Auditors training/experience

Customers are likely to require internal auditors to at least have taken an Internal Auditor Training Course that meets the requirements of ISO 10011 but are unlikely to require Lead Auditor Registration. VDA 6.3 on Process audits requires the auditor to have at least two years practical experience in process management in the automotive industry and to have performed at least three process audits with the support of a technical expert from the process area. 

HD 19/03 has specific requirements for Road Safety Auditors training and experience requirements. Three categories of Auditors are specified Team Leader, Team Member and Observer. The requirements for each category are as follows ... 

In terms of qualifications, Australia appears to have the most demanding recruitment requirements for GMP inspectors. The TGA s GMP auditors need to have worked in industry before their appointment and undergo 6-12 months formal training after appointment. Similarly, GMP inspectors in the Netherlands must have acquired experience in the pharmaceutical industry. 

Any portion of the study that is a "field study" may also be audited. A field study auditor would inspect many of the same items already mentioned, but at the field site location. These include the training and experience of the field personnel, the calibration and maintenance of equipment, the field management and operations, the test substance application, and the sampling. Special problems are sometimes encountered in the field because the site is physically displaced from the main site of the study. Despite the physical displacement, the equipment must still be calibrated and maintained, the protocols and SOPs must be followed, there must be proper record-keeping, and there must be regular inspections by the QAU. 

There is no standard professional education for QA auditors and, therefore, practical experience is indispensable before embarking on the QA job. Before joining the QA department, the QA candidate may have worked in clinical monitoring, data management, pharmacovigilance, regulatory affairs, training and other areas of clinical research. 

QA auditors are often actively involved in providing training on GCP and regulatory topics related to clinical research. They gain first-hand experience regarding interpretations, shortcoming... 

Those individuals who are selected to perform audits or inspections should be qualified by having previous work experience in that area. They should also be trained and educated on the company s audit approach and the use of its audit instruments. The auditor must understand the technical aspects of operations and be familiar with all job procedures, manufacturing processes, and company policies. The individual(s) who perform the inspection should have good problan-solving skills and possess investigative abilities. Auditors must work independently, be objective in their assessments, and possess skills to communicate effectively. 

The inclusion of training and experience requirements in the Standard was welcomed by most experienced Road Safety Auditors but caused some problems in the wider Road Safety Audit community. Although the requirements are for guidance only, clients often insist on the Road Safety Auditors complying to the letter. Some smaller local authorities initially found themselves without sufficient numbers of qualified auditors but many have now achieved compliance or are working towards it. 

In order to ensure that Road Safety Auditors comply with the experience and training outlined above, HD 19/15 requires at least one member of the Road Safety Audit Team to have a Certificate of Competency (see Chapter 4). 

There are very few HA standards where such specific requirements are included, and this situation could be said to have created anomalies. For example, there are no prescribed training and experience requirements for a designer of a traffic signal junction, but the Road Safety Auditors checking the scheme may need to comply with HD 19/15. 

The 2003 standard introduced the concept of three levels of Road Safety Auditor (Team Leader, Team Member and Observer), and described the training and experience required for each level. These are described in Chapter 3 of this book. 

To achieve a Certificate of Competency in Road Safety Audit via this route, a Road Safety Auditor must demonstrate that he or she has the required training, skills and experience set out in the HA standard to become either a Road Safety Audit Team Leader or a Team Member. This is achieved by the candidate producing a portfolio of work that can be checked by a professional body. 

Road Safety Audit guidelines and procedures were introduced in 2008 for internal roads by the Municipality of Abu Dhabi City (2008). In 2010, the Abu Dhabi Government produced Road Safety Audit Procedures for Main Roads (Abu Dhabi Department of Transport, 2010). Both procedures were based on a combination of guidance taken from the UK and the USA, and require practising Road Safety Auditors to meet minimum training and experience requirements similar to those outlined in the UK s Safety Audit standard. 

The document requires practising Road Safety Auditors to meet minimum training and experience requirements similar to those outhned in the UK s Safety Audit standard. 

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