Quality laboratory processes

The principles and concepts of TQM have been formalized into a quality management process, as illustrated in Figure 19-3. The traditional framework for managing quality in a healthcare laboratory has emphasized the establishment of quality laboratory processes (QLPs), QC, and quality assessment (QA). A QLP includes analytical processes and the general poHcies, practices, and procedures that define how all aspects of the work get done. QC emphasizes statistical control procedures but also includes nonstatistical check procedures, such as linearity checks, reagent and standard checks, and temperature monitors. QA, as currently applied, is primarily concerned with broader measures and monitors of laboratory performance, such as turnaround time, specimen identification, patient identification, and test utility. Quality assessment is the proper name for diese activities rather than quality assurance. Measuring performance does not by itself improve performance and often does not detect problems in time to prevent harmful effects. Quality... 

Hoechst has developed a ehemieal reeyeling plastie for Hostaform, a polyaeetal engineering material. Post-use engineering parts and produetion serap are recovered and converted back into the original monomers by depolymerisation. They are then repolymerised to form plastics with the same molecular structure as before, without loss of quality. The process at Hoechst s laboratory and pilot plant operations is outlined. EUROPEAN COMMUNITY GERMANY WESTERN EUROPE Accession no.497548... 

The company is divided in several organizational units Sales, Customer Service Department, Purchasing, Production, Storage and Quality laboratory. Despite the fact that these units are all involved in the operational process, they do not reflect the actual process flow, instead they represent the way in which the company has organised its human resources into groups. 

The requirements of the standard can be split into four major groups, which are those mentioned as activities in the quality management process. A fifth group is the quality management system per se. The model shown in the slide, taken from the ISO 9004 2000 standard, illustrates the process linkages as well as the interactions between the interested parties and the laboratory. Monitoring the satisfaction of interested parties requires the evaluation of information as to whether the laboratory has met their requirements. 

The laboratory management shall define the documentation and records needed to establish, implement and maintain the QMS and support an effective and efficient operation of the laboratory processes. A statement of the quality policy and quality objectives conveys the management commitment to quality and the customer oriented practices. The entire QMS is defined and documented in the... 

The quality plan defines the inputs and outputs of any laboratory process. For example, the quality plans refer to the analytical methods, the irrstnrments and laboratory equipment that are used for the analysis, the characteristics of the analysis results etc. All laboratory processes (e g. analytical methods) and laboratory products (e g. analytical resrrlts) should be subject to verification and validation to ensme that they are fit for the ptrrpose. The acceptance criteria should be defined and records should always be kept as evidence of meeting the requirements. 

During the audit process the auditors inspect the effective and efficient implementation of the laboratory processes, the capability of processes, the performance results, the improvement activities and they are also looking for opportunities for improvement. The aim of the internal audit is to determine whether the quality management system conforms to the planned arrangements and if it is effectively implemented. 

The cost of appraisal in a laboratory is about measuring the laboratory performance, morritoring of the laboratory processes, doing internal quality control, internal and external laboratory audits and so on. 

There are several critical areas in the laboratory process, which have a potential to completely invalidate a sample in a technical sense and from a legal perspective. Because the laboratory process is poorly understood by most of the outsiders, we will review every step of it in order to comprehend the relationships between different steps and to recognize the effects each one has on data quality. 

A typical data user is only interested in those QC checks that determine the quality of a particular set of data. Internal laboratory processes, such as initial demonstration of capability or corrective action, are not a concern of a data user unless a gross analytical error has been discovered that casts doubt over the elfectiveness of the laboratory quality system. 

This paper has examined the role of calibration and evaluation of measurement uncertainty in clinical laboratories arising from the request for traceability assurance. To produce results which are accurate and reliable within the stated uncertainty, all uncertainties of the quality measurement process and the traceability chain should be demonstrated. Also, the quality of a spectrophotometric result depends critically on RMs and photometric systems whose traceability have been properly demonstrated. 

Validation should cover the whole analytical procedure—from the preparation of the laboratory sample to the evaluation of the result, that is, the whole range of intended matrices, and should be performed within the expected range of concentrations. The intended use of the analytical results should also be considered. This means that the result can be used to evaluate compliance with regulations, to maintain quality and process control, to make regulatory decisions, to support national and international trade, and, last but not least, to support research. It should be clearly understood that validation is carried out in order to evaluate the performance of the applied analytical procedure, not the performance of the analyst or the laboratory. 

Lignin occurs as a large percentage of the noncellulosic part of wood. Newer laboratory processes yield quality lignin with molecular weights of 200 to 1000, but kraft process lignin has a molecular weight of 1000 to 50,000 and is altered chemically by sulfonation. 

Summary beta-HMX can be prepared by reacting hexamine with ammonium nitrate and nitric acid in the presence of excess glacial acetic acid and acetic anhydride. The rate of additions is crucial to ensure proper HMX formation. After the reaction is complete, the alpha-HMX is refluxed with water to ensure quality and purification. The resulting water insoluble product is then filtered-off, and then recrystallized from acetone to produce excellent crystals of beta-HMX. Commercial Industrial note For related, or similar information, see Serial No. 696,888, November 15th, 1957, by The United States Army, to Jean P. Picard, Morristown, NJ. Part or parts of this laboratory process may be protected by international, and/or commercial/industrial processes. Before using this process to legally manufacture the mentioned explosive, with intent to sell, consult any protected commercial or industrial processes related to, similar to, or additional to, the process discussed in this procedure. This process may be used to legally prepare the mentioned explosive for laboratory, educational, or research purposes. 

Water samples collected for determination of inorganic constituents were processed in the field and shipped to the USGS National Water Quality Laboratory for analysis (Fishman, 1993 Fishman and Friedman, 1989 Garbarino, 1999). Filtered samples were collected after passing through a... 

The sizes of the analytical errors that must be detected if the control procedure is to maintain a specified quality can be determined from a general analytical model for translating quality requirements into laboratory process specifications. ... 

The type and sophistication of materials characterization instrumentation made available for a given IC facility will depend on several factorsi oost/benefit, quality perceptions, process complexity, maturity of the process. Commercial support labs are becoming more readily available to meet the VLSI challenge. The mix of in-house versus external laboratory support then becomes a matter of choice based on considerations of sample turn-around time, maintaining security of proprietary devices or processes, and outside versus inside expenditures. 

Many laboratories operate quality control (QC) procedures to underpin sample preparation methods. Laboratories processing large numbers of relatively uniform samples, as in a production line environment, or research laboratories processing a smaller number of samples with varied matrices, have effectively the... 

Batch crystallization has several desirable features and advantages in laboratory and industrial applications. Industrial batch crystallizers are commonly used to manufacture a wide variety of crystalline materials with desirable product features and quality. Laboratory batch crystallizers are often used to characterize crystallization kinetics and CSDs and to determine the effects of process conditions on these kinetics and CSDs. 

Another extremely important aspect of an effective quality system is documentation. Accurate and full documentation of all activities is required to ensure the integrity of data generated in the laboratory. Standard operating procedures and working instructions should be prepared and used for the laboratory processes, and all such documents should be controlled. Any notes made, calculations, or changes to procedures should be recorded and, if necessary, explained. It is useful to adopt the phrase If you did not write it... 

In an analytical situation typical of a quality or process control laboratory, adequate sample is provided for all tests to be conducted More sample may be obtained if needed. In addition, the sample matrix is usually known and Its effects understood. 

Depending on individual and historically developed legislation on occupational exposure measurements, there are a great variety of regulations among the European member states. In some states, a laboratory which performs such measurements has to prove its competence in a quality certification process, e. g., in accordance with ISO standard 17025 [6-96]. This requires scientific competence, maintenance of organizational standards, and the possession of appropriate laboratory equipment. 

Process scale-up, which deals with transferring the laboratory process to a semicommercial or commercial scale facility while achieving the same cost, quality, and physicochemical characteristics as those achieved in the lab. 

---