Performance standards are outcome oriented, meaning that the focus is on the goal or the results of a process rather than on the process itself. For this approach to be successful and effective, the outcome of a process must be defined in advance, and a system implemented to periodically evaluate that this outcome is satisfactorily achieved. Professional input and judgement are necessary to evaluate the application of the performance standard in diverse research environments. Therefore, performance standards are flexible to fit the different situations.
Performance standards can be applied instead of, or on top of engineering standards. Engineering standards are usually found in the regulatory requirements or other documents which specify both the characteristics and technical details required in order to meet the standard. An engineering standard not only specifies what the standard or outcome must be, but also how it is achieved. Engineering standards dictate the methods that must be used in order to achieve the standard/outcome. However, engineering standards allow little or no flexibility in methods that is sometimes helpful when implementing practices for unique programs.
Guidance, Examples and Expectations
There are activities where performance standards have been traditionally and successfully implemented, for example for the international recognition and accreditation of animal care and use programs (see Resources).
A very simple example is the animal cage washing process. Here, what matters is that the cage is clean at the end of the process, regardless of this process being manual, automatic, or using different products and times. What is needed is that the criteria for what “clean” means are defined and that a procedure to regularly check that these criteria are met is in place (e.g. a defined maximum level of bacterial growth in microbiological tests of cages periodically performed after cleaning).
The same approach can be easily extrapolated to many of the activities involved in research programs. For example, there may be different technical systems for data storage. It should be expected that there is a system to regularly check secure storage of the research data and its accessibility. Therefore, it should be ensured that personnel have the know-how to store and access the data when needed, because that is the actual expected outcome.
Another example is the self-assessment process of the quality system. Given the differences between research units (size, research areas, etc.), assigning a single frequency for when to perform the self-assessment that applies to all research units is not meaningful. Thus, in this case, Performance standards should be established by each research unit relating to the number and severity of deviations from the quality system identified during the self-assessment processes.
|Performance Standard||Engineering Standard|
|Definition||Defines the desired outcome in detail and provide measurable criteria for assessing whether the outcome is achieved, but do not specify in detail a method or technique for achieving the desired outcome.||Defined in a formal document that establishes uniform engineering or technical criteria, methods, processes and practices.|
|Example||The cages are considered clean if the periodic microbiological testing is below a certain limit.||A description of how the cages must be cleaned.|
|There should be lack of any recognizable pattern or predictability in the correctly developed randomization sequence (i.e., “randomness” principle).||Tools (e.g. software) and specific methods (e.g. blocking) to develop and apply randomization schedule.|
- Bayne, K.A. and Martin, D.P., AAALAC International: Using performance standards to evaluate an animal care and use program, Lab. Animal, 27(4), 32, 1998.
- Bayne, K.A. & Miller, J.G. (2000). Assessing animal care and use programs internationally. Laboratory Animals, 29, 27–29. 
- Bradfield, J.F., Guillén, J. & Anderson, L.C. (2018). Harmonizing international animal care and use programs. In: Management of Animal Care and Use Programs in Research, Education, and Testing, 2nd Edition. Boca Raton: CRC Press, 15–68. 
- Guillen, J. (2012). Accreditation of animal care and use programmes: The use of performance standards in a global environment. Animal Technology and Welfare, 11:2,89–94. 
- Guillén, J., Borkowski G.L. (2020). Evaluation of Ethical Review and Oversight Processes by AAALAC International.