LOG IN

Members and suppliers: Join our online community

Access our full library of resources, register for events and webinars and share audits and other assessments

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 PSCI works. If you have any suggestions for improvements or additions to our resources please contact us.

Search & Filter

Clear Filters

Taking Part In A PSCI Audit

Organisational Information Link
30 Aug 2021

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 Programme

Approved Audit Firms

Organisational Information Link
30 Aug 2021

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 Programme

Supplier Self-initiated Audit Brochure (For suppliers)

Document
17 Mar 2021

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 Programme

PSCI Audit Finding Classification Examples

Document
10 Feb 2021

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 Programme

2020 PSCI AUDITOR TRAINING (VIRTUAL) - SESSION 2 - RECORDING AND SLIDES

Training
1 Feb 2021

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 Programme

2020 PSCI AUDITOR TRAINING (VIRTUAL) - SESSION 4 - RECORDING AND SLIDES

Training
1 Feb 2021

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 Programme

2020 PSCI AUDITOR TRAINING (VIRTUAL) - SESSION 3 - RECORDING AND SLIDES

Training
1 Feb 2021

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 Programme

2020 PSCI AUDITOR TRAINING (VIRTUAL) - SESSION 1 - RECORDING AND SLIDES

Training
1 Feb 2021

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.

New Audit Firm Application Brochure

Document
28 Jan 2021

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 Programme

PSCI Supplier Conference 2020 China Session 1: Audit finding analysis – what are PCI audits saying? - Recording and Slides

Training
9 Oct 2020

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。

PSCI supplier Conference 2020 India Session 1: Audit finding analysis – what are PCI audits saying? - Recording and slides

Training
2 Oct 2020

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.

PSCI webinar: Updated Audit Guidance - Recording and Slides

Webinar
8 Jun 2020

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.

Full PSCI SAQ & Audit Report Template (WORD VERSION)

Document
19 Apr 2020

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

More Info…
Select your preferred language from the options below
  • Ethics
  • Human Rights & Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Programme

Corrective Action Plan Template (WORD VERSION)

Document
25 Mar 2020

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).

  • Audit Programme

Corrective Action Plan Template (EXCEL VERSION)

Document
24 Mar 2020

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).

  • Audit Programme

Data Sharing Agreement

Document
3 Mar 2020

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

Select your preferred language from the options below
  • Audit Programme

PSCI Auditor Training 2019 Hangzhou

Training
12 Dec 2019

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.

Introduction presentation for PSCI audit opening meeting

Document
1 Aug 2019

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

  • Audit Programme

PSCI Audit Program Brochure

Document
4 Jul 2019

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 March 2021

  • Audit Programme

PSCI Auditor Training 2018 Vienna

Document
17 May 2019

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

  • Audit Programme

Abbreviated PSCI SAQ & Audit Report Template (WORD VERSION)

Document
7 Feb 2019

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

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

  • Ethics
  • Human Rights & Labor
  • Health & Safety
  • Environment
  • Management Systems
  • Audit Programme

Abbreviated PSCI SAQ & Audit Report Template (EXCEL VERSION)

Document
7 Feb 2019

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

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

  • Audit Programme

Full PSCI SAQ & Audit Report Template (EXCEL VERSION)

Document
7 Feb 2019

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

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

Select your preferred language from the options below
  • Audit Programme
Audit Guidance for PSCI Audits

Audit Guidance for PSCI Audits

Document
14 Nov 2018

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 6, October 2020
Updated to reflect option for Fully Remote or Partly Remote audits (page 34), alongside Onsite Audits.

  • Audit Programme

PSCI Audit Sharing Platform Member User Guide

Document
14 Nov 2018

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 Programme

PSCI Introductory Training for Auditors

Webinar Video Link
26 Oct 2018

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 Programme

PSCI Member Audit Sharing Target

Document
11 Jul 2018

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 Programme

PSCI Auditor Training 2017 Shanghai (Day 1)

Training
22 Nov 2017

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

  • Audit Programme

PSCI Auditor Training 2017 Shanghai (Day 2)

Training
22 Nov 2017

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

  • Audit Programme

PSCI Auditor Training 2017 Shanghai (Day 3)

Training
22 Nov 2017

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

  • Audit Programme

Webinar slide deck - Audit Programme Webinar, 4th Oct 2017

Slides
5 Oct 2017

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.

PSCI Auditor Evaluation Tool

Document
26 Sep 2017

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 Programme

PSCI Auditor Training 2017 Hyderabad

Training
20 Mar 2017

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

  • Audit Programme

PSCI Auditor Training 2015

Training
14 Feb 2017

PSCI Auditor Training presentation deck from 2015

  • Audit Programme

PSCI Audit Sharing Platform Supplier User Guide

Document
1 Feb 2016

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 Programme

Pre-Audit Document Request List

Document
3 Aug 2015

Pre-Audit Document Request List

  • Audit Programme

Shared Audit Process Diagram

Document
6 Jul 2015

Through the application of the PSCI Principles, better social, economic and environmental outcomes will result for all those involved in the pharmaceutical supply chain. As an industry, we will focus our efforts on positive social and environmental changes, and building supply chain capacity.

  • Audit Programme

Joint Audit Process Diagram

Document
6 Jul 2015

Through the application of the PSCI Principles, better social, economic and environmental outcomes will result for all those involved in the pharmaceutical supply chain. As an industry, we will focus our efforts on positive social and environmental changes, and building supply chain capacity.

  • Audit Programme