Personnel standards

Full gowning is required for all filling suite personnel and support personnel. Standard operating procedures identify the method and type of gowning for each classified room. 

McGovern MM, Benach M, Wallenstein S, Boone J, Lubin IM (2003) Personnel standards and quality assurance practices of biochemical genetic testing laboratories in the United States. Arch Path Lab Med 127 71-76... 

In the United States, as a result of the personnel standards of CLIA and current staffing shortages, many laboratories have been left without the technical and analytical skills to manage quality effectively. Consequently, in the authors opinion, the use of statistical QC is declining in many... 

A respondent from Kenya on being asked what standards were, remarked as follows this is where we have a problem...the word "standard" is misused both at global and national levels. Such a remark underscores the need to deconstruct standards and classify them. He went on to describe what he considered to be standards, such as the guideline that describes good manufacturing practice (GMP) (which he termed a standard in itself), facility standards and personnel standards, as some of the key issues to be considered. In this section we discuss consecutively the two types of standards identified above technical standards and institutional or organizational-based standards... 

Another set of standards that technical experts in Kenya identified are facility and personnel standards. These encompass environmental and structural standards for buildings and health, educational and technical standards for personnel (which are often assumed). One Kenyan respondent remarked that [facility standards] - that s where the problem of Africa lies. He reported that facility standards are assumed but not clearly enunciated by regulators, and are especially problematic for old production facilities that have to be refurbished. A Kenyan respondent said, for example, that the WHO talks of competent people and suitable premises in its requirements for pre-qualification - which, however, leaves a lot of room for different interpretations. Facility standards are linked to environmental standards and determine air quality and... 

After many decades of application, industry has completely accepted standard NDT as an inevitable but invaluable part of production and maintenance of components. Its application has been well-regulated, acceptance criteria for weld defects exist, good schemes for personnel qualification are in place and equipment has evolved to a standard of nearperfection. NDT has become a commodity. Pioneering years are over. 

NDT has a very important formal status. Requirements for performanee of NDT, acceptance criteria and requirements for personnel qualification are implemented in codes and standards. The NDT procedure is part of the contract. During the many years that NDT methods have been used in industry a well-established situation has evolved, enabling the use of NDT for the evaluation of welds against Good Workmanship Criteria on a routine basis, thus maintaining workmanship standards and minimising the risks of component failure. 

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. 

One of the greatest tasks in providing compendial standards is to obtain, adapt, or develop test methods for determining compliance with the standards. Such methods must be capable of routine use in many laboratories by different personnel and equipment. There is a vast difference between a method that can be used in one laboratory by speciaHsts and one that can be used in many laboratories by generaHsts to determine whether chemicals pass or fail the estabHshed specifications. Additionally, the deterrninations must be reHable, because the results obtained may determine whether a product is safe or legal. 

Standard reference materials provide a necessary but insufficient means for achieving accuracy and measurement compatibiUty on a national or international scale. Good test methods, good laboratory practices, well-qualified personnel, and proper intralaboratory and intedaboratory quaUty assurance procedures ate equally important. A systems approach to measurement compatibiUty is ikustrated in Figure 2. The function of each level is to transfer accuracy to the level below and to help provide traceabiUty to the level above. Thus traversing the hierarchy from bottom to top increases accuracy at the expense of measurement efficiency. 

The nature of potential exposure ha2ards of low level microwave energy continues to be investigated (116—118). In the United States, leakage emission from microwave ovens is regulated to the stringent limit of 5 mW/cm at 5 cm (119). There is no federal limit on emission from industrial systems but the IMPI has set a voluntary standard which specifies 10 mW/cm at 5 cm (120). Emission values are equivalent to personnel exposures at several meters, well below limits that had previously prevailed in eastern Europe. This conclusion, derived for microwave ovens, should be vaUd for all microwave systems (121). 

Pilot plants are often more hazardous than process plants, even though they are smaller ia size, for many reasons. These iaclude a tendency to relax standard safety review procedures based on the small scale, exceptionally qualified personnel iavolved, and the experimental nature of the research operations the lack of estabhshed operational practice and experience lack of information regarding new materials or processes and lack of effective automatic iatedocks due to the frequendy changing nature of pilot-plant operations, the desire for wide latitude in operating conditions, and the lack of hill-time maintenance personnel. 

Much of the experience and data from wastewater treatment has been gained from municipal treatment plants. Industrial liquid wastes are similar to wastewater but differ in significant ways. Thus, typical design parameters and standards developed for municipal wastewater operations must not be blindly utilized for industrial wastewater. It is best to run laboratory and small pilot tests with the specific industrial wastewater as part of the design process. It is most important to understand the temporal variations in industrial wastewater strength, flow, and waste components and their effect on the performance of various treatment processes. Industry personnel in an effort to reduce cost often neglect laboratory and pilot studies and depend on waste characteristics from similar plants. This strategy often results in failure, delay, and increased costs. Careful studies on the actual waste at a plant site cannot be overemphasized. 

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 standard operating procedures demand great attention as they reflect personnel safety issues, safe operating limits and quality considerations. They should be written simply and clearly. The level of detail is determined by the training and experience of the operations staff but should also take into account the hazards inherent in the process. 

---