Leveling the PlayingTHIRD-PARTYCERTIFICATIONFieldPresented by:Rick Curkeet PERickCurkeet,PE03/01/2013The case for Independent Third-Party Certification inthe Revised Wood Burning Appliance NSPStheRevisedWoodBurningApplianceNSPS•EPA should adopt independent third party (ITP) certification as thecertification mechanism, and use the qualityassurance/qualitycontrolycomponent of that program as the QA/QC program for the NSPS, inplace of the QA/QC programs currently in the regulation.•ITP certification works, and is already being used to determineli ith f t t d d f th licompliance withsafety standardsforthe same appliances.•The QA/QC component of the program also works, and is a tremendousimprovement over the QA/QC provisions in the current NSPS.Current NSPS relies upon emissions testing as a QA/QC tool–CurrentNSPSreliesuponemissionstestingasaQA/QCtool.– With standards below 4 g/hr, and intralaboratory precision of thewoodstove test method≥3 g/hr, emission testing can’t be used for thispurpose.– the precision of the methods for other appliance categories is likely to beworse, not better.– Other QA/QC tools, like frequent “k” list inspections, no longer makesense with the precision of laser metal cutting equipmentsensewiththeprecisionoflasermetalcuttingequipment.ITPC Efficiency•Responsive to market demand.–ITP certification agencies have the ability to allocateresources in response to increased demand for servicesquickly and efficiently.–Competition provides incentives to control costs whileCompetitionprovidesincentivestocontrolcostswhilemaintaining timely, efficient service.•Rapid adjustment to changing requirements.•Infrastructure required to issue and maintainInfrastructurerequiredtoissueandmaintaincertification is already in place.– Trained inspectors already monitor factories for appliancesafetycertification.– Certification process is well established and understood bythe industry.Third-Party Certification & EPA NSPSThird-Party Cert. EPA Cert. (Current NSPS)StandardsPer NSPSPer NSPSPerNSPSPerNSPSTesting Labs ISO/IEC 17025AccreditedEPA AccreditedCertificationProcessISO/IEC 17065AccreditedIssued by OECA –TestReport ReviewS illU dIPl tM ft Kli turveillancenannouncedIn-antInspection - quarterlyManufacturerK-listverification. Re-TestsNon-compliance Design variance,Complaint InvestigationSEA and RCA Tests (rarelydone)ComplaintInvestigationCosts Minimal and borne bymanufacturerEPA Admin. CostsMfgr. Pays for Audit TestsConformity Assessment(Product Certification)(ProductCertification)•Testing/EvaluationParticulate Emissions and Heating EfficiencyCertified per ASTM E2618-08•Documentation Validation•Marking/LabelingManufacturer: ODHH Inc.Model: 150 Clean HeatSerial #: 123456Particulate Emissions Rate:0.13 lb/mmBtu OutputUse: Heating Season Only.Delivered Heating Efficiency: 73%Maximum Heat Output: 128,000 Btu/hr w/ reload at 2.5hr. intervals.8-Hour reload output: 85,000 Btu/hr.– Identification of certified products– Standards, Classification, Rating•Monitoring or AuditingFuel: Seasoned Cordwood only.Particulate Emissions0 lb/mmBtu Output 0.60Better WorseThis Model 0.13Delivered Heating EfficiencyMonitoringorAuditing– Follow-up InspectionsDeliveredHeatingEfficiency0 Percent 100Worse BetterThis Model 73%IMPORTANT:THIS APPLIANCE IS INTENDED TO BURNSEASONED CORDWOOD FUEL ONLY. OPERATE INACCORDANCE WITH MANUFACTURER'S OPERATINGINSTRUCTIONS ONLYFAILURE TO OPERATE THISINSTRUCTIONSONLY.URETOOPERATETHISAPPLIANCE AS DIRECTED MAY RESULT IN VIOLATION OF AIRQUALITY REGULATIONS AND SUBJECT THE OPERATOR TOENFORCEMENT ACTIONS INCLUDING FINES AND/ORREMOVAL ORDERS.System StructureLegislativeAuthorityCodes & RegulationsAccreditationStandards&ProductCertificationCriteriaManufacturerBody–TestLabCertifiedProductsRegulation – Basic Elements•Specifystandards to be used to evaluate compliance.y p•Specify acceptance criteria.•Specify requirements for certification process.Specifyrequirementsforcertificationprocess.•Specify compliance time frame.•Specify non-compliance penalties if applicableSpecifynoncompliancepenaltiesifapplicable.Why do we need “Third-Parties”?“First-Party” =SELLER“Second-Party”(Manufacturer, Importer,Distributor, Retailer)= BUYER(Consumer, Regulator, AHJ)Third-Partiesprovide independentassurance of aproduct’squality, performance, safety, or suitability for end use.Why Trust a“Third-Party”?WhyTrustaTheir only marketable commodity is:“CREDIBILITY”.To demonstrateCREDIBILITYThird-Parties obtain“ACCREDITATIONS”ACCREDITATIONS .If buyers feel the 3rd-Party favors the seller he/she canl i t ditcomplainto accreditors.Likewise, if sellers feel the 3rd-Party favors buyers.LoseACCREDITATIONS= LoseCREDIBILITY=OUT ofBUSINESS.Conformity Assessment Standards•ISO/IEC 17010 – Accreditation•ISO/IEC 17020–Inspection AgenciesISO/IEC17020InspectionAgencies•ISO/IEC 17025 – Testing and Calibration Laboratories•ISO/IEC 17030 – Third-party Marks of Conformity•ISO/IEC 17065 – Third-party Product CertificationI t ti lInternationalElectrotechnicalCommissionACCREDITATIONS: ISO/IEC 17010•Accrediting bodies participate in InternationalLaboratory Accreditation Cooperation (ILAC)LaboratoryAccreditationCooperation(ILAC)organizations.– Asia Pacific Laboratory Accreditation Cooperation (APLAC)European cooperation for Accreditation (EA)–EuropeancooperationforAccreditation(EA)– Inter America Accreditation Cooperation (IAAC)•ILAC North American MRA Signatories include:– A2LA– NVLAP–ICC-IAS– SCC– ANSI/ASQ (ACLASS)What do “ACCREDITORS” do?•Verifies that the Testing and Certification agency conforms toVerifiesthattheTestingandCertificationagencyconformstostandards.•Most require copies of operating procedure documents,personnel résumés, calibration records, etc.personnelrésumés,calibrationrecords,etc.•Most conduct regular audits of agency’s testing and inspectionprograms.•Generally publish lists of“Approved”or“Recognized”agenciesGenerallypublishlistsofApprovedRecognizedagencies.Levels of Certification:(Private Sector)(PrivateSector)•Supplier’s Declaration of Conformity (least stringent)– Supplier (manufacturer, importer, retailer) does testing, validation,and auditing. (Assumed to be biased.)•Affiliated Certification(Trade Associations))– Lab does testing. Association does validation and auditing.(Requires autonomous independent administrator to prevent biastoward members.)towardmembers.)•Third-Party Certification (most stringent, unbiased)–Independent agency does testing,validation, and auditing.(U ll i d h lif f t d bli lf th(Usually requiredwherelife safety andpublic welfare aretheprimary concern.)In the U.S. product safety is ensured through theefforts of both the public and private sectorseffortsofboththepublicandprivatesectorsPublicPrivate•OSHA – products in the workplace•FCC – products connected to thenetwork•NRTLs•TCBsR t il 2dt•CPSC – consumer products•ICC Model Building Codes*•NHTSA – highway vehicles•FAA–air travel•Retailers,2ndparty•Recognized certifiers & Labs•Recognized certifiers & Labs•Recognized certifiers & LabsFAAairtravel•FDA – medical devices, pharma.•HUD – housing, buildings•Coast Guard – marine safetyRecognizedcertifiers&Labs•Recognized certifiers & registrars•Recognized certifiers & Labs•Recognized certifiers & Labs•MSHA–mining safety•Customs•DOE/EPA – EnergyStar•Recognized certifiers & Labs•NRTLs, labs, inspection bodies•Recognized certifiers & Labs* Includes safety certification requirements for solid fuel appliances.Examples of Third-Party CertificationAgenciesUnderwriter’s Laboratories - UL (1894)Canadian Standards Association - CSA(1919)Intertek -Warnock Hersey(1888), ETL (1890)i l i i di( )NationalSanitation Foundation–NSF1944)Omni -TestHow Third-partyCertification WorksCertificationWorksCertification Flow ChartApplicationFinal DesignDocumentationDetermineIn-PlantStandardsMonitoringSampleSelectionProductionMeetsSpec.?AuthorizeMarkingYESComplianceEvaluationCorrectiveAction–Suspend ATMNOSuspendATMSTEP 1: Identify Product•What is the product to be certified?Wh tt dd( ) i it t b j d d b ?•atsandard(s)isittobejudgedby?•What are the minimum requirements for acceptanceof the product?oftheproduct?Step 2: Document Design/Process•Compare product to designspecifications and drawingsspecificationsanddrawings.– Complete?– Accurate?•If the production process orprocedure is critical, witness anddocument production of samples.(P t t i ti )(Pretestinspection.)•In some cases samples are randomlyselected from stock bythe 3rdparty.yStep 3: Conduct Evaluation•Sample(s) must be traceable to documentedSample(s)mustbetraceabletodocumenteddesign/process.•Testing and evaluation under supervision and controlof third-party.•Full compliance with applicable standards required.Step 4: Create Inspection Documentation•Test Reports.•Design and process documentation.•In-Plant Quality Assurance Procedures.I iti l F t A dit•InitialFactoryAudit•Marking and Labeling Requirements.•Listing and Labeling contractListingandLabelingcontract.– Includes “Authorization to Mark”.•Thisprocess constitutes the “Certification Decision”based on thorough review of the documentation.The Certification Decision•ISO/IEC 17065 requires that the certification decision be made bypersonnel different from those who carried out the evaluationpersonneldifferentfromthosewhocarriedouttheevaluation.•This involves review of the documentation provided for accuracy,completeness and compliance with the specified standards.7.6 Certification decision7.6.1 The certification body shall be responsible for, and shall retain authorityfor, its decisions relating to certification.7.6.2The certification body shall assign at least one person to make the certificationdecision based on all information relatedto the evaluation, its review, and anyother relevant information. The certification decision shall be carried out by aperson or group of persons [e.g. a committee (see 5.1.4)] that has not beeninvolved in the process for evaluation (see 7.4).NOTE The review and the certification decision can be completed concurrently by thesame person or group of persons.Independence Requirements: ISO/IEC 17065•No affiliation or financial interest inprod cers endors or s ppliers of prod ctsproducers, vendorsorsuppliersofproductsit certifies.•No involvement in design of products itNoinvolvementindesignofproductsitcertifies.•Employment security of personnel is notEmploymentsecurityofpersonnelisnotsubject to influence of clients.•Sufficient financial strength and diversity ofSufficientfinancialstrengthanddiversityofbusiness that the loss or award and anysingle contract would not affect ongoingoperations.Independence Requirements: ISO/IEC 17065•The Certification body is responsible forass ring that independence and impartialitassuringthatindependenceandimpartiality(no conflict-of-interest) are rigorouslymaintained at all times.Step 5: Follow-Up Surveillance•Regular and UNANNOUNCEDvisits to productionfacilities.•Verify that products being“Marked”comply withVerifythatproductsbeingcomplywithdesign, process and QA requirements.•Document results and report anydeficiencies orydeviations.•No product modifications without review andverification of complianceverificationofcompliance.IMPORTANT!Without an effective and meaningfulFOLLOW-UP SURVEILLANCE PROGRAMUPSURVEILLANCEPROGRAMthe other steps are meaningless! If theproducer can submit one product forproducercansubmitoneproductfortesting and evaluation and then maked l b l thi diff t th i tandlabelsomethingdifferent,the pointof certification is lost.If Variances* Are Found!•3rd-Party must investigate and determine scope/severity of nonlicompance.•Determine appropriate remedial actions.– Rework, retro-fit, recall– Retest to verify compliance•If warranted will suspend or revoke authorization to applycertification mark.certificationmark.•Notification of Authorities of unsafe, hazardous or non-compliantproducts bearing the “mark”.•Because the process is governed by contract between themanufacturer and certification agency, resolution of noncompliance issues is quick and effective.*Variance – Any deviation from the certified design.Additional Requirements: ISO/IEC 170653 dP t t h d t i ti t•rd-Party musthave proceduretoinvestigate noncompliance allegations from any source.•3rdParty must have appeals procedure to resolve any-Partymusthaveappealsproceduretoresolveanyissues arising from its compliance or non-compliancedeterminations.•Must have procedure to protect client’s confidential andproprietary information. Insulates manufacturer’s CBIand IP from FOIA abuseandIPfromFOIAabuse.Certification Marks•These are the Third-Party’s identifying symbol(s)registered as“Certification Marks”with the USregisteredasCertificationMarkswiththeUSpatent office under “The Lanham Act”.•Third-Party must enforce control of the mark andPartymustenforcecontrolofthemarkandallow its application only to products produced incompliance with the certification program rules.IT WORKS!•Third-Party Certification is the dominant process that assuressafety, performance and fitness for purpose of products andmaterials on aglobal basis.•Virtually all building materialsand many consumer products are3rd-party certified for:– Fire safety– Electrical safety– Structural performance– Energy EfficiencyA h di t F d l R l ti h b i d•Areas wheredirectFederalRegulationhasbeen requiredareincreasingly moving to third-party certification.– Food and Drug Safety–CPSC Consumer Products Safety RegulationsCPSCConsumerProductsSafetyRegulations– FCC Electromagnetic Interference and Compatibility–EPA/DOE EnergyStar– EPA WaterSenseEnergyStar Program Added ITPC for ManyCategoriesIT’S A GOOD FIT!•Virtually all solid fuel appliances are required to be thirdVirtuallyallsolidfuelappliancesarerequiredtobethirdparty certified for compliance with safety standardsunder state and local regulations.•Most of the work is already done - adding emissions andefficiency performance certification, therefore, adds veryminimal cost for manufacturers and consumers.•Regulators have a very simple and reliable method ofverifying that products comply with specified limits. Justlook for the label.EPA Oversight•Certification Bodies will promptly notify EPA when certificationsare issued, withdrawn or modified and maintain publiclyaccessible on-line listings of certified products.•Certification Bodies willprovide regulatoryauthorities with accessgyto any product certification documentation requested.•EPA to conduct periodic audits of CB’s performance.•CB’to provide EPA with audit reports issued by accreditingstoprovideEPAwithauditreportsissuedbyaccreditingbodies.•EPA can ask for investigation ofany suspected non-complianceissues CB’are obligated to respondissues.CB sareobligatedtorespond.•EPA can challenge accreditations issued to CB with accreditors incases of suspected abuse or failure to comply with requirements.