Insight

Standards and Standards Qualification
A Case-In-Point

by Dirk Van Hoesen, John Randolph, Uri Gat

International trade requires high-quality standards and mechanisms that assure compliance with those standards. In this column, Gat, Van Hoesen, and Randolph describe the difficulty one national laboratory experienced in acquiring a suitable waste cleanup pump from an experienced Russian manufacturer—due to a lack of compliance with international accreditation and certification standards that are recognized and acceptable.

Introduction
Standards have many applications. To achieve and justify its goals, a standard must be developed and backed up by a process and an authority that are reputable, recognized, reliable, and responsible. Standards qualification refers to a source of a product (e.g., manufacturer) using, applying and, in applicable cases, qualifying and being certified as an appropriate and reliable applicator of a standard. Examples of qualification are cases of certification to the ASME Boiler and Pressure Vessel Code (B&PVC), or certification and registration to ISO 9000, Quality Assurance Model. This qualification provides the users of the product with assurance that the product is indeed what they expect it to be according to the standard specified, and that the product is suitable for the intended use. As a side benefit the certification to a standard provides some prima-facie liability indemnity.

The Pulsating Mixer Pump
The Oak Ridge National Laboratory (ORNL), as part of its site cleanup efforts, is removing radioactive liquid and sludge waste from underground tanks (gunite tanks). The waste dates back as far back as the Manhattan Project. The search for a suitable mixer pump to remobilize the waste identified a Pulsating Mixer Pump, manufactured by the Russian Federation Ministry of Atomic Energy (MinAtom) Mining and Chemical Combine (MCC), as particularly suitable. The mixer pump was deemed suitable because it fulfilled the technical specifications and was previously used in service of pumping radioactive liquids and wastes at Russian facilities. The mixer pump and the associated piping are subjected to a pressure of 1.6 MPa.

An additional, significant reason for selecting the particular mixer pump was its manufacturer. The manufacturer is a Russian plant that is engaged in the manufacture and processing of nuclear weapons-plutonium. It is U.S. policy to assist Russia in transitioning its weapons producing facilities and personnel from weapons and military production to civilian, economically viable production. As part of this effort it is deemed appropriate to support production and purchase of equipment from such weapons facilities that have nonmilitary applications. This is particularly so when the product can readily compete in worldwide markets and applications. The pulsating mixer pump fits all these prerequisites. Three pumps and associated support equipment are being purchased by the Department of Energy (DOE) through Fernald Energy Technology Center (FETC).

Quality Assurance
The mixer pump housing and its associated pipes constitute pressure boundaries. The pump mixes radioactive waste that must be thoroughly and reliably contained at all times. DOE and the operator of ORNL, under whose jurisdiction this entire operation falls, require that a U.S.-recognized and accepted quality assurance program be provided prior to manufacture, installation, and operation of the mixer pump.

Under common circumstances, equipment for such an application would comply with and be certified to a U.S. standard. An example for such assurance could be the ASME B&PVC, or ASME Standard B31.3 for Process Piping, which in turn invokes the B&PVC.

The Russian Manufacturer
The Russian manufacturer had been producing the pump, and other products, for quite some time. These products were fully acceptable to the Russian, and before that the Soviet, government complex systems. In some cases Russian standards were applied. For selling the pumps outside the Russian complex the manufacturer is faced with a new situation in which the products are no longer accepted by a system-assigned credibility, and furthermore the Russian standards applied are not recognized, and hence not accepted, as sufficient. The manufacturer offered to provide a quality assurance program patterned after the ISO 9000, Quality Systems-Model for Quality Assurance in Design, Development, Production, Installation, and Servicing. There are two major problems with this approach:

1) Quality assurance can not be applied retroactively and be considered valid, and

(2) The manufacturer was not qualified, accredited, certified or registered for the ISO 9000 program. Hence, after-the-fact actions can not apply retroactively.

The Purchaser’s Alternatives
The purchaser of the mixer pumps is now faced with difficult alternatives. The mixer pump’s application in a high pressure and radioactive waste service excluded acceptance without a legally recognized and accepted assurance program. A combination of three alternative options is being considered.

1) The purchaser will review and ad hoc “certify,” for its own purposes, relevant portions of the quality assurance program that the manufacturer supplies.

2) The purchaser will witness and accept critical steps of the manufacturing process and review documentation such as weld radiographs developed during the manufacturing process.

3) A pressure test will be applied to the final actual system (which is an accepted alternative, recognized in the B&PVC) by subjecting the system to a pressure in excess of the service pressure. The entire system will be cold tested, prior to hot deployment to assure adequate system operations.

The alternatives considered are costly and time consuming, but must be carried out. The review of the quality program in place has a language barrier and a culture and technology gap to bridge, neither of which is simple to overcome. The witnessing of critical steps requires elaborate and lengthy preparations. For example, to witness welding, the details of the materials used and the adequate welding process and materials must be known in detail. However, the differences between the ones used by the manufacturer and the ones used, recognized, and understood by the purchaser may require preparations that are tantamount to developing and writing the respective standards. The pressure testing requires adequate facilities, arrangement, instrumentation and procedures. Significant cost factors for each of these alternatives include the geographical distance and the associated high cost of travel and the time required to connect.

Conclusions
The trade of economic goods across international boundaries that do not comply with recognized and accepted internationally accredited standards, codes and programs is extremely difficult. For critical items, an ad hoc acceptance plan is expensive and probably in most cases economically prohibitive.

The value of a product (to the purchaser and user) is greatly determined by the acceptance of the standards and codes to which it was produced.

Alternatives to programs that are in place and accredited during the entire manufacturing process are surveys and reviews that amount basically to an accreditation program. These alternatives are done on an ad hoc basis and focus on elements that are critical and necessary for the particular product. Confirmation tests are required for items that constitute a health or an economic risk. All of these are, in most cases, economically unacceptable for individual products.

For an enterprise that intends to engage in an economically viable international trade the desired route seems to be to comply with recognized international standards in a fully accredited way. One of the major standards that is internationally recognized and established, and has built-in provisions for accreditation and registration that are internationally recognized is ISO 9000, Quality Management and Quality Assurance Standards, that comprises a “family” of standards that apply to various circumstances and situations. //

Talk to the Editor: Maryann Gorman