Shared audits: a simple, cost-effective solution for suppliers, subcontractors and service providers

Suppliers, subcontractors and service providers are increasingly called upon by their customers to carry out assessment audits. These periodic checks require an ongoing commitment of time and resources, affecting day-to-day business and generating significant costs. How can companies improve efficiency, save time and money? 

Shared audits represent a collaborative and strategic approach to quality and compliance, particularly relevant to medical device and pharmaceutical manufacturers. This article explores the nature of shared audits, how they work and the benefits they offer manufacturers and their partners in these highly regulated sectors.

What is a shared audit?

A shared audit, also known as a pooled or joint audit, is a collaborative approach where several organizations join forces to carry out a single audit on a common supplier or service provider. Instead of each company conducting its own audit, which can be redundant and costly, a shared audit enables a group of companies to share the results of a single audit, carried out by a qualified auditor. This method is particularly suited to industries where suppliers serve several customers with similar or identical quality requirements. In the context of medical device manufacturers, for example, this usually involves several companies coming together to audit a third-party manufacturer or component supplier to ensure that it meets the required quality and regulatory compliance standards. On the other hand, suppliers can better manage their agendas by grouping their customers together.

How shared audits work

Suppliers or manufacturers may propose that interested companies form an audit consortium or group. An auditor or independent audit organization is selected to assess the supplier or service in question. The audit is carried out in 5 steps:

• Step 1: Selection of an audit date with a duration sufficient enough to examine all quality system processes, associated operations, and applicable standards necessary for the effective completion of the audit. All customers are informed of the audit date to enable them to position themselves accordingly.
• Step 2: If a customer requests an audit, the audited entity can propose a date for a full audit. The auditor or independent audit organization should be contacted directly for details. Customers are assured that the audit will cover all quality system processes and will take into account any customer-specific issues (particular activities, ongoing changes or CAPA files, specifications, etc.) which will be taken into account by the auditor.
• Step 3: Customers register for the audit date; their specific requirements are taken into account, including the desired audit scope, any particular points of attention, and the desired format of deliverables. A quotation is provided for the service.
• Step 4: Completion of the shared audit and communication of deliverables:

• Step 5: Direct management of audit follow-up by each customer (validation of CAPA plan and monitoring of actual implementation of action plan).

Once the audit is complete, the report is shared between all participating companies. Group members can then make informed decisions about their relationship with the audited supplier without having to carry out individual audits.

The benefits of shared audits for manufacturers and suppliers

What are the advantages of a shared audit for a manufacturer or supplier? There are many advantages to conducting shared audits, including: 

• Reduced costs and resources

Audits are essential to ensure compliance with the stringent regulatory standards imposed on manufacturers of medical devices and pharmaceutical products. However, they can be costly and time-consuming. Shared audits significantly reduce the costs associated with auditing, as costs are shared between participants. In addition, it frees up internal resources that can be reallocated to other quality or production activities.

• Improved quality and compliance

By sharing the skills and knowledge of a qualified auditor, manufacturers can benefit from a more thorough and objective assessment of their suppliers. This can lead to a better understanding of potential risks and the identification of opportunities for quality improvement, which is crucial in the medical device and pharmaceutical industries where patient safety is paramount.

• Reduce audit redundancy

Suppliers to the medical and pharmaceutical industries often face a multitude of audits from different customers, which can lead to operational disruption and audit fatigue. Shared audits reduce the frequency of audits for a given supplier, reducing the workload for the supplier and improving overall supply chain efficiency.

• Access to expertise

Small and medium-sized companies may not have the resources to hire highly qualified auditors. By participating in shared audits, they gain access to expertise that might otherwise have been out of reach, ensuring that audits are conducted with the level of competence required by industry and regulations.

• Meeting regulatory requirements

Regulators, such as the Food and Drug Administration (FDA) in the USA or the European Medicines Agency (EMA) in Europe, require medical device and pharmaceutical manufacturers to maintain a robust and compliant quality system. Shared audits can help demonstrate this commitment to quality and compliance, while meeting regulatory requirements more effectively.

Conclusion

Shared audits offer a multitude of benefits for medical device and pharmaceutical manufacturers and their partners alike. They offer significant cost savings, improved quality and compliance, reduced audit redundancy, stronger business relationships, access to specialized expertise, and the ability to meet regulatory requirements more strategically. By adopting this collaborative approach, companies can not only optimize their audit processes, but also contribute to the continuous improvement of the safety and efficacy of products that have a direct impact on the health and well-being of patients.

Are you a client or supplier in need of a trusted partner to conduct audits? 

Efor Group can help you set up internal or shared audits, or mock-ups to prepare for inspections by health authorities. With over 200 audits conducted worldwide in 2023, and a customer satisfaction rate of 99.5%, our expert auditors will provide you with the support you need to make your audits a success. Contact us today to find out more about our services: audit@cvo-europe.com  or via the Efor/Audit website.