Documentation quality

Related to pierception of visual quality documentation of vista conditions... 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

Quality documentation and records Use of statistical methods Economics Auditing... 

Quality documentation and records This requirement should be developed during the whole of the installation process. You need to document your system. However, you must carefully consider the timing of publication. In some projects it may be appropriate to issue documentation from day one and routinely update it. 

The use of desktop computer equipment and software to create high-quality documents such as newsletters, business cards, letterhead, and brochures is called Desktop Publishing, or DTP. The most important part of any DTP project is planning. Before you begin, you should know your intended audience, the message you want to communicate, and what form your message will take. 

Quality control examinations shall include the requirements of the construction organization s Quality System Program for materials, products, components, workmanship, quality documents, procedures and personnel qualifications, construction, and subcontract services. 

To fulfil the requirements of ISO/IEC 17025 it is useful to create a uniform header for quality documents and especially for the quality manual chapters, which e.g. could contain on the first page ... 

In addition to these regulatory issues there are some homemade limitations to common quality documentation (e.g. normally, pharmaceutical companies prefer to market tablets in polyethylene bottles in the United States, in contrast to blister packs for the European market and different trade names, colours or pack sizes are also unavoidable in certain cases). The consequence of these differences is the fact that a common Module 3 (Quality) and therefore a common Quality Summary in Module 2 cannot be compiled. 

The documentation level refers to the position of a quality document in the quality assurance documentation system. 

This list is not conclusive as there are many other terms in general use or contained in various standards and quality documents. 

Product and document changes are reviewed to verify that there is no degradation of quality. Document changes are distributed at the proper time to the appropriate point in the system to ensure that work and functions are accomplished in accordance with requirements. 

This requirement is achieved by raising and using the following quality documentation. 

Standard operating Written, authorized and controlled quality document that procedure (SOP) details instructions for the conduct of laboratory activities ... 

Check all source documents for document quality. Make sure there are no missing pages, cropped pages, or text that is not legible. For poor-quality documents that cannot be improved, mark each page best copy available. ... 

Table 4. Secretariat quality documents describing the collection of samples during on-site inspection. The documents hsted in the table are part of the Secretariat s quality management system and undergo regular revision. Thus, their names and codes may change in future...

The Secretariat developed a set of quality documents for the preparation and handling of the GC/MS system (see Table 6). 

After the authentication, the Secretariat s Office of the Internal Oversight (OIO) then certifies this data. The OPCW Laboratory has a quality system, which has been accredited by the Dutch Accreditation Council (RvA). The accreditation covers the quality system as well as the specific activity of the OCAD process and other processes. The OPCW Laboratory has in place quality documents (standard operating procedures (SOPs) and work instruction) for the OCAD process. 

Kishonti, E. 1975. Influence of heat resistant lipases and proteases in psychrotrophic bacteria on product quality. Document 86, International Dairy Federation, Brussels, pp. 121-124. 

Master seed cultures quality, documentation, suitability. 

An opportunity for the auditor to view actual quality documents and records (example checklist for audits is included as Appendix 6E)... 

In the following section, we show that not only does literate programming provide high quality documentation of programs and algorithms but also facilitates their publication. 

The information on the IMP in the CTA is necessarily not as complete as in a MA, and the overall intent is that the extent of information should be proportional to the clinical phase of the protocol, while complying with the new Guidance document for Good Manufacturing Practices as they apply to IMPs (Annex 13, Rev 1 of the document). A further guideline is forthcoming on the requirements to the chemical and pharmaceutical quality documentation concerning IMPs in clinical trials (see European Commission Directive 2003/94/EC). 

Glass is generally considered to be the oldest form of packaging material, and the glass industry is probably the most quality documented and systemised of component suppliers (e.g. its list and descriptions of defect types are extensive). 

From the inspectorates viewpoint, however, quality documentation is critical for all the key stages before and during manufacture. In the event of complaints or referrals from the market or regulatory inspectorates, it is archived batch and test documentation that must provide traceability to the quality conformance history of ... 

European Medicines Agency (2004) CPMP/CHMP/QWP185401 Draft guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials. (http //www.emea.eu.int/Inspections/docs/18540104en.pdf)... 

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