1) The document discusses improper quality activities that have occurred at Japanese companies since 2000, including falsifying records and reports.
2) It introduces the "Fraud Triangle" which identifies motivation, opportunity, and rationalization as factors that can lead to improper activities. Motivation may come from personal desires or job pressures, while opportunity relates to weaknesses in rules or oversight.
3) The document aims to raise awareness of behaviors that could lead to quality issues and help ensure Fujikura meets quality compliance through understanding examples of past issues and focusing on prevention.
Is lack of SEDEX/ WRAP/SA 8000 certification hurting your business?Browne & Mohan
As global trade has expanded, companies have realized a need to implement systems to eradicate human exploitation including bonded labor, safer working conditions and right wages. Several standards have been created to support institutionaization of safer, healthy and inclusive work environment. Standards like SMETA (by SEDEX-Supplier Ethical Data Exchange), SA8000 (by Social Accountability International), WRAP (by Worldwide Responsible Accredited Production), FLA Accreditation (by Fair labour Association), etc have been pushed by the demand side of various industries. In this paper, Browne & Mohan consultants present the advantages of social compliance, how companies must prepare themselves for these standards and how they must sustain their efforts.
Comprehensive Compliance for Environmental, Safety, Quality Requirements in C...Nimonik
Nimonik has 7 step process to ensure thorough and comprehensive regulatory compliance for environmental, occupational health and safety and quality requirements for your organization. By following these steps, you will reduce your operational risk and optimize your processes to become a proactive compliance company. This presentation also covers compliance risks such as accidents and penalties, challenges that organizations face along with a case study of Lac Megantic Oil Train Car disaster in July 2013 that killed 47 people and spilled 6 million litres of oil.
Continous compliance october 2019 webinar (2)Nimonik
Compliance can be broken down into three key questions:
- What are your requirements?
- What actions are you taking to meet your requirements?
- How do you verify the actions are effective?
These seemingly straightforward questions are surprisingly challenging to implement. Ultimately, your compliance program is only as good as your operational discipline which is only as good as your processes. So the real question is - Do your processes revolve around compliance or is compliance an afterthought?
This webinar will discuss the key steps to embed compliance in your processes. You will walk away with a toolkit on how to achieve continuous compliance across your operations.
Key Take-Aways:
- A structure to move from reactive to preventative compliance
- Tools to identify your processes that may have compliance issues
- How to convince upper management that continuous compliance drives efficiency
The audit summary report is for Dongguan changsheng silicone products CO.,LTD. The full audit was conducted on June 24, 2015 and found areas of improvement were needed in some areas and good compliance in others. Key areas needing improvement included ensuring workers are aware of their legal rights, limiting monthly overtime hours to 36 hours or less, establishing a worker representative election process, conducting risk assessments for transmittable/non-transmittable diseases, providing occupational health checks to all workers exposed to hazards, and displaying accident procedures. Corrective action plans with deadlines were agreed to address the issues.
The document discusses five common errors companies make when implementing ISO 13485:2003 for medical devices.
1) Misunderstanding process validation requirements and not validating all processes related to product realization.
2) Incorrectly claiming exclusions from requirements instead of stating requirements are not applicable.
3) Stating requirements are "not applicable" without proper justification based on the nature of the medical device.
4) Creating excessive documentation that is difficult to maintain and understand instead of using clear process maps and concise procedures.
5) Failing to establish effective continuous improvement programs to monitor and improve the quality management system over time.
NITRA offers a variety of consultancy and testing services to help organizations assess performance and efficiency. These include techno-economic studies, asset valuation, project monitoring, infrastructure setup, debt restructuring, quality audits, manpower analysis, and more. NITRA has six ISO-accredited labs for physical, chemical, heat and flame, polymer, eco, and environmental testing. They also provide distance learning programs, in-factory training, and consultancy services related to energy conservation, environmental monitoring, and wastewater treatment systems.
The document discusses computerized system validation and electronic records requirements. It provides an overview of US FDA regulations regarding computerized systems including 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It also discusses concepts like closed and open systems, audit trails, electronic signatures, and the Good Automated Manufacturing Practice (GAMP) guidelines for computer system validation.
Management Systems Certification SchemeRajeev Vats
Bureau of Indian Standards has been operating Management Systems Certification Scheme since 1991. Initially, BIS started the scheme with Quality Management System Certification (IS/ISO 9001) and over the years it has gradually expanded its activities to various other Management Systems
Is lack of SEDEX/ WRAP/SA 8000 certification hurting your business?Browne & Mohan
As global trade has expanded, companies have realized a need to implement systems to eradicate human exploitation including bonded labor, safer working conditions and right wages. Several standards have been created to support institutionaization of safer, healthy and inclusive work environment. Standards like SMETA (by SEDEX-Supplier Ethical Data Exchange), SA8000 (by Social Accountability International), WRAP (by Worldwide Responsible Accredited Production), FLA Accreditation (by Fair labour Association), etc have been pushed by the demand side of various industries. In this paper, Browne & Mohan consultants present the advantages of social compliance, how companies must prepare themselves for these standards and how they must sustain their efforts.
Comprehensive Compliance for Environmental, Safety, Quality Requirements in C...Nimonik
Nimonik has 7 step process to ensure thorough and comprehensive regulatory compliance for environmental, occupational health and safety and quality requirements for your organization. By following these steps, you will reduce your operational risk and optimize your processes to become a proactive compliance company. This presentation also covers compliance risks such as accidents and penalties, challenges that organizations face along with a case study of Lac Megantic Oil Train Car disaster in July 2013 that killed 47 people and spilled 6 million litres of oil.
Continous compliance october 2019 webinar (2)Nimonik
Compliance can be broken down into three key questions:
- What are your requirements?
- What actions are you taking to meet your requirements?
- How do you verify the actions are effective?
These seemingly straightforward questions are surprisingly challenging to implement. Ultimately, your compliance program is only as good as your operational discipline which is only as good as your processes. So the real question is - Do your processes revolve around compliance or is compliance an afterthought?
This webinar will discuss the key steps to embed compliance in your processes. You will walk away with a toolkit on how to achieve continuous compliance across your operations.
Key Take-Aways:
- A structure to move from reactive to preventative compliance
- Tools to identify your processes that may have compliance issues
- How to convince upper management that continuous compliance drives efficiency
The audit summary report is for Dongguan changsheng silicone products CO.,LTD. The full audit was conducted on June 24, 2015 and found areas of improvement were needed in some areas and good compliance in others. Key areas needing improvement included ensuring workers are aware of their legal rights, limiting monthly overtime hours to 36 hours or less, establishing a worker representative election process, conducting risk assessments for transmittable/non-transmittable diseases, providing occupational health checks to all workers exposed to hazards, and displaying accident procedures. Corrective action plans with deadlines were agreed to address the issues.
The document discusses five common errors companies make when implementing ISO 13485:2003 for medical devices.
1) Misunderstanding process validation requirements and not validating all processes related to product realization.
2) Incorrectly claiming exclusions from requirements instead of stating requirements are not applicable.
3) Stating requirements are "not applicable" without proper justification based on the nature of the medical device.
4) Creating excessive documentation that is difficult to maintain and understand instead of using clear process maps and concise procedures.
5) Failing to establish effective continuous improvement programs to monitor and improve the quality management system over time.
NITRA offers a variety of consultancy and testing services to help organizations assess performance and efficiency. These include techno-economic studies, asset valuation, project monitoring, infrastructure setup, debt restructuring, quality audits, manpower analysis, and more. NITRA has six ISO-accredited labs for physical, chemical, heat and flame, polymer, eco, and environmental testing. They also provide distance learning programs, in-factory training, and consultancy services related to energy conservation, environmental monitoring, and wastewater treatment systems.
The document discusses computerized system validation and electronic records requirements. It provides an overview of US FDA regulations regarding computerized systems including 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It also discusses concepts like closed and open systems, audit trails, electronic signatures, and the Good Automated Manufacturing Practice (GAMP) guidelines for computer system validation.
Management Systems Certification SchemeRajeev Vats
Bureau of Indian Standards has been operating Management Systems Certification Scheme since 1991. Initially, BIS started the scheme with Quality Management System Certification (IS/ISO 9001) and over the years it has gradually expanded its activities to various other Management Systems
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
The document discusses environmental, health, and safety (EHS) management strategies including environmental compliance programs, auditing, and the services offered by EHS Management Strategies, LLC. It provides an overview of key aspects of developing and implementing an effective EHS program such as proper waste management, pollution prevention, and emergency planning. It also summarizes the purpose of environmental auditing as a tool to assess compliance and identify issues in order to drive continuous improvement. EHS Management Strategies, LLC offers consulting services to help clients develop, audit, and certify their EHS management systems.
ISO 13485 is an international standard for quality management systems for the design and manufacture of medical devices. It supersedes earlier standards and has been harmonized with European medical device directives. Certification to ISO 13485 proves advantageous, and sometimes essential, for medical companies exporting products globally as it demonstrates compliance with regulatory requirements. i3 Consulting is an experienced consulting firm that can help organizations implement an ISO 13485-compliant quality management system and achieve certification.
Process Area Site Assessments techniques for the ManagementNimonik
Safety is senior management's responsibility. Irrespective of the internal and external safety audits, they should go on site visits to see for themselves the safety culture at their organization. But some members of management are hesitant to go on site visits as they feel they lack the skills to evaluate risks and hazards.
In this slideshow, John Wolfe, himself part of management at Suncor Energy, shares best practices for site visits to help leaders go well-prepared for the site visits.
The document provides an overview of MedAccred, an industry-managed supplier quality accreditation program focusing on critical manufacturing processes for medical devices. It describes the benefits of MedAccred accreditation for both OEM subscribers and suppliers. Key points include that MedAccred aims to improve quality and consistency through standardized audits of critical suppliers, reducing risk and costs for OEMs while increasing opportunities for accredited suppliers. The audit process and requirements for initial and ongoing accreditation are summarized.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
1. Workplace safety audits are important inspections to minimize accidents and losses but companies often see them as unnecessary costs.
2. There are no standard guidelines for occupational safety and health audit systems so companies develop their own.
3. Audits inform companies on their health and safety performance and compliance, identifying areas for improvement.
1) The document discusses the importance of testing software for defects that can cause failures and harm. It defines key terms like mistake, defect, fault, failure, error, and bug.
2) Defects can arise during various stages of software development like requirements, design, coding, and use. Testing is important for finding defects and ensuring quality.
3) The costs of defects increase substantially the later they are found. Thorough testing can provide confidence in a software system's quality by identifying defects.
This document provides an introduction to fundamentals of testing. It discusses why testing is necessary, explaining that human errors can introduce defects at any stage of development that may later cause failures. Testing helps reduce risks by finding defects, especially early ones which are cheaper to fix. The document also distinguishes between defects, failures, and their causes/effects. It notes testing is part of quality assurance and helps improve quality by providing confidence if few defects are found through rigorous testing.
This document provides an overview of a quality training course, including:
- The importance of participation and confidentiality for all participants.
- The course objectives to introduce quality tools and help organizations develop quality manuals and strategies.
- The syllabus which will cover topics like quality systems, procedures, management aspects, and problem solving techniques.
- Assessment methods including a project, exam, and continuous assessment during the course.
- Recommended reading materials and standards that provide the framework for the course.
Project Pluto Will Adopt The Incremental Build Model EssayDiane Allen
The validation package should include a validation protocol, validation reports summarizing the results of executing the protocol, and a conclusion on whether the process or system passed validation. It provides documented evidence that the process, equipment, or system performs as intended based on predetermined acceptance criteria. The package gives quality assurance confidence in consistent and repeatable operations.
Webinar 5 steps to running compliant background checks Caitlyn Shipley
This document provides a 5-step process for running compliant background checks:
1. Conduct an individualized assessment of any potentially adverse information by considering the nature, time, and nature of the offense.
2. If considering not hiring an applicant due to adverse information, follow the Fair Credit Reporting Act's adverse action steps which include sending pre-adverse and post-adverse action notices.
3. The pre-adverse action notice informs the applicant of the intent not to hire and allows them to respond.
4. Unless a dispute is filed, a post-adverse action notice will be sent after 7 days to finalize the hiring decision.
5. Running a background check properly involves
This document provides an overview of quality assurance and quality control processes. It defines quality assurance as process-oriented and administrative, focusing on oversight, audits and reviews. Quality control is defined as product-oriented and focuses on 100% testing, inspection and documentation to verify conformance to requirements. The roles of quality assurance is to monitor compliance on behalf of the owner and facilitate reconciliation of non-conformances, while quality control is responsible for implementing the quality system and testing per contract requirements. Safety and quality are also discussed as being closely related, with quality ensuring the safety of engineered products and processes.
Document Control Effectiveness in ISO 15189 Accredited Laboratoriesinventionjournals
ISO 15189 is the global quality management standard published by the International Organization for Standardization (ISO). Document control is one of the Key requirements of ISO 15189. It is considered Document control is the major quality element to establish a quality management system. The research study was carried out to understand the effectiveness of a document control system followed in accredited medical laboratories. It was the key objective to identify the importance of document control system hypothesis vs practical implementation and Challenges of Document control system implementation. It was really hard to categorize the implementation status of document control, but I have tried to analyze it. In the study volume of up to date control document usage in functional area is estimated. Various effects of document control are also analyzed before implementing the accreditation system and post accreditation system. A structured document control system is also observed and compared with pre and the post accreditation system. In the study all reported events are analyzed to find out out the reported event in related to document control system. Risk analysis of document used in the laboratory is also analyzed. Total risk scoring is done based on the document risk involvement. Major challenges observed in the manual document control system. A suggestive idea is prescribed in the improvement of a document control system.
1) Testing is a process that occurs throughout the software development life cycle to find defects, provide confidence, and prevent defects. It includes both static and dynamic testing.
2) The fundamental test process includes planning and control, analysis and design, implementation and execution, evaluating exit criteria and reporting, and test closure activities.
3) Testing requires a different mindset than development, as testers look critically at software to find defects rather than working to solve problems like developers. Independent testing helps ensure quality.
This document discusses deviations in manufacturing processes and their proper handling according to GMP regulations. It defines what constitutes a deviation and differentiates between planned and unplanned deviations. It outlines the obligations to properly document, investigate, and report on deviations to determine their impact. The proper steps for investigating deviations are provided, including determining what happened, who was involved, and identifying the root cause. The importance of corrective and preventive actions is emphasized to prevent future deviations and ensure product quality.
Quality assurance and quality control are related but distinct concepts. Quality assurance refers to planned and systematic activities implemented in a quality system to provide confidence that quality requirements will be fulfilled, while quality control refers to procedures intended to ensure a product or service adheres to defined quality standards. The document outlines key steps in a quality assurance process including identifying organizational goals and customers, obtaining feedback, and making continuous improvements. It also describes a quality control system with incoming, in-process, and outgoing inspection stages to maintain quality throughout production.
This document has been prepared to provide a summary on the changes between ISO 13485:2003 and ISO 13485:2016. The documents contains the following:
a. Benefits of the new version of the standard.
b. Few key definitions
c. Mapping between the versions as per ISO.org.
d. Summary of key changes between the versions of the standard
The document discusses environmental, health, and safety (EHS) management strategies including environmental compliance programs, auditing, and the services offered by EHS Management Strategies, LLC. It provides an overview of key aspects of developing and implementing an effective EHS program such as proper waste management, pollution prevention, and emergency planning. It also summarizes the purpose of environmental auditing as a tool to assess compliance and identify issues in order to drive continuous improvement. EHS Management Strategies, LLC offers consulting services to help clients develop, audit, and certify their EHS management systems.
ISO 13485 is an international standard for quality management systems for the design and manufacture of medical devices. It supersedes earlier standards and has been harmonized with European medical device directives. Certification to ISO 13485 proves advantageous, and sometimes essential, for medical companies exporting products globally as it demonstrates compliance with regulatory requirements. i3 Consulting is an experienced consulting firm that can help organizations implement an ISO 13485-compliant quality management system and achieve certification.
Process Area Site Assessments techniques for the ManagementNimonik
Safety is senior management's responsibility. Irrespective of the internal and external safety audits, they should go on site visits to see for themselves the safety culture at their organization. But some members of management are hesitant to go on site visits as they feel they lack the skills to evaluate risks and hazards.
In this slideshow, John Wolfe, himself part of management at Suncor Energy, shares best practices for site visits to help leaders go well-prepared for the site visits.
The document provides an overview of MedAccred, an industry-managed supplier quality accreditation program focusing on critical manufacturing processes for medical devices. It describes the benefits of MedAccred accreditation for both OEM subscribers and suppliers. Key points include that MedAccred aims to improve quality and consistency through standardized audits of critical suppliers, reducing risk and costs for OEMs while increasing opportunities for accredited suppliers. The audit process and requirements for initial and ongoing accreditation are summarized.
This document discusses different types of quality audits, including internal audits conducted by a company to ensure quality standards are met, external audits conducted by outside parties to ensure standards are met for suppliers or customers, and different focused audits like process, product, and system audits. It also outlines the audit process and how to prepare for an audit by having the proper documentation in place like protocols, consent forms, safety reports, agreements, personnel records, case report forms, and source data.
How Design Controls & Risk Management Best Practices Reduce Customer Complain...Greenlight Guru
We all know how much emphasis FDA inspectors and ISO auditors place on your customer complaint and CAPA processes. And rightfully so.
But what if there were things you could do to minimize the struggles and challenges associated with customer complaint and CAPA management?
Good news. You can decrease the number of customer complaints and reduce the volume of issued CAPAs through good product development Design Controls and Risk Management practices.
Specifically this presentation will cover:
-Influence Design Controls has on Customer Complaints
-How Customer Complaints impact your CAPA system
-Best practices for Design Controls
-Best practices for Risk Management
-Risk-based approaches to Customer Complaint and CAPA management
1. Workplace safety audits are important inspections to minimize accidents and losses but companies often see them as unnecessary costs.
2. There are no standard guidelines for occupational safety and health audit systems so companies develop their own.
3. Audits inform companies on their health and safety performance and compliance, identifying areas for improvement.
1) The document discusses the importance of testing software for defects that can cause failures and harm. It defines key terms like mistake, defect, fault, failure, error, and bug.
2) Defects can arise during various stages of software development like requirements, design, coding, and use. Testing is important for finding defects and ensuring quality.
3) The costs of defects increase substantially the later they are found. Thorough testing can provide confidence in a software system's quality by identifying defects.
This document provides an introduction to fundamentals of testing. It discusses why testing is necessary, explaining that human errors can introduce defects at any stage of development that may later cause failures. Testing helps reduce risks by finding defects, especially early ones which are cheaper to fix. The document also distinguishes between defects, failures, and their causes/effects. It notes testing is part of quality assurance and helps improve quality by providing confidence if few defects are found through rigorous testing.
This document provides an overview of a quality training course, including:
- The importance of participation and confidentiality for all participants.
- The course objectives to introduce quality tools and help organizations develop quality manuals and strategies.
- The syllabus which will cover topics like quality systems, procedures, management aspects, and problem solving techniques.
- Assessment methods including a project, exam, and continuous assessment during the course.
- Recommended reading materials and standards that provide the framework for the course.
Project Pluto Will Adopt The Incremental Build Model EssayDiane Allen
The validation package should include a validation protocol, validation reports summarizing the results of executing the protocol, and a conclusion on whether the process or system passed validation. It provides documented evidence that the process, equipment, or system performs as intended based on predetermined acceptance criteria. The package gives quality assurance confidence in consistent and repeatable operations.
Webinar 5 steps to running compliant background checks Caitlyn Shipley
This document provides a 5-step process for running compliant background checks:
1. Conduct an individualized assessment of any potentially adverse information by considering the nature, time, and nature of the offense.
2. If considering not hiring an applicant due to adverse information, follow the Fair Credit Reporting Act's adverse action steps which include sending pre-adverse and post-adverse action notices.
3. The pre-adverse action notice informs the applicant of the intent not to hire and allows them to respond.
4. Unless a dispute is filed, a post-adverse action notice will be sent after 7 days to finalize the hiring decision.
5. Running a background check properly involves
This document provides an overview of quality assurance and quality control processes. It defines quality assurance as process-oriented and administrative, focusing on oversight, audits and reviews. Quality control is defined as product-oriented and focuses on 100% testing, inspection and documentation to verify conformance to requirements. The roles of quality assurance is to monitor compliance on behalf of the owner and facilitate reconciliation of non-conformances, while quality control is responsible for implementing the quality system and testing per contract requirements. Safety and quality are also discussed as being closely related, with quality ensuring the safety of engineered products and processes.
Document Control Effectiveness in ISO 15189 Accredited Laboratoriesinventionjournals
ISO 15189 is the global quality management standard published by the International Organization for Standardization (ISO). Document control is one of the Key requirements of ISO 15189. It is considered Document control is the major quality element to establish a quality management system. The research study was carried out to understand the effectiveness of a document control system followed in accredited medical laboratories. It was the key objective to identify the importance of document control system hypothesis vs practical implementation and Challenges of Document control system implementation. It was really hard to categorize the implementation status of document control, but I have tried to analyze it. In the study volume of up to date control document usage in functional area is estimated. Various effects of document control are also analyzed before implementing the accreditation system and post accreditation system. A structured document control system is also observed and compared with pre and the post accreditation system. In the study all reported events are analyzed to find out out the reported event in related to document control system. Risk analysis of document used in the laboratory is also analyzed. Total risk scoring is done based on the document risk involvement. Major challenges observed in the manual document control system. A suggestive idea is prescribed in the improvement of a document control system.
1) Testing is a process that occurs throughout the software development life cycle to find defects, provide confidence, and prevent defects. It includes both static and dynamic testing.
2) The fundamental test process includes planning and control, analysis and design, implementation and execution, evaluating exit criteria and reporting, and test closure activities.
3) Testing requires a different mindset than development, as testers look critically at software to find defects rather than working to solve problems like developers. Independent testing helps ensure quality.
This document discusses deviations in manufacturing processes and their proper handling according to GMP regulations. It defines what constitutes a deviation and differentiates between planned and unplanned deviations. It outlines the obligations to properly document, investigate, and report on deviations to determine their impact. The proper steps for investigating deviations are provided, including determining what happened, who was involved, and identifying the root cause. The importance of corrective and preventive actions is emphasized to prevent future deviations and ensure product quality.
Quality assurance and quality control are related but distinct concepts. Quality assurance refers to planned and systematic activities implemented in a quality system to provide confidence that quality requirements will be fulfilled, while quality control refers to procedures intended to ensure a product or service adheres to defined quality standards. The document outlines key steps in a quality assurance process including identifying organizational goals and customers, obtaining feedback, and making continuous improvements. It also describes a quality control system with incoming, in-process, and outgoing inspection stages to maintain quality throughout production.
The document discusses the importance of properly investigating and documenting exception events to minimize financial costs and compliance risks, providing guidance on roles and responsibilities in the investigation process and the basic elements to define an exception, determine its quality impact, and conduct the investigation to identify root causes and corrective/preventative actions.
The document discusses GMP compliance audits. It defines GMP audits as a process to verify that manufacturers follow good manufacturing practices regulations. There are two types of audits - onsite audits, which involve visiting the production site, and desktop audits, which review documentation without a site visit. Audits check various aspects of production including personnel, facilities, equipment, processes, warehousing and more. They help identify issues, ensure proper controls, and improve compliance.
Managing non conformance colonel sri(titto sunny)Traum Academy
Non-conformance refers to any failure to meet established requirements. There are major and minor non-conformances. Managing non-conformance involves discovering, identifying, segregating, analyzing, approving, documenting, disposing, closing out, and tracking non-conforming items. A key part of the process is using a Non-Conforming Material Report to document each instance and the appropriate actions. Effective management of non-conformance benefits quality, operations, and profitability by identifying causes and preventing future issues.
Fundamentals of testing - Testing & Implementationsyogi syafrialdi
As we go through this section, watch for the Syllabus terms bug, defect, error, failure, fault, mistake, quality, risk, software, testing and exhaustive testing. You'll find these terms defined in the glossary.
Standards are sets of rules that outline specifications to help ensure quality, safety and performance. They provide organizations with shared guidelines to meet expectations. Specific standards exist for processes, products, certification, documentation like manuals and procedures. Quality standards aim to reduce risks, ensure uniformity and compliance with regulations. Common standards include ISO, PS marks, and quality management systems. Maintaining and following standards is important for organizations and consumers.
This document contains information about internal auditing basics, including the audit process, terminology, types of audits, and accepting an audit assignment. It discusses the key steps of an audit as plan, perform, report, and follow-up. It defines important terms like auditor, auditee, client, and internal vs external audits. It categorizes audits as product, process, and system audits. Finally, it outlines the questions an auditor should ask when accepting an assignment: availability, conflict of interest, and competence. The overall document provides foundational information and concepts to understand internal auditing.
Similar to Quality Compliance (ver1.1) for fetl (20)
Defending Weapons Offence Charges: Role of Mississauga Criminal Defence LawyersHarpreetSaini48
Discover how Mississauga criminal defence lawyers defend clients facing weapon offence charges with expert legal guidance and courtroom representation.
To know more visit: https://www.saini-law.com/
The Future of Criminal Defense Lawyer in India.pdfveteranlegal
https://veteranlegal.in/defense-lawyer-in-india/ | Criminal defense Lawyer in India has always been a vital aspect of the country's legal system. As defenders of justice, criminal Defense Lawyer play a critical role in ensuring that individuals accused of crimes receive a fair trial and that their constitutional rights are protected. As India evolves socially, economically, and technologically, the role and future of criminal Defense Lawyer are also undergoing significant changes. This comprehensive blog explores the current landscape, challenges, technological advancements, and prospects for criminal Defense Lawyer in India.
This document briefly explains the June compliance calendar 2024 with income tax returns, PF, ESI, and important due dates, forms to be filled out, periods, and who should file them?.
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
Sangyun Lee, 'Why Korea's Merger Control Occasionally Fails: A Public Choice ...Sangyun Lee
Presentation slides for a session held on June 4, 2024, at Kyoto University. This presentation is based on the presenter’s recent paper, coauthored with Hwang Lee, Professor, Korea University, with the same title, published in the Journal of Business Administration & Law, Volume 34, No. 2 (April 2024). The paper, written in Korean, is available at <https://shorturl.at/GCWcI>.
What are the common challenges faced by women lawyers working in the legal pr...lawyersonia
The legal profession, which has historically been male-dominated, has experienced a significant increase in the number of women entering the field over the past few decades. Despite this progress, women lawyers continue to encounter various challenges as they strive for top positions.
सुप्रीम कोर्ट ने यह भी माना था कि मजिस्ट्रेट का यह कर्तव्य है कि वह सुनिश्चित करे कि अधिकारी पीएमएलए के तहत निर्धारित प्रक्रिया के साथ-साथ संवैधानिक सुरक्षा उपायों का भी उचित रूप से पालन करें।
Genocide in International Criminal Law.pptxMasoudZamani13
Excited to share insights from my recent presentation on genocide! 💡 In light of ongoing debates, it's crucial to delve into the nuances of this grave crime.
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
Receivership and liquidation Accounts
Being a Paper Presented at Business Recovery and Insolvency Practitioners Association of Nigeria (BRIPAN) on Friday, August 18, 2023.
2. 2/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Background of the course
Major improper activities concerning quality by Japanese companies (2000-2017)
2000 Covering up of recalls by an automotive manufacturer
2002 Falsification of production venue of beef by a food manufacturer
2005 Forgery of a structural statement
2007 Falsification of quality labeling of minced beef
2015 Falsification of piling data
2017 Inspection by unqualified personnel at an automotive manufacturer
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
Such improper activities would ruin brand images, and impact management / operations.
This is because Japanese society has become rapidly compliance oriented, and strict
compliance to laws and regulations, rules, agreements, etc. has become necessary.
We have conducted inspections and reviews on general quality management at Fujikura
Group.
As a result, many improper cases have been reported, and we ended up announcing these
cases externally in August 2018.
Many improper activities concerning quality by leading Japanese companies
have been reported across many industries / trades since the year 2000.
3. 3/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Definition of improper activities concerning quality
In this course, “improper activities concerning quality” are defined as:
“Intentional” violation of laws and regulations, public standards, and/or
agreements with customers regarding quality and/or labeling of products
and/or services.
However, it is worth noting that violations caused by negligence should also be avoided
as a matter of course.
Some examples are:
Falsification of inspection records
Filled an inspection forms and reports with false data.
Did not carry out inspections
Inspections agreed with a customer were not carried out.
Difference in inspection method
Inspection was carried out by a different method from what had been agreed with a
customer.
4M change procedure not carried out
Application to a customer when manufacturing conditions are changed as agreed with the
customer was not carried out.
False report regarding process capabilities, manufacturing environment, etc.
Even though there is an agreement with a customer on process capabilities, manufacturing
environment, etc., a false report on them was made to the customer.
4. 4/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Purpose of the course
“Compliance” has been understood as “compliance to laws and
regulations,” but it also entails compliance to agreements with
customers, rules, etc.
“Regarding the laws and regulations,” educational courses on the
Anti-corruption Law, the Antitrust Law, and the Subcontract Law are
carried out at Fujikura Group.
In this course, however, we focus on the people’s behavioral
awareness that may lead to improper activities concerning quality.
Let’s attain common understanding as to the “people’s behavior” from
top executives to temporary employees.
Let’s meet trust from our customers and contribute to society by
understanding what quality compliance is through this course.
5. 5/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Contents
As a beginning,
2.1 We will explain improper activities concerning quality in Japan before
presenting how to avoid progression of such activities with examples.
Then,
2.2 We will present the Fraud Triangle proposed by Professor Donald
Cressey, who specialized in organized crime, as the background of such
improper activities.
And finally,
2.3 We will check Fujikura Quality Policy, which plays an important role in
the quality compliance activities.
Additionally,
3.1 A comprehension check is waiting for you. So learn carefully.
6. 6/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.1 Improper activities concerning quality in Japan
As a beginning,
we will explain improper activities
concerning quality in Japan.
Contents are:
1.1 Major improper activities concerning quality by Japanese
companies
1.2 Improper activities concerning quality
1.3 Mechanism of falsification / covering up
1.4 Why you think “It is OK” when actually it isn’t?
・Case 1: Falsification of shipping inspection data
・Case 2: Covering up of nonconformity
1.5 To avoid the progression of such improper activities
concerning quality
7. 7/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.1.1 Major improper activities concerning quality by Japanese
companies
Major improper activities concerning quality by Japanese companies (2000-2017) [Repeated]
2000 Covering up of recalls by an automotive manufacturer
2002 Falsification of production venue of beef by a food manufacturer
2005 Forgery of a structural statement
2007 Falsification of quality labeling of minced beef
2015 Falsification of piling data
2017 Inspection by unqualified personnel at an automotive manufacturer
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
Complex factors exist behind these
improper activities concerning quality
8. 8/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.1.2 Improper activities concerning quality
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
At the Japanese Society for Quality
Control, “improper activities
concerning quality” are discussed.
Improperactivitiesconcerningquality
(1) Lack of know-how
(inferior technology)
(2) Improper activities concerning know-how
(improper management)
Improve the technology
(i) Intentional (crime)
(ii) Falsification / covering up
Not covered
here
Next
Divided into two categories
Further divided into two categories
9. 9/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.1.3 Mechanism of falsification / covering up
How does the [falsification / covering up] takes
place?
Let’s consider operations differing from the
standard documents (rules).
Lack of knowledge
Lack of skills
Careless mistake
No
Creation of and education on standard documents
You think “It is OK” when actually it isn’t
Evaluation / training of skills
Error proof
e.g.
Automation
No
No
Yes
Yes
Yes
Were you aware of the standard
documents?
Can you comply with the standard
documents?
Were you trying to comply with the
standard documents?
10. 10/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.1.4 Why you think “It is OK” when actually it isn’t?
To comply with rules, consider
• the reasons why they are
established, and
• recognition and evaluation of
risks when they are violated.
Under what circumstances do you tend to think “It is OK” even
though it isn’t?
You think “It is OK,” since decision making based on
(i) Effect of complying with rules and
(ii) Efforts to complying with rules
are not properly carried out.
Effortsto
complyingwithrules
Effectof
complyingwithrules
Compliant
Notcompliant
Effectof
complyingwithrules
Effortsto
complyingwithrules
Compliant
Notcompliant
Effortstocomplying
withrules
Effectofcomplying
withrules
Compliant
Notcompliant
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
11. 11/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Case 1: Falsification of shipping inspection data
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
Let’s take a look at the cases where improper activities concerning quality took place.
Circumstances
Understanding of the
person in charge
Improper activities
Efforts to complying with
rules
Omission of sampling inspection before shipmentScene
Inspection methods are standardized
The person in charge of the inspection was delegated the
authority of implementation
100% automatic inspection was carried out during the
manufacturing process
It takes time to carry out sampling inspection
The PIC judged without proper reasons that sampling
inspection before shipment was unnecessary
Use of old data for the falsification
12. 12/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Case 2: Covering up of nonconformity
Let’s take a look at the cases where improper activities concerning quality took place.
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
Circumstances
Understanding of the
person in charge
Improper activities
Efforts to complying with
rules
Shipping inspectionScene
Inspection methods are standardized
The person in charge of the inspection was delegated the
authority of implementation
Failing acceptance inspection by the customer may result
in insufficient supply
Changes to standards or operation methods take time
before obtaining the customer’s approval
Judged that the standards are not rational, without
proper reasons
No accident happened where the inspection results
affected safety
Passed nonconforming products, etc. by rewriting the
inspection report
13. 13/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.1.5 To avoid the progression of such improper activities
concerning quality
Source: Created based on “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
In the next chapter, the background of why improper activities concerning quality
take place will be examined in detail.
How can we avoid the progression of improper activities concerning quality?
Manage the complexity of operation
* Make routine operations simple, effective, and efficient as necessary
How to proceed with establishing rules and delegation of authority
* Clarify the person who judges and decides after assuming possible issues
when establishing rules and delegation of authority of routine operations
Development and management of personnel
* Educate / train personnel who are in charge of information reporting so
that they understand the importance of information and all have fair
recognition of adverse effects caused by creating and reporting information
14. 14/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.2 Background of the improper activities
Next, we will explain
Background of the improper activities.
Contents are as follows:
2.2.1 What is “Triangle of improper activities”?
2.2.2 What is “motivation”?
• Types of motivation
• Self-check of “motivation”
• How to deal with “motivation”
2.2.3 What is “opportunity”?
• Malfunctioning and emasculation of rules
• Self-check of opportunities
• Dealing with the opportunities
• “Internal Reporting System” of Fujikura Group
2.2.4 What is “justification”?
• Self-check of “justification”
2.2.5 What would you “lose”?
15. 15/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Source: Created based on “System Fraud Triangle”
2.2.1 What is “Triangle of improper activities”?
American specialist in
organized crime
D. R. Cressey
(1919~1987)
Motivation
Circumstances of the PIC
and trigger
Justification
Excuse
Opportunity
Work environment
Improper activities
Professor Donald Cressey, who was an American specialist in organized crime,
proposed three factors behind improper activities in 1953, which was published
as the Fraud Triangle in 1991 by Professor Steve Albrecht.
Objective circumstances
Obvious to anyone
Subjective circumstances
Internal to the person in charge
Improper activities take place when all three
factors come together
16. 16/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
e.g., Omission of sampling inspection before shipment
Improper activities take place when all three factors come together
If any one of the factors is missing, the improper activities are hard to take place
Above mentioned
“Falsification of inspection data prior to shipment (omission of sampling
inspection before shipment)” will be examined based on the three factors.
The three factors of “motivation,” “opportunity,”
and “justification” will be explained next.
Motivation
Circumstances of the PIC
and trigger
Three factors of improper activities
Opportunity Work environment
Justification Excuse
I need to go home early because one of my family
members is sick
Omission of sampling inspection before shipment
Inspection is carried out by one person
This person can bring an approval stamp outside
Past omission of the inspection did not cause
problems with the characteristics
17. 17/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.2.2 What is “motivation”?
Let’s examine “motivation” that is important in people’s behavior.
Here, “motivation” is a set of subjective circumstances that motivate
improper activities.
In other words, it is a feeling that improper activities are critical in
solving “one’s own desires / worries.”
Even under similar circumstances (opportunity),
• Depends on the “person,” or
• If he/she is inexperienced or experienced for a
prolonged period of “time,”
the circumstances may or may not constitute a motivation.
Source: Created based on “Fraud Triangle” by D-Quest Group and “Courses for Raising Sensitivity
for Company Ethics and Compliance” by the Japan Management Association
18. 18/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Types of motivation
Source: Created based on “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
Motivation
Circumstances of the PIC and
trigger for doing improper
activities
Strong personal desire
• Improving treatment
• Fear of dismissal or
unemployment
Job related problems
• Cannot achieve the target
Problems that cannot be solved by laws and regulations,
or company rules
• Dissatisfaction against the company
• Grudge against the boss
Pressure
• Strong pressure for accomplishing the
assignment
Private problems
• Sickness of a family member
Let’s examine what can be a motivation.
You can see that “anything around you” can result in a
“motivation” of improper activities for any kind of person.
19. 19/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Check the “motivation” yourself!
You can see that anybody has
“motivation” for improper activities.
Source: Created based on Wisdom Bag for Labor Management
and “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
Now start the self-check.
Some of the examples are as follows:
• I made a mistake in the job and cannot report it to the boss
• A difficult goal that I cannot achieve is imposed
• I have a job whose due date is hard to keep
• I can make profit by committing an unjust activity
• I have a grudge feeling for treatment by the company such as salary
or position
• I am anxious about dismissal or unemployment
If even one of the above is applicable, it is important to recognize that you have a
risk for committing improper activities
20. 20/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
How to deal with “motivation”
Every job entails a certain level of “pressure.”
However, if you continue to be under extreme pressure, you
may be unable to make correct decisions.
The “pressure” may lead to “improper activities.”
Then how can we deal with such a situation?
• Taking good care of your own mental health,
• Having someone from whom you can seek advice, etc.
are some of the measures.
If you have subordinates,
• Be careful whether your subordinates make a conjecture about your hidden
intention to take an improper action
e.g., Let’s make every effort to achieve the goal
→You can do anything to achieve the goal
• Clarify the system and standards of evaluation / promotion and make them
known to the subordinates
Source: Created based on “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
21. 21/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.2.3 What is “opportunity”?
“Opportunity” here refers to an objective environment that facilitates the
conduct of improper activities.
In other words, it is a work environment in which you can do improper
activities whenever you want to.
Work environment can be divided into two types.
“Position”
• Doing a specific job by one person
• Only one person knows the job
• Only one person can do the job
“Authority”
• Authorized to use an approval stamp all by oneself
Source: Created based on “Fraud Triangle” by D-Quest Group and “Courses for Raising
Sensitivity for Company Ethics and Compliance” by the Japan Management Association
22. 22/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
“Malfunctioning” and “emasculation” of rules
Normally, it is “natural” to deal with a work process by stipulating “rules
and systems” so that improper activities with “position / authority” may
not take place.
But in actual cases,
Malfunctioning … neglecting rules
• Criteria are not met, but since there is no problem with
the performance, I will put the stamp of “pass” here.
Emasculation … loophole of the rules
• You can put the stamp of “Inspected” even though it has
not been inspected.
Source: Created based on “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
You are expected to
• Discover,
• Share within the division, and
• Eliminate
the “opportunities” of “risks for improper activities” that can
occasionally be seen in the workplace.
23. 23/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Check the “opportunities” yourself!
Eliminating risks of the “improper activities” at the
“opportunities” will tip the balance of the “triangle of the
improper activities,” thereby preventing the “improper
activities” from taking place.
Now, check your own workplace.
Some of the examples are as follows:
Examples of “position / authority”
• Doing the same job for a long period of time
• Some of the jobs are not transparent to people other than the PIC
Examples of “malfunctioning / emasculation”
• Rules for approval and/or decision making are not determined for some of the jobs
• Some of the jobs are undertaken by a person who does not deserve the authority
(approval stamp)
• There are rules that are not kept or are not functioning
Source: Created based on “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
If even one of the above is applicable, it is important to recognize that you have “risk(s) of
improper activities” by “opportunities.”
24. 24/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Dealing with “opportunities”
(i) Ask your colleagues about their stories and for their opinions.
→Problems would surface by sharing information.
(ii) Report to / consult your boss
→ If you address your boss as follows,
“Points would become clear and the argument would become concrete”
so that your boss will understand your point smoothly.
• Use questions…e.g., “Is the customers’ quality information well
managed?”
• Point out…e.g., “Anyone can bring the customers’ quality
information outside.”
• Propose…e.g., “You need to review how the customers’ quality
information is stored.”
What should you do if you discover “opportunities” that may
lead to improper activities in the workplace?
25. 25/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.2.4 What is “justification”?
“Justification” here refers to a subjective environment that can be used to
accept the conduct of improper activities.
In other words, it means overcoming “qualms” that you feel when conducting
improper activities by inventing reasons that are favorable to you.
This is a matter of personal ethics.
Some examples are as follows:
• There are no rules in the company
• Colleagues are also doing it
• I am not evaluated fairly
• Improper activities (omission of inspections, etc.) does not affect quality,
etc.
• To improve performance of the department and/or company
• Prioritizing delivery date will lead to the next order
Source: Created based on “Fraud Triangle” by D-Quest Group and “Courses for Raising
Sensitivity for Company Ethics and Compliance” by the Japan Management Association
26. 26/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Check “justification” yourself!
Source: Created based on “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
Judgment criteria of “good or evil” depend on one’s personal ethics.
Ethics may be different for each person.
Such variation may lead to improper activities in daily operations.
Let’s discuss the situation at your workplace.
If everyone in the workplace all has common perception that improper activities “can
never be accepted”, risks for conducting improper activities through “justification” would
be reduced.
Now start the self-check.
Some of the examples are as follows:
• You can do anything as long as it does not violate laws and regulations
• If your boss accepts, violation of rules will be approved
• If told “It has been done for quite some time now,” I will accept it even though I feel
uncomfortable
• If the customer accepts, you can violate the agreement with the customer by keeping
it secret
• Anything would be acceptable if it is for achieving a goal
27. 27/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.2.5 What would you “lose”?
Conducting improper activities concerning quality can be stopped if everyone has a high ethical
standard.
However, there are times when you are bewildered.
If such is the case, thinking about “what you lose” may “stop” the improper activities.
By “doing,” what would you do if you compare
<What you lose> now, and
<What you will get> in the future?
Present Future
What you get
What you lose
If you act
By “doing,” what would you do if you
compare
<What you get> now, and
<What you will lose> in the future?
Ask yourself and listen to “your internal voice.”
That way, you would have fewer regrets!
What you
get now
What you will
lose in the
future
What you
lose now
What you will get
in the future
28. 28/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.3 Quality Compliance Activities
Finally, we will explain the Quality Compliance Activities.
Contents are as follows:
2.3.1 Compliance expands as time goes by
2.3.2 What happens if you disregard compliance?
2.3.3 To avoid violation of compliance,
• Management philosophy of the Fujikura Group
• Fujikura Quality Policy
We will review the above-mentioned items.
29. 29/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.3.1 Compliance expands as time goes by
The word “compliance” comes from “respond (to something),
obey, and protect,” and is recognized as complying with laws
and regulations.
[Nothing special] about <complying with laws and
regulations>.
Meaning of <compliance> is expanding with time.
Internal rulesAgreement with customers
Compliance with laws and regulations
Laws regarding business activities
Laws for consumers
Laws for employees
Laws regarding the internet
etc.
People’s behavior (ethics of individual person) Triangle of improper activities
30. 30/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.3.2 What happens if you disregard compliance?
Source: Created based on “Compliance for Employees” by Toshiba Solutions
What happens if you disregard compliance?
Possible consequences are:
Lose credibility of the company
Damage morale of the employees
Lose human resources to outside
Then what should we mind?
Daily efforts
• Identification of risks for improper activities
• Collect information on improper activities in society and/or the industry
• Audit and education / training
etc.
When a problem occurs,
• Organize facts
• Investigate causes
• Respond properly
• Fulfill accountability in relation to media and customers
31. 31/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
2.3.3 To avoid violation of compliance
Two steps for avoiding “compliance violation” will be explained.
The first step
• Recognition and understanding of the management philosophy of
Fujikura Group [MVCV] by each employee.
• Its basis is “Fujikura Quality Policy.”
The second step
• Understanding the true purpose of “laws,” “agreements with
customers,” and “company regulations.”
Let’s check these items on
the next slide
32. 32/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
The first step: management philosophy
Mission
• It defines the “raison d’être” of the company
• It applies universally
Vision (what we want to be)
• “Grand target of the future”
• It can be updated and changed
Core values (basic values)
• Type of behavior to obey and values to share
• Judgment criteria for what you should focus on in behavior or
process
33. 33/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Management philosophy of the Fujikura Group (MVCV)
Mission
・ Fujikura Group contributes to value creation of customers and society
through technology that “connects”
・ We will continue to take on everlasting challenges in the field of
technology that “connects,” and provide valuable products and
solutions, thereby meeting customers’ trust and contributing to society
Vision
▪ To become the most trusted partner to customers in the field of
technology that “connects.”
▪ To become a leader in the field of technology that “connects” by
developing highly advanced and useful products and solutions
continuously.
▪ To form a group of globally competent talented people through the
awareness that “everyone plays a leading role.”
34. 34/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Management philosophy of the Fujikura Group (MVCV)
Core values (basic values)
Customer Satisfaction
“Is the customer satisfied?”
Recognize everyone you are working with is a customer, and ask
yourself “Is the customer satisfied?” to provide high quality products
and services to the customer.
Change
“Are you committed to progress?”
Trying to progress and improve is sound and is a driving force for
change.
Individuals and organizations are to utilize every resources available for
the change and keep up with the changing customer needs.
Collaboration
“Are you cooperating with each other to utilize everyone’s ability?”
Fully utilize the abilities of every individual employee to meet customer
needs appropriately, thereby making Fujikura Group an excellent
company group.
For that purpose, create a totally optimized company culture where
everyone respects, encourages, and cooperates with each other.
35. 35/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Management philosophy of the Fujikura Group (MVCV)
Code of conduct
▪ Above all, think and behave from the
customers’ point of view
▪ Always think of what to retain and what to
dismiss
▪ Show your goal clearly
▪ Always research to get one step ahead
▪ Act quickly based on the facts
36. 36/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Fujikura Quality Policy (revised on April 1, 2019)
1. Pursue management based on “quality” to provide best
quality products and services to our customers.
2. Every employee is to be aware of the importance of
quality compliance strongly once again, comply with
laws and regulations, public standards, and agreements
with customers, and never repeat improper activities
concerning quality.
3. Create a transparent company culture by promoting
communication in the workplace and report to a boss
promptly when you recognize quality compliance
problem.
FETL company Quality Policy check revise or continue with simplify
37. 37/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
The second step: Relevant laws
Major laws that are related to business
are as shown below.
All the laws are stipulated according to certain social requirements.
Please understand the background of each law.
1. Fundamental norms that define basic principles / rules of organization and governance of a
country
Constitution
2. Laws regarding business activities
Civil Code, Companies Act, Act on Prohibition of Private Monopolization and Maintenance
of Fair Trade, Copyright Act, Patent Act
Unfair Competition Prevention Act, Act on the Protection of Personal Information, etc.
3. Laws for consumers
Basic Act on Consumer Policies, Consumer Contract Act, Product Liability Act
Consumer Product Safety Act, etc.
4. Laws for employees
Labor Standards Act, Whistleblower Protection Act, etc.
5. Laws regarding the internet
Act on Prohibition of Unauthorized Computer Access, etc.
Source: Created based on Business Compliance written by Nobuo Gohara
38. 38/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Summary
(i) Customer oriented business operation does not necessarily mean to
“obey what you are told by a customer,” but is to
・ Understand content of standards and agreements,
・ Agree with the customer, and
Sometimes, guide the customer;
(ii) Exertion of leadership by all levels of leaders to recognize
・What must be done and
・What must not be done;
(iii) Be aware that every individual employee is contributing to the
organization;
(iv) Identify risks of improper activities keeping the triangle of improper
activities in mind; and
(v) Perform better communication with stakeholders.
ABC method
A…Do obviousthings
B… properly
C…Without ignoring
Justification
Excuse
Opportunity
Work environment
Motivation
Pressure
Improper activities
39. 39/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
3.1 Comprehension check
How was the course?
Do you have a better understanding of what quality compliance is?
Let’s execute daily operation with a firm determination that you will never
repeat improper activities concerning quality through this course.
This material has been reviewed while quoting the materials below.
Quoted materials (in random order)
(1) “To secure the quality oriented country of Japan” by the Japanese Society for Quality Control, etc.
(2) System Fraud Triangle
(3) “Courses for Raising Sensitivity for Company Ethics and Compliance” by the Japan Management Association
(4) Wisdom Bag for Labor Management
(5) “Fraud Triangle” by D-Quest Group
(6) IT glossary that makes you “understand” what was seemingly “understandable” but actually was “hard to understand”
(7) Business Compliance written and edited by Nobuo Gohara
(8) Kawaii furii sozai shuu (cute free materials) by Irasutoya
Lastly, you will have a comprehension check. Repeat it until you can answer all the questions correctly.
40. 40/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 1 If the following statement is correct, select “〇”; otherwise select “X.”
At the Japanese Society for Quality Control, “improper activities concerning
quality” are discussed.
When you are not making a decision based on
・ The effect of complying with rules and
・ Efforts to complying with rules,
you may end up accepting improper activities saying “It is OK.”
To comply with rules,
・ Understanding the background of the rules, and
・ Recognition and evaluation of the risks when rules are violated
are important.
<<〇>> [〇]
<<〇>> [X]
41. 41/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 2 Choose the best combination of words from below for the blanks of [1] - [3] in
the following sentence.
Factor of risks for improper activities [1] is obvious to anyone, and classified as
“objective circumstances.”
Factors [2] and [3], on the other hand, are something internal to PIC, which others
cannot be aware of, and are classified as “subjective circumstances.”
<<〇>> A… 1: Motivation 2: Opportunity 3: Justification
<<〇>> B… 1: Justification 2: Opportunity 3: Motivation
<<〇>> C… 1: Opportunity 2: Motivation 3: Justification
42. 42/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 3 If the following statement is correct, select “〇”; otherwise select “X.”
Three factors of risks for improper activities are:
・ “Opportunity”…workplace environment
・ “Motivation”…circumstances of PIC or trigger
・ “Justification”…excuse.
Improper activities are likely to take place when all three factors come together.
<<〇>> [〇]
<<〇>> [X]
43. 43/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 4 The table below shows the three factors of improper activities of “omission of
sampling inspection prior to shipment.”
Choose the best combination of words from below for the blanks of [1] - [3] in
the table.
<<〇>> A… 1: Justification 2: Motivation 3: Opportunity
<<〇>> B… 1: Opportunity 2: Motivation 3: Justification
<<〇>> C… 1: Motivation 2: Opportunity 3: Justification
[1]
Circumstances of the PIC
and trigger
Three factors of improper activities
[2] Work environment
[3] Excuse
I need to go home early because one of my family
members is sick
Omission of sampling inspection before shipment
Inspection is carried out by one person
This person can bring an approval stamp outside
Past omission of the inspection did not cause
problems with the characteristics
44. 44/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 5 Which one of the statements below is most inappropriate as an explanation of
“motivation,” one of the three factors of risks for improper activities?
<<〇>> A… Various things can be a “motivation” for PIC. Everyone has a trigger for
improper activities.
<<〇>> B…“Motivation,” one of the three factors of risks for improper activities, is
internal to the PIC, and others cannot avoid the occurrence of such improper
activities.
<<〇>> C…“Motivation,” one of the three factors of risks for improper activities, may be
influenced by time; e.g., certain circumstances may have been “pressure” to
someone while it is “no longer” pressure to the same person now after
experience.
45. 45/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 6 Which one of the statements below is most inappropriate as an explanation of
words and deeds that a boss should consider for “motivation,” one of the three
factors of risks for improper activities?
<<〇>> A… I make the “Internal Reporting System” of the company known to everybody
in the department.
<<〇>> B… I always mention that achieving the goal of the department is the top
priority, and is a responsibility of every individual member of the
department.
<<〇>> C… I pay attention to subordinates so that they do not take a wrong action by
conjecturing the hidden intention of my order.
46. 46/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 7 Which one of the statements below is most inappropriate as an explanation of
“opportunity,” one of the three factors of risks for improper activities?
<<〇>> A… If you do the same job for a long period of time, “risk for improper
activities” by “opportunity” rises, making the improper activities more likely
to happen.
<<〇>> B… Products do not meet the shipping standards, but should be shipped if there
is no problem with the performance because you can reduce waste that
way, and thereby contribute to society.
<<〇>> C… If there are operations with which rules for approval or decision making are
not established, “risk for improper activities” by “opportunity” rises, and
“improper activities” are more likely to happen.
47. 47/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 8 Choose the most inappropriate statement as an explanation of “opportunity,”
one of the three factors of risks for improper activities.
<<〇>> A… When reporting to and seeking consultation from your boss, it is better to
begin with questions and then point out the problem before providing your
proposal so that your boss will understand your problem better.
<<〇>> B… It is better to use the “Internal Reporting System” without consulting your
colleagues or boss at all when you find the “opportunity,” one of the three
factors of improper activities at your workplace.
<<〇>> C… It is also effective to set up a vacation system of one week or so, where
some other person takes over the job during vacation.
48. 48/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 9 Choose the most inappropriate statement as an explanation of “justification,”
one of the three factors of risks for improper activities.
<<〇>> A… If you are sure to be able to judge “good from evil,” you are aware that
“improper activities should not be done,” which would stop the improper
activities. However, if there are some reasons to “justify” improper
activities, nothing can stop such activities, resulting in conducting one.
<<〇>> B… One example of “justification” (excuse) is “falsifying shipping data of
defective products” because “you need to prioritize delivery date to obtain
the next order.”
<<〇>> C… “To improve performance of the department or company” is one example of
“justification” (excuse), but it is inevitable.
49. 49/43Fujikura Ltd. Quality Control Center[Electronic version] Quality Compliance (Ver. 1.1)
Comprehension check
Question 10 Below is the “Fujikura Quality Policy.”
Choose the best combination of words from below for the blanks of [1] - [3] in
the table.
1. Pursue management based on [1] to provide best quality products and services to our
customers.
2. Every employee is to be aware of the importance of [2] strongly once again; comply with
laws and regulations, public standards, and agreements with customers; and never repeat
improper activities concerning quality.
3. Create a transparent company culture by promoting communication in the workplace and
report to [3] promptly when you recognize quality compliance problem.
<<〇>> A…1: Quality 2: Quality Compliance 3: Boss
<<〇>> B…1: Quality Compliance 2: Boss 3: Quality
<<〇>> C…1: Boss 2: Quality 3: Quality Compliance