Compliance evaluation

There are two general classes of compliance evaluation, termed direct and indirect . 

Another useful method of direct compliance evaluation uses slow-turnover chemical marker-substancs incorporated into the drug formulation... 

Prior to 1987, all indirect methods of compliance evaluation failed to prevent patients censoring the data that was collected. History taking, diaries, and counts of returned dosage forms can all be manipulated to conceal evidence of delayed or omitted doses, and have repeatedly been shown to be unreliable (Cramer et al 1989 Cramer 1991 Kruse et al 1993 Guerrero et al 1993) and to grossly overestimate compliance in both clinical trials and ordinary practice. 

Typically, the aim of Phase I is to evaluate tolerability, some pharmacodynamic properties, and the human pharmacokinetics of a new drug. When witnessed administration of a single dose is all that the protocol requires, then compliance evaluation is not an issue. However, subsequent normal volunteer studies may examine the tolerability of repeat doses, even outside of a research facility, and the problems outlined above then apply. Furthermore, in studies of drug interactions, it is essential to know whether and when the subjects took the test drugs. 

These audits and appraisals provide an important element of compliance evaluation leading to improved compliance. 

Do you work with your supply base to resolve issues found during social compliance evaluations and also document specific corrections and improvements ... 

Monitor and measure your OH S performance Evaluate legal and nonlegal compliance Evaluate compliance with legal requirements Evaluate compliance with nonlegal requirements Investigate incidents and take remedial action Investigate your OH S incidents Take corrective and preventive action Establish and control OH S records Conduct internal audits of your OHSMS Review requirements... 

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. 

In principle, the relaxation spectrum H(r) describes the distribution of relaxation times which characterizes a sample. If such a distribution function can be determined from one type of deformation experiment, it can be used to evaluate the modulus or compliance in experiments involving other modes of deformation. In this sense it embodies the key features of the viscoelastic response of a spectrum. Methods for finding a function H(r) which is compatible with experimental results are discussed in Ferry s Viscoelastic Properties of Polymers. In Sec. 3.12 we shall see how a molecular model for viscoelasticity can be used as a source of information concerning the relaxation spectrum. 

As discussed previously, industiy is beginning to realize that there are profound benefits associated with pollution prevention including cost effectiveness, reduced hability, enhanced public image, and regula-toiy compliance. Nevertheless, there are barriers or disincentives identifiea with pollution prevention. This section will briefly outline both barriers and incentives that may need to be confronted or considered during the evaluation of a pollution prevention program. 

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. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

Once the bids are tabulated for specification compliance in the form of a chart for easy review by all others involved in the project, an overall evaluation should be made, factoring in energy cost, first cost, and time value of money using an established economic equation. Most companies have a standardized formula. If the data are available, total cost of ownership can be estimated, which for larger equipment is considered a good measure for evaluation. 

In considering the economics of process alternatives, it is important to think about the total life cycle costs. There is an increasing interest in this concept in the environmental area, with a recognition of the need to incorporate waste treatment, waste disposal, regulatory compliance, potential liability for environmental damage, and other long term environmental costs into project economic evaluation. Similarly, we must consider life cycle safety costs. Some examples of factors which should be considered include ... 

Like VDA 6.1, AVSQ 94 does not include the requirements of ISO 9001. In this way issues of copyright are overcome, a practice shared by VDA and EAQF but not QS-9000. However, unlike VDA 6.1, AVSQ 94 follows the 20 elements of ISO 9001 with two additional elements, covering financial considerations and product safety. Those questions that go beyond ISO 9001 are marked and as every question is numbered it simplifies the evaluation process. A scoring method is employed to classify organizations in terms of a conformity index. Each question is awarded a point (0, 2.5, 5, 7.5, or 10), where 10 points means full compliance, 7.5 points means minor inadequacies, 5 points means inadequacies in application requiring improvement, 2.5 points means serious inadequacies in application, and 0 points is used for criteria not applied. Unfortunately all questions carry the same weight as no account of the impact of omission on product quality or customer satisfaction is included. 

On the due date when the tenders should have been received, record those that have been submitted and discard any submitted after the deadline. Conduct an evaluation to determine the winner - the subcontractor that can meet all your requirements (including confidence) for the lowest price. The evaluation phase should involve all your staff that were involved with the specification of requirements. You need to develop scoring criteria so that the result is based on objective evidence of compliance. 

Hazards analysis techniques fall in two broad categories. Some techniques focus on hazards control by assuring that the design is in compliance with a pre-existing standard practice. These techniques result from prior hazards analysis, industry standards and recommended practices, results of incident and accident evaluations or similar facilities. Other techniques are predictive in that they can be applied to new situations where such pre-existing standard practices do not exist. 

The most common hazards control technique is a checklist. The checklist is prepared by experienced personnel who are familiar with the design, construction and operation of similar facilities. Checklists are relatively easy to use and provide a guide to the evaluator of items to be considered in evaluating hazards. API RP 14J has examples of two checklists which can be used to evaluate facilities of different complexity. Because production facilities are very similar and have been the subject of many hazard analyses, a checklist analysis to assure compliance with standard practice is recommended for most production facilities. The actual procedure by which the checklist is considered and the manner in which the evaluation is documented to assure compliance varies from case-to-case. 

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