Audits concept

Another link exists between the PIF concept and the sociotechnical assessment methods described in Section 2.7 The checklists used in the TRIPOD methodology are essentially binary questions which evaluate whether the sets of PIFs making up each of the general failure types are adequate or not. The hierarchical sets of factors in HRAM are essentially PIFs which are expressed at increasingly finer levels of definition, as required by the analyst. The audit tool which forms MANAGER also comprises items which can be regarded as PIFs which assess both management level and direct PIFs such as procedures. 

This potential for consolidation in the area of documentation systems was used as an example to sell the overall integration concept. Documentation was an area of constant complaint and senior management could easily visualize opportunities for improvement in basic resource requirements, as well as secondary effects on resources for training, auditing and other activities. Exhibit 10-1 was a key part of the presentation that the VP, ESH made to senior management. 

Compatibility. See incompatible materials Compliance, audits, 114—115 Concept stage, life cycle issues, 20-23 Consequence analysis, risk assessment, 91 Corporate memory, documentation,... 

The development of specialist community teams is occurring against a background of increasing concern about the entire concept of community care which has been criticised by both the Commons Social Services Committee in f 9851 and the Audit Commission in... 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

For example, audit trails may be implemented by using database triggers. A trigger is a feature of the Oracle database, which allows code written by the user to be executed based on an event. The concept implies that the edition of a record will produce an event. The event may be defined as an insert, update, or deletion of data from a database table. 

Florence Nightingale may be considered to have first introduced the concept of quality and audit into nursing practice when she recorded mortality figures during the Crimean War. 

Records held in memory, e.g., temperature profile from an Antoclave, and retained for a period (say, 10 batches) to enable reprint, should not be disconnted as an electronic record on the grounds that it is not committed to dnrable media. Althongh the record may not have yet been saved to dnrable media, it may still be vnlnerable to nnanthorized alternation. FDA dnrable media concept was intended to exempt the keyboard buffer from audit trails. The example cited raises data integrity issnes. 

Accountability is, perhaps, a unique feature of the PNGV. Accountability consists of three elements hardware deliverables, visible milestones, and external technical audit. The hardware dehverables, which are obligations of the industry partners, consist of proof-of-technical-concept vehicles to be delivered in calendar year 2000 and production-feasible prototypes to be delivered in calendar year 2004. 

A new concept Flexibibilization of scope of accreditation or Accreditation of types of tests or Scope in testing has emerged [11] in microbiology. It has been used by German and Swiss accreditation bodies for nearly ten years in other fields. Under this concept, an accredited laboratory, which has shown solid technical competence in the past, could, after establishment of a validation file, directly incorporate the new developed test method or application inside its scope of accreditation without a separate specific inspection. This laboratory could also at any moment retry new test methods or application. Surveillance audits then confirm (or fail to con-... 

Scope of accreditation comes to refer to a detailed list of individual tests in conformity with accreditation references and reflects the situation of a given laboratory at the time when an audit is conducted. Each test is specific to a product or type of products analyzed, to a set of parameters measured, to a range of measurement applicable to this particular test, and to test methods used by a given laboratory for this particular test. Product as a concept could also be expressed as a range of product. Accreditation for a test method could drown methods considered as equivalent if they are established via identical methodology-... 

This approach is clear, strict, and comprehensible to all clients. Laboratories which perform the same functions over and over and which do not change the scope of their activity can by this means have their competence clearly established for potential clients. Due to its rigidity, any significant modification of the scope of accreditation concept would require an extensive audit by the appropriate accreditation agency. 

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