Documentation audit - meaning

If reviewers of completed forms are not the preparer, they need to be trained in procedures to audit the quality of the collected information and documentation files. This training may include means to check the completeness and credibility of the collected data by cross checking the data against other reference files, such as maintenance files or operating logs. 

The main requirement of the audit team is to collect objective evidence throughout the audit task by means of interviews with the staff, examination of documents, and observation of activities and conditions at the work or site. The following methods may be used as a guideline or as appropriate to your company s operations to achieve the audit aim ... 

Audit Trail An electronic means of auditing the interactions between records within an electronic system, so that any access to the system can be documented as it occurs, to identify unauthorized actions in relation to the records, e.g., modification, deletion, or addition (DOD 5015.2-STD). 

Whether elderly patients taking lithium received proper monitoring was questioned in a case note audit of 91 patients, over 40% of whom had deviations from practice standards. These included absence of pretreatment laboratory tests, infrequent monitoring of serum lithium concentrations, lack of adequate adverse effects documentation, and the use of risky concomitant drugs (403). In a placebo-controlled study, there was poor tolerance of hthium augmentation of antidepressants in 76% (13/17) of elderly (mean age 70 years) patients at a mean serum concentration of 0.63 mmol/1, due to tremor and muscle twitches, cognitive disturbance, tiredness and sedation, and gastrointestinal upsets (404). 

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. 

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. 

The underlying principle of GLP requires that the retention of records, other documentation, samples and specimens should provide, wherever possible, the means for full study reconstruction. Thus, it follows logically that also samples from each batch of test and reference item should be collected and retained. In this way it can be ensured that any questions regarding the quality, purity, stability and identity of the test item, that might turn up during the Quality Assurance audit or the scientific assessment of the study, could be resolved by an independent analysis of the reserve sample, without necessitating the repetition of the study itself in case of major doubts about the test item. The requirement that a sample for analytical purposes from each batch of test item should be retained would therefore not seem to pose major problems of interpretation and implementation. 

The benefits of having a quality management system are that we have a form of internal quality control that allows us to have consistency of the service we provide. Our work will be verified, documents checked, and internal quality audits conducted. This means that we are continually assessing the practices set down in the documents of the quality management system. 

The auditor will have to be selective regarding the documents that he reads and the people who are chosen for interviews. There simply is not enough time to read and discuss everything. An experienced auditor will sense where the soft spots are and, based on the information received to that point, will use his or her experience to choose the follow-up questions. For example, if the operating procedures on the facility being audited are much shorter than the operating procedures on other similar facilities, he or she may choose to investigate this element with increased scrutiny. The shortness of the procedures may indicate that the facility has a deficiency in this area (or it may mean that they were very well written). 

Most of the system safety effort involves providing a service. That service is to identify, analyze, and control hazards as early in the life cycle as possible in order to produce cost-effectively a safer end product. Several products are produced as part of the system safety effort. These products (all documents) communicate and document risk information to management and provide a means of monitoring and auditing the effort. 

Once the technical work and analysis is completed and the appropriate documents developed, reviews and audits of the technical work and resultant documents must be performed. Depending upon the consequences of the hazard identified in the safety function, a certain, defined level of independance is required between the originator and reviewer (assessor). This may mean a different department within the same company (preferrably one that has expertise with functional safety management and lEC 61508/62061) or outside certified SIL reviewers/ assessors. 

For carriers that use an electronic mobile communication/ tracking system that does not meet the standards, there is one word of warning. The records from these non-qualified systems must still be retained for six months and can (and will) be requested and used as supporting documents during an investigation or audit. The fact that the system does not qualify only means that the carrier cannot use it to ease the supporting documents recordkeeping requirements. 

The Quality Management department is expected to carry out regular target-performance comparisons of specifications and requirements, document the evaluations, and provide management with information on the results. For all possible discrepancies from the desired state, for example, complaints, results out of specification (OOS), changes, deviations, and audit results (internal and external audits), the appendant information are collected centrally and processed by means of the Corrective And Preventive Action (CAPA) system. These monitoring and control functions are performed by the staff of quality management. 

Typici stakeholders in model evaluation are the model developers, safety officers in industry and consultants applying models during preparation of safety reports, and authorities facing approval of these safety reports. The preferable approach is that either a model developer or a user is able to undert e the evaluation. An independent agent with appropriate expertise can also undertake the evaluation. Because the question of impartiaUty may be raised, the relation between the evaluator and the model should be documented. In each case, however, the evaluation report should be fully verifiable (e.g., by means of an audit). 

For the structured over-all analysis of deviations the Corrective And Preventive Action system (CAPA system) can be used. This system means to document, analyse, solve, and if possible prevent all problems and deviatiOTis. It uses data from other quaUty assurance systems, such as complaints, deviations, recalls, out of trend (OOT) and out of specifications (OOS) data, notices from internal and external audits. By combining aU these data in mie system, a better overview of confounding factors is obtained, which enables an organisation to address problems structurally and prevent recurrence. 

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