Party Audits Research Articles

L’audit croisé inter-radiopharmacies, un outil de progrès individuel et collectif

Radiopharmacy is a high-risk hospital pharmacy carried out in a complex regulatory environment. Adopting an audit culture is a priority issue to secure the radiopharmaceutical drug circuit. The objective of the study is to demonstrate the value of cross auditing, a hybrid between internal and third party auditing. A 125-item evaluation tool applying to the entire radiopharmacy activity was designed. Two radiopharmacies were audited internally and then a cross-audit was organized between the two units. For one of the units, 12 items were rated differently during the two audits. Four of the ten non-conformities that were not observed during the internal audit were rated as critical by the radiopharmacist auditor. For the second radiopharmacy, 15 items were rated differently, two of which were rated as critical. Personal opinion may unintentionally influence a reasoning, but the independence of the auditor during cross auditing is a guarantee of objectivity. It is an alternative to internal audits which have become routine and less efficient and unlike third party audits, the auditor is familiar with the constraints and concerns of the field. The interest of this approach goes beyond the simple evaluation of non-conformities. Cross auditing encourages the sharing of experience and know-how between professionals in the same field. It creates a dynamic collaboration between establishments and contributes to the individual and collective improvement of the safety of the radiopharmaceutical drug circuit.

What would QMS implementation really bring to a company?‐ Theoretical review on benefits and disadvantages researched in practice

PurposeThis study aims to provide information on particular combination of benefits or disadvantages with exact timing of their appearance in the company after its first certification, along with the information on the value range each benefit and disadvantage would take, as well as on the duration period of expected values.Design/methodology/approachSurvey was conducted from October 2015 to January 2019 in 306 certified companies with respondent rate of 58.82%. A questionnaire, structured using literature review to identify all possible benefits and disadvantages of QMS, was used to determine the time of appearance, value range and duration of each identified benefit or disadvantage. Results were used to define indicators for fully applied QMS in each age of its maturity, then the indicators were verified using the records of two ISO certified companies.FindingsThere is a difference in the set of benefits and disadvantages in companies with fully implemented QMS and those that are using QMS only to maintain the certificate. In each age of QMS application a specific set of benefits and disadvantages can be expected as well as the volume range of each of them. These timely sets of benefits and disadvantages can be used as indicators to distinguish well-implemented QMS from those partially implemented.Research limitations/implicationsThe sample consists of companies from Balkan area, therefore economy, politics and culture could have influenced results, predominantly regarding the value ranges of some benefits and disadvantages.Practical implicationsCompanies which already have implemented or are about to implement QMS may use results of the research to plan its effects in years ahead, concerning costs and profit dynamics, as well as to prepare themselves for upcoming probable issues. Auditors can use results in addition to certification criteria to determine the level of QMS implementation and to forecast whether audited company would keep the certificate in the future.Social implicationsSupply chain management could use research findings in selection of chain members to support and speed up third party audits since the benefits and disadvantages of fully implemented QMS are known for each QMS age. This would further imply better structure of supply chains, which would consequently lead to lower production costs, higher quality and competitive prices at the market, which has beneficial implications on the whole society.Originality/valueFor each age of QMS maturity, starting from the first year of certification, expected combination of benefits and disadvantages along with its expected value range and duration are defined. A set of indicators with their expected values.

Prioritization of industry level interventions to improve implementation of design for safety regulations

Introduction: Many countries introduced mandatory Design for Safety (DfS) or Prevention through Design (PtD) requirements to reduce construction accident rates. However, there is a knowledge gap on the relative importance of industry level interventions to improve the implementation of DfS regulations. Thus, this study aims to identify and prioritize a set of industry level interventions to help regulators and industry associations understand the industry’s perceptions and improve the implementation of mandatory DfS. Method: A mixed method approach consisting of 59 semi-structured interviews, four focus group discussions, and an online poll was implemented. Results: Key challenges faced during DfS implementations were identified (lack of guidelines, lack of commitment towards DfS, the inadequate capability of DfS team, and limited effectiveness of DfS Professionals (DfSPs)). The study elicited eight industry level interventions to overcome these challenges and ranked them based on effectiveness and ease of implementation. The ranked industry level interventions in descending order are continuing training for DfSPs, samples and guidelines, DfS training for non-DfSPs, Building Information Modelling (BIM) for DfS review, strengthening DfSP as a profession, DfS awards for developers, third party audits for DfS reviews, and submission of DfS Risk Register to regulator. Conclusions: Identified interventions were classified into four intervention categories: (a) improving competency/ knowledge; (b) technological tools; (c) checks/ audits; and (d) recognitions/ certifications. The key contributions of this study are the identification and prioritization of industry level interventions for DfS, and the classification of safety interventions available to industry associations and regulators. Practical applications: Findings from this study help regulators and industry associations prioritize their resources to improve the implementation of mandatory DfS. Moreover, regulators and industry associations can also use the generic framework of industry level interventions to identify possible interventions to improve other mandatory WSH processes.

Procedural Factors Influencing Forest Certification Audits: An Empirical Study in Romania

In the recent decades, forest certification based on third-party external audits has gained momentum. This type of certification has been developed as a monitoring tool aimed at improving governance in corporate environmental management and differentiating products in the increasing environmentally sensitive markets. Although the scholarly literature has extensively analyzed the adoption and dissemination of forest certification, the findings of the external audits and certification practices remain under researched. On the basis of the analysis of 105 audit reports issued by accredited third-party certification bodies in Romania, this article sheds light on procedural factors that have significant influence on the characteristics of non-conformities (NCs) identified by Forest Stewardship Council (FSC) third party audits. Our research offers empirical evidence that certain procedural factors such as the type of assessment, auditing days, number of auditors, or the presence of foreign members in an audit team have a significant influence on the auditing process outcomes: number and grade of non-conformities, standard references, or methods of NC detection. The study opens interesting new lines of research—the influence of procedural or other types of contextual factors on certification outcomes—and provides indications on the effectiveness of the certification procedures and guidelines in certification process quality assurance.

АСПЕКТИ СТВОРЕННЯ БЕЗПЕЧНИХ І НАДІЙНИХ ЗОН ПАРКУВАННЯ ВАНТАЖНИХ ТРАНСПОРТНИХ ЗАСОБІВ У ЄВРОПІ, ЇХ ВПЛИВ НА БЕЗПЕКУ ДОРОЖНЬОГО РУХУ ТА ДОТРИМАННЯ СОЦІАЛЬНИХ УМОВ

The current situation is considered on the development of safe and secure parking areas for trucks in Europe. The reports of the International Road Transport Union were analyzed on the European Union-funded project on Safe and secure truck parking areas for trucks in Europe and a final report on the study of safe and secure places for truck parking in the EU. The analysis of European regulations is carried out on road infrastructure safety management, specification of truck parking zones, rules of working time and rest of the driver, as well as Ukrainian legislation on these issues. With a view to provide a consistent definition of secure truck parking areas and a quality framework, an EU-wide rating system and security and service at SSTPAs has been defined during the study that included participation by all key stakeholders within the road transport and logistics sector. This rating system should now be implemented as a standard by a newly created EU expert group. The quality of the entire system and of the individual secure truck parking areas shall be guaranteed by ensuring that independent third party audits will occur for all secure truck parking areas within the system. In the future this quality system could also link to ITS solutions for the road transport sector. The implementing the study results in both existing truck parking areas and in new truck parking areas and thereby increasing the number of available secure parking areas throughout Europe, there is a strong probability that cargo crime and incident rates will be reduced significantly and that the security and well-being of truck drivers will be improved, thereby benefitting road safety as well. Recommendations for possible measures to improve the legislation of Ukraine are provided in terms of establishing the SSTPA in view of the EU-Ukraine Association Agreement provisions. Keywords: road safety, freight road transport, Safe and secure truck parking areas (SSTPA), EU Mobility package, driving and rest time rules of driver, Ukraine – EU Association Agreement.

Sustainability Reporting with Regard to Environmental Performance by Top Indian Textile Companies

A sustainability report is an organizational report that informs about economic, social, and environmental performance caused by its business activities. The purpose of this paper is to determine the level of sustainability reporting of environmental performances across the top textile companies in India. The content analysis method was used to describe the sustainability reporting method. It was found that, 20% of them are reporting as per global reporting initiative (GRI) guidelines and 50% as per the business responsibility format mandated by the Ministry of Corporate Affairs, Government of India. It may be concluded that 70% of the industries are adhering to the business responsibility report. It may be hence concluded that the policy makers may need to 1. Upgrade the business responsibility reporting with a few definite quantitative measures 2. Make third party audits mandatory for business responsibility reporting.

Implementing systems engineering and project management processes in a Canadian company – Overview and Results Achieved

AbstractThis article presents a project consisting of implementing project management and systems engineering processes at CSinTrans Inc. (CSiT), a Canadian company founded in 2011. CSiT provides multi‐modal transit information systems as well as information integration to the transit industry worldwide. The Basic profile of the ISO/IEC 29110 for systems engineering has been used as the main reference for the development of these processes.The reasons that prompted CSiT to implement the ISO/IEC 29110 are mentioned. The approach and details on how the standard has been implemented are presented. The lessons learned are described. CSiT developed three process groups to match the attributes of projects such as size and nature. The selection of tools to support the processes is discussed.Third‐party audits, conducted annually since 2016, that led CSiT to become the first systems engineering company successfully audited with ISO/IEC 29110, are presented as well as the benefits obtained.ISO/IEC 29110 has helped raise the maturity of the organization by implementing proven practices and developing consistent work products from one project to another. ISO/IEC 29110 was a good starting point to align processes with specific practices of CMMI® Maturity Levels 2 and 3. ISO/IEC 29110 has also helped CSiT in developing light processes as well as remaining flexible and quick in its ability to respond to its customers.To illustrate the implementation of the Basic profile of ISO/IEC 29110 in other engineering domains, this article briefly presents the implementation in the automotive, agriculture, aeronautic, nuclear and space domains in 6 enterprises of France in 2018.

Matthias WittekindtDie Tankstelle von Courcelles

rithms are able to predict and manipulate our online behavior. McNamee’s “concerns had been building throughout 2016 and reached a peak with the news that the Russians were attempting to interfere in the presidential election.” He reached out to Zuckerberg and Sandberg with a two-page memo detailing his concerns and listing instances where Facebook was causing harm. The answer was swift and polite but treated McNamee’s letter as a PR problem rather than seriously addressing his concerns. Instead of further trying to appeal to Zuckerberg and Sandberg, McNamee teamed up with like-minded individuals like Tristan Harris of the Center for Humane Technology and Renée DiResta of New Knowledge to prompt public and political action, which contributed to Zuckerberg testifying at two congressional hearings in April 2018. What McNamee is calling for is a regulatory -body “equivalent of the Food and Drug Administration (fda) for technology ” that ensures technology is once again deployed to serve humans, not vice versa. The concrete regulations he envisages reach from requiring third- party audits of algorithms , to making “a filter bubble-free view of Facebook News Feed and Google search results” mandatory, to granting users ownership and absolute control over their data including the ability to migrate data to other companies, which would significantly facilitate the entry of start-ups. Zucked is not a scientific study but the account of one person who came to worry about the impact of a company whose founder he once advised. This comes both with its advantages and shortcomings . Many arguments— on addictive behavior and mental health impacts, for example—the reader will likely be willing to follow. After all, don’t most of us feel like we are wasting too much time scrolling through the social-media platform of our choice? Yet intuition and personal experience do not necessarily extrapolate to the wider population. McNamee somewhat concedes this point and lists a wealth of material to complement his own. One book that is not included in this list is The Age of Surveillance Capitalism, by Shoshana Zuboff, which was published only a week before Zucked. At nearly seven hundred pages in length, Zuboff’s book adds important depth to the argument that both are making, and, since its publication, McNamee himself has thrown considerable praise its way. Zuckerberg himself may not see the same need for regulation as many of his critics do, but today even he senses that there is something wrong with the power his company wields: “Lawmakers often tell me we have too much power over speech, and frankly I agree.” Felix Haas Zurich, Switzerland Matthias Wittekindt Die Tankstelle von Courcelles Hamburg. Edition Nautilus. 2018. 256 pages. Die Tankstelle von Courcelles (The petrol station of courcelles) is the latest offering from German novelist Matthias Wittekindt. As a prequel to the series set in Fleurville, it sees Ohayon as a young gendarme investigating a fatal shooting. Although it was awarded second place in the prestigious Deutscher Krimi Preis in 2019, you could be forgiven for initially believing it is a coming-of-age novel. Ohayon’s minimal presence underlines that this novel is not a police procedural of the regional krimi genre, which is highNota Bene Dina Nayeri The Ungrateful Refugee Catapult In her first work of nonfiction, Dina Nayeri completely recalibrates the immigration conversation, raising provocative questions and providing human stories that illustrate the realities of life as a refugee. She calls particular attention to the harmful manner in which Western governments privilege certain dangers over others, challenging her readers to rethink their preconceived notions of the refugee crisis. The urgency of the issue is augmented by Nayeri’s unfailing tenderness in telling stories that are both deeply personal and globally resonant. The Penguin Book of Migration Literature Ed. Dohra Ahmad Penguin Classics This compact but dense collection delivers precisely what it promises, a thoughtfully curated selection of literature penned by writers in migration from one country to another. With pieces drawn from various time periods (the selection by Phillis Wheatley being an especially powerful inclusion), the text is divided up broadly into writing about departures, arrivals, generational assimilation, and, in one case, a return to the place of origin...

Third party audits of the psychosocial work environment in occupational health and safety management systems

Occupational health and safety management (OHSM) systems certified according to OHSAS 18,001 are gaining importance. A key element in OHSAS 18,001 is third party audits. Psychosocial risks are only briefly mentioned in the standard, and the question therefore remains whether audits in practice cover these risks to a sufficient extent. The article provides a first answer to this question through a study of the whole value chain from accreditation of certification bureaus to the subsequent audits and workplace reactions. The results indicate that the accreditation body pays limited attention to psychosocial risks. Furthermore, auditors are often uncertain as to how they should handle such risks. As a consequence, although auditors may pin point psychosocial work environment issues, auditing practices do not ensure a consistent and encompassing coverage of these issues in their audit reports. Of particular concern is the fact that the strongest instrument (non-conformity) is not utilised at all when auditing psychosocial work environment issues. In sum, the results call for stronger inclusion of the psychosocial work environment in the standard as well as in the accreditation and audit processes.

Differences between official inspections and third party audits of food establishments

Official food control inspections (official inspections) of food establishments and third party audits of food safety management systems (FSMSs) based on international standards both focus on food safety, which has raised discussions on whether FSMSs and their audits could reduce official inspections in food establishments. The aim of this study was to investigate whether the findings of official inspections and third party audits in food establishments are in alignment and to survey the inspectors' and food business operators’ (FBOs) perceptions of official inspections and audits. The results can be used in planning the use of audit results as part of official food control. The results show that both inspectors and auditors recognized non-compliances/non-conformities, but significant discrepancies between the findings of official inspections and audits existed, making the utilization of audit results challenging. However, most of the FBOs and inspectors agreed that official inspections and audits overlap, and the majority also agreed that audits of a certified FSMS could under certain circumstances reduce official inspections.

Impact of Third Party Audits on Compliance and Corruption: Evidence Using a Policy Experiment

Using a policy experiment in India, we examine the impact of a third party audit on tax compliance. Employing the generalized difference-in-difference methodology, we find that growth in tax payment is 58 percentage points higher under a regime with no third party audit. The fact that the differential growth in tax is negatively associated with differential growth in discretionary expenses and also absence of any real growth of treated firms, suggestively indicate collusion and corruption. Our results hold up-to a battery of placebo tests, absorption of time varying and time invariant unobservable factors and, display heterogeneity based on expected lines.

Vendor Risk Assessment

This article seeks to draw the attention of the executive management of enterprises to the growing importance of vendor risk assessments. Given that modern enterprises outsource non-core processes and operations to business partners and vendors, it is immensely important that a thorough risk assessment is performed of all control aspects and at all times—before the outsourcing and continuing risk assessments. Regulators hold enterprises responsible for data leakages by business partners and vendors. Therefore, enterprises need to ensure that appropriate metrics for measurement of vendor and business partner performance is well laid out in the agreements with the vendors and business partners. Indicative reference framework such as COBIT 5 framework for vendor management, how we manage a cloud service provider and key risk assessment processes have been provided to assist the executive management. Third party audits of businesses and operations of key vendor and business partners need to be conducted.

Improving the confectionery industry supply chain through second party audits

Purpose This study evaluated benefits and constraints of improving suppliers' quality and food safety systems through second party audits Design/methodology/approach A quantitative quality and food safety audit tool was developed to perform second party audits within the confectionery industry supply chain. Nine flour mills and four food packaging producers were included in the audit program. Initial audits were performed at the beginning of the program, with follow-up audits performed after one year. Findings Level of implementation of food safety and quality requirements were presented as scores. Flour mills improved their scores from 38.6% to 64.4% during the period of two years. In contrast, at the end of the second year, food packaging producers showed a lower level of improvement from 34.0% to 45.6%. This research confirmed that certification status does not imply high performance of a quality / food safety system. Companies experienced problems in identifying processes, setting performance indicators and objectives and implementing problem solving tools. Quality control has been identified as a dimension where most companies do not document their control methods and have no method in place to verify consistency in their results. Control of risks in terms of HACCP implementation was identified as the main food safety constraint Research limitations/implications Limitations of the research stem from the use of results from one part of the confectionery supply chain, from auditing a limited number of companies and from excluding the technological level of the audited companies Practical implications This study provides a valuable insight for quality and/or food safety assurance managers on benefits of using second party audits as a supply chain developing tool. Originality/value The findings of this study are worthy, as second party audits are identified as slow but effective tools in directing suppliers towards improvements

Enactment of the Food Safety Modernization Act

The United States’ Food Safety Modernization Act (FSMA) revises the US Food and Drug Administration's regulatory authority. While expanding FDA's authority, the legislation replicates and relies on private systems of standards and third party audits, albeit with modifications. This article argues that public and private actors develop food safety regulations within multiple types of institutional venues, including private standards regimes, courts, congresses, and government regulatory agencies. It examines how interactions within each of these venues are shaped by stakeholders’ interests, and how the relevant subset of interactions within these venues ultimately shaped the FSMA. The article concludes by offering insights into what consequences these interactions and outcomes may have on the roles and capacities of affected stakeholders in food safety governance.

Evaluating the effectiveness of stakeholder advisory committee participation in forest management planning in Ontario, Canada

The study evaluates the success of Ontario's forest SACs (Local Citizens Committees), including public involvement in open houses for forest management planning using a content analysis of third party audits. Evaluations are discussed in terms of five established components of success: conflict resolution among competing interests, building of trust in institutions, incorporating public values into decisions, improving the substantive quality of decisions and informing and educating the public. Also discussed are the four established process components that facilitate success: responsiveness of the lead agency, motivation of participants, quality of deliberation among participants, and degree of public control over the process. The study has four findings. First, audits did not explicitly address components, were inconsistent, and lacked comprehensiveness, reporting on all four evaluative components that facilitate success but only four of five evaluative components of success. Consequently, our ability to determine overall success was highly constrained. Second, despite the constraints, given three of five outcome components were either not achieved, undermined or limited, and that a fourth was mixed, it appears that effectiveness of LCCs during the study period reflects more failure than success. Third, the component most associated with facilitating success, responsiveness of the lead agency, was generally high. Fourth, the key lesson is that the inability to re-frame citizens as integral participants in civic discourse may have been the weakest point in supporting the strong democracy so critical for deliberation between agencies and citizens.

Application of Failure Mode and Effect Analysis (FMEA) for audit of HACCP system

The aim of the study was to design the HACCP system audit method which allows precise assessment of the system functioning in practice. The method was based on specially elaborated audit questionnaire, covering all HACCP steps and principles, associated with analysis of audit findings by FMEA. External third party audits were carried out in two medium-size bakeries located in Poland. The method allowed precise identification of high and critical risks in HACCP areas of verification and recordkeeping. In view of the obligatory of HACCP system in food industry and periodically emerging food safety scandals in the EU and other countries, it appears advisable to strength control and use methods enabling precise identification of the risk. Therefore, the incorporation of FMEA analysis within the verification procedure of HACCP system may be a convenient tool for better food safety assurance. The designed method is

Quality and food safety issues revealed in certified food companies in three Western Balkans countries

Certification of quality and food safety management system is increasing, with various business drivers that demand third party audits. A survey was undertaken where audit reports and revealed findings (nonconformities and/or improvement opportunities) were analyzed from 123 quality and/or food safety audits performed in 60 food companies. The results showed that QMS audits revealed most of the findings in the management process (21.8%), followed by control (14.5%). Findings related to documentation and control of records increase as the system evolves. Food safety audits showed that the majority of findings are related to managing food safety issues (17.5%) and various aspects of food safety control (15.5%). Further analysis showed that the majority of findings (59.6%) are related to prerequisite programs including GHP requirements. These audits generated twice as much nonconformities than quality management system audits. The survey recognized that in the sampled companies, managing quality and food safety as well as control of quality and food safety represent a problem which should be addressed by most of the companies.

Gap Analysis towards Harmonisation of the MQA Code of Practice for Programme Accreditation with the Quality Management System of MS ISO 9001:2008

The academic programmes at UKM are managed by various faculties, institutes and centres through the Quality Management System (QMS) of MS ISO 9001:2008 for Management of Undergraduate and Postgraduate Studies. This system ensures that all processes are conducted smoothly and in accordance with the requirements of the standards which encompass the design of an academic programme up till the management of examinations and graduation. The efficiency and effectiveness of the system is monitored through a series of scheduled internal audits, third party audits by the certifying body and also through the annual Management Review Meeting. In addition, in its efforts to obtain the status of a Self-Accrediting Institution, UKM mandated that all the academic programmes complied with the standards stipulated in the Code of Practice for Programme Accreditation (COPPA) produced by the Malaysian Qualifications Agency (MQA). As both these standards have different approaches in quality assurance of an academic programme, it is necessary to align and harmonise both systems such that they complement each other. Therefore, this paper presents the gap analysis consequent to a mapping between the requirements of COPPA with the QMS document. The results showed that 80% of the COPPA requirements are already covered in the QMS, whereas coverage with the remaining 20% requires amendments in specific clauses in the QMS document and other policies such as the Policy on Teaching and Learning, Policy on Bridging of Academic Programmes and Policy on Information Communication Technology. The findings of the study can be used to ensure full compliance with COPPA if the processes described in the modified QMS and policies are implemented in totality.

Problem identification method in certified quality management systems

The paper presents some assumptions of the problem identification method in certified quality management systems in which the results obtained by the third party audits find their application. The procedure of collecting and processing the information was defined. The method was tested in practice upon 270 and 892 organizations—the clients of two international certification bodies which have the largest contribution in the process of quality management systems certification in Poland. The results obtained during the testing procedure were presented with special attention paid to the possibilities of investigating both general and specific problems of the selected groups of organizations. An exemplary table of results and the analysis of their application for problem assessment in the systems were presented. Wide range of applications of the method was discussed. The method being considered as universal could find numerous applications in a variety of cases in Poland. Problem identification procedure could feature both quality and quantity approach. The method presented provides information which have been analyzed for its accuracy and objectivity. The method was then compared with other problem identification methods used at present.

Policy Issues in Prevention through Design

Introduction: Many countries introduced mandatory Design for Safety (DfS) or Prevention through Design (PtD) requirements to reduce construction accident rates. However, there is a knowledge gap on the relative importance of industry level interventions to improve the implementation of DfS regulations. Thus, this study aims to identify and prioritize a set of industry level interventions to help regulators and industry associations understand the industry’s perceptions and improve the implementation of mandatory DfS. Method: A mixed method approach consisting of 59 semi-structured interviews, four focus group discussions, and an online poll was implemented. Results: Key challenges faced during DfS implementations were identified (lack of guidelines, lack of commitment towards DfS, the inadequate capability of DfS team, and limited effectiveness of DfS Professionals (DfSPs)). The study elicited eight industry level interventions to overcome these challenges and ranked them based on effectiveness and ease of implementation. The ranked industry level interventions in descending order are continuing training for DfSPs, samples and guidelines, DfS training for non-DfSPs, Building Information Modelling (BIM) for DfS review, strengthening DfSP as a profession, DfS awards for developers, third party audits for DfS reviews, and submission of DfS Risk Register to regulator. Conclusions: Identified interventions were classified into four intervention categories: (a) improving competency/ knowledge; (b) technological tools; (c) checks/ audits; and (d) recognitions/ certifications. The key contributions of this study are the identification and prioritization of industry level interventions for DfS, and the classification of safety interventions available to industry associations and regulators. Practical applications: Findings from this study help regulators and industry associations prioritize their resources to improve the implementation of mandatory DfS. Moreover, regulators and industry associations can also use the generic framework of industry level interventions to identify possible interventions to improve other mandatory WSH processes.