Our client asked us to assess 3 components of their HSE programs: Lockout/Tagout, Asphyxiant Gases and Confined space. Our global team and partners completed this project on time and under budget!

1. EHS Global Auditing Case Study
Merck
September 18, 2015

2. Global Case Study
Due to a recent incident, client required an independent assessment
of the Health, Safety and Engineering program with a focus on 3
assessment areas (LOTO, Confined Space, Asphyxiant Hazards) at
their US and global facilities. A comprehensive assessment was
needed to include a review of self-assessments, programs &
procedures, training, production & support equipment, associate &
supervisor interviews in local country languages.
Deliverables include but not limited to: site assessment schedule, site
pre-review meeting, site assessment action plan, site assessment
report template, draft & final assessment report, PM schedule.
Supplier needed to provide project management expertise and local
country auditors thoroughly familiar with local regulations.

3. Business Need
Provide Global Audit PM and auditors well versed in local country
regulations.
Efficient project & logistics management, standardized documentation
(including invoicing) and the ability to deploy a global team based on
client budget schedule and regulatory commitments.
Consistent approach and process across the program.
Effective quality management including reporting of KPIs.
On-time and in-budget project implementation.
Stable team and long term partner.

4. Our Delivery
Project Sponsor
Responsible for understanding project requirements, preparing the project proposal and executing the MSA
and/or SOW.
Project Managers (1 US/1 Global)
Serve as the primary point of contact for client.
Serves as the in-house Subject Matter Expert (SME) on the project and is responsible for
determining the scope of the project including timelines, deliverables and scheduling.
Ensures that the best resources are assigned to the project.
Ensure that each US and Global Auditor is focused on producing the highest quality deliverables,
and making knowledge transfer a top priority.
Ensures that the final report produced by the auditor meets highest level of quality and accuracy.
In addition to PM responsibilities, all reports are reviewed by PMs to ensure consistency and
quality of the final report

5. Our Delivery
Auditors (local and international auditors)
Responsible for conducting in-depth audits and providing gap
analysis compared to local country regulations, generally accepted
industry practices and client SOPs.
Responsible for providing exceptional customer service and
producing high quality deliverables that are consistent with the
project plan and all applicable regulatory requirements.
Committed to meeting the project objectives and milestones
regardless of the roadblocks encountered.

6. Results: Global Resources Deployed
UNITED STATES
6 Sites
ASIA
Beijing & Hong Kong, China
Singapore (2 sites)
Malaysia
Indonesia
India (5 sites)
EUROPE
Germany (2 sites)
Belgium
Switzerland
Ireland
Spain
Brazil
1 Site

7. Results
Provided complete end to end global auditing service for
2015/2016, based on client budget and timelines.
Deployed 2 PMs & 8 Auditors
Confidence that client is capable of supporting the global demands
of a growing marketplace and meeting the stringent expectations
of regulatory agencies around the world.
Guidance on responding to and/or avoiding regulatory actions
thereby establishing a clear path to profitability and mitigating
risk.

8. TCG Global Audit Services
Pharmaceutical and Biotechnology companies all over the world
trust us to perform comprehensive audits to the latest EHS
regulations and expectations, and to work with them in the
development, implementation and verification of corrective action
plans (CAPAs) that are comprehensive, compliant and
sustainable.
Our success factors:
Distinguished and Seasoned EHS auditors
Global Capability
Performance & Project Management
Immediate Deployment

9. Opportunities to Build Partnerships