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System audit meaning

The NMMS must be able to benefit from and contribute to other existing tools for measuring or understanding an organisation s performance, e.g. other safety-related information systems, audits, Total Quality Programmes, etc. This also means that the level of acceptance of a NMMS should, in itself, be considered as an important measure of an organisation s performance or "safety culture" (see Chapter 6). [Pg.33]

Internal safety system audits should take place every 6 months by a trained team of internal accredited auditors. The audit is not merely a safety inspection. A safety audit provides the means for a systematic analysis of each elanent of a loss prevention program to determine the extent and quality of the controls. It is a critical examination of all, or part, of a total safety operating system, and it is a management tool that measures the overall operating effectiveness of a company s safety and health program. [Pg.86]

A more direct role in developing safety standards and systems also means that the regulators roles of system approval and audit, accident investigation and instigating legal penalties become compromised if the regulatory body has been implicated in decisions that are found to be less than... [Pg.117]

Maximum usefulness and focus on end use. Remember that the PSM assessment phase is a means to an end the design and installation of a workable PSM system within your company. This means you may want to gather information that might otherwise not be included in comparable studies, audits, or reviews, e.g., data concerning resource allocations and requirements. If so, these considerations should be factored into both selection of your assessment method and the specific design of the tools you select. [Pg.77]

These checklists may be used to indicate compliance with standard procedures. As indicated above, a checklist is easy to use and can be applied to each stage of a project of plant development. A checklist is a convenient means of communicating die minimal acceptable level of liazard evaluadon diat is required for any Job, regardless of scope. As such, it is particularly useful for an inexperienced engineer to work tlirougli die various requirements in the checklist to reach a satisfactory conclusion. However, a system checklist should be audited and updated regularly. [Pg.441]

Only four of tiie 10 countries— Australia, Estonia, Malaysia and the Netherlands —operate an audit system to evaluate the GMP performance of inspectors or the inspectorate. Auditing of distribution-channel inspection is carried out by Malaysia, the Netherlands, Uganda and Venezuela. In Australia, GMP audit is both internal and external, and involves an extensive review of process and technical approach. Further training, advice, revision of job description, legal proceedings and dismissal of inspectors are some of the means used to correct any weaknesses observed. [Pg.72]

Peer review This involves setting up mechanisms for mutual review of dmg regulation systems. It serves as a means of external auditing, whereby the performance of one agency can be compared with that of others. Systems for international peer comparison of QC laboratories are one example. Proficiency tests are performed by the participating laboratories in such a way that each laboratory learns how well it is performing in comparison with the others. [Pg.135]

The electronic data capture systems that have become commonplace in the research and analytical laboratory allow rapid and efficient acquisition, manipulation, and reporting of vast amounts of scientific data. In addition, they have provided a means to generate a permanent audit trail which describes the conditions under which a... [Pg.1036]

Tables I and II present the results of the Work Group discussions for the screening and site-specific level models, respectively. The assessment in these tables is based on a ranking scale between 0 and 100 0 indicates situations where no testing has been attempted and 100 identifies areas where extensive testing has been completed with sufficient post-audits to validate the predictive capability of relevant models. The scores can also be interpreted to mean the extent to which additional field testing would improve our understanding of how well the models represent natural systems. It is important to note that the scores do not indicate model accuracy per se they show the degree to which current field testing has been able to identify or estimate model accuracy. Tables I and II present the results of the Work Group discussions for the screening and site-specific level models, respectively. The assessment in these tables is based on a ranking scale between 0 and 100 0 indicates situations where no testing has been attempted and 100 identifies areas where extensive testing has been completed with sufficient post-audits to validate the predictive capability of relevant models. The scores can also be interpreted to mean the extent to which additional field testing would improve our understanding of how well the models represent natural systems. It is important to note that the scores do not indicate model accuracy per se they show the degree to which current field testing has been able to identify or estimate model accuracy.
It has to be shown by means of internal audits, that the operation (i.e. the daily work in the laboratory) is in compliance with the quality system. This must be stated in the quality manual A schedule has to be defined and a standard procedure for internal audits has to be prescribed. [Pg.152]

As a result of the fundamental principles above, all computer systems performing regulated operations must protect their electronic records by means of access controls, audit trail controls, and Part 11-associated operational checks. For those computer systems that implement electronic signatures, the security and control of electronic signatures must also provided. [Pg.131]

Audit Trail An electronic means of auditing the interactions between records within an electronic system, so that any access to the system can be documented as it occurs, to identify unauthorized actions in relation to the records, e.g., modification, deletion, or addition (DOD 5015.2-STD). [Pg.177]

In business terms, auditing of software developers will allow you to assess the vendor s technical competence, vendor reaction to your company s user requirements specification (URS), vendor QA system adequacy, supplier experience with GXP systems, and quality level of vendor-prepared validation and qualification protocols. In short, vendor auditing is a regulatory expectation and auditing provides a means of assessing the supplier s ability to deliver a validatable system that will achieve the requirements of your company s URS. [Pg.225]

Autoencoders are a unique and specialized class of software. One must remember that coding is a means to an end. Data consistency is the desired result. For this reason, companies will use different dictionaries and methods to code adverse events and drugs. There is no standard other than the dictionaries used for the process. Autoencoders are usually custom systems developed by a company for its own use. Commercial autoencoders do exist, and they generally provide facilities to audit the coding and provide custom dictionaries based on the general dictionaries above. [Pg.434]


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