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Common Medical Device QMS Audit Problems: Little or No Audit Preparation


  • Despite best intentions, medical device companies’ internal audits are often carried out as last-minute affairs.
  • Formalized audit preparation time, adherence to checklists and simple time management can help a firm’s audit personnel perform their duties more effectively.

Medical device quality system audit problems: no audit preparationIn the second in a series of blog posts examining common problems medical device firms deal with related to quality management system audits, Emergo discusses how lack of proper internal audit preparation leads to last-minute scrambles and business headaches.

(Emergo’s previous post on QMS audit problems covered management support issues.)

Although quality system audit schedules are typically published at the beginning of each year, firms’ internal auditing personnel may nonetheless find themselves caught by surprise when actual audit dates approach. In such instances, companies undertake last-minute preparations of checklists and audit questions that they should have taken months to develop, and rush to familiarize themselves with processes and procedures that should have been examined days or months ahead of time.

Problem: Lack of internal audit preparation

Proper preparation for internal quality system audits is crucial for positive versus negative outcomes; time management makes up a large part of this preparation. Scheduling and formal allotment of time for audit preparation is necessary.

What does appropriate audit preparation look like? Auditing staff can generate checklists and questions relevant to procedures they’re examining, and familiarize themselves with procedures under their auditing scope ahead of time. The first time auditing a process or procedure is usually the most difficult for internal staff because no prior checklists exist, so proper preparation time makes a big difference in these cases.

Solution: Planning, and sticking to plans

Examples of steps and strategies medical device companies can take to ensure better audit preparation include:

  • Utilize Outlook or other calendar programs to schedule preparation time
  • Formally allot work time for audit preparation activities
  • Establish checklists and questions, and require adherence to them.
  • Familiarize yourself with processes and procedures to be audited before auditing them

Stay tuned for additional Emergo blog coverage of QMS audit problems.

Quality system auditing resources and support

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