1、INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Reco ended Practice 019.1 IEST-RP-C019.1 Qualifications for Organizations Engaged in the Testing and Certification of Cleanrooms and Clean-Air Devices INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Arlington Place
2、One 2340 S. Arlington Heights Road, Suite 10 Arlington Heights, IL 6005-4516 Phone: (847) 981-010 Fax: (847) 981-4130 E-mail: iestiest.org Web: ww.iest.org 2 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C019.1 IEST-RP-C019.1 INSTITUTE OF ENVIRONMENTAL SCIENCES AND
3、TECHNOLOGY Copyrighted material 3 This Recomended Practice is published by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY to advance the technical and enginering sciences. Its use is entirely voluntary, and determination of its aplicability and suitability for any particular use is solely th
4、e responsibility of the user. This Recomended Practice was prepared by and is under the jurisdiction of Working Group 019 of the IEST Con-tamination Control Division. Copyright 206 by the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY First printing, January 206 ISBN 978-0-9747313-5-3 PROPOSAL F
5、OR IMPROVEMENT: The Working Groups of the INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY are continualy working on improvements to their Recomended Practices and Reference Documents. Sugestions from those who use these documents are welcome. If you have a sugestion regarding this document, pleas
6、e use the online Proposal for Improvement form found on the IEST website at ww.iest.org/proposal/form.html. INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Arlington Place One 2340 S. Arlington Heights Road, Suite 10 Arlington Heights, IL 6005-4516 Phone: (847) 981-010 Fax: (847) 981-4130 E-mail:
7、 iestiest.org Web: ww.iest.org 4 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C019.1 IEST-RP-C019.1 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 5 Qualifications for Organizations Engaged in the Testing and Certification of Cleanrooms and
8、 Clean-Air Devices IEST-RP-C019.1 CONTENTS SECTION 1 SCOPE AND LIMITATIONS.7 2 REFERENCES7 3 TERMS AND EFINITIONS.7 4 BACKGROUND AND PURPOSE.8 5 TESTING AND CERTIFICATION ORGANIZATIONS: QUALIFICATION CRITERIA8 6 PERSONEL: LEVELS OF PROFICIENCY.9 APPENDIX A BIBLIOGRAPHY14 6 Copyrighted material INSTI
9、TUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C019.1 IEST-RP-C019.1 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Copyrighted material 7 INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY Contamination Control Division Recommended Practice 019.1 Qualifications for Organizations Engaged
10、in the Testing and Certification of Cleanrooms and Clean-Air Devices IEST-RP-C019.1 1 SCOPE AND LIMITATIONS 1.1 Scope This Recomended Practice (RP) defines recom-mended qualifications for organizations engaged in the testing and certification of cleanroms, clean-air de-vices, HEPA- and ULPA-filtered
11、 systems, and asoci-ated components. In adition, this RP: 1) Establishes profesional categories for personel performing testing. Each category consists of recom-mended minimum requirements for education, train-ing, and experience, al of which should be verified by the testing and certification organ
12、ization, and 2) Establishes levels of competence to be demon-strated by the personel. 1.2 Limitations The provisions of this RP are not aplicable when ad-ditional particular skils, knowledge, and education are required for the testing and certification of specialized equipment. Examples include, but
13、 are not limited to, biological safety cabinets per NSF 49 and nuclear air systems per ASME 509/510. 2 REFERENCES Se Apendix A, Bibliography, for a listing of docu-ments that contain information esential to the under-standing of cleanrom principles. 3 TERMS AND EFINITIONS The folowing terms are defi
14、ned in reference to their use in the context of this Recomended Practice: certificate of calibration A document provided by the calibration company that certifies the test equipment has ben calibrated to a known standard. certification The culmination of procedures leading to validation, expresed in
15、 the form of writen evidence (e.g., cer-tificate of compliance) that verification has ben ac-complished in acordance with specified testing procedures, such as ISO 1464 or IEST-RP-C06. certification organization An organization providing on-site testing and certifi-cation services. This may be an ou
16、tside vendor per-forming testing for profit or gain, or in-house staf that is part of the company owning the equipment being tested. Throughout this document, certification organization is refered to as “organization.” certification technician A person who has demonstrated proficiency sufi-cient to
17、met the criteria for qualification by pasing a writen and operational examination that aseses the ability of the candidate, as acquired through train-ing and experience, to test and certify cleanroms and clean-air devices (se section 6). 8 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND
18、 TECHNOLOGY IEST-RP-C019.1 clean-air device A clean bench, clean workstation, downward module, or equipment designed to control particulate air cleanlines in a localized working area and incorpo-rating, as a minimum, a HEPA filter and a blower. cleanrom A rom in which the concentration of airborne p
19、arti-cles is controled and which contains one or more clean zones. in-house A term refering to capabilities that exist within, as oposed to outside of, a company. ongoing training A continuing program of continuing education of qualified personel. onsite testing and certification Testing and certifi
20、cation of equipment at the location of usage. proficiency Demonstration of specified level of technical ability. qualifications Documented training, skils, and proficiency that should be met or complied with for a given requirement. testing Examination and evaluation of given characteristics. 4 BACK
21、GROUND AND PURPOSE This Recomended Practice is intended to provide guidance to: 1) Equipment owners in selection and evaluation of an independent testing/certification organization, 2) Equipment owners that have or are preparing to have an in-house testing/certification organization, and 3) Independ
22、ent testing/certification organizations. Equipment owners evaluating a certification organiza-tion or companies having an in-house certification organization should be familiar with and have an un-derstanding of industry standards and practices. This knowledge and understanding wil aid recipients in
23、 receiving apropriate and meaningful cleanrom and clean air equipment test results. 5 TESTING AND CERTIFICATION ORGANIZATIONS: QUALIFICATION CRITERIA The organization should be responsible for the educa-tion, training, and other verification of the proficiency of its personel. The folowing is a list
24、 of programs that a qualified organization should have; this list is not intended to be al-inclusive. 5.1 Education/training program The organization should have a comprehensive writen program that defines the knowledge and practical abili-ties required at each stage of the education/training proces
25、. Requirements should include demonstration of both writen and practical skils, an on-going educa-tion and training program, periodic evaluation of task performance, and periodic evaluations and reviews to ensure the continuing proficiency of testing personel. Al aspects of the education/training pr
26、ogram should be documented. Writen records of education and training should be kept in each employe personel file. 5.2 Standard operating procedures The organization should have writen procedures for testing, certification, and operations. These standard operating procedures (SOPs) should be maintai
27、ned as folows: a) Al SOPs should be reviewed for content on an established routine schedule and updated as neded. b) SOPs should be based on reference documents that are curent and maintained. c) Documents should specify control procedures to ensure use of the curent aproved procedures and revisions
28、. d) Training documented in the SOPs should be con-ducted before the SOPs take efect. e) SOPs should be made readily acesible to testing personel and to customers during quality audits. 5.3 System for monitoring changes in the industry The organization should demonstrate knowledge and awarenes of cu
29、rent industry standards and practices, and should have an established writen program for monitoring and evaluating changes in industry stan-dards and practices, new equipment, and technological advances. This efort should also include membership IEST-RP-C019.1 INSTITUTE OF ENVIRONMENTAL SCIENCES AND
30、 TECHNOLOGY Copyrighted material 9 and participation in trade organizations, participation in standards organizations, atending seminars and conferences, and subscriptions to trade magazines. 5.4 Safety awareness program The organization should implement a program for safety awarenes. The program sh
31、ould include training in general safety, respiratory protection, and environ-mental hazards as they aply to safe operations or cleanroms and clean-air devices. A risk asesment should be performed based on potential hazards at each customer site. Apropriate safety training should be conducted and doc
32、umented. 5.5 Customer complaint process The organization should have a writen program for documenting complaint handling, resolution, and inci-dence tracking. 5.6 Insurance/bonding The organization should provide apropriate insur-ance/bonding for the services provided when required. This coverage sh
33、ould include completed operations and worker compensation. 5.7 Equipment and equipment calibration program The organization should use apropriate test equip-ment for the specified test as determined in the writen procedure, industry standards for that equipment, or as agred betwen customer and supli
34、er. The organization should have a writen program that mets or exceds aplicable industry standards for calibration of testing equipment. Al equipment should have a curent certification of calibration document. Al calibration and repair records should be kept on file for at least seven years. The org
35、anization should have a writen procedure for receiving equipment upon return from calibration. The procedure should include review of calibration docu-ments and diagnostic testing of equipment to ensure the equipment is in proper working order. The organization should have a writen procedure for adr
36、esing the efects of test equipment found to be out of tolerance. When equipment is found to be out of tolerance, the organization should have a writen procedure to evaluate work performed with this equipment since the previous in-tolerance calibration document. 5.8 File maintenance Testing and certi
37、fication records should be maintained and protected for al work or service performed for at least seven years. At the time of disposal, records should be destroyed. Personel qualification records should be maintained at least for the length of employment and available for review during quality audit
38、s. 5.9 Competency The organization should be technicaly proficient and competent in guiding the customer in selection and specification of the apropriate, typical, or required testing for their specific industry or aplication. 6 PERSONEL: LEVELS OF PROFICIENCY This section includes criteria that qua
39、lify personel to conduct procedures for field certification of clean air equipment, components, devices, and systems. Four levels of proficiency are defined, and typical expecta-tions are listed for each. This section is intended to provide a direction for personel qualifications, and is not intende
40、d to be al-inclusive. 6.1 Level 1 Technician The Level 1 Technician should be capable of perform-ing al of the required procedures for testing, and should be capable of meting the physical and ethical requirements of asociated activities. This position is entry level and requires no prior experience
41、 or educa-tion within the industry. The Level 1 Technician works under the direct supervision of a qualified Level 3 or Level 4 Technician at al times. 6.1.1 Typical entry qualifications Wilingnes to learn and advance within the company Wilingnes and ability to be a team player and to work efectivel
42、y alone Profesional presence and atitude, pride in pro-ducing quality work, acurate and detail oriented Basic math skils (metric and US customary) and the ability to understand math principles as re-lated to the industry Ability to comprehend technical data and reason out problems Efective oral, lan
43、guage, and writen skils in comunication 10 Copyrighted material INSTITUTE OF ENVIRONMENTAL SCIENCES AND TECHNOLOGY IEST-RP-C019.1 Understanding of the ned to folow established safety procedures and proper protocol High schol education or GED equivalent 6.1.2 Typical duties of Level 1 Technician Part
44、icipate in training programs as neded to achieve Level 2 Perform data-recording asignments Complete adjustments and repairs to cleanroms and clean air devices under the direct supervision of a Level 3 or Level 4 Technician Perform test procedures as instructed and super-vised by a Level 3 or Level 4
45、 Technician 6.1.3 Training for Level 1 Technician Training at this level should provide orientation in the principles and practices related to cleanroms and clean air devices, including as a minimum, but not limited to, the folowing: Basic principles: The Level 1 Technician should be educated in bas
46、ic contamination control principles and how to work within a clean environment or with clean air devices. Basic design and performance: The Level 1 Tech-nician should be educated in the design and perform-ance of cleanroms and clean air devices. This includes the diference betwen unidirectional and
47、non-unidirectional airflow performance, as wel as airflow principles. Airborne contaminants: Training should include the efect of airborne contaminants on products, including the definition of impact on electronic, microelectronic, pharmaceutical, biotech, aerospace, or any other indus-try that has
48、a ned for control of airborne contamination. Sources of contamination: The Level 1 Technician should be educated in the sources of contamination including, but not limited to, people, proces equip-ment, production materials, leaks through or around filter systems, manufacturing aids, facility design
49、, and the product itself. Design of filters: The training should include an under-standing of the theory, design, and function of HEPA and ULPA filters, pre-filters, and pre-filter systems. Test instrumentation: Training should establish basic knowledge of test instrumentation set-up, operation, and trouble-shoting. Safety: Training should include general job safety, practices, and procedures in acordance with OSHA and other regulatory agencies. Advanced training should be given in areas of personal safety, such as respirator use and chemic
