Audit systems audits

Reason for the audit and type of audit being performed, (e.g. mock FDA audit, documentation audit, systems audit). 

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). 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

Good The management systems audited provided reasonable protection against significant loss or noncompliance with regulations and directives. Any deficiencies found were deemed minor. Relevant management systems are documented and routinely followed. Some corrective action may be necessary. 

Needs Improvement The management systems audited provided limited protection from significant loss or non-compliance. Some required management systems may be... 

It would also have an audit system to confirm that lessons learned were indeed captured. 

Opportunities for improvement can be identified through Process and product measurement systems System audits... 

Figure 17.2 Internal quality system audit process...

The system audit process is shown in Figure 17.2. Certain activities such as the opening and closing meeting have been omitted for clarity because they are not always needed for internal audits. The product audit process would be somewhat different but the principles would be the same. Further guidance on the conduct of audits can be found in Appendix C. 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

The system audit to verify that the quality system complies with the appropriate part of ISO 9000. The system audit is a composite of a documentation audit and implementation audit (see below). This is now required in ISO/TS 16949 clause... 

Conduct a system audit at least once a year to verify that the system is still intact and compliant with the standard. 

External audits carried out by second or third parties. They include a documentation audit, implementation audit, and the determination of the effectiveness of the system. 

Despite these potential benefits, there are possible problems associated with the use of generic safety audit systems. Questions that need to be considered in the case of such standardized audits include ... 

Procedures Do Not Correspond to the Way the Job Is Actually Done. Procedures are often developed when a system is first commissioned and are seldom revised to take into account changes in the hardware or the operating regime. In addition, procedures are often not written on the basis of a systematic analysis of the task as perceived by the workers or other personnel who have to use them. The remedy for this is to make sure that individuals who are going to use procedures are actively involved in their development. In addition, effective updating and auditing systems need to be in place to ensure that procedures are correct, and available to the persons who need them. 

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. 

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