Review and audit

This section shall describe the methods for the review and audit of the safety aspects of facility operations, as well as the composition and qualifications of the review and audit group, the rules for group meetings, and the items to be reviewed by the group, such as changes to the licence, the operational limits and conditions, the procedures and the facility new tests experiments and procedures and evaluation of unplanned events. 

Information on the audit function of the group should be provided, including the items to be audited, the intervals between audits, and how the audit findings are addressed by the facility management within the QA programme for facility operation (see Chapter A. 18, Quality Assurance). 

Reports are usually used as part of a decisionmaking process. If this is the case, clear, unembellished facts are needed. Exceptions to this would be where the report is a proposal document or where a recommendation is specifically requested. Unless this is the case, it is better not to make recommendations. 

A report should play a key role in organizing information for the use of decision makers. It should review a complex and/or extensive body of information and make a summary of all the important issues. 

It is relatively straightforward to produce a report, as long as the writer keeps to a clear format. Using the format described here, it should be possible to tell the reader as clearly as possible  

There may be a request for a special report and this is likely to be longer and more difficult to produce. Often it will relate to a critical incident and the decision makers will be looking for information to heip them  

Audit is a business discipline which is frequently used, for example, in finance, environmental matters and quality. It can equally well be applied to health and safety. 

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Process Safety Analysis This part treats the analysis of a process or project from the standpoint of hazards, risks, procedures for making potential damage estimates, and project reviews and audits. It can be helpful to management in assessing risks in a project. It consists of the following ... 

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

The following sections will describe the project review and audit processes separately, addressing the why, when, and how for each process. 

Develop recommendations to improve the management system to prevent the existence of safety hazards, including training, checklists, inspections, safety reviews, and audits,... 

Write a transfer report, review and audit all data including raw data... 

The data obtained as a result of these reviews and audits shall be reviewed by the QA manager and sent for approval to quality control, production, and purchasing. Final release must be authorized by quality control. 

Quality assurance associates will generally be using interviews, reviews and audits as the mechanism to determine if the firm is compliant with regulations, current accepted practices (cGCP, cGLP, and cGMP activities), and internal procedures. 

Traditionally, reviews and audits may be conducted in one of three ways ... 

QA should be involved at the outset in helping to define compliance requirements. Clear responsibility needs to be given to particular QA departments to ensure ongoing provision of resource for review and audit activities. There also needs to be a clear escalation process for the QA function to progress on any compliance issues identified. 

Are project activities and dehverables reviewed and audited by quality assurance personnel Is consistency maintained across different projects ... 

Are defect prevention activities subject to quality review and audit ... 

ANSI (1988), IEEE Standard for Software Reviews and Audits, ANSI/IEEE Std. No. 1028-1988 (corrected 1989), The Institute of Electrical and Electronic Engineers, New York. 

Given the perceived failure of spontaneous reporting systems and the paucity of ADR reports/ some institutions have instituted more active methods of ADR detection to supplement spontaneous reports. Medication order screening has become a common practice in U.S. hospitals. Manual chart reviews and audits and computer programs are used for retrospective/ concurrent/ and prospective medication utilization evaluation. Certain events often prompt an evaluation of a suspected adverse reaction. These include abrupt discontinuation of a medication/ abrupt dosage reduction/ orders for antidotes and emergency medications/ orders for special tests or serum drug concentration measurements/ and abnormal results from laboratory tests and medical procedures. 

QA auditors should help investigate suspected fraud or misconduct by means of data and document review and audits at the concerned sites. Their independent and objective perspective of the situation will be important to provide an unbiased view and a valid assessment. Investigations of fraud should always be conducted by two auditors. 

We have made Process Hazards Reviews and Audits distinct from incident or accident investigations, although either of these... 

While this whole review system that has been described may sound like an overwhelming and time consuming task, the Du Pont Experimental Station is convinced that Process Hazards Reviews and Audits are worthviiile and are conducting more of them every year. 

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