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Common Medical Device Audit Problems: Difficult Auditees

EMERGO SUMMARY OF KEY POINTS:

  • Difficult auditee behaviors can hamper or derail medical device quality system audits.
  • Auditor training in communication and interview techniques can help defuse behavior issues.

Common medical device QMS audit problems, part 3Part three of our blog series on common medical device quality system audit problems examines ways to deal with difficult auditees in order to successfully obtain information and evaluate processes.

Previous posts in the series focused on lack of management support and poor audit preparation.

Problem: Uncooperative auditee

Successfully performing an audit requires, among other things, adequate interactions with managers of quality processes and procedures under examination. However, when a manager exhibits difficult behavior, proper execution and completion of an audit can quickly become a challenge.

Difficult behaviors include aggression or lack of cooperation because the audit is disrupting the manager’s schedule, being “too busy” to devote necessary time and effort to the auditor, or simply not caring about the audit. Since audits are intended to function and preventive actions to identify nonconformities and areas for improvement, lack of cooperation on an auditee’s part can diminish the audit’s purpose and benefit to the organization.

Solution: Honing communication skills

Managing uncooperative or resistant auditees can require significant interpersonal skills on the part of auditors. To prepare for difficult interactions, auditors have options: Training in verbal and nonverbal communication skills, understanding cultural differences, and clearly explaining to auditees the purpose and benefit of conducting the audit. Auditors should also consider developing open-ended questions for their checklists in order to draw out auditees’ responses and avoid terse or vague answers.

Another option is to stop an audit altogether if an auditee’s difficult behaviors persist; in such cases, auditors should notify the auditee’s supervisor, or the company’s audit program manager or chief executive.

QMS audit training and support services from Emergo:

  • Internal auditor training for ISO 13485 and FDA QSR quality systems
  • Gap, internal, pre-certification and supplier QMS audits for medical device companies

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