Closed-Loop Corrective Action

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Closed-Loop Corrective Action

• an operations management
• presentation by
• Bobbi Dodd

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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

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What Will be Covered ?

• Implement corrective action
• Handle customer complaints
• Handle product nonconformity
• Ensure effectiveness of action
• Software available for CLCA
• Summary/Exercise

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Report of Product Nonconformity

• Internal report
• Use TQM procedures for control of nonconforming
  product
• External report
• Similar procedures to those for handling customer
  complaints

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Ensure Effectiveness of Corrective Action

• Verify that planned action has been taken
• Verify that the action has been effective in
  eliminating the original nonconformance

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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

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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)

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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