Presented to Vermont ASQ Section 112
21 Sep 2011
David Russo, CMQ/OE, CQA
QMS Manager GE Healthcare
 ISO 9001 (13485): 8.5.2 “The organization shall take
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”
 Unexpected, unwanted events with a Quality System.
 ASQ: The result of a nonfulfillment of a specified
requirement.
 A mature CAPA system can serve as a useful tool for
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.
 Event-chain based NC investigation typically looks back at a series of adverse
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
that occurred in a batch chemical reactor in England
 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. 237–270)
 CAPA Process - structured, formalized way to
investigate NC and determine appropriate corrections,
corrective actions and preventative actions and
measure their effectiveness. (With records)
 Each step can use quality tools
to standardize the approach and
document the outcomes.
 ISO 13485 and QSR require
records of each step
 QMS has systems to detect NC
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Customer Complaints
Equipment Monitoring
Production Sampling
Auditing
Inspection
Trending
Accident Report
Etc…
 Output = Specific Problem
Statement
 Where, Who, Risk, Compliance?
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Is/Is Not
Contradiction Matrix
Expert Interviews
Data/Trends
Data/Records
Timeline
 Evaluation rubric may be defined
by your QMS (severity, probability
of harm, $$ exposure)
 Keep records
 Determine what happened, how it happened,
extent, identify true root cause(s)
 Seven classic quality tools (ASQ)
 Flowchart
 Checksheet
 Cause/Effect diagram (Ishikawa, fishbone)
 Pareto chart
 Control chart
 Histogram
 Scatter Diagram
 More tools
 5-whys
 Is/Is-not
 Contradiction matrix
 Keep Records
 Lists corrective and preventive actions (if
applicable)•Clearly addresses root causes
 Commensurate with the risk of the issue
 Where effectiveness checks are defined
 Identification of task owners and task due dates
 Implementation due date
 Keep records
Action (Plastic part had air content over spec limit)
C, CA, PA
•Rewrite procedure for mold setup
CA
•Rewrite procedure for inspection process
CA
•Poke yoke process for ensuring proper ratio mix
CA
•Containment: identify potentially affected products and recall
C
•Error-proof the monitoring process
CA
•Design new products to not need air in the mold process
PA
 Implementing a verified solution
 Testing during formation of
action plan
 Validate
 Tracking (where, how many, who)
 Keep records
 Monitor performance indicators à
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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
 17 miles east of Sharon Springs, Kansas a
loaded coal train from Denver to Chicago.
 A wheel bearing became overheated and melted
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.