Audit reporting results

In addition to fulfilling the in-house requirements for quality control, state and local air monitoring networks which are collecting data for compliance purposes are required to have an external performance audit on an annual basis. Under this program, an independent organization supplies externally calibrated sources of air pollutant gases to be measured by the instrumentation undergoing audit. An audit report summarizes the performance of the instruments. If necessary, further action must be taken to eliminate any major discrepancies between the internal and external calibration results. 

The audit report should state the results of the audit, what was found compliant as well as what was found noncompliant. 

As with audits, survey results form the basis of a facility-specific report for circulation to facility management and the PSM team. This report may follow the questionnaire format, with responses tabulated and analysis and commentary provided at the end. If necessary, baseline PSM assessments can be performed by a single individual using a survey method. 

Corrective action shall be used as a root for improvement. Sources of information for the consideration of corrective action include customer complaints, non-coirformity reports, internal audit reports, output from management review, output from data analysis, outputs from satisfaction measurements, results of self-assessments etc. Corrective action usually entails significant cost, which is balanced against the impact of the problem being considered before the final decision to proceed with the appropriate corrective action. 

The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 4.2.4) are defined in a documented procedure. 

The waste audit program is Intended to provide assistance to California s small quantity generators of hazardous waste. This is accomplished by issuing contracts to evaluate waate reduction opportunities in industries typically comprised of small to medium businesses. Waste-generating operations are studied to identify potentials for reducing waste, recycling or recovering resources, or alternative treatment measures. The economic feasibilities of the various alternatives are analyzed, and the study results are compiled in a final waste audit report. 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

If an outside developer is being utilized (whether developing custom software or providing a packaged COTS product), describe the steps taken to qualify the software developer. If an audit was performed, briefly state the results and reference the audit report. 

Standard procedures for conducting the quality audit should also be addressed in the Vendor qualification program. An audit cycle includes the preparation of an audit, performance of the audit, reporting of the results of the audit, and audit closure or follow-up requirements. Figure 2 illustrates the audit process. 

Upon completion of the audit, the auditors should provide the contractor with a report citing any problems which they have identified with the contractor s operation that might interfere with the contractor being able to successfully work on their company s project. The contractor should respond in writing to the audit report and address how they will handle each observation. Based on the results of their audit and the responses of the contractor, the audit team can then make a recommendation to the responsible personnel within their organization as to the acceptability of the contractor. 

The Final Audit Report includes the team s detailed cost-benefit analyses of the three to five most value-added recommendations. The steering committee then presents the audit results to the entire senior management team and the Board of Directors. 

Audit principles, procedures and techniques This includes knowledge on the ethical and professional conduct of audits, interaction with auditees and co-auditors, confidentiality, fair presentation of results and observations in an audit report and the need to be objective throughout the audit process and to base conclusions only on audit evidence. 

ICH GCP (1995) defines an audit report as A written evaluation by the sponsor s auditor of the results of the audit . Format and layout of audit reports vary greatly between companies and can range from a simple list of audit findings to a detailed description of all audit areas, observations and conclusions. The lead auditor is responsible for preparing the audit report and should be assisted by the entire audit team. Ideally, the audit report should be prepared as soon as possible after the audit. The report should be a complete and accurate representation of the audit conducted, and not include opinions or assumptions. 

Standard operating procedures represent evidence of management control. Inventories, test results, raw material assays, shipping codes, and internal audit reports all represent evidence of planning, follow through, and compliance. 

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

One might possibly be tempted to interpret the economy issue in Quality Assurance resource utilisation also in an additional way, namely that Quality Assurance could perform report audits for short-term studies in just a random fashion, analogous to the inspectional practice. This possibility, however, is precluded by the GLP Principles. They require that Quality Assurance inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately... 

QC sample analysis program and results, instrument testing and maintenance records, results of performance demonstration projects, results of data assessment, audit reports, and record retention policies. 

Supplier audit The overall goal of a Supplier Audit is to provide the pharmaceutical manufacturer with confidence in the computer system supplier and also to determine where validation efforts need to concentrated during the project. The results of this review should be documented in a Supplier Audit Report. 

SAP is working to support such an audit repository. The Industry Business Unit Pharmaceuticals (IBU Pharma) has ordered a third-party audit by KMl (Kemper-Masterson) and will provide this audit report to any prospect or customer as a first step. SAP expects this to be sufficient for a large number of customers, especially small companies. Others can base their audit activities on the results of the public audit report and investigate details that may not be covered. 

Safety audit reports are written document which the auditors compile in accordance with relevant laws and regulations in order to realize the implementation of a safety audit of the audited entity on the basis of production safety audit opinion. Safety audit report is the direct results of audit work. Safety auditors should work in accordance with the content, scope and requirements of safety audit. And the auditors should also process work papers by sorting and analysis, comprehensive, classification, analysis of audit evidence to identify problems and correct the audit opinion as well as conclusions What s more, those responsible should be asked to sign in safety audit reports. 

An often-heard criticism of safety audits is that incidents resulting in significant injury or damage occurred after the audit was completed and that the contents of the audit report had little or no relation to the causal factors for those incidents. One reason that occurs is that the audit process does not examine the procedures in place to identify those obscure hazards that are the causes of low probability-high consequence incidents. 

Mindfulness -The ratio of near miss reports versus adverse events in the voluntary incident reporting system -The extent to which external audits provide results that are in accordance with findings in internal audits or the prevalent conceptions of persoimel... 

BOEM should use this information, along with information from BOEM inspection reports and operator self-inspection plans and reports, to conduct selective audits. The results of such audits should be used to encourage organizations to improve their safety performance. BOEM should strongly encourage industry to incorporate any lessons learned into designs for worker safety. 

Review a process safety audit report. Summarize the procedures used and the resulting recommendations. Find out how the results were actually implemented. 

---