What is the Essence of Quality, Beyond CAPA? Part 1

"What is the Essence of Quality, Beyond CAPA?" podcast with Dan Matlis from Axendia.
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Show Notes
Podcast with Dan Matlis, segment 1 of 2. Discussion on PACA vs. CAPA.

• PACA - Proventive and Corrective Action
• Corrective Action - Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence.
• Proventive Action -
  Action taken to eliminate the cause of a potential non-conformity, defect, or other undesirable situation in order to prevent occurrence
• Is CAPA a Reactive or Proactive Program?
  Both - Corrective Action = reactive
  Preventive Action = proactive
• Do what you say - Execute
  Say what you do - SOP’s
  Improve it - Innovate
  Prove it - Test
• We hear a lot about CAPA in Life-Science Organizations, how did this approach come about?
  Explicit requirement in 21 CFR 820 100 a

  CAPA for Med Devices

  Pharma and Biotech it is implicit in GMP, but heavily enforced

  Guide To Inspections Of Quality Systems

  August 1999

  Heavy emphasis on CAPA

• FDA cGMPs for 21st Century
  Encourage adoption of new technologies

  Promote industry use of modern quality system approaches

  Encourage risk-based approaches which focus on critical elements

  Ensure FDA review, compliance and inspection policies based on state-of-art pharmaceutical science

• Today, most Life-Science companies have implemented some kind of CAPA system, yet over the last few years, quality issues have gotten the industry significant negative publicity. How do you explain this?
  Organizations are structures as silos

  Not just silos but armored reinforced silos with motes around them

  Stand alone CAPA systems CAPA is yet another silo

  Lack of data to perform root cause analysis

  Reactive rather than proactive

• What are the results of this approach?

  CAPAs must be addressed within an often predetermined time period

  Not surprising, a large percentage of closed manufacturing CAPAs result in updated SOPs or operator training

  This is often due to a lack of visibility into the manufacturing process.

  Manufacturers must have real-time data to perform Root Cause analysis to truly understand the source of deviations.