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Corrective and PreventiveAction BasicsNovember 4, 2014Joseph TartalPostmarket and Consumer Branch ChiefDivision of Industry and Consumer EducationOffice of Communication and EducationCenter for Devices and Radiological HealthU.S. Food and Drug Administration
Learning Objectives Know the purpose of Corrective and Preventive Action Have the ability to distinguish between each definedterm Understand the requirements in 21 CFR 820 QualitySystem Regulation Identify various types of data and tools Recognize examples and best practices Be aware of compliance concerns2
Purpose of the Corrective andPreventive Action Subsystem To collect and analyze information to identify actualand potential product and quality problems To investigate product and quality problems andtake appropriate and effective corrective orpreventive action To verify or validate the effectiveness of correctiveand preventive actions3
Purpose of the Corrective andPreventive Action Subsystem To communicate corrective and preventive actionsto the appropriate people To provide information for management review To document activities4
Definition: Correction“Correction” action to eliminate a detectednonconformity.1. A correction can be made in conjunction witha corrective action.2. A correction can be, for example, rework orregradeISO 9000:2005(E)5
Definition: Corrective Action“Corrective action” action to eliminate the cause of adetected non-conformity or other undesirable situation.1. There can be more than one cause for anonconformity.2. Corrective action is taken to prevent recurrence.3. There is a difference between correction andcorrective action.ISO 9000:2005(E)6
Definition: Preventive Action“Preventive action” action to eliminate the causeof a potential non-conformity or other undesirablesituation1. There can be more than one cause for apotential nonconformity.2. Preventive action is taken to preventoccurrence.ISO 9000:2005(E)7
21 CFR 820 RegulatoryRequirement - ProceduresEstablish and maintain procedures forimplementing corrective and preventiveaction21 CFR 820.100(a)8
The Preamble on ProceduresThe procedures (for implementing correctiveand preventive action) must provide for controland action to be taken on devices distributed,and those not yet distributed, that aresuspected of having potential nonconformities.Preamble, Comment 1589
Where to Start? PlanningPlans should include I. Establishing Data Sources and CriteriaII. Measuring and Analysis of Data SourcesIII. Improvement PlansIV. Input to Management10
Establishing Data SourcesInternalSourcesExternalSources11
Examples of Internal Data Sources Process ControlData Test/Inspectiondata Device HistoryRecords Internal Audits Nonconformingmaterial reports Rework andScrap/Yield Data Training records12
Examples of External Data Sources Supplier Controls Customers Complaints Servicing repairs Adverse EventReporting (MDR) FDA Even similardevices fromcompetitors13
Data AnalysisAnalyze processes, work operations, concessions,quality audit reports, quality records, service records,complaints, returned product, and other sources ofquality data to identify existing and potential causes ofnonconforming product, or other quality problems.21 CFR 820.100(a)(1)14
Approach to Data AnalysisNon-statistical & Statistical TechniquesUse a risk-based approach to rank areas,Select items with major impact, i.e. Product related orProcess relatedProceed with items from high to low impact andeventually assure all areas are addressed Use of Statistical Methodology; 21 CFR 820.100(a)(1)Appropriate statistical methodology shall be employedwhere necessary to detect recurring quality problems 15
Investigate to DetermineRoot CauseInvestigate the cause of nonconformitiesrelating to product, processes, and thequality system21 CFR 820.100(a)(2)16
The Preamble on InvestigationsThe requirement in this section is broader than therequirement for investigations under Sec. 820.198,because it requires that nonconforming productdiscovered before or after distribution beinvestigated to the degree commensurate with thesignificance and risk of the nonconformity.More . . .17
The Preamble on Investigations the requirement in this section applies toprocess and quality system nonconformities, aswell as product nonconformities if a moldingprocess with its known capabilities has a normal 5percent rejection rate and that rate rises to 10percent, an investigation into the nonconformanceof the process must be performed.Preamble, Comment 16118
Identify Corrective andPreventive ActionsIdentify the action(s) needed to correct andprevent recurrence of nonconformingproduct and other quality problems21 CFR 820.100(a)(3)19
Identify Action(s) to be taken No further action necessaryCorrectionCorrective ActionPreventative Action20
The Preamble on Risk and Degree ofCorrective and Preventive Action the degree of corrective and preventive actiontaken to eliminate or minimize actual or potentialnonconformities must be appropriate to themagnitude of the problem and commensurate withthe risks encountered. . .Preamble, Comment 15921
Verify/Validate Corrective andPreventive ActionsVerify or validate the corrective and preventiveaction to ensure that such action is effectiveand does not adversely affect the finisheddevice21 CFR 820.100(a)(4)22
The Preamble on Verificationand ValidationFDA has revised Sec. 820.100(a)(4) toreflect that preventive, as well as corrective,action must be verified or validated.Preamble, Comment 16323
Implement Corrective andPreventive ActionsImplement and record changes in methodsand procedures needed to correct andprevent identified quality problems21 CFR 820.100(a)(5)24
Communicating CAPA Information Disseminate information related to quality problems ornonconforming products to those directly responsiblefor assuring the quality of such product or theprevention of such problems. 21 CFR 820.100(a)(6) Submit relevant information on identified qualityproblems, as well as corrective and preventive actions,for management review.21 CFR 820.100(a)(7)25
The Preamble on CAPA Activities forManagement Review. . . Only certain information need be directed tomanagement. The manufacturer’s procedures shouldclearly define the criteria to be followed to determinewhat information will be considered “relevant” to theaction taken and why. FDA emphasizes that it is alwaysmanagement’s responsibility to ensure that allnonconformity issues are handled appropriately.Preamble, Comment 16426
Documenting Corrective Action andPreventive Action ActivitiesDocument all activities required under thissection, and their results21 CFR 820.100(b)27
The Preamble on CAPA andInternal Audits and Mgmt ReviewsTwo comments stated that the records required underSec 820.100(b) should be treated as part of the internalaudit. FDA disagrees with these comments FDA hasthe authority to review such records and the obligation todo so to protect the public health. . . Manufacturers willbe required to make this information readily available toan FDA investigatorPreamble, comments 16628
FDA InspectionManufacturers should consider that theirCorrective Action and Preventive Actiondocumentation can demonstrate to FDA that themanufacturer’s quality system is effective andenables the manufacturer to identify problemsquickly and implement effective corrective andpreventive actions29
Guidance Available GHTF: Quality Management SystemMedical Devices – Guidance on corrective actionand preventive action and related QMS processes;SG3; 2010 GHTF: Quality Management SystemMedical devices - Nonconformity Grading Systemfor Regulatory Purposes and Information Exchange;SG3; 201230
Providing Industry Education1. CDRH Learn – Multi-Media Industry Education§ over 80 modules - videos, audio recordings, power point presentations, software-based“how to” modules§ accessible on your portable devices: http://www.fda.gov/Training/CDRHLearn2. Device Advice – Text-Based Education§ comprehensive regulatory information on premarket and postmarket ulationandGuidance3. Division of Industry and Consumer Education (DICE)§ If you have a question - Email: DICE@fda.hhs.gov§ Phone: 1(800) 638-2014 or (301) 796-7100 (Live Agents 9am – 4:30 pm EST)§ Web ndConsumerEducation/default.htm31
2 Learning Objectives Know the purpose of Corrective and Preventive Action Have the ability to distinguish between each defined term Understand the requirements in 21 CFR 820 Quality
