Federal Registers - Table of Contents|
| Publication Date:||03/03/1994|
| Publication Type:||Notice|
| Fed Register #:||59:10180-10185|
| Standard Number:||1910.7|
| Title:||Entela, Inc.; Application for Recognition as a Nationally Recognized Testing Laboratory|
[Docket No. NRTL-2-93]
Entela, Inc.; Application for Recognition as a Nationally Recognized Testing Laboratory
AGENCY: Occupational Safety and Health Administration, Department of Labor.
ACTION: Notice of application for recognition as a nationally recognized testing laboratory, and preliminary finding.
SUMMARY: This notice announces the application of Entela, Inc. for recognition as a Nationally Recognized Testing Laboratory (NRTL) under 29 CFR 1910.7, and presents the Agency's preliminary finding.
DATES: The last date for interested parties to submit comments is May 2, 1994.
ADDRESSES: Send comments to: NRTL Recognition Program, Office of Variance Determination, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., room N3653, Washington, DC 20210.
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 Application
Notice is hereby given that Entela, Inc. (ENT) has made application pursuant to section 6(b) of the Occupational Safety and Health Act of 1970, (84 Stat. 1593, 29 U.S.C. 655), Secretary of Labor's Order No. 1-90 (55 FR 9033), and 29 CFR 1910.7 for recognition as a Nationally Recognized Testing Laboratory.
Entela, Inc., 3033 Madison, SE., Grand Rapids, Michigan 49548.
Regarding the merits of the application, the applicant contends that it meets the requirements of 29 CFR 1910.7 for recognition to certify products in the areas of testing which it has specified.
Entela, Inc. states that its application documents demonstrate that for each specified item of equipment or material to be certified, it has the capability (including proper testing equipment and facilities, trained staff, written testing procedures, and calibration and quality control programs) to perform testing and examination of equipment and materials for workplace safety purposes to determine conformance with appropriate product test standards. (See Ex. 2.A.).
The applicant states also that it shall provide, to the extent needed for the particular equipment or materials listed, labeled, or accepted, the following controls or services:
(i) Implementation of control procedures for identifying the listed and labeled equipment or materials (see exhibit 2.A., appendix VII, and exhibit 2.H.).
(ii) Inspection of the run of such item at factories for product evaluation purposes to assure conformance with the test standards (see exhibit 2.A., appendix VIII, and exhibit 2.H.).
(iii) Conduction of field inspections to monitor and to insure the proper use of its identifying mark or labels on products (see exhibit 2.H.).
Entela claims that it is completely independent of employers subject to the tested equipment requirements, and of any manufacturers or vendors of equipment or materials being tested for these purposes (see exhibit 2.B. and 2.J.).
The applicant also claims that it maintains effective procedures for producing creditable findings or reports that are objective and without bias, and for handling complaints and disputes under a fair and reasonable system (see exhibit 2.H. and 2.J.).
In summary, Entela, Inc. claims that it maintains the experience, expertise, personnel, organization, equipment, and facilities suitable for accreditation as an OSHA Nationally Recognized Testing Laboratory.
Entela's Grand Rapids facility consists of two adjacent structures that each contain two buildings covering a total of 40,000 square feet. Approximately 20,000 square feet of floor space is allocated to product testing. The main reception area is housed in the main building, along with the conference room, main records storage area, the wet chemistry labs, small scale flammability test room, tensile test area, with the metallurgical laboratories located on the upper floor. The weathering and environmental aging chambers, administrative offices, and nuclear records storage area are located in a leased building attached to this main building. The third building contains the appliance test area, vibration and electronics laboratory. The fourth building contains the Quality Assurance Department, certain records storage, California flammability test chamber, fabrication shop, and a metrology laboratory.
Natural gas and city water and electricity are supplied to all of the buildings. Special utilities include liquid nitrogen which is stored outside the second building, and a de-ionized water system.
Environmental conditions are controlled in specific laboratory areas. The temperature and humidity variations in these laboratories are continuously monitored and recorded, as required by specific test requirements. There are temperature and humidity chambers to control and monitor environmental conditions for specific product testing.
The laboratory has a shipping and receiving department for receipt, retention, and disposal of samples for testing. Incoming samples are inspected and identified with numbered tags. All samples for one test have tags with the same number. Each unique tag number, the samples, and the purchase order, are reviewed, and the shipping/receiving clerk prepares a work order request, after which the samples are distributed to the test areas and copies of the work order distributed to the appropriate departments. A copy of each unique tag and work order is retained by the shipping and receiving department. Another copy of the work order is sent to the test department with the samples. The test department completes the work order when all product evaluations are accomplished, and returns it to the shipping and receiving department for sample disposition. The sample inventory and traceability information is kept in the shipping and receiving log, and work order information is maintained on a computer data-base. All storage locations for incoming samples are in the shipping and receiving areas, which are located indoors. The laboratory is automating the shipping and receiving numbering system so that the work order numbers are identical with the sample tags.
Each staff member wears an Entela photo I.D. Visitors can only enter via the front lobby and are required to sign in on the visitor log. They are issued safety glasses and name tags by the receptionist and are escorted while on the premises. Other entrances are kept locked with limited access. Separate test and conference areas are available for those clients requiring confidentiality. The use of screens and partitions are also utilized in the laboratory.
Entela Inc. has recently upgraded their fire protection and security systems to include smoke detectors and proximity sensors. These are connected to the security system which dispatches local fire and police departments.
Test equipment is available to perform most measurement and testing in accordance with the identified test standards. Unavailable unique test equipment is purchased or leased through an Entela-approved source.
An inventory list identifies all pieces of equipment by the department number or location in the laboratory, gage number, instrument name, manufacturer, model and serial number, range of operation, calibration frequency, and the date the instrument was placed in service. Operational and calibration information is located in files in the Quality Assurance Office.
Test equipment is calibrated periodically depending upon the application, ranging from daily to once every three years. Electrical equipment is typically calibrated once per year, at a minimum. Adjustments are made to the calibration frequency via a corrective action report to address complaints or to ensure credible results. A written general procedure identifying the calibration history, records, and frequency of usage is utilized to determine any deviation from the equipment manufacturer's recommended or Entela's usual calibration intervals.
The Quality Assurance (QA) Department is responsible for maintaining the calibration database, the department monthly recall reports, and the procurement of calibration services. Each department is responsible for timely calibration and preventive maintenance of its equipment. The QA Department retrieves or locks out any equipment that is not turned in for calibration. New and repaired test equipment is calibrated prior to use. When a piece of equipment is received for repair or routine calibration, its "as received" calibration status is noted. This status is evaluated for its effect on testing that has been performed with that equipment to determine whether retesting is necessary.
Each item of test and measuring equipment is required to have a label that depicts its calibration status. For example, it may have a calibration label or may be labeled, "Before Each Use", "Out of Calibration", "Out of Service", or "For Reference Only". Calibration labels identify the date when last calibrated as well as the date for the next calibration.
Repair and Calibration records are maintained for the life of the equipment in the master calibration files and on the database computer (calibration). Calibration standards are traceable to NIST or to international standards bodies. Primary standards include: Gage and hardness blocks, laser interferometers, and chemical references.
The QA Department issues monthly calibration recall notices and preventive maintenance reports to each department based upon the master calibration database. The department managers are responsible for complying with any of the requirements noted in the report. The Quality Assurance manager will remove any non-calibrated equipment and place it in a locked storage area unless the equipment meets the criteria for extension of calibration.
A number of test and evaluation procedures were reviewed in various ongoing program areas. The specific ongoing programs the laboratory is involved with that identify the records required to be maintained for an investigation are followed. These programs use ANSI/UL Standards, ASTM test procedures, the Quality Control Manual, Third Party Certification Program (TPCP) Manual, 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. The staff responsible for safety testing generally consists of degreed engineers and chemists. In most instances, the test standard provided sufficient detail for laboratory personnel to conduct a step-by-step approach to develop repeatable and accurate test and evaluation data. 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. 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.
Several Standard Test Procedures (STPs) were reviewed in various program areas. Entela will develop and submit additional STPs, where necessary, prior to listing products related to these procedures. Specific program procedures and policies are developed by the individual departments and are audited twice per year by the President or Vice President of the laboratory. Management and the project manager are responsible for assuring that procedures are followed. These operating and testing procedures are determined by the work order which specifies which standard(s) and provisions are to be utilized. Operational procedures and policies are implemented through the training program at Entela, Inc. The master copy is located in the Standards Library, with controlled copies located in each department.
Present policy utilizes 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.
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 standards, which are also available for distribution to interested parties. Consumer inquiries and complaints are also addressed in the TPCP Manual.
Entela personnel serve on technical committees to enable them to be cognizant of changes to the standards with which they are involved. The laboratory is continuing to develop committee membership in various new product areas of interest.
Test procedures contain the following: Instructions on equipment; preparation of test samples; standard testing techniques; references to specific standards, including titles and dates; testing equipment and accuracies; precautionary statements for operator safety; test data obtained, measurement resolution and data recording time; ambient conditions and/or adverse environmental conditions; and acceptance criteria tests. These test procedures are reviewed annually and are approved by the technical department manager and the QA manager.
Sample test data sheets and attached work orders contain the following: Standard and clause numbers; product model number; measuring and test equipment I.D.; test date and report number, signature of tester/reviewer; and Q.A; ambient conditions; test observations and deviations; test data in the form of compliance, non-compliance, or the need for further review.
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 use 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. Entela has documented specific procedures for the recording of any deviations and the associated technical rationale, or for the modification of testing protocol.
The project manager, department manager, and test engineer, are responsible for the preparation and review of the final report. The test report is written by the test engineer or senior technician. The senior technician is also responsible for reviewing and signing the test data before it is reviewed by the project manager. A modified review process of data sheets and reports has been instituted to ensure that all signatures are in place and that any abnormalities or unusual test results are identified.
Listings are revised with replacement pages. A new report is prepared if extensive changes are required. Copies of the listing report are given to the customer and to jurisdictional authorities, where required, and placed in follow-up inspection files.
Standards updates are secured by maintaining update services for a variety of standards. For example, UL standards quarterly index update service is subscribed to and used to verify the latest edition of their standards.
The project manager is responsible for providing the test engineer with the latest revision of the appropriate standards. Superseded standards are archived in the library and labeled as such, superseded standards beyond 5 years are placed in filing boxes, labeled, and stored in records storage.
The NRTL Program checklist has been developed so that the file of a product listing is evaluated to assure its completeness through the project manager's review of the file and use of the file checklist.
Safety testing records (OSHA/NRTL) are to be stored with the nuclear files which are in a locked fireproof storage room in a fireproof filing cabinet in the third building. No flammability testing is conducted in this building. A procedure for control of files is in place to protect them from damage, theft, or records loss. Duplicate records are not stored off site.
The records are alphabetized by client. The verification and identification of test reports of listed products is accomplished through the use of the director of certified products. A label numbering system is to be utilized for the NRTL program that will take into account the various products, manufacturing sites, and variations of a model line.
The office manager is responsible for filing and maintaining these records. Procedures are in effect to distribute, recall, and revise test records.
The Quality Assurance System consists of separate but interrelated functional areas that report directly to the President or the Vice President of operations. The Quality Assurance Manager is responsible for the internal quality of the laboratory and its operations, and reports directly to the President of the laboratory. The director of Quality Assurance Services reports to the Vice President of Operations and is responsible for the various programs that address the client's preproduction qualifications, suppliers of laboratory services, follow-up program, manufacturing monitoring and quality assurance assessment. The individuals in the two positions assist each other in accomplishing the workload without interfering with their job requirements or the lines of authority. The Quality Manager is independent of operations and has the responsibility and authority for overseeing all activities related to the internal laboratory quality program.
An internal audit program performed every six months is in place on behalf of management to determine if all operations are complying with the requirements of the current quality systems, procedures, policy decisions, calibration programs, test procedures, and safety programs. This audit evaluates both the operational function and the quality assurance program at the same time, and is performed by the president or vice president of the laboratory. Personnel interviewed in the electrical and calibration areas were actively aware of the program. The corrective action reports and the corrective action logs showed no discrepancies.
Variations and discrepancies are addressed via a Corrective Action Report (CAR). CARs not finalized in an appropriate time frame are discussed at the directors' and managers' meetings and monitored by the laboratory President.
Entela, Inc. is devoting additional resources in the quality assurance area and will review weekly all open corrective action reports of problems and root cause analysis. A corrective action system is in place to document audit findings and to implement corrective actions with specified time limits.
Entela performs follow-up inspections at various facilities for other ongoing programs. 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 agreement 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 manufacturers 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.
Entela, 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 a 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 factory anomalies of 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.
Distribution of labels placed on products is controlled, requiring the manufacturer to obtain labels only from Entela. These labels are then cached in a locked storage room.
An organizational chart identifies key laboratory personnel and shows the relationship between administration, operation, and quality control. There are approximately 65 personnel in the Entela organization.
A written position description for each job title of personnel involved with product testing and evaluation includes the necessary education, training, technical knowledge, and the experience required for the position. The position description specified the extent and limitation of responsibility for the position. New position descriptions and training programs are in place for the follow-up inspection areas.
Written job descriptions are referenced in the Quality Control Manual for staff involved with product testing and evaluation. These job descriptions contain minimum requirements, education, technical knowledge and experience requirement for their respective position.
The President and Vice President of Operation, who have overall responsibility for the technical operations of the laboratory, have technical degrees. Personnel assigned to the TPCP have the necessary education, training, technical knowledge, and experience specified by their position description. Training logs reviewed in the electrical and in the calibration areas were current. Calibration training records showed that the calibration supervisor qualified his staff on each piece of equipment prior to any technician being allowed to perform independent calibrations. The training records identify each staff member and the test methods, procedures, and evaluations he or she is qualified to perform. Continuing education and training programs are held to instruct personnel on the proper methods of testing and evaluation. This documented training program incorporates appropriate test methods, equipment and operational procedures, product evaluations, inspections, and technical/engineering course work, and is updated annually.
The laboratory has a progressive performance appraisal system that provides for self-evaluation, peer-evaluation and supervisory-evaluation. The evaluation factors are both quantitative and qualitative. The laboratory also includes a company evaluation as a part of the employee program.
The laboratory has developed procedures that will enable it to accept components and materials tested and evaluated by another NRTL laboratory. These procedures include evaluating the listing report, and reserving the right to retest and audit the components as it deems necessary. Components tested and evaluated by Entela will fall under their follow-up service agreement. An approved source list has been revised to include company name, address, and area of expertise.
The TPCP identifies the circumstances when testing and evaluation of a product may be accomplished at the client's facility, such as when the equipment is large and not easily shipped or when specialized test facilities are required. The TPCP also identifies the general criteria for qualifying the manufacturer's facility to include the witnessing of the tests.
A procedure exists for the qualification of subcontractors for the supply of services in support of the laboratory functions. The laboratory maintains a listing of approved external testing sources for general laboratory support and a separate list for those suppliers that qualify under 10 CFR part 50 for the nuclear industry. This listing and any associated files has been reviewed for its completeness.
The applicant states that Entela, Inc., was originally founded in 1974 as a Michigan Corporation called Entel Engineering Services (no longer in existence) specializing in structural steel inspection, with departments in structural engineering, field service inspection, asbestos inspection, and geotechnical engineering. In 1981, equipment and personnel were added to initiate an in-house materials laboratory. Through a continued growth commitment and dedication to meet its client's needs, the applicant states that it experienced dramatic growth, necessitating the formation of certification programs within Entela, Inc.
The services offered at Entela, Inc. (also doing business as Entela Laboratories, Inc., but one in the same company according to the applicant), 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 this time, Entela, Inc. employs over 75 individuals and has two facilities, located in Grand Rapids, Michigan and Taipei, Taiwan. Presently, all testing is performed at the Grand Rapids facility, and only follow-up inspections are carried out in Taiwan.
Entela, Inc. desires recognition for testing and certification of products when tested for compliance with the following test standards:
Entela, Inc. addressed all of the criteria which must be met for recognition as an NRTL in its initial application and in its further correspondence. For example, the applicant submitted a list of its test equipment and instrumentation; a roster of its personnel including resumes of those in key positions and copies of position descriptions; copies of a typical test report; a factory inspection form and an inspection summary; a summary of its listing, labeling, and follow-up services; a statement of its independence as a testing laboratory; appeals procedure; typical calibration forms; and a copy of its Third Party Certification Manual and its Quality Assurance Manual. This QA Manual includes a description of its document control; identification and control of materials, parts, and components; inspection; test control; control of measuring and test equipment; inspection, test, and operating status; quality assurance records; and audits.
Nine major areas were examined in depth during the on-site laboratory evaluation: Facility; test equipment, calibration program; test and evaluation procedures; test reports; records; quality assurance program; follow-up listing program; and personnel.
The discrepancies noted during the on-site evaluation were adequately responded to (Ex. 3.A.(2)) prior to the preparation of the final on-site evaluation (Ex. 3.A(1)). With the preparation of the final report, the survey team was satisfied that the testing facility appeared to meet the necessary criteria required by the standard, and so noted in the On-Site Review Report (Survey). (See Ex. 3.A.).
Following a review of the application file and the on-site survey report of the Entela facility, the NRTL Recognition Program staff concluded that the applicant appeared to have met the requirements for recognition as a Nationally Recognized Testing Laboratory and, therefore, recommended to the Assistant Secretary that the application the preliminarily approved.
Based upon a review of the completed application file and the recommendation of the staff, the Assistant Secretary has made a preliminary finding that Entela, Inc. can meet the requirements for recognition as required by 29 CFR 1910.7.
All interested members of the public are invited to supply detailed reasons and evidence supporting or challenging the sufficiency of the applicant's having met the requirements for recognition as a Nationality Recognized Testing Laboratory, as well as appendix A, of 29 CFR 1910.7. Submission of pertinent written documents and exhibits shall be made no later than (May 2, 1994), and must be addressed to the NRTL Recognition Program, Office of Variance Determination, room N 3653, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210. Copies of the Entela, Inc. application, the laboratory survey report, and all submitted comments, as received, (Docket No. NRTL-203), are available for inspection and duplication at the Docket Office, room N 2634, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address.
The Assistant Secretary's final decision on whether the applicant satisfies the requirements for recognition as an NRTL will be made on the basis of the entire record including the public submissions and any further proceedings that the Assistant Secretary may consider appropriate in accordance with appendix A of 1910.7.
Joseph A. Dear,
[FR Doc. 94-4898 Filed 3-2-94; 8:45 am]
Federal Registers - Table of Contents|