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.

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:
  • Cost of nonconformance or penalty to manufacturers, including legal liability,
  • Cost of the conformity assessment process and the financial burden on manufacturers, especially with respect to the production volume,
  • Length of the conformity assessment process and its impact on the introduction of innovative technologies, and
  • Duration of validity of certification and the cost and time associated 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, manufacturing, 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 performance 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, especially if the degree of competition is low, opportunities for substitution 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 conformity assessment process is long and arduous, it may delay the introduction 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 behavior 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 other resources) required for entering the market are significant, manufacturers 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 specifications, the conformity assessment process will be easier to implement. The costs and time associated with periodic recertification are also important to the manufacturer. 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. 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 compromise 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.

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 adequate. Therefore, for PPT products for low-risk use, the role of federal agencies in the conformity assessment process would be to specify the standards to which the product must conform and require first-party declaration 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 Protective 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 certified 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 standards, periodic (unannounced) inspection of production facilities, evaluation of quality control techniques and standards in the manufacturing plants, product audits, post-marketing evaluations and surveillance, and 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, additional 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 certified 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 protective clothing may have only one tier or class of risk. Thus, the committee 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 assessment for that PPT product. Given the complexity and time required to develop such a detailed classification scheme, the committee did not engage 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 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. 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.