Compliance examination

May, Peter. J and Soren Winter (1999) Regulatory Enforcement and Compliance Examining Danish Agro-Environmental Policy Journal of Policy Analysis and Management 18(4) 625-651. 

CO Is would be issued by USCG to vessels on the basis of evidence of vessels compliance with the subchapter. USCG oversees the third-party organizations that conduct TSMS audits and surveys, and USCG will conduct compliance examinations at least once every 5 years, along with additional random compliance checks based on risk, which is to be determined by an analysis of management and vessel safety histories. 

Other. In this context the now popular system of compliance examination (COMPEX) is a non threatening, non discriminatory process which transcends the threshold debate on profiling by ensuring a balanced and proper use of profiling in all its aspects by examining non targeted passengers as weU as on a random basis. 

Quality in NDT depends upon a number of factors. Qualification of NDT personnel, technical state and correctness of choice of testing equipment, availability of approved working procedures of examination, calibration of NDT equipment have decisive importance among those factors of an NDT laboratory. Assessment of NDT laboratory competence is provided through accreditation in compliance with the EN 45000 series standards. 

The situation is not so simple when these various parameters are time dependent. In the latter case, the moduli, designated by E(t)and G(t), are evaluated by examining the (time dependent) value of o needed to maintain a constant strain 7o- By constrast, the time-dependent compliances D(t) and J(t)are determined by measuring the time-dependent strain associated with a constant stress Oq. Thus whether the deformation mode is tension or shear, the modulus is a measure of the stress required to produce a unit strain. Likewise, the compliance is a measure of the strain associated with a unit stress. As required by these definitions, the units of compliance are the reciprocals of the units of the moduli m in the SI system. 

Since the compliance is essentially the inverse of the modulus, it is not surprising that the same four regions of mechanical behavior show up again here. The data for polystyrene is more fully developed, so we shall examine if. 

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

Maintenance embraces regular inspection, periodic examination by competent persons , and repairs. Accidents may arise as a result of the lack of maintenance, during maintenance, and as a consequence of faulty maintenance. Preventive maintenance can be a legal requirement for, e.g., pressure vessels/boilers, lifting gear, power presses. A system is required for monitoring compliance witli scheduled preventive maintenance programmes, backed up by in-service inspection. Breakdown... 

Water sample collection techniques differ depending on the source being tested. The minimum number of water samples collected from a distribution system which are examined each month for coliforms is a function of the population. For example, the minimum number required for populations of 1,000 and 100,000 are 2 and 100, respectively. To ascertain compliance with the bacteriological requirements of drinking water standards, a certain number of positive tests must not be exceeded. When 10-ml standard portions are examined, not more than 10 percent in any month should be positive (that is, the upper limit of coliform density is an average of one per 100 ml). 

The implication is that the audit should focus on performance and not on conformance. It is therefore not sufficient to verify conformity with a supplier s documented policies and practices. The auditor should examine the documented system for compliance with all requirements and examine operations to verify the results achieved are those required by the policies and practices and by the standard. 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

Records. The manufacturer shall keep records of all calculations and tests. When requested by prospective purchaser or by a user of the equipment, the manufacturer shall examine the details of computations, drawings, tests, or other supporting data necessary to demonstrate compliance with the specification. It shall be understood that such information is for the sole use of the user or prospective purchaser for checking the API rating, and the manufacturer shall not be required to release the information from his custody. 

Although written reports are the inspecting authority s end product they by no means comprise the whole of the professional service that is supplied or is available on request. The authority s quality assurance objective is likely to be on the lines of client satisfaction allied to compliance with contractual obligations . Although reports are almost certainly monitored, they are a poor indicator of the quality of the examination, and the authority s quality control will rely less on report... 

Compliance with the principles of GMP is one of the major factors considered by the Licensing Authority when examining an applicahon for a licence to manufacture under the Medicines Act (1968). Similar codes exist in the USA and other countries. 

Yield and other mass-related metrics such as atom economy, reaction mass efficiency and mass intensity have been examined by Constable et al with regard to their significance concerning greenness and costs. The importance of using a (product) concentration term, which can be mass intensity or mass index, is additionally emphasized by Laird et al This is in compliance with Winterton, who in his twelve more green chemistry principles demands the establishment of full mass balances. 

Thereafter, the primary functions of the study QA specialist fell into two main headings. First, GLP compliance during the collection and documentation of commodity samples had to be assured. This was done via observation of several collections for different shops (collection incidents) at various geographic locations. In these audits, the study QA specialist examined specific items, such as (1) did the shopper follow the written instructions, (2) were the correct types and numbers of samples collected, (3) was the documentation maintained as required, (4) were the samples labeled and packaged correctly, and (5) were the samples delivered to the shipper as required Findings were communicated to study management and used as appropriate in subsequent shops. 

Concomitant or prior medications may be used in either safety or efficacy analyses. The presence of specific medications may be used as covariates for inferential analyses. Also, medications are often summarized to show that the therapies under study come from medically comparable populations. Medications may be used to determine protocol compliance and to help define a protocol-compliant study population. Concomitant medications may be examined to determine whether they interact with study therapy or whether they can explain the presence of certain adverse events. From a CDISC perspective, prior medications would be considered a finding while concomitant medications would be considered an intervention. 

All piroxicam batches were manufactured in compliance with Good Manufacturing Practices, and three formulations having fast, moderate, and slow dissolution were chosen for comparison to a lot of the innovator s product in a human bioavailability study [100]. The resulting pharmacokinetic data provided still another opportunity to examine the effects of formulation variables. To explore the relationship between the in vitro dissolution of piroxicam from these capsules and in vivo absorption, Polli [ 102] used the following previously described [145] deconvolution-based model ... 

An examination of the published literature does not suggest that this problem is extensive, although there are some reports [20] of high intrasubject variability. There is no reason to doubt that statisticians are well able to develop tests that could be used to quantify intrasubject variability [9,20-24]. However, the question as to how serious or widespread this problem may be in clinical practice is still in need of reliable data. In clinical use it is possible that for many, if not all drugs, intrapatient variability may well be more a function of patient compliances, variations in diet, use of other... 

It is important to examine the influence of impurities or additives, such as sizes and lubricants, since these are often prime sources of higher AOX values rather than the substrate itself. It is equally important to assess the contribution of auxiliaries in the bleaching bath to the total AOX value. Kleber [224] has reported several studies of systems requiring compliance with an AOX consent of 3 ppm. Table 10.20 shows that (a) synthetic... 

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