By Daniel R. Matlis
No, it is not a typo; I mean to spell it C-A-C-A.
Last week, I had the opportunity to present at Camstar’s 2008 “Vision to Value” Manufacturing 360 Customer Conference. One of my sessions was entitled “Shifting from CAPA to PACA”. The takeaway message was simple: Our industry must move from the current Reactive “Corrective and Preventive Action” (CAPA) to a proactive “Preventive and Corrective Action” (PACA) approach of Quality management.
A brief History of CAPA systems in Life-Sciences:
In 1996, the FDA’s Center for Device and Radiological Health issued the Quality System Regulation. 21 CFR § 820.100 (a) requires manufacturers to establish and maintain procedures for implementing CAPA.
In the fall of 1999, FDA conducted a series of industry workshops on its new Quality System Inspection Technique (QSIT). The fourth slide in the presentation showed this chart depicting the “Top Ten FDA 483 Items” for Non-QSIT inspections.
It did not take Life-Science companies long to begin implementing some kind of a CAPA or Quality Management System.
The challenge is that Life-Science companies have often focused on the “Corrective” rather that the “Preventive” aspects of CAPA.
In most organizations “Time to Closure” is the Key Performance Indicator used to measure the effectiveness of the CAPA system. Yet, the word “time” is never mentioned in 21 CFR § 820.100 (a).
The regulation does include requirements for:
- Verifying and Validation
- Implementing and Recording
Furthermore, the amount of time a CAPA is open has little or no correlation with the successful implementation of a CAPA. Identifying the root cause of the issue and implementing an appropriate plan to address it does.
Root cause analysis can be a time consuming process. This is especially true when critical information resides in desperate disconnected systems or, worse yet, on paper records.
Unfortunately, the emphasis on “Time to Closure” has lead to a significant percentage of closed CAPAs resulting in updated SOPs or operator training. As the closure date draws near, and the pressure to meet the time requirement increases, some fall into the trap of assigning “human error” as the source of the problem.
One of the attendees brought the point home. “We call ours a CACA system” he said, “since we often implement Corrective Action upon Corrective Action (CA, CA…) to address recurring issues.” This is an example of the industry’s focus on the “Corrective” rather that the “Preventive” aspects of CAPA.
Moving to a proactive approach to quality requires a paradigm shift. It requires driving toward zero Corrective Actions by increasing Preventive Actions. You don’t have to fix it if it didn’t break.
So what does it take for this shift from CACA to CAPA and ultimately PACA?
- Cultural change from “Testing Quality Out” to “Building Quality In”
- Shift in organizational structures from silos to seamless
- Meaningful understanding of people, product and process characteristics
- Control of “critical to quality” product and process parameters
- Mash up of fragmented systems to gain visibility across the enterprise
- Distillation of actionable facts from ineffectual data
- Root cause analysis based on all available and relevant data
- Intelligence and Pattern Recognition tools to identify trends before they become problems
- Fully integrated platforms to keep pace in the Age of Continuous Innovation