Qualification process description

As an example for a subsequent level, the second level qualification criteria for criterion A 1 (suitability assurance) are given in table SI. Table S 2 gives the second level criteria of a part (namely the quality assurance part) of first level criterion A 2 (product assurance). The second part would be a table for V V, which has not been included, as only the principle of the qualification process is shown in this paper. For the same reason, also the further details of the first level criteria documentation, product safety, system safety, interface, compensation by operating experience, error reporting, and modification are not elaborated. Thus the GOTO. .. and other references in the description part of the tables, which are the pointers to the more detailed criteria are in most cases empty. 

The PQ is the phase in which either a technical system is tested over a long period of time (e.g., water system), or a complex technical system is tested overall (connected filling line). For many systems OQ is the last phase performed during qualification. If there are only a few performance tests needed, it might be more practical to include them during OQ or process validation. Combining OQ and PQ decreases the number of documents (less documentation work in the future) and cuts approval time and effort. Again, the procedure for PQ is the same as for IQ and OQ ([develop PQ protocols, approve PQ protocols (by the quality assurance, production, and technical departments), perform PQ, work out the PQ report, and approve the PQ report (by the quality assurance, production, and technical departments)]. The documentation and test description are identical to those in the OQ phase. 

Personal qualifications are taken into account in the model concept to recognize that each person is able to carry out a variety of activities. This portfolio of possible activities can be directed at specific job descriptions that are representative for the different organizational units and work means related to the process. In Fig. 5.10, a section of the Person Net is shown. 

The Validation protocol should clearly describe the procedure to be followed for performing validation. The protocol should include at feast the objectives of validation and qualification study, site of the study, the responsible personnel, description of equipment to be used (including calibration before and after validation). SOPs to be followed, standards and criteria for the relevant products and processes, the type of validation, and time/frequency should be stipulated. The processes and/br parameters to be validated (e.g., mixing times, drying temperatures, particle size, drying times, physical characteristics, content uniformity etc.) should be clearly identified. 

In these examples, we are referring to numerous modeling aspects, such as process structures, hierarchical organizations, employee qualification, documents (data), and external or internal output as well as production and IT resources. Obviously, an enterprise model, particularly a business process model for the purpose of optimization, must be fairly complex. Moreover, it should address multiple aspects, for which numerous description methods are necessary. These various purposes determine the kind of modeling objects as well as the required granularity. 

Installable platform Description Mitigation of risks is installation test and Selection process qualification test with any platform combination Mamtenance... 

Qualification, verification and validation of models Qualification refers to the development of the conceptual model. Qualification means that the model needs to be interpreted with a sufficient confidence level. Knowledge incorporated into the model must be re-used without loss or bad interpretation by actors coming from different domains and involved in other decision processes in the enterprise (Chapurlat and Braesch, 2008, 715). Verification checks that the code does what was intended and that the model represents reality. The verification and validation (V V) definitions used in this report are adopted from the 1998 American Institute of Aeronautics and Astronautics (AlAA) Guide (2) "Verification is the process of determining that a model implementation accurately represents the developer s conceptual description of the model and the solution to the model. Validation is the process of determining the degree to which a model is an accurate representation of the real-world from the perspective of the intended uses of the model". Although V V are processes that collect evidence of a model s correctness or accuracy for specific scenarios, V V cannot prove that a model is correct and accurate for all possible conditions and applications. It can provide evidence that a model is sufficiently accurate. Therefore, the V V process is completed when sufficiency is reached. 

Because this initial decomposition is so strongly linked to a specific industrial application and its associated qualification procedure it is not possible to provide an industry independent process. Nevertheless, a description is required of the major controlling parameters which make up the definition of the Real World Problem, such as loads, design critical factors etc. When these factors are examined it is clear that the process is one of finding a taxonomy which adequately defines the terms being addressed. To illustrate the points being made the specific case of deriving a basic definition of the loads is now considered. 

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