Audits integrity

Maintenance (Mechanical Integrity) —Pre-Startup Review —Management of Change —Safety Audits — Accident Investigation... 

Pre-Startup Safety Review Mechanical Integrity Hot Work Permit Management of Change Incident Investigation Emergency Planning and Response Compliance Audits Trade Secrets... 

The team should be realistic about the time required to see improvements in end-of-pipe measures in most cases the pilot project success will be measured on efficiency improvements and other in-process measures alone. In this case it is important to demonstrate that all PSM and ESH issues are being managed. You should consider having a management systems audit (validation) conducted by a group independent of the integration project team. This may be done in conjunction with the next scheduled audit. This may be a corporate or divisional audit function or a consultant engaged specifically for this task. 

Some deficiencies in the integrated systems may be seen at once others will be visible only after project resources have been withdrawn and the system is self-supporting. It is important to examine the integration straight after installation and a few months later. These reviews should draw on the results of the independent audits and should involve staff from the pilot... 

Number of audits conducted. This measure is most useful when compared to the planned number of audits and the number of findings per audit. These data allow the number and frequency of audits to be varied, for example, if the number of findings per audit is low the number of audits might be reduced. This measure can also be used to compare to the number of audits that were required before the systems were integrated. 

This potential for consolidation in the area of documentation systems was used as an example to sell the overall integration concept. Documentation was an area of constant complaint and senior management could easily visualize opportunities for improvement in basic resource requirements, as well as secondary effects on resources for training, auditing and other activities. Exhibit 10-1 was a key part of the presentation that the VP, ESH made to senior management. 

However, many of these tools, while enabling markedly faster and more detailed analysis than paper-based methods, still mimic static, one-by-one paperlike reports with no real-time auditing capability. Moreover, these COTS do not have integrated data analysis and automated data screening capabilities and are not optimized for systematic analyses. Furthermore, the ad hoc analyses that these COTS produce lack interactive, automatic auditing reproducible functions. Thus these tools are often used to produce the same dense, unwieldy paper tables of counts and percentages that were created manually before personal computers became ubiquitous. 

Traditional analytical methods make extensive use of computers, but typically these methods still require constant restructuring of the data and multiple analytical tools. This endless restructuring wastes time and productivity and also makes the analytical processes difficult to document, audit, and reproduce in real time. This situation also makes it difficult to reconstruct and update analyses in real time when new adverse event data become available or when new questions need to be asked. The application of comprehensive data standards allows the use of integrated, reusable software for analyzing adverse event data. This integration facilitates the reproducibility of the results. 

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. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

The integration of different forms of study information from various locations and sources is possible with electronic information. Both study management and quality assurance are addressing critical issues associated with this process. Study Directors must now keep track of more data and study reports than ever before. Quality assurance (QA) departments must have systems in place to audit electronic data. 

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

The audit review should cover five main areas raw materials and utilities, processes and integrated source control, end-of-pipe emission control systems, final emissions and discharges, and storage and handling.91213 Risk category is usually identified as high, medium or low (H/M/L). 

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