Federal Registers - Table of Contents|
| Publication Date:||07/26/1994|
| Publication Type:||Notice|
| Fed Register #:||59:37997-38001|
| Title:||Entela, Inc.; Recognition as a Nationally Recognized Testing Laboratory|
Occupational Safety and Health Administration
[Docket No. NRTL-2-93]
Entela, Inc.; Recognition as a Nationally Recognized Testing Laboratory
AGENCY: Occupational Safety and Health Administration, Department of Labor.
ACTION: Notice of Recognition as a Nationally Recognized Testing Laboratory.
SUMMARY: This notice announces the Agency's final decision on Entela, Inc. for recognition as a Nationally Recognized Testing Laboratory (NRTL) under 29 CFR 1910.7.
FOR FURTHER INFORMATION CONTACT: Office of Variance Determination, NRTL Recognition Program, Occupational Safety and Health Administration, U.S. Department of Labor, Third Street and Constitution Avenue NW., Room N3653, Washington, DC 20210.
Notice of Final Decision
Notice is hereby given that Entela, Inc. (ENT) which made application pursuant to 29 CFR 1910.7 for recognition as a Nationally Recognized Testing Laboratory, has been recognized as a Nationally Recognized Testing Laboratory for the equipment or material listed below.
The address of the laboratory covered by this recognition is: Entela, Inc., 3033 Madison SE., Grand Rapids, Michigan 49548.
Entela, Inc. was originally founded in 1974 as a Michigan Corporation specializing in structural steel inspection. In 1981, equipment and personnel were added to initiate an in-house materials laboratory. This was followed by a formation of certification programs within Entela, Inc.
The original company as founded is Entel Engineering Services with departments in structural engineering, field service inspection, asbestos inspection, and geotechnical engineering. Rapid growth in its laboratory division led to the formation of Entela Laboratories, which is a testing consulting company providing services to the manufacturing industry. The services offered at Entela Laboratories include metals chemistry, simulated environmental testing, plastics/non-metals testing, product testing, electrical/electronics testing, metallurgy, mechanical engineering, third party certification programs, metrology, and calibration. As of July 1992, Entela, Inc. employed over 75 individuals and had two facilities, located in Grand Rapids, Michigan and Taipei, Taiwan. This recognition, however, does not extend to the Taiwan facility.
Entela, Inc's. initial application, dated July 31, 1992 (Ex. 2A) was amended by letter dated February 9, 1993 (Ex. 2D) to apply for recognition for an additional standard. The application was then amended three additional times by letters dated February 11, 1993 (Ex. 2E), May 19, 1993 (Ex. 2G), and November 30, 1993 (Ex. 2I), to its present form. The final on-site review report (Ex. 3A), consisting of an on-site evaluation of ENT's Grand Rapids testing facilities and administrative and technical practices, conducted from February 8 through 11, 1993 [Ex. 3A(1)] and the corrective action taken by Entela, Inc. [Ex. 3A(2)], and the OSHA staff recommendation, were subsequently forwarded to the Assistant Secretary for a preliminary finding on the application. A notice of ENT's application together with a positive preliminary finding was published in the Federal Register on March 3, 1994 (59 FR 10180-10185). Interested parties were invited to submit comments.
There were 36 responses to the Federal Register notice of the ENT application and preliminary finding (Docket No. NRTL-2-93), all of which agreed with OSHA's preliminary determination.
The Occupational Safety and Health Administration has evaluated the entire record in relation to the regulations set out in 29 CFR 1910.7 and makes the following findings:
Section 1910.7(b)(1) states that for each specified item of equipment or material to be listed, labeled or accepted, the laboratory must have the capability (including proper testing equipment and facilities, trained staff, written testing procedures, and calibration and quality control programs) to perform appropriate testing.
The on-site review report indicates that ENT does have testing equipment and facilities appropriate for the areas of recognition it seeks. The laboratory has available all the general test equipment required to perform the testing required by the standards. If any unique pieces of additional equipment are necessary, ENT will obtain them as required through an ENT approved source.
ENT's laboratory has adequate floor space for testing and evaluation and an adequate number of technical and professional personnel to accomplish the services required for the present workload in the areas of recognition it seeks. Environmental conditions in the laboratory are adequately controlled for the type of testing performed in the laboratory.
OSHA has determined that Entela, Inc. has appropriate written test procedures, and calibration and quality control programs to enable it to adequately perform appropriate testing.
Creditable Reports/Complaint Handling
Section 1910.7(b)(4) provides that an OSHA recognized NRTL must maintain effective procedures for producing creditable findings and reports that are objective and without bias. Entela, Inc. meets these criteria.
ENT's application as well as the on-site review report indicate that ENT does maintain effective procedures for producing creditable findings and reports that are objective. The laboratory maintains a system for identifying product samples submitted for testing to ensure that there is no confusion regarding the identity of the samples or the results of the measurement.
The specific ongoing programs the laboratory is involved with that identify the records required to be maintained for an investigation were followed. These programs use ANSI/UL Standards, ASTM test procedures, the Quality Control Manual (Ex. 2J), Third Party Certification Program (TPCP) Manual, (Ex. 2H), Client Test Procedures, and Departmental Operational Procedures. These procedures contain construction or testing parameters to be met by the product being evaluated and, as required, the chronological order of evaluation. Where appropriate, the test engineer provides a narrative report along with the test data to document compliance of a product with the standard. Standardized tests that are frequently run have a standard test data sheet available that contains the necessary information for the laboratory technician.
Sample test and evaluation procedures and reports for the NRTL Program activities were reviewed. These sample reports include narrative descriptions. The test procedure format and scope are identified in the Third Party Certification Program Manual, and describe the content and scope for the Standard Operational Procedure for the program. The laboratory has developed a generalized processing procedure for the product classes of electrical appliances and lighting products in final form, and in draft form for flammability testing.
Permanent records are compiled to document all technical and quality related activities of the Certification and Testing Division. The system for controlling all technical and quality records is described in the Quality Assurance Manual.
The certification reports contain the following: Name and location of submitter and factory; title, number, and date of standard used for evaluation; file number, report date, edition number and revision date; description of product including drawings, specifications, and photographs; conditions of product use; construction and testing narratives which describe how the product(s) comply with the standard; tests and results of tests; deviations and technical rationale for acceptance. The Quality Assurance Manual and the Third Party Certification Program Manual identify the minimum information and reporting format required for an investigation. Most reports followed the required format, and ENT is taking appropriate action to assure that all reports will do so in the future. Entela has documented specific procedures for the recording of any deviations and the associated technical rationale, or for the modification of testing protocol.
The present policy is to utilize a technical committee and standards experts to determine the appropriate standard in evaluating a product. Standard interpretations are developed by consensus of the technical committee. The Project Manager distributes technical advisory letters describing standards policy on interpretation or deviation decisions to all parties affected. The laboratory personnel are members of various organizations which develop standards applicable to their on-going programs in the automotive flammability, metallurgical, quality, electrical and chemical testing areas.
In addition, the laboratory, in order to be recognized, must also maintain effective procedures for handling complaints under a fair and reasonable system.
A technical committee and standards experts determine the appropriate standard or standards to be utilized in evaluating the product. Disagreements between the applicant and the laboratory regarding standards applicability are resolved using the Entela Inc., Third Party Certification Committee, technical experts, and input from the standards-writing organization. The decision of the laboratory regarding which standard is applicable is final.
The TPCP Manual addresses the interpretation of these standards and the appeals procedure available to a client, when there is a disagreement with that interpretation. The TPCP Committee interprets the section of the standard, which are also available for distribution to interested parties. The mechanism for dealing with consumer inquiries and complaints is also adequately addressed in the TPCP Manual.
Type of Testing
The standard contemplates that testing done by NRTLs fall into one of two categories: Testing to determine conformance with appropriate test standards, or experimental testing where there might not be one specific test standard covering the new product or material. ENT has applied for recognition in the first category.
Section 1910.7(b)(2) requires that the NRTL provide certain follow-up procedures, to the extent necessary, for the particular equipment or material to be listed, labeled, or accepted. These include implementation of control procedures for identifying the listed or labeled equipment or materials, inspecting the production run at factories to assure conformance with test standards, and conducting field inspections to monitor and assure the proper use of the label.
Entela presently performs follow-up inspections at various facilities for programs outside of the NRTL program, which have demonstrated its capability in this area. Written procedures are in place for the various programs. For example, the TPCP Manual, which is presently used in the Government Services Administration (GSA) Furniture Certification Program, identifies the various steps, policies and procedures that will be used in the NRTL Program. A separate manual is presently used in Entela's Certified Automotive Parts Association (CAPA) Program. The Nuclear Program is covered under the Quality Manual.
The Entela, Inc. follow-up inspection procedure for the NRTL program requires quarterly inspections on an unannounced basis at the manufacturing facility.
This program is designed to assure that:
1. The Entela, Inc. mark is applied only to certified products;
2. That the terms of the agreement with the manufacturer are adhered to when the Entela Inc. mark is used;
3. Defects noted during previous inspections have been corrected;
4. Document control procedures and support staff training should provide the assurance that all facility assessment records are on file.
NRTL factory inspections will be performed at the rate of at least four inspections per factory per year. The frequency varies with product volumes, types of products, and the manufacturer's prior record.
When products fail to meet the requirements, the Quality Services Division takes action to either have the manufacturer correct the defect immediately, quarantine stock until the product can be reworked or reevaluated by the Entela testing engineer, or remove the Entela, Inc. mark from the product.
Entela, Inc. has a standard follow-up inspection form that will be used to document the findings at the manufacturing site. The inspector or inspecting engineer will use this form along with the follow-up inspection file for that manufacturing site and product to evaluate the product.
Engela, Inc. has a pre-qualification checklist for the evaluation of a manufacturing facility that will be used prior to the factory labeling of any products in the NRTL Program, as well as the Follow-Up Service Inspection Report. The TPCP Manual identifies the procedures required for the selection of product samples to test.
Entela, Inc.'s Quality Services Division will monitor products in the field, when prompted by either factor anomalies or complaints, and investigate field complaints. Entela, Inc reserves the right to utilize safety related public notification and mandatory recall procedures. All consumer complaints are forwarded to the Quality Services Director, Vice President, or President, as appropriate.
Section 1910.7(b)(3) requires that an NRTL be completely independent of employers subject to the tested equipment requirements and of any manufacturer or vendor of equipment or materials being tested. The applicant stated in its application that it is in complete compliance with this requirement.
OSHA believes, based upon an examination of the application with particular reference to Exhibits 2B and 2J, that Entela, Inc. is independent within the meaning of section 1910.7(b)(3).
Section 1910.7 requires that an NRTL use "appropriate test standards", which are defined, in part, to include any standard that is currently designated as an American National Standards Institute (ANSI) safety designated product standard or an American Society for Testing and Materials (ASTM) test standard used for evaluation of products or materials. As to the non-ANSI, UL test standards for which ENT has applied to test products, to, OSHA previously had examined the status of the Underwriters Laboratories Inc. (UL) Standards for Safety and, in particular, the method of their development, revision and implementation, and had determined that they are appropriate test standards under the criteria described in 29 CFR 1910.7(c) (1), (2), and (3). That is, these standards specify the safety requirements for specific equipment or classes of equipment and are recognized in the United States as safety standards providing adequate levels of safety; they are compatible and remain current with periodic revisions of applicable national codes and installation standards; and they are developed by a standards developing organization under a method providing for input and consideration of views of industry groups, experts, users, consumers, governmental authorities, and others having broad experience in the safety fields involved.
Final Decision and Order
Based upon a preponderance of the evidence resulting from an examination of the complete application, the supporting documentation, and the OSHA staff finding including the on-site report, OSHA finds that Entela, Inc. has met the requirements of 29 CFR 1910.7 to be recognized by OSHA as a Nationally Recognized Testing Laboratory to test and certify certain equipment or materials.
Pursuant to the authority in 29 CFR 1910.7, Entela, Inc. is hereby recognized as a Nationally Recognized Testing Laboratory subject to the conditions listed below. This recognition is limited to equipment or materials which, under 29 CFR Part 1910, require testing, listing, labeling, approval, acceptance, or certification, by a Nationally Recognized Testing Laboratory. This recognition is limited to the use of the following test standards for the testing and certification of equipment or materials included within the scope of these standards.
ENT has stated that all the standards in these categories are used to test equipment or materials which may be used in environments under OSHA's jurisdiction. These standards are all considered appropriate test standards under 29 CFR 1910.7(c):
ANSI/UL 45 - Portable Electric Tools
* - Exclusive of radiant panel testing. * * - Limited to equipment of no greater than 500 amperes.
* * * - Limited to motors rated no greater than one-half horsepower.
Entela, Inc. must also abide by the following conditions of its recognition, in addition to those already required by 29 CFR 1910.7:
This recognition applies only to work done at the Grand Rapids facility;
This recognition does not apply to any aspect of any program which is available only to qualified manufacturers and is based upon the NRTL's evaluation and accreditation of the manufacturer's quality assurance program;
The Occupational Safety and Health Administration shall be allowed access to ENT's facilities and records for purposes of ascertaining continuing compliance with the terms of its recognition and to investigate as OSHA deems necessary;
If ENT has reason to doubt the efficacy of any test standard it is using under this program, it shall promptly inform the organization that developed the test standard of this fact and provide that organization with appropriate relevant information upon which its concerns are based;
ENT shall not engage in or permit others to engage in any misrepresentation of the scope or conditions of its recognition. As part of this condition, ENT agrees that it will allow no representation that it is either a recognized or an accredited Nationally Recognized Testing Laboratory (NRTL) without clearly indicating the specific equipment or material to which this recognition is tied, or that its recognition is limited to certain products;
ENT shall inform OSHA as soon as possible, in writing, of any change of ownership, facilities, or key personnel, including details;
ENT will continue to meet the requirements for recognition in all areas where it has been recognized; and
ENT will always cooperate with OSHA to assure compliance with the letter as well as the spirit of its recognition and 29 CFR 1910.7.
Effective Date: This recognition will become effective on July 26, 1994 and will be valid for a period of five years from that date, until July 26, 1999, unless terminated prior to that date, in accordance with 29 CFR 1910.7.
Signed at Washington DC this 19th day of July 1994.
Joseph A. Dear
[FR Doc. 94-18107 Filed 7-25-94; 8:45 am]
Federal Registers - Table of Contents|