Auditor’s report

The Companies Act 1985 requires all hmited companies to produce annual accounts and to give a copy of them to the Registrar of Companies for filing the public has access to these files. The Companies Act further requires that the company accounts should include a balance sheet, a profit and loss account and an auditor s report. It also requires the disclosure of a substantial amount of supplementary information. Companies which fall below certain size thresholds are exempt from some of these provisions. As mentioned in Section 2.2.3, companies whose shares are traded on a stock exchange are also subject to disclosme rules imposed by the stock exchange these requirements are more stringent than those imposed by the Companies Act. 

The External Auditor shall transmit his report and opinion and the audited financial statements, in accordance with any directions given by the Conference of the States Parties, to the Executive Council. The Executive Council shall examine the audited financial statements and the External Auditor s report and opinion, and shall forward them to the Conference of the States Parties with such comments as it deems appropriate. The External Auditor s report and opinion and the audited financial statements shall be submitted to the Executive Council preferably not later than 31 May following the end of the financial period to which they relate. 

The Director-General shall report semi-annually to the Conference of the States Parties, through the Executive Council, on the implementation of the recommendations of the External Auditor as contained in the External Auditor s Report on the financial statements of the OPCW and as endorsed by the Conference of the States Parties. 

The External Auditor or his representative shall be present when the External Auditor s report and opinion is first considered by the Executive Council. In addition, the External Auditor or his representative may present his report and opinion to the Conference of the States Parties if he considers this necessary, or may be present during subsequent consideration of the External Auditor s report and opinion by the Executive Council or the Conference of the States Parties, if so requested by the Council or by the Conference of the States Parties. 

The External Auditor shall report in writing to the Conference of the States Parties on the financial operations of the period. The External Auditor s report should include ... 

Authorization to provide the final report to the lATF shall be specified in the certification contract. The auditor needs to advise the supplier at the Closing Meeting that a copy of the full report will be supplied to the lATF This also implies that the lATF is the auditor s customer. 

The notebook used should be a laboratory-type notebook with bound pages. The notebook should be clearly labeled as to the audit type, date, and auditor(s). Many auditors prefer to use a notebook for a single audit so it may be filed with the checklist and the final report. 

Signature page for auditor(s) and date of finalization of report... 

Howard Garston-Smith, formerly of Pfizer, has published a book on software quality assurance. It provides a postal audit checklist reproduced in Appendix 7C. If the supplier has already prepared an internal ISO 9000 mapping or an internal audit report on how it aligns to industry standards such as the GAMP Guide, this can be offered as an alternative to the auditor s postal checklist. A reduced postal checklist may be agreed upon, at the very least. Wherever possible, photocopies of actual example documents and test records should be inspected for documentary evidence of validation. Remember that the pharmaceutical and healthcare companies are themselves being inspected for documentary evidence of validation. 

Suppliers should be advised at the outset of an audit that they wiU be accorded the opportunity to review and correct a draft of the Audit Report before it is issued, as we have mentioned above. There should also be some agreement as to the timetable expected for the issue of a draft report. It is not proper for a supplier to seek to approve the audit report since that could amount to an attempt to gag the auditor. By permitting the audit in the first place, the supplier has effectively given the auditor permission to exercise his/her professional impartiality and this freedom may not subsequently be withdrawn. The contents of the report are the auditor s opinions and should not be influenced except where they are based on factual misconceptions that must be corrected by the supplier. The auditor has a duty of care to the supplier to permit this. The supplier should retain a copy of the draft Audit Report with a note of their review comments. A final copy of the approved and issued report must also be furnished to the supplier by the auditor as the basis for future business relationships. 

In the previous GCP guidelines, the auditor s activity was confined to the company. The auditor used the CRF as a source document and checked the clinical database and final report against it. 

However, an auditor may report that many of the elements of the standard to do with operating procedures have not been completed and so the audit requirements have not been met. It is namral at this point for the facility management to ask the auditor to offer an opinion as to the causes of these failings. If the auditor does offer an opinion then he or she has moved into a reviewer role. An auditor s opinions and insights may be extremely valuable, but they are not a part of the formal auditing process. 

An auditor must always be independent of the facility being reviewed and must always have complete freedom to observe and report on aU aspects of the operation covered by the auditor s Scope of Work. His or her outside perspective not only ensures that there is no conflict of interest it can also provide alternative points of view that can be helpful to the people working within the facility if he or she is asked to offer advice following the formal audit. 

The auditor must be carefiil not to personalize his or her work. The identification of a deficiency does not symbolize success, nor is it a personal triumph. The auditor s job is to report facts as dispassionately as possible. 

The auditor should prepare a draft report as quickly as possible. No matter how effective the auditor s note-taking may have been there will always be some observations and facts that were not properly written down. These should be captured before the auditor forgets them. It also gives the client an early opportunity to correct any factual errors in the report. 

Whenever the scope of the External Auditor s audit is restricted or he is unable to obtain sufficient evidence, he shall note the matter in his opinion and report, making clear in the report the reasons for his comments, and the effect of any restrictions or lack of evidence on the financial position and the financial transactions recorded. 

VAGO. Road safety camera program Victorian Auditor-General s Report. 2011, Victoria, Australia. 

Examples of Quality Audit report forms are shown in Tables 9.5 and 9.6 at the end of this chapter. Table 9.5 shows Report Form 1 which includes a record of what has been examined, so that subsequent audits can examine other aspects of the laboratory s operations. Note that when improvement actions are required, the form records not only what needs to be done, but also by when it must be completed, as shown in Table 9.6 (Report Form 2). The form is signed by the auditor and the responsible person from the area being audited. In the UK, the accreditation body UKAS refers to the corrective action as improvement action . This further emphasizes the continual improvement aspect of the ISO/IEC 17025 and ISO 9001 Standards. The examples shown in Tables 9.5 and 9.6 will probably have to be modified to meet a laboratory s particular requirements. It should also be remembered that both report forms should indicate (usually as a footer or header) the title of the document, its issue date, issue number, who authorized the document, page number and total number of pages. 

The new GCP requires that sponsors shall compile plan and operating procedures on auditing and implement auditing in conformity with the plan and the procedures, thus auditors audit not only the sponsor s in-house process but also processes at study sites. Within the sponsoring company, usually aU CRFs and study reports are subject to the audit. Study sites are selected for audit based on auditors SOP, usually based on sampling methodology. Audit certificate for each clinical trial is required to be incorporated into new drug submission dossier. 

The EPA and FDA audit is a formal process involving advance notice, planning and scheduling (Figure 8.2), and a follow-up report, as well as the actual on-site observations and interviews. The advance notice includes an announcement of what specifically is to be audited. When the auditors arrive, the study director and lab workers are interviewed as a group, in what may be called an "opening conference," and the audit plan is laid out for everyone s full understanding. Included here would be a review of the purpose... 

Based on technical report 32, PDA has established a third party inspection program in the field of software suppliers. It works like the one described for IPEC s BPE GMP audits. By March 2002, 117 auditors had been certified, and the audit repository center, as the service provider licensed by PDA, lists 22 audit reports [33]. 

Exit conference agenda—expression of auditor appreciation for the vendor s time, discussion of final report format, and summary of audit findings... 

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. 

There is also voluntary guidance that has been issued with respect to the desirable attributes for a sustainability assurance provider (auditor). In GRI s Sustainability Reporting Guidelines, a number of issues are recommended for consideration by organizations as they select their assurance provider (GRI, 2002) ... 

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. 

Preparing for the site audit requires the review of key trial documents before visiting the site for the on-site part of the audit. The QA auditor should review at least the trial protocol (and amendments), the current investigator s brochure (to the extent necessary). Ideally, the following documents should be studied as well before the audit any site-related documents including the IEC submission and approval, approved informed consent form used at the site, monitoring reports for the... 

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