Average number of Nonconformances during internal quality audit for Medical Device Manufacturers

What is the average number of NCs issued during internal quality audit for Med Device manufacturers?

  • 1-2

    Votes: 1 33.3%
  • 3-4

    Votes: 2 66.7%
  • 5-6

    Votes: 0 0.0%
  • 7-8

    Votes: 0 0.0%
  • 9-10

    Votes: 0 0.0%
  • 10+

    Votes: 0 0.0%

  • Total voters
    3
#1
I am putting together slides comparing the performance of our quality department against the greater medical device industry. A benchmark slide to present during upcoming presentations would be useful. I suspect there is an inverse correlation between number of nonconformances identified per internal audit and number of nonconformances per external audit. Obviously, there is a great deal of variability between individual auditors, but the law of large numbers should reduce the impact.

Note: there is a related poll pertaining to external audits (not just notified body surveillance audits) in a separate post.
 
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RoxaneB

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#2
I am putting together slides comparing the performance of our quality department against the greater medical device industry. A benchmark slide to present during upcoming presentations would be useful. I suspect there is an inverse correlation between number of nonconformances identified per internal audit and number of nonconformances per external audit. Obviously, there is a great deal of variability between individual auditors, but the law of large numbers should reduce the impact.

Note: there will be a related poll pertaining to external audits (not just notified body surveillance audits) in a separate post.
The number of findings in any audit - be it internal or external and regardless of field/industry/standard - should not be dependent on the variability between auditors, but rather on the (maturity of the) management system and organizational culture.

What conversation are you hoping to spark by showing such a slide?

I'd offer that there is less of a 'concern' on the number of findings, but more on the nature of them (e.g., risk, focus points, spread across processes ve all in one process, etc.)
 

Zero_yield

No cost too great...for Quality
#3
I will say anecdotally for the site I'm at: I've seen management give increasing time and resources to internal audits over the past 5-10 years (including making people available during audits, being present themselves throughout the audits and during closing meetings, using audits as an opportunity to develop their direct reports, and pushing for effective CAPAs) pay off with fewer and lower severity external audit findings. We've had several external audits recently with no nonconformances at all.

I'd say we normally see about ~10 "candidates" for a nonconformance during the internal audits I've been a part of. A few of those will be resolved in some way (i.e., the auditor was misinterpreting a local procedure, etc.), a few become recommendations, and a few become nonconformances. Even those "resolved" issues will often result in some action ("If we can't agree on what this procedure says, why do we expect a technician to understand what it says, much less an external auditor?").
 
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