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QA基础知识考试试题 答案

QA基础知识考试试题 答案

QA基础知识考试试题姓名:分数:一. 填空题(每空2分,共50分)1.公司质量方针:“传承国粹、求真质优、科学管理、精益求精”。

2.生产现场检查项目主要包括:工艺卫生、设备状态、生产现场的物料管理、生产现场监控管理、其他现场检查。

3.库房现场检查包括:物料接收记录、分类账、账物卡的一致性、储存条件、状态标识、温湿度、卫生情况等。

4.QA在企业的作用:确保质量方针、目质量标得到有效的落实;确保整个质量系统得到有效运行及不断的完善提升。

5.QA的做事原则:“依法治国”:有法可依,依法办事,执法必严。

6.QA的立场:坚定、执着、一丝不苟!7.QA做事方式:现场、现物、基于事实的决策二.名称解释(每题10分,共20分)1.QA可以解释为对人、对过程,致力于使管理者、顾客和其他相关方相信有能力满足质量的要求2.质量管理体系指建立质量方针和质量目标,并为达到质量目标所进行的有组织、有计划的活动. 三.简答题(共30分)1.QA的工作范畴(10分)质量体系运作落实的监督及异常的跟进;生产过程中设备的维护保养、设备参数、生产方式、质量检验与检测落实的符合性检查;不合格品的处理及管理;质量事故的组织改善;客户反馈产品信息的处理及跟进2.质量保证岗位职责(20分)1 在质量管理部统一领导下,按照工艺要求和质量标准有计划有重点地开展质量监督工作,对分管范围的产品质量负主要责任。

并参与质量标准的制定。

2 遵守企业质量管理方面的各项规定,执行企业的质量方针、目标。

3 认真做好日常质量监督检查记录,及时以书面形式向质量管理部汇报质量监督情况及质量处罚情况。

4 参与车间产品质量分析、质量事故调查活动,对影响产品质量的薄弱环节及时向相关车间负责人提供质量反馈情况,做好产品质量问题的调查研究工作。

5 按照GMP的要求进行日常监督工作。

监督生产人员对SOP、工艺操作规程及其他有关文件的严格实施,发现有不符合GMP行为发生可令其改正,直至暂停生产并发出书面警告至生产管理部门,同时向本部门负责人报告。

QA考试试题及答案

QA考试试题及答案

QA考试试题姓名________ 工号________ 分数________一、填空题(20分,每空1分)1、企业应当采取适当措施,避免体表有伤口、患有传染病或其他可能污染药品疾病的人员从事的生产。

2. 进入的人员不得化妆和佩带饰物。

3. 洁净区与非洁净区之间、不同级别洁净区之间的压差应当。

4.取样区的空气洁净度级别应当。

5. 自检应当有。

6. 批生产记录的每一页应当标注产品的、和。

7、生产设备不得对产生任何不利影响。

8. 设备所用的润滑剂、冷却剂等不得对药品或容器造成。

9.不合格的设备如有可能应当搬出生产和质量控制区,未搬出前,应当有醒目的。

10.用于药品生产或检验的,应当有使用日志。

11. 物料供应商的确定及变更应当经批准后方可采购。

12. 不符合贮存和运输要求的退货,应当在监督下予以销毁。

13. 配制的每一物料及其重量或体积应当由他人独立进行,并有记录。

14. 主要固定管道应当标明和。

15. 物料和产品发放及发运应当符合和的原则。

二、选择题(50分,每小题2分)1.企业必须建立质量保证系统,同时建立完整的(),以保证系统有效运行。

A: 文件体系B: 组织机构C: 质量控制系统D:质量管理体系2.《药品生产质量管理规范2010年修订》自()起施行。

A. 2011年6月1日B. 2011年5月1日C. 2011年4月1日D. 2011年3月1日3. 下述活动也应当有相应的操作规程,其过程和结果应当有记录()A. 确认和验证B. 厂房和设备的维护、清洁和消毒C. 环境监测和变更控制D. 以上都是4. 以下为质量控制实验室应当有的文件()。

A. 质量标准、取样操作规程和记录、检验报告或证书B. 检验操作规程和记录-----包括检验记录或实验室工作记事簿C. 必要的检验方法验证报告和记录D. 以上都是5.主要固定管道应当标明内容物()。

A 名称B 流向C 状态 D名称和流向6.应当对制药用水及原水的水质进行定期(),并有相应的记录。

QA培训试题

QA培训试题

现场QA操作技能培训岗位: 姓名: 得分:培训人:培训地点: 培训日期:培训方式:由培训人先讲解,再操作演示,然后由取样人员操作,直至操作正确。

考核内容:1、进入洁净区时的更衣操作是否符合规定。

(4分)2、检查操作室和设备的状态标示。

(4分)3、检查物料的状态标示,核对物料的品名、规格、批号、数量等是否与生产指令单及物料领料单一致。

(8分)4、检查物料放置、工器具放置。

(4分)5、检查人员卫生、工艺卫生、环境卫生。

(4分)6、检查物料的外观及称量复核。

(8分)7、检查生产用模具的规格。

(4分)8、检查生产过程的工艺控制参数是否和生产工艺一致。

(8分)9、检查生产操作人员,是否按产品生产工艺规定的要求,定期进行过程控制。

(12分)10、是否按操作规程规定的频次、方法、判断标准进行现场抽查。

(12分)11、是否按规定要求对包装时的产品批号、生产日期、有效期进行复核。

(8分)12、检查生产操作人员是否及时填写记录,并检查是否符合规定要求。

(4分)13、现场检查时,是否及时填写记录且符合规定。

(4分)14、取样操作是否符合规定要求。

(8分)15、是否按操作规程要求检查清场情况、并发放清场合格证。

(8分)原辅料、包装材料取样操作技能培训岗位: QA取样员姓名:得分:培训人:培训地点: 培训日期:培训方式:由培训人先讲解,再操作演示,然后由取样人员操作,直至操作正确。

考核内容:1、接到“请验单”,复核所需取样的物料的供应商出厂检验报告单。

(4分)2、并按批取样。

按物料品种、件数计算需取样件数和数量。

(4分)3、现场核对:(各4分)(1)状态标识、品名、规格、批号等应与请验单一致。

(2)供应商名称、批准文号、执行批准、生产地址等应与质量部确认的原辅料合格供应商名录中内容一致。

(3)核对外包装:应完整、无破损、无污染、密闭。

如有封印,封印必须清楚,无启动痕迹。

4、取样步骤:(各4分)(1)确定取样间在清洁有效期内,填写取样间状态标志牌,取样间清洁有效期为5天(2)开启取样间净化系统30分钟后,将取样工具、盛样品容器和辅助工具放入传递窗内,开启紫外灯15分钟。

QA考核试题

QA考核试题

GMP培训考核试卷姓名:部门:分数:90分以上优□85分以上良□80分以上及格□一、填空题:(20分)(第一大题直接答在题签上)1、在新的发展阶段继续全面建设小康社会、发展中国特色社会主义,必须坚持以邓小平理论和“三个代表”重要思想为指导,深入贯彻落实。

2、新《兽药管理条例》自年月日实行。

3、5S管理包括:、、、、。

4、新《兽药管理条例》规定对兽用生物制品实行管理制度。

5、我们的企业精神是:、、准确、精干、、。

6、易邦的企业宗旨是。

7、人与人之间最需要做的是的工作。

8、禽类一类动物疫病有:、。

9、禽类二类动物疫病有:、、、、等。

10、禽类三类动物疫病有:、等。

二、名词解释:(30分)(第二大题直接答在题签上)1、批:2、质量保证:3、质量控制:4、质量管理:5、质量事故:6、物料平衡:三、贯穿全部《兽药GMP》的三条主线是什么?(10分)四、请回答《兽药管理条例》的主要内容。

(10分)五、请回答《兽药生产质量管理规范》的主要内容及基本要求。

(10分)六、生产禽流感灭活疫苗时,员工应如何做好个人的安全防护?(10分)七、请你结合本职工作岗位谈谈本岗位SOP。

(10分)附加题:关于员工培训,您有何建议?参考答案一、填空题:(20分)(第一大题直接答在题签上)1、在新的发展阶段继续全面建设小康社会、发展中国特色社会主义,必须坚持以邓小平理论和“三个代表”重要思想为指导,深入贯彻落实科学发展观。

2、新《兽药管理条例》自 2004 年 11 月 1 日实行。

3、5S管理包括:整理、整顿、清扫、清洁、素养。

4、新《兽药管理条例》规定对兽用生物制品实行批签发管理制度。

5、我们的企业精神是:务实、高效、准确、精干、敬业、文明。

6、易邦的企业宗旨是以科技进化服务,用管理铸造精品。

7、人与人之间最需要做的是沟通的工作。

8、禽类一类动物疫病有:高致病性禽流感、鸡新城疫。

9、禽类二类动物疫病有:鸡传染性喉气管炎、鸡传染性支气管炎、鸡传染性法氏囊病、鸡产蛋下降综合征、鸡马立克氏病等。

QA笔试试题答案

QA笔试试题答案

QA笔试试题一、填空题(每题3分,共计30分)1、QA的使命是:就是提供过程的可视性,让项目有机会把所有关键因素控制好,保证产品的质量2、质量管理是指:在质量方面指挥和控制组织的协调的活动3、审核可以采取的形式有:检查记录、参与和观察、访谈4、出现异常需要把握的现场三状有;现场、现物、现状5、QA的中文意思是:品质保证6、检验状态标识的作用是:区分产品是否红检验合格、区分产品的型号批次号、为了更容易找到产品7、系统方案有效的关键因素有:需求的关联性、成员经验、多方面的考虑8、审核的目的是:在于评估它们与规约、标准、合同协议或其它准则的符合性。

9、QA的评审步骤有:策划、审核、报告、处理10、QA报告的类别有:审核报告、阶段性过程质量总体报告,报告的价值:在于帮助组织优化过程,提高组织效能。

二、多项选择题(每题3分,共15分)1、质量管理包括( ABCD )A、质量策划B、质量控制C、质量保证D、质量改进2、产品是活动或过程的结果,包含( ABCD )A、一项服务B、具特定形状的有形产品C、一种知识产物D、流程性材料3、按照产品实现过程,品质检验分为( ABD )A、进料检验B、过程检验C、抽样检验D、最终检验4、包装检验一般要检验( ACD )A、核对标签内容B、刷油C、包装数量D、包装方式5、下列哪些为固定质量信息( ABCD )A、产品质量统计表B、不合格品评审表C、产品质量检验单D、返工/返修单三、判断题(每题3分,共12分)1、缺陷类别中MAJ指的是轻微缺陷(X )2、不合格品:指不满足规范的要求(√)3、QA检验依据生产通知单、ECN、BOM单、最终检验规范及其相关合同更改、客户资料联络单,可不依据样品( X )4、质量的定义必须是符合要求,而不是“好”(√)5、质量保证是保证进度的有效手段落(√)四、简答题(共43分)1、简述QA的工作职责与工作流程是什么?(11分)2、QA审核发现问题之后如何处理?(10分)3、如何保证公正客观?(9分)4、试举工作之中遇到的最关键的三个成熟特征、三个不成熟的特征?(10分)。

QA考试题及答案

QA考试题及答案

QA人员考试题姓名:得分:时间:一、填空题:(每题1.5分,共30分)1.我公司质量方针为:质量第一、科学管理、持续改进、优质产品。

2.我公司质量目标为:确保出厂产品质量100%合格;确保客户满意度98%;确保产品安全事故0。

3.《药品生产质量管理规范(2010年修订)》已于2010年10月19 日经卫生部部务会议审议通过,自2011年3月1日起施行。

机能并规定有适应症或者功能主治、用法和用量的物质,包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射8.生产车间洁净区应能够将区域温度控制在18~26℃,相对湿度控制在45~65% ,应能够将洁净区与非洁净区之间、不同级别洁净区之间的压差应当≥10Pa 。

相同洁净级别的不同功能区域(操作间)之间也保持适当的压差梯度。

二、不定项选择题:(每题2分,共30分)1.实施GMP的目的:能最大限度地()A、防止污染B、防止交叉污染C、防混淆D、防人为差错2. 下列设备状态标志底色,哪个是错误的?(A )A. 设备停用:黑色B.设备性能状况完好:绿色C. 设备维修中:红色D. 设备待维修:黄色3. 药品生产所用的原辅料、与药品直接接触的包装材料应当符合相应的质量标准。

通过怎样的措施来保证?( D )A. 供应商的选择和评估B.定点采购C. 按批验收和取样检验D.以上都是4.产品生产记录应当至少保存至药品有效期后( D )年。

A. 4B. 3C.2D.15.制药用水应当适合其用途,至少应当采用( B )。

A.自来水B.饮用水C.纯化水D.注射用水6.物料必须从( C )批准的供应商处采购。

A.供应管理部门B.生产管理部门C.质量管理部门D.财务管理部门7.现有一批待检的成品,因市场需货,仓库( C )。

A.可以发放B.审核批生产记录无误后,即可发放C.检验合格、审核批生产记录无误后,方可发放D.检验合格即可发放8.批包装记录至少应包括( B )A.产品的品名、规格、生产单位B.产品的品名、批号、规格C.产品的注意事项、贮存条件D.产品的批准文号、主要成分9.紫外灯的累计使用时间不得超过( A )小时。

QA考卷及答案

QA考卷及答案

QA人员过程控制培训测试姓名:得分一、填空(共36分,每空格2分)。

1. 现场检查的方式包括、、。

2. 控制不良产品产生应主意哪些环节:原材料、设备、、、、。

3. QA:抽查复核质量控制点,检查操作人员是否按照文件规定执行;质量控制点:主要的、、。

4. 设备状态标识包括:、、、。

5. 过程控制异常情况的处理中,偏差处理:、物料隔离、标识、报告、、记录、释放控制;紧急程序处理:、、执行、记录、释放控制。

二、判断题(共10分,每题2分)。

1.现场质量管理的目标,是要生产符合设计要求的产品。

()2.现场质量管理是质量管理部门和管理人员的事,生产工人的任务是按规定完成生产定额。

()3.只要保证不合格的原材料不投产,不合格的半成品不转入下工序,不合格的成品不出厂,就完成了质量检验的职能。

()4.质量检验是质量管理的重要组成部分。

()5.建立健全质量保证体系是实行全面质量管理的重要标志。

()三、选择题(共12分,每题3分)。

1. 药品生产质量管理规范是药品生产和质量管理的基本准则。

其适用于范围是()。

A、影响成品质量关键工序B、成品质量形成的生产工序C、防止标签混淆的包装工序D、药品生产的全过程2. GMP 文件:是指企业根据()与其实施细则建立一套详细、具体、具有可操作性的适合自己企业的 GMP 文件(SMP,SOP,MF(master formulae),QS(quality standard)等),员工必须严格依照企业制订的 GMP 文件进行操作,操作后必须及时记录。

A、药品质量管理规范B、药品经营质量管理规范C、药品生产质量管理规范D、药品生产管理规范3. 批检验记录应保持清洁,不得撕毁和任意涂改;更改时,应()。

A、彻底涂掉或刮掉原数据B、在更改处签名C、交由车间负责人签名D、在更改处签名和签更改日期,并使原数据仍可辨认4. 下列那个选项是错误的()A、抽查工程部压差记录应及时性、准确性、真实性B、所有工艺规范必须经过工艺验证,合格后方可用于正式生产C、浮游菌与沉降菌二选其一,建议选择沉降菌D、灌胶囊工序中,装量差异的抽查与复核,30min至少一次四、简答题(共42分)。

QA,QC人员培训试卷

QA,QC人员培训试卷

QA,QC人员试卷一.填空题(70分)1.对检验人员的工作质量考核,主要是________________、________________和________________的及时性和完整性。

(检验工作量)(检验准确性)(数据记录)2.QC小组选择活动课题的依据一般有三条,一是________________,二是________________三是________________。

(企业方针目标)(生产薄弱环节)(用户需要)3.以工人为主,以稳定提高产品质量、降低消耗为目的的QC小组称________型小组;以三结合为主,以攻克技术关键为目的的QC小组称________型QC小组;以科室职能部门为主,以提高工作质量为目的的QC小组称________型QC小组。

(现场)(攻关)(管理)4.QC小组活动有利于推动从产量第一向________________转变;事后把关向________________转变;分散管理向________________转变;生产第一向________________转变。

(质量第一)(事先预防)(系统)(用户第一))5.检验员要当好“三员”并做到“三满意”。

“三员”是指:产品质量的________员、“质量第一”的________员和生产技术的________员。

“三满意”是指:为生产服务态度让________________满意;检验过的产品让________________满意,;出厂的产品让________________满意。

(检验)(宣传)(辅导)(工人)(下工序)(用户)6.“三检制”就是指:________、________和________,“三自检验制”就是指操作者的________________、________________和________________。

(自检)(互检)(专检)(自检)(自分)(自盖工号)7.“三工序”活动就是指复查________________的质量,保证________________的质量,坚持优质准时为________________服务(上道工序)(本道工序)(下道工序)8.设置建立质量管理点,加强工序管理,是企业建立生产现场________________的基础环节。

QA考试题

QA考试题

QA考试题姓名:阅卷人: 得分:问答题:(70分,每题7分)1.年度产品质量回顾内容包括哪些?1) 关键工艺控制和关键测试结果的审核。

2) 所有不符合规格标准的产品批号的回顾。

3) 所有关键的偏差或违规行为及其有关调查的审核。

4) 任何工艺或分析方法变动的回顾5) 稳定性考察结果的回顾6) 所有与质量有关的退货、投诉和召回的回顾7) 整改措施的适当性的审核8) 其他回顾:变更;自检报告;每次检查的整改落实情况;供应商质量情况;再验证;年度评价及建议等。

2.IQ、OQ、PQ、DQ、PV 的定义?IQ---(Installation Qualification) 安装确认:证明厂房、辅助设施和设备的建造和安装符合设计标准;OQ---(Opaerational Qualification) 运行确认: 证明厂房、辅助设施和设备的运行符合设计标准;PQ---(Performance Qualification) 性能确认:证明厂房、辅助设施和设备在正常操作方法和工艺条件下能持续有效地符合标准要求;DQ---(Design Qualification) 设计确认:证明厂房、辅助设施、设备的设计符合 GMP 要求;PV----(Process Validation) 工艺验证:证明一个生产工艺在规定的工艺参数下能持续有效地生产出符合预定的用途、符合药品注册批准或规定的要求和质量标准的产品。

3. GMP 的硬件、软件与人的关系?在 GMP 硬件、软件和人这三大要素中,人是主导因素,软件是人制定、执行的,硬件是靠人去设计、使用的。

离开高素质的"GMP 人",再好的硬件和软件都不能很好地发挥作用。

硬件、软件达标与否,比较容易识别,而人达标与否,就很难分辨得清。

因此,为了真正达到认证标准,企业就必须按要求对各类人员进行行之有效的教育和培训,要象抓硬软件建设工作那样,去搞好"GMP 人"素质提高的建设工作,切不可将教育培训工作流于形式。

QA适岗培训考核试题(一)

QA适岗培训考核试题(一)

QA适岗培训考核试题(一)培训考试涉及相关文件规程有:GMP文件管理规程;GMP文件编码管理规程;产品质量年度回顾管理规程;记录管理规程;变更控制规程;偏差管理规程;数据完整性管理规程;GMP培训管理规程。

基本信息:[矩阵文本题] *1.填空题根据文件类型,技术标准类的类型代码为 ______,管理标准类的类型代码为 ______,工作标准类的类型代码为 ______,职责类的类型代码为GR,记录类的类型代码为 ______,通知类文件的类型代码为贵汉药质字。

[填空题] *空1答案:STP空2答案:SMP空3答案:SOP空4答案:REC2.判定题文件管理员负责所有 GMP 类文件的编码工作,必要时,其他人可以编号[判断题] *对错(正确答案)3.判定题制剂生产工艺规程的文件编号一般模式为:STP-PP-产品序列号-流水号;[判断题] *对(正确答案)错4.判定题因技术标准分支-技术通则(GPT)之通则三(《产品质量标准通则》STP-GPT-03)的特殊性,其附件记录编号规则为:STP-GPT-03-产品序列号-版本号; [判断题] *对(正确答案)错5.判定题因技术标准分支-技术通则(GPT)之通则三(《产品质量标准通则》STP-GPT-03)的特殊性,其附件记录编号规则为:STP-GPT-03-产品序列号-版本号; [判断题] *对(正确答案)错6.判定题当因实际使用需要,需对其文件或附件记录内容进行变更时,只对修改后的文件或附件记录版本号进行调整,其版本号自动跳至下一个版本号。

版本号起始位“00”,后是“01”、“02”以此类推; [判断题] *对(正确答案)错7.判定题未修订的文件或附件记录版本号不做调整。

通过建立文件、附件目录表,对其版本号进行记录追踪; [判断题] *对(正确答案)错8.判定题制定 GMP 文件文件管理规程的目的:指 GMP文件在整个使用周期中的控制程序,包括制订、审核、批准,修订与再审,以及格式、编号、发放、归档和销毁,以规范公司文件的管理,确保其符合 GMP 规范要求; [判断题] *对错(正确答案)9.选择题本公司GMP文件包括哪几大类:工作标准、、。

制药qa现场岗位职责试题及答案(多篇)

制药qa现场岗位职责试题及答案(多篇)

制药qa现场岗位职责试题及答案(多篇)篇:制药QA转正考试试题及答案QA转正试题部门:姓名:分数:一、填空题(每空3分、共57分)1、新的或改造的厂房、设施、设备需进行安装。

2、供应商或第三方提供验证服务的,企业应当对其提供的确认与验证的、数据或的适用性和符合性进行审核、批准。

3、企业应当根据用户需求和设计确认中的技术要求对、设施、进行验收并。

4、安装和运行确认完成并符合要求后,方可进行确认。

5、工艺验证应当证明一个生产工艺按照规定的工艺参数能够持续生产出符合和的产品。

6、工艺验证批的批量应当与的批量一致。

7、企业应当根据确定工艺验证批次数和取样计划,以获得充分的数据来评价工艺和产品质量。

8、在产品生命周期中,应当进行持续工艺确认,对商业化生产的产品质量进行和分析,以确保工艺和产品质量始终处于受控状态。

9、持续工艺确认的结果可以用来支持产品,确认工艺验证处于受控状态。

当趋势出现渐进性变化时,应当进行并采取相应的措施。

10、为确认与产品直接接触设备的清洁操作规程的有效性,应当进行。

11、清洁验证的次数应当根据确定,通常应当至少进行连续次。

12、关键的生产工艺和操作规程应当定期进行,确保其能够达到预期效果。

二、判断正误(每空3分、共15分)1、企业应当根据科学知识及经验对质量风险进行评估,以保证产品质量。

()2、企业的厂房、设施、设备和检验仪器应当经过确认,应当采用经过验证的生产工艺、操作规程和检验方法进行生产、操作和检验,并保持持续的验证状态。

()3、制药用水应当适合其用途,并符合《中华人民共和国药典》的质量标准及相关要求。

制药用水至少应当采用纯化水。

()4、所有生产和检验设备都应当有明确的操作规程。

()5、原料药生产设备所需的润滑剂、加热或冷却介质等,应当避免与中间产品或原料药直接接触,以免影响中间产品或原料药的质量。

()名词解释(每空5分、共15分)1、工艺验证:2、清洁验证:3、中间控制:四、简答题(共13分)1、结合你所在的岗位,谈谈对“质量保证”的看法?确认与验证培训试题答案一、填空题1、确认2、方案、报告3、厂房、设备、记录4、性能5、预定用途、注册要求6、预定的商业批7、质量风险管理原则8、监控、趋势9、质量回顾分析、评估10、清洁验证11、风险评估、三12、再验证二、判断正误1、√2、√3、×4、×5、√ 三、名词解释1、为证明工艺在设定参数范围内能有效稳定地运行并生产出符合预定质量标准和质量特性药品的验证活动。

qa考试试题

qa考试试题

qa考试试题一、选择题1. 下列哪个选项是正确的?A. 地球是平的。

B. 太阳是宇宙的中心。

C. 人类的祖先是恐龙。

D. 光速是可变的。

答案:D2. 以下哪种植物是水生植物?A. 仙人掌B. 玫瑰C. 睡莲D. 橡树答案:C3. 以下哪个历史事件不是发生在20世纪?A. 法国大革命B. 第一次世界大战C. 第二次世界大战D. 中国文化大革命答案:A4. 以下哪个作家是以科幻小说著称的?A. 莎士比亚B. 马克·吐温C. 刘慈欣D. 村上春树答案:C5. 以下哪个不是人体必需的微量元素?A. 铁B. 锌C. 钙D. 铂答案:D二、填空题1. 请填写以下诗句的上句或下句:“床前明月光,________。

”答案:疑是地上霜2. 请填写化学元素周期表中,原子序数为8的元素名称。

答案:氧3. 请填写下列成语的缺失部分:“______,焉得虎子。

”答案:不入虎穴4. 请填写以下著名画作的作者:“蒙娜丽莎”是由哪位艺术家创作的?答案:达·芬奇5. 请填写下列物理公式的缺失部分:“功= ______ × 力× 距离”。

答案:力的作用时间三、简答题1. 简述牛顿第三定律。

答:牛顿第三定律,也称为作用与反作用定律,指的是对于任何两个相互作用的物体,它们之间的作用力和反作用力总是大小相等、方向相反。

2. 描述温室效应是如何影响地球气候的。

答:温室效应是指地球大气层中的温室气体(如二氧化碳、甲烷等)能够吸收并重新辐射地球表面的热量,从而导致地球表面温度上升的现象。

这个过程会导致全球气候变暖,进而影响天气模式、海平面上升、极地冰川融化等,对生态系统和人类活动产生深远影响。

3. 阐述互联网对现代社会的影响。

答:互联网极大地改变了现代社会的信息传播、商业活动、教育方式和人们的日常生活。

它使得信息获取更加快速和便捷,促进了全球化进程,改变了商业模式,创造了新的就业机会,同时也带来了信息安全和隐私保护等新的挑战。

食品qa考试试题及答案

食品qa考试试题及答案

食品qa考试试题及答案一、单项选择题(每题2分,共20分)1. 以下哪个不是食品添加剂?A. 防腐剂B. 着色剂C. 增味剂D. 维生素答案:D2. 食品包装上的“QS”标志代表什么?A. 质量安全B. 食品安全C. 卫生安全D. 健康安全答案:B3. 食品中添加的“三聚氰胺”对人体有何影响?A. 有益健康B. 无害C. 有害D. 无影响答案:C4. 以下哪种食品添加剂是允许使用的?A. 苏丹红B. 甲醛C. 亚硝酸钠D. 砷酸盐答案:C5. 食品的保质期是指什么?A. 食品生产日期B. 食品销售日期C. 食品最佳食用日期D. 食品过期日期答案:C6. 食品中的“转基因”指的是什么?A. 基因突变B. 基因重组C. 基因复制D. 基因缺失答案:B7. 以下哪种食品添加剂是用于改善食品口感的?A. 甜味剂B. 防腐剂C. 着色剂D. 增味剂答案:A8. 食品中的“重金属”对人体有什么影响?A. 有益健康B. 无害C. 有害D. 无影响答案:C9. 以下哪种食品添加剂是用于延长食品保质期的?A. 甜味剂B. 防腐剂C. 着色剂D. 增味剂答案:B10. 食品中的“亚硝酸盐”对人体有何影响?A. 有益健康B. 无害C. 有害D. 无影响答案:C二、多项选择题(每题3分,共15分)1. 以下哪些是食品添加剂?A. 防腐剂B. 着色剂C. 维生素D. 抗生素答案:A B2. 以下哪些是食品中可能存在的有害物质?A. 三聚氰胺B. 重金属C. 亚硝酸盐D. 维生素答案:A B C3. 以下哪些是食品中常见的营养成分?A. 蛋白质B. 脂肪C. 碳水化合物D. 抗生素答案:A B C4. 以下哪些是食品中可能存在的非法添加剂?A. 苏丹红B. 甲醛C. 亚硝酸钠D. 砷酸盐答案:A B D5. 以下哪些是食品中可能存在的安全风险?A. 转基因B. 重金属C. 亚硝酸盐D. 维生素答案:A B C三、判断题(每题1分,共10分)1. 食品添加剂都是有害的。

药学qa测试题及答案

药学qa测试题及答案

药学qa测试题及答案药学QA测试题及答案一、选择题1. 药物的半衰期是指:A. 药物在体内被代谢或排泄掉一半所需的时间B. 药物作用强度的一半C. 药物的剂量D. 药物的疗效持续时间答案:A2. 下列哪项不是药物的副作用?A. 过敏反应B. 毒性反应C. 治疗作用D. 后遗效应答案:C二、填空题1. 药物的________是指药物在体内达到最大效应所需的时间。

答案:起效时间2. 药物的________是指药物在体内达到稳态浓度所需的时间。

答案:稳态时间三、判断题1. 所有药物都可以通过肝脏代谢。

()答案:错误2. 药物的剂量越大,其疗效越好。

()答案:错误四、简答题1. 请简述药物的药动学和药效学的区别。

答案:药动学主要研究药物在体内的吸收、分布、代谢和排泄过程,而药效学则研究药物的作用机制、作用强度以及如何影响生物体。

2. 药物的不良反应有哪些类型?答案:药物的不良反应包括副作用、毒性反应、过敏反应、后遗效应等。

五、计算题1. 假设某药物的半衰期为4小时,求该药物在24小时内的剩余量百分比。

答案:根据半衰期公式,剩余量百分比= (1/2)^(24/4) ≈ 6.25%六、案例分析题1. 患者A因感冒发热,医生开具了对乙酰氨基酚(扑热息痛)500mg,每4小时服用一次,连续服用3天。

请分析患者A的用药是否合理,并给出建议。

答案:患者A的用药基本合理,但需要注意对乙酰氨基酚的每日最大剂量不应超过4000mg,以防肝脏损害。

同时,建议患者A在用药期间避免饮酒,以免增加肝脏负担。

七、论述题1. 论述合理用药的重要性及其基本原则。

答案:合理用药是指根据病情、药物特性、患者个体差异等因素,科学选择药物种类、剂量和用药时间,以达到最佳治疗效果,减少不良反应。

基本原则包括:正确诊断、合理选择药物、正确计算剂量、合理安排用药时间和途径、注意药物相互作用、监测药物疗效和不良反应等。

7月份QA考试题题库0.doc

7月份QA考试题题库0.doc

一、填空题:1、外购或外销的屮间产品和待包装产品应当有质量标准;如果中间产品的检验结果用于成品的质量评价,则应当制定与成品质量标准相对应的屮间产品质量标准。

2、企业必须有内容正确的书面质量标准、生产处方和丄艺规程、操作规程以及记录等文件。

3、企业应当建立文件管理的操作规程,系统地设计、制定、审核、批准和发放文件。

与本规范冇关的文件应当经质量管理部门的审核。

4、文件的内容应当与药品牛产许可、药品注册等相关要求一致,并有助于追溯每批产品的历史情况。

5、文件应当标明题口、独类、口的以及文件编号和版木号。

文字应当确切、清晰、易懂,不能模棱两可。

6、记录填写的任何更改都应当签注姓名和口期,并使原冇信息仍清晰口J辨,必要时,应当说明更改的理由。

7、批记录应当由质量管理部门负责管理,金少保存至药品冇效期后二年。

质量标准、工艺规程、操作规程、稳定性考察、确认、验证、变更等其他重要文件应当长期保存。

8、使用电子数据处理系统的,只有经授权的人员方可输入或更改数据,更改和删除情•况应当有记录;用电了方法保存的批记录,应当采用磁带、缩微胶卷、纸质副木或其他方法进行蚤份,以确保记录的安全,且数据资料在保存期内便于查阅。

9、每种药品的每个生产批量均应当有经企业批准的丄艺规程,不同药品规格的每种包装形式均应当有10、各门的包装操作耍求。

工艺规程的制定应当以注册批准的工艺为依据。

11、质量控制包括相应的组织机构、文件系统以及取样、检验等,确保物料或产品在放行前完成必耍的检验,确认其质量符合要求。

12、应当根据科学知识及经验对质量风险进行评佔,以保证产品质量。

13、质量风险管理过程所采用的方法、措施、形式及形成的文件应当与存在风险的级別相适应。

14、质量管理部门应当参与所有与质量有关的活动,负责审核所有与本规范有关的文件。

15、职责通常不得委托给他人。

确需委托的,其职责可委托给具有相当资质的指定人员。

16、企业应当指定部门或7人负责培训管理工作,应当冇经生产管理负责人或质量管理负责人审核或批准的培训方案或计划,培训记录应当予以保存。

QA试题库

QA试题库

质量专业应知应会试题库政策法规及专业理论一、填空1.设备验证的程序包括预确认、安装确认、性能确认和运行确认组成。

2.验证可分成四种类型:前验证、同步验证、回顾性验证、再验证。

3.新版GMP认证检查项目共259项,其中关键项目条款号前加“*” 92项,一般项目167项。

4.厂房应有防止昆虫和其他动物进入的设施。

5.传染病、皮肤病、皮肤有伤口不得从事直接接触药品的生产。

6.洁净室(区)的温度和相对湿度应与药品生产工艺要求相适应。

无特殊要求时,温度应控制在18-26℃,相对湿度应控制在45%-65%。

7. 安全生产八字方针是安全第一、预防为主。

8.PDCA 是指P:策划D:实施C:检查 A :处置9.对库内存放的物料,根据其储藏温度要求放入相应的库区,冷库 2℃-10℃内、阴凉库 20℃以下内、常温库 0℃-30℃内。

10.对工艺用水取样测定的取样点有制水点出口、用水点出口、贮水罐出口。

11. 待验、合格、不合格物料要严格管理。

不合格的物料要专区存放,有易于识别的明显标志,并按有关规定及时处理。

12.生产设备应有明显的状态标志,并定期维护保养。

13.与设备连接的主要固定管道应标明管内物料名称和流向。

14.粉尘多的操作间与其他操作间应保持负压。

15.洁净区与非洁净区的压差大于≥10帕。

16.生产、检验设备必须填写使用、维修、保养记录。

17. 用以生产和检验的仪器、仪表、量具、衡器等,其适用范围和精密度应符合生产和检验要求,应有明显的合格标志,应定期校验。

18.SOP的中文含义是标准操作程序。

19.SMP的中文含义是标准管理程序。

20.洁净区内最大的污染源是人。

21. 药品的标签、使用说明书应专库(或专柜上锁)存放,专人保管、专人领用。

22. SPC是指为了贯彻预防原则,应用统计技术对过程中的各个阶段进行评估和监控,从而达到保证产品质量满足要求。

23.批号的定义用以识别批的一组数字或字母加数字。

24.洁净区应根据生产要求提供足够的照明,主要工作室的照度宜为300勒克斯。

QA测试题

QA测试题

QA 测试题(总分100)姓名: 卡号: 得分:一、填空题(每空2分,共42分).1.检验时发现有超出允收标准须填写_________要求QC 重工,并注明____________及不良品上___________并将REJ数量和ACC 数量记录于____________.2.QC 检OK 之产品QA 抽检按照_____________表中的_________________进行抽检,有特殊检验标准时需依_____________提供资料为准. 3.QA 抽检时发现同一机种连续__________不合格,QA 将抽检方式改为___________方式. 4.电阻用字母________表示,电阻的分类有________电阻和________电阻,电阻的单位有: ________;________;________。

5.5S 是指 整 理、整 顿、清 扫、清 洁、素 养。

6.区分工作场所内的物品为“要用的”和“不要用的”是属于5S 中的 整理 范畴。

二、选择题(每题2分共20分).1.重缺及轻缺用字母表示( A ).A.MAJ 及 MINB.MIN 及MAJC.0.4及0.65D.0.65及0.42.下列说法正确的是( D ).A.点胶板中二极管只要推力足即可,无需重视胶量大小.B.误配&翻件属主要缺点.C.过炉后PCB 板变形或变黄属于重缺.D.该处本应置件而未置件属漏件.3.电感、电晶体、二极管分别用字母( A )表示A. A. L Q DB. L R CC. Q L DD. L Q D4.公司的5S 应如何做? ( A )A 、随时随地都得做,靠大家持续做下去B 、做三个月就可以了C 、第一次靠有计划地大家做,以后靠干部做D 、车间来做就行了5.5S 运动是一项什么样的工作? ( C )A 、暂时性B 、流行的C 、持久性D 、时尚的6.公司需要整顿的地方是什么? ( C )A 、工作现场B 、办公室C 、全公司的每个地方D 、仓库7.二极管正确的基板图示为:( B )+--+-+A BC8.车间的室内温度应保持在( B )A. 20℃ ±5℃B.23℃ ±5℃C. 25℃ ±5℃D. 28℃ ±5℃9.车间的相对湿度应在( C )A.25% RH ~55% RHB.35% RH ~65% RHC. 45% RH ~75% RHD. 55% RH ~85% RH10.静电手环测试时测试仪亮什么颜色的灯为OK 品( A )A.绿色B.红色C.红色加绿色D.均不亮三、判断题<正确打“V ”,错误打“X ”>(每题2分共8分).1. 电阻丝印(符号)为272的电阻,阻值为 2700Ω.( √ )2.当某客户反馈有不良现象时,内部库存品照常出货,QA 只针对QC 检好之产品针对性的重点检验( × ).3.SMT 中文表示为:表面粘着(或贴装)技术( √ )4. 品质的定义就是:第一次就做好( √ )重工通知单 AQL QA 抽检报表 碳膜 精密 千欧(K Ω) 兆欧(M Ω) 欧姆(Ω) 3批 加严抽检 抽检样品大小 R 客户 不良现象 做好标示四、问答题(每题10分共30分).1.批量为280采用二级检验水准,批量为600采用二级水准,如AQL表所示请指出抽检数最及允收拒收的标准<几收几退>?2.若同一机种抽检3批以上则须判退,你应怎样处理?3.怎样才能有效的作抽检动作,抽检依据的内容有哪些?。

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Software Testing and Quality AssuranceChapter 1 Introducing Software Quality Assurance1. Please describe which tasks SQA Activities can be broken down into. (p1.4)A:SQA activities can be broken down into the following tasks:(1)Application of technical methods:This helps the development team to achieve high quality design specifications and develop high quality software design.(2)Conducting Formal T echnical Reviews (FTRs):These are structured review meetings in which a review team assesses the software product technically.(3)Enforcement of standards:This task is a combination of two subtasks:Process monitoring and Product Evaluation.(4)Control of change:It combines manual methods with automated tools to provide a mechanism for the control of change.This process ensures software quality by formalizing requests for change, evaluating the nature of the change, and controlling the impact of the change.(5)Measurement:The quality of a software product can be measured by using software metrics. (6)SQA Audits:These are conducted to inspect a process or a product in detail by comparing the process or product with established procedures and standards.Audits review the management, technical, and quality assurance processes being followed during software development.(7)Record keeping and reporting:This provides procedures for collecting and circulating SQA information.2. Which phases the SDLC consists of? (p1.5)A:(1)Software conception and initiation(2)Analysis(3)Design(4)Construction(5)T esting3. Please describe SQA activities in the Software Analysis Phase. (p1.6)A:(1)These involve reviewing of the Requirements Document created as part of the software requirement phase.(2)These ensure that the software requirements are complete, testable, and correctly expressed as functional, performance, and interface requirements.(3)The SQA activities in this phase can be recorded in the Software Requirement Review Checklist.4. Please describe SQA activities in the Software Design Phase. (p1.7)A:SQA activities in the software design phase involve assuring the following factors:(1)The design adheres to the approved design standards defined in the management plan created in the project initiation phase.(2)All software requirements are mapped to the software components.(3)All action items are resolved according to the review finding of the high-level design review documentation.(4)The approved design is placed under configuration management.(5)The development team follows approved design standards.(6)The allocated modules are included in the detailed design.(7)The results of design inspections are included in the design.(8)All action items are resolved according to the review findings of the detailed design review documentation.5. Please describe SQA activities in the Software Construction Phase. (p1.9)A:SQA activities in the software construction phase involve assuring the following factors: (1)Audit of the results of coding and design activities including the schedule in the software development plan(2)Audit of configuration management activities and the software development library (3)Audit of deliverable items(4)Audit of nonconformance reporting and corrective action system(5)FTR of code6. Please describe SQA activities in the Software Testing Phase. (p1.9)A:(1)These involve monitoring the testing process for conformance to standards.(2)These ensure that the software testing process is in accordance with plans and procedures.(3)T est documentation is reviewed for completeness and adherence to standards. (4)SQA activities in this phase also involve reviewing the test plan.(5)The observations from a test plan review are recorded in the Test Plan Review Checklist.7. Please describe the differents between two Quality activities, QA and QC. (p1.10) A:(1)QA is a planned and systematic set of activities that involve monitoring and improving the software development process.(2)QA is oriented to the prevention of defects rather than their detection and is used to implement the defined quality policy of an organization through the process of development and continuous improvement.(3)Quality Control (QC) is the process by which the quality of a product is compared with specific standards, and action is taken if the quality does not match the applicable standards.(4)QC is oriented to detection of defects rather than prevention.8. Please list some QA activities, and some QC activities. (p1.11)A:Quality Assurance (QA) activities include:(1)Quality Audit(2)Process definition(3)T ool selection(4)Training(5)Peer review(6)Requirements tracking(7)Quality metrics collectionQC activities include:(1)Inspection(2)T esting(3)Checkpoint review9. Please describe the Role of Metrics in SQA, and the four main steps of creating a metric. (p1.12)A:QA is a planned and systematic set of activities that involves monitoring and improving the software development process. Metrics are important in QA because they help measure and evaluate various aspects of the software development process These measurements help organizations improve their processesMetrics are crucial for the development process and project management because they enable you to measure the quality of each factor in a project. Measuring the quality of various factors helps determine if the project will meet time and quality requirements.In addition, over a period of time, metrics help track your progress. Y ou can use metrics to compare various projects of different sizes After calculating metrics, you need to communicate them to the management and to every person involved in the process. Then, you need to organize several meetings to analyze metrics. Based on. the analysis, .areas of improvement are identified and suggestions are invited to improve the processes Based on the suggestions, corrective action is decided and implemented. After implementing the changes, you need to again implement the processes to verify whether or not they solved the problem.The QA and develOpment team decides upon the metrics to be created and tracked in the beginning of a software project There are four main steps of creating a metricDefining the goal of the metric: It is important to define a goal because it helps design the metric The goal should be clear, measurable, and explicit For example,the goal can be to measure the number of defects reported by the clientIdentifying the requirements of the metric The requirements include human resource, data collection techniques, and methodologies used to process the data For example, the requirements of a metric that measures the number of defects reported by clients include the availability of quality assurance professionals and past data to specify severity criteria Identifying the organizational baseline value for the metric A baseline value is an average value that an organization identifies based on prior experience. A metric is designed to achieve the baseline value.1. Which of the following is a quality control activity?A. Quality auditB. T ools selectionC. TrainingD. Inspection2. Which of the following is a quality assurance activity?A. T estingB. T ools selectionC. InspectionD. Walkthrough3. Which of the following SQA activities involves assessing and review the prototype and product design for quality?A. Application of technical methodsB. Conducting FTRsC. Enforcement of standardsD. Control of change4. Which of the following SQA activities ensures that the development team follows the documented steps to complete a process?A. Application of technical methodsB. Conducting FTRsC. Enforcement of standardsD. Control of changeChapter 2 Introducing Software Testing1. Please describe the benefits of early testing. (p2.4)A:The benefits of early testing include:(1)Reduces the possibility of introducing errors when making changes.(2)Reduces the possibility of forgetting design decisions and conditions.(3)Saves the time required to reanalyze designs and code.(4)Reduces the possibility of similar errors by providing early feedback.(5)Reduces the number of defects that leak through various phases of SDLC, which helps reduce the defect tracking overhead.2. Please describe the steps of Testing Life Cycle. (p2.6)A:(1)Risk analysis(2)Planning progress(3)T est design(4)Performing tests(5)Defect tracking and management(6)Quantitative measurement(7)T est reporting3. Please describe the Roles in a testing team, and their responsibility of each role. (p2.8)A:(1)The key roles in a testing team are:T est managerT est leadT est environment specialistT ester(2)A test manager plans and coordinates the test process for a project and is responsible for:a. Representing the testing team for interdepartmental interactionsb. Interacting with customers and vendors, if requiredc. Recruiting, supervising, and training staffd. Creating a test plane. Creating the budget and schedule for the test process, including test-effort estimationsf. Acquiring hardware and software for the test environmentg. Ensuring proper configuration management of the test environment and the test producth. Defining the test processi. Tracking progress of the test processk. Coordinating pre- and post-test meetings(3)A test lead directs the testing team and is responsible for:a. Providing technical leadership for the test programb. Providing support for customer interface, recruiting, test-tool introduction, test plan execution, staff supervision, and cost and progress status reportingc. Verifying the quality of the requirements, including testability, requirement definition,test design, test-script and test-data development, test automation, test-environment configuration, test-script configuration management, and test executiond. Interacting with test-tool vendors to identify the best ways to leverage test tools on the projecte. Receiving information about the latest test approaches and tools, and transferring this knowledge to the test teamf. Conducting test-design and test-procedure walkthroughs and inspectionsg. Implementing test-process improvements based on surveys conductedh. Tracing the test procedures to the test requirements by using the Requirements Traceability Matrixi. Implementing the test processj. Ensuring that the test-product documentation is complete(4)A test environment specialist specializes in setting up the test environment and is responsible for:a. Installing test tools and establishing the test-tool environmentb. Creating and controlling the test environment by using environment setup scriptsc. Creating and maintaining the test databased. Maintaining a requirements hierarchy within the test-tool environment(5)A tester helps deliver a quality product and is responsible for the following activities during the testing process:a. Developing test cases and proceduresb. Creating test datac. Reviewing analysis and design artifactsd. Executing testse. Using automated tools for executing testsf. Preparing test documentationg. Tracking defectsh. Reporting test results4. Please describe the key performance areas of a tester. (p2.11)A:(1) Defect-detection efficiency(2)Schedule slippage in test case design and test execution(3)Productivity (total number of test cases designed or executed, depending on the nature of project)(4)Number of weighted defects in user acceptance testing(5) Initiatives taken in:Self developmentDeveloping toolsCertificationsT ools learned5. Please describe the main technical skills and behavior skills of a tester. (p2.11) A:(1)T echnical: The technical skills include the following:a. Knowledge of software development, operation, and maintenance processesb. Knowledge of the applicationc. Knowledge of tools that aid in software developmentd. Knowledge of project managemente. Knowledge of the testing processf. Knowledge of test process documentation(2)Behavioral: The behavioral skills include the following:a. Sensitivity to small detailsb. T olerance for chaosc. Organized approach1. Errors that are undetected at a particular stage in the development life cycle and are carried forward to next stage are called .A. Leakage errorsB. Logical errorsC. Debugging errorsD. Integration errors2. Which of the following cannot be achieved by testing?A. Detecting errors in a software productB. Verifying that a software product conforms to its requirementsC. Showing that a software product has no defectsD. Establishing confidence that a program does what it should3. Which of the following is the correct sequence of phases in the testing life cycle?A. Risk analysis, planning, test design, performing tests, defect tracking and management, quantitative measurement, test reportingB. Planning, risk analysis, test design, performing tests, defect tracking and management, quantitative measurement, test reportingC. Planning, risk analysis, test design, performing tests, test reporting, defect tracking and management, quantitative measurementD. Risk analysis, planning, test design, performing tests, quantitative measurement, test reporting, defect tracking and management4. In which phase of the testing life cycle are defects communicated to the development team?A. Defect tracking and managementB. Performing testsC. T est reportingD. Quantitative measurementChapter 3 Planning Software Tests1. Please describe which phases the test planning process includes. (p3.3)A:The test planning process includes the following phases:(1)Pre-planning(2)T est planning(3)Post-planning2. In the pre-planning phase, the test specifications are identified. Which components are included in the test specifications? (p3.3)A:This phase identifies the test specifications. The test specifications include the following components:a. T est objectivesb. T est assumptionsc. T est success/acceptance criteriad. T est entrance/exit criteria3. Which activities are included in the test planning phase? (p3.4)A:The test planning phase includes the following activities:(1) Performing requirements traceability(2) Estimating test effort(3) Scheduling the test iterations(4) Planning resources(5) Identifying testing approaches(6) Defining test quality control4. Which components the test plan should focused on? (p3.5)A:The test plan focuses on the following components:(1) Scope of test(2) T est objectives(3) List of assumptions(4) Results of risk analysis(5) Resource allocation(6) T est schedule(7) T est design(8) T est environment(9) T esting tools and techniques(10)T est completion criteria5. Which steps should be followed when create a test plan? (p3.5)A:T o create a test plan, the steps to be followed are:(1)Forming a test team(2)Understanding project risks(3)Building the test plan6. Which activities should be involved when developing a test plan? (p3.6)A:The development of a test plan involves the following activities:1. Documenting test objectives2. Creating a test matrix3. Writing the test plan7. The post-planning phase of the test planning process includes identifying a configuration management plan for the software project. Which activities are included in the configuration management? (p3.13)A:Configuration management includes the following activities:(1)Baseline control(2)Software configuration identification(3)Configuration control(4)Configuration status accounting(5)Software configuration authentication(6)Software development libraries8. Please describe the V model and W model. (p3.14)A:The cost of correcting a defect that is detected early in the development life cycle is much less than the cost of correcting a defect detected at a later stage. Therefore, to reducethe cost of correcting defects, you must try locating defects early in the development life cycle..The V model proposes an approach to software development in which both the software development process and the software test process begin simultaneously When the project starts, the development team starts the software development process and the testmg team starts planmng for the test process This planning is based on the documents created during the development processThe V model places the development phases such as requirements, analysis, design, and coding on one side of the V The various types of testing such as umt, integration, system, and acceptance, are placed on the other side of the V.Unit testing involves testing each individual unit of software to detect errors in its code. A developer or a peer programmer typically does unit testingIntegration testing involves testing two or more previously tested and accepted units to illustrate that they work together when combined into a single entity Integration testing exposes faults in interfaces and in the interaction between integrated components System testing is the process of testing a completely integrated system to verify that itmeets specified requirements This testing is performed to identify defects that will surface only when a complete system is assembled. System testing includes testing for performance, security, and recovery from failure.Acceptance testing is the process in which actual users test a complete information system to determine whether it satisfies the acceptance criteria This testing enables the customer to determine whether to accept or reject the system.1. According to the V model, documents created during the analysis phase can be used to define the .A. System test criteriaB. Acceptance criteriaC. Integration test criteriaD. Unit test criteria2. Which of the following configuration management activities involve performing configuration reviews and audits?A. Baseline controlB. Configuration controlC. Configuration status accountingD. Software configuration authentication3. Which of the following activities is performed as part of the pre-planning phase of testing?A. Documenting risks related to testingB. Creating test matrixC. Defining the success/acceptance test criteriaD. Forming a testing team4. Which of the following is a dynamic testing technique?A. ReviewB. WalkthroughC. AuditD. T estingChapter 4 Identifying Test Approaches1. Please describe static testing and dynamic testing. (p4.3)A:Static testing: Static testing verifies the conformance of a software system to its specification without executing the code. This testing involves analysis of the source text by individuals.Dynamic testing: Dynamic testing involves executing the source code to check if it works as expected.2. Please describe the types of errors can be located by using functional approaches. (p4.3)A:Functional approaches are useful for locating the following types of errors:Incorrect functionalityMissing functionalityInterface errorsIncorrect specificationsInitialization errorsT ermination errors3. Please describe the benefits and limitations of using functional test approaches. (p4.3)A:The benefits of using functional test approaches are:●They are effective for large units of code.●T esters do not need any knowledge of implementation, including specificprogramming languages.●T esters and developers can be independent of each other.●T ests are conducted from a user's point of view.●T ests help easily identify ambiguities or inconsistencies in the specifications.●T est cases can be designed as soon as the specifications are complete.●The limitations of functional test approaches are:●Can leave many program paths untested.●Cannot be used for complex segments of code. Therefore, such segments cancontain errors.●Cannot determine a reason for failure.●Difficult to design tests without clear and concise specifications.4. Please describe the benefits and limitations of using structural test approaches. (p4.5)A:The benefits of structural testing approaches are:●Useful in locating non-specified functions that cannot be detected using functionalapproaches●More effective than functional approaches for small modulesThe limitations of structural test approaches are:● A program contains a large number of logical paths. It is not practically possible tocheck all logical paths because it involves time and effort. Y ou can test only some important logical paths.●It is necessary for the tester to know programming languages.●These approaches do not ensure meeting user requirements.5. Please describe which types of testing structural test approaches and functional test approaches should be applied to. Four basic types of testing are: Unit Testing, Integration Testing, System Testing, and Acceptance Testing. (p4.5)6. Please describe the Structural Testing Techniques. (p4.6)A:The structural testing techniques are:●Stress testing: Involves testing the system in a manner that demands resources inabnormal quantity, frequency, or volume.●Recovery testing: Verifies the ability of the system to recover from varying degrees offailure.●Operations testing: Ensures that when an application is developed, it is tested andthen integrated into the operating environment.●Compliance testing: Verifies whether the application is developed in accordance withinformation technology standards, procedures, and guidelines.●Security testing: Identifies security defects in the software.7. Please describe the Functional Testing Techniques. (p4.8)A:The functional testing techniques are:●Requirements testing: This type of testing is conducted to verify that a systemperforms correctly over a continuous period of time.●Regression testing: When a change is made to one segment of a system.●Error-handling testing: This type of testing is done by a group of individuals who thinknegatively to anticipate what can go wrong with the system.●Manual-support testing: This involves testing the interface between users and theapplication system.●Intersystem testing: Applications are often interconnected with other applications.●Control testing: This type of testing is conducted to ensure that processing isperformed in accordance with the intent of the management.●Parallel testing: When a new system is developed.1. Which of the following is a static testing technique?A. Black-box testingB. White-box testingC. ReviewsD. Regression testing2. Which of the following is a structural testing technique? A. Unit testing B. System testing C. Acceptance testing D. Requirements testing3 Which of the following is a functional testing technique? A. Stress testing B. Executing testing C. Recovery testing D. Regression testing4. Which of the following is a dynamic testing technique? A. ReviewB. WalkthroughC. AuditD. White-box testingChapter 5 Designing the Test Environment1. Please describe the test process and its minor process activities by using ETVX diagram. (p5.4)A:A test process provides a systematic approach to accomplish the objective of testing. A test process can also be defined as a set of minor process activities within major process activities represented by the Entry-T ask-Verification-Exit (ETVX) diagram.2. Please describe the Life Cycle of a Test Process. (p5.5) A:There are various phases in the life cycle of a test process. These phases are as follows: ●System study: The purpose of the system study phase is to understand the testprocess and define its requirements.●Design test cases: The purpose of this phase is to design and build a set of intelligenttest cases for the test process.●Execution: The purpose of the execution phase is to execute the test cases preparedin the design test cases phase.●Wind-up: The purpose of the wind-up phase is to provide an organized and formalwrap up of the test execution phase.3. Please describe the criteria affecting the selection of an appropriate testing tool. (p5.6)A:The criteria affecting the selection of an appropriate testing tool are as follows:●The objectives of testing should be accomplished successfully.●The tool should be easy to use.●The time spent in installing and learning about the tool should be the least.●The tool should be compatible with the platform and software used for testing.●The purchase cost of the tool should be within the project budget.4. What steps the testing team should follow while designing the test environment? (p5.7)A:While designing the test environment, the testing team should follow the given steps:●Gather information about proposed test environment.●Document the test environment specifications for the project.●Simulate the server environment.●Simulate the client environment.●Design domains for testing.●Keep the test logs and reports safe for the future.5. What is a test bed? What are the benefits of test beds? And what are the factors that affect test bed decisions? (p5.8)A:A test bed is a test environment that contains the hardware, simulators, software tools, and other support elements necessary for conducting the test.Benefits of test beds are:●Observing the impact of running applications in an environment changed by softwarepatches,new software installed, ornew hardware purchased before these are used on an everyday basis.●Developing off-line maintenance procedures that help minimize non-functionalperiods of the application software.The following factors affect test bed decisions:●Budget and resource constraints: Setting up a test bed requires specific hardware,software, and other resources.●T echnical support constraints: Maintaining a test bed requires technical support fromspecialized personnel.6. Please describe the testing tool types. Which ones are the Manual tools? (p5.14) A:Some of the important testing tools are as follows:●Unit testing tools●Regression testing tools●Load testing tools●Traceability tools●Code coverage tools●Manual toolsThe most frequently-used manual tools are as follows:●Checklists●T est scripts●Decision T ables1. Which testing is used when there is high risk of a recent change affecting unchanged areas of the application software?A. Parallel testingB. Control testingC. Requirement testingD. Regression testing2. Which of the following steps is not a part of the process of setting up a regression-testing tool?A. Designing the framework of testingB. Identifying the utility functions related to the application softwareC. Configuring an isolated network with servers of specified configurationD. Designing test scenarios3. Which of the following statement holds true for test bed?A. A test bed is the key to quality and stability in a software testing processB. A test bed captures the input of test processC. A test bed helps define a test script in exact terms by defining the hardware and software requirements.D. A test bed executes a test case on time.4. Which testing ensures that the operations of an application software continue after a disaster?A. Recovery testingB. Operations testingC. Compliance testing。

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