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action to eliminate the cause of nonconformities in order to prevent recurrence. CFR: 21 CFR 820.100 (Medical Device) (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action
requirement.
analyzing past events, correcting existing non conformities and preventing future events. A mature CAPA system goes beyond regulatory compliance to positively impact our customers by increasing the value of our products and services.
events to "assign blame" to a person or device Example; Three Mile Island (1979) Summary of Events The accident began about 4:00 a.m. on March 28, 1979, when the plant experienced a failure in the secondary, non-nuclear section of the plant. The main feed water pumps stopped running, caused by either a mechanical or electrical failure, which prevented the steam generators from removing heat. First the turbine, then the reactor automatically shut down. Immediately, the pressure in the primary system (the nuclear portion of the plant) began to increase. In order to prevent that pressure from becoming excessive, the pilotoperated relief valve (a valve located at the top of the pressurizer) opened. The valve should have closed when the pressure decreased by a certain amount, but it did not. Signals available to the operator failed to show that the valve was still open. As a result, cooling water poured out of the stuck-open valve and caused the core of the reactor to overheat. http://www.nrc.gov/reading-rm/doc-collections/fact-sheets/3mile-isle.html
What happens when the system is at fault? Example: Consider an example of a industrial accident
The computer was responsible for controlling the flow of catalyst into
the reactor and also the flow of water into the reflux condenser to cool off the reaction. Additionally, sensor inputs to the computer were supposed to warn of any problems in various parts of the plant. The programmers were told that if a fault occurred in the plant, they were to
leave all controlled variables as they were and to sound an alarm. On one occasion, the computer received a signal indicating a low oil level in a gearbox. The computer reacted as its requirements specified: It sounded an alarm and left the controls as they were. By coincidence, a catalyst had been added to the reactor, but the computer had just started to increase the cooling-water flow to the reflux condenser; the flow was therefore kept at a low rate. The reactor overheated, the relief valve lifted, and the contents of the reactor were discharged into the atmosphere
Leveson, Nancy G. A New Accident Model for Engineering Safer Systems. SafetyScience, 42(4), April 2004, pp. 237270)
investigate NC and determine appropriate corrections, corrective actions and preventative actions and measure their effectiveness. (With records)
to standardize the approach and document the outcomes. ISO 13485 and QSR require records of each step
Customer Complaints Equipment Monitoring Production Sampling Auditing Inspection Trending Accident Report Etc
Statement
Pareto chart
Control chart Histogram Scatter Diagram More tools
5-whys
Is/Is-not Contradiction matrix Keep Records
Keep records
C, CA, PA
Rewrite procedure for mold setup Rewrite procedure for inspection process Poke yoke process for ensuring proper ratio mix Containment: identify potentially affected products and recall Error-proof the monitoring process Design new products to not need air in the mold process
CA CA CA C CA PA
action plan
Validate Tracking (where, how many, who) Keep records
compare before and after Achieve specific targets -- achieving a pre-determined PPM level Statistical Data Analysis-Performance must lie within a set of statistically derived control limits Emphasis should primarily be on identifying the most effective fix Verification and validation are completed prior to implementing the action Keep records
off letting the truck support drop down and grind on top of the rail creating white hot molten metal droppings that spewed down onto the rails.
The alert crew noticed a small amount of smoke
halfway back in the train and immediately stopped the train in compliance with the rules.