An audit is a process of gathering evidence to evaluate how well an organisation’s processes and procedures match a set of audit criteria. Audits are therefore always carried out against a defined set of criteria. In the H&I laboratory for instance CPA and EFI have defined standards against which audits are undertaken. Evidence gathered from an audit is used to determine how well policies are being implemented, how well procedures are being applied and how well requirements are being met. Audit evidence includes records, factual statements, and other verifiable information that is related to the audit criteria being used.
Horizontal, Vertical and Examination audits are three types of audits prescribed by CPA. A Horizontal audit examines one element in a process on more than one item. An example from an H&I laboratory would be examining the sample reception element of the laboratory testing process for multiple samples. Such a sample reception Horizontal audit would consists of a detailed check of all aspects of the quality management system for sample reception, including checking for the existence of SOP’s, checking that any process documentation such as worksheets that need to be filled in are being completed correctly and fully, checking the training records of the staff involved and that any policies described in the Quality Manual, for instance sample labelling policies, are being fully implemented. This would be repeated for multiple samples.
A Vertical audit examines multiple elements in a process, on one item. An example from an H&I laboratory would be to take at random a single laboratory result report and trace all the activities that contributed to the final report, checking that all activities conformed to the pre examination, examination and post examination and quality management system procedures of the laboratory. A vertical audit is constructed to consist of a number of questions based on the standards being examined. Typical questions include is the request form available for the randomly selected sample, are there written procedures covering sample reception, is there evidence that the laboratory tests being used have been validated, are there written procedures for internal quality control of tests, if equipment is being used is there evidence of calibration and service history, are there written procedures for reporting of results, does the report meet the requirements of the standard, are there documented procedures for storage of process and sample records and for storage and disposal of clinical material and is there evidence of staff having the appropriate qualifications and training for the tasks they are undertaking.
An Examination audit examines a person undertaking a test procedure. There are two objectives in an examination audit. Firstly, to ensure that what is being done reflects what is described in the Standard Operating Procedure (SOP) and secondly to check that the person carrying out the examination has a good understanding of all aspects of the examination. H&I laboratories are required to carry out regular internal examination audits. In a typical external CPA lead audit, each of the two auditors will carry out a minimum of two examination audits. If the laboratory carries out specialist screening services or is required to report to an external agency, then at least one examination assessment covering this area of the work is carried out.
The CPA provides an examination audit report form which is used to report external examination audits and can be used for internal examination audits. The form provides for recording details of the examination that is audited including the SOPs that are used in that examination. It also allows a space to provide evidence that the operator has an underpinning knowledge of the procedure.
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