Documentation standards for

A documentation standard for the PQ test plan can be found in the IEEE standard 829-1998, presented in Table 20.4. The key sections of a PQ test plan are the features to test and those that will not be tested and associated with the features to be tested are the written notes of the assumptions, exclusions, and limitations to the testing imdertaken. The assumptions, exclusions, and limitations of the testing effort were recorded in the appropriate section of the qualification test plan to provide contemporaneous notes of why particular approaches were taken. This is very useful if an inspection occurs in the future, as there is a reference back to the rationale for the testing. It is also very important as no user can fully test a CDS or any other software application. 

These paper records are the operative facts in a court of law, in an administrative dossier, and before most functionaries. In this sense, there are virtually no other facts for the state than those that are contained in documents standardized for that purpose. An error in such a document can have far more power—and for far longer—than can an unreported truth. If, for example, you want to defend your claim to real property, you are normally obliged to defend it with a document called a property deed, and to do so in the courts and tribunals created for that purpose. If you wish to have any standing in law, you must have a document that officials accept as evidence of citizenship, be that document a birth certificate, passport, or identity card. The categories used by state agents are not merely means to make their environment legible they are an authoritative tune to which most of the population must dance. 

This section contains forms for documenting that all training requirements have been met, sample preparation instructions as necessary to the execution of the validation experiments, and data recording forms. Places for signatru es for performance and review should be included on each form as appropriate to company quality and documentation standards. For examples, see Tables 2 and 3.]... 

Some consumers now have requirements for integration of documents, text, and graphics, or images with the rest of their chemical information. The community is still struggling with individual standards for chemical structures, for data, and for documents. Standards for integration are not even being considered. Unless we are careful, this will lead to another round of software systems to solve today s problems, and another round of incompatible systems in the future. 

We are confident that any user of this combined evaluation technique, as well as the development of future test standards for manual ultrasonic testing will benefit from this result, because it allows a greater flexibility in the applicable method without loosing reliability. Often an expensive production of a reference block can be avoided and therefore testing costs are reduced. Since all calculations are performed by a PC, the operator can fully concentrate on his most important duty scanning the workpiece and observing the A-scan. Additional time will be saved for the test documentation, since all testing results are stored in the instrument s memory (the PC s hard drive) with full link to the Software World (Microsoft Word, Excel, etc.). 

In addition to utiHty patents, some countries pubHsh patent documents under different or less stringent standards for patentabiHty and with shorter patent terms. For example, plant patents cover asexually reproduced plants. Design patents cover the decorative aspects of a product. UtiHty models and petty patents cover products with differences from the prior art that need not meet the nonobviousness standards set for utiHty patents. 

In 1971 the OSHA standard for benzene (20 CFR, Part 1910.0000) adopted a permissible exposure limit (PEL) of 10 ppm benzene measured as an 8-h TWA. In October of 1976 NIOSH updated its earlier criteria document on benzene and recommended that OSHA lower the benzene exposure standard from 10 to 1 ppm. This proposed implementation was blocked by the United States Supreme Court iu 1980 on the basis of iusufficient evidence linking benzene to cancer deaths. By the mid-1980s convincing evidence of the carciuogenicity of benzene appeared through animal studies which justified reconsideration of the 1 ppm PEL (130). 

The presentation will focus on the differences and similarities of these systems as well as problems encountered in their practical use. By looking at the analytical process chain characteristics, such as the reliability and traceability of data, documentation standards and total costs of QM are discussed and evaluated. Suggestions for harmonization of QM-Systems and reduction of bureaucracy will be made, resulting in an improvement of the overall practical applicability and cost reduction of QM. 

The chief executive should formally document the organization s quality policy. This policy should include the relative priority assigned to continuous quality improvement, the acceptable standard for quality, and the system to achieve that standard. 

USEPA (United States Environmental Protection Agency). 1982. Development Document for Effluent Limitations Guidelines and Standards for the Iron and Steel Manufacturing Point Source Subcategory. EPA440/ 1-82/024. Washington, D.C. 

Control Technique Guidelines (CTG) EPA documents designed to assist state and local pollution authorities to achieve and maintain air quality standards for certain sources (e.g., organic emissions from solvent metal cleaning known as degreasing) through reasonably available control technologies (RACT). 

Assigned protection factor This was not included in the standard. However, the latest documentation indicates that OSHA will eventually add APFs into the standard. For now, employers should rely on the best available information when selecting the appropriate respirator. 

The interface between lATF and ISO/TC 176 was in the form of a pilot study to consider the implication of sector standards. The output was in the form of a new ISO document a Technical Specification. The requirements for such a document are for a revision within three years and a limit of only one revision, after which it must either cease or become a full standard. The document when submitted for ballot to ISO/TC 176 significantly exceeded the 66% favorable majority required for its adoption. 

The implication is that the audit should focus on performance and not on conformance. It is therefore not sufficient to verify conformity with a supplier s documented policies and practices. The auditor should examine the documented system for compliance with all requirements and examine operations to verify the results achieved are those required by the policies and practices and by the standard. 

It is not mandatory that you have documented procedures for forming the quality policy and the quality objectives, defining the responsibility of personnel, identifying resources, or conducting management reviews. However, section 4 of the standard is titled Quality s /stem requirements and section 4.2 requires that a quality manual be prepared covering the requirements of the standard. It follows therefore that you need to address the requirements of section 4.1 in your quality manual. You have a choice of how you address the requirements providing they are documented. 

The standard requires a documented process for determining customer satisfaction, including the frequency of determination and how objectivity and validity are assured. 

The standard requires firstly that the supplier establishes and maintains documented procedures for contract review. 

The standard requires that the supplier establishes documented procedures for coordinating contract review activities. 

Planning new documents, funding, prior authorization, establishing need, etc. Preparation of documents, who prepares, drafting process, text, diagrams, forms, etc. Standards for the format and content of documents, forms, and diagrams Document identification conventions Issue notation, draft issues, post approval issues... 

The standard requires that any obsolete document retained for legal and/or knowledge preservation purposes are suitably identified. Note that this requirement only applies to documents and not data. 

The standard requires that where, and to the extent that taceability is a specified requirement, the supplier is to establish and maintain documented procedures for unique identification of individual product or batches and goes on to require this identification to be recorded. 

The standard requires suppliers to establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for product are met. 

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 requires the supplier to establish, document, and maintain documented procedures for implementing corrective and preventive action. 

The standard requires the supplier to establish and maintain documented procedures for the storage of quality records and in addition requires quality records to be stored in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. 

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