Quality system inspection technique

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

The new medical device regulations were codified in 1996, significantly altering the way in which medical device manufacturers were inspected by the FDA. The quality systems inspection technique (QSIT) was launched as part of the new strategy for inspecting the device industry. This inspection technique allowed FDA to move closer to global harmonization guidelines... 

The emphasis of inspections is moving away from particular products toward general operational capability. This move was hrst evident in the Quality Systems Inspection Technique (QSIT) adopted by the FDA for medical device inspections in January 2000. Companies are considered out of control if any one of the main quality management controls inspected is found noncompliant with regulatory requirements ... 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

Before we can define the mission for any particular test or inspection system we must be able to specify customer needs. While a detailed framework for designing inspection systems is given in Section 7, we must consider now how to define such needs. One way is to apply a failure modes and effects analysis (FMEA) to the product and design a test and evaluation system to cover each of the potential failure modes. But this technique does not make the customer an explicit part of the design process, whereas we have seen earlier (Section 1) that direct customer input is increasingly needed in more customized products. A preferable technique is to begin with customer function and quality requirements as the basis for a list of product attributes that form the basis of test and inspection. In attributes inspection (Section 2.1), this list is often a defect list or fault list defining the discrete defects that the inspection system must ensure the customer never experiences. 

In order to monitor the success of a safety program, both a successful auditing program and quality safety metrics are needed because audits are another technique used in the evaluation and data collection process of the program. An audit or inspection is the monitoring function conducted in an industrial organization to locate and report existing and potential hazards, or man-environment systems or conditions, that have the capacity to cause accidents or illnesses in the workplace (Petersen 1998). 

With the availability of hardware, questions in quality control of foods are addressed also with LF-NMR imaging. One example is non-destructive fruit inspection, where a volumetric, but spatially resolving technique is needed. Extensive research has been done in seeds detection , with the main focus on the online capability and the methodical development to fulfil the constraints. In , the focus is the examination of motional effects in the online application Mandarins are conveyed through a 4.7 T NMR system with 54 mm/s, applying fast imaging sequences (FLASH) to minimize motional artefacts. 

Reviewing documentation is a standard safety conformance appraisal (audit) technique. It is important to understand whether hazards are tracked to completion and if the tracking system is effective. In addition, it can be used to determine the quality of specific activities—for example, activity-based safety, behavior-based safety, self-inspections, or routine hazard analyses. 

Nondestructive Testing (NDT, NDE, NDi, NDC) -Techniques used to examine the quality of adhesive bonds without causing damage to the item or bond. The terms NDT (Testing), NDE (Evaluation), NDI (inspection) and NDC (Characterisation) tend to be Interchangeable. Nondestructive inspection systems may be manual or automated to some extent. Whilst effective for finding defects in the bond, no method currently exists which allows a reliable, quantitative measure of bond strength. 

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