Sample Documentation

Figure 15.4 shows a procedure for the refilling of returnable containers with a chemical of assured quality. (This will require some combination of documentation, sampling and analysis to ensure that the chemical is of the correct type, and in the intended condition.) This is applicable to drums and plastic containers, and bottles, but some modifications are necessary for pressure systems, i.e. gas cylinders, covered by the Pressure Systems Safety Regulations 2000 including ... 

In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation. 

Rights of access to, removal or delivery of the data, documents, samples and materials must be specified. 

At the end of the facilities inspection and data audit, the inspector will present the laboratory with a Receipt for Samples form. This form lists all of the copies of documents, samples, etc., the inspection team collected for use in documenting the findings of the audit in their report. The laboratory will be given a closing session in which the auditors and the Inspector will discuss their findings. Frequently, this conference also provides a time for a question and answer session or an exchange of ideas. 

Environmental samples may occasionally become legal evidence, and their possession must be traceable. An official document called the Chain-of-Custody Form serves the purpose of documenting sample transfer from one party to another. It is a record that tracks samples through their complete life span and serves as analysis request form. Over the years, the use of the COC became the industry standard regardless of whether the samples are being collected for legal purposes or not. 

COC forms are usually printed as white originals with one or two attached carbon reproduction copies of different colors. A sequential number often (but not always) identifies each form this number is useful for sample tracking. The carbon copy stays at the project site as part of project records, and the original is sent with samples to the laboratory. The laboratory will in turn include a fully completed original COC form with the sample data package. (Technically, a fully completed COC form should include a record of sample disposal, but in reality this never happens because laboratories document sample disposal with internal records). 

Documenting sample transfer from one person to another is a critical legal issue, and many legal claims have been dismissed in court based on incomplete or incorrect COC forms. The sampling team must fill out the COC form with great care, not only because it may become a legal document but also because it is often the only written record related to sample identification, type, and requested analysis that the laboratory will get. 

Collect samples and document sampling according to procedures described in the SAP take a photograph if unusual conditions are encountered. 

Sample Custodians determine from the COC Form whether a temperature blank has been enclosed with the samples. If a temperature blank has been enclosed, Sample Custodians remove the ice, the packing material, and the samples from the cooler and line them up on a receiving table or in a fume hood, if samples emanate odor. They measure the cooler temperature by inserting a thermometer into the temperature blank. If the blank is not present, they measure the temperature inside the cooler by placing a thermometer or an infrared temperature probe between sample containers. The temperature of the cooler upon arrival to the laboratory should be 2-6°C whether it has been measured inside the cooler or in the temperature blank. To document sample conditions upon arrival at the laboratory, laboratories record the cooler temperature on the COC Form or use a separate cooler receipt form, similar to one shown in Appendix 17. Samples are then placed in storage refrigerators or walk-in coolers kept at 2-6°C. 

The laboratory should verify and document the proper functioning of the software immediately after any new data acquisition or management systems have been installed. The baseline verification consists of manual calculations to confirm the correctness of all computer calculations. Ongoing verification takes place during laboratory data review process whenever a reviewer replicates one of the results generated by the computer or a manual calculation from a bench sheet. All information used in the calculations (raw data, calibration data, laboratory QC checks, and blank results) is kept on file for the reconstruction of the final result at a later date, should it become necessary. Bench sheets that document sample preparation are also kept on file for the same purpose. 

Proper basic knowledge in science in association with GLP data-collection standards helps to achieve research integrity and success. It is expected that all workers, organizations, and industries adhere to GLP standards for study documentation, sample handling, data management, and reporting. Only the use of GLP and manpower together can enrich chemical safety for the improvement of human health and safety worldwide. 

The effect of adsorbed water vapor on the tomb of Nefertari depends, in part, on the materials used in its construction. Thirteen small, well-documented samples of ancient plasters taken from throughout the tomb were analyzed in detail to determine the composition of the plaster material. Some results are summarized in Table I. 

A revision of the lighting practices in this tomb, for example the use of readily available, sharp-cut-off UV filters, must be undertaken to exclude possible photodegradation of pigments. At present, a system of fluorescent lights illuminates the walls from the base of each mural. This system is adequate now because of its infrequent use. However, the situation will be different if increased visitation is allowed. We are studying all these aspects of the conservation scheme with existing, well-documented samples taken from this tomb and other nearby tombs. 

Various sample t es (soil, sediment, biota) from different locations were analysed. In most cases commercially available reference materials were used due to their well-documented sampling conditions and wide variety of sampling sites. Furthermore, bioindicators, especially moss samples were measured. These samples were from higher-contaminated (collected by the Hungarian Nuclear Society in Chernobyl and Pripjaty) and less-contaminated (Hungary and South-France) sites. The sample types, sampling locations and dates are summarized in Table 1. 

If triplicate retest results are not over-limit, it is assumed that the original over-limit result was due to a non-assignable cause (NAC). Determine the probable cause of the over-limit count (i.e., unusual activities noted on test documentation, sampling, lab error, etc.). A record of positive NACs should be kept and analyzed to determine ways to improve affected processes and sampling procedures. Return to routine monitoring. 

Article 9 of the Medical Preparations Regulations (Statutory Instrument No. 43 of 1996) describes the conditions under which the Board may refuse an application for a PA. They occur when the applicant fails to submit information, documents, samples or other materials, or when the Board is satisfied, following examination. 

The underlying principle of GLP requires that the retention of records, other documentation, samples and specimens should provide, wherever possible, the means for full study reconstruction. Thus, it follows logically that also samples from each batch of test and reference item should be collected and retained. In this way it can be ensured that any questions regarding the quality, purity, stability and identity of the test item, that might turn up during the Quality Assurance audit or the scientific assessment of the study, could be resolved by an independent analysis of the reserve sample, without necessitating the repetition of the study itself in case of major doubts about the test item. The requirement that a sample for analytical purposes from each batch of test item should be retained would therefore not seem to pose major problems of interpretation and implementation. 

Figure 5.11. A sample report documenting sample info, peak results, chromatogram, and spectral data.

NMF and PLSA methods are computationally heavy. A model is often generated based on a subset of the complete corpus (random or representative document sampling). Similarly to categorizations methods, the models in turn can be applied to other documents to generate a characteristic vector. A particular vector will characterize a new document within the themes identified by the pregenerated model, but the presence of any additional themes or topics will be missed. 

Noble gas studies have been done on well-documented samples from two very different solar system bodies, the Earth and Moon. There is one other planet. Mars, from which we have samples, but those samples are nearly 20 (at the start of 2002) Martian meteorites, rocks from unknown locales on Mars. Even from those, though, we have learned enough to realize that Mars is a fascinating compromise between the Earth and Moon. 

The frequency of sampling/testing is always determined in contract documents. Sampling/ testing frequencies that are usually used are given in Table 9.5. 

To document sample quality, assessment of sample parameters may be necessary. For example, hemolysis can interfere with some immunoassays. For urine, pH measurement, specific gravity, and microscopy analysis to assess white blood cell or bacterial contamination may be useful. 

Validation runs may not be re-injected simply on the basis of failure to meet the method targets for precision and accuracy. Data for an entire validation run may be rejected only if there is an assignable cause. Rejection of data due to assignable cause includes documented sample processing errors or for other documented reasons, e.g., the data were lost or corrupted during acquisition or data processing or there was a documented hardware failure. Complete documentation of the failed run and the reasons for the failure should be maintained in the study file. 

Data for individual calibration, QC and study samples may be rejected based on assignable cause. Rejection of data due to assignable cause includes documented sample processing errors or when there was a suspected hardware failure (e.g. autoinjector, chromatography, interface or mass spectrometer problem). Assuming that criteria have been established prior to the analytical run, data may also be rejected for other observed conditions, such as when unusual internal standard response is observed, e.g. samples with double the expected internal standard area or samples with no internal standard... 

A3. Does the site have a documented sampling strategy used to identify health hazards and assess employees exposure (including duration. 

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