Audits verification

Quality Politics, Quality Objectives, Audit, Verification, Accreditation, Certification, DIN EN ISO 9000, 9001, 9002, 9003, 9004, DIN EN ISO 17025, 17020 and so on. Some of the definitions of the terms are difficult to understand. It is however often only pouring old wine into new wineskins For example, simply saying that for a successful constmction project, a detailed constmction schedule is necessary, which co-ordinates the work of the trades carefully, or that for a standardised test, certain organisational sequences must be adhered to, does not constitute new inventions. Often, in themselves well-known procedures are only formalized and uniformly specified in standards. 

The GMP details certain requirements for the quahty system, such as the independence and responsibihties of the quahty control unit. It requires such activities as internal audit to monitor GMP conformance, employee training, complaint investigation, failure analysis, and verification of proper manufacture and test by QC prior to release of the batch. 

This also implies that verification of conformity cannot be extended over several audits - each requirement has to be verified on the initial audit. 

The standard requires that trained personnel be assigned for management, performance of work, and verification activities including internal quality audits. 

By producing defining specifications that prescribe requirements for products or services and also the means by which these requirements are to be verified in-house in terms of the inspections, tests, analyses, audits, reviews, evaluations, and other means of verification... 

Procedures will contain many provisions, not all of which may be susceptible to verification at the time of the audit. This may be due either to time constraints or to work for which the provisions apply not being scheduled. It is therefore necessary to record which aspects have or have not been audited and engineer the program so that over a one to three year cycle all procedures and all requirements are audited in all areas at least once. 

Product verification requires inspection and testing programs to confirm that product meets the quality requirements. In PSM and ESH terms, the product is the management of environmental, health and safety issues and may be difficult to separate from measurement (Chapter 7) and Audit. 

Audits of each phase of the study should include personnel training, preparation of collection forms, application calibration, each sample collection procedure, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage. Data collection in the field is often tedious if automated logging devices are not in place. To ensure data integrity, the paper and ink used for field studies should be waterproof. Each data collection form should contain appropriate locations for information detailing the time and location of sample collection, sample transport and sample analysis. Data collection forms should be stored in an orderly fashion in a secure location immediately upon return of field teams from the field at the end of each day. It is also important for data quality for studies to collect necessary field data seven days per week when required. In our experience, poor study quality is likely when field sample and data collection do not proceed on weekends. 

Each data point must be transferred from data sheets into spreadsheets or databases. Verification of each datum should be performed by an individual who did not enter the data being verified. Audits of each phase of the study should be performed (i.e. preparation of collection forms, application calibration, each type of sample collection, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage). 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

Part of the confusion surrounding the model testing and validation process is largely because different meanings have been attached to the terms calibration, verification, validation, and post-audit in the technical literature. As a result of the Pellston conference, I have adopted the following relationship among these terms ... 

Thus, the process of model testing and validation (considered synonymous) should ideally include the steps of calibration (if necessary), verification, and post-audit analyses. I indicate "ideally" because in many applications existing data will not support performance of all steps. In chemical fate modeling, chemical data for verification is often lacking and post-audit analyses are rare (unfortunately) for any type of modeling exercise. 

Inspections by owner include inspections, verifications, and audits of the construction of piping systems, which include fabrication, welding, heat treatment, assembly, erection, examination, and testing, in addition to the construction organization s documented procedures, personnel qualifications, and quality control records. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

A subtle shift has taken place, however. Ten years ago a laboratory might have been (appropriately) cited for poor data protection practices. Now a citation might be issued for lack of an audit trail, even with evidence that the data have never been compromised. In effect the regulatory attention has shifted back a step, from verification of data to verification of data protection devices (audit trails). The FDA now requires an automated regulatory tool as a QA monitor in all but the most unautomated laboratory environments. 

The act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services or documents conform to specified requirements is known as verification. 

The management staff responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of actions taken and the reporting of verification results (see 8.5.2). 

All relevant departments are provided with adequate resources and trained personnel for the activities related to product realization including inspection, test, monitoring of the design, production, installation, and servicing of the process and/or product. Verification and audit activities are carried out by personnel independent of those having direct responsibility for the work being performed. 

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