, 2006 - Journal of GXP Compliance, January 2006, Volume 10, Number 2星期三，8月30日，2006 - Journal of GXP Compliance，2006年1月，10卷，2号INTRODUCTION引言Environmental Monitoring describes the microbiological testing undertaken in order to detect changing trends of microbial counts and micro-flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.环境监测描述了在洁净室或受控环境下，为了监测微生物数量和微生物群落繁殖的变化趋势而进行的微生物测试。
所测结果提供关于房间结构，空调系统性能，人员卫生，更衣行为，设备和清洁操作的信息。
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.在过去十年里，环境监测愈发复杂，从任意取样，按照假想的房间网格进行测试，到现阶段注重风险评估并使用风险评估工具确定环境监测的最佳方法。
This paper explores current trends in the application of risk assessment to the practice of environmental monitoring by examining the following key areas:本文从以下几个重要方面探讨了将风险分析应用于环境监测的现有趋势：∙Determining the Frequency of Monitoring: Using the concept（理念、观念）of risk assessment to decide how often to monitor different types of cleanrooms ∙确定监测频率：按照风险分析理念，确定不同类型洁净室的监测周期。
∙Risk Assessment Tools（工具）: Applying risk assessment tools to establish methods for environmental monitoring 。
∙风险评估工具：运用风险分析工具确定环境监测方法。
∙Numerical（数字的、数值的）Approaches: Considering a numerical approach to assess risk data using a case study of an aseptic（无菌的）filling operation ∙数值法：使用无菌灌装操作案例分析考虑采用数值法评估风险数据The examples used are from a sterile drug manufacturing facility and focus mostly on aseptic filling; however, the concepts and tools are applicable to the environmental monitoring of other types of manufacturing and packaging operations.使用案例来自无菌药品生产设备，大多为无菌灌装；然而，理念和工具也同样适用于其他类型生产和包装操作的环境监控。
DETERMINING THE FREQUENCY OF MONITORING: 确定监测频率In developing an adequate （适当的、胜任的）environmental monitoring programme, there should be a balance between using resources efficiently and monitoring at sufficiently（充分地、足够地）frequent intervals（应对资源的有效利用率和监测频率的间隔上进行平衡）so that a meaningful picture can be obtained. Sources of guidance with respect to monitoring frequencies are very limited within Europe, and the monitoring frequencies specified within the United States Pharmacopoeia (USP) <1116> may not be suitable for all facilities. Some guidance can be obtained from the International Organization for Standardization’s (ISO) standards: principally ISO 14644 and ISO 14698. However, these do not always fit with regulatory guidance documents because they apply to （适用于、应用于）controlled environments across a range of （一系列、一些）industries other than pharmaceuticals, where standards can be higher (Jahnke, 2001).合理的环境监测项目应当平衡高效利用资源和监测频率这二者的关系，只有这样才有意义。
在欧洲，关于监测频率方面的指导资源非常有限，USP规定的监测频率不一定适用于所有的设备。
可以从ISO标准获取一定的指导：主要是ISO 14644 and ISO 14698. 然而，这些标准不一定符合法律指导性文件，因为它们适用于多个行业的受控环境，不仅仅是标准更高的药品行业(Jahnke, 2001).When establishing an environmental control programme, the frequency of monitoring different controlled areas can be determined based on ‘criticality factors’ relevant to e ach specific area.在确定环境控制程序时，应在每个功能区的“临界因数”基础上，确定不同受控区域的监测频率。
Criticality Factors：临界因数The establishment of a criticality scheme on which to base monitoring frequencies is designed to target monitoring of critical process steps. Therefore, the final formulation process would receive more monitoring than an early manufacturing stage with a relatively closed process.监测频率所基于的临界机制目的在于监控关键工序步骤。
因此，同相对封闭的初阶段生产工序而言，最终配苗工序所接受的监控更多。
Using a criticality factor is a means of assigning a monitoring frequency based on the risk assessment of each critical area. The risk assessment relates to the potential product impact from any risk. For example, an area of open processing at an ambient temperature, a long exposure（暴露的）time, and the presence of water, would constitute（组成）a high risk and would attract a higher risk rating（等级）. In contrast （相比之下）, an area of closed processing, in a cold area, would carry a substantially lower risk and associated risk rating.使用临界因数是一种基于各个关键区域风险分析以确定监测频率的方法。
风险分析与风险对产品的任何潜在影响相关。
如，室温开放工艺区，长暴露时间，水的存在，这些将构成高风险，和高风险级别。
