5
Conformity Assessment for Non-Respirator PPT: A Risk-Based Framework

Given the wide range of current approaches used to conduct conformity assessment that are described in part in Chapters 2 and 3, the committee saw the need for a structured framework to evaluate personal protective technologies (PPT) products protecting against comparable risks. 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 approach1 to risk assessment. The necessary starting premise for PPT conformity assessment is that well-defined and adequate design specifications and performance standards with pass–fail criteria are in place for these products; the committee recognizes that further work on product standards is needed in some cases.

GUIDING PRINCIPLES FOR CONFORMITY ASSESSMENT

In discussions on conformity assessment issues, the committee realized that several overarching principles were guiding its considerations. To determine the optimal approach for conformity assessment and then

1

Systems engineering is an interdisciplinary approach to product development across the cycle from conceptualization to production to operation. The process begins with defining customer needs and required functionality early in the development cycle, documenting requirements, and then proceeding to design synthesis and system validation while considering the complete product cycle: operations, performance, manufacturing, testing, cost and schedule, training and support, and disposal (INCOSE, 2010).



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5 Conformity Assessment for Non-Respirator PPT: A Risk-Based Framework Given the wide range of current approaches used to conduct confor- mity assessment that are described in part in Chapters 2 and 3, the com- mittee saw the need for a structured framework to evaluate personal protective technologies (PPT) products protecting against comparable risks. 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 commit- tee’s proposed tiered approach to conformity assessment that is based on a systems engineering approach 1 to risk assessment. The necessary start- ing premise for PPT conformity assessment is that well-defined and ade- quate design specifications and performance standards with pass–fail criteria are in place for these products; the committee recognizes that further work on product standards is needed in some cases. GUIDING PRINCIPLES FOR CONFORMITY ASSESSMENT In discussions on conformity assessment issues, the committee rea- lized that several overarching principles were guiding its considerations. To determine the optimal approach for conformity assessment and then 1 Systems engineering is an interdisciplinary approach to product development across the cycle from conceptualization to production to operation. The process begins with defining customer needs and required functionality early in the development cycle, do- cumenting requirements, and then proceeding to design synthesis and system validation while considering the complete product cycle: operations, performance, manufacturing, testing, cost and schedule, training and support, and disposal (INCOSE, 2010). 105

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106 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES implement that approach, the committee deemed the following as under- lying principles to a conformity assessment framework: • Conformity assessment efforts for PPT should be focused on re- ducing or eliminating the risks of worker injury, illness, or death; therefore the framework should be risk based. • End users can provide realistic and practical input into the types of equipment needed to protect against job hazards and should be involved in developing and implementing conformity assessment processes. • Adequate standards for product performance, use, and testing need to be clearly specified and serve as a prerequisite to con- formity assessment. • The burden and cost of conformity assessment processes need to be considered. • A total life cycle approach is needed that includes postmarketing testing, evaluation, and surveillance, as well as an effective recall system. • The conformity assessment process should promote and not in- hibit product innovation. 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 third- party 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. For instance, if a bulletproof vest is penetrated by a projectile, the impact can be fatal for the user; therefore, the degree of potential risk due to failure is high. The probability of occurrence of failure will depend on the task in which the worker is engaged. Thus, the potential risk to the safety and health of the worker should be the key factor in determining the type of conformity assessment process that should be adopted; the greater the risk to the end user in the event of product failure, the greater should be the rigor of the conformity assessment process. This could be implemented for PPT used in medium and high-risk work environments through independent third- party testing and certifying processes.

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107 A RISK-BASED FRAMEWORK Pragmatic Factors In addition to this health and safety perspective, a set of factors should be considered from a pragmatic perspective in the selection of the type of conformity assessment process. The pragmatic factors include the following: • Complexity of the product—design, manufacturing, and use; • Cost—economic and time: o Cost of nonconformance or penalty to manufacturers, includ- ing legal liability, o Cost of the conformity assessment process and the financial burden on manufacturers, especially with respect to the pro- duction volume, o Length of the conformity assessment process and its impact on the introduction of innovative technologies, and o Duration of validity of certification and the cost and time as- sociated with periodic recertification; • Degree of competition in the marketplace for the specific PPT and the barriers to entry for innovative products or new companies; • Availability of reliable test methods for effectively determining compliance; • Globalization of PPT production and deployment; • Follow-up and penalties on fraudulent products; and • Implications from a public health perspective. As the complexity of the product increases—in design, manufactur- ing, or use—the chances of error or nonconformity increase. Moreover, if the product is part of an ensemble, the opportunities for interface- related errors increase, and these could potentially compromise perfor- mance in the field. In such instances, the conformity assessment process becomes very important. If the cost of nonconformance is high for the manufacturer either because of severe penalties or loss of business, there may be a greater incentive for the manufacturer to ensure the conformity of the product. 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, espe- cially if the degree of competition is low, opportunities for substitution

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108 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES are minimal, or supply is limited, among many factors. Such increases in costs could potentially deter end-user organizations from procuring the necessary PPT due to budgetary constraints. If the duration of the con- formity assessment process is long and arduous, it may delay the intro- duction of newer technologies on an ongoing basis; in the extreme case, manufacturers may decide not to release newer technologies just to avoid the high conformity assessment costs. Of course, the manufacturer’s be- havior will be governed by the degree of competition in the field for that PPT. Absence of competition or low levels of competition may cause manufacturers to delay introduction of newer technologies to avoid the cost of the conformity assessment process. If the manufacturing capabilities (equipment, infrastructure, and oth- er resources) required for entering the market are significant, manufac- turers who could potentially engage in the production of inferior products may be deterred. If defects in products can readily be seen or recognized by the user prior to use, the conformity assessment process may not need to be highly rigorous. If standard test methods have been defined and are readily available for assessing the conformance of the product to specifi- cations, the conformity assessment process will be easier to implement. The costs and time associated with periodic recertification are also im- portant to the manufacturer. The PPT industry and marketplace are be- coming 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. Finally, the use of such a process can serve as a deterrent to the entry of low quality, ineffective, or counterfeit products in the marketplace that could potentially compro- mise the user’s safety and health. Thus, in selecting the level of conformity assessment process for PPT, a holistic view of the health and safety and pragmatic perspectives must be considered, with the ultimate objective of ensuring that the right PPT is used by the worker for the task at hand.

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109 A RISK-BASED FRAMEWORK A TIERED APPROACH TO PPT CONFORMITY ASSESSMENT The basis for the tiered framework for non-respirator PPT conformi- ty assessment is the level of potential risk to the user in the event of product failure (equivalent to the worker not using PPT for the task) and other pragmatic considerations such as the size of the population using the product; the economics of the conformity assessment process; and other factors discussed earlier. In looking at the potential conformity as- sessment 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, involve- ment in the standards-setting process, development and assessment of potential test methods, post-marketing testing and evaluation, health sur- veillance, enforcing penalties or providing incentives, and serving as an information clearinghouse. The committee considered other approaches currently in use that ap- ply risk categorization to conformity assessment for PPT and other de- vices. As described in earlier chapters, the European Union has a risk- based approach to PPT conformity assessment and the Food and Drug Administration (FDA) uses a broader risk-based categorization of medi- cal devices. While the framework developed by the committee is also risk-based, it does not attempt to duplicate or emulate those methodolo- gies. The committee’s analysis and consideration of a wide range of con- formity assessment approaches and issues detailed throughout this report have led to the proposed risk-based tiered categorization approach for PPT that is summarized in Table 5-1. Prior to implementing the confor- mity assessment approaches, it would be the government’s responsibility to specify the required standards that must be met for PPT products used in the workplace, which is in keeping with the current role of the Occu- pational Safety and Health Administration (OSHA) and other regulatory agencies. PPT with Low Degree of Potential Risk For products that present a low risk of injury, illness, or death to the user in the event of product failure, first-party testing and declaration of the product’s conformance to voluntary consensus standards would be

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110 TABLE 5-1 Risk-Based Framework for Non-Respirator Personal Protective Technologies (PPT) Conformity Assessment Conformity Assessment Responsibilities Degree of Conduct Provide Risk to the Post-Marketing Oversight to User’s Declaration of Testing, Listing of Institute the Conformity Safety and Product Accredit Product Evaluation, Recall Certified Tracking Assessment Healtha Productsb Testing Testing Labs Compliance Surveillance Products Label Process Low First party Voluntary First party Voluntary First party First party Medium Third party Third party Third party Third party Third party Federal Third party govt. agency High Third party Third party Third party Third party Third party Federal Third Federal govt. govt. party agency agency NOTE: The term third party is used to denote that the responsibility could be carried out by either private-sector organizations or federal government agencies that are independent of the product manufacturer. Govt. = government. 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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111 A RISK-BASED FRAMEWORK adequate. Therefore, for PPT products for low-risk use, the role of feder- al agencies in the conformity assessment process would be to specify the standards to which the product must conform and require first-party dec- laration by the manufacturer that the product meets the standards. 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. The committee recommends in Chapter 6 that the National Personal Pro- tective Technology Laboratory (NPPTL) develop and maintain an online resource (available through a website and/or other sources) that provides access to lists of all certified products in this category (and for high-risk use). Such a resource could help end users identify the correct product for the specific task and allow for easy identification of products that do not meet required standards. Links could be provided to listings of certi- fied products from third-party private-sector certifying organizations as well as to similar databases in other agencies such as the Coast Guard’s Maritime Information Exchange—Approved Equipment (USCG, 2010). Such a site would not only help end users select the correct PPT product, but it would also help spot problems and potentially prevent substandard products from reaching end users. PPT with High Degree of Potential Risk For products that present a high risk of illness, injury, or death to the user in the event of product failure, third-party testing and declaration of conformity assessment would be required. The conformity assessment process should include the specification of design and performance stan- dards, periodic (unannounced) inspection of production facilities, evalua- tion of quality control techniques and standards in the manufacturing plants, product audits, post-marketing evaluations and surveillance, and

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112 CERTIFYING PERSONAL PROTECTIVE TECHNOLOGIES enforcement. The role of federal agencies in the conformity assessment process for these products would be to do the following: • Specify the required standards; • Require third-party testing and certification by accredited entities; and • Provide oversight to any technical issue that may arise and assist the certifying organization in the enforcement of the conformity assessment process for non-respiratory PPT. For products with high degree of risk in the event of product failure, ad- ditional requirements would include the use of tracking labels that could lead to faster recall or compliance enforcement in the event of product failure. As in the case of products in the medium degree of risk category, NPPTL should provide a resource that provides access to lists of all certi- fied products in this class (as described above). The committee recognizes that the proposed tiered approach to risk classification must be considered on an individual product basis and also take into account the specific task in which the PPT will be used. For instance, the degree of risk to the user’s hearing loss when using hearing protection in an automobile repair facility may be comparatively lower than the risk to another worker using hearing protective equipment on the airport runway. So, hearing protection PPT may call for two or more risk tiers. On the other hand, firefighters are subjected to a high degree of risk due to product failure when engaged in firefighting and hence their pro- tective clothing may have only one tier or class of risk. Thus, the com- mittee emphasizes that it is important to carefully evaluate the specific PPT product in conjunction with its use in a specific task and accordingly assign it to the appropriate risk category. Finally, the host of pragmatic factors presented earlier should be weighed in along with the health and safety factors in determining the appropriate level of conformity assess- ment for that PPT product. Given the complexity and time required to develop such a detailed classification scheme, the committee did not en- gage in that task and proposes it as a recommendation in Chapter 6. The committee recognizes that many conformity assessment processes already in place can fit into this framework. What will be im- portant will be to make decisions that provide workers across all occupa- tions 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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113 A RISK-BASED FRAMEWORK Classifications of PPT should be revisited periodically as evidence and knowledge gained through health surveillance systems and analyses of the results of conformity assessment processes are accumulated over time. REFERENCES INCOSE (International Council on Systems Engineering). 2010. What is systems engineering? http://www.incose.org/practice/whatissystemseng.aspx (ac- cessed August 2, 2010). USCG (U.S. Coast Guard). 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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