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