Certifying Personal Protective Technologies Improving Worker Safety (2011) / Chapter Skim
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5 Conformity Assessment for Non-Respirator PPT: A Risk-Based Framework
5 Conformity Assessment for Non-Respirator PPT: A Risk-Based Framework
Pages 105-114
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From page 105... ...
This chapter begins by establishing guiding principles that the committee believes are critical to determining the role of government in conformity assessment processes. The chapter then details the committee's proposed tiered approach to conformity assessment that is based on a systems engineering approach 1 to risk assessment.
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From page 106... ...
Risk-Based Approach The degree of potential risk to the user from the failure of a product during use in a specific task should determine the rigor of the conformity assessment process, whether the process calls for first-, second-, or thirdparty declaration of conformity. The potential risk is a function of the probability of product failure and the impact on user health and safety due to the failure, assuming proper use of the product.
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From page 107... ...
A cost is associated with the conformity assessment process. If the cost is prohibitively high, especially if the production volumes are low, the cost may deter manufacturers from seeking conformity assessment or they might attempt to pass on the increased cost to the customer, especially if the degree of competition is low, opportunities for substitution
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From page 108... ...
The PPT industry and marketplace are becoming increasingly global, which means production processes are distributed around the world as manufacturers attempt to respond to user needs and also reduce production costs. Consequently, strict process and quality control systems are needed in manufacturing, thus requiring a rigorous conformity assessment process.
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From page 109... ...
In looking at the potential conformity assessment approaches, federal agencies could play several roles, ranging from no intervention to complete oversight of the conformity assessment process. Other potential roles include laboratory accreditation, involvement in the standards-setting process, development and assessment of potential test methods, post-marketing testing and evaluation, health surveillance, enforcing penalties or providing incentives, and serving as an information clearinghouse.
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From page 110... ...
a Risk is based on the potential for illness and injury that would result from failure of the PPT product. b Listing could provide links to lists of certified products from third-party private-sector and government certifying organizations and agencies.
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From page 111... ...
PPT with Medium Degree of Potential Risk For products that present a medium risk of injury, illness, or death to the user in the event of product failure, third-party testing and declaration of conformity assessment would be required. The role of federal agencies in the conformity assessment process would be to do the following: • Specify the required standards; and • Require third-party testing and certification by accredited entities.
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From page 112... ...
The committee recognizes that many conformity assessment processes already in place can fit into this framework. What will be important will be to make decisions that provide workers across all occupations who face risks of similar severity to be able to use protective equipment that is adequately tested and, where necessary, that there is third-party confirmation that the product is safe and effective for use.
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From page 113... ...
2010. United States Coast Guard Approved Equip ment Listing (http://cgmix.uscg.mil/equipment/equipmentsearch.aspx (ac cessed July 20, 2010)
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