Operationality

The checklist also serves as a summary of and operationalization of the complex Part 11 requirement. When an auditor—either an independent expert or an FDA investigator—can check as compliant all identified issues, the system is de facto operating under the letter and spirit of 21 CFR Part 11. Any issue that emerges as questionable, unclear, noncompliant, or absent requires investigation, explanation, and remediation. 

The results of this four-step procedure, presumably utilizing the included checklist or equivalent to operationalize Part 11 for a specihc computer system... 

The first of these issues is known as operationality (Minton et al., 1990) and will be discussed in Section V. The second problem requires us to equip the deduction process with a means to know when deductions are irrelevant, or to change the way the conditions are expressed to avoid the problem altogether. In general, neither of these solutions can be accomplished in a domain independent way. However, the latter solution confines the domain dependency to the conditions themselves, rather than the deduction mechanism, and thus is preferred. 

Operationality criterion. A predicate over concept definitions, specifying the form in which the learned concept must be expressed. 

In an earlier section, we had alluded to the need to stop the reasoning process at some point. The operationality criterion is the formal statement of that need. In most problems we have some understanding of what properties are easy to determine. For example, a property such as the processing time of a batch is normally given to us and hence is determined by a simple database lookup. The optimal solution to a nonlinear program, on the other hand, is not a simple property, and hence we might look for a simpler explanation of why two solutions have equal objective function values. In the case of our branch-and-bound problem, the operationality criterion imposes two requirements ... 

In choosing the definition of operationality, we are deciding the tradeoff between the number of predicates required to evaluate the condition versus the complexity of each predicate. This tradeoff further reduces to the cost of matching the facts to the predicates, versus the cost of evaluating a given match. If there are many different ways to match the facts to the predicates, but only one is successful, we will tend to have high match cost, unless we can find some ordering of the predicates, such that the unsuccessful ones are eliminated early. This topic has been the subject of much discussion see Minton et al. (1990) for details. 

To express operationality within our representation framework, we will use two methods ... 

Implicitly, we can express the fact that a predicate is operational by not including it on the right-hand side of an implication. In this case, it can never be further expanded or explained, and hence if it is not operational, we will fail to generate a satisfactory explanation. This definition makes it difficult to distinguish between the operationality of facts at one level of the branching structure versus another. 

Explicitly, we can express the operationality by including a predicate Operational), which does not appear as a consequent. We can then assert that certain facts are operational by including Operational fact — i) in the database. 

This explicit inclusion of operationality allows us to declare explicitly some facts about the pair (x, y), such as their state variable values, as operational. This will not permit the explanation to stop at other partial solutions, whose states have not been declared operational thus we will use this approach. 

This Translation of Sections of the Nineteenth-Century German Alchemist Gottlieb Latz Monumental Work Die Alchemie Deciphers the Chemical Formula Hidden Within the Tablet That Openly Demonstrates All the Principles of Alchemy. Contents Translator s Preface by Dennis William Hauck Foreword by Dr. Gottlieb Latz Chapter One The Origin of the Emerald Tablet Chapter Two The Ancient Arcana Revealed Chapter Three First Revision The Tabula Smaragdina Chapter Four Second Revision The Tabula Hermetica Chapter Five Third Revision The Tabula De Operatione Solis... 

Based on the results of the primary survey and consultations at various levels, one of the findings of this study has been that in order to operationalize a C R mechanism for spent FLs, there is a need for an entity that would take the direct physical responsibility for such a system. 

To set up and operationalize DTCs, an estimated time of 2-2.5 months would be required by PROs once they are selected. To import the recycling system, erect the commission in India, the estimated time would be around 4—5 months. It is preferred that if DTCs are imported in first instance and made operational as in initial months, there would not be any feed stock available for the recycling unit. Once their operation is stabilized, one can import recycling unit and commission it. These facilities would be required to obtain necessary consent to establish and operate and also to obtain authorization from respective SPCBs in the state where they are commissioned. 

Operationalization of DTCs to facilitate collection of fused fluorescent lamps. 

Background In 1989, the U.S. Congress mandated that an MDP be established within NIDA. In 1990, NIDA created the Medications Development Division (MDD) (now the DPMCDA) to operationalize the goals of the MDP. 

Construct validation suggests that classification is central to and inseparable from theory. Classification of a disorder forms a representation of the theoretical construct that is needed for the basis of elaboration and testing of the theory. A classification system like the DSM provides a means of translating or operationalizing abstract theoretical ideas into more concrete (often behavioral) definitions. Testing the theory (classification system) rests on tests of its internal and external validity. These tests inform us about the adequacy of both the classification system and the theory. It is conceivabe that theory and classification evolve together over time. Theory creates an initial classification scheme that is evaluated and, when refined, informs us about theory. 

The final consideration in operationalizing a taxon is the number of indicators. Generally, greater numbers are preferred. MAXCOV requires at least three indicators and simulations suggest that three may work reasonably well, but this number is far from ideal. In a large simulation study, Beauchaine and Beauchaine (2002) found that an increase in indicator numbers from three to four and from four to five produced considerable incremental improvement. However, six appeared to be a point of diminishing returns that is, five indicators performed almost as well as six. Moreover, MAXCOV outputs for six or more indicators are rather unwieldy. We believe it is better to have a few high quality indicators than to add low quality indicators to the set just to increase their number. 

The first task is to select some operationalization of a panic attack. The investigator can rely on the DSM definition or she or he can perform a CCK analysis of the phenomenon. Specifically, panic attack symptoms can be ana-... 

It is less clear how one should handle the requirement of unexpected and recurrent panic attacks. This is an inclusion criterion in form, while it is an exclusion criterion in function. This requirement can be operationalized either as a selection filter or as a component of the syndrome. We think it useful to break up unexpected and recurrent into two components and consider them separately. The unexpectedness of the panic attack is such a fundamental requirement in the DSM definition that it makes sense to operationalize it as a selection criterion. According to the DSM, individuals who have only experienced situationally bound panic attacks cannot have a panic disorder diagnosis, which can happen if this criterion is used as an indicator in CCK analyses. An individual can become a taxon member by being elevated on some, but not necessarily all, indicators. Moreover, unexpectedness of a panic attack cannot be easily coded as a continuous variable, which can present computational difficulties, especially for MAXCOV. 

The recurrent nature of panic attacks can be viewed as an exclusion criterion, but it can as easily be considered an integral part of the syndrome, especially if one adopts a position that a person who had one panic attack but is severely impaired and a person who is mildly impaired but has frequent panic attacks should both qualify for the diagnosis. Since the DSM requirement of at least two unexpected panic attacks seems arbitrary, we would analyze recurrence as one of the criteria. Specifically, we propose to operationalize recurrence as a simple frequency measure, the history of unexpected panic attacks (i.e., 1, 2, 3). 

In terms of the other criteria, each of the three components of worry— worry about panic likelihood, worry about panic-related consequences, and behavior change associated with panic-related worry—can be operationalized as separate indicators. However, this operationalization might be a bit tricky. 

These are exciting findings, but there are some concerns about their validity. In the biometric analysis, taxon membership was operationalized with continuous measures, which are arguably inferior to dichotomous taxon membership (dichotomized Bayesian probabilities). This is because continuous measures are probably somewhat contaminated by the dimensional variance associated with the construct, whereas dichotomous taxon membership... 

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