Most manufacturers of medical devices depend on numerous suppliers to provide components, assemblies, design services, sterilization and more. Manufacturers are required to audit key suppliers periodically to ensure compliance with their quality agreements.
For some suppliers, this could mean hosting over a hundred audits per year, which represents a significant cost in time and personnel. To add to that, suppliers will be working in 2021 to reduce exposure to employees from outside visitors such as auditors as restrictions are gradually lifted.
The disruption of 2020 has propelled supplier auditing forward in new ways, such as an increase in remote auditing. Medtech suppliers are also now finding the concept of the shared audit to be of significant value in working down the backlog of audit requests while reducing exposure in the plant.
In a shared audit, the supplier notifies its customer base a few months in advance of an upcoming shared audit day using a third party auditing service. The auditing service provider works with each individual company signed up for the audit to include each company’s agenda items, and each company gets a custom audit report after the audit concludes.
Steri-Tek, a sterilizer in Hayward, CA, often finds 15-20 customers signing up an annual shared audit. “It’s an incredible concept and great value-added service to a supplier’s customers, especially startups,” said Jeff Sauter, Director of Business Development, in a recent interview.
The shared audit frees the supplier’s customer from having to send their own auditor at significant time, expense, and exposure. This is a considerable benefit to many organizations, and the process is indistinguishable from a solo audit. Agenda items are given to an auditor in advance, and the organization receives an audit report tailored to their needs and concerns for a lot less money than doing themselves.
Steri-Tek recommends notifying customers of the upcoming shared audit about 3-4 months in advance, and making it an annual event. “We get tremendous response because it’s very attractive to customers,” said Sauter.
Scott Sershen, VP of R&D at BlackSwan Vascular, has equally complimentary things to say about shared supplier audits from the customer perspective. “A shared supplier audit allows us to meet the needs of our supplier auditing procedure without having to schedule individual site audits. This saves us time and resources while enabling us to maintain compliance with the requirements of our quality management system,” he said.
Companies participating on audit day do not know the identity of other participants. “Every customer is unique. Absolutely no information is shared or exposed,” said Sauter.
Industry disruption in 2020 served to underscore that it doesn’t make sense for 15 startups to each send an auditor to the same supplier to repeat the same audit. More suppliers are realizing the potential for shared audits to not only reduce audit support burden, but also offer a popular value-add service to their customers at no cost to themselves.
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