Supporting a Global Audit Program - A Case Study

The following case study shows how our unique business model provides consistent quality audits and business value

Client: Fortune 500 US Global Company

Sector: Pharmaceuticals

Services: Environmental, health and safety (EHS) auditing for compliance to laws, regulations, company policies, and best practices; EHS Management Systems

Additional Specialty Focus Areas: Process Safety; Radiation Safety; Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); Toxic Substance Control Act (TSCA); Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); Leak Detection and Repair Program (LDAR)

Countries Involved: USA & Puerto Rico, Canada, United Kingdom, Argentina, Austria, Belgium, France, Germany, India, Ireland, Italy, Netherlands, Spain, Turkey, Venezuela, Egypt, Russia, Mexico, Brazil, China, Korea, Taiwan, Australia, Singapore and Japan.

Value to Client

• The Client executed consistent high quality audits by involving experienced professional in-country convergence auditors across its worldwide operations.
• convergence provided country auditors with a special technical expertise to augment the Client’s internal audit team, enabling a rigorous review of operations the Client deemed a risk or potential liability.
• The Client was able to reduce the size of audit teams by about one-third, reducing costs and the logistical burden on the auditees.
• The convergence resources helped the Client consider audit findings from a more systematic perspective, focusing recommendations and subsequent activities on company-wide improvements.
• convergence country auditors reduced communication gaps with the auditee with their bilingual skills, and ensured the audit team understood and appreciated regional and country practices or culture.
• With the growth and maturation of the Client’s engagement with convergence, there is now a global network of EHS professionals that understand the Client’s culture, systems and audit program. convergence resources can work as a seamless part of the Client’s EHS audit teams without the Client’s expense or burden of adding additional in-house resources. 

the client said..."convergence consistently brought the right person with the right expertise and experience to complement the audit team"

Client Summary

The Client is in a heavily-regulated industry, with EHS and other regulations overlapping to create a complex, challenging situation. Furthermore, regulations and enforcement practices can vary significantly from one country to another. Compliance must be documented and assured on an ongoing basis to avoid costly product recalls, significant liabilities, and damage to company reputation.

Client Needs

The Client was looking to reduce audit expenses, make audits less burdensome for the audited facilities and bring a fresh perspective to
the internal audit teams. 

How it Started

Intrigued by convergence’s use of in-country resources and deep pharmaceutical sector experience, the Client invited convergence to join the internal audit team and audit EHS compliance at one manufacturing facility in Europe. The key stakeholders – audit team, facility management, and line staff – appreciated the difference in the audit result.

As an outcome of the early successful audits in which convergence joined the Client audit team, the Client decided on a different approach to their internal audit program. Looking back the Director HSE Compliance Assurance explains, “Our Global HSE Audit Services group wants to ensure that we critically evaluate all of our auditable units. We made a conscious decision almost ten years ago that at least one external auditor should participate in our Global HSE audits to make certain that our internal evaluations received the utmost scrutiny.”

It Takes Off

convergence has worked with the Client for nearly a decade as its audit program matured to include audits on management systems, internal standards, and focused issues including: process safety (PSM); radiation safety, REACH, TSCA, FIFRA and LDAR. The convergence model proved ideal for the focused audits as well
because it brought top-notch professionals in the technical area of focus to the audit team. These experienced professionals provided benchmarking information, and helped the Client assess the impact of new or emerging issues.

the client said..."This audit model has driven numerous HSE improvements throughout the corporation and these enhancements continue to drive our efforts toward world class HSE performance."

Over the years the Client’s EHS audit program has typically involved 20 audits each year in approximately 25 different countries. The operations are diverse, and include manufacturing, research & development, laboratories, distribution centers, and marketing and sales offices. 

The Client’s Director of HSE Compliance Assurance describes their satisfaction with their relationship with convergence:

“Our alliance with convergence consulting allows us to acquire the specific and local HSE expertise needed for our varied types of audits, which are performed  throughout the world. This audit model has driven numerous HSE improvements throughout the corporation and these enhancements continue to drive our efforts toward world class HSE performance.”