CA PA
Pradeep Kumar S.
????????Site Remediation, Technical Trainer,Industry 4.0,cGxP, Black Belt Lean 6 Sigma,Quality Operation Excellence, Pharmacist√, QA-DP (AQA, DQA, IPQA, Validation, QMS, PLM, Audit & Compliance, Regulatory Support )
I recently had a chat with a pharma company employee that, he was stuck in a CAPA time loop. ??
They had perfect procedures, Sherlock Holmes-level investigations, and action plans so detailed they could rival a NASA launch type checklist. ???
And yet… the same issues kept coming back like an unwanted sequel to a bad movie. ????
? So, what was the real culprit?
Their employees were technically trained but not truly equipped to break the cycle of doom (a negative belief cycle, where a series of beliefs, actions, and reactions work to reinforce negative beliefs and unwanted behaviors).
So, we switched things up! Here’s what happened when they injected CAPA effectiveness checks into their training (no, not intravenously ??):
?? Employees had to prove they could apply corrective actions in real-world scenarios—because "reading the SOP" isn’t the same as understanding it. ??♂?
?? CAPA's started tackling behavioral & procedural issues, not just slapping a Band-Aid on the process.
?? Repeat deviations dropped 40% in 12 months. That’s right—less déjà vu (past-life experience recall recognition), more compliance breakthroughs! ??
?? Moral of the story? A CAPA is only as strong as the people executing it. If you are feel like a never-ending game of whack-a-mole (to spend time on problems that need to be dealt with quickly), it’s time to rethink training.
?? Want a simple, no-nonsense guide to make your CAPAs actually work?
Kaizen Cycle shall follow.... for CAPA