【正文】 Test Engineer shall assure that said personnel are supervised, petent, and that they work in accordance MPS quality systems. MPS maintains current job descriptions for all managerial, technical, and key support personnel involved in testing. The following will be defined: The responsibilities with respect to performing tests and calibrations. The responsibility with respect to the planning of test and/or calibrations and evaluations of results. The responsibilities for reporting opinions and interpretations. The responsibilities with respect to method modification and development and validation of new methods. Expertise and experience required. Qualifications and training programs Managerial duties See Job Description and Training Program procedure QA003. The management at MPS shall authorize specific personnel to perform certain types of testing and calibration, to issue test reports, to give opinions and interpretations and to operate particular types of equipment. MPS shall maintain records of authorization(s), petence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information shall be readily available and shall include the date on which authorization and/or petence is confirmed. See “Technical Qualification List” (ref.: Job Description and Training Program Procedure QA003).ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 12 OF 17 Acmodation and environmental conditions Environmental controls for the test laboratory are appropriate for the test(s) being performed. A temperaturecontrolled environment is maintained as required by those tests being performed. Human factors relating to light, ventilation and space are considered with respect to performing required tasks safely and effectively. For each area that requires a controlled environment, MPS shall document the conditions that might affect the test, see Record Control Procedure QA012. Environmental factors that may adversely affect test measurements are controlled to the degree necessary so as not to invalidate test results or increase the measuring uncertainty. Tests shall be stopped when the environmental conditions jeopardize the results of the tests. A calibrated temperaturemonitoring device is available and operating, whenever testing necessitating temperature is being performed. The Laboratory room temperature is recorded and maintained in file in the Laboratory and is readily accessible. Effective separation is maintained in work areas for safety and quality purposes. It is the policy of MPS to maintain all areas in a clean and orderly manner. Tools, equipment and materials are stored in their proper location at the end of each workday, unless extended or continuous testing requires the use of the equipment. Desktops, countertops, floors, etc, are cleaned as needed by the Laboratory personnel. Housekeeping is included as an audit item, see Internal Quality Auditing, procedure QA014. Test and Calibration methods and method validation All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be part of the document control system. Work instructions are written for each test performed. The latest valid edition of all instructions and manuals shall be used. Where the customer does not specify a testing method, the Test Engineer will select a published national or international standard. Methods that have not been established as a standard are fully documented, statistically validated and agreed to by the involved parties. When MPS must develop a procedure for performing a test, it must be a planned activity. The test plan must identify how the test will progress from start to finish. Whatever testing plan is used, it must be documented. When developing procedures for performing new tests, the procedure should contain the following information: Appropriate identification Revision of the document Scope Description of the type of item to be tested Parameters or quantities and ranges to be determined Apparatus and equipment, including technical performance requirements Reference standards and reference materials required Environmental conditions required and any stabilization period needed. Description of the procedure including:ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 13 OF 171. Affixing of identification marks, handling transporting, storing and preparation of items.2. Checks to be made before the work is started.3. Checks that the equipment is working properly and, whererequired, calibration and adjustment of the equipment before each use.4. Method of recording the observations and results.5. Any safety measures to be observed. Criterion and/or requirements for approval/rejection. Data to be recorded and method of analysis and presentation. The uncertainty or procedure for estimating uncertainty, where needed. Validation of methods All standard and nonstandard test methods and procedures are validated to ensure that such methods and procedures are fit for their intended use as well as the customer. The results of such validation are recorded together with the procedure utilized and any other relevant information. The record states whether the method or procedure is fit for the intended use. The range and accuracy of the values obtainable from validated methods shall be relevant to the customers needs. Estimation of Uncertainty of measurement All testing equipment calibrated in house shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations and all types of calibrations see Estimation of Measurement Uncertainty Procedure QA015. Documented procedures detail the methods used for estimating uncertainty of measurement and include all uncertain