Inspection process-based

On a daily base the fiinetioning and the sensitivity of the system is tested to ensure the quality of the inspection process. 

Process-based, that is, to inspect the process that the laboratory uses to perform a specific activity. 

Procedures are in place to ensure that the measurement and inspection processes are in a state of control, and that the uncertainties associated with the measurement are suitably small, so as to have a negligible effect on decisions or actions based on inspection results or measurements. 

The best way of effectively determining a maintenance schedule is by keeping a detailed log on the history of each valve. Inspection frequency should be based on criteria which is explained hereafter. We will demonstrate how to build a schedule of inspection activities based on historical data for each individually installed valve This procedure starts with installation An SRV is tagged and is given a passport containing all of its data, process data and revision dates with comments and the spare parts used and when. Actually, the basis of this passport already exists when it leaves the manufacturer (on the tag plate) and the basic records of the valve are also kept with the manufacturer for later reference. 

In view of the high frequency and routine nature of some short-term studies, it has been recognized in the OECD Consensus Document on QA and GLP that each study need not be inspected individually by the QA during the experimental phase of the study. In such cases, a process-based inspection may cover each study-type. 

It is important, whenever individual study-based inspections do not take place, that the QA statement must clearly describe the same. For instance, whether the inspection is related to process-based and when performed. The QA statement must also indicate that the final report was audited. 

Following the grinding or CMP process, the oxide thickness was measured by the conventional measurement tool using optical interference and the planarity was characterized by the profilometer. For the defect analysis, the defect inspection tool based on light scattering and AFM was used. 

These figures clearly show how a greenness evaluation of a process based only on "visual inspection of synthetic schemes can be misleading a very large part of the waste comes from isolation steps, which do not appear in synthetic schemes. Moreover, some green metrics, such as atom economy do not consider at all this portion of waste. 

The first two types have already been dealt with above and they do not need any further comments. It is the term process-based inspection that remains to be explained in some detail. 

Process-based inspections are conducted to monitor procedures or processes of a repetitive nature. They are utilised when a process is undertaken very frequently within a laboratory, and when it is therefore considered inefficient or impractical to undertake inspections of the respective activity for each and every individual study. They are therefore primarily performed independently of specific studies. It is clearly to be recognised that this performance of process-based inspections will result in some studies not being inspected on an individual basis during their experimental phases, as has been explicitly acknowledged in the QECD Consensus Document mentioned above. 

It has to be recognised on the other hand that even in study-based inspections there is some element of process-based inspecting, since activities of a repetitive nature, like the application of the test item to the test animals in a chronic toxicity study, will only be inspected on a random basis once or a few times during the conduct of the study. While it is thus customary to assume that, for the purpose of covering phases which occur with a very high frequency within a single study, a limited number of inspections will be suffi-... 

A further consideration - which follows from the one mentioned above -in terms of the validity of process-based inspections for the ascertainment of GLP compliance in the conduct of any single study not specifically inspected, is the problem of temporal relationships between inspections and the actual study activities. Thus, the more remote the last inspection has been from the study in question, the less reliability might be placed upon the inspection results in terms of their ascertaining the GLP compliance of study conduct. This issue has therefore to be given due consideration in the Quality Assurance program as well as in the Quality Assurance SOPs. 

While thus the term and the use of process-based inspections have been defined, the applicability of this inspection type with regard to study types may seem less clear. Therefore it is of utmost importance to define clearly and unequivocally those study types which would qualify for this facilitation of the Quality Assurance function. To this end, the Quality Assurance has to develop SQPs which should primarily define the circumstances under which process-based inspections may be performed and which should also present a final list of the respective study types. It probably needs not to be especially mentioned that it would certainly be advisable to develop these SQPs in collaboration with the respective Study Directors and on the basis of historical data regarding study frequencies. 

In a way, this possibility to have process-based inspections for certain study types instead of study-based ones being performed by Quality Assurance may have seemingly been contradicted by the GLP Regulations of the US... 

Therefore, for any given single study, it would be sufficient to address these issues in process-based inspections, and the requirement that each study should be inspected at least once could be fulfilled by the - in any case performed and also for short-term studies necessary - final report audit. Whether it is thus indeed the well-understood intention of GLP that each and every study, however short its duration, and however repetitive and routine its nature, would have to be inspected at least once in order to achieve full compliance, should, with regard to the wordings in the OECD Principles and the respective Consensus Document, not be a topic for debate anymore. 

It is a self-evident truth and should not need to be specially mentioned that, of course, the Quality Assurance Statement in the final study report will have to reflect this and that the relevant inspections will be clearly labelled as process-based inspections , as is shown below in the example of figure 10. 

Process based inspections At or about the time this study was in progress inspections and audits of routine and repetitive procedures employed on this type of study were carried out These were conducted and reported to appropriate Company Management as indicated above. 

Figure lo Quality Assurance Statement for a study, the experimental part of which had been inspected in a process-based manner. 

The key to the successful operation of Quality Assurance functions lies, as everywhere, in a good planning. Logically, prospective planning should concern not only Quality Assurance inspections, but it has to be applied to all of the various Quality Assurance activities. However, due to the special nature of study- and process-based inspections, and to the time restrictions connected with them, the need for proper instruments and procedures is very much obvious in this special area. Certain critical study activities may be performed in only a few minutes if the Quality Assurance inspector would wish to inspect exactly this specific phase of the study, he or she had better be present at the precise time, when this activity would be going on. Since this is a prerequisite for the required precision in the attendance at specific activities or study phases, a well developed communication network between Quality Assurance and study personnel can be seen as an obvious necessity. 

There is another point that has to be taken into account by Quality Assurance when writing (or by the Regulatory Authority when reading) a Quality Assurance statement. The format of the Quality Assurance statement will be specific to the nature of the study and thus of the final study report. While it is required for all studies that the statement include on the one hand the full study identification and on the other the dates of relevant Quality Assurance monitoring activities, these latter may be of a variable nature with respect to their connection to the study. For example in the case of short-term studies, where single or repeated inspections for each study are inefficient or impractical, where thus individual study-based inspections have not been part of the Quality Assurance activities, and where therefore the Quality Assurance statement is referring to process-based inspections only, details of the monitoring inspections that did take place must be included. These should demonstrate that Quality Assurance did in fact monitor the critical phases of... 

This latter point might best be illustrated by the case of the Quality Assurance SOP on inspections. Quality Assurance has the possibility to perform facility-based, study-based and process-based inspections, as has been described in detail in section 4.2 (see page 138). In writing the respective SOPs, it will be insufficient, however, to provide only a description on how such inspections will be performed. This is to say that describing the standard way of performing these inspections will only represent one part of the necessary information to be given in these SOPs. As important as the how should be the when . Thus, the respective SOPs of the Quality Assurance will have to consist of the following parts ... 

Purpose This SOP covers the way facility-/study-/process-based inspections are to be performed in order to ascertain the GLP compliance in these areas. ... 

Applicability Facility-based inspections will be performed at regular intervals of about x months independent of specific studies. Study-based inspections wiU be performed within the time limits specified by the master schedule and the single inspections will be set according to the defined critical phases of the studies. Process-based inspections will be conducted at regular intervals (of about x months, or for each yth study) for those study types that fulfil the following conditions ... ... 

Two professional associations, one based in the USA and another based in Europe, exist for the purpose of creating human tissue banking standards. The American Association of Tissue Banks (AATB) and European Association of Tissue Banks (EATB) provide standards for operation, tissue bank staff certification, and an accredited inspection process. The AATB and EATB have been very active in establishing tissue-banking standards for other countries with organizations that wish to develop human tissue banks for therapeutic, and more recently, research purposes. 

PERFORMING THE ANALYSIS. After a checklist is prepared, it can be applied by less experienced engineers if necessary. Team members should walkthrough and visually inspect the process areas to compare the process equipment and operations to the checklist items. The checklist can be reviewed in either hard copy or computer-based form. The analysts respond to the checklist items based on observations from their visual inspections, process documentation, interviews with operating personnel, and personal perceptions. If the process... 

---