Inspections planned

Information on implementation of GMP inspection plans is available in only some of the countries. Where data exist, they indicate that plans were successfully followed or even exceeded their targets. This applies to Cuba, Malaysia, the Netherlands, Uganda, Venezuela and Zimbabwe. For Cyprus, however, inspections of domestic plants fell short of the planned values. Cyprus has 10 domestic manufacturers, and nine inspections were planned, but in 1997 only seven were carried out. The Netherlands has 86 manufacturers and 28 inspections were planned in 1998 all of them were carried out. Venezuela has 41 manufacturers and 23 inspections were planned in 1997, of which 35 were carried out. So a low implementation rate does not necessarily indicate a low inspection rate. Enforcement measures are available in case of non-compliance in Cyprus, Estonia, Malaysia, Tunisia, Uganda, Venezuela and Zimbabwe. In Cuba, no enforcement measures are specified for failure to comply with GMP standards. Comparatively speaking, there is less likely to be a workplan for inspection of distribution channels than there is for GMP inspection. Only four countries — Cyprus, Estonia, Uganda and Venezuela — carry out inspection of distribution channels based on such a plan. 

Monitoring and control of suitable process and product characteristics during production and installation The approval of processes and equipment, as appropriate Engineering drawings and inspection plans stipulating the acceptance and rejection criteria... 

In-process inspection is employed at appropriate points in the process. The quality plan or an inspection plan specifies the type of inspection. Inspection points may include, but are not limited to one or more of the following ... 

Patrol inspection by an inspector following an established procedure or inspection plan... 

For in-process control and determination of quality levels, inspection plans and quality control charts are used (as relevant). For sampling plans and acceptance criteria. Military Standard 105E is used. 

In addition, many States Parties have failed to notify points of entry for inspection teams and also failed to give notification of their National Authority, which complicates inspection planning by the Technical Secretariat. 

Tischuk, John L. (2002). The Application of Risk Based Approaches to Inspection Planning. Tischuk Enterprises (UK). 

In preparation for the inspection, the procurement agency should ensure that the manufacturers who have submitted EOIs to supply products are listed in a recording system for inspection planning purposes. 

A control plan is the sum of the procedures and equipment used to ensure that the internal requirements are met. It includes control charts, sampling plans, 100% inspection, feed-forward/feedback mechanisms, and mistake-proofing tech-niques/devices. Some items may be performed by equipment like automatic controllers, and some are performed by operators and checkers. There may not be a single document called a control plan. Instead, these controls might be spread across a number of documents including a statistical process control plan, an inspection plan, an operator manual, and various other standard operating procedure and specifications. 

Visual and other non-intrusive examinations are an essential part of maintenance. This typically begins with an inspection plan that outlines the type and frequency of inspection. The anticipated damage mechanism and the probability determine the type of inspection. The frequency is determined by the consequences associated with the damage. The consequences and the probability together constitute the risk-based inspection (RBI) strategy. 

Samples of each batch of the finished products shall be selected on at random basis during packaging, and examined for defects, in accordance with a suitable inspection plan which delineates a classification of defects and an acceptable level. 

FIGURE 22.5 Relationship between component, equipment item, system, nnit, and facility. (From ASME, Inspection Planning Using Risk-Based Methods, ASME PCC-3-2007, August 2008. With permission.)... 

An inspection plan (or written scheme of examination [WSE]) endorsed by the inspection and corrosion management services team/independent competent person that contains... 

Inspection results such as the identification of damage mechanisms, rate of deterioration, and equipment tolerance to the types of deterioration should be used as variables in assessing the remaining life and future inspection plans. The results can also be used for comparison or validation of the models that may have been used for PoF determination. 

ASME, Inspection Planning Using Risk-Based Methods, ASME PCC-3-2007, August 2008. 

An independent Quality Control structure is in charge of regularly inspecting the facilities. The frequency of inspection, their contents, and the inspection report format are defined in the Process Inspection Plan. This document is a technical... 

To facilitate management of the allocation of resources for inspections, the regulatory body should develop site specific inspection plans in which the aforementioned factors are taken into account. The inspection plans should be recorded in such a way that they can easily be modified to take into account continuing activities, and they should be reviewed periodically and modified as necessary. 

As a part of today s quality management, multiple methods of measurement and statistics are used to detect, analyze, and eliminate potential or existing faults as a task of quality assurance towards an internal or external customer. A basic precondition for a comprehensive quality assurance approach is to gain and involve internal and external customer requirements and to assess products and processes by these requirements and indicate problems. To plan and accomplish these assessments are the main objectives of quality assurance. Due to the high complexity of today s products and processes, inspection planning and adequate capability of the measurement equipment represent two of its key elements. 

Tolerance verification it defines inspection planning and metrological procedures for functional requirements, functional specifications, and manufacturing specifications. It is very important to consider tolerance verification early in the design activities to be able to assess uncertainties. Tolerance verification permits to close the process loop, to check the product conformity, and to verify assumptions made by the designer. 

Preventive Maintenance measures, inspection plans, integrated condition monitoring systems and the availability of service and spare parts at any time over the entire lifetime ensure reliability of an electrolysis system. 

This use of the recording system for site emalysls verification combined with addition laboratory ainalysis to strengthen the site results, is being specified for the majority of new inspections planned for the near future. This present series of trials is designed to establish the reliability and repeatability of this new recording technique. 

Sin, Maneesh Tore Markeset 2009. A methodology for risk-based inspection planning of oil and gas pipes based on fuzzy logic fiamework. Engineering FaOure Analysis In Press, Accepted Manuscript. 

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