Quality Control procedures

The other analytical methods necessary to control the typical specification given in Table 5 are, for the most part, common quality-control procedures. When a chemical analysis for purity is desired, acetylation or phthalation procedures are commonly employed. In these cases, the alcohol reacts with a measured volume of either acetic or phthalic anhydride in pyridine solution. The loss in titratable acidity in the anhydride solution is a direct measure of the hydroxyl groups reacting in the sample. These procedures are generally free from interference by other functional groups, but both are affected adversely by the presence of excessive water, as this depletes the anhydride reagent strength to a level below that necessary to ensure complete reaction with the alcohol. Both procedures can be adapted to a semimicro- or even microscale deterrnination. 

Quality assurance programs are designed to serve two functions (1) assessment of collected air quality data and (2) improvement of the data collection process. These two functions form a loop as air quality data are collected, procedures are implemented to determine whether the data are of acceptable precision and accuracy. If they are not, increased quality control procedures are implemented to improve the data collection process. 

With the first part of the project having been completed, two more challenges remained. We first had to decide how we would ensure that the quality of data from each column set remained high. This meant setting up a quality control procedure for each GPC. The second challenge was determining what to do when we ran out of columns from a particular hatch of gel from the manufacturer. 

With the move of many large chemical companies in the United States and abroad becoming more and more global, the need to be able to compare high-quality data between various company locations becomes essential. We have addressed part of this issue, i.e., high temperature GPC data, in three ways. First, we have standardized on one type of GPC column. Second, we have implemented a quality control procedure to make sure that data stay at a high quality. Finally, we have a procedure in place to approve future batches of gel to assure that the chromatograms from batch to batch will be very comparable. 

Waite, R., ed. (199.S). Manual of Aviation Fuel Quality Control Procedures. West Conshohocken, PA ASTM. 

Collectively, the combination of appropriate facilities, equipment, documentation, manufacturing practices and quality control procedures provide a basis for effective product and process control. This is illustrated in Figure 11.10. 

With surface irrigation, water quality control procedures include careful land leveling and controlled water application to ensure adequate and rapid watering of... 

Unfortunately these and other existing quality control procedures do not answer aU problems. There remains a clear need for development of PCR reference materials that win provide information both on quality and quantity levels. For quality the reference materials should be host-specific and PCR primers, for positive control, may correspond to host specific house keeping genes e.g. b-actin. For quantitative analysis, fluorescence dyes in specific primers might be used in order to measure accurately the amount of DNA present. Such practices, and other as yet un-realized procedures, will be needed to achieve reliable results in the quantification of DNA analysis. 

In some cases, bacterial spores can also be passed onto the paper sheet and these can withstand the short exposure to high temperature drying. Hence these spores can remain on the paper sheet and if used in food contact applications, could lead to this paper being rejected under quality control procedures. 

In-process and final quality-control procedures to assure that the quality designed and manufactured into the product is actually there... 

Field demonstration. A field demonstration is always necessary to supplement a bench-scale evaluation, as some technical issues cannot be undertaken in a laboratory environment. In addition, field data help address nontechnical issues. Proper planning is critical for the implementation of a successful demonstration to ensure that all monitoring equipment, construction, and quality control procedures are in place. 

The project s homepage (Organic HACCP, 2005) contains instructions on how simple quality control procedures can be implemented in enterprises where CCPs occur, either because these enterprises perform the most relevant step for such control measures or because the potential problems are not adequately controlled by other enterprises. 

TABLE 6.1 IHC Profile, Cellular Morphology, and Core Density Quality Control Procedures employed at Leica Microsystems... 

Describe the quality control procedures required, frequency of QC checks during batch analysis, pass/fail criteria, action to take in the event of a failure. Cross-reference to the relevant sections above. 

Good quality control procedures are crucial to allowing the results of this project to integrated year upon year. More than 10% of all samples analyzed are for quality control. About half of these are duplicates the others are blanks, certified or internal reference standards and spiked samples. 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

As shown above, these include a laboratory to be third-party assessed to international accreditation standards, to demonstrate that it is in statistical control by using appropriate internal quality control procedures, to participate in proficiency testing schemes which provide an objective means of assessing and documenting the reliability of the data it is producing and to use methods of analysis that are fit-for-purpose . These requirements are summarised below and then described in greater detail later in this chapter. 

By using the combination of specific method accreditation and generic accreditation it will be possible for laboratories to be accredited for all the analyses of which they are capable and competent to undertake. Method performance validation data demonstrating that the method was fit-for-purpose shall be demonstrated before the test result is released and method performance shall be monitored by on-going quality-control techniques where applicable. It will be necessary for laboratories to be able to demonstrate quality-control procedures to ensure compliance with the EN 45001 Standard,3 an example of which would be compliance with the ISO/AOAC/IUPAC Guidelines on Internal Quality Control in Analytical Chemistry Laboratories.12... 

The list has been constructed on the premise that contractors will use methods of analysis that are appropriate and accredited by a third party (normally UKAS), participate in and achieve satisfactory results in proficiency testing schemes and use formal internal quality control procedures. In addition, Parts B and C are made available to the potential contractors so that they are aware of what other demands will be made of them and can build the costs of providing the information into their bids. 

Turconi, S., Shea, K., Ashman, S., Fantom, K., Eamshaw, D.L., Bingham, R.P., Haupts, U.M., Brown, M.J., and Pope, A.J., Real experiences of uHTS a prototypic 1536-well fluorescence anisotropy-based uHTS screen and application of well-level quality control procedures, /. Biomol. Screen., 6, 275, 2001. 

It turned out that meeting a 20 ppb limit was not excessively burdensome on major manufacturers of peanut butter and other peanut products, at least in the United States aflatoxin tended to concentrate in discolored or otherwise irregular peanuts, which, fortunately, could be picked up and rejected by modern electronic sorting machines. Manufacturers did, however, have to institute substantial additional quality control procedures to meet FDA limits, and many smaller manufacturers had trouble meeting a 20 ppb limit. An extensive USDA program of sampling and analysis of raw peanuts, which continues to this day, was also put into place as the first line of attack on the problem. 

Subpart F, Drug Compounding Controls. This explains the written procedures for the compounding of drug products that must be performed in order to assure that the finished products have the identity, strength, quality, and purity they purport or are represented to possess. It also discusses some of the final quality control procedures, including, but not limited to, the following (as appropriate) ... 

The above list of potential advantages of automated immunostainers summarizes their strengths. Automation cannot, however, correct faulty cell or tissue preparahve techniques, which would lead to the failure of any immunostaining method. Automated staining also cannot correct for the improper selection of tissue to be examined, or for selection of antisera and associated reagents that produce nonoptimal or inconclusive results. Automation is no panacea for laboratories that have poor quality control procedures, since good laboratory practices are required to operate automated Stainers successfully. 

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