Quality Assurance costs

Storage and receiving are activities that can greatly contribute to a safe and economic operation. It is here that quality control can be achieved at minimal cost. Label verification and other quality assurance measures can increase the confidence level that the correct chemicals have arrived, thereby potentially circumventing the use of wrong chemicals. Wrongly shipped chemicals can be returned to the manufacturer with minimal or no cost to the batch operation owner. As with all processes and activities it is of great importance to apply the principles of inherent safety, in particular the minimization and attenuation principles (CCPS G- 41). 

Some tolled products can be reworked if they fail quality assurance tests. In these cases the production cost may go up, but the product is not a complete loss. However, other tolled products, some pharmaceuticals for example, could be completely ruined by similar processing mishaps. Losses in these cases can be quite extensive. Test runs and approved rework procedures for such products may help avoid these losses. 

Several methods have evolved to achieve, sustain, and improve quality, they are quality control, quality improvement, and quality assurance, which collectively are known as quality management. This trilogy is illustrated in Figure 2.1. Techniques such as quality planning, quality costs, Just-in-time , and statistical process control are all elements of... 

Figure 9.9 The principle of applying a full quality assurance (QA) system to minimise product failures and reduce costs.

Monitoring programs must have their own quality assurance programs. These may be called project quality assurance plans or protocols for specific purposes O). If reliable vendors of services are used, the bulk of the quality assurance effort can be placed on those activities unique to the program. Without reliable vendors, QA efforts will be ineffective since it is not cost effective to police quality assurance practices at all lower levels nor to screen all data for its validity. 

Obviously, GMP requirements, especially extensive personnel training, calibration, qualification and validation, enhanced documentation, extensive cleaning and sanitation, and sharpened in-process control must considerably influence process organization and output. All these GMP-related activities are costly and time consuming, and will result in decreased productivity and increased production costs. On the other hand, a quality assurance system contributes to consistent production with a lower number of rejected batches and complaints. 

Assume that without the proper use of reference samples in an exploration program, a site is purchased that is in fact barren. Hill (1974), for example, cites a 20 % added analytical cost for quality control and quality assurance. He further cites a possible cost of 220 million for purchasing and developing a mine site. The analytical expense for QA QC based on use of reference samples is trivial in comparison to the potential loss, if the analyses of exploration survey samples are faulty and the mine worthless as a result. 

The revised database holds over 23 000 analyte values for 660 measurands and 1670 reference materials produced by 56 different producers, from 22 countries. The database is restricted to natural matrix materials (i.e. made from naturally occurring materials, excluding calibration standards manufactured from pure chemicals). Information has been extracted from the relevant certificates of analysis, information sheets, and other reports provided by the reference material producers. As a general rule, the authors have only included in the compilation reference materials for which a certificate of analysis or similar documentation is on file. Information included in the survey is on values for measurands determined in reference materials, producers, suppliers, the cost of the materials, the unit size supplied, and the recommended minimum weight of material for analysis, if available. The new searchable database has been designed to help analysts to select reference materials for quality assurance purposes that match as closely as possible, with respect to matrix type and concentrations of the measurands of interest and their samples to be analyzed see Table 8.3. 

The commercial testing lab may not need the data base of the R D lab nor the speed of the Quality assurance lab, but because of the immediate link between its operations and its economic success, a system would be deemed beneficial if it reduced cost per test, enhanced responsiveness to customers, or speeded the collection of receivables through automatic invoicing. 

Most of the authors of individual chapters are senior scientists and/or industry based quality assurance specialists who have participated in the EU-funded Integrated Project (IP) QualityLowInputFood. The project aims are improving the quality and safety and reduction of cost in the organic and low input food supply chains . Several chapters in handbook report preliminary results from the IP and/or associated/linked projects supported by national governments and/or industry (see IP website www.qlif.org for further details). 

It is quite clear that in the near future extraction of non-ionic surfactants from solid matrices will be based on SFE, PLE and sonication methods. The initial costs for SFE/PLE equipment will be earned back quickly by the reduction of man-hours and solvent consumption per sample. For sonication methods, not even this financial barrier is present. More emphasis must be laid on quality assurance of the extraction, clean-up and detection methodologies. The recently available 13C-labeled standards will help to account for matrix... 

Dissolution is becoming one of the most commonly automated functions in the modern pharmaceutical development and quality assurance (QA) laboratory. To the experienced dissolution analyst the reasons seem obvious. Dissolution methods are time-consuming and require a significant amount of labor. Beyond the cost of labor, the true cost of increased regulatory requirements and documentation can be better managed through automation. Additionally, the increased pressure to... 

Decision making Select closure alternative Establish schedule and funding profile Establish public and community communications program Develop schedule baseline Develop cost baseline and manpower estimates Develop health and safety plan Develop special technology Prepare facility closure plan Implement quality assurance plan Install special systems (e.g., CMS) Partial release of areas to EPA closure criteria learned ... 

AFRO Essential Drugs Price Indicator. Nearly 300 essential medicines and dosage forms are listed. Details are provided by Member States and low cost essential drugs suppliers. Published by the Regional Office for Africa and the WHO Collaborating Centre for the Quality Assurance of Medicines, University Potchefstroom, South Africa. 

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