Audits report

Postaudit Process The postaudit process consists of preparation of a draft report, preparation of a final report, development of artion plans, and follow-up. A draft report of the audit findings should be prepared shortly after the completion of the on-site audit. The draft report usually undergoes review and comment by facility personnel involved with the audit, experienced auditors not involved with the subject audit, functional specialists, and attorneys. The review of the draft report is done to assure that a clear, concise, and accurate report is issued, and not to modify or change the findings. Once this review procedure is completed, a final report can be issued and distributed based on a distribution list provided by the facility personnel. The final audit report should be issued in a timely manner and meet the time requirement specified in the audit plan. 

An action plan shoiild be developed by the appropriate personnel of the audited facility to address any deficiencies stated in the audit report. Action plans should state what is to be done, who is responsible for getting it done, and when it is to be completed. Ration e for not taking any action for any of the stated deficiencies should also be documented. The action plan is an important step in closing the audit process. 

The final audit report, action plans, progress reports, and any closure report should be retained by the facility based on the facihty record retention pohcy. Typically, these items will be retained until future audit documentation replaces them. In some cases, audit records are retained for the life of the plant. 

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. 

Audits, reports, fiscal controls, intended use plan sec. 606... 

Surveillance audits Consultancy Auditor database Auditor qualification Audit reports Minimum audit man-days... 

The audit report shall provide a full report on the operations audited consistent with the content of Annex 1 of the Rules. The audit report has to contain more detail than an equivalent ISO 10011 audit report (see also Annex 3 requirements). 

Actual man-days have to be reported in the audit report. 

The standard requires suppliers to define the type and extent of control exercised bp the supplier over subcontractors and goes on to require that these controls be dependent upon the type of product, the impact of the product on the quality of the final product, and, where applicable, on the quality audit reports and/or quality records of the previ-ousty demonstrated capability and performance of subcontractors. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

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

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. 

Don t copy the audit report to anyone other than the auditee s manager without the manager s consent. 

Based on the audit findings, the team typically issuesa report that summarizes the status of current management systems and identifies pacesetter programs and areas of non-compliance or exceptions. These findings should be provided both to the facility manager and to the PSM team, for consolidation into overall recommendations. A sample audit report is shown in Figure 4-5. 

This sample uses CCPS PSM Element 5, Management of Change, to illustrate a useful audit report format. The full report would include similar treatment of the other 11 PSM Elements. 

FIGURE 4-5. Baseline Audit Report for Management of Change... 

The evaluation of existing systems and the most recent audit reports provide a baseline for efficiency and cost performance from which any improvements can be measured. Historical performance will provide a baseline for end-of-pipe improvements. The measurement system itself will measure improvement the initial record of performance provides a baseline... 

The types of records needed to demonstrate adherence to requirements and standards as well as effective operation of the quality (ESH/PSM) management system are covered in this element. In addition to many of the quality records listed (e.g., inspection reports, audit reports, operational procedures, and drawings), ESH/PSM requirements might include training records, permits, hazard analyses, audit and other response plans, and accident/inci-dent investigation reports. 

The aforementioned reviews and assessments were assimilated to characterize the effect of dielectric, rotational, and mechanical hazards on motor performance and operational readiness. Functional indicators were identified that can be monitored to assess motor component deterioration caused by aging or other accidental stressors. The study also includes a preliminary discussion of current standards and guides, maintenance programs, and research activities pertaining to nuclear power plant safety-related electric motors. Included are motor manufacturer recommendations, responses from repair facilities to a questionnaire, in-service inspection data, expert knowledge, USNRC-IE audit reports, and standards and guides published by the Institute of Electrical and Electronics Engineers (IEEE). 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

In-life or critical phase audits must be completed in a timely and efficient manner. They must not detract from the conduct of the study or interfere with the execution of critical activities within the study. However, QA must be able to clearly determine the actual progress of the study. Audit reports must clearly identify the actual findings of the audit. The reports must be relayed to the Study Director and to study management in a timely manner. If deviations occur or if minor findings are reported, they must... 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

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. 

A GLP audit report will identify any deviations from the GLP principles or other deficiencies found at the time of audit. These deficiencies may be minor ... 

The auditor should summarize the findings, both good and bad, noting the number of observations made on Audit Report Form 2 (Table 9.6). 

Table 9.6 Example of an audit report form where improvement/corrective action is required... 

Under the audits section of the PSM standard employers are required to certify that they have evaluated their compliance with the standard at least every three years. The recommendations from the audit must be followed. The audit reports need to be retained as long as the process exists. 

Thus, while the submission of fidly audited reports is preferable, the agency does allow for the use of incomplete reports. 

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. 

Times given are for a QA audited report, from completion of the in vivo phase of the study, but excluding any recovery period. It is possible to reduce these times by one-third if given adequate priority. 

QAU Report Following the audits described above, the QAU discusses the findings with the study director and writes an audit report. The study director responds to the QAU report in writing the report is given to the management, signed, and included in the final report. 

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