Training Auditors

Separate independent quality audit departments could be set up, staffed with trained auditors. 

Many firms rely on a C of A supplied by the supplier in lieu of actually performing required testing. This becomes a more proactive means of assuring the quality of the material. Acceptance of a C of A is possible after a partnership is established with the supplier through a formal qualification and evaluation of the supplier s capabilities and reliability. Typically the process involves an initial questionnaire, followed by an audit by trained auditors and purchasing representatives. This helps determine if the supplier is qualified to produce the material consistently and in accordance with the firm s expectations. The material then needs to be approved for use in the manufacturing process this is typically done with three distinct... 

External safety system audits were arranged, and external international auditors spent a week on the property evaluating the safety system. A four-star safety rating was achieved and issued by the National Occupational Safety Association (NOSA) of South Africa. The internal trained auditors then followed up with 6-monthly internal audits. 

Especially in the nuclear industry and other potentially high consequence endeavors, there are formal sets of rules for the QA and safety audit process. ANSI/ASME NQA-1 (ASME 2001) nuclear quality audits use certified and trained auditors and lead auditors who are also expert in the areas being audited. 

It is recommended as a reference in training auditors and in determining whether the qualifications of auditors are adequate for a particular assignment. 

The customers have little influence in the training, qualification, and selection of auditors. 

It should be recognized that there is no requirement for auditors to be trained as Lead Assessors or Registered Internal Quality Auditors. Staff need only to be trained sufficient to carry out the task given to them. 

Implementation audits could be carried out by trained line personnel supervised by an experienced quality auditor. 

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. 

Train your quality auditors to a defined standard and train sufficient auditors to enable your program to be met. 

In December 1998 I was fortunate to be invited to participate in the development of the ISO/TS 16949 certification scheme and later to represent the UK Society of Motor Manufacturers and Traders (SMMT) on the lATF Training Council, set up to design the auditor qualification program. I would therefore like to acknowledge Bob Lawrie and Robert Coles of the SMMT for providing the opportunities in which I was able to learn about the lATF and ISO/TS 16949. 

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. 

In addition, a system for making sure staff are appropriately qualified and trained for the work that they are doing must be in place. This will enable an auditor to see clearly the demonstrated competence of the staff and how this has been checked. The requirements for all major items of equipment must be listed, to ensure that the equipment in use is suitable for the task, is in working condition and, where necessary, is calibrated. For all of the instrumentation there needs to be a documented schedule for maintenance. Measurements must be traceable, that is, the laboratory must be able to show how the calibration of measurement instruments is traceable to National or International Standards. Where this presents practical problems, as in some chemical measurements for example, interlaboratory comparison and the use of reference materials (and preferably Certified Reference Materials) will be required. 

It is important to point out that post-9/11 the chemical industry sector has taken great strides to protect its critical infrastructure. For instance, government and industry have developed vulnerability assessment methodologies for critical infrastructure systems and trained thousands of auditors and others to conduct them. 

Those leading audit teams should be experienced in the audit process. All auditors should have some training in the audit process, particularly in the gathering of data ... 

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. 

Keeping a trained QA auditor on staff is expensive. If the lab does not have a full range of GLP projects it... 

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