FDA Inspectors Crave a Good Hot Cup of CAPA

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

One of my favorite all-time bands, The Kinks, have a fantastic tongue-in-cheek song called “Have a Cuppa Tea” that satirizes the British belief that a good hot cup of tea will solve all of the world’s problems. I think the FDA misread “Cuppa” and instead decided that if it focused on CAPA it, too, would solve all the of the [medical device] world’s problems.

 

And that’s probably not going to change in 2012, either.

Why is CAPA so important? Melissa Torres, part of the Center for Devices and Radiological Health’s Quality System Team in the Office of Compliance, put it clearly. CAPA matters because it is “linked to so many other requirements.”

Consider this, CAPA touches on:
  • 820.198 Complaint files
  • 820.90 Nonconforming Product
  • 820.80 Acceptance Activities
  • 820.200 Servicing
  • 820.22 Audits
  • 803 Medical Device Reporting (MDR)
  • 806 Reports of Corrections and Recalls…

“…and many more,” Torres emphasizes. Plus, dealing with CAPA effectively helps FDA inspectors relax because they get the sense you have detected and resolved any significant problems.

On the flip side, if you don’t have CAPA in control, you’re going to need a lot stiffer drink than a cup of tea.

The top 10 observations for 2011 were:
  • 21 CFR 820.100(a) – Procedures for Corrective and Preventative Action (CAPA) have not been adequately established;
  • 21 CFR 803.17 – Written Medical Device Report (MDR) procedures have not been developed/maintained/implemented;
  • 21 CFR 820.198(a) – Complaint handling procedures for receiving/reviewing/evaluating  complaints have not been established/defined/documented/completed/implemented;
  • 21 CFR 820.100(b) – Corrective and Preventative Action activities and/or results have not been adequately documented;
  • 21 CFR 820.75(a) – A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures;
  • 21 CFR 820.22 – Quality audits/reaudits have not been performed;
  • 21 CFR 820.22 – Procedures for quality audits have not been adequately established;
  • 21 CFR 820.30(a) – Procedures for design control have not been established;
  • 21 CFR 820.30(i) – Procedures for design change have not been adequately established;
  • 21 CFR 820.20 – Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.

The top 10 observations for 2010 were:

  • 21 CFR 803.17 – Written Medical Device Report (MDR) procedures have not been developed/maintained/implemented;
  • 21 CFR 820.100(a) – Procedures for corrective and preventive action have not been adequately established;
  • 21 CFR 820.100(b) – Corrective and preventive action activities and/or results have not been adequately documented;
  • 21 CFR 820.75(a) – A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures;
  • 21 CFR 820.198(a) – Complaint handling procedures for receiving/reviewing/evaluating  complaints have not been established/defined/documented/completed/implemented;
  • 21 CFR 820.50 – Purchasing controls,. Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established;
  • 21 CFR 820.198(a) – Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established;
  • 21 CFR 820.198(c) – Complaints involving the possible failure of a device/labeling/packaging to meet any of its specifications were not reviewed/evaluated/investigated where necessary;
  • 21 CFR 820.22 – Procedures for quality audits have not been adequately established;
  • (tie) 21 CFR 820.22 – Conducted quality audits/reaudits have not been performed;
  • (tie) 21 CFR 820.30(i) – Design changes – lack of, or inadequate procedures.

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