Quality data recording

The scan mode display is divided into a number of windows, that display the data recorded from the active inspections. In addition, the A-scan data from the ultrasonic probes can be displayed in probe monitor windows, for monitoring the signal quality. Figure 7 shows the scan mode display for simultaneous recording of two P-scan inspections (displayed in the same presentation window) and a T-scan inspection together with 3 probe monitor windows. 

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

In order to demonstrate the achievement of quality and the effectiveness of the quality system, records will need to be gathered in from the locations where they were produced. This is more than a convenience because you will be unable to analyze all the data efficiently unless you need it in front of you. If you are lucky enough to operate a computer network and all the data is available on the network, data collection is a simple affair. However, many organizations still rely on paper records and therefore you will need a means of enabling such records to be either submitted to the analysis points or collected from source. To facilitate the collection of records you will need to insert submission or collection instructions in the relevant procedures which specify the records. 

It should be noted that the data collection and conversion effort is not trivial, it is company and plant-specific and requires substantial effort and coordination between intracompany groups. No statistical treatment can make up for inaccurate or incomplete raw data. The keys to valid, high-quality data are thoroughness and quality of personnel training comprehensive procedures for data collection, reduction, handling and protection (from raw records to final failure rates) and the ability to audit and trace the origins of finished data. Finally, the system must be structured and the data must be coded so that they can be located within a well-designed failure rate taxonomy. When done properly, valuable and uniquely applicable failure rate data and equipment reliability information can be obtained. 

High-quality data. Miscoding, duplicate records, missing data items, and other data problems must be kept to a minimum. 

The quality of data recorded from weak, high-mass-ion beams can usually be improved by the use of signal averaging. The computer software necessary is now available from the mass spectrometer manufacturers. Although signal averaging has not yet been applied to high-mass-carbohy-... 

Given a set of existing (x, y) data records, where x is a vector of operating or decision variables, which are believed to influence the values taken on by y, y is a performance metric, usually assumed to be a quality characteristic of the product or process under analysis ... 

In this chapter we revisited an old problem, namely, exploring the information provided by a set of (x, y) operation data records and learn from it how to improve the behavior of the performance variable, y. Although some of the ideas and methodologies presented can be applied to other types of situations, we defined as our primary target an analysis at the supervisory control level of (x, y) data, generated by systems that cannot be described effectively through first-principles models, and whose performance depends to a large extent on quality-related issues and measurements. 

Audits of each phase of the study should include personnel training, preparation of collection forms, application calibration, each sample collection procedure, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage. Data collection in the field is often tedious if automated logging devices are not in place. To ensure data integrity, the paper and ink used for field studies should be waterproof. Each data collection form should contain appropriate locations for information detailing the time and location of sample collection, sample transport and sample analysis. Data collection forms should be stored in an orderly fashion in a secure location immediately upon return of field teams from the field at the end of each day. It is also important for data quality for studies to collect necessary field data seven days per week when required. In our experience, poor study quality is likely when field sample and data collection do not proceed on weekends. 

Since toxicity is a necessary but not sufficient quality of a rodenticide, the next phase of the testing was conducted to determine the acceptability of the treated diet to rats and mice. The test consisted of twenty rats per treatment level with at least twenty control animals. The tests were run from three to ten days, with the feed consumption data and necropsy data recorded for each animal. The desirable candidate compounds should comprise at least 30% of the total diet of the rats and should have a mortality of 90% or more. 

Many scientists confuse the terms QC and QA. In terms of clinical trials, there is a very real difference. QC is the operational techniques and activities undertaken by all participants to verify that the quality requirements of the clinical trial have been fulfilled whereas QA verifies that the QC has satisfied these requirements. In other words, QC is where the data recorded is checked with source documents, and that measurements and procedures followed are those described in SOPs and the protocol. QA is where independent individuals establish that QC is in place and report any deficiencies without bias. 

A bottom-up approach may be used to follow up on a specific quality problem identified from trend analyses, product nonconformities, adverse experiences, customer complaints, or other sources of quality data. Starting with quality records associated with the problem, the auditor will work his or her way up through the... 

For a section that embodies the rationale of the standard, subsection 5.9 is remarkably short. The laboratory must have quality control (QC) procedures that are documented, with QC data recorded in such a way that trends are detectable and, where practical, statistical techniques applied. Five QC techniques are offered as a nonexclusive list ... 

Data from electrophoresis is normally recorded photographically. Densitometry may also be performed on the stained gel or bands may be excised/eluted for further analysis (Mayer et al., 1998). The bands may also be isolated from the gels by blotting methods such as electroblotting (McSweeney et al., 1994 O Malley et al., 2000) or immunoblotting (Addeo et al., 1995 Moio et al., 1992) for further characterization and identification. All of the electrophoretic methods, to a certain extent, provide good quality data. But due to the difficulty in quantitative analysis, very few examples are available on the quantification of protein fractions using... 

Maintenance records Application software documentation Data reproduction accuracy Documented verification of process steps Operator identification Data record review by quality control Electronic record/signature type, use, control, and audit trail... 

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