Audit team, formation

ICH GCP (1995) defines an audit report as A written evaluation by the sponsor s auditor of the results of the audit . Format and layout of audit reports vary greatly between companies and can range from a simple list of audit findings to a detailed description of all audit areas, observations and conclusions. The lead auditor is responsible for preparing the audit report and should be assisted by the entire audit team. Ideally, the audit report should be prepared as soon as possible after the audit. The report should be a complete and accurate representation of the audit conducted, and not include opinions or assumptions. 

A format for recording the Road Safety Audit Team members comments is shown above. 

It is best when an auditor or a particular audit team repeat audits around three times (or three years). This would allow this auditor or this team to have audited this facility three times. During this time frame auditors can not only build a relationship with local management at the branches, but also ensure that progress is being made. Changing auditors for every audit can lead to confusion and a general lack of continuity. Three years would be the maximum time that the format of the audit would remain unchanged. Because the safety culture would have developed substantially over that three-year period, the audit form would probably need to address a different level of issue. 

Audits are undertaken to ensure OE programs and processes are properly implemented and maintained and to provide information to management for improvements. The OE audit should include the objective and criteria to be used, activities, and areas to be covered, frequency of audits, composition and leadership of the audit team, how the audits wiU be conducted and method and format of audit reports (see Figure 10.1 and Table 10.1). 

A format for recording each Road Safety Audit Team Member s comments is shown below ... 

As with audits, survey results form the basis of a facility-specific report for circulation to facility management and the PSM team. This report may follow the questionnaire format, with responses tabulated and analysis and commentary provided at the end. If necessary, baseline PSM assessments can be performed by a single individual using a survey method. 

This audit led to the formation of two teams, one to tackle locomotive design issues and the other for safety reporting and action. As a result of team activities, many ergonomic actions were implemented. These included management actions to ensure a uniform wagon fleet, autonomous inspection/ repair teams for tracks, and multifunctional teams for safety initiatives. 

Road Safety Audits are always documented in formal reports, but do not necessarily follow a standard format. Each audit is a unique effort that is tailored to the particular location or project, and the resultant report will follow general guidelines. The report format is determined by the team leader. A report may include ... 

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