Audits management issues

On completion of an audit and before the auditors leave the premises, the management of the site will be briefed as regards the main observations during the audit. Where issues arise, FDA inspectors use Form 483 to present the manufacturer with a list items that may be deemed as non-compliant with the regulations. Should any non-conformances be highlighted at the audit close-out session, management should state their commitment to correcting these and, if possible, indicate what the... 

The management system is owned by and is the responsibility of the top management, ft is incumbent on the management to review the overall effectiveness and currency of the system and the range of services offered by the laboratory. This should be done annually, and should include input from internal audits, clients, staff, and quality control records. The review should also consider supplier performance, wider management issues, and any changes that have affected the laboratory. The review should be used to... 

A tool intended for use by a range of personnel should be easily and rapidly employed and its results should be repeatable and auditable. These criteria suggest that its operation should be mechanistic and based on rules. Yet, the management issues to be analysed by the intended method can have subtle, unexpected and unintended effects, which suggests that their successful exploration requires a creative approach. The method s design must therefore provide procedure-based operation, in which the procedures demand, in appropriate places, creativity. This needs to be designed for. 

The EC Directive on Road Infrastructure Safety Management issued in 2008 introduced the idea of a Certificate of Competence (EU, 2008). The Directive requires that at least one member of a Road Safety Audit Team holds such a qualification in order to carry out Road Safety Audits on highway improvements on the Trans-European Road Network (TERN). 

The regular HSS was on a month s leave. Responsibility for management of site safety and health at Site A was assigned to several individuals ineluding the response manager, the Teehnieal Assistanee Team (TAT), health and safety oflfieer (HSO), and the on-seene eoordinator. It was not elear at the time of the audit whieh of these individuals aetually fulfilled the role of full-time HSO, nor was it elear how these individuals would eoordinate and eommunieate on overlapping health and safety issues. 

Whichever the approach, the report should be presented to the manager of the area audited if several managers are affected, the report should also be presented to the manager above them. However, audit reports should not be issued to a person s manager without their knowledge and agreement. 

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. 

Product verification requires inspection and testing programs to confirm that product meets the quality requirements. In PSM and ESH terms, the product is the management of environmental, health and safety issues and may be difficult to separate from measurement (Chapter 7) and Audit. 

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. 

Line management should establish a system to provide consistent information about incidents and compliance issues, together with associated follow-up actions. Progress should be reviewed regularly, and can be recorded on a punch-list-style report showing status, estimated completion date, and whether an item is open or closed. When action items are completed, they can be moved to a closed punch-list for future audit trail purposes. 

There are advantages to utilizing an "outside" individual or organization to perform the audit. First, such an arrangement provides company management and the study director with an obviously non-biased and fresh perspective on the operation and may rejuvenate a company s interest in the activity. It would also provide a third-party look at a company s operation and confirm with company officials areas that need improvements — especially if adherence to the GLP is at issue. Such an arrangement would also... 

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