What are the material issues the company has identified?

In its 2016 Sustainability Report the University of Melbourne has identified a range of material issues, most important of which are responsible investment, campus development, governance, sustainable campus operations, digital innovation and student engagement on sustainability issues. This case study is focused on how the University empowers students to take solid action on sustainability issues.

Stakeholder engagement in accordance with the GRI Standards

The Global Reporting Initiative (GRI) defines the Principle of Stakeholder Inclusiveness when identifying material issues (or a company’s most important impacts) as follows:

“The organization should identify its stakeholders, and explain how it has responded to their reasonable expectations.”

Stakeholders must be consulted in the process of identifying a company’s most important impacts and their reasonable expectations and interests must be taken into account. This is an important cornerstone for CSR / sustainability reporting done responsibly.

Key stakeholder groups the University of Melbourne engages with:   

Stakeholder Group

Students

Employees

Business

Industry

Government and Community Partners

Suppliers

How stakeholder engagement was made to identify material issues

The University is committed to engage its stakeholders in decisions related to sustainability issues.  The stakeholders are identified based on their particular interests, as well as, their ability to determine the sustainability performance of the University. Specifically, within the year 2016, the University received feedback from internal and external stakeholders, student representatives, business partners, industry groups, government and community organisations. This feedback has been incorporated into sustainability decision making procedures.

Stakeholder engagement assisted the University of Melbourne to identify the issues of major importance to its community, to comprehend and address the University’s material impacts and acknowledge the necessary commitments to make the greatest contribution to undertaking sustainability issues.

What actions were taken by Melbourne University to engage students with sustainability issues?

In its 2016 Sustainability Report the University of Melbourne reports that it took the following actions for encouraging and enabling students to engage with sustainability issues:

• Engagement of students in sustainability initiatives was wide-reaching in 2016, comparing to 2014, and included:
• The Fairtrade Steering Committee. The students, both undergraduate and postgraduate, organized a one-day Fairtrade market across campus in May 2016, aiming to engage and raise awareness on Fairtrade and other sustainability related topics.
• The “Follow Your Waste” tour. The university staff and students visits the landfill centre used by the University contactors.
• The Student Union (UMSU) environment group organised a series of workshops to strengthen the University’s Sustainability Charter and Plan.
• Active involvement of staff and students in the Sustainability Advocates Forum.
• C16Hack held in April/May of 2016. The students participated in a series of workshops that challenged them to provide innovative solutions to various sustainability issues on campus.
• Bee keeping tours and lectures. This educational and information sharing series engaged a large number of students, as well as, staff and the general public
• Four “Ride to Uni” events, promoting cycling as a sustainable means of transport, health and wellbeing.
• Launch of Green Impact in March 2017. Green Impact is an international, sustainability change and engagement programme launched in the UK by the National Union of Students. The programme aims at raising awareness of sustainability issues globally, by giving people a concrete approach to address sustainability issues and enabling them in achieving these actions. Engaging students is an essential component of the programme.

• Arming graduate students with the knowledge and skills so they can contribute to sustainability through their future professions:

As the graduates must be ready to adapt to the industries of the future sustainable economy, the University of Melbourne is taking action and is committed to developing by 2020 all undergraduate degree programs (at the course and/or major level) to enable students to understand and apply sustainability knowledge in their field.

After finishing their studies, [tweetthis]University of Melbourne graduates have a well-developed approach on sustainability issues[/tweetthis].

Which GRI indicators/Standards have been addressed?

The GRI indicator addressed in this case is: G4-EC8: Significant indirect economic impacts, including the extent of impacts and the updated GRI Standard is: Disclosure 203-2 Significant indirect economic impacts

 

78% of the world’s 250 largest companies report in accordance with the GRI Standards

SustainCase was primarily created to demonstrate, through case studies, the importance of dealing with a company’s most important impacts in a structured way, with use of the GRI Standards. To show how today’s best-run companies are achieving economic, social and environmental success – and how you can too.

Research by well-recognised institutions is clearly proving that responsible companies can look to the future with optimism.

FBRH GRI Standards Certified and ISEP approved Sustainability Course | Venue: London LSE

By registering for the next 2-day FBRH GRI-Standards Certified and ISEP approved Course you will be taking the first step in gaining the many benefits of sustainability reporting.

 

References:

1) This case study is based on published information by the University of Melbourne, located at the link below. For the sake of readability, we did not use brackets or ellipses. However, we made sure that the extra or missing words did not change the report’s meaning. If you would like to quote these written sources from the original, please revert to the original on the Global Reporting Initiative’s Sustainability Disclosure Database at the link:

http://database.globalreporting.org/

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

Note to the University of Melbourne: With each case study we send out an email to your listed address in request for a comment on this case study. If you have not received such an email please contact us.

What are the material topics the organization has identified?

In its 2015 Sustainability Report UNOPS identified a range of material topics, such as exit strategy and project closure, anti-corruption, compliance, environmental impact of services including transportation, non-discrimination, health and safety, responsible economic management, responsible procurement. Among these, having a positive impact on the communities where it operates stands out as a key material topic for UNOPS.

Stakeholder engagement in accordance with the GRI Standards

The Global Reporting Initiative (GRI) defines the Principle of Stakeholder Inclusiveness when identifying material issues (or a company’s most important impacts) as follows:

“The organization should identify its stakeholders, and explain how it has responded to their reasonable expectations.”

Stakeholders must be consulted in the process of identifying a company’s most important impacts and their reasonable expectations and interests must be taken into account. This is an important cornerstone for CSR / sustainability reporting done responsibly.

Key stakeholder groups UNOPS engages with:   

Stakeholder Group

UNOPS Executive Board

Internal Personnel UNOPS senior management Regional and country office management

Partners and funding sources Multilateral partners and funding sources (e.g. UN Agencies, international financial institutions e.g. World Bank, other multilateral institutions e.g. the Global Fund) Governments Trust Funds Foundations

Host governments Government officials and decisions makers Regional and local authorities

Cross-sector partners Non-commercial partners (e.g. Green Project Management, academia, private sector) Local implementing partners and grantees (non-commercial)

Local communities Local beneficiaries/community Civil society

Suppliers Suppliers of goods, works and services

Media and watchdogs Local and national media Other thought leaders

How stakeholder engagement was made to identify material topics

UNOPS validated an initial materiality matrix of potential material sustainability risk topics by means of a workshop with key internal stakeholders. To further explore and validate the topics, 14 interviews with primarily internal stakeholders and three external stakeholders (a partner, a donor and a supplier) took place, along with an online survey sent to 1,809 UNOPS personnel in English, French and Spanish (with a 44% response rate, which was regarded as satisfactory). The survey and interview results were taken to a second workshop with internal stakeholders, which helped UNOPS develop a final materiality matrix.

What actions were taken by UNOPS in order to have a positive impact on the communities where it operates?

In its 2015 Sustainability Report UNOPS reports that it took the following actions for having a positive impact on the communities where it operates:

• Contributing to economic sustainability
• UNOPS contributes to economic sustainability by, among others, implementing effective management and investment strategies with national governments, supporting livelihoods by creating local employment opportunities, and improving access to markets, through local suppliers. In 2015:
  • 44% of all projects included activities that contributed to economic sustainability
  • 29% of all projects created work for local people
  • 15% of UNOPS senior management was hired locally

• Contributing to social sustainability
• UNOPS contributes to social sustainability by, among others, respecting international human rights principles, engaging local communities, placing emphasis on the protection of vulnerable groups, and improving access to food, water, sanitation, education and justice. In 2015:
  • 58% of all projects included activities that contributed to social sustainability
  • 38% of all projects included local community engagement                                             

• Building national capacity
• UNOPS collaborates with its partners to develop skills in the communities where it operates. In 2015:
  • UNOPS supported the training of over 62,000 people in health, project management and improved sanitation, among others
  • 55% of all projects included activities that helped develop national capacity, with 33% of all projects providing on-the-job-training to local people
  • 28% of all projects included formal certification programmes

• Facilitating access to healthcare
• Much of UNOPS’s work is about developing healthcare infrastructure across the globe. In 2015:
  • UNOPS procured and distributed $15,730,032 worth of goods and services in support of activities concerning malaria, tuberculosis, HIV/AIDS, and, also, maternal, new-born and child health

• Strengthening safety and security in post-conflict countries
• The UNOPS Peace and Security Centre assists partners with implementing and managing projects in post-conflict countries. In 2015:
  • UNOPS supported, among others, mine-action, humanitarian, stabilization and explosive management activities, and the weapons and ammunition management work of UNMAS (United Nations Mine Action Service) and partners in 17 countries and territories

Which GRI indicators/Standards have been addressed?

The GRI indicators/Standards addressed in this case are:

1) G4-8: Report the markets served (including geographic breakdown, sectors served, and types of customers and beneficiaries) – the updated GRI Standard is: Disclosure 102-6 Markets served

2) G4-EC6: Proportion of senior management hired from the local community at significant locations of operation – the updated GRI Standard is: Disclosure 202-2 Proportion of senior management hired from the local community

3) G4-EC7: Development and impact of infrastructure investments and services supported – the updated GRI Standard is: Disclosure 203-1 Infrastructure investments and services supported

4) G4-EC8: Significant indirect economic impacts, including the extent of impacts – the updated GRI Standard is: Disclosure 203-2 Significant indirect economic impacts

5) G4-SO1: Percentage of operations with implemented local community engagement, impact assessments, and development programs – the updated GRI Standard is: Disclosure 413-1 Operations with local community engagement, impact assessments, and development programs

 

78% of the world’s 250 largest companies report in accordance with the GRI Standards

SustainCase was primarily created to demonstrate, through case studies, the importance of dealing with a company’s most important impacts in a structured way, with use of the GRI Standards. To show how today’s best-run companies are achieving economic, social and environmental success – and how you can too.

Research by well-recognised institutions is clearly proving that responsible companies can look to the future with optimism.

FBRH GRI Standards Certified and ISEP approved Sustainability Course | Venue: London LSE

By registering for the next 2-day FBRH GRI-Standards Certified and ISEP approved Course you will be taking the first step in gaining the many benefits of sustainability reporting.

 

References:

1) This case study is based on published information by UNOPS, located at the link below. For the sake of readability, we did not use brackets or ellipses. However, we made sure that the extra or missing words did not change the report’s meaning. If you would like to quote these written sources from the original, please revert to the original on the Global Reporting Initiative’s Sustainability Disclosure Database at the link:

http://database.globalreporting.org/

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

Note to UNOPS: With each case study we send out an email to your listed address in request for a comment on this case study. If you have not received such an email please contact us.

What are the material issues the company has identified?

In its 2014 Corporate Social Responsibility Report Evergreen Marine identified a range of material issues, such as ethics, morality and ethical management, domestic and foreign compliance, competition compliance and response, ship and equipment maintenance/upgrades, improving competitiveness. Among these, making sure that its new container ships are environmentally friendly and energy efficient stands out as a key material issue for Evergreen Marine, in view of its commitment to ship management practices that reduce pollution at sea, to the air or on land.

Stakeholder engagement in accordance with the GRI Standards

The Global Reporting Initiative (GRI) defines the Principle of Stakeholder Inclusiveness when identifying material issues (or a company’s most important impacts) as follows:

“The organization should identify its stakeholders, and explain how it has responded to their reasonable expectations.”

Stakeholders must be consulted in the process of identifying a company’s most important impacts and their reasonable expectations and interests must be taken into account. This is an important cornerstone for CSR / sustainability reporting done responsibly.

Key stakeholder groups Evergreen Marine engages with:

Stakeholder Group	Method of engagement
Employees	·         Internal company bulletins ·         Regular and ad hoc meetings ·         Education and training ·         E-mail, telephone, in writing
Government Agencies	·         E-mail, telephone ·         Missive, meeting, visit ·         Education and training, symposiums
Non-Government Organizations	·         E-mail, telephone ·         Missive, meeting, symposium, visit
Suppliers	·         E-mail, telephone, work meeting ·         Labor safety organization meeting ·         Supplier evaluation
Customers	·         E-mail, telephone ·         Missive, meeting, visit ·         Information on corporate website
Shareholders	·         Visit, investor service area on the corporate website
Communities	·         Telephone, visit

How stakeholder engagement was made to identify material issues

To communicate with stakeholders in a timely manner, learn what important issues are of concern to stakeholders so they can be incorporated into the corporate sustainable development strategy and establish a mechanism for unobstructed communication and feedback, Evergreen Marine has adopted a rigorous approach based on the methodologies defined in GRI 4.0 and AA1000 as standard. This ensures that stakeholders communications conform to the three principles of Inclusivity, Materiality and Responsiveness. Under these principles, the communication process involves the identification of stakeholders, the channels of communication, the issues of concern and materiality analysis of such issues. The process and conclusion provides Evergreen Marine with important information in sustainable development as well.

Stakeholders are internal and external groups or individuals that have an influence on Evergreen Marine or are influenced by it. To fulfill Evergreen Marine’s stakeholders commitment and respect their rights, the competent departments within Evergreen Marine have used the appropriate channels to set up a platform for stakeholders communication. Positive relations are maintained by responding in a suitable manner to the issues of concern to stakeholders. Evergreen Marine engages with stakeholders through the authoring of the CSR report and the operation of the Corporate Social Responsibility (CSR) Committee.

The identification of stakeholders, their issues of concern, the verification of issues and their materiality analysis all follow a pre-defined procedure as shown below:

• Identify each unit’s stakeholders and communication channels
• Investigate and compile the issues of concern
• CSR team compiles stakeholder types and issues of concern
• Report and verify stakeholders and issues of concern
• Sort issues of concern by importance
• Include material issues in CSR indicator analysis and data collection

The CSR Committee directs each unit to identify their respective stakeholders through systemic analysis. The stakeholders of each unit are then sorted in different categories. The results of internal identification and discussions were reviewed by the CSR Committee. Employees, the government, non-government organizations, suppliers, customers, shareholders/investors and communities were ultimately identified as stakeholders important to Evergreen Marine.

Positive stakeholders communication and interaction plays an important role in Evergreen Marine’s operations. By using a variety of different communication channels, Evergreen Marine hopes to collect and effectively respond to the precious opinions of its stakeholders. The form of communication varies due to the diversity of stakeholders. There are both routine and extraordinary channels. The issues of concern also vary as well.

Once the list of stakeholders was confirmed, internal departmental meetings were convened to compile the issues of concern collected through routine communication channels as well as screen and compile important information from 2014.

What actions were taken by Evergreen Marine to make sure that its new container ships are environmentally friendly and energy efficient?

In its 2014 Corporate Social Responsibility Report Evergreen Marine set the following targets for making sure that its new container ships are environmentally friendly and energy efficient, based on the company’s approach to materiality – on taking action on what matters, where it matters:

• Voluntarily applying for Green Passport certification

Though not statutorily required, Evergreen Marine took its social responsibility on marine environmental protection into account and voluntarily applied for Green Passport certification of new ships in order to comply with future international conventions on ship recycling.

• Reducing oil spill risk

The L-type container ship is designed with a double-skinned hull and internal fuel oil tanks to reduce the risk of fuel oil tanks being ruptured during collisions and causing an oil spill. The airspace stern tube sealing system prevents lubricant leaking from the stern tube to pollute the seawater.

• Complying with NOx Tier III emission regulations

In the L-type container ship space has been reserved in the engineering section so that equipment can be installed in the future to comply with the strict NOx Tier III emission regulations. When nitrous oxides (NOx) produced by the combustion process are released into the atmosphere they not only cause photochemical smog in urban areas but also have a serious impact on human respiratory function. NOx is also readily water-soluble so it leads to acid rain. Acid rain seeping into the soil results in soil acidification, disrupting agricultural production. International NOx emissions regulations are becoming increasingly stringent. NOx Tier III requires the NOx emissions to be kept below 3.4g/kW. From January 1, 2016, ships sailing in Emission Control Areas (ECA) would be required to keep their NOx emissions within Tier III standards. Current NOx ECAs include North America and the US Caribbean. The L-type container ship was therefore designed from the start to provide sufficient space in the engineering section for the future installation of equipment required for compliance with NOx Tier III emission regulations.

• Preventing air pollution through Alternative Maritime Power (AMP)

The U.S. state of California has instituted the so-called Cold Iron Policy in recent years. Once a ship docks in a Californian port, all of the ship’s internal combustion engines including the shipboard generator must be shut down. This is to prevent waste heat and smog produced by combustion from impacting the air quality and visibility in and around the port. Once a ship has docked, the shipboard generator must be shut down. Shipboard power is then provided from the shore. The L-type container ship is equipped with Alternative Maritime Power (AMP). If ports outside of California also install shore power facilities in the future, the L-type can then connect to shore power when it docks at these ports so that smoke from the ship’s engines and generators doesn’t impact on local air quality.

• Preventing water pollution through ballast water treatment equipment and gray water holding tanks

Ballast Water Treatment Plant: When a ship is empty or not carrying a heavy enough load, a certain amount of seawater is taken onboard to maintain stability. This is known as “ballast water”. When a ship enters port, excess ballast water is discharged to facilitate loading. The IMO (International Maritime Organization) estimated that around 3 ~ 5 billion tons of seawater are carried from port to port every year. The discharge of this ballast water into the port may harm native species or introduce harmful pathogens that impact on the ecological environment of another region. While no international convention currently requires the installation of ballast water treatment equipment, such equipment is now voluntarily installed on all new L-type ships to conform to conventions.

Gray water holding tank (sewage holding tank): Environment awareness has gained increasing importance in recent years. Nations are now strengthening the protection of their ports as well. Brazil in South America was among the first to impose restrictions on the discharge of gray water in port by commercial shipping. The U.S. East Coast is now beginning to impose such restrictions as well. While there is no international convention on the installation of gray water holding tanks as yet, this was included in the design of the Evergreen L-type.

• Using a variety of energy-saving designs

[tweetthis]The L-type container ship uses a variety of energy-saving designs[/tweetthis] certified by classification societies as being already compliant with the IMO EEDI 2020 ship efficiency standard:

Optimized hull design: The hulls of Evergreen container ships have adopted the optimized hull design treatment that keeps drag to a minimum, increasing hull efficiency and reducing fuel consumption.

Use of HT47 (Higher Tensile Steel): The L-type makes use of new high tensile-strength steel to achieve the same level of structural strength for less weight of steel. The reduction in hull weight reduces oil consumption, improving energy efficiency and reducing carbon emissions. It is around 2,000 tons lighter than equivalent 8,000 TEU container ships.

Rudder Bulb design: The rudder bulb design reduces drag from following wake to achieve an energy saving of around 2%.

Energy-saving bulbous bow: The energy-saving bulbous bow design is designed to help counter the degradation in fuel efficiency when the ship deviates from its design speed and draught. This design improves energy efficiency by around 12 ~ 21% at operating speeds and draughts.

Electronically controlled engine: The electronically controlled engine can be run at a lower speed and consume less fuel than conventional engines, improving energy efficiency and reducing emissions.

Variable frequency control seawater pump: The seawater pump on the L-type features variable frequency control to reduce ship power consumption, improving energy efficiency and reducing emissions.

Which GRI indicators/Standards have been addressed?

The GRI indicators/Standards addressed in this case are:

1) G4-EN11: Operational sites owned, leased, managed in, or adjacent to, protected areas and areas of high biodiversity value outside protected areas – the updated GRI Standard is: Disclosure 304-1 Operational sites owned, leased, managed in, or adjacent to, protected areas and areas of high biodiversity value outside protected areas

2) G4-EN12: Description of significant impacts of activities, products, and services on biodiversity in protected areas and areas of high biodiversity value outside protected areas – the updated GRI Standard is: Disclosure 304-2 Significant impacts of activities, products, and services on biodiversity

3) G4-EN26: Identity, size, protected status, and biodiversity value of water bodies and related habitats significantly affected by the organization’s discharges of water and runoff – the updated GRI Standard is: Disclosure 306-5 Water bodies affected by water discharges and/or runoff

4) G4-EN27: Extent of impact mitigation of environmental impacts of products and services

 

References:

1) This case study is based on published information by Evergreen Marine, located at the link below. For the sake of readability, we did not use brackets or ellipses. However, we made sure that the extra or missing words did not change the report’s meaning. If you would like to quote these written sources from the original, please revert to the original on the Global Reporting Initiative’s Sustainability Disclosure Database at the link:

http://database.globalreporting.org/

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

Note to Evergreen Marine: With each case study we send out an email to your listed address in request for a comment on this case study. If you have not received such an email please contact us.

What are the material issues the company has identified?

In its 2014 Corporate Responsibility Report Merck & Co. identified a range of material issues, such as pricing and commercialization, intellectual property, privacy of patient data, continuity of supply, capacity building. Among these, promoting patient and product safety stands out as a key material issue for Merck & Co., recognizing that when people take its medicines and vaccines, they must feel that they are safe to use.

Stakeholder engagement in accordance with the GRI Standards

The Global Reporting Initiative (GRI) defines the Principle of Stakeholder Inclusiveness when identifying material issues (or a company’s most important impacts) as follows:

“The organization should identify its stakeholders, and explain how it has responded to their reasonable expectations.”

Stakeholders must be consulted in the process of identifying a company’s most important impacts and their reasonable expectations and interests must be taken into account. This is an important cornerstone for CSR / sustainability reporting done responsibly.

Key stakeholder groups Merck & Co. engages with:

Stakeholder Group

Patients and caregivers

Healthcare professionals

Payers

Governments, multilateral organizations and regulators

Shareholders

International and local organizations

Local communities

Environmental stakeholders

Employees

Suppliers and business partners

Trade and industry associations

How stakeholder engagement was made to identify material issues

From a list of hundreds of potentially material issues, Merck & Co. identified 42 to test with internal and external stakeholders. Internally Merck & Co. engaged with senior executives from key functional areas and business units including Ethics & Compliance, Global Clinical Development, Scientific Affairs, Global Health Innovation, Global Medical Affairs, Global Public Policy, Human Resources, Manufacturing, Market Access, Philanthropy, Safety and Environment, Vaccines and others. Merck & Co.’s goal was to understand which of the 42 material issues were most linked to the company’s business strategy and to its business success. Merck & Co. asked its business leaders to select the issues of highest importance in terms of their impact on:

• Financial value and revenue
• Operational excellence
• Compliance with regulations
• Corporate reputation
• Shareholders
• Employees and their level of engagement

Externally, Merck & Co. engaged more than 30 stakeholder groups that represented a cross section of advocacy interests, including on-the-ground implementation partners, socially responsible investors, environmental NGOs, public health advocates and health providers. Through in-person interviews, Merck & Co. asked its stakeholders to indicate which issues were important to their groups or communities; where action from the private sector, and from the company in particular, is critical; and how Merck & Co. can drive excellence through its corporate responsibility efforts.

Stakeholders were asked to rank the list of 42 material issues and impacts; assess the company’s performance on these priority issues; and share their expectations related to strategy, reporting and stakeholder engagement. This process was less of an accounting exercise and more of a strategic one, designed to both understand Merck & Co.’s impacts and articulate its priorities. Merck & Co. asked stakeholders to evaluate its 42 priority issues based on criteria heavily influenced by the International Integrated Reporting Council (IIRC), including impacts on and contributions to the six “capitals”: Financial, Manufactured, Intellectual, Social and Relationship, Human and Natural. Merck & Co. augmented these criteria with considerations such as critical risk factors, unique opportunities for the private sector and for the company, and contributions to the global sustainability agenda set by the United Nations.

What actions were taken by Merck & Co. to promote patient and product safety?

In its 2014 Corporate Responsibility Report Merck & Co. set the following targets for promoting patient and product safety, based on the company’s approach to materiality – on taking action on what matters, where it matters:

• Promoting monitoring and compliance

The Global Clinical and Pharmacovigilance Compliance (GC&PVC) function at Merck & Co. is part of the company’s Research Laboratories (MRL) Compliance organization, which in turn is part of the Global Compliance Organization (GCO). This group is responsible for conducting independent, periodic audits of the processes, computerized systems, technology and collaborative partners supporting the Human Health and Animal Health divisions within the company. Merck & Co.’s research laboratories have a comprehensive, risk-based audit and compliance oversight program that encompasses a broad range of GC&PVC audits and assessments of the following:

Clinical investigator sites: Audits to assess compliance with the protocol and with GC&PVC regulations and guidelines

Collaborative partners: Pre-contractual assessments and selected post-contractual audits of contracted research organizations (CROs), central laboratories and other third-party business partners and vendors

Computerized systems and technology: Audits and assessments of the computerized systems and technology supporting clinical development

Internal process/systems audits: Systematic evaluations of compliance of clinical and animal health development processes with standard operating procedures, Global Development Procedures (ICH-GCP) and other applicable regulations and guidance

Country operations audits: Periodic and systematic assessments of the company’s clinical trial and animal health operations and activities carried out by its subsidiaries worldwide

Business partner audits: Audits of external companies with which a licensing or development agreement exists in which compliance with contractual and regulatory requirements is assessed

Verification audits: Audits to verify that the corrective actions that have been implemented are effective at remediating the noncompliance

Through the oversight and implementation of this comprehensive audit program, GC&PVC provides independent assurance to the company’s senior management that the operations, processes and computerized systems and technology supporting Merck & Co.’s Human Health and Animal Health development activities comply with applicable global regulations and guidelines as well as internal company policies and procedures.

• Promoting risk management for all products

Clinical Safety and Risk Management (CSRM) leads the Risk Management & Safety teams for all products, from the beginning of Phase IIb through the end of the product life cycle. CSRM is responsible for the formation of a proactive clinical safety risk-management strategy, including the Risk Management Plan, which is a regulatory requirement in many countries for marketed drugs and vaccines. Development of the overall risk-management strategy incorporates all available internal information (e.g., basic research data and animal and human studies with the product and/or related products) and external information (e.g., literature and public data related to the class of drugs and/or therapeutic target) that contribute to the overall risk-benefit assessment of the product. The strategy focuses on activities needed to identify, evaluate and manage potential patient-safety risks. The Risk Management & Safety teams assess patient safety using product labeling, physician and patient educational programs, and other risk-minimization strategies, as appropriate. The Risk Management & Safety teams also implement strategies to determine the effectiveness of these interventions, as appropriate.

• Rigorously studying products and working with regulators and healthcare professionals to characterize their safety profile

Merck & Co. rigorously studies its products and works with regulators and healthcare professionals over many years to characterize their safety profiles. Initially, test compounds are evaluated in the laboratory. If they pass stringent laboratory tests, the compounds move into next-stage testing in animals. Only a few compounds ever make it that far. If the compound makes it through the animal-testing stage, Merck & Co. then begins clinical development, during which multiple studies are conducted over several years. Clinical testing begins in Phase I in a small number of people and progresses through Phase III, in which the safety and efficacy of a medicine is rigorously evaluated. If the clinical studies are successful, Merck & Co. submits extensive documentation and data to regulators in a product-licensing application. Before approving a medicine or vaccine for use, regulators scrutinize these extensive data and analyses. Even after a product is approved, Merck & Co. continues to actively monitor the safety of its medicines and vaccines in various ways, including post-marketing studies. If Merck & Co. identifies safety issues following a product’s approval, it works closely with the regulatory authorities to communicate promptly and appropriately with healthcare professionals and patients.

• Communicating about product risks

Merck & Co.’s information leaflets in its product packaging contain information on possible side effects and, if appropriate, how to avoid some potential problems. Merck & Co. includes contact details on its corporate website for patients, caregivers and health professionals to report adverse experiences in the U.S. Outside the U.S., adverse events are reported according to local laws and practices. Depending on label changes and their context, Merck & Co. may determine, in consultation with regulatory agencies, that more extensive communications may be appropriate. In such cases, Merck & Co. works with regulatory authorities to contact healthcare professionals in a timely manner, so that they can communicate these findings to patients through appropriate mechanisms. Contacting healthcare professionals might include “Dear Doctor” letters and media releases.

• Identifying, evaluating and reporting adverse experiences occurring in association with the use of products

Although regulations vary by country, most countries require drug manufacturers to promptly review adverse experience (AE) information they receive from any source, both domestic and foreign, relating to the use of their products. Manufacturers are also required to have written procedures in place for evaluating and reporting adverse experiences. In accordance with global regulatory reporting requirements, Merck & Co. has developed a written procedure to provide personnel worldwide – including all contractors – with a consistent and thorough process for identifying, evaluating and reporting AEs occurring in association with the use of its products. These procedures cover the reporting of AEs originating in clinical studies and those associated with the use of marketed products. Adherence to these procedures ensures timely and accurate monitoring of the safety profile of Merck & Co.’s investigational and marketed products globally. To report an adverse experience to regulatory authorities, Merck & Co. needs at least minimal information: the name of the product involved, the adverse experience, an identifiable patient and an identifiable reporter. In addition to submission of individual AE reports to regulatory authorities, either within 15 calendar days or periodically, Merck & Co. also files aggregate reports either quarterly, twice a year or annually for as long as it markets a product. Merck & Co.’s Risk Management & Safety teams review adverse experience information received from all sources (foreign, domestic, clinical trials, published literature, post-marketing) for its products and determine what actions may need to be taken with reference to the evolving safety profile of Merck & Co.’s products. These teams include physicians and epidemiologists who are trained to review this type of data. It can be difficult to determine the exact cause of an adverse experience because many patients have more than one condition and may be taking multiple products. Merck & Co.’s Global Safety staff takes great care to make sure that AE reporting is as accurate as possible. Merck & Co. reviews the data to determine if there are any patterns or emerging trends that need additional surveillance. Another major safety focus is the ongoing oversight and monitoring of Merck & Co.’s product labels. Merck & Co.’s Label Review teams monitor information on its products and work with the company’s Product Safety teams to develop or update product labeling. Information is then communicated to regulatory agencies worldwide. Employees responsible for monitoring and reporting adverse experiences undergo rigorous training every other year. New employees within Merck & Co.’s research laboratories – including all contract personnel – working in areas related to clinical research and global safety undergo training on Merck & Co.’s AE policies and procedures when they join the company. All other employees are trained in AE reporting procedures as part of Merck & Co.’s Code of Conduct training.

Which GRI indicators/Standards have been addressed?

The GRI indicators/Standards addressed in this case are:

1) G4-PR1: Percentage of significant product and service categories for which health and safety impacts are assessed for improvement – the updated GRI Standard is: Disclosure 416-1 Assessment of the health and safety impacts of product and service categories

2) G4-PR3: Type of product and service information required by the organization’s procedures for product and service information and labeling, and percentage of significant products and service categories subject to such information requirements – the updated GRI Standard is: Disclosure 417-1 Requirements for product and service information and labeling

 

References:

 

1) This case study is based on published information by Merck & Co., located at the links below. For the sake of readability, we did not use brackets or ellipses. However, we made sure that the extra or missing words did not change the report’s meaning. If you would like to quote these written sources from the original, please revert to the following links:

http://database.globalreporting.org/

http://www.msdresponsibility.com/ (September 2015)

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

Note to Merck & Co.: With each case study we send out an email to your listed address in request for a comment on this case study. If you have not received such an email please contact us.

What are the material issues the company has identified?

In its 2015 Citizenship Report Microsoft identified a range of material issues, such as climate change and energy, data privacy and security, device lifecycle impacts, environmental/social applications of technology, ethical business practices, talent management and development, human rights. Among these, helping its suppliers – across a supply chain that spans 25 countries around the world – create and maintain safe working environments stands out as a key material issue for Microsoft.

Stakeholder engagement in accordance with the GRI Standards

The Global Reporting Initiative (GRI) defines the Principle of Stakeholder Inclusiveness when identifying material issues (or a company’s most important impacts) as follows:

“The organization should identify its stakeholders, and explain how it has responded to their reasonable expectations.”

Stakeholders must be consulted in the process of identifying a company’s most important impacts and their reasonable expectations and interests must be taken into account. This is an important cornerstone for CSR / sustainability reporting done responsibly.

Key stakeholder groups Microsoft engages with:

Stakeholder Group	Method of engagement
Customers	·         Online feedback ·         Support communities ·         Product satisfaction surveys ·         Usability studies ·         Research forums ·         Business account manag­ers ·         Customer service representatives
Investors	·         Earnings calls and annual meeting ·         Director video interview series and direct communications from independent members of Microsoft’s board to shareholders
Employees	·         Annual online anonymous poll of all Microsoft employees around the world
Suppliers	·         Capacity-building workshops and trainings ·         Supplier advisory boards ·         Annual supplier summit ·         Participation in industry coalitions ·         Anonymous Voice of the Supplier Surveys
Communities	·         Microsoft’s local citizenship teams work directly with community groups and in partnerships with local non­profits
Industry coalitions and public-private partnerships	·         Active participation in industry coalitions to address citizenship issues
Civil society /nongovernmental organizations (NGOs)	·         Engagement with thousands of NGOs working on various issues from environmental sustainability to employee diversity or child safety
Policymakers	·         Microsoft engages actively in policy issues relevant to its business, directly and through industry associations

How stakeholder engagement was made to identify material issues

To inform its decisions, Microsoft regularly communicates with thousands of stakeholders globally ranging from parents concerned about their child’s online safety to international human rights experts. These engagements take many forms. Employees from Microsoft’s business and operational groups regularly identify and engage with stake­holders in the course of their daily work activities. Microsoft’s Citizenship and Public Affairs team also manages a number of stakeholder relationships and ongoing dialogues to help inform and guide the company’s strategies. Microsoft connects with leading thinkers on corporate responsibility and societal challenges in groups such as Business for Social Responsibility, CSR Europe and the World Economic Forum. Microsoft learns from them and other advocacy groups, socially responsible investors, corporate responsi­bility rating agencies, other external stakeholders and its own employees to identify new and emerging citizenship issues. Microsoft also bases its work on international frameworks such as the United Nations Global Compact, the UN Guiding Principles on Business and Human Rights and the Global Reporting Initiative’s Sustainability Reporting Guidelines.

As regards customers, Microsoft gains insights from online feedback, support communities, product satisfaction surveys, usability studies, research forums, business account manag­ers and the company’s customer service representatives. Regarding investors, beyond traditional investor communications such as earnings calls and Microsoft’s annual meeting, Microsoft seeks to proactively provide investors with corporate gover­nance information through diverse communications, including a director video interview series and direct communications from independent members of its board to shareholders. Microsoft proactively reaches out to institutional investors—including public pension funds and socially responsible investors—about governance and citizenship-related topics and delivers a summary of their feedback to the board. In FY15, these engagements reached investors holding over 40 percent of Microsoft’s outstanding shares. Microsoft seeks to transparently provide information sought by socially responsible investors and corporate responsibility rating agencies and seeks their insights to identify new and emerging citizenship issues.

Microsoft asks for – and acts on – employee feedback in multiple ways, including conducting an annual online anonymous poll of all its employees around the world. The poll, with a nearly 85 percent response rate, asks employees to share feedback about the Microsoft work experience, including how they feel about their workgroups, organization and company as a whole. Microsoft engages with suppliers through capacity-building workshops and trainings, supplier advisory boards, hosting an annual supplier summit and participation in industry coalitions, such as the Electronics Industry Citizenship Coalition. Microsoft also conducts anonymous Voice of the Supplier Surveys, which include questions on citizenship issues.

Microsoft’s local citizenship teams work directly with community groups and in partnerships with local non­profits. They share views and insights from local com­munities with Microsoft’s global Citizenship and Public Affairs team in direct communications, through regular conference calls and at an annual global summit. Also, across the breadth of its business, Microsoft engages with thousands of NGOs working on issues ranging from environmental sustainability to employee diversity to child safety.

What actions were taken by Microsoft to help its suppliers create and maintain safe working environments?

In its 2015 Citizenship Report Microsoft set the following targets for helping its suppliers create and maintain safe working environments, based on the company’s approach to materiality – on taking action on what matters, where it matters:

• Providing training resources

Microsoft created a training platform called SEA (Social and Environmental Accountability) Academy that includes labor, ethics, environ­mental, health and safety (EH&S) training course modules for suppliers. In FY15, Microsoft also conducted trainings for 504 trainees from its high-risk sup­pliers. The courses are also designed as a “train the trainer” with project management training to complement the expert content and provide tools on how to successfully improve their factories.

• Working with factory management to build a culture of health and safety

Microsoft worked with factory management to emphasize the need to use competent and experienced EH&S professionals to define and implement the programs necessary to build a culture of health and safety. To address this, Microsoft piloted a number of training modules in its Tier 1 and high-risk Tier 2 suppliers, including: Safety Culture, EH&S Professionals and Senior Management Capability Improvement, EH&S Employee Participation, Risk Behavior Change, EH&S Standardization, Risk Assessment, Chemical Safety and Management, Line Manager EH&S Skills Improvement, Safety Officer Certification for EH&S Staff, Prevention of Occupational Disease, Effective Water Management. In FY15, 528 SEA (Social and Environmental Accountability) professionals from the Microsoft Device Supply Chain attended the company’s SEA in-house training, representing factories with more than 32,000 workers.

• Tracking key health and safety performance indicators

Microsoft tracks key health and safety performance indicators for its Tier 1 factories using standard OSHA metrics. In FY15, Microsoft’s Tier 1 suppliers aver­aged a work-related injuries and illness rate of 0.045 versus an industry benchmark of 1.4 and a lost working-hour accident rate of 0.031 versus an industry benchmark of 0.7.

• Implementing a new supplier improvement program

In FY14, to address the growing need for additional capacity building among some Tier 2 suppliers, Microsoft launched a new program to provide targeted component suppliers with onsite consulting from the SEA program team. Microsoft also continued its program to target its lowest performing compo­nent suppliers with special additional inspections that include Microsoft executives as well as SEA and Sourcing team members. This subset of suppliers face an additional compliance scorecard and must improve their performance within a quarter. Additional time may be given in certain occasions that are justified and approved by the SEA team. As a result of the close engagement and collaboration with suppliers to make improvements identified during these audits and assessments, factory and worker conditions have advanced at many of Microsoft’s suppliers. Suppliers who failed to meet the requirements are subject to phase-out and termination of business with Microsoft.

Which GRI indicators/Standards have been addressed?

The GRI indicators/Standards addressed in this case are:

1) G4-12: Describe the organization’s supply chain – the updated GRI Standard is: Disclosure 102-9 Supply chain

2) G4-LA14: Percentage of new suppliers that were screened using labor practices criteria – the updated GRI Standard is:  Disclosure 414-1 New suppliers that were screened using social criteria

3) G4-LA15: Significant actual and potential negative impacts for labor practices in the supply chain and actions taken – the updated GRI Standard is: Disclosure 414 -2 Negative social impacts in the supply chain and actions taken

 

References:

1) This case study is based on published information by Microsoft, located at the links below. For the sake of readability, we did not use brackets or ellipses. However, we made sure that the extra or missing words did not change the report’s meaning. If you would like to quote these written sources from the original, please revert to the following links:

http://database.globalreporting.org/

https://www.microsoft.com/about/csr/responsible-supply-chain/ (June 2016)

2) http://www.fbrh.co.uk/en/global-reporting-initiative-gri-g4-guidelines-download-page

3) https://g4.globalreporting.org/Pages/default.aspx

4) https://www.globalreporting.org/standards/gri-standards-download-center/

Note to Microsoft: With each case study we send out an email to your listed address in request for a comment on this case study. If you have not received such an email please contact us.