1. PSCI Audit Opening Presentation
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PSCI Audit Opening Presentation
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2. AUDIT OPENING PRESENTATION
PSCI
BACKGROUND
STRATEGY
MEMBERSHIP
ADDRESSING THE CHALLENGE
PRINCIPLES
SHARING OF AUDITS
AUDIT PROCESS
REVIEW OF AUDIT AGENDA
SUMMARY

3. INTRODUCTION TO PSCI
The Pharmaceutical Supply Chain Initiative (PSCI) is a group of pharmaceutical and healthcare companies who share a vision of better social, health, safety and environmental outcomes in the communities where we buy.
We believe that collectively PSCI members can share knowledge and expertise, across our industry, to drive complex, global change more effectively than any one organization alone.
We have joined forces to promote responsible supply chain management and better business conditions across the industry.
Our vision is to establish and promote responsible practices that will continuously improve ethics labor, health, safety and environmentally sustainable outcomes for our supply chains.
AUDIT OPENING PRESENTATION

4. THE PSCI STRATEGY VISION & PURPOSE
PRIORITY AREAS
STRATEGIC PILLARS AND OBJECTIVES
VISION & PURPOSE
GOVERNING WITH TRANSPARENCY AND MANAGING WITH ACCOUNTABILITY
SUPPLIER CAPABILTY
Our VISION is to establish and promote responsible practices that will continuously improve ethics, labor, health, safety and environmentally sustainable outcomes for our supply chains.
The PURPOSE of the initiative is to bring together members to define, implement, and champion responsible supply chain practices; fair and safe work places, responsible business practices, environmental sustainability and efficiency of resources and improved supplier capability. 
Worker protection
Process safety
Fair treatment
Wages, benefits and working hours
Freely chosen employment
G.1 Allow greater diversity of members
G.2 Be a healthy, growing, trusted organisation
G.3 Develop ways to measure PSCI’s impact
Sustainable sourcing and traceability
Management capability and systems
Business resilience
Transparency and disclosure
Business integrity and fair competition
Bribery and corruption
Data privacy
Data security
Water use and management
Waste management
Pharmaceuticals in the Environment
Anti-Microbial Resistance
Energy use and carbon footprint
1.1 Promote the PSCI Principles, audit and methodology to define the industry’s expectations
1.2 Secure a higher profile for PSCI within member companies
1.3 Lay the foundations for becoming the one- stop-shop for responsible procurement in Pharma
2.1 Deliver excellence in supplier capability building
2.2 Enhance collaboration among members and suppliers
2.3 Explore a supplier recognition model
3.1 Build external partnerships
3.2 Build PSCI’s external profile and visibility
3.3 Offer PSCI as the delivery partner for other sustainability objectives
FAIR AND SAFE WORK PLACES
RESPONSIBLE BUSINESS PRACTICE
ENVIRONMENTAL SUSTAINABILITY AND EFFICIENCY OF RESOURCES
1. LEADERSHIP
2. A COMMUNITY OF IMPROVING SUPPLIERS
3. PARTNERING
THE PSCI STRATEGY
Presenter note: not needed to cover in detail, but nice to provide as reference and mention the Vision and that PSCI has a strategy
AUDIT OPENING PRESENTATION

5. THE MEMBERSHIP
40 member* companies already share the PSCI VISION and are committed to continuous improvement in the supply chain
Members as at April 2019
*Full members have the following symbol: The rest are associate members.
We have 30 member companies and are governed by an elected Board of Directors which is our primary decision making body.
The basic principle is inclusivity. PSCI welcomes all companies that are serious about embracing our vision in the pharma and healthcare supply chain.
Comment 2 level of Membership (Full and associate)
AUDIT OPENING PRESENTATION

6. ADDRESSING THE CHALLENGE
INTERNATIONAL STANDARDS / FRAMEWORKS
CAMPAIGNS
LEGISLATION
PATIENTS & VALUE BASED HEALTHCARE
PRESSURE FROM BUYERS
Legislation and stakeholder expectations have changed, putting greater pressure on business to be more transparent about where their products and services come from, and the conditions under which they are made/delivered. PSCI is responding to these challenges. Such as:
International standards/frameworks:
SDGs
ILO Protocol on Forced Labour
G20 Anti-Corruption Action Plan which includes a focus on healthcare procurement
Campaigns:
Nordea, India pollution (investor engagement)
Sum of Us campaign on Anti-Microbial Resistance (NGO activism)
Legislation :
Modern Slavery Act and others
New legislation on AB&C
EU Data Protection Regulation
EU Conflict Minerals Regulation
Patients and value based healthcare
Pressure from buyers e.g. UN (SPHS) / NHS who are demanding responible procurement credentials
AUDIT OPENING PRESENTATION

7. ADDRESSING THE CHALLENGE
SUPPLY CHAIN ISSUES
FIRE
BONDED LABOUR
POLLUTION
BRIBERY AND CORRUPTION
WORKING HOURS
Negative impacts in the supply chain are business risks for our members, e.g.:
Pollution
Bribery and corruption
Working hours
Fire
Bonded labour
AUDIT OPENING PRESENTATION

8. THE PSCI PRINCIPLES Presenter note: Critical slide to cover
AUDIT OPENING PRESENTATION

9. THE PSCI SHARED AUDIT PROGRAM
Understanding how you can benefit from participating in a PSCI Shared Audit
Shared Audits
The PSCI Shared Audit Program allows Supplier audits to be shared among PSCI members via a secure web-based platform.
Once the audit is complete, it can then be shared with other PSCI members, provided that the supplier agrees and signs a PSCI Data Sharing Agreement (DSA). The DSA protects the rights of all parties and is mandatory for sharing any supplier audit-related information. It can be signed electronically within the PSCI audit platform or scanned and ed to the Secretariat.
Benefits
Audits cost time and money. Sharing audits means fewer audits for each Supplier and that brings efficiency gains for Suppliers and members alike.
Common auditing guidelines and a consistent industry approach for auditing gives Suppliers a clearer understanding of what's expected of them.
Shared Audits also provide greater visibility within the supply chain. They allow PSCI to see trends and patterns in the supply chain, and to better understand where improvements are needed.
The data collected gives invaluable insights into the issues Suppliers struggle with and feeds directly into PSCI Supplier capability building program.
AUDIT OPENING PRESENTATION

10. AUDIT PROCESS Roles/Responsibilities Sponsor Supplier
The audit process consists of the below phases:
Roles/Responsibilities
Align audit logistics & scope
Review returned SAQ & documentation provided
Conduct audit via agreed PSCI protocol
Author report, conduct internal review and send to supplier
Communicate any critical findings within 24 hours
Upload redacted audit report & CAP on PSCI portal
Follow up/complete CAP
Complete SAQ
Inform in case of specific PPE or arrival procedures
Host PSCI audit, provide documentation timely fashion
Propose CAP and send back to Sponsor within 30 days, align with sponsor
Begin to address CAP
Provide authorization via platform (preferred) or sign Data Sharing Agreement and send to PSCI Secretariat
Provide update on CAP showing progress to close findings & reduce risk
Sponsor
Supplier
In some cases the Sponsor will hire a PSCI approved audit firm to conduct the audit on their behalf
AUDIT OPENING PRESENTATION

11. AGENDA FOR ONSITE AUDIT
Opening meeting [management team including health, safety and environmental (HSE) representatives, manufacturing/technical operations representatives, union and HR representatives];
A site tour of all key production and infrastructure areas (e.g. storage areas, laboratories, waste and wastewater treatment areas, offices canteen, medical facilities, sanitary facilities, dormitories) in scope of the audit including informal, impromptu interviews with operators;
Employee interviews (individual and group interview, including union representative interview and interviews of temporary and part-time employees and contractors);
Interviews with Management (HR, HSE and site representative, engineering or maintenance staff);
Document review sections covering:
HR documentation including documents and records (if authorized) of those individuals interviewed;
Labor / Ethics related documentation;
HSE related documentation.
Pre-closing meeting: Preparation of a draft Corrective Action Plan for closing meeting;
Closing meeting with management team: auditors to share findings, get sign-off from site management that findings were communicated and understood; discussion about corrective actions and timelines for implementation.
AUDIT OPENING PRESENTATION

12. FINDING CRITICALITIES
Finding criticalities will vary per PSCI member company
Critical Findings:
Are very high risk findings that require immediate action to protect human life, the health of employees or the environment;
May result in loss of license to operate or serious damage to reputation;
Require immediate corrective action by the supplier;
Need to be communicated to the audit sponsor prior to audit report finalization.
Examples of critical findings
Severe violations of human rights or labor rights (e.g. presence of child labor in a facility of forced labor, over-excessive working hours);
Health and safety issues that can cause immediate life threatening situation or serious injuries to employees and other individuals on site;
Environmental or safety issues that could result in serious and immediate harm to the community.
Other findings:
All other major or minor audit findings, which need to be corrected by the supplier in an appropriate period of time.
Critical findings must be communicated to audit sponsor ASAP/within 24 hours.
Due to the different audit finding classification systems applied by the individual PSCI members, PSCI audit findings schemes vary between critical/major/minor or critical/other. This audit will use classification <critical/major/minor or critical/other>
AUDIT OPENING PRESENTATION

13. AUDIT PURPOSE - SUMMARY
The PSCI audit is the tool used for on-site Supplier evaluations and aims to:
Undertake a risk-based review of the Safety, Health and Environmental and Management Systems in place to evaluate consistency with the PSCI Principles;
Ensure Suppliers adhere to national and regional legislation and that relevant licenses and permissions are in place for all the Supplier’s activities;
Assess supplier Labor practices and provide assurance that the supplier is respecting Human Rights;
Help to identify areas for improvement;
Share best practice.
The audit activities include verifying, through documented evidence, that the Supplier:
Conducts its operations in a safe and responsible manner to minimise negative impacts on society and the environment and ensure sustainable business operations.
AUDIT OPENING PRESENTATION

14. SHARING PSCI AUDITS How to share a PSCI audit
After the audit, you will receive an which asks you log into the PSCI audit sharing platform and approve sharing with PSCI members. You can login to the PSCI Audit Sharing Platform here.
Nothing will be shared until you approve which PSCI members you want to share the audit with.
For more information please see the PSCI Audit Sharing Platform User Guide for Suppliers or contact the PSCI Secretariat
Alternatively, you can also share the audit by filling out a data sharing agreement and sending it to the PSCI Secretariat Your sharing preference will then be set for you in the audit sharing platform.
AUDIT OPENING PRESENTATION

15. QUESTIONS?
Let’s begin the audit…

16. RESOURCES
Who is PSCI?
PSCI Pamphlet:
PSCI Video:
PSCI Principles
PSCI Principles:
PSCI Principles E-learning Tool :
PSCI audit program:
PSCI Shared Audit Program Brochure:
PSCI Audit Collaboration:
PSCI Audit Guidance:
AUDIT OPENING PRESENTATION

17. AUDIT OPENING PRESENTATION