Life cycle assessment data quality

Life-Cycle Assessment Data Quality Workshop. Wintergreen, Virginia, 4 to 9 Oct 1992. Published by SETAC, 1994. 

J. Fava, A. Jensen, L. Lindfors, S. Pomper, B. De Smet, J. Warren, and B. Vigon, Life-cycle Assessment Data Quality A Conceptual Framework, Society for Environmental Toxicology and Chemistry (SEATAC) and SEATAC Foundation for Environmental Education, 1994. 

The International Reference Life Cycle Data System Handbook is a series of technical guidance documents in line with the ISO 1404 and 14044 standards, along archetype goal and scope situations. This Handbook along with supporting tools provides the basis for ensuring consistency and quality across life cycle assessment data, methods, and studies for all applications. 

May, J. and Brennan, D. (2003) Application of data quality assessment methods to an LCA of electricity generation. International Journal of Life Cycle Assessment, 8(4) 215-225. 

In this chapter the risk assessment is briefly introduced. Risk assessment is divided into four steps hazard identification, hazard characterization, exposure assessment, and risk characterization. This chapter also highlights five risk and life cycle impact assessment models (EUSES, USEtox, GLOBOX, SADA, and MAFRAM) that allows for assessment of risks to human health and the environment. In addition other 12 models were appointed. Finally, in the last section of this chapter, there is a compilation of useful data sources for risk assessment. The data source selection is essential to obtain high quality data. This source selection is divided into two parts. First, six frequently used databases for physicochemical... 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

GMP risk assessment Qualified/trained resource System life-cycle validation System environment Current specifications Software quality assurance Formal testing/acceptance Data entry authorization Data plausibility checks Communication diagnostics Access security Batch release authority Formal procedures/contracts Change control Electronic data hardcopy Secure data storage Contingency/recovery plans Maintenance plans/records... 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

Description of process/environment Quality-related critical parameters Purpose and objectives of the system Major benefits of the system Special requirements Specific training needs System operating strategy Related GMP compliance/regulations Physical and logical boundaries System GMP risk assessment System validation rationale Life-cycle documentation Assumptions and prerequisites Limitations and exclusions Quality-related critical parameters/data Standard operating procedures System requirement specification Supplier and system history... 

The two key elements of an LCA of the fuel cell system are the assessment of the entire life cycle of the fuel cell system and the assessment of a variety of environmental impacts because of it. The first step is the goal and scope definition, in which the system, the intended application, the data sources, and system boimdaries are described and the functional unit, that is, the reference of all related inputs and outputs, is defined. The criteria for selecting input and output flows or processes have to be specified, hi this step, the data quality requirements time-related and geographical coverage the consistency, representativity, and imcertainty of the data and the critical review procedure have to be described. 

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