Most personal protective equipment (PPE) in the United States is tested and evaluated by the supplier to requirements of voluntary product standards, and the supplier attests to the product’s conformance to the standard by marking or labeling. Federal regulations require that employers provide PPE that meets minimum performance requirements, but in most cases do not specify any type of conformity assessment. Previously, only respiratory protection was subject to a conformity assessment through NIOSH. All that is about to change.
ANSI/ISEA 125-2014, American National Standard for Conformity Assessment of Safety and Personal Protective Equipment, is designed to provide a standardized conformity assessment system that can be used by suppliers, specifiers, users and regulators. As a stand-alone document, it can be applied as a uniform reference across a range of product categories.
“Right now, there is an assumption of conformity for all PPE except for respirators,” said an ANSI/ISEA 125-2014 consensus panel member. “That is to say, if you purchase a $1.50 pair of ‘ANSI Z87’ safety glasses made in China, will they be as protective as a $20 pair made in the USA? Maybe/maybe not.”
According to the foreword of the final standard, obtained exclusively by EHS Today, it is intended as a resource that can be referenced by end-user purchasers of products, who may include compliance to this standard as a requirement of a purchase contract with a supplier; by regulatory authorities having jurisdiction over workplace safety and health, or by product standard development committees to define their conformity assessment requirements for a particular product performance standard.
“It is industry's gamble and ultimately their employee's safety could be relying on an unsubstantiated claim,” said the panel member, who is a global EHS senior manager for a Fortune 100 company. “By only purchasing PPE from manufactures that certify to ANSI/ISEA 125-2014 (especially Level 3), employers can be assured that statements of conformity to PPE standards are validated claims. This translates to due diligence by industry and a lower risk portfolio for employees.”
What Is Conformity Assessment?
Conformity assessment is defined as the demonstration that specified requirements relating to a product, process, system, person or body are fulfilled. For safety and personal protective equipment (PPE), the specified requirements are found in product standards, along with test methods, sampling procedures and labeling and marking requirements. Conformity assessment includes testing, evaluation of test data to determine conformity, declaration of conformity and accreditation of laboratories, certification bodies and quality management systems.
In the United States, there are multiple approaches to PPE conformity assessment. Respiratory protection PPE is subject to federal regulations requiring government testing and certification. Some product standards include specific conformity assessment requirements, including in some cases independent third-party certification.
As part of their benchmark research, the developers of the standard studied conformity assessment models in use around the world. These models include comprehensive national requirements for standards, testing and certification; the multinational European system based on product performance requirements established in legislation; and the decentralized system in the United States.
Three Levels of Conformity Assessment
ANSI/ISEA 125-2014 provides three levels of conformity assessment. For each level, there are requirements for initial and ongoing testing, quality management, corrective and preventive action, recordkeeping and declaration of conformity. Where standards are specified for these processes, accreditation requirements are included. The standard provides the option to select a method of conformity assessment that provides a suitable level of assurance of conformity for any product or application.
“It is beyond the scope of this standard to prescribe the appropriate level of conformity assessment for any product category, hazard or work environment.,” the foreword notes. “This is a decision that is made by the end-use purchaser who references standards, by a regulatory agency with authority over the use of PPE or by the product standards committee whose members are closest to the product category and the product’s application.”
Guidance for selecting the appropriate level of conformity is included in an appendix.
Assigning PPE to a Category
Three categories of PPE are described as a framework within which a conformity assessment level for a given type of PPE can be assigned. The categories are, roughly, “low,” “medium” and “high” with respect to the level of rigor that is required to demonstrate conformance. Establishing a PPE category is based on the following general assumptions:
- Risks and hazards are contemplated based on reasonably expected outcomes, not imaginable best- or worst-case scenarios.
- The seriousness of an injury is evaluated on an objective basis and includes consideration of where the injury fits in the entire spectrum of workplace injuries. Any injury, regardless of severity, inherently is considered more serious or grave to the person injured. However, highly individualized and subjective outlooks regarding potential injury or illness should be avoided in establishing a PPE category.
- The user is wearing and using the PPE properly. Scenarios related to user misuse such as wearing spectacles down on the nose or tying high-visibility apparel around the waist, should not be considered.
- The PPE was properly selected for the hazard and is appropriate for the reasonably expected outcomes and events within the environment.
- The PPE is maintained and inspected according to the manufacturer’s instructions.
- The PPE-related “cause” of an injury is limited solely to incidents in which: the PPE does not perform as specified because of a nonconformance in the PPE that is not detectable to the user; or the magnitude of the hazard or event does not exceed the performance ability of the PPE per the performance standard.
Visit EHSToday.com tomorrow for an in-depth interview with ISEA President Dan Shipp and Cristine Z. Fargo, director, Member and Technical Services, ISEA, who will provide insights about the development of ANSI/ISEA 125-2014.