Documentation and recommendations

According to Russian normative documents and recommendations by the IAEA, when developing the project and scientific evaluation study of SNF storage facility safety the following issues, being the main ones, should be considered ... 

Hammond ME, Fitzgibbons PL, Compton CC, et al. Collie of American Pathologists Conference XXXV solid tumor prognostic factors-which, how and so what Summary document and recommendations for implementation. Cancer Committee and Conference Participants. Arch Pathol Lab Med. 2000 124 958. 

The four steps in the procedure are observation, analysis, documentation, and recommendation, (not The four steps in the procedure are . ..) The procedure requires four steps observation, analysis, documentation, and recommendation. 

Recording of Condition and Appearance. As complete a record as possible should be gathered on the appearance, dimensions, and properties of the object at the time it is brought under the care of the conservator. Photographs, sketches, weights, measurements of dimensions, surface texture, and color are all useful pieces of information and should be noted as a first order of priority. The type and location of deterioration should be documented and recommendations made for the prevention of its progression. This record can be used to appraise the condition of the object at any future time, and its collection will provide a working plan for the conservation of the object. 

Because each country has its own patent laws, the precise meaning of the bibhographic data and the legal significance of the pubUshed patent document vary from country to country. The Patent Cooperation Treaty (PCT) provides a recommended code to distinguish the various types of documents and to simplify storage and retrieval of patent data (2), but the code is implemented differentiy by different countries. For example, in the United States an A-document in 1995 was a patent in the Nethedands, an A-document was a pubUshed unexamined appHcation. It is essential to understand each country s system to interpret the status of its patent documents. 

In 1971 the OSHA standard for benzene (20 CFR, Part 1910.0000) adopted a permissible exposure limit (PEL) of 10 ppm benzene measured as an 8-h TWA. In October of 1976 NIOSH updated its earlier criteria document on benzene and recommended that OSHA lower the benzene exposure standard from 10 to 1 ppm. This proposed implementation was blocked by the United States Supreme Court iu 1980 on the basis of iusufficient evidence linking benzene to cancer deaths. By the mid-1980s convincing evidence of the carciuogenicity of benzene appeared through animal studies which justified reconsideration of the 1 ppm PEL (130). 

Regarding corrective actions, the regulation states The employer shall establish a system to promptly address and resolve the incident-report findings and recommendations. Resolution and corrective actions shall be documented. The regulation does not define promptly in definitive terms, but the intent is that all corrective actions must be implemented immediately. 

NIOSH. 1992. NIOSH recommendations for Occupational Safety and Health. Compendium of Policy Documents and Statements. U.S. Department of Health and Human Services. Public Health Services. Centers for Disease Control. National Institute for Occupational Safety and Health. Publication no. 92-100. Cincinnati, Ohio. 

Exponent. 2003. Fish contaminant monitoring program review and recommendations prepared for Michigan Department of Environmental Quality, Water Division, Lansing, MI, Doc. No. 8601969.001 0501 0103 BH29. http //www.deq.state.mi.us/documents/ deq-wd-fcmp-fcmpfinal.pdf... 

Even if most examples and procedures presented apply to in-house validation, the procedure does not distinguish between validations conducted in a single laboratory and those carried out within inter-laboratory method performance studies. A preference for inter-laboratory studies can be concluded from the statement that laboratories should always give priority to methods which have been tested in method performance studies. Within the procedure a profound overview of different categories of analytical methods according to the available documentation and previous external validation is given. For example, if a method is externally validated in a method performance study, it should be tested for trueness and precision only. On the other hand, a full validation is recommended for those methods which are published in the scientific literature without complete presentation of essential performance characteristics (Table 9). 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

The first, the PrHA report, contains all necessary information except for a "...system to promptly address the team s findings and recommendations assure that the recommendations are resolved in a timely manner and that the resolution is documented ..." That information is separately documented, as discussed in Section 6.0 of this handbook. Two useful references on the documentation of PrHAs are Freeman, 1991 and Hendershot, 1992. 

Activities documenting and tracking implementation of corrective actions or safety improvements are not part of a PrHA report. However, the PSM Rule requires a documented, integrated system for managing and monitoring action items. This system must assure that action items and recommendations are addressed and documented in a timely manner. Implementation schedules for corrective actions or safety improvements must be tracked. Finally, the system must assure that all affected operating and maintenance personnel and other affected employees are notified of planned actions. 

The accident investigation report is written using the principles of technical documentation. Items 1-4 are objective and should not include the authors opinions. Items 5-7 appropriately contain the opinions of the authors (investigation team). This technical style allows readers to develop their own independent conclusions and recommendations. As a result of these criteria, the accident investigation report is a learning tool, which is the major purpose of the investigation. 

The following documents of the manufacturer can be used as part of this qualification Description and instruction manual, installation drawings and - instructions, test and take over-certificates, and soft ware documentation. It is recommended to list and specify all necessary documents and their format in the purchase order, as this reduces time and effort for the buyer as well for the seller. 

A very good description of the accident, originating from internal as well as external documents. Always recommendations and lessons to be learned are available. The coding has been done in an extensive way and an extended abstract is available. 

NIOSH. 1992. NIOSH recommendations for occupational safety and health, compendium ofo policy documents and statements. Cincinnati, OH. 

In September 1999, the PMACWA requested that the tenure of the committee be extended to review the results of the Demo I tests. The committee was asked to determine if and how the results affected the findings and recommendations in the original report, as well as to reevaluate the steps for implementation it had indicated were required (NRC, 1999). In March 2000, the committee published a supplemental report (NRC, 2000a) documenting its review of the Demo I test results and the impact of those results on the conclusions of the initial report (NRC, 1999). The ACW I Committee completed its task at the end of March 2000 and was disbanded. 

In addition to the regulations under 21 CFR, the FDA publishes Guidance for Industry and documents called Points to Consider (PTCs) as guidelines and recommendations to industry to adopt as part of the compliance program. 

If it has not been already completed, the first recommended task is to establish/designate a validation team within the company—perhaps one snch team at each of mnltiple sites. If one elects to have a separate team at mnltiple sites, these teams mnst make certain that they carry ont the validation processes consistently across all sites. In larger corporations, this is often accomplished via a central validation committee managing the individnal gronps at the varions sites. For smaller companies a team may consist of only one individual. The goal of the team(s)/committee is to draft comprehensive validation plans and protocols across all the instrnments, systems and processes that reqnire validation. They must then diligently execnte, document and verify each validation procedure. 

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