Audits management expectations

Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that were identified for corrective action in a previous audit. If you are not already familiar with this facility, learn the type of product produced and how it is organized by personnel and function. What does your customer, that is, your superior or senior facility management, expect to learn from this audit ... 

Safety auditing is an exceptionally valuable process, but time-consuming and expensive. Safety professionals should not be surprised if informed managements expect substantial results from the audit process that benefit their operations. Safety and health professionals conducting audits should prepare well for their exit interviews. This means ... 

The steering or review committee will study the safety audit findings and determine if the recommendations from the audit team are in line with management expectations and vision. Most, if not all, of the audit team s findings are accepted and approved. After this acceptance and... 

Under a comprehensive quality system the QU can expect an expanded and more visible role within the organization with greater accountability to and interaction with upper management. The QU should ideally be independent of the other organizational units to assure clear delineation of responsibility and authority and avoid conflicts. In certain instances, such as auditing, independence or objectivity is central... 

People selected for the audit team must know safety and loss prevention standards and terminology. In addition, they must be familiar with Dow s Minimum Requirements and with management s expectations for safety and loss prevention performance. 

The FDA has now reconsidered and at present only requires the meaning and content of electronic records to be preserved. This is achieved typically through appropriate validation of supporting computer systems and by applying audit trails where necessary to individual electronic records. Metadata will normally be managed through computer validation rather than as part of the electronic record as required previously by the FDA. This is consistent with other regulatory authorities who only expect constructive evidence to support the accuracy of electronic records. 

The Project Manager is not expected to do a detailed audit of all invoices and backup materials, but only to monitor the critical items and point out to the accountants those areas where close scrutiny is warranted. The detailed audit is the job of accounting. It behooves the Project Manager to sit down with the Contract Engineer, at the beginning of the contract work, to review the contract, to understand all the critical provisions, and to summarize them for the benefit of the members of the project team. 

As discussed in Chapter 6, dashboards will increasingly be used to communicate process safety metrics and performance to local line management. Such dashboards may reflect current, summary, or cumulative data (such as the number of days without a leak), current conditions (such as the fill level of a tank), or the results of the most current inspection or audit. An organization s process safety metrics can evolve in a hierarchical way so that individual indicators can be rolled up from the process level to the site level and eventually even the organizational level. Dashboards can be expected to evolve similarly to report such rolled up information to upper management. 

A multitude of external providers are used to deliver services in clinical trials, for example CROs, site management organizations (SMOs) and academic research organizations (AROs). To ensure that they are capable of providing the services in a reliable manner and to the standards expected in compliance with current regulatory requirements, capability audits are conducted at service providers prior to contracting. 

While most chemicals companies buy in to the Responsible Care programme, what is being looked for here is the employment of, and a particular intention to work to, a recognised environmental management system such as ISO 14001, the European Eco-Management and Audit System (EMAS) or a management verification system such as that run by the US Chemical Manufacturer s Association. While it is expected that the company will have a significant proportion (>25%) of its production sites certified, a yes score may be achieved with a lower proportion if there is evidence that the company shows a continuous upward trend. 

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