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Our resource library is made available freely to all in order to advance responsible supply chain practices. Here you will find information and guidance on responsible supply chain issues and the way that the PSCI works. If you have any suggestions for improvements or additions to our resources please contact us.

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This resource was published on 30 September

INDIA SUPPLIER CONFERENCE 2022 - SESSION 2 - SLIDES

The second session of the 2022 PSCI India supplier conferences took place in-person on the 22nd of September and covered Audit, Environment, Scope 3, PiE/AMR

The full slide deck is available for download below.

The presentations covered are as follows:

  • PSCI Audit Program – Practical Guidance & Panel Discussion
    Rincy Joseph, Senior Manager SSHE Supplier Management, Bayer
  • Engaging Suppliers to Reduce Scope 3 Emissions Towards Net Zero
    Robert Williams, Director of Procurement Sustainability, Astra Zeneca
  • Ban on Identified Single Use Plastic – The Whats, Whys and Hows
    Ashish Jain, Founder-Director, Indian Pollution Control Association (IPCA)
  • Climate change – Risks to Organizations
    Shivananda Shetty, Partner & Head, ESG and Climate Change, KPMG
  • Supplier Water Quality & Pharmaceuticals in Environment
    Balaji Gurumurthy, Environmental Compliance Lead, Novartis
  • Reducing AMR Risk Through Effective Control of Antibiotic Manufacturing Emissions
    Dharmesh Kharwar, Director, NGB Laboratories
  • PSCI Musi River Project
    Manjit Singh, Associate Director of Corporate Sustainability, Centrient Pharmaceuticals
    Senthil Kumar, Supplier Operations, Pfizer
  • Case studies – Implementation of Good Practice in Management of API Containing Waste Streams
    Ashok Kumar Podisetty, Head of EHS, Neuland Laboratories Limited
  • Developing PiE/AMR Capabilities in India
    Aditya Shirodkar, Global Senior EHS Specialist, Abbott
  • Environment
  • Spills & Releases
  • Waste Management
  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
  • Audit Program
This resource was published on 29 September

Supplier Conference 2022 (China) - Session 1 - Slides | 2022年PSCI 供应商会议(中国) - 第一场 - ppt

Training

The first session of the 2022 PSCI China supplier conferences took place virtually on 6 September and covered PiE / AMR and Environment.

Please click “DOWNLOAD” to access to session 1's deck.

The first session includes:

Business continuity plan
Roderick | Technical director | Shanghai STRM Technology Co., Ltd.

PSCI Audit program – practical guidance 
Catherine Zhang | Head of HSE experts APAC | PSCI China sub team lead | Bayer 

Supplier sharing: CAPR formulation & common audit findings 
Ying Lin | EHS & Assistant GM | Zhejiang Raybow Pharmaceutical Co. LTD
Danhua Xu | EHS associate manager | Tianyu Pharmaceutical Co. LTD

The new Data Privacy Law in China
Chris Zhang | Senior partner | Dentons Law Firm

New labor codes 
Minnie Mai | Senior technical manager | TUV

——————————————————————————————————————
业务连续性计划 
员文权 | 技术总监 | 上海翊员科技有限公司

PSCI审计项目分享
张晓花 |亚太区健康安全环境专家组负责人 | PSCI 中国小组负责人 | 拜耳

供应商实践分享: 不同审计体系共性发现项CAPR制定 
林迎 | 总经理助理(分管EHS)| 浙江瑞博制药有限公司
许丹华 | EHS副总经理 | 临海天宇药业有限公司

中国新数据隐私法 
张勇 | 高级合伙人 | 大成律师事务所 

新劳工法规
麦璐 | 高级技术经理 | 德国莱茵

  • Ethics
  • Data Privacy
  • Management Systems
  • Audit Program
This resource was published on 11 March

Audit Program Supplier FAQ

Document

This document addresses the common questions suppliers have around the PSCI audit program. The key points include:

  • Who is the PSCI? What is the PSCI Audit program?
  • Why should I share a PSCI audit conducted at my site?
  • Who can access my audit and is my information secure?
  • How do members use the audit reports? Will I be ‘punished’ for a bad audit?
  • Can you take me through the PSCI audit steps? How to use the Audit platform?
  • Audit Program
This resource was published on 1 December 2021

Full PSCI SAQ & Audit Report Template (Excel Version)

Document

EXCEL VERSION
PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers

For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.

Content Version 6, February 2019
Content Version 7, remote audit options added, October 2020
Content version 7.1, small technical fixes, including correctly referencing finding type on CAP tab, showing suppliers responses to topic areas that are not audited, May 2021
Content version 7.2, fix formating issue of finding classifications on the Company Specific Questions tab, June 2021
Content version 8.0, simplified the Categorisation of Suppliers (Category A, B or C), removed/ added a few questions, rewording some questions, December 2021

Abbreviated version template for Service Providers & General Manufacturers are also available: Excel version.

The SAQ is currently available in the following languages:

  • English
  • Español | Spanish
  • 中文 (简体) | Chinese (simplified)
  • 日本語 | Japanese
Select your preferred language from the options below
  • Audit Program
This resource was published on 1 December 2021

Abbreviated PSCI SAQ & Audit Report Template (Excel Version)

Document

EXCEL VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers

For optimum functionality, we recommend using the most up to date version Microsoft Excel. If you only have access to Excel 2003 or earlier, we recommend using the Word version of the SAQ.

Content Version 6, February 2019
Content Version 7, remote audit options added, October 2020
Content version 7.1, small technical fixes, May 2021
Content version 7.2, fix formating issue of finding classifications on the Company Specific Questions tab, June 2021
Content version 8.0, simplified the Categorisation of Suppliers (Category A, B or C), removed/ added a few questions, rewording some questions, December 2021

Full version template for Core Suppliers, External Manufacturers, Component and Material Suppliers are also available and come in multiple languages: Excel version.

  • Audit Program
This resource was published on 30 August 2021

Taking Part In A PSCI Audit

A clear process has been defined to ensure PSCI Audits are consistent and rigorous. A suite of tools are available to support and guide through the process. Follow the link to read more about:

  • Key Audit Resources
  • Supplier Categories
  • How to Get Started
  • What's in Scope
  • What's Involved
  • Audit Program
This resource was published on 30 August 2021

Approved Audit Firms

In order to ensure quality and integrity, PSCI Audits are carried out either by qualified internal auditors working at PSCI member companies or by professional and independent third party audit firms.

PSCI has approved fifteen professional, independent third party audit firms to perform PSCI Audits.

  • Audit Program
This resource was published on 17 March 2021

Supplier Self-Initiated Audit Brochure (For Suppliers)

Document

Supplier Self-initiated Audit Programme (SSIA) is a pilot programme led by PSCI Audit Committee to encourage suppliers to take a proactive, risk-based approach and self-initiate PSCI audits for their facilities.

With the pilot programme this year, the PSCI will pay for a new Supplier Self-initiated Audit of the supplier facility. The audit should be completed by a PSCI approved audit firm and shared with PSCI members on the Link. Any supplier to PSCI Member can apply to participate in SSIA.

This document for suppliers explains:

  • What is SSIA and the benefits
  • Who can participate and the requirements
  • How to conduct a SSIA

Members are welcome to share the brochure with suppliers you would like to see conducting a PSCI audit.

If you are interested in learning more about the programme, please contact Audit Committee Secretariat Blake Zheng for more information. Thank you.

  • Audit Program
This resource was published on 10 February 2021

Audit Finding Classification Examples

Document

This document provides a guidance for auditors to classify Critical-Major-Minor findings under all five PSCI principles. It is for guidance only and each organization can have its own interpretations.

It is intended to be a living document, which will be reviewed and updated regularly by SAQ/Audit and Audit Guidance sub team.

  • Audit Program
This resource was published on 1 February 2021

Auditor Training 2020 - Session 2 - Recording & Slides

Training

The second session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 25 November and covered below presentations.

  • Environmental protection
    Manjit Singh, Associate Director- Corporate Sustainability, Centrient Pharmaceuticals
  • Stormwater management and Zero Liquid Discharge key points
    Daniel Rehm, HSE Advisor, External Manufacturing EMEA & API, Elanco
  • Introduction to PiE and AMR
    Dr Paul Barnett, Director, Environment Health & Safety, GlaxoSmithKline
  • Assessing Antibiotic Manufacturing Sites Capability in Controlling their Antibiotic Emissions
    Jonathan Stanway, Downstream & Pilot Plant Manager, Biotechnology & Environmental Shared Service, Pharma Supply Chain, GlaxoSmithKline

This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.

The recording of the session is available here. Chinese users can download the recording here (password: PSCI).
Slides are available for download below.

  • Environment
  • Audit Program
This resource was published on 1 February 2021

Auditor Training 2020 - Session 4 - Recording & Slides

Training

The fourth session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 3 December and covered below presentations.

  • Plant General Safety
    Pratap Padalkar, Associate Director, Chemical Development & Manufacturing, Gilead
  • Occupational health and industrial hygiene in plants
    Pratap Padalkar, Associate Director, Chemical Development & Manufacturing, Gilead
  • High risk work and red flags for dangerous working
    Roberta Haski, HSE Leader, External Manufacturing & Commercial, Asia Pacific, Japan, ANZ

This session was facilitated by Lei Sun, Partner at Carnstone.

The recording of the session is available here. Chinese users can download the recording here (password: PSCI).

Slides are available for download below.

  • Safety - High Risk Areas
  • Audit Program
This resource was published on 1 February 2021

Auditor Training 2020 - Session 3 - Recording & Slides

Training

The third session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 2 December and covered below presentations.

  • Process safety risk – Identifying reactive hazards and powder processing hazard in pharmaceutical industry
    Kumarkrishna Bhattacharjee, Head HS&E Supplier Assurance and Risk India Region, Novartis
  • Emergency preparedness & response
    Daniel Rehm, HSE Advisor, External Manufacturing EMEA & API, Elanco

This session was facilitated by Lei Sun, Partner at Carnstone.

The recording of the session is available here. Chinese users can download the recording here (password: PSCI).
Slides are available for download below.

  • Process Safety
  • Emergency Preparedness & Response
  • Audit Program
This resource was published on 1 February 2021

Auditor Training 2020 - Session 1 - Recording & Slides

Training

The first session of the 2020 PSCI Auditor Training (Virtual) took place virtually on 24 November and covered below presentations.

  • PSCI Audit Update 2020
    Birgit Isabelle Skuballa, Head HSE Audit & Supplier Management, Bayer

  • Corporate Responsibility with a Social Compliance Audits
    Dinesh Subhedar, Group Third Party Risk Management -Labour Rights (India and West Asia), Novartis (NBS Human Resources)

This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.

The recording of the session is available here. Chinese users can download the recording here (password: PSCI).

Slides are available for download below.

This resource was published on 28 January 2021

New Audit Firm Application Brochure

Document

For those interested in becoming PSCI approved audit partners, this document covers:

  • Document checklist
  • Application process
  • Re-initiating application if not approved for the first time

Last updated December 2020

  • Audit Program
This resource was published on 9 October 2020

Supplier Conference 2020 (China) Session 1 - Audit Finding Analysis – What Are PCI Audits Saying? - Recording & Slides

Training

This presentation detailing our audit finding analysis was delivered by:
此演讲由下列嘉宾分享PSCI 共享审计发现研究:

  • Lei Jiang, EHS Senior Director, STA Pharma | 蒋磊, 高级环境健康安全总监, 合全药业

This session was facilitated by Maggie Zhang, Partner Manager at Carnstone.
本环节由凯嵘管理咨询合伙人经理张缤莉主持。

The recording is available here (code: PSCI). The slides are available for download below.
会议视频请点击此链接 获取(提取码:PSCI)。会议PPT请在下方点击“DOWNLOAD”下载。

This resource was published on 2 October 2020

Supplier Conference 2020 (India) Session 1 - Audit Finding Analysis – What Are PCI Audits Saying? - Recording & Slides

Training

This presentation detailing our audit finding analysis was delivered by:

  • Shelly Shope, HSE Advisor, Elanco, and PSCI supplier capability committee co-chair

This session was facilitated by Simon Hodgson, Managing Partner at Carnstone.

The recording is available here. The slides are available for download below.

This resource was published on 8 June 2020

Updated Audit Guidance Webinar - Recording & Slides

Webinar

This webinar first aired on 27 May and explained the updates and changes to the Audit Guidance document. We were delighted to be joined by the following speaker:

  • Birgit Skuballa, from Bayer

The webinar attracted over 100 registrants and around 90 people joined on the day.

Participants are invited to share feedback about this webinar here.

The recording is available here.

The slides used during the webinar are available to download below.

Finally, we want your views! We're encouraging all suppliers to take this short survey to help the PSCI understand the impact it has on suppliers.

This resource was published on 19 April 2020

Full PSCI SAQ & Audit Report Template (Word Version)

Document

MS Word version
PSCI Self Assessment Questionnaire and Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers

More Info…
  • Ethics
  • Human Rights & Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Program
This resource was published on 25 March 2020

Corrective Action Plan Template (Word Version)

Document

This document can be used by suppliers to document agreed corrective actions, the type of finding(e.g. Critical-Other, Critical-Major/Minor), the time period for completion, the type of verification (e.g. desk top review of documents or follow up visit), the responsible individual at the supplier for the individual corrective actions, details on the implemented corrective action and a status assignment (open/closed).

Since 20 April 2022, the Word versions of the templates (Full, Abbreviated, CAPR) have been removed completely following a consultation process and notice period. Access to these is only be possible in exceptional circumstances and by contacting the PSCI Secretariat. Please use the Excel versions: Full, Abbreviated, CAPR

  • Audit Program
This resource was published on 24 March 2020

Corrective Action Plan Template (Excel Version)

Document

This document can be used by suppliers to document agreed corrective actions, the type of finding(e.g. Critical/Major/Minor), the time period for completion, the type of verification (e.g. desk top review of documents or follow up visit), the responsible individual at the supplier for the individual corrective actions, details on the implemented corrective action and a status assignment (open/closed).
Content version v4.0, March 2020
Content version v5.0, December 2021

  • Audit Program
This resource was published on 3 March 2020

Data Sharing Agreement

Document

Supplier Data Sharing Agreement (Last updated May 2021).
A Chinese version is now available.

Select your preferred language from the options below
  • Audit Program
This resource was published on 12 December 2019

Auditor Training 2019 (China)

Training

Presentation Pack from the 2019 PSCI Auditor Training, 26-27 September in Hangzhou, China.

You can also find the recap video here.

Please find the links below to the training slides of both days.

This resource was published on 1 August 2019

Introduction Presentation For PSCI Audit Opening Meeting

Document

Introduction presentation for PSCI audit opening meeting.

Version 1 - 07/02/2017
Version 2 - 01/08/2019
Version 3 - 15/04/2020
Version 4 - 31/08/2020
Version 5 - 31/08/2021
Version 6 - 20/12/2021

  • Audit Program
This resource was published on 4 July 2019

Audit Program Brochure

Document

This document gives a summary of the PSCI Audit Program and process and answers frequently asked questions including:

  • Why do we audit?
  • What are "Shared" Audits?
  • Who benefits from Shared Audits?
  • Initiating a PSCI Audit
  • What happens in a PSCI Audit?
  • Who carries out the audit?

Last updated December 2021

  • Audit Program
This resource was published on 17 May 2019

Auditor Training 2018 Vienna

Document

Presentation Pack from the 2018 PSCI Auditor Training, 4 - 5 December in Vienna, Austria

  • Pharmaceuticals In The Environment
  • Anti-Microbial Resistance
  • Audit Program
This resource was published on 7 February 2019

Abbreviated PSCI SAQ & Audit Report Template (Word Version)

Document

WORD VERSION
Abbreviated PSCI Self Assessment Questionnaire & Audit Report Template for Service Providers & General Manufacturers

Version 5, February 2019
Version 6, remote audit options added, October 2020

Since 20 April 2022, the Word versions of the templates (Full, Abbreviated, CAPR) have been removed completely following a consultation process and notice period. Access to these is only be possible in exceptional circumstances and by contacting the PSCI Secretariat. Please use the Excel versions: Full, Abbreviated, CAPR

  • Ethics
  • Human Rights & Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Program
This resource was published on 14 November 2018

Audit Sharing Platform Member User Guide

Document

This PSCI Audit Sharing Platform User Guide explains how to use the Audit Sharing Platform for members. The platform underpins the PSCI Audit Sharing Program. It is the platform for sharing audits with the PSCI membership.

Please refer to the PSCI Shared Audit Program Guidance for more information about the PSCI Audit Sharing Program.

  • Audit Program
This resource was published on 14 November 2018
Audit Guidance For PSCI Audits

Audit Guidance For PSCI Audits

Document

This document is designed to be used by PSCI members, audit contractors and suppliers. It provides a detailed overview of the audit process and corresponding roles and responsibilities at each stage of the process.

Version 7, December 2021
Updated to reflect changes to Supplier Categorisation, classification of findings only as critical/major/minor (and added link to finding classification guidance document) and remove reference to the now withdrawn OHSAS 18001.

  • Audit Program
This resource was published on 26 October 2018

Introductory Training For Auditors

This PSCI webinar is a training video for auditors. This was recorded in September 2018.

The slides shown in this webinar can be found here.

  • Audit Program
This resource was published on 11 July 2018

PSCI Member Audit Sharing Target

Document

This document defines the PSCI member audit sharing target.
Approved by the PSCI Board in May 2018.
Applicable from January 2019.
Lightly refreshed in March 2021 to include remote audit counting and provide clearer definition of terms used.
Updated the web link to Approved Audit Firms in July 2021.

  • Audit Program
This resource was published on 22 November 2017

Auditor Training 2017 (China) - Day 3

Training

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Program
This resource was published on 22 November 2017

Auditor Training 2017 (China) - Day 2

Training

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Program
This resource was published on 22 November 2017

Auditor Training 2017 (China) - Day 1

Training

Presentation Pack from the 2017 PSCI Auditor Training, 20 - 22 November, in Shanghai, China.

  • Audit Program
This resource was published on 5 October 2017

Audit Programme Webinar - 4th October 2017 - Slides

Slides

Slides from the PSCI Audit Programme Webinar, Oct 2017
The webinar explained the supplier self-initiated audit model and launched the new Excel based audit templates.

This resource was published on 26 September 2017

Auditor Evaluation Tool

Document

This Excel template is designed to help PSCI members, suppliers and audit firms check auditors against the PSCI's requirements, to ensure that they have the expertise needed to conduct PSCI audits. It is also used by new audit firms in their application process to demonstrate their capacity.

This evaluation tool is also known as PSCI Auditor Information Template (HSE & Social Auditors).

Last updated March 2021.

  • Audit Program
This resource was published on 20 March 2017

Auditor Training 2017 (India)

Training

Presentation booklet from the 2017 PSCI Auditor Training, 28 Feb - 1 March, in Hyderabad, India

  • Audit Program
This resource was published on 14 February 2017

Auditor Training 2015

Training

PSCI Auditor Training presentation deck from 2015

  • Audit Program
This resource was published on 1 February 2016

Audit Sharing Platform Supplier User Guide

Document

This PSCI Audit Sharing Platform User Guide explains how to use the Audit Sharing Platform for suppliers. The platform underpins the PSCI Audit Sharing Program. It is the platform for sharing audits with the PSCI membership.

Please refer to the PSCI Shared Audit Program Guidance for more information about the PSCI Audit Sharing Program.

  • Audit Program
This resource was published on 3 August 2015

Pre-Audit Document Request List

Document

Pre-Audit Document Request List

  • Audit Program