NTEP Conformity Assessment Program. Jim Truex NTEP Administrator

Transcription

1 NTEP Conformity Assessment Program Jim Truex NTEP Administrator July 13, 2010

2 The Standards Consumer Advisory Regulatory Industry NIST 2

3 Streamlining Type Evaluation Up to 17 Evaluations 17 Certificates 1975 NIST Report of Test 1 Evaluation 1 Certificate 1965 State and Local Prototype Testing 1 or More Evaluations 18 Certificates 1985 Birth of NTEP 3

4 Recognizing NTEP North Dakota Vermont Rhode Island Texas NTEP Certificate Required (46 States, DC) US Virgin Islands No NTEP Certificate Required (4 States, US Virgin Islands) 4

5 New Scales Code U.S. Free Trade Agreements required NCWM to harmonize where practical (OIML R 60 & R76) International Class Structure Step Tolerances Influence Factor Requirements 5

6 Connecting the World Canada NCWM OIML 6

7 Does the Golden Egg Exist? A lingering question for 25 years At stake Fair competition (a level playing field) Assurance for end users The very reasons we have NTEP The integrity of NTEP 7

8 A Change of Guard NIST (NBS) managed NTEP for 15 years NIST counsel advised NCWM in 1999 that they could not withdraw certificates NCWM agreed to administer NTEP starting in 2000 NCWM now positioned to also administer a Conformity Assessment Program Not as a regulatory program As an ethical obligation to stakeholders 8

9 Production Meets Type Two tools have always existed Initial Verification Certificate Review Neither addresses verification of T.N.8. requirements Temperature effects Power Supply 9

10 Conformity Assessment Program Administrative Certificate Review Initial Verification Verified Conformity Assessment Program (VCAP) Conformity Assessment 10

11 Devices with an NTEP CC Starts with the NTEP Certificate Holder Responsible for tracking changes to NIST Handbook 44 Responsible for notifying NTEP of metrological changes Responsible for re-submitting certified devices to NTEP when necessary 11

12 Initial Verification Depend on expertise of inspectors Centralized reporting system is under development Proposed user interface on website for reporting Proposed import of data from state database Centralized database at NCWM Methodology for evaluating the data and addressing concerns 12

13 Administrative Certificate Review Under the Conformity Assessment Program, Certificate holders review their certificates and verify accuracy of information Not fully implemented at this time Issues are forwarded to NTEP from: The NTEP certificate holder Inspectors Service agents The competition 13

14 VCAP Manufacturer responsibilities under VCAP Sampling Testing Correcting Auditing Pilot for load cells is underway Intended for all weighing devices subject to influence factor testing in NTEP 14

15 The Auditor's Responsibilities Accredited by ANSI-ASQ National Accreditation Board for management systems Shall have international auditors available Required to notify NCWM when major breakdown is found in CC holder's VCAP program Required to submit completed "Systems Audit Checklist" to NCWM with clear statement of compliance as a result of the audit 15

16 The VCAP Checklist These are "Systems Audit" checklists Two checklists are in place and readily available to auditors Checklist for Manufacturers Checklist for Private Label Certificate Holders Copies are provided for your reference and are available for download from 16

17 Manufacturer Checklist Verify Documented quality system Testing facilities and procedures Sampling Records of testing and corrective actions Witness testing Adequate control over subcontractors and suppliers Is corrective or preventive action required? Statement of auditors findings 17

18 Private Label Checklist Verify Certificate is traceable to an action parent certificate Records of VCAP compliance by the supplier No other suppliers are being used Supplier's records agreement with certificate holder's purchase records Plan for reporting non-compliance to the supplier and to address noncompliant devices already in stock Is corrective or preventive action required? Statement of auditors findings 18

19 FAQ's Available on NCWM website: Supporting document has been developed Assist auditors 19

20 VCAP Timeline for Load Cells Process Manufacturer Timeline Private Label Timeline Refine VCAP and communicate Ongoing Ongoing NCWM receives Audit Report January June 2010 January November 2010 NTEP receives Audit Report January September 2010 June 2010 March 2011 Notify non-compliant CC holders prior to maintenance fee due date July 2010 May 2011 December 2010 May 2011 Declare non-compliant CCs inactive May 2011 November

21 The Cost Dependent on: The auditor Location (travel expenses) Issues encountered during the audit Of audits already completed, it has been a range of $ 5000 $ 8000, driven largely by travel costs Initially, this is a recurring cost once every three years Subsequent audits may be less costly 21

22 Consequences of VCAP Inactive Status for failure to submit audit report verifying VCAP compliance by the required date Devices manufactured after that date are not considered traceable to a certificate of conformance Withdrawn Status is when production devices do not meet type Devices manufactured after that date are not considered traceable to a certificate of conformance Devices already in service or in the distribution process are subject to state enforcement activity 22

23 Is VCAP Necessary? NTEP is supposed to provide a level playing field and protect the end user The Conformity Assessment Program answers the call VCAP seems to be the most reasonable method of verifying T.N.8. in ongoing production VCAP verifies what should already be occurring in the manufacturing process 23

24 Recap of Conformity Assessment Initial Verification Administrative Certificate Review VCAP 24

25 VCAP Responsibilities Manufacturer Private Label Private Label Timeline Sample Test Traceable to active parent CC Purchase and sales records Review audit Communicate Corrective Action Plan of action Take action Audit Audit 25

26 Questions FAQ's at Direct future questions to: Jim Truex NTEP Administrator

27 Thank You