Effects of Imperfect Quality and Defective Items on Economic Production Lot Size

The classical EPQ model has been used for a long ti me and is widely accepted and implemented. Nevertheless, the analysis for finding an economic lot size has based on a number of unrealistic assumptions. A common unrealistic assumption in using EPQ is that all units produced are of good quali ty. The classical EPQ model shows that the optimal lot size will generate minimum ma nufacturing cost, thus producing minimum setup cost and inventory cost. However, this is only true if all products manufactured in the process are assumed to be of good quality (i.e. all products are within the specification limits). In rea lity this is not the case, therefore, it is necessary to consider the cost of im perfect quality items, because this cost can influence the economic lot size. Ma ny studies and recent papers have indicated that there is a significant relation ship between economic production lot size and process/product quality. However, their models included either the imperfect quality items (not necessarily de fective) which are to be sold at a discounted price or defective items which can be reworked or rejected. The aim of this paper is to provide a framework to integrate three different sit uations (discounted pricing/rework/reject) into a single model. 100% inspection is performed in order to distinguish the amount of good quality items, imper fect quality items and defective items in each lot. In this paper, a mathematica l model is developed, and a numerical example is presented to illustrate the sol ution procedures. It is found that the economic production lot size tends to inc rease as the average percentage of imperfect quality items and defectives (rejec ted items) increases.

An Inventory Model of Production with Level Dependent Demand Allowing Few Defective Items

This paper considers a model regarding the products with finite life which allows defective items in reproduction and causes a small amount of decay. The market demand is assumed to be level dependent linear type. The model has also considered the constant production rate which stops after a desired level of inventories and that is the highest level of it. Due to the market demand, defective item and product’s decay, the inventory reduces to the zero level where again the production cycle starts. With a numerical search procedure, the proof of the proposed model has been shown. The objective of the proposed model is to find out the total optimum inventory cost, optimum ordering cost and optimum ordering cycle.

Statistical Analysis of Defective Items of Pharmaceutical Wholesale Enterprises

Objective To provide some references and suggestions for promoting the healthy development of pharmaceutical wholesale enterprises,improving the scientific supervision level of the drug regulatory department and ensuring the quality of drugs in the circulation.Methods Retrieving the items on the official websites of the national and provincial drug regulatory departments from 2017 to 2019 that didn’t meet the requirements of the 2016 edition of the Good Supplying Practice in pharmaceutical wholesale enterprises under various inspections,the defective items were summarized and analyzed,and further study of the changes of defective items was conducted.Results and Conclusion 908 pharmaceutical wholesale enterprises had definite defective items,and 218 items violated the Guidelines for On-site Inspection of the Good Supplying Practice,with a cumulative frequency of 3874 defects.Defective items with high-frequency mainly occurred in storage and maintenance,facilities and equipment,personnel and training,general rules and sales.The average defect frequency in each pharmaceutical wholesale enterprises increased year by year,but the proportion of serious defective items decreased significantly.It is recommended that based on improving drug quality,pharmaceutical wholesale enterprises should strengthen personnel training to enhance their awareness of quality responsibility.Besides,the drug regulatory department should increase inspection and crackdown on illegal business operations and the deception of pharmaceutical wholesale enterprises.

Synergic Effect of Reworking for Imperfect Quality Items with the Integration of Multi-Period Delay-in-Payment and Partial Backordering in Global Supply Chains

In intercontinental trade and economics goods are bought from a global supplier.On occasion,the expected lot may include a fraction of defective items.These imperfect items still have worth and can be sold to customers after repair.It is cost-effective and sustainable to rework such items in nearby repair workshops rather than return them.The reworked items can be returned from the workshop to the buyer when shortages are equal to the quantity of imperfect items.In the meantime,the supplier correspondingly deals a multi-period delay-in-payments strategy with purchaser.The entire profit has been maximized with paybacks for interim financing.This study aims to develop a synergic inventory model to get the most profit by making an allowance for reworking,multi-period delay-in-payments policy,and shortages.The findings of the proposed model augment inventory management performance by monitoring cycle time as well as fraction of phase with optimistic inventory for a supply chain.The results demonstrate that profit is smaller if the permitted period given by supplier to buyer is equal to or greater than the cycle time,and profit is greater if the permitted period is smaller than the cycle time.The algebraic method is engaged to make a closed system optimum solution.The mathematical experiment of this study is constructed to provide management insights and tangible practices.

河南省药品批发企业GSP监督检查储存与养护缺陷项目分析

目的:通过对2020-2022年河南省药品批发企业GSP监督检查中储存与养护环节的共性问题进行分析,为药品批发企业规范开展储存与养护工作提供建议。方法:对2020-2022年河南省GSP监督检查的药品批发企业存在的缺陷进行汇总,通过Apriori算法寻找各缺陷项目与储存与养护章节下缺陷项目的相关性,统计分析药品储存与养护章节存在的问题,并提出建议。结果:储存与养护缺陷在药品批发企业缺陷中出现的频次最高,主要缺陷*08308、一般缺陷08405出现的频次高、占比大,一般缺陷06501、08305与04603的相关性需要引起重视。结论:药品批发企业应强化自身主体责任意识,加强人员岗位培训,建立健全质量管理体系与制度,借助科学技术规范开展经营活动。药品储存与养护的从业人员应增强法律意识,遵守职业道德,保障药品质量安全,促进药品流通行业持续健康发展。

山东省药品类阿胶生产质量风险分析

目的汇总监管数据,识别山东省药品类阿胶生产质量风险,为山东省药品阿胶生产企业提出风险防控措施。方法对2020~2022年在阿胶专项检查中涉及的阿胶类生产企业的缺陷问题进行统计分析,根据阿胶工艺特点,结合文献资料,提出风险防控措施。结果被检查单位没有发现使用杂皮源,能够按照《中国药典》(2020年版)标准进行成品检验,严格执行GMP进行质量管理。企业需要持续关注人员培训、完善企业质量管理体系建设、规范设施设备管理、加强确认与验证管理工作。结论发现山东省内药品阿胶类生产企业在生产质量管理方面存在的共性问题,探讨存在的主要风险点,为药品类阿胶生产企业更好实施GMP提供参考。

山东省专营中药饮片批发企业许可缺陷及对策

目的通过分析山东省专营中药饮片批发企业许可情况及现场检查发现的问题,提出对策与建议,为保障山东省中药质量提供参考。方法对2020—2022年山东省专营中药饮片批发企业许可检查的缺陷项目进行统计,分析存在的问题,并提出相应的对策。结果许可检查问题集中在质量管理体系文件、机构和质量管理职责、人员与培训、设施与设备方面。结论企业应严格落实主体责任,完善质量管理体系,重视内审工作,提高培训的实效性,转型升级,提高产业集中度。监管部门应强化监管,提高中药检查员现场检查能力,加快职业化、专业化的中药检查员队伍建设。

江西省有源医疗器械生产企业现场检查情况分析及建议

目的促进有源医疗器械生产企业质量体系的不断提高。方法对江西省2021年至2022年日常监督检查中83家次有源医疗器械生产企业现场检查发现的缺陷问题进行汇总,分析并归纳生产企业管理存在的主要缺陷问题,并提出相应建议。结果现场检查中高频缺陷项主要分布于设备(16.37%)、厂房与设施(15.93%)、文件管理(15.27%)、生产管理(12.83%);存在问题主要为厂房与设备管理缺失,体系文件不健全,生产管理水平有待提高。结论应加强江西省有源医疗器械生产企业的质量体系运行监管,引导企业不断提高自身生产和质量管理水平,提升法律法规意识,并不断提高职业化检查员的综合能力。

基于质量缺陷分析的针对性管理在住院病案首页填写中的应用效果

目的:分析基于质量缺陷分析的针对性管理在住院病案首页填写中的应用效果。方法:回顾性分析2022年1—6月3276份未实施基于质量缺陷分析的针对性管理的住院病案为实施前,同时分析2022年7月至2023年7月3513份实施基于质量缺陷分析的针对性管理的住院病案为实施后。比较实施前后不同类型病案首页项目缺陷检出率、各科室及不同人群特征病案首页填写质量缺陷检出率。结果:实施后项目填写不全、疾病编码不规范及病案首页项目缺陷总检出率均低于实施前,差异有统计学意义(P<0.05);实施后呼吸内科、消化内科病案首页项目缺陷总检出率低于实施前,差异有统计学意义(P<0.05);实施后,男性、女性、学历为专科、职称为住院医师、主治医师的首页项目缺陷总检出率均低于实施前,差异有统计学意义(P<0.05)。结论:基于质量缺陷分析的针对性管理应用于住院病案首页填写可降低病案首页项目缺陷检出率、科室及不同人群特征病案首页填写质量缺陷检出率。

药品经营企业缺陷项目整改探讨

质量管理体系的完善是一个循序渐进的持续过程。药品经营企业质量管理体系的持续完善提升,离不开药品监督管理部门的高压态势监管,也离不开药品经营企业有效完成对监管过程中所发现缺陷项目的整改。目前,对于药品经营企业如何科学、规范、有效、高质量地完成对药品监督管理部门检查时所发现缺陷项目的整改内容,国家药品监督管理局尚未发布相关的指导文件。本研究在梳理缺陷项目整改基本理念和原则的基础上,结合实际经验,以风险管理理念为指导,探讨药品经营企业缺陷项目整改步骤和要求,阐述整改报告撰写要点,并总结整改不到位时存在的常见问题,旨在为药品经营企业系统、有效、科学地完成对药品监督管理部门检查所发现缺陷项目的整改提供参考,并建议:企业应从实际出发,举一反三,运用风险管理理念,落实企业主体责任,全员参与,科学、有效、系统地完成各缺陷项目的整改,防微杜渐,杜绝违法违规等重大问题发生,减少各方面差错,保证所经营药品质量的安全性、有效性,经营管理层面的依序性、合法性、合规性。

药品生产企业现场检查缺陷项目分析及对策建议

目的为药品生产企业执行《药品生产质量管理规范》,提高药品生产质量管理提供对策建议。方法采用回顾性统计分析方法,对2020年~2022年甘肃省429家药品生产企业现场检查发现缺陷项目进行分析。结果按照出现频次统计,缺陷项目主要分布在设备、质量控制与质量保证、文件管理、机构与人员、附录中药饮片、厂房与设施、物料与产品、生产管理。结论企业应进一步落实主体责任,提高安全生产意识,有针对性做好生产管理工作,注重药品生产质量管理人才培养及强化实际培训效果,建立符合自身实际的文件体系,保证质量体系有效运行。

An EPQ Model with Imperfect Production Systems with Rework of Regular Production and Sales Return

The Economic Production Quantity (EPQ) model is commonly used by practitioners in the fields of production and inventory management to assist them in making decision on production lot size. The common assumptions in this model are that all units produced are perfect and shortages are not allowed. But, in real situation the defective items will be produced in each cycle of production and shortages and scrap are possible. These assumptions will underestimate the actual required quantity. Hence, the defective items can not be ignored in the production process. Rework process is necessary to convert those defective into finished goods. This study proposes EPQ model that incorporates both imperfect production quality and falsely not screening out a proportion of defects, thereby passing them on to customers, resulting in defect sales returns. To active this objective a suitable mathematical model is developed and the optimal production lot size which minimizes the total cost is derived. An illustrative example is provided and numerically verified. The validation of result in this model was coded in Microsoft Visual Basic 6.0.

基于不完美检验的验收抽样方案经济设计

为降低抽样方案造成的风险及损失,利用误检概率和批产品不合格品率的先验分布,计算了生产方和使用方风险的后验概率.在综合考虑抽检成本、复检成本、误判损失的基础上,构建了一个基于不完美检验的整数非线性规划经济模型,提出了最佳抽样方案,并与无检验错误的抽样方案进行了比较.最后,讨论了模型参数对抽样方案和两类风险的影响.结果表明,在不合格品率较小时,有检验错误的平均检验量相对较大;两者的平均检出质量非常接近,但平均检出质量上限相较无检验错误时略低.

河南省药品生产企业《药品生产质量管理规范》符合性检查情况分析

目的规范药品生产企业安全、合规生产,为药品监督管理部门制订监管措施提供参考。方法统计并分析河南省2020年5月至2021年11月在对172家次高风险药品生产企业《药品生产质量管理规范》(GMP)符合性检查中发现的缺陷项目,并有针对性地提出改进措施与建议。结果共发现缺陷项目1028项,其中主要缺陷26项,一般缺陷1002项,严重缺陷0项。涉及缺陷条款1045条次,主要分布于质量控制与质量保证(19.23%)、文件管理(17.89%)、设备(17.03%)、确认与验证(6.03%)、物料与产品(5.93%)、附录中的无菌药品(5.93%)。生物制品、无菌药品(注射剂、滴眼剂、眼膏剂、无菌原料药)、毒性饮片生产企业分别发现缺陷项目62项、682项、269项,分别涉及缺陷条款66条次、687条次、270条次。结论在执行GMP过程中,药品生产企业应强化质量控制与质量保证体系的管理,建立并完善文件管理体系,加强全过程培训,做好厂房设施设备的日常使用及维护;药品监督管理部门应持续优化资源配置,提升科学监管能力。

2020-2021年山东省药品经营许可变更检查缺陷项目分析

为防控药品批发企业的经营质量安全风险,本文对2020-2021年山东省药品批发企业变更检查缺陷项目进行数据统计,分析了药品批发企业的变更类型和现场检查缺陷项目,探讨了药品批发企业存在的经营质量管理问题,并对山东省药品批发企业的管理提出了合理化、专业性的对策和建议。

山东省生物制品生产质量管理风险分析与探讨

目的:了解山东省生物制品产业和质量管理现状,识别生物制品生产中存在的共性问题和主要风险点,规范生物制品的生产质量管理。方法:统计分析2019-2021年山东省生物制品生产检查情况和缺陷项目,对检查发现的风险点进行探讨分析。结果与结论:山东省生物制品生产检查缺陷集中在确认与验证、质量控制与质量保证、无菌保证、生产管理等方面,企业应在质量管理体系运行过程中予以重点关注。

山东省依企业申请药品生产质量管理规范符合性检查质量风险分析

通过归纳法律法规对药品生产质量管理规范(GMP)符合性检查的要求,统计分析2021年和2022年山东省承担的依企业申请开展的药品生产质量管理规范符合性检查情况发现,企业申请检查情形较为复杂,在质量管理、生产管理、确认与验证、数据管理等方面还存在质量风险。药品生产企业需关注在生产质量管理方面存在的薄弱环节,落实持有人主体责任,持续提升执行GMP的规范性和水平;监管部门需明确不同情形检查要点,科学高效开展现场检查。

广州市高风险药品经营企业监督检查缺陷项目分析

目的为药品监管部门制订有针对性的药品经营企业监管措施提供参考。方法统计2021年广州市27家高风险药品经营企业在监督检查中发现的缺陷项目,分析企业在执行《药品经营质量管理规范》过程中存在的主要问题和产生原因,并提出相应对策与建议。结果27家企业累计检查项目6329项次,出现严重缺陷项目的企业有8家(29.63%)。缺陷项目共计248项次(3.92%),其中严重缺陷项目11项次(4.44%),主要缺陷项目185项次(74.60%),一般缺陷项目52项次(20.97%)。缺陷条款项次数量较多的章节为质量管理体系文件30项次(12.10%),校准与验证30项次(12.10%),储存与养护28项次(11.29%),人员与培训28项次(11.29%),设施与设备27项次(10.89%),机构和质量管理职责27项次(10.89%)。结论药品经营企业应增强合规意识,加强对质量管理工作的重视,完善质量管理体系;药品监管部门应完善监管机制,加强对药品检查员的培养;药品行业协会应充分发挥沟通协调作用。

江西省药品经营企业GSP监督检查缺陷项目分析

目的:本研究旨在为江西省药品经营企业(含药品批发企业和药品零售连锁企业总部)提供有效的药品经营质量管理规范(GSP)监督检查指导,以提高其药品经营质量管理水平。方法:通过对2021~2022年期间江西省药品经营企业GSP监督检查中发现的缺陷项目进行综合分析,确定常见的缺陷项目类型,提炼出影响其质量管理的主要原因,并提出相应的改进措施。结果与结论:为确保药品经营质量管理的有效性,药品经营企业应当加强对质量管理的认知,提高培训的针对性,加强对仓储水平的管理,为企业持续符合GSP标准奠定坚实的基础。

江西省77家次化妆品生产企业飞行检查缺陷项目统计分析

为更好地实施《化妆品监督管理条例》提供技术参考和对策建议。统计江西省2020年9月至2022年11月77家次化妆品生产企业飞行检查中发现的缺陷项目并进行总结、分类、归纳,确定化妆品生产企业存在的主要问题、共性问题,分析其形成原因,提出可行建议。企业应提高主体责任意识并落实到位,重视员工培训,提高员工素质能力,完善质量管理体系并严格落实相关文件要求。监管部门应加强专职检查员队伍建设,准确把握政策要求,加大飞行检查力度,引导企业持续合规高质量发展。