Category: QMS Subsystem: CAPA

CAPA Owners Need Love Too!

CAPAThere are two kinds of problem solving in the medical device world:

1 – Solving for improvements in effectiveness and efficiency

2 – Solving for corrective action/preventive action (CAPA) compliance

The transition from #1 to #2 seems to perplex organizations entering the medical device arena for the first time. CAPA is too often seen as a burden, stealing valuable time from scientists and engineers who would rather focus on what they know best – designing and making new products.

Ironically, many of these same wannabe medical device companies have a robust Lean and Six Sigma culture, where a large percentage of employees hold Green Belts.…

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All Topics, Medical Device Quality Assurance, QMS Subsystem: CAPA

CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

FDA QMS subsystems CAPA and P&PC

What can FDA’s data tell you? Sometimes you learn something new ‒ other times the data validates what you already know.

FDA’s CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers.

The data addresses findings related to five quality system subsystem areas: Corrective and Preventive Action (CAPA), Production and Process Controls (P&PC), Management Controls (MGMT), Design Controls (DES), and Document Controls (DOC).…

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All Topics, QMS Subsystem: CAPA, US FDA 21 CFR Part 820 (QSR)