EMERGO SUMMARY OF KEY POINTS:

• Getting management buy-in for medical device QMS audits can be a challenge at many firms.
• Audit personnel at device manufacturers should emphasize audits as essential business practices to gain support from senior executives.
• Audit reports should highlight specific risk mitigation and cost saving benefits to senior management.

Undergoing an audit from a third party or conducting your own inspection of your medical device quality management system (QMS) can be a complex process with many moving parts—any of which can go wrong if not carefully monitored. Over a series of blog posts, we’ll discuss various common problems that manufacturers often encounter during QMS audits, and how to avoid them.

Problem: No management support

When initiating a QMS audit, a manufacturer’s auditing staff should ask why they’re doing so. Compliance or financial factors may compel firms to perform audits, or they may be doing so in order to meet certain procedural requirements. Fundamentally, however, medical device companies should realize that audits are business tools necessary to improve their quality systems. Thus, auditing staff must convey to company managers, executives and/or boards of directors that audits represent essential business practices, not just onerous ordeals to be endured and then neglected once they’re concluded.

Executive managers’ responsibilities for setting audit criteria and supporting audit programs are explained in ISO 19011; however, many executives may not be as familiar with ISO 19011 as they should. Audit managers and staff should therefore explain the necessity and reasons for performing internal, supplier and other quality audits to senior management in order to win and maintain executive buy-in.

Solution: Educating senior staff

Gaining support from management can prove a stiff challenge for audit personnel, but such support is absolutely necessary not only for successfully conducting an audit but also incorporating audit findings to improve a manufacturer’s quality management processes.

Generally speaking, auditing staff should utilize five steps and strategies to ensure management supports their efforts:

• Communicating the cost of audit observations
• Explaining the regulatory effects of nonconforming issues found
• Educating senior staff by stating and restating management’s role in the audit process
• Distributing audit reports to senior managers
• Making sure that a member of senior management participates in an actual audit

Just as crucially, auditing staff should emphasize in their reports to management the business benefits of taking audits seriously: lowering regulatory risk, improving internal processes and saving money for the firm overall.

(Subsequent posts on audit problems cover poor audit preparation, dealing with difficult auditees, and audit reports.)

Emergo resources and support for QMS auditing

• ISO 13485 consulting and implementation
• Medical device gap, internal, pre-certification and supplier QMS audits
• Medical device internal auditor training