Documentation requirements

Includes radiation limits, prior approval, QA programmes, testing procedures, i nformation/documentation requirements, and marking/labelling/placarding. 

The scope includes carnage of dangerous substances by wagons, large containers, small containers and tanks. Cover the documentation requirements, the mode of transport, the information needs, loadmg/unloadmg, security, safety... 

Maintains information about hazardous waste generators, transporters, disposal facilities, materials shipped, and how they have been shipped. Assists with Uniform Hazardous Waste Manifest document required by RCRA. Generates records and letters. Requires 200K memory plus IK memory for each record and a printer that can penetrate a six-part form. 

Provide potential contractors/subcontractors with documentation requirements and contractor/subcontractor prequalification forms... 

The confusion matrix (NSAC-60) is a method that identifies potential operator errors lemming from incorrect diagnosis of an event. It can be used to identify the potential for an operator to conclude that a small LOCA has occurred, when it is actually a steam line break. This provides a method for identifying a wrong operator response to an off-normal plant condition. It is particularly useful in Step 5 of the. SHARP procedures, Documentation requirements are presented in Table 4.5-2. 

The MSF model (NUREG/CR-3837) is used principally to determine the level of dependence between safety systems introduced by maintenance, testing, and calibration activities. It is a mathematical model which modifies the independent failure probability of any single component by considering that a component with which it is redundant has already failed. This allows the conditional failure probabilities of redundant components to be calculated to determine the overall system failure probability. Documentation requirements are given in Table 4.5-6. 

The paired comparisons method (NUREG/CR-3688) is a structured expert judgment method in which human errors are compared in pairs. By combining the judgments of the group of experts, the errors arc arranged in order of likelihood of occurrence, of the human errors considered, they can be used as "anchor points list. Documentation requirements are given in Table 4.5-8. 

It is more common for a complete PSA to take 16 to 24 months with several rnuiilhs tor preparation, review, and revision of the final report. The final report for a level 3 nuclear plant PSA, includes an analysis of external events, in several large volumes. Completeness and consistency in such a large document requires several months of team leadership and selected analysts. Given these resources, it may be possible to complete the technical analyses for a Level 1 PSA in a year or less, but the final report will take several more months to prepare. 

Specify the documentation requirements and format, such as checklists for recording inspections, startup, and functional performance tests. 

It is necessary to verify that all the documentation needed to produce and install the product is compatible that you haven t a situation where the design documentation requires one thing and the production documents require another or that details in the... 

The documentation required varies but is likely to include the following ... 

An adequately documented requirement would be a written contract, schedule of work, and/or specification. However simple the requirement, it is wise to have it documented in case of a dispute later. The document needs to carry an identity and if subject to change, an issue status. In the simple case this is the serial numbered invoice and in more complicated transactions, it will be a multi-page contract with official contract number, date, and signatures of both parties. 

The documentation required of the design output necessary to manufacture, procure, inspect, test, install, operate, and maintain a product or service... 

Prepare standard requirements for subcontracted design activities which specify the documentation requirements. 

Staff should be told the reason for change and you should employ some means of ensuring that where changes to documents require a change in practice, adequate instruction is provided. A system that promulgates change without concern for the consequences is out of control. The changes are not complete until everyone who is affected by them both understands them and is equipped to implement them when necessary. 

Ensure your quality system procedures identify all the types of document requiring control including external documents. 

Number of different documents required by PSM and ESH programs and elements... 

The DS team spent one session compiling a list of the documentation requirements that they were aware of from their individual experiences. This documentation ranged from vessel details and drawings to accident/incident reporting to MSDSs to safety procedures. Many different departments and functions were involved. Some documentation was kept in hard copy form, while the rest was in electronic form but on several different systems. The... 

The guidance document requires calculation of actual yields and percentages of expected yields. The yield should be recorded at the conclusion of each phase of manufacturing of an API. The expected yield and ranges are established during process validation or from a pilot-scale production run [66]. 

The project may or may not be complete when results are delivered to the client. Often there are documentation requirements such as operation manuals, complete... 

Documentation is another essential ingredient in all quality systems. It serves as a mantra for auditors and inspectors that ... if it is not documented it does not exist or it never happened . The documentation requirements can be split into two main categories (i) procedures outlining what must be done and (ii) records showing what has been done. 

Documentation Requirements (Quality Manual, control of documents and records)... 

Documentation requirements - Create quality policy, quality manual, procedures, and document control and distribution function. Retain records for the expected lifetime of the device or a minimum of 2 years... 

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

All application verification and soil samples must be individually labeled with unique sample identification (ID) and other identifying information such as study ID, test substance name, sample depth, replicate, subplot and date of collection, as appropriate. Proper study documentation requires that sample lists and labels be created prior to work commencing in the field. Water- and tear-resistant labels should be used since standard paper labels may become water-soaked and easily torn during sample handling. Sample lists should have the same information on them as the labels and are a convenient place to record plot randomization, initials of the individual who collected the sample, and date of collection. As such, the sample list is important in establishing chain of custody from the point of sample collection until its arrival at the laboratory. 

Tetzlaff, R. F., GMP documentation requirements for automated systems, Part... 

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