Competence, checks

Main Objective Validation of new methods Competency check of analytical laboratories... 

Laboratories shall operate a system of analytical qualify control that is subject to checking from time to time by a person who is not under the control of the laboratory and who is approved by the eompetent authority for that purpose (Council Directive 98/83/EC, 1998). A suitable direction for such a competence check is available (EN/ISO/IEC 17025,2005). Laboratories qualified for drinking water analyses should fulfill the requirements for an aeereditation procedure preferably according to EN/ISO/IEC 17025 (2005). 

Failure of competence assessment— Within the three domains, clear procedures are in place for reassessment and retraining in the event that an individual fails a competence check. 

Competence checks of contractors can be made in two stages - one when a general assessment is made as part of a pre-contract qualification process, and secondly as part of a project-specific check. At either stage, competence checks may include ... 

A final component of a quality control program is the certification of an analyst s competence to perform the analysis for which he or she is responsible. Before an analyst is allowed to perform a new analytical method, he or she may be required to successfully analyze an independent check sample with acceptable accuracy and precision. The check sample should be similar in composition to samples that the analyst will routinely encounter, with a concentration that is 5 to 50 times that of the method s detection limit. 

STANDARD SAMPLES AND EXPERIMENTAL CHECKING OF COMPETENCE OF ANALYTICAL LABORATORIES... 

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. 

The high sound levels produced by an electric arc furnace can be contained within a furnace enclosure if a proper acoustical design is carried out. Any design should be checked by a competent acoustician. The following points should be considered ... 

Competent personnel in conjunction with the manufacturer s maintenance instructions improve safe operation of all plant by means of regular maintenance. Re-commissioning in a safe manner should always follow this. It is particularly important that valves such as safety shut-off valves, non-return valves, etc. are regularly checked for soundness. 

The Competent Authorities are obliged to appoint Inspectors for checking that all activities associated with clinical trials are conducted in compliance with the regulations. The inspectors can inspect any sites concerned with the clinical trial, particularly the trial site (GCP), the manufacturing site of the investigational medicinal product (GMP), any laboratory used for analyses in the clinical trial (GLP), and/or the sponsor s premises. 

What behaviours are associated with each of these If, for example, one of your competencies is customer responsiveness, the behaviours associated with it might include reacts to client needs in a timely and effective manner clarifies client expectations checks for safisfacfion priori-fizes client needs anticipates client needs. 

Check that there is a certificate for the carrying tank in which a competent person has certified it as suitable for the purpose for which it is to be used. These purposes should be specified in the certificate. 

A check from marks on the cylinder indicating that it has undergone proper examination at appropriate intervals by a competent person. 

The most difficult problem of risk evaluation linked to chemicals will be discussed in this Part. This is primarily a medical problem, which therefore comes within the competence of the company medical officer and epidemiologists, but neverthel need not only be dealt with by them. The person in charge of safety control in a place where chemicals are handled also has to tackle this problem. This person will have to take into account the level of toxicity risk of a substance. This will determine the constraint level of the measures to be taken, its favoured means of penetration, which depends on the activity, and its penetration properties specific to the organism. The physical properties of the substance (which will determine the nature of the precautions to be taken) and also the values of toxicity parameters have to be taken into account. He has to check the container labelling and know how to interpret and explain the toxicity instructions on this labelling. 

Gautier Can you do the experiment to check whether this difference in responsiveness between G1 and G2 is dependent on transcription Another explanation would be that the passage into S phase changes the transcriptional competence of the cell. 

This safety check is in the first approach a check the responsible manufacturer or importer has to do in his own responsibility. In a second approach, it is to some extent also a check which is done by the competent authorities, especially the European Chemicals Agency (ECHA) and the national authorities. 

If the energy is transferred by trivial emission/reabsorption, it will lengthen the measured lifetime of the donor emission, not shorten it as happens in resonance energy transfer. This comes about because intervening absorption and emission processes take place prior to the final fluorescence emission (the reabsorption cannot take place until the photon has been emitted) the two processes do not compete dynamically, but follow in a serial fashion. In FRET, such an emission/reabsorption process does not occur, and the fluorescence lifetime of the donor decreases. This is an experimental check for reabsorption/reemission. 

Check that evidence is available that you are competent to carry out the method. 

In addition, a system for making sure staff are appropriately qualified and trained for the work that they are doing must be in place. This will enable an auditor to see clearly the demonstrated competence of the staff and how this has been checked. The requirements for all major items of equipment must be listed, to ensure that the equipment in use is suitable for the task, is in working condition and, where necessary, is calibrated. For all of the instrumentation there needs to be a documented schedule for maintenance. Measurements must be traceable, that is, the laboratory must be able to show how the calibration of measurement instruments is traceable to National or International Standards. Where this presents practical problems, as in some chemical measurements for example, interlaboratory comparison and the use of reference materials (and preferably Certified Reference Materials) will be required. 

How the Chinese check with superior authority is not well known. Important negotiations take place in Peking so that the Chinese can refer to their leadership. While that is obvious, it seems that the competence of the Chinese negotiators to make decisions is probably quite limited in the technical sphere as well as in the commercial field. 

The possibility of diversions being facilitated in such ways raises two important issues for competent authorities to address. Firstly, when a pre-export notification appears with the name of a well-known company with a licit requirement for the substance, the notification should not be responded to before actually checking with the company concerned whether it had actually placed the order. Secondly, when such a diversion attempt is detected, full investigations should be launched by the authorities in both the importing and exporting countries to determine how and from whom the order was received. 

At the time of receipt of the letter of intent, the proposed invented (trade) name will be checked. Elowever, review of the trade name more than 6 months in advance of the submission date is also acceptable, although such an early checking will only serve to detect objections that exist at that time and not later. This check is performed by the EMEA in liaison with the national competent authorities, in order to determine whether the name would raise any identifiable public health concern, for resolution 1 month thereafter. 

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