Pharma supply chain management: questions to ask an audit partner - Part 1

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28 Jan 2025

Focus on audit methodology and skills

When considering pharma supply chain management, a true partnership between an external audit provider and the client is based on a relationship of trust and communication that enables an in-depth understanding of each company's specific needs. It goes without saying that the external audit partner must perform well and demonstrate that it has a robust quality system.

There are several factors to consider when choosing an external audit partner: Does the service provider have the required international reach, in relation to the location of the supplier sites? Does the service provider have a clearly defined methodology, embedded in a robust quality system? Does the service provider have the necessary skills for planning and coordinating audits? And does the service provider have a pool of experienced and qualified auditors?

Is there a clearly defined audit methodology?

A well-defined audit methodology forms the basis of an effective audit process, providing a structured framework for the preparation, conduct and post-audit activities. Prior to the audit, key information is communicated to the supplier and partner, including the audit objective, scope, number of auditors and duration of the audit. During the preparation phase, discussions with the audit partner help to identify any specific questions and points of attention to focus on, if there are any. This will lead to the drafting of an audit agenda, which is first sent to the customer for approval before being forwarded to the supplier. At the same time, a questionnaire is sent to the supplier to help the auditor prepare for the audit.

After the audit, and while awaiting the formal audit report, an initial written summary is sent to the customer. If a critical deviation is identified during the audit, the customer is alerted very quickly. An audit report is then prepared by the auditor, reviewed by the audit partner and sent to the customer for approval. Of course, the customer has the opportunity to ask questions or request clarification if necessary. In some cases, a telephone conversation with the auditor may be useful. Once approved, the audit report is sent to the audited entity and an action plan in response to the discrepancies is requested. These discrepancies do not come as a surprise to the supplier, as they have already been notified, explained and accepted at the audit closing meeting.

On receipt of the action plan, it is assessed by the auditor, who takes into account the relevance of the proposed actions and the deadlines set for implementing them. If necessary, the auditor may request additional information.

A clearly defined audit methodology is the cornerstone of an effective audit process. It defines the framework for the preparation, performance and post-audit activities. The external audit partner must demonstrate a thorough methodology that will streamline the audit process and ensure comprehensive assessments. This audit methodology must form part of a robust quality system that guarantees the high quality of the services provided.

What are the skills of the audit provider's operations team?

It is essential to check that the audit partner has a qualified in-house team. Ongoing training, in addition to basic training, helps to ensure that team members remain up to date with regulations and is able to engage in discussions and answer questions effectively. It is also essential to establish a key contact, as this simplifies the channels of communication. This key contact may be a salesperson or designated representatives from different teams, depending on the structure of the audit partner. Knowing who to contact with any queries is essential to successful collaboration.

In addition, the in-house team must have the necessary qualifications to allow technical verification of all deliverables including, of course, the audit reports. This includes ensuring accuracy and alignment with the audit scope and framework. The ability to provide feedback on audit reports and to engage in discussions, either with the auditor or with the internal technical team, reinforces the level of confidence and ensures that any concerns or clarifications can be dealt with quickly and effectively.

In conclusion, choosing the right external audit partner for pharma supply chain management hinges on a foundation of trust, clear communication, and a robust quality system. Key factors include the partner's global reach, a well-defined audit methodology, and the qualifications of their operations team. A strong audit methodology ensures comprehensive assessments, while a skilled operations team facilitates smooth communication and accurate deliverables. By prioritizing these elements, you can establish a successful partnership that supports your organization's quality and compliance goals.