1. Closed-Loop Corrective Action
an operations management
presentation by
Bobbi Dodd

2. 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
A brief overview of the upcoming slides.

3. What Will be Covered ? Implement corrective action
Handle customer complaints
Handle product nonconformity
Ensure effectiveness of action
Software available for CLCA
Summary/Exercise
Continued brief overview of the upcoming slides.

4. What is Closed-Loop Corrective Action (CLCA)?
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
The term broken apart into its separate definitions.
The term “closed loop” has been used to describe numerous feedback loops, for example between plans for production and available capacity and between planned and actual occurrences
“A control loop is operating in a closed-loop manner when the results of the control manipulations are compared to the set point. The proceeds by which the comparison against the set point takes place is called feedback.” Walsh, Wurster and Kimber. Quality Management Handbook

5. 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
A complete term definition. This is Corrective Action as defined by Hoyle, David ISO 9000 Quality Systems Handbook Third Edition. Bodenham, Hereford, Great Britain: Biddles Ltd, Guildford and King’s Lynn. The closed-loop is effected by making sure the change is implemented and monitoring that the corrective action has been successful.
Closed-loop corrective action is required by ISO 9000 through various steps and this presentation will focus on the steps required to fulfill that requirement. However, closed-loop corrective action should be built into any quality system whether or not it is looking for ISO 9000 certification.

6. 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
A problem has to exist to take corrective action. ISO 9000 Clause 4.14 (the clause dealing with corrective action) requires a company to investigate the cause of a nonconformity and record the results of the investigation.
The ISO 9000 standard requires that when a quality problem occurs, an organization must determine its cause and take appropriate corrective action to ensure that it doesn’t happen again, and that each step in the process must be documented.
ISO only addresses the correction and prevention of nonconformances, i.e. departures from specific requirements (“. . .either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or requirements prescribed by the supplier which are perceived as satisfying a market need.” Hoyle, David at p )
Corrective action to avoid the recurrence of ANY problem would seem to be an intuitive, sensible course of action to take, providing it is economical (see slides 9 and 10, Is Corrective Action Necessary). Also, without corrective action, searching for causes has little point.

7. 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
Seven quality tools, sometimes known as the “magnificent seven,” the “seven QC tools” and the seven process improvements tools include (Russell and Taylor. Operations Management, p. 110):
Pareto Analysis used to classify problems according to cause to identify major problems (80% of defects result from 20% of causes);
Cause-and-Effect Diagrams (also called “fishbone” diagram) used to divide causes of a problem into categories;
Histograms used to show the variation of characteristics or frequency of data related to a problem;
Control Charts used to detect abnormal trends around control limits;
Scatter Diagrams used to illustrate the association between two pieces of data;
Flow Charts used to diagram the steps in a process and help focus on where a problem is; and
Check-sheets used to tabulate results through routine checks of a situation
When you encounter a ‘don’t know’ then continue investigating until you find an answer.

8. 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
The root of most causes is usually caused by management, planning, organization or control.
Once you identify the true cause of the nonconformity, you can propose corrective action to prevent its recurrence. But, of course, validate causes before taking action.

9. 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
The ISO 9000 standard requires that you document and maintain documented procedures for implementing corrective and preventive action.
Some possible procedures are: failure investigation procedure, nonconforming. material review procedure, customer complaints procedure, quality system document change procedure, specification change procedures, maintenance procedure.
The corrective action procedures need to accommodate various corrective action strategies, from simple intradepartmental analysis with solutions that affect only one area, procedure, process or product to projects that involve many departments, including suppliers, and customers on occasion.

10. 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
The ISO 9000 standard requires that the corrective/preventive action taken to eliminate the cause of a nonconformity is appropriate to the magnitude of the problem and commensurate with the risks encountered.
This would imply, as would common sense, that corrective action would not be required (nor cost efficient) on every nonconformance. Action should only be taken on vital nonconformances. The effective collection and analyses of data will be able to determine those vital nonconformances needing corrective action and the scope of the action required.

11. 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
Risk analysis need to be part of the solution.

12. 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
The ISO 9000 standard requires you to determine the corrective action needed to eliminate the cause of nonconformities. Anyone can propose corrective action but the responsibility for taking action rests with those responsible for the process (management). The proposed solution can be approved or rejected and, if rejected, the loop of determining the action required needs to be revisited.
Some corrective actions may be multidimensional in that they may require training, changes to procedures, changes to specifications, changes in the organization, changes to equipment and processes – in fact so many changes that the corrective action becomes more like an improvement project. When corrective actions require interdepartmental action, it may be necessary to set up a corrective action team to implement the changes with a project manager.

13. 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
The ISO 9000 standard requires you to implement and record changes in the documented procedures resulting from corrective and preventive action.
You must have a system for preventing the recurrence of nonconformances.
Several forms may be required. Thus it may be advantageous to use form serial numbers for linking purposes. The many software packages on the market today addressing closed-loop corrective action take care of this possibly daunting tracking procedure for you (see slide 18).

14. 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
You can only effectively handle customer complaints that you have record of receiving. Employee discipline is required to ensure complaints are recorded.
A customer feedback procedure is suggested rather than limiting the procedure to complaints, as staff should be informed of compliments as well as complaints, because it improves morale.
The ISO 9000 standard addressed complaints under the corrective action heading; however, you should not limit your action to eliminating the cause and preventing recurrence. You should also take remedial action to deal with the particular complaint. Keeping the customer satisfied is the most important thing you can do.

15. Report of Product Nonconformity
Internal report
Use TQM procedures for control of nonconforming product
External report
Similar procedures to those for handling customer complaints
The ISO 9000 standard requires the corrective action procedures to include the effective handling of reports of product nonconformities.
Procedures should include:
The method of receiving and identifying the returned product
The method of logging reports of nonconformities from customers
The process of responding to customer requests for assistance
The process of dispatching service personnel to the customer’s premises
A form on which to record details of the nonconformance
A process for acknowledging the report so that the customer knows you care
A process for investigating the nature of the nonconformance
A process for replacing or repairing the nonconforming product and restoring customer equipment into service
A process for assessing all product in service that is nonconforming, determining and implementing recall action if necessary

16. Ensure Effectiveness of Corrective Action
Verify that planned action has been taken
Verify that the action has been effective in eliminating the original nonconformance
The ISO 9000 standard requires that controls be applied to ensure that corrective actions are taken and that they are effective. A corrective action report should define the action to be taken, the person responsible for implementing the action and the date by which it is to be completed. The person responsible should then report when the action has been completed so that it can be verified. The effectiveness of some actions can be verified at the same time but quite often the effectiveness can only be checked after considerable lapse of time. The same analysis it took to detect the nonconformance may need to be run to see if the nonconformance has been eliminated. Therefore, a corrective action report should indicate when checks for effectiveness are to be carried out and provision made for indicating that the corrective action has or has not been effective.

17. 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

18. Software Web Sites www.qualitysys.com (System 9000)
(EasyTrak medical industry specialization)
(SMART Corrective Action System)
(Failure Reporting Analysis and Corrective Action System)
(Quality Action Reporting)
Websites found during my research of this topic.

19. 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
This could be used as an exercise or built into you process management system to effectuate closed-loop corrective action.
Bibliography for slide show:
Goetsch, David L. and Stanley B. Davis. Understanding and Implementing ISO 9000 and ISO Standards. Upper Saddle River, New Jersey: Prentice Hall, 1998
Hoyle, David. ISO 9000 Quality Systems Handbook Third Edition. Bodenham, Hereford, Great Britain: Biddles Ltd, Guildford and King’s Lynn, 1998.
Walsh, Loren, Ralph Wurster and Raymond J. Kimber, eds. Quality Management Handbook. Wheaton, IL: Hitchcock Publishing Company, 1986.
Washington, Marcietta Swilley. ISO 9001 Update Corrective Actions and You [On-line]. Available: hq.nasa.gov/hqiso9000ppt/ CPASArticle-final.doc
Washington, Marcietta Swilley. NASA Headquarters Corrective and preventive Action System (CPAS) Training [On-line]. Available: hq.nasa.gov/hqiso9000ppt/CPASTTraining2.ppt
Author Unknown. Case Studies: Closing the Loop on Corrective Action [On-line]. Available: