sDoC A Presentation to OSHAByACIL June 12, 2002 Enhancing Public Health and Safety Through Quality Testing and Engineering.

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Presentation transcript:

sDoC A Presentation to OSHAByACIL June 12, 2002

Enhancing Public Health and Safety Through Quality Testing and Engineering

What is ACIL? The national trade association representing: independent, commercial engineering and scientific laboratory, testing, consulting, product certifying, and R&D firms; manufacturers’ laboratories; and consultants and suppliers to the industry.

ACIL’s Mission To enhance our members’ success by: Providing advocacy, education, service and mutual support; and by Promoting quality, ethics, objectivity and free enterprise

ACIL Membership ACIL represents over 350 member organizations: – ACIL member companies operate over 1,500 facilities across the U.S. and abroad, including Canada, Mexico, Japan, Europe and Russia – They range from the one-person specialty laboratory to multi-disciplined, international corporations employing thousands

ACIL Sections Environmental Sciences Conformity Assessment Civil Engineering Microbiology & Analytical Chemistry

National Accreditation Labs within ACIL’s Conformity Assessment Section are accredited to ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories.

National Accreditation Depending on the products to be tested, a lab may seek further accreditation, such as to ISO/IEC Guide 65, General Requirements for Bodies Operating Product Certification Systems

What is the Role of Third Party Certification? To serve all stakeholders at interested in conformity assessment activities: regulators, manufacturers, and consumers.

NRTLs (Nationally Recognized Testing Laboratories) Applied Research Laboratories, Inc. (ARL) Canadian Standards Association (CSA) Communication Certification Laboratory, Inc. (CCL) Curtis-Straus LLC (CSL) Detroit Testing Laboratory, Inc. (DTL) Electro-Test, Inc. (ETI) Entela, Inc. (ENT) Factory Mutual Research Corporation (FMRC) Intertek Testing Services NA, Inc. (ITSNA) MET Laboratories, Inc. (MET) National Technical Systems, Inc. (NTS) NSF International (NSF) SGS U.S. Testing Company, Inc. (SGSUS) Southwest Research Institute (SWRI) TUV America, Inc. (TUVAM) TUV Product Services GmbH (TUVPSG) Underwriters Laboratories Inc. (UL) Wyle Laboratories, Inc. (WL)

OSHA’s NRTL Program Current OSHA regulations (29 CFR 1910 Subpart S) require that electrical equipment must be free from recognized hazards that are likely to cause death or serious physical harm to employees. 29 CFR (b). IT and telecommunications equipment are subject to the requirements of Subpart S. 29 CFR (a). Electrical Utilization Systems

OSHA’s NRTL Program All installation or equipment is acceptable to the Assistant Secretary of Labor, and approved within the meaning of Subpart S: – (i) if it is accepted, certified, or listed, or labeled or otherwise determined to be safe by a nationally recognized testing laboratory; or – (ii) requirements where no NRTL operates … – (iii) requirements for custom made equipment … (29 CFR )

OSHA’s NRTL Program “Approved” is defined as “acceptable to the authority enforcing this Subpart.” The authority approving this Subpart is the Assistant Secretary of Labor for Occupational Safety and Health. The definition of acceptable indicates what is “acceptable” to the Assistant Secretary of Labor, and therefore approved within the meaning of this Subpart. 29 CFR Therefore, “approved” means “acceptable” and equipment is “acceptable” if it meets the requirements of 29 CFR

Nine Options Under OSHA NRTL ProgramNine Options Under OSHA NRTL Program There are currently nine programs available to manufacturers under the NRTL program for the acceptance of test data and product evaluations.

Number 1 - The Basic ProcedureNumber 1 - The Basic Procedure All product testing and evaluation is performed in- house by the NRTL that will certify the product.

Number 2Number 2 Acceptance of testing data from independent organizations, other than NRTLs. – This option allows an NRTL to accept test data from other independent, third party laboratories utilized by a manufacturer.

Number 3Number 3 Acceptance of product evaluations from independent organizations, other than NRTLs – This option allows an NRTL to accept product evaluations from third party product certification organizations that are not NRTLs.

Number 4Number 4 Acceptance of witnessed testing data – This option allows an NRTL to accept a manufacturer’s test data by witnessing the testing at the manufacturer’s facility.

Number 5Number 5 Acceptance of testing data from non-independent organizations. – This option allows an NRTL to accept a manufacturer’s test data with no witnessing to additional testing.

Number 6Number 6 Acceptance of evaluation data from non- independent organizations – This option allows an NRTL to accept a manufacturer’s product evaluation, but it requires an NRTL review prior to marketing.

Number 7Number 7 Acceptance of continuing certification following minor product modifications by the client – This option allows the manufacturer to continue to apply the NRTL’s certification mark even though there are minor product modifications. Additional site visits or testing are not required.

Number 8Number 8 Acceptance of product evaluations from organizations that function as part of the International Electrotechnical Commission Certification Body (IEC-CB) Scheme – This scheme, which is operated exclusively in the private sector, allows certification bodies to accept each other’s product evaluations worldwide for a large variety of products thereby reducing testing and certification.

Number 9Number 9 Acceptance of services other than testing or evaluation performed by subcontractors or agents. – This option allows the NRTL to accept any other services related to product compliance by subcontractors or agents.

ACIL Position on Supplier’s Declaration of Conformity (SDOC)

Conditions for Considering SDOC sufficient historical data exists an operating, effective post-market surveillance system is in place

Data Conditions manufacturer understanding of technical, regulatory and market requirements product safety, health and environmental concerns have been satisfied confidence needs of acceptance interests have been satisfied data sources

Post-Market Surveillance customer complaints marketplace surveillance and testing factory surveillance and testing regular independent audits of manufacturer’s declarations of conformity penalties for noncompliance designed by all stakeholders and flexible

The Role of Laboratory Accreditation in SDOC mandatory provides confidence in data produced accreditation requirement could only provide equivalence with third party laboratory’s testing capabilities but not their independence

Third Party Certification Provides the Greatest Value of All Forms of Conformity Assessment Procedures

Third Party Certification Is independent Is cost effective Results in safer and more reliable products Has immediate acceptance in the marketplace Instills consumer confidence Distinguishes manufacturers making compliant products Can aid in defense of a product liability action

Independence Provides an objective review of product safety and performance free from marketplace demands and company pressures

Cost Effective Independent laboratories have specialized testing equipment and competent staff Independent laboratories have the experience in performing evaluations Competition among certifiers increases effectiveness and efficiency Many government agencies rely on effective private sector certification programs to support their regulatory needs

Safer and More Reliable Products Manufacturers generally use design engineers, rather than safety engineers, in designing their products Third party testing, following an audit of manufacturer’s facilities, ensures compliance

Immediate Acceptance in the Workplace Employers, workers and distributors recognize and have confidence in the third party certification market as an assurance of safety and performance

User Confidence Post-market surveillance and verification provide assurance of continued compliance A complaint handling system ensures that unsafe products are identified and quickly removed from the marketplace

Distinguishes Compliant Products Manufacturers that make products that comply with specified requirements are easily distinguished from those that do not Without third party certification, an employer or worker cannot know what components have been used to make the product

Product Liability Defense Third party certification is a standard the courts use in determining liability in the event of product failure. It demonstrates that the manufacturer used the highest degree of care available to ensure safe and effective products are used.

In summary, the value of Third Party Certification results from: Independence Cost Effectiveness Safety and Reliability Confidence Superior Manufacturing Liability Protection

ITIC Proposal to OSHA Based on three fundamental tenets: (1)IT industry’s safety track record (2)time to market (3)redundant worldwide testing requirements

ITIC Proposal Urges OSHA to make a finding of the IT product violations are de minimus to create an “option” for SDOC as one of mechanisms whereby the Assistant Secretary Labor “approves” equipment to follow the same regulatory procedures used in other product areas to determine what is “approved” or “accepted” by the Assistant Secretary of Labor in creating this option

IT Industry’s Safety Track Record There is currently no industry data on the IT industry’s track record All data cited by ITIC is third party generated To move to an SDOC system data would have to be developed over time and meet the requirements of the ACIL Position Statement on SDOC related to data requirements

Time to Market Issues Time to market becomes a concern when a product that does not comply is submitted to an NRTL Compliant products are generally tested and certified in less time than a manufacturer can do it ACIL Product Failure Survey is being performed to demonstrate that a majority of IT products to do not comply when they are first submitted to an NRTL

Redundant Worldwide Testing Requirements There is only one testing requirement worldwide, and that is by a third party Under the current NRTL program, Option Numbers 4-9 allow a manufacturer to test and validate a product once The IECEE (CB Scheme), of which IT equipment is a part, allows certifications to be accepted worldwide by participating National Certification Bodies (NCBs)

IT Product Violations as “De Minimus”

Custom Made Equipment ITIC contends the SDOC is already available to manufacturers of “custom-made” equipment, citing, in part, Section (iii).’ The full citation, however, requires inspection by the Assistant Secretary and his authorized representative. His authorized representative is an NRTL.

SDOC for Other Workplace Equipment Products categories such as body protection, safety belts and lanyards, et al (listed in ITIC Attachment) are not covered by Hazard Communication is not a product None of products are electrical

The SDOC “Option” for Approval The regulations are quite clear that “approved” means acceptable to the Assistant Secretary when it is accepted, certified, listed or labeled or otherwise determined to be safe by a nationally recognized testing laboratory For OSHA to create this “option” – the safety of the products would have to be proven, and – a marketplace surveillance system implemented The only regulatory proceeding available to create this “option” is a Notice of Proposed Rulemaking