Commissioning and Performance

Thus, we come to a very Interesting conclusion. While we have been able to list at least eight reasons why organizations and people commission and perform quantitative assessments, only the first two of these reasons are relevant when we ask the question fdiat are the characteristics of "good" quantitative assessment ... 

Additional labour will have to be employed (for the duration) till plant is commissioned and performance guarantee terms are hilly met. 

CMS Collaboration, Commissioning and performance of the CMS pixel tracker with cosmic ray muons. JINST 5, T03007 (2010)... 

This work was supported by the US Nuclear Regulatory Commission and performed at Sandia National Laboratories, which is operated for the US Department of Energy under Contract Number DE-AC04-76DP00789. 

In instrumentation, Valeria s professional skills are related to the development constmction, commissioning, and performing experiments on time-of-flight and monochromatic reflectometers. 

Performance rests for local venrilatlon systems are classified in the following three ways type, commissioning, and in-use tests. 

All processes and equipment should be proven capable of performing the task for which they were designed and so should either be subject to qualification tests or process capability tests. There may be documentation available from the supplier of the equipment which adequately demonstrates its capability, otherwise you may need to carry out qualification and capability tests to your own satisfaction. In the process industries the plant is specially designed and so needs to be commissioned and qualified by the user. Your procedures need to provide for such activities and for records of the tests to be maintained. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

The requirement is (Article 7.2) An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available. Eurther (Article 23) The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals, but which involve fewer animals or which entail less painful procedures, and shaE take such other steps as they consider appropriate to encourage research in this field. ... 

Union, a 6 months extension of exclusivity may be granted if studies are performed demonstrating safety and efficacy in a paediatric population. In the European Union the problem of off-label use in paediatrics has been recognised by the Commission and a proposal is now in draft form to introduce new legislation in 2006. 

It is essential that an environmental chamber be qualified at its intended range of use prior to commissioning for routine operation in a stability program. A qualification protocol should be prepared describing the qualification procedures and must include predefined acceptance criteria for successful qualification. The qualification consists of three components an installation qualification, operation qualification, and performance qualification. 

As noted, excipient manufacture should take place using qualified equipment and a validated process. Generally excipient equipment has been in place for many years so that classical methods of qualification, which is done as new equipment is commissioned, are inapplicable. To retrospectively qualify the installation, operation, and performance of equipment, it is suggested to rely on historical records. For installation and operation qualification, a protocol is prepared that illustrates how maintenance and production records will be used to support the hypothesis that the equipment was installed properly and is operating as intended. Then the protocol is executed by reviewing the maintenance and production records for the supporting data. Finally a report is prepared that includes the data from the records, which support the conclusion that the installation and operation of the equipment conforms to protocol requirements. It is suggested that maintenance and production records for a minimum of one year but preferably five years be reviewed. 

Electromagnetic Compatibility (EMC). In-house and site testing services are available for EMC. The Spectrum Control, Inc is equipped for testing to MIL-STD-461, MIL-I-6iSI and similar RFI (Radio Frequency Interference) specs and also performs testing in accordance with.FCC (Federal Communications Commission) and HEW (Health, Education Welfare) requirements. The personnel are familiar with RADHAZ (Radiation Hazard) filter design and measurement problems... 

In the electrical field the International Electrotechnical Commission (IEC) performs the same function as ISO. The work of this body is of interest where rubbers are used in electrical insulation, etc. As regards electrical test methods for rubber, ISO and BSI have tended to adapt the basic procedures and principles standardised by IEC or to rely on the IEC standards. 

The experimental work referred to in this article and performed in our laboratory was generously supported by the American Cancer Society, PRP-30 and E-157 by the U. S. Atomic Energy Commission, AT(30-1)3630 and by the National Science Foundation, GB-6058. The author is indebted to Drs. Barnard, Heppel, Holley, Lehman, Tener, and Weinfeld for the critical reading of the manuscript. 

The object of loop testing is to ensure that all instmmentation components in a loop are in full operational order when connected together and are in a state ready for process commissioning and validation (Operational Qualification [OQ] and Performance Qnalification PA2])- Loop testing also encompasses the integration of instrumentation with any associated compnterized control systems. 

Commission Directive 2005/31/EC of 29 April 2005 amending Conncil Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method for ceramic articles intended to come into contact with foodstnffs. OJ L no, 30.4.2005, p. 36. 

There follow illustrations of the mechanisms by which drugs can enhance performance in various sports naturally, these are proscribed by the authorities (International Olympic Committee (IOC) Medical Commission, and the governing bodies of individual sports). 

Most basic validation activities within the cGMP pilot plant are identical to those expected in practice in a manufacturing facility. A validation master plan should be developed that addresses the design specifications and qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of all major utility systems, process equipment, and computer control systems. Installation and commissioning data should be retained as part of an engineering documentation package. A workable... 

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