Process issues, audits

This annex of the Rules contains a flowchart identifying the key stages in the audit process from the initial request for certification through to issue of the certificate. Pre-audit is not a documentation audit. Supplier must provide all required data prior to site visit. 

Turn around time can be increased by situations such as workload distribution (i.e., delay while other samples are processed), analysis difficulties, weather interruptions, employee absence, and external audits. These issues may increase the minimum time by a factor of two or three. Such eventualities must be considered in providing your client with a reasonable turnaround time. 

Audits frequently unearth issues that must be addressed. The timetable for responding to these issues by making changes to current practice is another element of the integrity of the audit. Too long a time period makes a mockery of the audit process. 

Audits are conducted under rules of continuous communication—when a problem is found, the emphasis is on full understanding of the identified problem as well as identification of potential solutions. Deficiencies are documented and adjudicated. Contentious issues sometimes arise, but an attempt is made to resolve them during the audit process. 

There will inevitably be some conflict between safety and other issues within the audit process. Some examples are given below. 

Some audits continue to be imdertaken against design standards, rather than against the likelihood of crashes (an experience issue). Some TDesign and Construct contracts struggle to effectively deal with road safety issues within the audit process. 

This book has examined the Road Safety Audit process, provided extensive examples of road safety control data, and investigated the type of issues commonly raised by Road Safety Auditors. 

Use a target risk-based auditing process and use the last 12 months of industry data to determine issues. 

Many safety professionals believe that their expertise and experience in safety ensure that they will be competent auditors. However, competence is not the issue. If different auditors, in spite of their competence, give substantially different scores, what is the appropriate result for publication The average The score produced by the most senior auditor Reliability in this context is reliability as a measurement tool or a tool to consistently produce safer system results. Audits done by knowledgeable professionals can and do produce improved safety results if actions are implemented. We just have not found a way to predict just how much improvanent should be expected or a way to use the results to reliably measure two sites, units, groups, and so on, against one another. Without establishing reliability and validity of the audit process, we cannot use this process to determine who will have the better safety performance in the future. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

Postaudit Process The postaudit process consists of preparation of a draft report, preparation of a final report, development of artion plans, and follow-up. A draft report of the audit findings should be prepared shortly after the completion of the on-site audit. The draft report usually undergoes review and comment by facility personnel involved with the audit, experienced auditors not involved with the subject audit, functional specialists, and attorneys. The review of the draft report is done to assure that a clear, concise, and accurate report is issued, and not to modify or change the findings. Once this review procedure is completed, a final report can be issued and distributed based on a distribution list provided by the facility personnel. The final audit report should be issued in a timely manner and meet the time requirement specified in the audit plan. 

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. 

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. 

Corrective action tracking provides management with the status of audit issues and agreed-upon corrective actions. It also provides an opportunity, in some cases, to review corrective action at a later date subsequent to completion (e.g., a year later). CCPS (1989) provides more detail on the corrective action process. 

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