"Creativity is piercing the mundane to find the marvelous"
Whether you need an internal or external Audit, we can support your organization.
The role of Internal Audit is to provide senior leaders and governing bodies of an organization an objective source of information regarding the organization’s risks, control environment, operational effectiveness, and compliance with applicable laws and regulations.
As Internal Audit reports to senior leadership, it is only appropriate that its activities are directed by CEO or Board of Directors through its Audit Committee. Members of Internal Audit must be independent of internal politics and unbiased to provide leadership with objective source of information. Under the direction of Audit Committee, Internal Audit works with management to systematically review control activities over critical systems and processes.
The reviews performed by Internal Audit are often called internal audits.
Compliance Audits evaluate compliance with applicable laws, regulations, policies and procedures. Some of these regulations may have a significant impact on the company’s financial well-being. Failure to comply with some laws, such as the Foreign Corrupt Practices Act (FCPA) or General Data Protection Regulation (GDPR), may result in millions of dollars in fines or preclude a company from doing business in certain jurisdictions.
Environmental Audits assess the impact of a company’s operations on the environment. They may also assess the company’s compliance with environmental laws and regulations.
Information Technology Audits may evaluate information systems and the underlying infrastructure to ensure the accuracy of their processing, the security and confidential customer information or intellectual property. They will typically include the assessment of general IT controls related logical access, change management, system operations, and backup and recovery.
Operational Audits assess the organization’s control mechanisms for their overall efficiency and reliability.
Performance Audits evaluate whether the organization is meeting the metrics set by management in order to achieve the goals and objectives set forth by the Board of Directors.
There are primarily two reasons to conduct a supplier audit: the quality management system (QMS) requires it, or there’s a problem.
Typically, critical suppliers are audited on an annual basis, while suppliers with poor quality metrics are audited more frequently. Whether they’re routine or for cause, supplier audits offer manufacturers greater visibility into whether a supplier’s products, processes or management system adhere to a defined quality standard. Absent a solid understanding of a supplier’s quality-related activities, manufacturers will struggle to know if the supplier’s quality system is unstable.
Conducting supplier audits is an essential and well-established tool for identifying, eliminating and preventing quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits.
To ensure that a supplier can provide the material or products meeting quality specifications and requirements, here are five tips for pharmaceutical manufacturers to consider when conducting an onsite supplier audit.