The Self-inspections(Internal Audits)Process as a Part of the Pharmaceutical Quality System:Formation of a Risk-Based Approach to Internal Audits Planning

The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.

Quality of Accounting Information and Internal Audit Characteristics in Nigeria

The basic goal of accounting is to provide quality accounting information that will aid reliable decision-making. The quality level of this accounting information comes from the company＇s governance practices, thereby emphasizing the importance of corporate governance in companies. Recently, following the financial crises resulting in accounting scandals, attention has been moving towards internal audit function as an important factor in the structure of corporate governance. This paper therefore examined the extent of the relationship between internal audit function and the quality of accounting information of companies. The study adopted the survey research design. The research instrument employed was questionnaire which was administered to internal auditors of the ＂Big Four＂. Linear regression analysis was employed in the analysis of the data collected with the use of Statistical Packages for Social Sciences （SPSS）. The results revealed that there is a significant relationship between the internal audit characteristics and the quality of accounting information. It was recommended that in order to provide credibility to the financial statement, there should be a law in place mandating attachment of internal auditors report to the financial statement.

The Effect of Audit Objectives on Audit Quality Why is There Little Disclosure of Significant Deficiencies in Japanese Internal Control Audits？

Many prior research findings indicate that audit quality differs between the Big 4 and non-Big 4 audit firms using an indicator variable. However, most previous research focuses on only outcome measures, such as audit fees, going concern reports, and non-audit services. This study investigates audit quality differentiation between the Big 4 and non-Big 4 audit firms hypothesis from an audit objective point of view. One of the material objectives of Japanese internal control audit institutions is to facilitate assessment and improvement of internal controls by corporations themselves. The findings of this study indicate that the Big 4 audit firms accomplish this objective better than non-Big 4 audit firms. Consequently, most Big 4 clients do not disclose significant deficiencies （SDs）, implying that they improve the quality of internal controls through internal controls auditing. This paper concludes that Big 4 firms produce a higher audit quality level than non-Big 4 firms, and this quality difference iS related to how an audit objective is interpreted and implemented.

The Effect of the Board of Directors and Audit Quality on Disclosure of Internal Control Practices: Evidence from European Companies

The purpose of this paper is to examine the effect of the board of directors,namely board size,board independence,and CEO duality,as well as audit quality on the disclosure of internal control information.The sample consists of 164 European companies listed in the STOXX Europe 600.Based on positive agency theory,the authors posit that board of directors and audit quality influence corporate internal control disclosure practice.The content analysis and the design of the evaluation criterion were used to calculate the disclosure index of internal control.Thus,multiple regression analysis is utilized to analyze the results of this paper.The average internal control information disclosure index was 0.285,indicating that most of the companies in our sample do not disclose enough information about the internal control.This low level of forward-looking information disclosure makes it very difficult for corporate stakeholders to determine the future performance of the company.Multivariate results indicate that internal control disclosure is positively and significantly associated with board independence,CEO duality,and audit quality.This study contributes to the literature on the various governance characteristics and disclosure by showing that the disclosure of internal control information in European countries is positively and significantly associated with board independence,separation of duties,and audit quality.Our study was based on a sample of European companies including countries regulating IC disclosure as well as unregulated settings.As noted by Bedard and Graham(2014),regulatory differences in countries can contribute insights on the costs and benefits of disclosure.Findings also have policy implications for investors,managers,and regulators.

Internal Control and Internal Audit in the Function of Supervising the Operations of Companies

The management of a modern company is faced with the need to make business decisions regarding the achievement of business goals.Increased interest in establishing internal control is affected by the presence increased corruption and the erosion of business morality.For internal controls,everyone is interested,from external auditors to management,board of directors,shareholders of large public companies and the state.With the constant growth of the company,the decentralization of business has been compounded by the management process.Therefore,in addition to internal control,internal audit is required.The company’s management cannot deal with oversight because it has to deal with strategic issues.This is where internal audit is performed as an expert service.The results of the conducted empirical research showed that the stages of development of internal control in enterprises in Montenegro do not correspond with the achieved degree of development of this profession in the countries of the developed market economy.

Auditing the Auditors： The Audit Oversight Board and Regulating Audit Quality in Malaysia

The setting-up of the Malaysian Audit Oversight Board （AOB） in 2010 under the Securities Commission Amendment Act 2010 has extended the role of regulators into the statutory audit domain for public listed companies. Although the auditing profession in Malaysia has International Auditing Standards as prescribed minimum level of quality in the delivery of audit assurance services, self-regulation by the profession alone appears inadequate to ensure the delivery of quality audit services. With co-regulation, auditors now are monitored not just by the profession but also by a new statutory body with considerable regulatory powers to sanction auditors where quality of the audit process has been found wanting. This study solicits the opinions of auditors on their expectations of what the new regulator can achieve. Based on interviews with a sample of 30 auditors, the study finds that the majority believe that audit quality will be taken to a new level following AOB＇s remit of registration of auditors, compliance inspection with International Standard on Quality Control （ISQC）, monitoring of financial statement quality, and its power of sanctions. A review of AOB＇s early years＇ inspection confirms these expectations.

The Applic ation of Internal Quality Audit in ADCOP Project

Internal quality audits are a key activity in the quality management ofoil projects.Quality management aims at meeting project quality requirements,coordinatingproject progress,assisting in controlling project costs,and realizing continuousimprovement in project quality management.

Laboratory Quality Audit in 25 Anti-Retroviral Therapy Facilities in North West of Nigeria

Introduction: A laboratory’s ability to consistently produce high-quality and reliable results hinges on adopting laboratory standards that guide daily practices to ensure steady quality improvement. Although assessment is an extremely rewarding exercise in health care quality improvement processes, it is always considered very time consuming and expensive in developing world settings. A quarterly internal audit was conducted in 25 FHI360 supported Antiretroviral Treatment laboratories in the North West of Nigeria which can surely provide reference for other countries. Methodology: A checklist adapted from the World Health Organization/African Regional Office laboratory accreditation checklist was used to quantitatively evaluate 7 quality essentials (QEs). A team composed of technical staff from FHI360, State Ministry of Health and facility laboratory heads, conducted the audits, developed and monitored intervention plans. Information obtained with the checklist was captured in excel, validated and imported into Grappa Prism software version 5.0 for analysis. Results: Most (92%) facilities were at secondary level with (8%) at tertiary level. The mean total score on all QEs across the facilities was 63.34 ± 9.77 in quarter (Q) 1, 68.8 ± 10.91 in Q2, 72.59 ± 8.02 in Q3 and 72.72 ± 9.16 in Q4 (p ≤ 0.0001). The most improved QE through Q1-Q4 was organization and personnel (32.2%), while signage/bench top reference had an 18.6% point decline. In ranking facilities based on differences of total scores between Q4 and Q1, Kachia General Hospital was the highest with 27 point increase. Considering the mean percentage score for all quarters per facility, 4 had ≥ 80%, 19 had between 60%-80% and 2 had <60%. The total non-conformities cited for QI-Q4 were 185, 100, 78 and 64 respectively with highest recorded in internal and external quality control and the least in facility and safety. Conclusion: We recorded some improvement in most QEs confirming the benefits of internal audits, reviews and follow-up. However, much more is needed in terms of technical assistance, capacity building, mentorship, and commitment at facility and state level to meet minimum acceptable laboratory quality standards.

专用设备外观AUDIT检查方案设计

本文引用AUDIT基本方法,站在用户角度对专用设备的外观进行再检查、再评价,发现改进方向并实施初步改进。通过设计和实施检查方案,明确产品外观质量改进的重点为外套筒等零部件的涂漆层质量,采取消缺措施后,产品外观质量得到提升,检查结果准确反映了质量水平的变化。试验结果表明,基于用户视角,针对专用设备外观设计的检查方案合理、有效,可以考虑利用其持续开展AUDIT检查。

新收入准则会影响审计费用吗?——来自A+H股上市公司的经验证据

收入是企业利益相关者评价企业财务状况和经营业绩的关键指标。新收入准则的实施成效也成为理论界与实务界共同关注的焦点议题。从审计费用的视角,以2018年修订后的新收入准则在A+H股上市公司的实施为研究契机,选取2017—2019年中国A股上市公司数据,实证检验新收入准则对审计费用的影响。研究发现,新收入准则的施行提高了企业的审计费用。机制检验发现,新收入准则通过增加重大错报风险和提高审计投入两条路径提高了审计费用。异质性检验发现,新收入准则对审计费用的正向影响主要存在于受新收入准则影响较大、存在内部控制缺陷、由大规模事务所审计的企业中。进一步研究发现,新收入准则在提高审计费用的同时,还会使审计质量得到一定程度的改善。研究结论丰富了新收入准则经济效应领域的研究文献,同时为审计师在新收入准则背景下提高专业胜任能力、完善审计工作及控制审计风险提供新思路。

董事会断裂带、内部控制与审计质量——基于制造业上市公司的数据

断裂带的存在极容易使董事会形成不同的子群体,而子群体间的相互作用又会反向牵制和干扰董事会的监督能力,进而影响审计质量。以2013—2021年中国沪深A股制造业上市公司为样本,探究董事会断裂带对审计质量的影响。研究发现:首先,董事会断裂带与审计质量呈倒U形关系,断裂带异常会干扰公司董事会监督职能的正常发挥,从而影响审计质量;其次,董事会断裂带与审计质量的倒U形关系主要源于任务导向断裂带的作用,在企业成熟期更为显著;最后,内部控制能够削弱董事会断裂带对审计质量的影响,而良好的内部控制有助于缓解股东与管理层的代理成本,弥补董事会子群体间冲突带来的负面影响,在合理范围内有效地提升审计质量。

建构高校内部质量保障体系:国际经验与中国路径

全球有三种典型的高校质量保障模式,第一种是以认证为主要特征的美国模式,第二种是以审核性评估为主要特征的英国模式,第三种是以授权评估为主要特征的日本模式。美国、英国、日本三国高等教育治理共同发展趋势是强化高校主体地位,由外部评估转向内部评估。21世纪以来,中国高校质量保障体系也越来越强调高校自我评价和质量文化建设,高校内部质量保障体系建设日渐成为重点。建构中国特色高校内部质量保障体系,一是要健全高等教育质量标准,突出标准的导向功能;二是要完善高校组织与制度,强化高校自我评价;三是要培育高校质量文化,以评估促发展;四是要把握共性与个性关系,基于国情创造性转化。

环境问责风险与重污染企业审计费用——基于中央生态环境保护督察的准自然实验研究

本文以2008-2017年我国A股上市制造业企业为样本,以中央生态环境保护督察组进驻为准自然实验,以重污染制造业企业为实验组、非重污染制造业企业为对照组,构建多期双重差分模型,检验环境问责制对重污染企业审计费用的影响。研究发现,环境问责制显著降低重污染企业的审计费用;机制检验发现,环境问责制通过提升重污染企业绿色治理水平、会计信息质量和管理层语调可靠度,来降低重污染企业审计费用;异质性检验发现,在政企关联强、风险承担水平低、地区公众环境关注高的企业,环境问责制对重污染企业审计费用的影响更显著。本研究拓展了中央生态环境保护督察的微观后果,为规范环境风险挑战下重污染企业的审计定价、优化环境规制体系提供理论与决策依据。

银行行政处罚监管与审计定价:溢出还是替代?——来自中国上市商业银行的经验证据

以2007—2021年沪深A股上市银行为研究样本,探究银行监管机构行政处罚监管对审计定价决策的影响,研究发现银行监管机构的行政处罚监管显著提高了银行审计定价,经过一系列稳健性检验后结论依然成立,佐证了溢出效应假说。同时,作用机制检验结果表明,行政处罚监管主要是通过风险溢价的路径提高了审计定价。进一步分析发现:行政处罚监管强度越大以及查出内部控制相关问题越多,审计定价越高;在非国有银行、非“四大”会计师事务所审计、内部控制质量低和信息不对称高这四种情形下,行政处罚监管对审计定价提高的影响更为显著;行政处罚监管对外部审计的溢出效应能够促进双方发挥协同治理功能,从而更好地抑制了银行违法违规倾向。研究结论对银行监管机构和外部审计师加强协作,扎实推进党的二十大报告和中央金融工作会议强调的加强和完善现代金融监管、守住不发生系统性风险底线的方针具有重要启示意义。

政府审计与国有企业ESG表现

以2010—2021年我国沪深A股国有上市公司为研究样本,基于审计署央企审计活动,对政府审计与国有企业ESG表现的影响效应进行实证研究。研究结果显示:政府审计对国有上市公司的ESG表现具有明显的促进作用,这一结论在经过一系列稳健性检验后没有发生变化。机制检验发现,政府审计可以通过提升企业ESG关注度、驱动企业绿色创新和改善公司治理水平来提升其ESG表现。同时,在污染行业企业、内部控制水平较差企业和成熟期企业中,政府审计对ESG表现的促进作用更加明显。

内部审计负责人非正常变更对财务重述的影响

以2013-2019年深圳证券交易所中小企业板上市公司为研究样本,实证分析了内部审计负责人非正常变更与上市公司财务重述之间的关系。研究结果表明,企业内部审计负责人的非正常变更与企业财务重述呈现出显著正相关关系,而且当内部审计负责人的非正常变更造成的空缺时间高于行业均值时,更有可能引发财务重述;对企业财务重述的促发作用在企业管理层持股比例低、聘用非国际四大事务所的情况下表现得更为显著。

非财报问询函对审计意见的影响研究

现有研究重点探讨了财报问询函与审计行为的关系,非财报问询函对审计行为的影响尚不得而知。以2015—2021年A股上市公司为研究对象,探寻非财报问询函对审计意见的影响。研究发现,上市公司收到的非财报问询函数量越多,被出具非标准审计意见的概率越高,非财报问询函更有利于形成客观的审计意见。机制检验结果表明,非财报问询函通过揭示企业经营风险,进而影响审计师的审计意见决策。异质性分析发现,在内部控制质量低、信息披露质量低以及没有超额配置审计师的样本中,非财报问询函对非标准审计意见的正向影响更显著。以问询函类型为切入点,深化了监管问询函与审计行为的相关研究,也为探索构建“监管部门-中介机构”协同监管机制提供了新的思路。

普通高等学校内部审计质量的评价研究

运用层次分析理论讨论普通高等学校内部审计质量的评价问题。新时代高校内部审计的主要矛盾是发展的不平衡、不充分,研究高校内部审计的评价因素及其结构具有重要现实意义和理论价值。研究结果显示,高校内部审计质量的评价因素包括审计投入、审计过程、审计产出和审计环境等4个一级指标和内审体制、专业胜任能力、审计程序、审计报告等15个二级指标。一级指标中审计投入因素权重最高,二级指标中,专业胜任能力、内审体制、审计程序、审计报告等因素权重较高,是高校审计质量内部影响因素的核心指标;审计环境通过对内部影响因素起作用而间接影响高校内部审计质量。

企业数字化转型对内部控制质量的影响及作用机制研究

数字技术的飞速发展成为企业数字化转型和高质量发展的重要驱动力。从内部控制视角出发,选取2011—2022年沪深A股上市公司的数据作为样本,通过实证检验探讨企业数字化转型对内部控制质量的影响及作用机制。研究表明:企业数字化转型有助于提升内部控制质量;企业数字化转型通过提高内部治理水平、降低信息不对称程度以及提升内部审计监督效率等途径来促进内部控制质量的提升;人工智能、区块链、云计算、大数据和数字技术等数字化转型的不同维度均有助于提高内部控制质量;企业的高科技属性会加强数字化转型对内部控制质量的正向影响,而国有企业的产权性质会削弱数字化转型对内部控制质量的正向影响。建议引导企业强化数字化思维,重点推动非高科技企业数字化转型,加快国有企业数字化转型进程,进而提高企业内部控制质量,有效推动企业高质量发展。

内部控制、审计质量与企业高质量发展

为了加强企业的内部控制质量和审计质量,促进企业的高质量发展,以2017—2022年A股上市公司为样本数据,实证研究内部控制对企业高质量发展的影响以及审计质量在其中发挥的调节作用。研究发现,企业的内部控制质量越高,其高质量发展程度愈高,同时,审计质量越高,越能提升内部控制对企业高质量发展的效能。异质性的研究表明,在国有企业、大规模企业、实体企业、东部地区以及市场化程度高的企业中,较好的内部控制质量更能促进企业的高质量发展。由此可见,企业要重视内部控制的建设,严格把控内部控制的质量,增强企业的内部治理水平,谨慎选择审计机构,提高审计质量,实现高质量发展,进而推动中国经济的高质量发展。