Leveling the Pl

THIRD-PARTY CERTIFICATION

Field

Presented by:Rick Curkeet PE Rick Curkeet, PE03/01/2013
The case for Independent Third-Party Ce

the Revised Wood Burning Appliance NSthe Revised Wood Burning Appliance NS

• EPA should adopt independent third party (ITP) certification 

certification mechanism, and use the qualit

y 

 assurance/qua

component of that program as the QA/QC program for the Nplace of the QA/QC programs currently in the regulation. 

• ITP certification works, and is already being used to determ

compli ith f t t d d f th li liance with sa

f

e

ty s

tan

dar

ds 

for the same appliances. 

• The QA/QC component of the program also works, and is a 

improvement over the QA/QC provisions in the current NSP

– Current NSPS relies upon emissions testing as a QA/QC too

Current NSPS relies upon emissions testing as

a QA/QC too

– With standards below 4 g/hr, and intralaboratory precision of 

woodstove test method 

≥ 3 g/hr, emission testing can’t be us

purpose. 

– the precision of the methods for other appliance categories i

worse, not better. 

– Other QA/QC tools, like frequent “k” list inspections, no longe

sense with the precision of laser metal cutting equipment sense with the precision of laser metal cutting equipment.
ITPC Efficiency

• Responsive to market demand.

– ITP certification agencies have the ability to allocate 

resources in response to increased demand for servicequickly and efficiently.

– Competition provides incentives to control costs while Competition provides incentives to control costs while

maintaining timely, efficient service.

• Rapid adjustment to changing requirements.• Infrastructure required to issue and maintain Infrastructure required to issue and maintain

certification is already in place.

– Trained inspectors already monitor factories for applian

safety certification. 

– Certification process is well established and understoo

the industry.
Third-Party Certification & EPA NS

Third-Party Cert. EPA Cert. (Cu

Standards Per NSPS Per NSPS Per NSPS Per NSPSTesting Labs ISO/IEC 17025 

Accredited

EPA Accredited

Certification Process

ISO/IEC 17065 Accredited

Issued by OECA Report Review

S ill urveillance U dI nannounce

d In-Pl t an

t M ft K 

Inspection - quarterly

Manu

fac

turer 

K

verification. Re-

Non-compliance Design variance, 

Complaint Investigation

SEA and RCA T

Complaint Investigation done)

Costs Minimal and borne by 

manufacturer

EPA Admin. CosMfgr. Pays for A
Conformity Assessment

(Product Certification) (Product Certification)

• Testin

g/Evaluation

Particulate Certified pe

• Documentation Validation • Marking/Labeling

Manufacturer: ODHH Inc. Model: 150 Clean Heat Serial #: 123456 

Particulate Emissions R

Delivered Heating Effici

Maximum Heat Ou

8-Hour reload ou

– Identification of certified products– Standards, Classification, Rating

• Monitoring or Auditing

Particulate E

0 lb/mmB

 Better 

This Mo

Monitoring or Auditing Delivered Hea

– Follow-up Inspections

Delivered Hea

0 Per

Worse 

IMPORTANT: THIS APPLIANSEASONED CORDWOOD FUACCORDANCE WITH MANUINSTRUCTIONS ONLY INSTRUCTIONS ONLY. FAIL

APPLIANCE AS DIRECTED MQUALITY REGULATIONS ANENFORCEMENT ACTIONS INREMOVAL ORDERS.
System Structure

Legislat

e 

Authori

Codes & Regulations

Standards Accred

&

Product Certif

Criteria

Manufacturer Body 

L

Certified 

Products
Regulation – Basic Elements

•

S

py p ecify standards to be used to evaluate com

p

• Specify acceptance criteria.• Specify requirements for certification process. Specify requirements for certification process.• Specify compliance time frame.• Specify non Specify non

-compliance penalties if applicable compliance penalties if applicable.
Why do we need “Third-Parties”?

“FirstSELL

“Second-Party” 

(Manufa

Distributo

= BUYER(Consumer, Regulator, AHJ)

Third-Parties 

provide inde

pendent assurance of a 

pro

quality, performance, safety, or suitability for end use.
Why Trust a Why Trust a “Third-Party”?

Their only marketable commodity is: “CREDIBILITYTo demonstrate CREDIBILITY Third-Parties obtain 

“ACCREDITATIONS ACCREDITATIONS . ”

If buyers feel the 3rd-Party favors the seller he/she can compl i t dit lain to accreditors.

Likewise, if sellers feel the 3rd-Party favors buyers.

Lose ACCREDITATIONS = Lose CREDIBILITY = OBUSINESS.
Conformity Assessment Standards

• ISO/IEC 17010 – Accreditation• ISO/IEC 17020 ISO/IEC 17020

– Inspection Agencies Inspection Agencies

• ISO/IEC 17025 – Testing and Calibration Laboratories• ISO/IEC 17030 – Third-party Marks of Conformity• ISO/IEC 17065 – Third-party Product Certification

I t ti l In

ternational

ElectrotechnicaCommission
ACCREDITATIONS: ISO/IEC 1701

• Accrediting bodies participate in International 

Laboratory Accreditation Cooperation (ILAC) Laboratory Accreditation Cooperation (ILAC)

organizations.

– Asia Pacific Laboratory Accreditation Cooperation (APLAC– European cooperation for Accreditation (EA) European cooperation for Accreditation (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 conform

Verifies that the Testing and Certification agency conform

standards.

• Most require copies of operating procedure documents, 

personnel résumés, calibration records, etc. personnel résumés, calibration records, etc.

• Most conduct regular audits of agency’s testing and insp

programs.

• Generally publish lists of Generally publish lists of

“Approved Approved

” or

“Recognized Recognized

” ag

ag
Levels of Certification:

(Private Sector) (Private Sector)

• Supplier’s Declaration of Conformity (least stringent)

– Supplier (manufacturer, importer, retailer) does testing

and auditing. (Assumed to be biased.)

• Affiliated Certification 

( ) Trade Associations

)

– Lab does testing. Association does validation and aud

(Requires autonomous independent administrator to p

toward members.) toward members.)

• Third-Party Certification (most stringent, unbiased)

– Independent agency does testing, validation, and a

(U ll i d h lif f t d bli lf (Usually require

d w

here life sa

f

e

ty an

d public welfa

primary concern.)
In the U.S. product safety is ensured thro

efforts of both the public and private sectefforts of both the public and private sect

Public Private

• OSHA – products in the workplace • FCC – products connected to the 

network

• NRTLs• TCBs

R t il 2

d • CPSC – consumer products t

• ICC Model Building Codes*• NHTSA – highway vehicles• FAA

– air travel

•

R

etailers, 

2nd party

• Recognized certifiers & • Recognized certifiers & L

FAA air travel

• Recognized certifiers & L

• FDA – medical devices, pharma.• HUD – housing, buildings• Coast Guard – marine safety

Recognized certifiers

& L

• Recognized certifiers & re• Recognized certifiers & L• Recognized certifiers & L

• MSHA 

– mining safety

• Customs• DOE/EPA – EnergyStar

• Recognized certifiers & L• NRTLs, labs, inspection b• Recognized certifiers & L

* Includes safety certification requirements for solid fuel applianc
Examples of Third-Party Certificatio

Agencies

Underwriter’s Laboratories - UL (1894)Canadian Standards Association - CSA(1919)Intertek - Warnock Hersey (1888), ETL (1890)Nati l i i di iona

l San

itat

ion Foun

dat

ion 

–

NSF ( ) 1944

)

Omni -Test
How Third-party 

Certification Works Certification Works
Certification Flow Chart

Application

Final Design

Documentation

Determine In-Plant

Standards Monitoring

Sample

Selection

Production

Meets

Spec.?

A

M

YES

Compliance

Evaluation Corrective

Action

– Suspend ATM

NO

Suspend ATM
STEP 1: Identify Product

• What is the product to be certified?• Wh t a

t

st dd an

dar

d( ) i it t b j d d b ? (

s

) is it

to 

be 

j

u

dge

d

b

y

?

• What are the minimum requirements for accep

of the product? of the product?
Step 2: Document Design/Process

• Compare product to design 

specifications and drawings specifications and drawings.

– Complete?– Accurate?

• If the production process or 

procedure is critical, witness and document production of samples. (P t t i ti ) (Pre

tes

t inspection.

)

• In some cases samples are randomly 

selected from stock b

y the 3rdp y art

y.
Step 3: Conduct Evaluation

• Sample(s) must be traceable to documented Sample(s) must be traceable to documented

design/process.

• Testing and evaluation under supervision and 

of third-party.

• Full compliance with applicable standards requ
Step 4: Create Inspection Documentatio

• Test Reports.• Design and process documentation.• In-Plant Quality Assurance Procedures.• I iti l F t A dit Initi

al Fac

tory 

A

udit

• Marking and Labeling Requirements.• Listing and Labeling contract Listing and Labeling contract.

– Includes “Authorization to Mark”.

• This 

process constitutes the “Certification Dec

based on thorough review of the documentati
The Certification Decision

• ISO/IEC 17065 requires that the certification decision be 

personnel different from those who carried out the evaluapersonnel different from those who carried out the evalua

• This involves review of the documentation provided for ac

completeness and compliance with the specified standard

7.6 Certification decision7.6.1 The certification body shall be responsible for, and shall retain a

for, its decisions relating to certification.

7.6.2 The certification body shall assign at least one person to make the ce

decision based on all information related to the evaluation, its review, another relevant information. The certification decision shall be carried out person or group of persons [e.g. a committee (see 5.1.4)] that has not b

involved in the process for evaluation (see 7.4).

NOTE The review and the certification decision can be completed concurre

same person or group of persons.
Independence Requirements: ISO/IEC 17

• No affiliation or financial interest in 

prod cers endors or s ppliers of prod prod

ucers, vendors or

s

uppliers of prod

it certifies.

• No involvement in design of products it No involvement in design of products it

certifies.

• Employment security of personnel is no

Employment security of personnel is no

subject to influence of clients.

• Sufficient financial strength and diversi

Sufficient financial strength and diversi

business that the loss or award and any single contract would not affect ongoin

operations.
Independence Requirements: ISO/IEC 17

• The Certification body is responsible fo

ass ring that independence and impartass

uring that independence and impart

(no conflict-of-interest) are rigorously maintained at all times. 
Step 5: Follow-Up Surveillance

• Regular and UNANNOUNCED visits to product

facilities.

• Verify that products being Verify that products being

“Marked

” comply with comply with

design, process and QA requirements.

• Document results and re

p y ort an

y deficiencies o

deviations.

• No product modifications without review and 

verification of compliance verification of compliance.
IMPORTANT!

Without an effective and meaningFOLLOW-UP SURVEILLANCE PRO

UP SURVEILLANCE PRO

the other steps are meaningless! 

producer can submit one product producer can submit one product 

testing and evaluation and then m

and l b l thi diff t th 

d label something different, th

of certification is lost.
If Variances* Are Found!

• 3rd-Party must investigate and determine scope/severity 

compliance.

• Determine appropriate remedial actions.

– Rework, retro-fit, recall– Retest to verify compliance

• If warranted will suspend or revoke authorization to apply 

certification mark. certification mark.

• Notification of Authorities of unsafe, hazardous or non-co

products bearing the “mark”.

• Because the process is governed by contract between th

manufacturer and certification agency, resolution of noncompliance issues is quick and effective. 

*Variance – Any deviation from the certified design.
Additional Requirements: ISO/IEC 1706

• 3 dr

d

-P t t h d t i ti t Par

ty mus

t

have proce

dure 

to investiga

te n

compliance allegations from any source.

• 3rd

-Party must have appeals procedure to reso

Party must have appeals procedure to reso

issues arising from its compliance or non-compdeterminations.

• Must have procedure to protect client’s confiden

proprietary information. Insulates manufacturerand IP from FOIA abuse and IP from FOIA abuse. 
Certification Marks

• These are the Third-Party’s identifying symbo

registered as registered as “Certification Marks Certification Marks” with the US with the US

patent office under “The Lanham Act”.

• Third-Party must enforce control of the mark a

Party must enforce control of the mark a

allow its application only to products produced compliance with the certification program rule
IT WORKS!

• Third-Party Certification is the dominant process that ass

safety, performance and fitness for purpose of products amaterials on a global basis.

• Virtually all building materials and many consumer produc

3rd-party certified for:

– Fire safety– Electrical safety– Structural performance– Energy Efficiency

• A h di t F d l R l ti h b i d Areas where direct Federal Regulation has been required 

increasingly moving to third-party certification.

– Food and Drug Safety– CPSC Consumer Products Safety Regulations CPSC Consumer Products Safety Regulations– FCC Electromagnetic Interference and Compatibility – EPA/DOE EnergyStar– EPA WaterSense
EnergyStar Program Added ITPC for M

Categories
IT’S A GOOD FIT!

• Virtually all solid fuel appliances are required to be 

Virtually all solid fuel appliances are required to be 

party certified for compliance with safety standards under state and local regulations.

• Most of the work is already done - adding emission

efficiency performance certification, therefore, addminimal cost for manufacturers and consumers.

• Regulators have a very simple and reliable method 

verifying that products comply with specified limits. look for the label.
EPA Oversight

• Certification Bodies will promptly notify EPA when certific

are issued, withdrawn or modified and maintain publicly accessible on-line listings of certified products. 

• Certification Bodies will p gy rovide regulatory authorities with 

to any product certification documentation requested. 

• EPA to conduct periodic audits of CB’s performance.• CB s’ to provide EPA with audit reports issued by accredit

to provide EPA with audit reports issued by accredit

bodies.

• EPA can ask for investigation of any suspected non-comp

issues CB issues. CB s’ are obligated to respond are obligated to respond.

• EPA can challenge accreditations issued to CB with accr

cases of suspected abuse or failure to comply with requir