Inspection in-process

Each QAU may exercise reasonable flexibihty and judgment to estabhsh an inspection schedule that it beheves is adequate to assure the integrity of the study. The FDA has indicated, however, that every study must be inspected in process at least once. Additional inspections may be randomly scheduled in such a way that over a series of studies each phase for each t5q)e of study is inspected. Any random sampling approach to inspections should be statistically based and should be described and justified in the QAU s SOPs. 

It is the responsibility of all departmental managers or supervisors (receiving inspection), in-process control, and quality control to understand and implement management responsibilities described in the procedures. The ISO systems coordinator (management representative) is responsible for SOP compliance. 

IV.58. Receipt inspection, in-process inspection, and final inspection measures should be planned and carried out to meet the requirements specified in regulations, standards, design and manufacturing documents, transport, servicing, maintenance, and operating procedures, instructions, applicable quality plans, etc. Essential criteria to be included in such inspection measures can be found in Safety Series No. 113 [IV.3]. 

Inspection, in-process (manufacturing) Inspections at various stages of production to... 

The Supplement B (reference) contains a description of the process to render an automatic construction of mathematical models with the application of electronic computer. The research work of the Institute of the applied mathematics of The Academy of Sciences ( Ukraine) was assumed as a basis for the Supplement. The prepared mathematical model provides the possibility to spare strength and to save money, usually spent for the development of the mathematical models of each separate enterprise. The model provides the possibility to execute the works standard forms and records for the non-destructive inspection in complete correspondence with the requirements of the Standard. 

Chan,R.W.Y., Hay,D.R., Matthews,J.R., MacDonald,H.A., (1988), Automated Ultrasonic System for Submarine Pressure Hull Inspection , Signal Processing and Pattern Recognition in Nondestructive Evaluation of Materials, C.H.Chen (ed). Springer-Verlag, pp. 175-187... 

The QAP system additionally was developped for inspection documentation purposes to meet the modern requirements in process documentation (ISO 9000). It is the basic system required to install a fully automated inspection by a camera system and image processing. 

PVDE is a nontoxic resin and may be safely used in articles intended for repeated contact with food (190). Based on studies under controked conditions, including acute oral, systemic, subchronic, and subacute contact implantation and tissue culture tests, no adverse toxicological or biological response has been found in test animals (191,192). PVDE is acceptable for use in processing and storage areas in contact with meat or poultry products prepared under federal inspection and it complies with the 3-A sanitary standards for dairy equipment. 

Flow is an important measurement whose calibration presents some challenges. When a flow measurement device is used in applications such as custody transfer, provision is made to pass a known flow through the meter. However, such a provision is costly and is not available for most in-process flowmeters. Without such a provision, a true cahbration of the flow element itself is not possible. For orifice meters, calibration of the flowmeter normally involves cahbration of the differential pressure transmitter, and the orifice plate is usually only inspected for deformation, abrasion, and so on. Similarly, cahbration of a magnetic flowmeter normally involves cahbration of the voltage measurement circuitry, which is analogous to calibration of the differential pressure transmitter for an orifice meter. 

Frequently a piece of equipment is used in different processes during its lifecycle. This could result in process conditions that exceed the safe operating limits of the equipment. Equipment inspection may provide a poor prediction of the equipment s useful life and reliability, due to the change of material handled or change in process chemistry over the life of equipment. Batch operations are also characterized by frequent start-up and shut-down of equipment. This can lead to accelerated equipment aging and may lead to equipment failure. This chapter presents issues and concerns related to the safe design, operation, and maintenance of various pieces of equipment in batch reaction systems, and provides potential solutions. 

Equipment inspec- Reevaluate and possibly reset inspection intervals tion may provide a when equipment is used for handling different poor prediction of chemistry equipment safety, Perform management of change review due to change of material handled or change in process chemistry over the life of equipment. ... 

Shear strength is measured via a simple single overlap shear specimen of standard dimensions (Fig. 9). In contrast to its simple appearance, the forces in a thin-adherend shear specimen can be quite complex due to the inherent offset loading of the specimen and subsequent bending in the substrates. The single overlap shear test is anything but a pure shear test, but the configuration is easy to manufacture, simple to test and is firmly entrenched in the industry as a primary examination technique for materials qualifications, inspection and process control. 

After preparation, a checklist may be used by less expert engineers than the preparers for inspecting the process areas to compare the process equipment and operations with the checklist oidrcr on hardcopy or laptop computer. The analyst fills in the checklist according to observations from their inspection, process documentation, and interviews with operators and their perceptions. 

For each quality objective you should have a plan that defines the processes involved in its achievement. Assess these processes and determine where critical decisions are made and who is assigned to make them. Audit the decisions and ascertain whether they were contrary to the objectives. A simple example is where you have an objective of decreasing dependence upon inspection. By examining corrective actions taken to prevent recurrence of nonconformities you can detect whether a person decided to increase the level of inspection in order to catch the nonconformities or considered alternatives. Any person found making such a decision has clearly not understood the quality objective. 

The test sample to have successfully passed all planned in-process and assembly inspections and tests prior to commencing qualification tests... 

Subcontracts enable you to choose the degree of control exercised over your subcontractors. With suppliers, your choices are often limited as you have no privileges. Control over your suppliers is therefore exercised by the results of receipt inspection or subsequent inspections and tests. If your confidence in a supplier is low, you can increase the level of inspection and if high you can dispense with receipt inspection and rely on in-process controls to alert you to any deterioration in supplier performance. 

Controlled conditions include in-process monitoring and in-process inspection and test. All controls need a verification stage and a feedback loop. You cannot control production processes without performing some kind of verification. 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

The standard requires the quality plan or documented procedures for final inspection and testing to require that all the specified inspections and tests, including those specified either on receipt of product or in-process, have been earned out and that the data meets specified requirements. 

The standard emphasizes that a nonconforming product is one which has failed a planned inspection and/or test. Up to that stage the product is neither conforming nor nonconforming - it is merely in-process. Hence the requirements of section 4.13 only apply after product or service has been inspected or tested and are clearly not intended to be applied at any other stage. 

Produce procedures for in-process and final inspection and test. 

Provide inspection stations in-process to which product is passed for inspection. 

Devices that you use for product verification at all stages in the quality loop need to be controlled and this includes devices used for inspection and test on receipt of product, in-process, and final acceptance before release to the customer. It also includes devices used during design and development for determining product characteristics and for design verification. Some characteristics cannot be determined by calculation and need to be derived by experiment. In such cases the accuracy of devices you use must be con-... 

The requirement may not apply to all product acceptance decisions. If your acceptance of the end product does not depend upon acceptance decisions being made on its component parts, any sampling carried out on receipt inspection or in-process is not important to the product acceptance decision and can therefore be ignored in your documented quality system. This is a wise course of action if you can be sure this will always be the case but if you can t, and more often than not you won t know, it is prudent to encompass a//sampling activities in your quality system. 

This element addresses the quality (adherence to ESH/PSM standards and specifications) of purchased materials and equipment, in-process inspections, and final product verification. Methodologies, frequencies, and sample size or scope of inspections are all expected to be specified. 

To augment the vibration-based program, you should also schedule the non-vibration tasks. Bearing cap, point-of-use infrared measurements, visual inspections and process parameters monitoring should be conducted in conjunction with the vibration data acquisition. 

Finally, the third limitation of predictive maintenance in process machinery is that downtime must be scheduled to allow for inspection of the equipment, which in itself poses risk. It is not an exaggeration to say that the source of the majority of equipment failures, which were studied, began shortly after predictive maintenance inspections made disassembly of equipment necessary. Figure 62.2 shows how trouble incident frequencies can increase contrary to expectations after inspection and overhaul. 

The use of electromagnetic acoustic transducers (EMAT) obviates the coupling problems already referred to, and has been applied successfully to the inspection of boiler tubes. Ultrasonic time of flight diffraction (TOFD), developed by the Harwell Laboratory" , is utilised to fingerprint flaws (cracks) in process plant. Subsequent examination at, say, six month intervals can indicate any growth or extension of the crack. It is claimed that changes in crack height of 0-5 mm or less be estimated. 

Hladky, K. and John, D.G., Corrosion Monitoring Using Electrochemical Noise , 2nd. Int. Conf. on Corrosion Monitoring and Inspection in the Oil, Petrochem. and Process Industries, London, Oyez Scientific and Technical Services Ltd., London (1984)... 

Corrosion Monitoring and Inspection in the Oil, Petrochemical and Process Industries , Proc. 

We have already noted in an earlier section that treatment of filler with a finishing agent also increases its abrasive attack on the parts of the processing equipment [271], At the same time it has been shown indirectly in [297,298] and directly by microscopic inspection in [294] that a synthesized polymer film remains on the polymerization-modified filler after the processing treatment, that is, there is always a medium which protects the molding equipment from the abrasive attack of the filler. In view of these observations, the polymeric composites with PMF are comparable, in terms of abrasive activity, with unfilled polymers [226, 227],... 

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