Total quality Procedures

PSM buiids on what is in piace, and seeks to integrate safety issues into ongoing business operations"as opposed to imposing an eiaborate exter-nai structure. The goais of PSM are process-oriented, not procedure-driven, and reflect the Total Quality Management principle of continuous improvement. 

Reported data should achieve a clear, purpose-oriented level of accuracy and precision, especially when data produced by several laboratories often needs to be compared as part of a decision process. It has become accepted by more and more analysts that to overcome differences between national standards and specifications and measurement procedures or to make Total Quality Management (TQM) an achievable reality, freely available and internationally agreed points of reference are needed. Therefore RMs and CRMs must be easily available indeed the availability of reference materials has been described as an issue of strategic importance to the EU (Maier et al. 1997). 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

In bioanalysis, High-Performance Liquid Chromatography (HPLC) is the analytical technique most frequently used. Often, extended sample preparation is required to make a biological sample (the matrix) suitable for HPLC-analysis. The compound of interest, the analyte, has to be isolated from the matrix as selective and quantitative as possible. The quality of the sample preparation largely determines the quality of the total analysis procedure. In a survey Majors [2] showed that approximately 30% of an error generated during sample analysis was due to sample preparation, which indicates the need for error reduction and quality improvement in sample preparation. 

The column flow, diameter and length are attractive parameters for shortening chromatographic runs. In comparison with steeper temperature profiles and isothermal runs at higher temperatures one has to remember that such procedures may lead to a more pronounced broadening of the peaks, which is acceptable as long as the total quality of the analysis does not suffer and the respective gain in speed of the separation is sufficient. 

Having a set of procedures written down and in place is only the very first small step down the road to a Total Quality organisation. The key to going further along this road, is to recognise that all procedures and processes can be continuously improved. The activity of continuous improvement requires the involvement of all staff, at whatever level in the organisation. In this activity nobody is exempt, least of all the Manager, who must lead by example [B-32]. 

Statistical process control is being implemented by catalyst manufacturers to detect and eliminate, if possible, causes of variations in quality. As many departments, such as operating, technical, purchasing, and R D, become involved in the pursuit of quality, a unified approach toward the implementation of total quality is being developed through an accreditation procedure for catalyst suppliers. 

Fig. 19. Schematic representation of a muitistage optimization procedure based on a series of total quality factors Qi-...

Implementation of a POCT service requires a POCT policy that establishes all of the procedures required to ensure the delivery of a high quality service, together with the responsibility and accountability of aH staff associated with the POCT. This may be (1) part of the organization s total quality management system, (2) part of its clinical governance policy,and (3) required for accreditation purposes.The elements of a POCT policy are listed in Box 12-5. 

To accomplish this, we must collect data. But how we collect that data is as important as the data themselves. Some data are worthless, some are priceless. The conditions and procedures used to find data ultimately determine their value. Statistical quality control (SQC), statistical process control (SPC), total quality management (TQM), and six sigma are all passive approaches to data collection. These procedures only observe and report what is happening. They cannot find the analytical cause-and-effect relationships needed for true process understanding and for controlling the sources of variability. 

The need to keep procedures up-to-date and accurate is a theme that mns throughout this book. Chapter 2 clearly shows that document control is a key element of process safety, environmental responsibihty, and quality. A workable Process Safety Management system requires that you control the access, review, approval, revision, and maintenance of procedures. If your plant has a Total Quality Management System in place, such as ISO 9000, document control for operating and maintenance procedures is essential to keep your certification current. 

It is recommended that any intending user of sampling plans should examine these documents closely, since they have the major advantage of being internationally accepted and practised. Procedures are very clearly explained and a knowledge of statistics is not essential to their implementation, although a clearer understanding of their derivation and scope will aid the total quality operation. 

Quality control can be defined as any process or procedure that has the purpose of maintaining an established or stated standard of quality for a product or process. The central aims of quality control are to ensure the consistent nature of the product or process of interest, to reduce costs and losses inherent in the process, and to maximize client satisfaction. These are generally embodied in the descriptive term total quality management (TQM). 

It is noteworthy, however, that traces of sulfur can have beneficial effects on the anti-wear resistance of fuel injection pumps. It is thus undesirable to reduce the sulfur content to extremely low values unless additives having lubricating qualities are added. Independently from total sulfur content, the presence of mercaptans that are particularly aggressive towards certain metal or synthetic parts is strictly controlled. The mercaptan content is thereby limited to 0.002% (20 ppm) maximum. The analysis is performed chemically in accordance to the NF M 07-022 or ASTM D 3227 procedures. 

Quevauviller Ph, Herzig R. and Muntau H (1996b) Certified reference material of lichen (CRM 482) for the quality control of trace element biomonitoring. Sci Total Environ 187 143-152 Quevauviller Ph, Lachica M., Barahona E, Rauret G, Ure A, Gomez A, and Muntau H (1997) The certification of the EDTA-extractable contents (mass fractions) of Cd, Cr, Ni, Pb, and Zn and of the DTPA-extractable contents (mass fractions) of Cd and Ni in calcareous soil by the extraction procedures given CRM 600. EUR Report 17555 Quevauviller Ph. Maier EA, and Griepink B, eds. (1995) Quality Assurance for Environmental Analysis. Elsevier. Amsterdam. 

The second question concerns the quality of the chemical control, directed more at the chemical analysis proper and its procedure. Important factors here are sufficient specificity and accuracy together with a short analysis time. In connection with accuracy, we can possible consider the quantization of the analytical information obtainable. For instance, from the above example of titration, if we assume for the pH measurement an accuracy of 0.02, an uncertainty remains of 0.04 over a total range of 14.0, which means a gain in information of n1 = 14.0/0.04 = 350 (at least 8 bits) with an accuracy of 5% as a mean for the titration end-point establishment of both acids, the remaining uncertainty of 1% over a range of 2 x 100% means a gain in information of n2 = 200 (at least 7 bits), so that the two-dimensional presentation of this titration represents a quantity of information I = 2log nx n2 = 15 bits at least. 

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