Quality systems staff training

Identihcation of computer systems Defined specifications for computer systems Control procedures for software programs Security access on computer systems Archiving records Quality assurance Staff training... 

Quality System (including status of required computer validation/revalidation, change control, and training/qualihcation of QA staff)... 

Many tools are in the hands of the analyst and management to adapt the laboratory to his task. Figure 1.3 shows that they are of various types. They have to be included in the entire management of the laboratory, e.g. training of staff and motivation must be planned and built in the lifestyle and the lifetime of the laboratory. Quality always pays or as W. Edwards Deming preached cheaper is not always better, better is always cheaper . It may appear to be expensive and time consuming, but it is the only way to cope with unexpected situations, e.g. absence of staff, sudden unexpected workload etc. It is out of the scope of this book to discuss all infrastructure and management aspects necessary to set up a quality system within a laboratory. 

This term has been defined as the quality specified or required by the customer , and requires active participation between the quality management and the total development function to finalise design standards which will allow and aid manufacturing compliance (with the supplier or sub-supplier organisation as well as with the customer). Additional attention has to be directed to the manufacturing facilities, documentation systems, process and staff training, which together will prevent quality deviations at source. 

To obtain a realistic assessment, the method and detail of the purchaser s evaluation of a new supplier must be formalised, and the results documented. The opportunity must be taken to view the supplier under normal operating conditions, with the involvement of the relevant technical staff. Systems of working routines must be made available and the operation of quality systems defined. The supplier company should explain its organisation (line/functional disposition), its personnel training policy, and its philosophy and commitment to quality. 

Quality assurance audits—As part of due diligence service to clients, agents frequently visit and audit manufacturing sites to train staff and upgrade the plants quality systems to the customer s standard before a client audit. 

Each country has its own accreditation body for laboratories. In the United States, NIST is administering the National Voluntary Laboratory Accreditation Program (NVLAP) [109]. The criteria for accreditation used by NVLAP is consistent with ISO Guide 25, which involves the following items (1) quality system, (2) staff competence and training, (3) facilities and equipment, (4) calibration and traceability, (5) test methods and procedures, (6) recordkeeping, and (7) test reports. 

Although it is likely that the number of staff involved will be small, there should be separate people responsible for production and quality control. All production operations should be carried out under control of a clearly identified responsible person. Personnel involved in release of investigational medicinal products should be appropriately trained in quality systems, GMP and regulatory requirements specific to these types of products. They must be independent of the staff responsible for production. 

Quality assurance (QA) refers to the planned and systematic actions and measures that the laboratory uses to ensure the quality of its operations. These measures include, amongst others, implementation of a quality system, a suitable infrastructure and laboratory environment, appropriately trained and skilled staff, calibrated and well-maintained equipment, quality control procedures. 

During an internal audit or self-inspection, trained employees of the organisation check the functioning of the quality system. They may use structured questions and checklists with which they compare the information in the quality manual and connected procedures with the actual situation. An experienced auditor will also use a more intuitive approach for instance getting information about (lack of) cooperation between sections or departments, exploring peculiarities or interviewing staff. When discrepancies are found, they will usually be classified as critical, important or minor. Subsequently corrective or preventive measures (see Sect. 35.6.15) should be taken to adapt the actual methods or the documentation in order to make them match again. 

A QA system describes the overall measures that a laboratory uses to ensure the quality of its operation. Typical items include suitable equipment, trained and skilled staff, documented and validated methods, calibration requirements, standards and RMs, traceability, internal QC, PT, nonconformance management, internal audits, and statistical analysis. 

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