Standards Enable… Product and
This is the first in a series of articles showing how several aspects of global trade — from conformity assessment to technology transfer — are enabled by voluntary consensus standards.
In the summer of 2008, the U.S. Congress passed into law new, tighter requirements for lead that can be found in children’s toys and other products, from backpacks to game pieces. If the lead level of a product exceeds 300 parts per million it does not meet the new limit.
But who is to determine the lead level, and how can one ensure that such a determination is trustworthy? In this specific case, a third party laboratory is to provide certification that the product conforms to the law. This sort of verification often uses standards developed by voluntary consensus standards developers such as ASTM International.
A Critical Link
Having standards is one thing, ensuring that products conform to such standards is quite another, and that is a critical link in the overall conduct of global business and commerce. Welcome to the frontier of conformity assessment.
Industry standards set the bar for buyers and end-users in government and industry as well as producers and suppliers with regard to safety, performance, interoperability and other characteristics. Likewise, conformity assessment denotes a measure of compliance by products, services, processes and personnel. (Click here for a statement about the principles of conformity assessment.)
For a more formal explanation of conformity assessment, the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) Guide 2:1996, Standardization and Related Activities — General Vocabulary, describes conformity assessment as “any activity concerned with determining directly or indirectly that relevant requirements are fulfilled.” In a pact entitled “The Agreement on Mutual Recognition in Relation to Conformity Assessment,” signed in 2000, the World Trade Organization agreed to govern conformity assessment.
Why Conformity Assessment?
Conformity assessment is a means of establishing confidence in compliance mandated for a specific product or service. This confidence influences the overall trust and reliability with which business is conducted in global trade. Product integrity as well as the quality of services relies on conformity assessment to ensure standards are met.
Processes, services and products are governed by standards, and such standards are at the core of conformity assessment.
“Standards are the backbone of conformity assessment,” says Joan Sterling, director of government relations for Intertek, a leading provider of auditing, inspection, testing, quality assurance and certification for global industry. “Conformity assessment programs may choose standards that result in certified products that satisfy a particular group or organization, such as a regulator or the buyer of a product.”
According to Sterling, the strength of the testing rests heavily on the strength of the underlying standard that governs the testing. “The standards chosen for use in conformity assessment should specify accurate and reproducible methods of testing for the specified characteristics to ensure validity,” she says. “The standards should also be clearly written and be capable of being uniformly interpreted.”
Having a uniform standard recognized by many fosters reliable conformity assessment and ultimately helps facilitate global trade with a more even playing field. “Manufacturers can build to a uniform standard and have that product accepted in many markets,” says Sterling. “The IECEE CB Scheme [IEC Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components] is one way that manufacturers can take advantage of these types of standards. Participating national certification bodies recognize and accept test results from each other resulting in a reduction of duplicative testing requirements for manufacturers. This helps streamline their compliance requirements and facilitates faster market access for their products.”
“As a participant in the IECEE’s Committee of Testing Laboratories, Intertek is obligated to participate in the CTL’s proficiency testing programs along with all the other CB testing laboratories,” says Bill Fiske Jr., director of engineering for Intertek. “This activity contributes substantially toward ensuring that all CB testing laboratories test the same things the same way and achieve statistically close to identical results. Not only are the aggregated results of the PT shared among all the labs, but each laboratory having outlying results is obligated to conduct root-cause analysis, take corrective action and repeat the test, and finally, there is a proficiency testing workshop preceding each CTL meeting, where the more common problems faced by laboratories are analyzed by the group. Not only has this activity raised the bar, so to speak, of laboratory quality around the world, but also on at least one occasion, the worldwide results of PT were so inconsistent that the CTL sent a proposal to change the product standard to the relevant IEC technical committee, with the aim of making the test more repeatable.”
A discussion of why conformity assessment is necessary must not overlook the all-important issue of safety. Safety of life and health is a critical condition that conformity assessment helps ensure.
This point is elucidated by Robert Waller Jr., president of the Juvenile Products Manufacturers Association in Mt. Laurel, N.J. “JPMA has sponsored a certification program using ASTM standards as the basis of the program for over 35 years,” explains Waller. “An independent third party test lab verifies that products meet the standards before a manufacturer is allowed to place the JPMA seal on their product/packaging. Currently, over 2,000 products are certified. The JPMA certification seal, which provides a reference to the applicable ASTM standard, provides consumers with added assurance that the product was designed and manufactured with safety in mind, and that it meets all voluntary and mandatory performance standards.”
The process highlights the importance of confidence in compliance. All commercial standards that specify limits, tolerances and allowances carry little weight if there is not a way of ensuring such compliance and communicating that compliance to the end party who will buy the product or service. “Most consumers purchase products with the assumption that the product meets all applicable standards,” Waller says. “The JPMA program provides consumers an identifiable seal at the time of purchase that the manufacturer has taken the additional step and had the product independently tested to a third party standard such as ASTM.”
There are numerous parties in global trade. Stakeholders in the supply chain include suppliers, consultants, manufacturers, distributors, end-users, governments and other entities. All affect conformity assessment and all are affected by it as well.
If a third party is to bear the responsibility of testing products in a laboratory, the ultimate compliance and confidence of the product resides in the proficiency of that particular laboratory. The tester also must be evaluated.
This has paved the way for a subtopic in most any discussion on conformity assessment: proficiency testing.
Paul Graboff, a retired lab director and American Association for Laboratory Accreditation auditor who is a member of ASTM International Committee D20 on Plastics, among others, says that proficiency testing is a requirement for a laboratory to receive accreditation.
“Proficiency testing shows a laboratory how its results compare with many other laboratories,” explains Graboff. “If used properly, a laboratory can improve the repeatability and reproducibility of its test results and reduce testing error.”
Test error reduction can be improved upon by ensuring that tests conform to specific standards. “For analytical testing, traceable standards are usually available,” Graboff says. “These labs are required to use these standards to demonstrate that their test results are correct. However, for mechanical testing such as the determination of the strength of plastics, plastics standards are not available.”
Leo Titus is president of ECS Mid-Atlantic LLC, a consulting engineering firm providing geotechnical engineering, environmental consulting and construction testing and inspection services in Chantilly, Va. He cites a case where attention to proficiency in the context of other laboratories helped uncover some weak test results for some of their services.
“We engage in proficiency testing in our laboratories,” says Titus. “On one occasion we received a poor rating on concrete testing. When we investigated the reason, we discovered that our primary lab technician was on vacation the week the samples were tested. We identified weaknesses in our training system, which resulted in inconsistent test procedures in the lab which were then corrected.”
“Conformity assessment is an essential part of our business,” adds Titus. “Certification of individuals and accreditation of facilities engaged in our business demonstrates to the users of our services that we have met minimum standards set by the industry. The greatest challenge in our industry is the various levels of enforcement of these standards by the jurisdictions across the country. Many areas of the country ignore certification and accreditation while others have strict enforcement. Those areas that have strict enforcement of standards realize a much more consistent and better quality end result.”
Jim Romeo is a freelance writer based in Chesapeake, Va. He is a mechanical engineer by education and background and holds a B.S. in mechanical engineering and an M.B.A. He writes about technology and its business applications.