Procedures design verification

Prepare procedures for the conduct of design verification activities. 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

The internal V V reports will be prepared by software design organization in accordance with EOP 42-6.00 (Independent Design Verification) and EOP 40-7.00 (Design Reviews) of GE engineering operation procedure (EOP) or equivalent to ensure the quaUty of the design process and the associated documents produced. 

Regarding the validation of the design space, there is no universally recommended procedure for verification of a model, and there is limited literature or regulatory guidance that addresses the extent of verification required to justify a design space (Hallow et al. 2010). In the present work, eight additional runs were performed inside the design space and confronted with the predictions of the optimization model. A 3 DoE was centered in the optimized operation point (see Fig. 8.30). The results obtained showed very small errors (the root mean squared error was 0.06 p,m for particle size and 0.003 g/ml for BD). 

Attachment 3 of OPS-DOE-90-016, "Safety-Related Equipment List Utilization," provides the controls over maintenance, procurement, inspection and other activities. The descriptions include the computerized information database the process by which the procedures applicable to maintenance, parts replacement, and other activities would be determined and the management controls used to verify that the appropriate procedures will be followed. A description of the methods for design verification of safety-related parts procurement and for maintaining a complete and current vendor information program is also provided. These practices were developed using guidance from commercial standards (References 5 and 6) and were found to be adequate in complying with the restart criteria. 

Establish Verification Procedures. Verification can be performed independently by the manufacturer and the regulatory agency to determine that the HACCP system within the plant is in compliance with the HACCP plan as designed. 

Process design results in the design output, following which the process has to be constructed or installed, personnel trained capability studies conducted, and process verification performed. It will therefore be necessary to generate several other procedures dealing with each of these topics. 

The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures. You may of course need to do both. As the quality system is often designed to accommodate all products and services you supply, it may not specify inspections and tests which are needed for particular products. This is one of the roles of the quality plan. Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable. These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2). There may... 

The standard does not require you to use statistical techniques but identify the need for them. Within your procedures you will therefore need a means of determining when statistical techniques will be needed to determine product characteristics and process capability. One way of doing this is to use checklists when preparing customer specifications, design specifications, and verification specifications and procedures. These checklists need to prompt the user to state whether the product characteristics or process capability will be determined using statistical techniques and if so which techniques are to be used. 

Typical questions that need to be answered are whether the CQP-based system is well designed (validity), whether activities (procedures, instructions, completion of registration forms) related to the monitoring system are executed properly (verification), and whether conditions (checking temperatures, concentrations, and other quality attributes) of processes are really achieved (production process verification). 

The DEA number is a unique character code which can be easily verified in most cases. The first two of the nine characters are alphabets. The first alphabet is either an A or B, or alternatively, a P or R the letters A and B designate a dispenser, while the letters P or R refer to a distributor. The second alphabet is derived from the first letter of the registrant s last name or his/ her business name. These two alphabets cannot always be verified. The third to ninth positions from left represent a seven digit number which can be verified. To understand the procedure, an example of DEA AB 0494168 verification is provided here. 

Unlike most static design procedures, dynamic design requires a trial and error approach. Only in the verification of shear capacities and in the design of support connections can member proportions be directly determined. For the dynamic analysis, the needed nonlinear response properties are determined from a trial section. The analysis results then indicate the adequacy of the trial section. Experience on the part of the designer will help in reducing the number of iterations. The use of simple computer based design approaches help to reduce the time required for each analysis iteration. 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

In the past decade, much development has taken place in regard to measuring the forces involved in these colloidal systems. In one method, the procedure used is to measure the force present between two solid surfaces at very low distances (less than micrometer). The system can operate under water, and thus the effect of addictives has been investigated. These data have provided verification of many aspects of the DLVO theory. Recently, the atomic force microscope (AFM) has been used to measure these colloidal forces directly (Birdi, 2002). Two particles are brought closer, and the force (nanoNewton) is measured. In fact, commercially available apparatus are designed to perform such analyses. The measurements can be carried out in fluids and under various experimental conditions (such as added electrolytes, pH, etc.). 

---