sDoC

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sDoC A Presentation to OSHA By ACIL June 12, 2002
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Enhancing Public Health and Safety Through
Quality Testing and Engineering
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What is ACIL?

• The national trade association representing
  independent, commercial engineering and
  scientific laboratory, testing, consulting,
  product certifying, and RD firms manufacturers
  laboratories and consultants and suppliers to
  the industry.

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ACILs Mission

• To enhance our members success by
• Providing advocacy, education, service and
  mutual support and by
• Promoting quality, ethics, objectivity and free
  enterprise

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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

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ACIL Sections

• Environmental Sciences
• Conformity Assessment
• Civil Engineering
• Microbiology Analytical Chemistry

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National Accreditation

• Labs within ACILs Conformity Assessment Section
  are accredited to ISO/IEC 17025, General
  Requirements for the Competence of Testing and
  Calibration Laboratories.

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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

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What is the Role of Third Party Certification?

• To serve all stakeholders at interested in
  conformity assessment activities regulators,
  manufacturers, and consumers.

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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)

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OSHAs 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 1910.303(b).
• IT and telecommunications equipment are subject
  to the requirements of Subpart S. 29 CFR
  1910.302(a). Electrical Utilization Systems

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OSHAs 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 1910.399)

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OSHAs 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 1910.399
• Therefore, approved means acceptable and
  equipment is acceptable if it meets the
  requirements of 29 CFR 1910.399.

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Nine 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.

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Number 1 - The Basic Procedure

• All product testing and evaluation is performed
  in-house by the NRTL that will certify the
  product.

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Number 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.

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Number 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.

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Number 4

• Acceptance of witnessed testing data
• This option allows an NRTL to accept a
  manufacturers test data by witnessing the
  testing at the manufacturers facility.

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Number 5

• Acceptance of testing data from non-independent
  organizations.
• This option allows an NRTL to accept a
  manufacturers test data with no witnessing to
  additional testing.

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Number 6

• Acceptance of evaluation data from
  non-independent organizations
• This option allows an NRTL to accept a
  manufacturers product evaluation, but it
  requires an NRTL review prior to marketing.

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Number 7

• Acceptance of continuing certification following
  minor product modifications by the client
• This option allows the manufacturer to continue
  to apply the NRTLs certification mark even
  though there are minor product modifications.
  Additional site visits or testing are not
  required.

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Number 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 others product evaluations worldwide
  for a large variety of products thereby reducing
  testing and certification.

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Number 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.

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ACIL Position on Suppliers Declaration of
Conformity (SDOC)
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Conditions for Considering SDOC

• sufficient historical data exists
• an operating, effective post-market surveillance
  system is in place

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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

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Post-Market Surveillance

• customer complaints
• marketplace surveillance and testing
• factory surveillance and testing
• regular independent audits of manufacturers
  declarations of conformity
• penalties for noncompliance
• designed by all stakeholders and flexible

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The Role of Laboratory Accreditation in SDOC

• mandatory
• provides confidence in data produced
• accreditation requirement could only provide
  equivalence with third party laboratorys testing
  capabilities but not their independence

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

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

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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
  manufacturers facilities, ensures compliance

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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

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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

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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

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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.

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In summary, the value of Third Party
Certification results from

• Independence
• Cost Effectiveness
• Safety and Reliability
• Confidence
• Superior Manufacturing
• Liability Protection

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ITIC Proposal to OSHA

• Based on three fundamental tenets
• (1) IT industrys safety track record
• (2) time to market
• (3) redundant worldwide testing requirements

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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

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IT Industrys Safety Track Record

• There is currently no industry data on the IT
  industrys 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

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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

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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)

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IT Product Violations as De Minimus
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Custom Made Equipment

• ITIC contends the SDOC is already available to
  manufacturers of custom-made equipment, citing,
  in part, Section 1910.399(iii).
• The full citation, however, requires inspection
  by the Assistant Secretary and his authorized
  representative. His authorized representative is
  an NRTL.

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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 1901.7
• Hazard Communication is not a product
• None of products are electrical

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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