General Audit Form

Audit forms typically carry with them a score. This score provides a numerical comparison of the results of one facility to the other. You can imagine that with the competitive nature of human beings, the score received on audits will be hotly contested. When considering even the general audit form offered in Appendix E, an answer to every question may not be forthcoming from every facility audited however, when the audit is being performed, a certain part of the facility may be shut down or certain information may be unavailable or not applicable. So, it may turn out that not all questions will be answered. In any case, the auditor needs to stay flexible when performing an audit. 

The audit/inspeetion form that you should use ean be developed from the safety plan. A qualified person should examine the safety plan and eome up with a eheeklist that should serve as an audit/inspeetion form. Allowanees should be made to inelude items not speeifieally noted in the safety plan but that may be observed during field walk-throughs. Certain highly pertinent seetions of what OSHA uses when performing a eomplianee inspeetion of hazardous waste sites is ineluded in Appendix D. This inspeetion/audit form eovers many of the basies and ean be used a general guide. 

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. 

Another link exists between the PIF concept and the sociotechnical assessment methods described in Section 2.7 The checklists used in the TRIPOD methodology are essentially binary questions which evaluate whether the sets of PIFs making up each of the general failure types are adequate or not. The hierarchical sets of factors in HRAM are essentially PIFs which are expressed at increasingly finer levels of definition, as required by the analyst. The audit tool which forms MANAGER also comprises items which can be regarded as PIFs which assess both management level and direct PIFs such as procedures. 

A slightly different situation exists with suppliers of computer systems to the pharmaceutical and healthcare industry. Suppliers generally understand the benefits of a quality approach, but unless the pharmaceutical and healthcare industries form a sigifificant proportion of their sales, then it is unlikely they really understand how their quality approach relates to the requirements of validation, despite what the suppliers salesmen might say. For this reason, while a supplier might be Level 3 or 4 on the CMM, the same supplier is likely to be Level 2 on the validation capability framework. It is very important for pharmaceutical and healthcare companies to undertake a Supplier Audit to determine the actual capability of their suppliers, and, in particular, to assess the competence of personnel assigned to their project. 

Based on the above-described trial-related audits, systems audits can be composed of such core audit elements and enriched by additional elements to form a systems audit. In general, the scope of any study-related audit can be broadened into a systems audit. The following paragraphs describe selected systems audit further information is available in literature (DGGF, 2003). 

An energy efficiency audit and a general pollution prevention assessment of the operations for a building industry, to determine if waste reduction and cost reduction are possible. Operations conducted at this facility include form fabrication, concrete mixing and pouring, and sand blasting and acid washing to impart the finish. These concrete slabs are formulated with a variety of sands and stone specific to the needs of the customer. 

The purpose of an audit is to collect objective evidence to permit an informed judgment on the status of a quality management system. In general, there are two main forms of quality management system audit external and internal audits. 

Audits can take many forms but generally they will involve one or more interviews between the auditor and key personnel. The subject is posed a series of ques-... 

Generally, findings fall into two categories—those directly in contravention with a stated rule or standard requirement, and those that should be noted to improve operations or safety. Both need to be coordinated with and approved by the audit team leader before being disclosed to the audited site. Each finding needs to have back-up justification with evidence. The evidence should be in the form of site records or the record of the auditor s interview with one or more site personnel. 

The inspectors are usually addressed by first-name, if he or she does not present and behave in a very formal way. This is common in the United States and, however, should not be interpreted as a chummy form of address (as it may imply for Europeans). It should be remembered that the inspection is a formal administrative act, similar to a tax audit or judicial investigation, despite the relaxed and casual appearance, or speech of the inspectors. Monitor the situation thoughtful and focused, and try to help the inspector to make his or her work as comfortable as possible. The general behavior shoirld be characterized by friendliness and commitment, because people from the American culture are accustomed to a friendly and open environment. A natural smile or friendly gesture is the best guarantee that you will reach the human touch of the inspectors. 

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. 

General aspects of loss confrol are discussed in section 2.2.4. Loss control profiling is one of the major evaluation and control techniques associated with loss control management. The technique of profiling has formed the basis for a number of proprietary auditing systems such as International Safety Rating System (ISRS), Complete Health and Safety Evaluation (CHASE) and Coursafe. 

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