Auditors Safety Case

The safety case is regarded as an increasingly important audit tool and of greater potential value than off-the-shelf safety audit schemes. Local managers are expected to undertake regular safety audits and are externally audited every three years. Railtrack s safety case is audited by its own auditors and also by the Railway Inspectorate, who assess Railtrack s procedures for auditing the train operating companies compliance with their safety cases (HSE, 1997 13 ff.). 

When all platforms are designed and operated to the same standards it is relatively easy to audit them. The auditor simply has to look up the appropriate code or rule in order to determine compliance. Such is not the case with a safety case system, where each platform has its own unique program against which it has to be evaluated. 

With respect to Safety Cases, the auditor or assessor has three key roles ... 

The importance of audits and how they are carried out has been discussed in Chapter 4. The audits of Safety Cases follow the same general principles, although the word assessof seems to be used in place of auditor, Either way, they are doing the same thing —they are checking that the Safety Case as implemented is meeting expectations. 

Notified Bodies, third-party bodies, which are required to audit safety cases via a contracted independent safety auditor. 

Alternatively, the quality team of the developer can review the CertPack. Although this will provide confidence to the developer about the adequacy of evidence, an independent auditor is more suitable for the long term assmance objectives of the system. Being part of the same conqjany, using the quality team to audit the CertPack may undermine the final safety case of the system. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

After the case report forms are retrieved from the investigational centers, they are typically reviewed by inhouse auditors. Medical review by a physician for safety and efficacy and review of adverse events may be conducted. The data are then entered into a computer database. 

Misconduct or fraud is a rare occurrence in clinical research, but when misconduct or fraud is confirmed the consequences can be disastrous (Lock et al., 2001 Eichenwald and Kolata, 2004). Fraudulent practices in clinical trials can lead to trial subjects being exposed to safety risks, to submitted or published clinical data being j eopardized and, if the product has been licensed based on false data, this may result in compromised patient safety. Therefore, any suspected case of misconduct or fraud should be taken seriously and be assessed -this is when QA auditors should be involved. 

There would be no need to prioritize the recommendations for risk reduction included in an audit report if resources were unlimited and all risk reduction proposals could be scheduled for corrective action immediately. But that is never the case. A safety auditor has an obligation to assign a priority indicator to each hazard/risk situation for which a recommendation is submitted in an audit report. 

However the assessment of hoist controls for equipment constructed prior to 1998 is often required as part of a safety audit and legislative compfiance assessments or as a result of equipment upgrades. These cases present challenges to owners and system auditors, particularly when serviceable components (both electrical and mechanical) may potentially be retained due to practical considerations. 

The two roles were not always distinct and neither were the job titles. Some engineers conducted inspections, even as they do today with their specialized knowledge. A newer term for persons checking on compliance is auditor. As a result, some safety engineers were engineers by training and others were not. Even today, compliance may involve engineers (see Case 1-1). 

There are two possible types of comment within an Exception Report. It may be that the client accepts an identified problem but that the recommendation cannot be implemented for various reasons. In this case, the Exception Report should describe the alternative measure to be implemented. Discussion between Road Safety Auditors and designers may help to come up with suitable alternatives. 

In this case the Road Safety Auditors will have achieved their objective — the safety issue has been addressed, albeit with a different solution. 

While the Road Safety Auditor concentrates on road safety issues, the client or design project engineer will have to weigh up the various consequences of implementing the recommendations within the Road Safety Audit Report. Generally, the project engineer will prepare an Exception Report or at least a feedback form explaining why recommendations have been rejected. However, occasionally there will be situations where decisions are very difficult and in these cases it may be necessary to introduce a system of arbitration. 

In case any of these scenarios develop. Road Safety Auditors are advised to maintain good records of their Road Safety Audit process, including any checklists used during the process, and to spell out precisely what information has been used for Road Safety Audit purposes. In the case of receiving an Exception Report on a problem at an early stage of the Road Safety Audit, Road Safety Auditors are advised to repeat the road safety problem at subsequent stages. 

However, it may be that none of these scenarios apply, in which case the Road Safety Auditors may have simply made a bad mistake, and overlooked a potential accident problem that other Road Safety Auditors would have been expected to identify. In this case there is a possibility of liability against the Road Safety Auditors. 

In the case of brand new ideas being put forward, the Road Safety Auditors may be tempted to be critical to avoid any future allegations should an accident occur. The auditors may resort to auditing to the Standards rather than trying to assess the real risks. 

Table 10.2 lists the issues most frequently rejected by the client, in descending order. In each case the Road Safety Auditors raised the issue on at least three occasions. 

Case 2. An oil refinery with almost 400 employees involves its employees in a variety of ways. Employees act as safety and health monitors assigned to preventive maintenance contractors. Employees developed and revised safe work procedures and are part of the team that develops and reviews job hazard analyses. They serve as work group safety and health auditors. 

The safety index is based on the classical indexing method—weighting the safety and hazard measure (which is dependent on the Best Case path of Event Tree). As we consider the spent time of the personal in the endangered area, the calculated risk can be acceptable if the probability of the presence of personnel is very small. In the other hand, the frequency of a fire at the enterprise is also small but safety measures can be unacceptable. This gives a signal to the auditor that safety measures have to be raised. 

Auditors and audit groups investigate whether a business or any of its organizational parts meets the requirements of occupational health and safety, and in case of technical devices, the reliability criteria as well. 

The ideal situation would be one in which a Road Safety Auditor could turn to a published source to answer all of the safety questions. However, this is not always the case. 

This chapter describes some of the iegai issues for Road Safety Auditors in the UK (or parts of the UK). It describes the circumstances where Road Safety Audits must be carried out and the reievant parts of the law that might apply in a claim regarding a Road Safety Audit. Some examples of legal cases are described. 

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