Closed Loop Corrective Action

Closed-Loop Corrective Closed-Loop Corrective Action Action

an operations managementan operations management

presentation bypresentation by

Bobbi DoddBobbi Dodd

What Will be Covered?What Will be Covered?

• What is CLCA?What is CLCA?• Determine the cause of a problem Determine the cause of a problem

(nonconformity)(nonconformity)• Corrective action proceduresCorrective action procedures• Is corrective action necessary?Is corrective action necessary?• Determine corrective action Determine corrective action

neededneeded

What Will be Covered ?What Will be Covered ?

• Implement corrective actionImplement corrective action• Handle customer complaintsHandle customer complaints• Handle product nonconformityHandle product nonconformity• Ensure effectiveness of actionEnsure effectiveness of action• Software available for CLCASoftware available for CLCA• Summary/ExerciseSummary/Exercise

What is Closed-Loop What is Closed-Loop Corrective Action (CLCA)?Corrective Action (CLCA)?

• Corrective Action:Corrective Action:– An action planned or taken to stop An action planned or taken to stop

something from recurring.something from recurring.

• Closed Loop:Closed Loop:– Fix the process by eliminating the root Fix the process by eliminating the root

cause of a problem so that it will not cause of a problem so that it will not reoccurreoccur

What is Closed-Loop What is Closed-Loop Corrective Action (CLCA)?Corrective Action (CLCA)?

““The pattern of activities which The pattern of activities which traces the symptoms of a problem traces the symptoms of a problem to its cause, produces solutions for to its cause, produces solutions for preventing the recurrence of the preventing the recurrence of the problem, implements the changes problem, implements the changes and monitors that the changes and monitors that the changes have been successful.”have been successful.”

Hoyle, DavidHoyle, David

Determine the Cause of a Determine the Cause of a NonconformityNonconformity

• Validate causes before planning or Validate causes before planning or taking actiontaking action– Identify the nonconformityIdentify the nonconformity– Collect data on nonconforming item, Collect data on nonconforming item,

quantity, frequency, etc.quantity, frequency, etc.– Identify when, where and under what Identify when, where and under what

conditions problem occurredconditions problem occurred

Determine the Cause of a Determine the Cause of a NonconformityNonconformity

• Investigate thoroughly; many tools Investigate thoroughly; many tools can helpcan help– The common seven quality tools when The common seven quality tools when – The simple why? Why? Technique can The simple why? Why? Technique can

often reveal the root cause of a often reveal the root cause of a problem very quicklyproblem very quickly

Sources of CausesSources of Causes

• Deficiencies in communicationDeficiencies in communication• Deficiencies in documentationDeficiencies in documentation• Deficiencies in personnel training and Deficiencies in personnel training and

motivationmotivation• Deficiencies in materialsDeficiencies in materials• Deficiencies in tools and equipmentDeficiencies in tools and equipment• Deficiencies in the operating Deficiencies in the operating

environmentenvironment

Corrective Action Corrective Action ProceduresProcedures

• Sources of nonconformity causes Sources of nonconformity causes are variableare variable

• It may be practical to employ It may be practical to employ corrective action provisions in corrective action provisions in procedures rather than a single procedures rather than a single corrective action procedurecorrective action procedure

Is Corrective Action Is Corrective Action Necessary?Necessary?

• All nonconformances are costly but All nonconformances are costly but correction is also costlycorrection is also costly

• Assess the degree of corrective Assess the degree of corrective action necessaryaction necessary– Determine the magnitude of the Determine the magnitude of the

problem and the risks encounteredproblem and the risks encountered

Is Corrective Action Is Corrective Action Necessary?Necessary?

• A manager needs to know:A manager needs to know:– What is the problem?What is the problem?– Has the problem been confirmed?Has the problem been confirmed?– What are the consequences of doing What are the consequences of doing

nothing?nothing?– What is the preferred solution? - How much What is the preferred solution? - How much

will it cost/save?will it cost/save?– What are the alternatives and their relative What are the alternatives and their relative

costs?costs?– How long before the problem damages the How long before the problem damages the

businessbusiness

Determine Corrective Determine Corrective Action NeededAction Needed

• Immediate action such as warning Immediate action such as warning notices, alerts, etc.notices, alerts, etc.

• Longer term action such as Longer term action such as changes to plans, procedures, changes to plans, procedures, specifications, training, etc. specifications, training, etc.

• RecordRecord both the both the causecause and the and the proposed solutionsproposed solutions

Implementing Corrective Implementing Corrective ActionAction

• ImplementImplement and and recordrecord changes to changes to documented procedures resulting documented procedures resulting from corrective actionfrom corrective action– Track implementation of corrective Track implementation of corrective

actionsactions– Link procedural change to the Link procedural change to the

corrective action procedurecorrective action procedure– Prevent recurrence of problemPrevent recurrence of problem

Effective Handing of Effective Handing of Customer ComplaintsCustomer Complaints

• Record complaint (including details)Record complaint (including details)– Define when a customer message is Define when a customer message is

classified a complaintclassified a complaint– Capture complaints from all interface Capture complaints from all interface

channels with customerchannels with customer

• Acknowledge complaintAcknowledge complaint• Investigate nature of complaintInvestigate nature of complaint• Establish a process for satisfying Establish a process for satisfying

customercustomer• Monitor progressMonitor progress

Report of Product Report of Product NonconformityNonconformity

• Internal reportInternal report– Use TQM procedures for control of Use TQM procedures for control of

nonconforming productnonconforming product

• External reportExternal report– Similar procedures to those for Similar procedures to those for

handling customer complaintshandling customer complaints

Ensure Effectiveness of Ensure Effectiveness of Corrective ActionCorrective Action

• Verify that planned action has been Verify that planned action has been takentaken

• Verify that the action has been Verify that the action has been effective in eliminating the original effective in eliminating the original nonconformancenonconformance

Software Available for Software Available for CLCA trackingCLCA tracking

• Dozens of quality management Dozens of quality management software packages are on the software packages are on the market that help facilitate the market that help facilitate the sometimes daunting task of sometimes daunting task of tracking the closed-loop corrective tracking the closed-loop corrective action processaction process

• A few of the web sites found during A few of the web sites found during preparation of this presentation are preparation of this presentation are listed on the following slidelisted on the following slide

Software Web SitesSoftware Web Sites

• www.qualitysys.com (System 9000) (System 9000)• www.relsys-inc.com (EasyTrak medical (EasyTrak medical

industry specialization)industry specialization)

• www.processintegrity.com (SMART (SMART Corrective Action System)Corrective Action System)

• www.fracas-software.com (Failure (Failure Reporting Analysis and Corrective Action Reporting Analysis and Corrective Action System)System)

• www.stochos.com (Quality Action Reporting)(Quality Action Reporting)

Summary – Can Also be Summary – Can Also be Used as an ExerciseUsed as an Exercise

• A closed-loop corrective action A closed-loop corrective action processprocess– Identify the Identify the problemproblem– Investigate the root Investigate the root cause cause of the of the

problemproblem– Develop a Develop a planplan which eliminates the which eliminates the

causecause– ImplementImplement the plan the plan– VerifyVerify the effectiveness of the the effectiveness of the

eliminating the causeeliminating the cause