Professional Documents
Culture Documents
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 pilot-
operated 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
Customer Complaints
Equipment Monitoring
Production Sampling
Auditing
Inspection
Trending
Accident Report
Etc…
Output = Specific Problem
Statement
Where, Who, Risk, Compliance?
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