Closed-Loop

Corrective Action

an operations management
presentation by
Bobbi Dodd
 What Will be Covered?
• What is CLCA?
• Determine the cause of a
problem (nonconformity)
• Corrective action procedures
• Is corrective action necessary?
• Determine corrective action
needed
What Will be Covered ?
• Implement corrective action
• Handle customer complaints
• Handle product nonconformity
• Ensure effectiveness of action
• Software available for CLCA
• Summary/Exercise
What is Closed-Loop
Corrective Action (CLCA)?
• Corrective Action:
– An action planned or taken to stop
something from recurring.
• Closed Loop:
– Fix the process by eliminating the
root cause of a problem so that it
will not reoccur
What is Closed-Loop
Corrective Action (CLCA)?
“The pattern of activities which
traces the symptoms of a
problem to its cause, produces
solutions for preventing the
recurrence of the problem,
implements the changes and
monitors that the changes have
been successful.”
Hoyle, David
Determine the Cause of
a Nonconformity
• Validate causes before planning
or taking action
– Identify the nonconformity
– Collect data on nonconforming
item, quantity, frequency, etc.
– Identify when, where and under
what conditions problem occurred
Determine the Cause of
a Nonconformity
• Investigate thoroughly; many
tools can help
– The common seven quality tools
when
– The simple why? Why? Technique
can often reveal the root cause of
a problem very quickly
Sources of Causes
• Deficiencies in communication
• Deficiencies in documentation
• Deficiencies in personnel training
and motivation
• Deficiencies in materials
• Deficiencies in tools and equipment
• Deficiencies in the operating
environment
Corrective Action
Procedures
• Sources of nonconformity
causes are variable
• It may be practical to employ
corrective action provisions in
procedures rather than a single
corrective action procedure
Is Corrective Action
Necessary?
• All nonconformances are costly
but correction is also costly
• Assess the degree of corrective
action necessary
– Determine the magnitude of the
problem and the risks encountered
Is Corrective Action
Necessary?
• A manager needs to know:
– What is the problem?
– Has the problem been confirmed?
– What are the consequences of doing
nothing?
– What is the preferred solution? - How
much will it cost/save?
– What are the alternatives and their
relative costs?
– How long before the problem damages
the business
Determine Corrective
Action Needed
• Immediate action such as
warning notices, alerts, etc.
• Longer term action such as
changes to plans, procedures,
specifications, training, etc.
• Record both the cause and the
proposed solutions
Implementing Corrective
Action
• Implement and record changes
to documented procedures
resulting from corrective action
– Track implementation of corrective
actions
– Link procedural change to the
corrective action procedure
– Prevent recurrence of problem
Effective Handing of
Customer Complaints
• Record complaint (including details)
– Define when a customer message is
classified a complaint
– Capture complaints from all interface
channels with customer
• Acknowledge complaint
• Investigate nature of complaint
• Establish a process for satisfying
customer
• Monitor progress
Report of Product
Nonconformity
• Internal report
– Use TQM procedures for control of
nonconforming product
• External report
– Similar procedures to those for
handling customer complaints
Ensure Effectiveness of
Corrective Action
• Verify that planned action has
been taken
• Verify that the action has been
effective in eliminating the
original nonconformance
Software Available for
CLCA tracking
• Dozens of quality management
software packages are on the
market that help facilitate the
sometimes daunting task of
tracking the closed-loop
corrective action process
• A few of the web sites found
during preparation of this
presentation are listed on the
following slide
Software Web Sites
• www.qualitysys.com (System 9000)
• www.relsys-inc.com (EasyTrak medical
industry specialization)
• www.processintegrity.com (SMART
Corrective Action System)
• www.fracas-software.com (Failure
Reporting Analysis and Corrective
Action System)
• www.stochos.com (Quality Action
Reporting)
Summary – Can Also be
Used as an Exercise
• A closed-loop corrective action
process
– Identify the problem
– Investigate the root cause of the
problem
– Develop a plan which eliminates
the cause
– Implement the plan
– Verify the effectiveness of the
eliminating the cause