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Kimhi Liat - KaL – consulting, support and quality management

    

KaL office– independent consulting, support and quality management. Advising for companies, Laboratories and organizations in the field of quality management.

Advantage in understanding Metrology (measurement theory), validation methods, developing an effective quality management system. Implementation and Maintenance of Quality Management Systems, Strategy and periodic assessment, Complex issues in Metrology (method validation, traceability - i.e. reference materials & reference range, uncertainty), Teaching and Training.

I have knowledge and experience in the management and recognition of different quality systems: ISO/IEC 17011, ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, OECD-GLP and more. Acted as a lead and professional assessor for Laboratory Accreditation
Authority (ISRAC) as well as an inspector for organizations that recognition for the principles of the OECD-GLP.

Experience in managing project and staff, and managing my self-time.

Security classify of Top Secret.

Target Clients: Organizations that required to establish a good and effective quality system, organizations that already have a quality system, but the management finds it as not yet effective, organizations that need help to preserve the quality assurance system in the field of testing operations research, validation, audits ect.

 

Professional experience:

I managed the Engineering Department in ISREL Laboratory Accreditation Authority- ISRAC (in the fields of construction, fire protection, nondestructive testing, pressure vessel, Metallurgy tests, chemical tests etc.).

developed new areas of accreditation as a cooperation with regulators including professional committees such as: with the
Ministry of Interior (building control inspection, testing PAL-KAL ceiling, separation area to prevent explosive accidents), Ministry
of Prime Minister (requirements for public & privet shelters), project with the "BETEREM" institute (requirements for building a safe
house for children) and more.

Acted as a lead assessor in ISRAC in the standards: ISO/IEC 17025-General requirement for the competence of testing and calibration laboratory, ISO/IEC 17020- Conformity assessment — Requirements for the operation of various types of bodies performing inspection, official inspector in OECD-GLP (Good Laboratory Practice) and a professional assessor in the field of construction material.

Collaborated with various governmental departments and international organizations such as ILAC (International Laboratory Accreditation Cooperation), EA (European Accreditation), GE (General Electric), and more.

Lectured on various topics such as: Quality standards to ISO/IEC 17025, ISO/IEC 17020, the principles of the OECD-GLP, courses regarding validation methods for analytical and engineering methods, evaluation of uncertainty of measurement, calibration and traceability, training courses for professional and leader assessors and more.

 

I was the head of the Quality Assurance Department of the Aminolab LTD. Aminolab is a testing laboratory in microbiology, analytical chemistry, environmental and pharmaceuticals. Certified to ISO/IEC 17025 by the Israel Laboratory Accreditation Authority,
recognized by: Ministry of Health, Ministry of Industry trade and Labor and Ministry of Environment.

Managed the Quality Assurance of OECD-GLP (Good Laboratory Practice) (Aminolab was certified to the OECD-GLP. Researched according to OECD-GLP rules at all stages of the research, took care of the whole quality Assurance requirements.

Managing a quality assurance system and professional understanding of analytical chemistry, Microbiology, Environmental quality and pharmaceutical. Expert in ISO/IEC 17025, GLP (good laboratory practice). requirement such as: internal audits, training, audits, CAPAs, PT(proficiency testing) between laboratories and between employees, preparation and evaluation of validation protocol and reports
of test methods etc. Auditor of GLP studies. Familiarity with the requirement of other quality assurance systems.

 

I was the laboratory manager of the central Laboratory of Readymix concrete (now: Cemex Israel).

managed the construction testing laboratory dealing with ready-mix concrete, mortar, chemical additives for improvement the
concrete quality as well as suitability, characterization and development of new products.  Managed the quality assurance system
of the company, according the requirements ISO 9002.

The main activities in the laboratory are testing mixed concrete, admixtures for concrete and mortar, including developed new products and raw materials, including development of new products according to customer's requirements.

Wrote the lab procedures. Made product profile for product certification in SII- standards Institute of Israel (admixtures for concrete, mortar - Readytit). Developed with a software company, the management requirements for laboratory software tests in establishing
a computerized system includes quality assurance laboratory test, to issue reports to support technology lab, cement plants and
technical supervision.

Technical supervision and project planning for new product research and technological support for introducing a new product to market.

Participated in experts committees of concrete and mortar for writing standards in the Standards Institute of Israel- SII.

Developed training programs and technological training for new employees in the company, including the establishment, implementation and acceptance of ISO 9002.

 

I worked as a research assistant in the development of printing processes at Indigo (now HP). Including management & development projects of different coating processes materials, thin films of polymers and silicon. The development was the connection of laboratory development transfer production processes, while continuing close monitoring of the production process, for the stabilization and preparation for automation process.

 

Engaged in the development process (with Spectrum LTD, later sold to Brome Ramat Hovav), starting from the literature survey through chemical reactions small tools, defining deliverables (different methods and developing separation methods of GC, HPLC), to large scale (20 liters) in order to continue the process full production

 

ליאת קמחי –       "קל יעוץ ליווי וניהול איכות"
טלפון נייד:                             052-3832030
דוא"ל:                   liatkimhi@gmail.com
 
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