Closed-Loop Corrective Action  <ul><li>an operations management </li></ul><ul><li>presentation by </li></ul><ul><li>Bobbi ...
What Will be Covered? <ul><li>What is CLCA? </li></ul><ul><li>Determine the cause of a problem (nonconformity) </li></ul><...
What Will be Covered ? <ul><li>Implement corrective action </li></ul><ul><li>Handle customer complaints </li></ul><ul><li>...
What is Closed-Loop Corrective Action (CLCA)? <ul><li>Corrective Action: </li></ul><ul><ul><li>An action planned or taken ...
What is Closed-Loop Corrective Action (CLCA)? <ul><li>“The pattern of activities which traces the symptoms of a problem to...
Determine the Cause of a Nonconformity <ul><li>Validate causes before planning or taking action </li></ul><ul><ul><li>Iden...
Determine the Cause of a Nonconformity <ul><li>Investigate thoroughly; many tools can help </li></ul><ul><ul><li>The commo...
Sources of Causes <ul><li>Deficiencies in communication </li></ul><ul><li>Deficiencies in documentation </li></ul><ul><li>...
Corrective Action Procedures <ul><li>Sources of nonconformity causes are variable </li></ul><ul><li>It may be practical to...
Is Corrective Action Necessary? <ul><li>All nonconformances are costly but correction is also costly </li></ul><ul><li>Ass...
Is Corrective Action Necessary? <ul><li>A manager needs to know: </li></ul><ul><ul><li>What is the problem? </li></ul></ul...
Determine Corrective Action Needed <ul><li>Immediate action such as warning notices, alerts, etc. </li></ul><ul><li>Longer...
Implementing Corrective Action <ul><li>Implement  and  record  changes to documented procedures resulting from corrective ...
Effective Handing of Customer Complaints <ul><li>Record complaint (including details) </li></ul><ul><ul><li>Define when a ...
Report of  Product Nonconformity <ul><li>Internal report </li></ul><ul><ul><li>Use TQM procedures for control of nonconfor...
Ensure Effectiveness of Corrective Action <ul><li>Verify that planned action has been taken </li></ul><ul><li>Verify that ...
Software Available for CLCA tracking <ul><li>Dozens of quality management software packages are on the market that help fa...
Software Web Sites <ul><li>www.qualitysys.com  (System 9000) </li></ul><ul><li>www.relsys-inc.com   (EasyTrak medical indu...
Summary – Can Also be Used as an Exercise <ul><li>A closed-loop corrective action process </li></ul><ul><ul><li>Identify t...
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Closed Loop Corrective Action

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Closed Loop Corrective Action

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  • Closed Loop Corrective Action

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

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