{domain:"www.qualitydigest.com",server:"169.47.211.87"} Skip to main content

User account menu
Main navigation
  • Topics
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Videos/Webinars
    • All videos
    • Product Demos
    • Webinars
  • Advertise
    • Advertise
    • Submit B2B Press Release
    • Write for us
  • Metrology Hub
  • Training
  • Subscribe
  • Log in
Mobile Menu
  • Home
  • Topics
    • 3D Metrology-CMSC
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Login / Subscribe
  • More...
    • All Features
    • All News
    • All Videos
    • Contact
    • Training

Got CAPA Backlogs?

Five underlying causes

The QA Pharm
Tue, 04/29/2014 - 09:56
  • Comment
  • RSS

Social Sharing block

  • Print
Body

You would think that the corrective and preventive action (CAPA) system would be a business enabler—a disciplined approach to permanently resolving problems once and for all. Unfortunately, the way most CAPA systems are designed and used, it is more of a stumbling block. The system gets so chock full of stuff that backlogs are the norm, and a logarithmic increase in staff is required if you really want to keep current—or at least close as many CAPAs as you open for any given week.

ADVERTISEMENT

You know the story: We have to get ready for the next inspection. The European Medicines Agency (EMA) said they were coming in, and we are also overdue for an FDA inspection. There is a clutching of the chest because we know we’re not in great shape. Our backlogs are back up again, and we can’t afford another observation about overdue CAPAs. And they are really on to us about liberally doling out extensions to the point that original target dates are meaningless to begin with. But we keep kicking the proverbial can down the road.

 …

Want to continue?
Log in or create a FREE account.
Enter your username or email address
Enter the password that accompanies your username.
By logging in you agree to receive communication from Quality Digest. Privacy Policy.
Create a FREE account
Forgot My Password

Add new comment

Image CAPTCHA
Enter the characters shown in the image.
Please login to comment.
      

© 2025 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute Inc.

footer
  • Home
  • Print QD: 1995-2008
  • Print QD: 2008-2009
  • Videos
  • Privacy Policy
  • Write for us
footer second menu
  • Subscribe to Quality Digest
  • About Us
  • Contact Us