Professional judgement

Should you not use measuring devices in your organization, these requirements will not apply. If your means of verification are limited to visual inspection or professional judgement, as is the case with organizations that deal only with documentation, you will have no devices to control. However, you may use tools or computer software to assist you to determine conformance and these will need to be proven capable of producing a reliable result. 

Table 5.1 summarizes the species listed above and ranks them as potential bioindicators of mercury contamination according to the characteristics discussed, from 1 (lowest) to 3 (highest), based on the assessments above and the best professional judgement of the authors of this chapter. 

To avoid any subjectivity in the judgement of performance characteristics presented by applicants, the permitted ranges of several parameters are fixed (e.g., recovery, repeatability, highest intensity of blank signals compared with the LOQ). However, in other cases professional judgement of the referee is required to assess validation results. Some of these aspects are discussed below. 

Identify available information, including information from quality control charts, performance in proficiency testing rounds, literature and validation information on related methods and data concerning comparison with other methods. Use the available information and professional judgement to review each relevant validation issue and sign-off issues adequately addressed and documented. 

Identify significant issues that require further attention and provide the missing information. Unless the validity of the method is in serious doubt, the method can continue to be used. However, the new validation information should be produced over a reasonable time-period and may involve experimental data and professional judgement. 

Health and safety considerations are addressed jointly by an industrial hygienist and a safety specialist. These are the individuals that are "the authority having jurisdiction" as referenced by the National Fire Protection Association. Because of the unique nature of many research laboratories, it is not always possible to adhere strictly to the NFPA Codes and these individual must use their professional judgement in applying the intent of the Codes. 

JOB REQUIREMENTS Ability to work independently with minimal direct supervision. Ability to work with hospital and pharmacy staff. Ability to handle frequent interruptions and adapt to changes in workload and work schedule. Ability to set priorities, make critical decisions, and respond quickly to emergency requests. Ability to exercise sound professional judgement. Ability to meet the pharmaceutical care needs of neonatal, pediatric, adolescent, adult, and geriatric patients. 

Demonstrates sound professional judgement consistent with clinical/academic background. 

Calibration using simple solutions of well-characterised pure substance standards or matrix matched standard solutions. Calibration solutions are prepared from materials whose identity and purity have been established to an appropriate level of uncertainty and where the effects of any impurities have been evaluated. Where appropriate and where available, standards provided by metrology institutes with demonstrated capability are used. In other cases, materials from other reputable suppliers or prepared in-house are used after appropriate characterisation. Where necessary, professional judgement is used to estimate the uncertainty associated with chemical standards. The target uncertainty of the identity is for practical purposes zero and for purity less than one-fifth of the desired overall uncertainty. 

Of course, another central question regarding fitness is whether a particular type of measurement is a suitable one for the purpose at all. This is, however, a matter of professional judgement addressed by the choice of an appropriate method. 

Incomplete and irrelevant specification of the above elements of the exposure scenario may be related to lack of knowledge, descriptive errors, aggregation errors, errors in professional judgement and incomplete analysis (USEPA, 1992). 

For emergency supply at the request of a patient, up to five days supply may be made (except in certain circumstances) (also see point 5 below). However, consideration should be given to supplying less than five days. Emergency supply at the request of a practitioner has no supply limit, although professional judgement should be exercised if the requested quantity appears excessive. 

As simplified validation procedures ( fast validation methods) must be used in many cases, the capability to use professional judgement in assessing whether the validation is comprehensive enough becomes pronounced. However, even when talking about simplified or fast validation procedures, the validation must be done with such a depth that the method is fit for the intended use and acceptable to the customer and/or authorities. It is clear that the definition of the use and scope of the method and assumption of uncertainty should not be misleading and too optimistic. 

Risk is the integration of hazard with dose, or rather, exposure. This means that an acknowledged hazard has to be quantified, semi-quantified, w at the very least, consideration needs to be given to the magnitude of the effects, even if the latter can only be achieved by professional judgement. The authors in this section have outlined a number of risks which indicates the wide range of events which need to be addressed in order to achieve chemical safety. 

The first of these is where to place the microbiological monitor in the product. The ruling is that it should be placed in the location most difficult to sterilize. To some extent this is a reflection of professional judgement. It is a curious anomaly that most ethylene oxide sterilizers of hypodermic products judge the most difficult position within the product to be between the two lands or ribs of the plunger tip because this is an enclosed cavity. However, at the same time, it is also the location where ethylene oxide is most likely to persist longest because of its preferential absorption into rubber. The location most difficult to sterilize may not be amenable to placement of biological monitors. In these circumstances it is usually recommended to use some other product or device packed in a similar or identical manner to simulate the actual product. 

Sample Location Selection, Uniform contamination over a complete aseptic manufacturing facility is remotely improbable. It would require a total breakdown of systems and would be evident in many ways other than environmental monitoring. The selection of locations for environmental monitoring becomes therefore a matter of professional judgement that should take account of two major considerations locations where, if contaminated, product quality would be most seriously affected and locations that due to some vicissitude of design or control are susceptible to microbiological contamination or proliferation. 

The scenario becomes far more complex when one is faced with information which is both misleading and undetectable. Here there are no cues for the clinician to mistrust the data, no reason to consult other sources or investigate the issue further. The so-called credibly incorrect scenario is often associated with the greatest degree of clinical risk as the human factor controls of professional judgement are effectively bypassed. 

Personal exposures estimated in one of the above ways are then compared with the occupational exposure limit for the solvent in question. If exposures exceed the limit there is clearly a need for action and if they are, say, less than one-tenth the situation may be regarded as satisfactory. Within this range, the need for action will be a matter for professional judgement, but it may be regarded as good practice to maintain exposures as low as reasonably practicable below such limits. 

Lawrence Trissel has written in the preface of his handbook Users of the Handbook information should always keep in mind that the information in the Handbook must be used as a tool and a guide to the research that has been conducted and published. It is not a replacement for thoughtfully considered professional judgement. ... 

For stock preparations, storage conditions and shelf life have to be justified on the basis of, for example, analytical data or professional judgement, which may be based on literature references. 

Clearly, the ideal would be for the developing company to be at the centre of the diagram. However, we know that companies positioned in other areas of the diagram can undertake satisfactory development of safety critical systems. There needs to be research and evaluation carried out to at least focus professional judgement in this key... 

---