Technical Competence

Procedure name List principal name of procedure first, alternative names next. List commonly used abbreviations. 

Clinical significance Give a brief explanation of how the test is used in cHnical medicine. Include reference intervals for specific diseases and recommended diagnostic and therapeutic action limits. 

Principle of method Give a brief statement of the principles on which the method is based. 

Specimen List type of specimens that can be used and recommended volume and minimum volume. Indicate conditions that render the specimen unacceptable, such as hemolysis or lipemia. List patient preparation procedures. Provide instruction for specimen handling before testing. 

Reagents and equipment Provide a list of reagents in order of their use, including standards. Indicate the names and addresses of suppliers and detailed instructions for preparation, including checks to be performed before use. List equipment used and special precautions required. 

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This standard proposal is limited to a format model. So, as it had been pointed out earlier, the implementation of this format requires some complementary work, which can partly be standardized. The definition of the Application Programming Interfaces (A.P.l.) could become a standard in the future. Nonetheless, this would require the creation of a new ad hoc group, with different technical competences. 

As referred to above, most of the modules involve the intervention of a third party, the so-called notified bodies. These bodies are designated by Member States as being competent to carry out the certification tasks for which they are notified. As a precondition for their notification they must fulfil the minimum criteria which are set out in the relevant directives. These conditions vary from independence, impartiality and professional integrity, to technical competence, possession of or access to necessary facilities and to liability insurance. Once notified, the Commission publishes a list of all notified bodies in the Official Journal, It is worth noting that there is free competition between notified bodies and that manufacturers can make their own choice from all notified bodies notified within the European Union. 

But laboratories using NDT methods have a set of features. Specific requirements were needed to be specified for evaluation of their technical competence. These requirements were reflected in rules of interstate standardisation - UMT 15-96 Requirements to the competence of laboratories of non-destructive testing and technical diagnostics . 

CTB 941.3-93 System of Accreditation for Verification and Testing Laboratory of Belarus. General Requirements for Estimation of Technical Competence of Verification and Testing Laboratory... 

Core Competencies. These are sets of skills and capabiUties that are difficult to dupHcate and have the potential to create entirely new businesses. Technical competencies often refer to sets of key technologies and the kinds of learning embedded in the organization and its people, the competency carriers. 

Core technical competencies may be composed of a number of core or key technologies. The competencies in turn can support product families, platforms, or core products, which then support individual products. These products may ultimately be found in a number of forms or shapes. For example, a key technology such as polymer characterization may support a competency in polymer synthesis and architecture, which in turn supports the platform of fluoropolymers and the product family of Teflon (DuPont) fluoropolymer resins that can be found as films, fibers, or in other forms. 

Eastman Kodak has identified 10 core competencies and developed a process for their management and utilization within the company (29). Similarly, Eaton Corporation selected seven core technical competencies, ranked them in importance, assessed their importance vs the known state-of-the-art for the industry, and developed action plans to extend the life of each (30). Eaton subsequently found the company could bring to market products designed with proven building blocks, thus minimizing risk and the need for additional capital equipment. In addition, the competencies were found to be reservoirs of proprietary advantage that had not previously been put to work. 

State-of-the-art equipment (2) leverage competencies, expertise, and resources across the firm ia an affordable way, ensuring knowledge flow ia shared areas of technical competencies (J) explore and develop new technologies, competencies, and busiaess options beyond the constraints of iadividual busiaesses (4) maintain a longer-term focus, separate from the day-to-day concerns of the business and (5) provide access to the world s best hires, technology leaders, consultants, and collaborators. 

Environmental analytical association Ecoanalytica produce standai d samples during last 12 years. Two topics will be discussed. The first is the principles of development of staictures and maintenance of quality of standai d samples. The organization of manufacture and maintenance of their stability ai e considered too in the report. Besides them authors consider scientifically-methodical aspects of preparation of samples for experimental check of technical competence of analytical laboratories and also samples for interlaboratory tests. 

This concept book is intended for nse by chemical engineers and other technical personnel involved in the design, operation, and maintenance of facilities and eqnipment where deflagration and detonation arresters (DBAs) may be reqnired. These people are nsnally technically competent individnals who are aware of, bnt not experts in, combnstion phenomena. The facilities where snch devices may be needed inclnde chemical plants, petrochemical plants, petrolenm refineries, pharmacentical plants, specialty chemical plants, storage tank farms, loading and nnloading facilities, and pipelines. 

The individual scientist is the key to the production of quality data and must have technical competence and a dedication to quality work. Passive following of good laboratory practices and good measurement practices is not enough. Involvement in their development is required if the quality assurance program is to be credible. Standard operations procedures (SOPs) do not minimize the need for technical competence. Analysts exhibit varying degrees of proficiency when... 

It is not necessary that participating laboratories be formally recognized, accredited or certified. Measurement of the property of interest should be completed by, or under the supervision of a technically competent manager qualified either in terms of suitable academic qualifications or relevant work experience. The participating laboratory should consider the analysis as a very special one, to be performed with special attention and all possible care, and not have it performed as part of its regular routine. 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

Pharmaceutical companies have to be continuously vigilant and forecast the future directions of drug development and regulatory requirements. They have to use their core technical competencies to deliver a pipeline of products to remain competitive and profitable in the long term. 

The authors wish to acknowledge the leadership and assistance of M. J. Coplan, Corporate Senior Scientist and Director. They wish to further acknowledge the support and technical competence of the following co-workers R. D. Burchesky,... 

Intended reader/user identified and technical competence level chosen... 

Decide on the selected reader s level of technical competence and then be consistent in writing to tbat level. Assume the reader has a certain minimum knowledge of chemical process safety. 

The standard ISO/IEC 17025 focuses on the technical competence for specific tests and this is attested by the accreditation body. 

Addresses the technical competence of laboratories to carry out specific tests and Is used worldwide by laboratory accreditation bodies as the core requirement for the accreditation of laboratories... 

A series of factors are of decisive importance for the operation and efficiency of a laboratory. They are a mixture of both management and technical competence issues. Guidelines on how to deal with them are included in widely accepted documents. 

Furthermore it is well known that the ISO 9000 series of standards are applieable in all kinds of aetivity, both in mannfaotnring and serviee sectors to this end, they can serve their pnrpose to demonstrate the company s qnality management awareness and organizatiom This may apply also to laboratories however it has nothing to do with the particnlar need of laboratories to demonstrate their technical competence with regard to specific tasks. 

Technical competence is dealt with only in accreditation and refers both to the methodology nsed and the peisormel involved. In accreditation, validation of methods and expression of imcer-tainty are of major importance as well as the calibration of eqnipment and traceability of measnrements. 

Only a small percentage (up to 10%) hold an ISO 9001 certification (or recogiution). Big laboratories made more use of their accreditation certificates to demonstrate compliance to ISO 9001, but not very successfully (up to 40%). Accreditation is considered as more effective than certification to consolidate market position and demonstrate technical competence. 

Accreditation was preferred to certification to demonstrate technical competence... 

ISO/IEC 17025 classifies the main requirements in two main categories, namely the Management Issues (Chapter 4 in the standard) and the Technical Competence Issues (Chapter 5 in the standard). The new standard ISO/IEC 17025 was, in this respect, fully in line with ISO 9001. A detailed correlation with ISO 9001 and 9002 was included in an Annex to the standard. 

The diagram illustrates the successive steps to be taken by a laboratory to establish reliability. The various steps refer to different levels of this procedure. First of all we need to ensure the organizational backgroimd to deal with all management issues. The second step includes issues related to the technical competence while the third step refers to the successful assessment that the target is met. The steps correspond to different levels, e.g. the first step to certification while the third step to accreditation. 

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