INDEX inspections

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

You may only need one procedure that covers all the requirements but this is not always practical. The provisions you make for specific quality records should be included in the procedures for controlling the activity being recorded. For example, provisions for inspection records should be included in the inspection procedures, provisions for design review records should be included in the design review procedure. Within such procedures you should provide the forms (or content requirements for the records), the identification, collection/submission provisions, the indexing and filing provisions. It may be more practical to cover the storage, disposal, and retention provisions in separate procedures because they may not be type-dependent. Where each department retains its own records, these provisions may vary and therefore warrant separate procedures. 

Aiken J. Panel criticizes FDA inspections of imported drugs. (CNN Online report, 9 June 2000.1 http //www.cnn.eom/2000/HEALTH/06/09/tainted.drugs/index.html. 

Lists of field-test notifications in the European Union, the USA, Canada, Australia and Japan respectively. Available from http //engl.jrc/it http //www.nbiap.vt.edu/ http // www.inspection.gc.ca/ http // www.health.gov.au/ogtr/index.htm www. s. affrc.go. jp/docs / sebtan / eguide / edevelp.htm. List of field tests applications for many countries in Asia, South America and Africa are available from http //binas.unido.org/binas/home/ php. 

Low Tinting Strength - The zinc borate has a refractive index similar to most organic polymers, which results in the retention of considerable translucency. This provides for easy visual inspection of the finished products and allows the use of lower pigment loadings in formulations requiring deep shades. 

The terms and definitions taken from ISO 2859-1 1999 Sampling procedures for inspection by attributes Part 1 Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection, Table 1, a portion of Table 2-A, and a portion of Table 10-L-l, are reproduced with permission of the International Organization for Standardization, ISO. This standard can be obtained from any ISO member and from the Web site of ISO Central Secretariat at the following address www.iso.org. Copyright remains with ISO. 

Sampling Procedures for Inspection by Attributes - Part 1 Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection , ISO 2859-1 1999, International Organization for Standardization (ISO), Geneva, Switzerland, 1999. 

Safety culture, for nuclear power facilities, 17 538 Safety data, developing, 21 844 Safety factors, See also Process safety Safety inspections, OSHA, 21 829 Safety issues/considerations for heated and cryogenic tanks, 24 303 teaching related to, 24 184 Safety issues, emulsion-related, 10 128 Safety measures, improved, 24 184 Safety performance indexes, nuclear power facility, 17 539 Safety regulation(s)... 

OSHA IMIS Records of workplace inspections, including those prompted by accidents where a worker is injured 1984-Present Information from OSHA field inspections, a third party More accurate description of impacts on employees and contractors Keyword indexing allows for easy search and retrieval Not comprehensive, limited to incidents selected by OSHA Inspections without abstracts cannot be keyword searched causal information unavailable Designed to assist compliance enforcement, not to report on incident causes Limited information from State-Plan states Not designed to be a lessons-leamed database... 

Pharmaceutical Inspection Cooperation Scheme website, http //www.picscheme.org/ index.php. 

The final portion of the GLP surveiUance inspection includes examination of records and reports as described under Parts 58.185, 58.190, and 58.195. To accomphsh this, FDA assesses the fachitys ability to store and retrieve study data, reports, specimens, and so on in a manner that maximizes their integrity and utihty. This must include an overview of how the firm maintains materials such as the raw data and the various specimens that are developed in the course of the study. The investigators must become famihar with the facility s archives regarding their location and accessibility. The individuals responsible for the archives must be identified and FDA must learn whether or not the archive is indexed and if the materials and records that have been transferred and stored elsewhere are appropriately identified. Furthermore, the procedures for adding or removing materials from the archives must be examined and individual test systems are selected randomly to determine that all raw data, specimens, and documents have been retained as required. 

In favourable cases, however, careful inspection of the powder XRD data alone may allow the presence of more than one phase to be identified without utilizing information from other techniques, as illustrated in the structure determination of cyclopentadienyl rubidium [96] fi om the powder XRD pattern of a mixture of two polymorphs. Initial attempts to index the powder XRD pattern failed, but closer... 

The essence of meta-analysis is inspection of the data. Thus, this approach produces a visual or numeric representation of each study in the context of all the others. A review of the actual data gives the critical reader a feel for the data, as well as an index of suspicion if there is undue variability, which is far more important than any statistical parameter. 

When the results from several studies are converted into similar units, a simple inspection of a graph or table readily reveals which studies have different outcomes from the majority. Such discrepancies can also be examined by a variety of statistical indices. For example, one can calculate a statistical index of homogeneity, remove the most discrepant study, and recalculate, revealing that all but one study is homogenous. If two studies are discrepant, one could remove both and again reexamine the indices of homogeneity, and so on. For an example, we summarize the relative efficacy of unilateral nondominant versus bilateral electrode placement for the administration of electroconvulsive therapy (ECT). Here, 10 studies had one result, and two others a different outcome (see Table 8-10 and Table 8-11, in Chapter 8). 

Indexing rotation photographs. Preliminary consideration. The spots on the equator of a rotation photograph are obviously reflections from atomic planes which were vertical during the exposure. In Plate VII the equatorial spots are reflections from planes parallel to the c axis, that is, hkO planes the third or l index for these reflections is 0 by inspection. The other two indices, h and k, of all the equatorial reflections may be found from the spacings of the planes, which are worked out from the reflection angles 6 by the Bragg equation. 

For the spots on layer lines above and below the equator, one index (l) is given by inspection. It should be remembered that the indices of reflections represent phase-differences between waves diffracted by neighbouring units aloiig the three axial directions (see p. 141). The spots on the first layer line above the equator lie oh a cone for which n in the equation nX = c cos (see p. 149) is 1 this means that waves coming from any one diffracting unit are one wavelength behind those from the next diffracting unit above it in fact, n in the cone equation is Z, the third index number. Thus, all spots on the fourth layer line (fourth cone) above the equator are from hk4 planes (those on the fourth layer line below the equator are from hk4 planes), and so on. 

The l index of every spot is thus obvious by mere inspection. The other two indices are best obtained by a graphical method. Just as all spots with the same l indices (in the present example) lie on definite lines, so all spots with the same hk values lie on definite curves. But these (hk curves have a form less simple than the l curves . The form of these curves is most readily determined by introducing a piece of mental scaffolding known as the reciprocal lattice —a conception which has proved to be a tool of the greatest value for the solution of all geometrical problems concerned with the directions of X-ray reflections from crystals. It was introduced by Ewald (1921). 

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