In the world of compliance and quality management, audits are a fact of life. Auditing verifies adherence to standards or regulatory framework requirements. While audits have received negative stigma and are commonly dreaded, if performed properly and regularly, audits are useful tools to make sure that compliance is consistently and effectively implemented throughout all canna operations.
There are three main categories of audits depending on the relationship between the auditor and the auditee. First party audits, also known as internal audits, are performed by the company’s QA department. Second party audits are external audits performed on a supplier by a customer. Third-party audits involve an independent auditing company to assess whether the company is successful in meeting prescribed standards.
Canna facilities can greatly benefit from third party audits. Here are three reasons why.
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Allows a fresh pair of eyes and provides objectivity
As two heads are better than one, two sets of eyes are more effective when reviewing and evaluating company compliance. Since internal QA staff ‘live and breathe’ the program everyday, it is helpful for an external party to verify the program. Third party auditors are able to come in and provide a completely neutral assessment and review of a company’s systems and processes without the natural familiarity that occurs over time with regular staff and day-to-day routines. The objectivity of a third-party audit provides a more accurate review of what is occurring within the company.
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Supports internal QA Department
Audits conducted internally can be taxing on time and labor resources and take away from overall business function. A third-party auditor is able to enter a location for the sole purpose of conducting an audit and perform the audit and interviews in a timely and efficient manner without interrupting the efficiency of the company. The third-party auditor also reduces the pressure on internal QA resources when delivering s to senior management and colleagues that are not that favorable.
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Creates a more robust Program
It is important to know which framework the audit will be performed, as this provides the context on the areas and processes that need to be verified. A federally licensed canna facility must be compliant with Good Production Practices (GPP), physical security requirements and other requirements defined in Health Canada’s Canna Regulations. Canna facilities that intend to export into Europe must also comply with EU GMP standards within the Eudralex framework.
Experienced third party auditors in these standards and framework have the benefit of having conducted audits in multiple environments and are able to share best practices that can strengthen individual programs. Industry-wide knowledge held by third party providers can serve to validate existing programs and provide recommendations for growth or change when deemed necessary.
A well prepared and well executed audit can make a substantial difference in improving operations and maintaining compliance. Thoroughly completed audits with proper follow through are viewed favorably by regulatory agencies and can strengthen a company’s Quality Management System.
