The Biogen Idec Approach to Managing Corrective and Preventive ...
Corrective vs Preventive Action
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Corrective vs. Preventive Action by Russ Westcott uality professionals frequently express confusion as to the dif- ference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a noncon- formity to occur. Many ISO 9000 regis- trar auditors tell their clients to use separate procedures and forms to doc- ument each type of action. Nothing in the standard says this must be done, but p. 13 includes the word “preve nt” in the clauses on corrective and pre- ventive action. On closer reading, however, section 8.5.2 says corrective action eliminates the cause of nonconformities to preven t recurrence, and section 8.5.3 says pre- ventive action determines and elimi- nates the causes of potential noncon- formities … to prevent occurrence. See, there is a difference! Common Misconceptions There are three common misconcep- tions about corrective and preventive action: 1. The stan dard ca lls for doc ument- ing every occurrence of a non- conformity. 2. A preven tive act ion is rea lly just calling a corrective action some- thing different. 3. The major reengineering of a process, product or service, or the introduction of a new process or equipment, is not a candidate for preventive action documentation. One way to dispel these is by sepa- rating situations into what I call a patch (a single occurrence of a noncon- formity that involves little risk and needs not be recorded), a corrective action (a more serious nonconformity involving some risk that requires action to prevent recurrence and must be re co rd ed ), a pre ve nt iv e ac ti on (a process that can be improved to pre- vent occurrence of a nonconformity and is to be documented) or a develop- mental action (a planned change to introduce a new process or product in response to strategic objectives, docu- mented as a preventive action). Consider the examples in Table 1. (Go to www.asq.org, and click on the cover of Quality Progress .) Corrective Action Process • Locate and document the root cause of the nonconformity. • Scan the entire system to ensure no other similar nonconformity could occur. • Analyze the effec t such a noncon- formity may have had on a prod- uct or service produced before the nonconformi ty was discovered, and take action appropriate to the severity of the situation by either recalling the product, notifying the customer, downgrading or scrapping product. • Establ ish t horou gh fo llow- up to ensure the correction is effective and recurrence has been prevented. Preventive Action Process • Take proacti ve step s to ensure a potential nonconformity does not occur. • Empl oy pr oces s and sy stem a naly - sis to determine how to build in safeguards and process changes to prevent nonconformance. For example, use a failure mode and effects analysis to identify risks and potential deficiencies and to set priorities for improveme nt. Developmental Action Process (T reated as Preventive Actions) • Init iate an impro veme nt proj ect, with project plans, justification for planned expenditures, resource controls and evaluation. • Contai n a r elated series of a ctions , often separated by long periods 104 I MARCH 2005 I www.asq.org Q Knowing the difference could make all the difference. so you can wait and see progress and results. • Use a va riety of ap pro pria te dis- ciplines at different times during the project. • Esta blis h a mean s for co mmu ni- cating what has been done and what has to be done to facilitate communication about changes to project team members. • Include a clear trail of actions taken and decisions made to sub- stantiate the decision to proceed, document lessons learned and avoid needless reinvention on future similar projects. Documenting and controlling cor- rective and preventive actions ensure appropriate action is taken within a reasonable timeframe and the result- ing changes work. BIBLIOGRAPHY ANSI/ ISO/AS Q Q9001- 2000 Quali ty Man- agement Systems—Requirements , ANSI/ ASQ, 2001. Robitaille, Denise, The Corrective Action Handbook , Paton Press, 2002. Stamatis, D.H., Failure Mode Effect Analysis: FMEA From Theory to Execution, second edition, ASQ Quality Press, 2003. RUSS WESTCOTT is president of R.T. Westcott & Associates, Old Saybrook, CT. He is a Fellow of ASQ and an ASQ certified quality auditor and quality manager. Westcott serves on several com- mittees of ASQ’s Quality Management Division and is a certified quality manager refresher course instructor. He is co-editor of several Quality Press books, including The Certified Quality Manager Handbook and The Quality Improvement Handbook , and author of Simplified Project Management for Quality Professionals . BACK TO BASICS comment Please If you would like to comment on this article, please post your remarks on the Quality Progress Discussion Board at www.asq.org, or e-mail them to [email protected].
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Transcript of Corrective vs Preventive Action
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Corrective vs. Preventive Action by Russ Westcott
uality professionals frequentlyexpress confusion as to the dif-ference between corrective and
preventive action. A corrective actiondeals with a nonconformity that hasoccurred, and a preventive actionaddresses the potential for a noncon-formity to occur. Many ISO 9000 regis-trar auditors tell their clients to useseparate procedures and forms to doc-ument each type of action. Nothing inthe standard says this must be done,but p. 13 includes the word preventin the clauses on corrective and pre-ventive action.
On closer reading, however, section8.5.2 says corrective action eliminatesthe cause of nonconformities to preventrecurrence, and section 8.5.3 says pre-ventive action determines and elimi-nates the causes of potential noncon-formities to prevent occurrence. See,there is a difference!
Common Misconceptions
There are three common misconcep-tions about corrective and preventiveaction:
1. The standard calls for document-ing every occurrence of a non-conformity.
2. A preventive action is really justcalling a corrective action some-thing different.
3. The major reengineering of aprocess, product or service, or theintroduction of a new process orequipment, is not a candidate forpreventive action documentation.
One way to dispel these is by sepa-rating situations into what I call apatch (a single occurrence of a noncon-formity that involves little risk andneeds not be recorded), a correctiveaction (a more serious nonconformityinvolving some risk that requiresaction to prevent recurrence and mustbe recorded), a preventive action (aprocess that can be improved to pre-vent occurrence of a nonconformityand is to be documented) or a develop-mental action (a planned change tointroduce a new process or product inresponse to strategic objectives, docu-
mented as a preventive action).Consider the examples in Table 1. (Goto www.asq.org, and click on thecover of Quality Progress.)
Corrective Action Process
Locate and document the rootcause of the nonconformity.
Scan the entire system to ensureno other similar nonconformitycould occur.
Analyze the effect such a noncon-formity may have had on a prod-uct or service produced before thenonconformity was discovered,and take action appropriate to theseverity of the situation by eitherrecalling the product, notifyingthe customer, downgrading orscrapping product.
Establish thorough follow-up toensure the correction is effectiveand recurrence has been prevented.
Preventive Action Process
Take proactive steps to ensure apotential nonconformity does notoccur.
Employ process and system analy-sis to determine how to build insafeguards and process changes toprevent nonconformance. Forexample, use a failure mode andeffects analysis to identify risksand potential deficiencies and toset priorities for improvement.
Developmental Action Process(Treated as Preventive Actions)
Initiate an improvement project,with project plans, justification forplanned expenditures, resourcecontrols and evaluation.
Contain a related series of actions,often separated by long periods
104 I MARCH 2005 I www.asq.org
Q
Knowing the difference could makeall the difference.
so you can wait and see progressand results.
Use a variety of appropriate dis-ciplines at different times duringthe project.
Establish a means for communi-cating what has been done andwhat has to be done to facilitatecommunication about changes toproject team members.
Include a clear trail of actionstaken and decisions made to sub-stantiate the decision to proceed,document lessons learned andavoid needless reinvention onfuture similar projects.
Documenting and controlling cor-rective and preventive actions ensureappropriate action is taken within areasonable timeframe and the result-ing changes work.
BIBLIOGRAPHY
ANSI/ISO/ASQ Q9001-2000 Quality Man-agement SystemsRequirements, ANSI/ASQ, 2001.
Robitaille, Denise, The Corrective ActionHandbook, Paton Press, 2002.
Stamatis, D.H., Failure Mode Effect Analysis:FMEA From Theory to Execution, secondedition, ASQ Quality Press, 2003.
RUSS WESTCOTT is president of R.T. Westcott& Associates, Old Saybrook, CT. He is a Fellowof ASQ and an ASQ certified quality auditor andquality manager. Westcott serves on several com-mittees of ASQs Quality Management Divisionand is a certified quality manager refresher courseinstructor. He is co-editor of several QualityPress books, including The Certified QualityManager Handbook and The QualityImprovement Handbook, and author ofSimplified Project Management for QualityProfessionals.
BACK TOBASICS
commentPlease
If you would like to comment on
this article, please post your remarks
on the Quality Progress Discussion
Board at www.asq.org, or e-mail
them to [email protected].
-
QUALITY PROGRESS I MARCH 2005 I 0000 I MARCH 2005 I www.asq.org
BACK TOBASICS
Situation Frequency Suggested action Type Comment
Final inspectionreturns part to operator to cor-rect. Correctedpart returned tooriginal lot.
Single occur-rence beforeshipment.
Rework, repair. Patch. May not need torecord; depends onmagnitude of risk and frequency.
Item or work unus-able.
Single occur-rence beforeshipment.
Scrap. Patch. May not need torecord; depends onmagnitude of risk andfrequency.
Item or servicedoes not meet customer require-ments.
Serious.Occurred more than once and after shipment.
Assign for action(and contact customer, asappropriate): Find root cause. Correct. Document. Evaluate
effectiveness.
Corrective action.
Situation thatcould potentiallyaffect process,product or serviceis found.
Nothing has occurred, yet.
Assign for action: Analyze what ifs. Evaluate poten-
tial effects offailure.
Identify solution. Implement
solution. Document. Evaluate
effectiveness.
Preventive action. May require long-term follow-up toensure effectiveness.
Desire to improvethe process, prod-uct or service forreasons other thannonconformance.
No nonconfor-mance exists,and no poten-tial for one isdetected.
Assign project: Analyze present
process. Reengineer
process. Document
process. Evaluate effec-
tiveness ofreengineeredprocess.
Developmentalaction. Use preven-tive action systemwith project man-agement.
Organizations fre-quently forget to takecredit for this type ofbreakthrough pro-ject.
Four Types of ActionTABLE 1
