General quality system documents

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

Whereas ISO Guide 34 sets requirements for the quality system of a GRM producer, ISO Guide 35 (1989) provides guidance on how to implement many of these requirements. Among these, the document also provides a general and statistical outline of the process that leads to CRMs. The current edition of ISO Guide 35 is a little outdated, but stiU most of the contents are valid. 

ISO Guide 34 (1996) Quality system guidehnes for the production of reference materials. (Revised March 1998 as ISO/REMCO document No 464 General requirements for the competence of reference material producers . The revised Guide 34 will appear early 2000.) International Organization for Standardization, Geneva. 

The general process of sample transformation into data is the same at every environmental laboratory. The differences are primarily in the manner various tasks are performed by laboratory personnel. To assure the quality of produced data, every laboratory must develop, implement, and maintain a quality system that is documented in the Laboratory QA Manual. The implementation of specific tasks related to sample management, analysis, and quality system, which may be different at different laboratories, is addressed through a set of laboratory s own SOPs. A full service laboratory has dozens of SOPs, describing every laboratory procedure and task from sample receiving to invoicing. The SOPs are updated as necessary and undergo internal review and approval. 

We also note that the approach of quantity over quality of documentation is preferred by many organizations. This course of action will lead to a general disillusionment with the validation process and should be avoided at all costs. A good installation qualification should fit on one or two sides of a page (three with boilerplate, if that is unavoidable). A user requirements specification (URS) may be no more than a paragraph. While it is plausible that a URS may turn out to be several hundred pages for an internally developed repository system, that would be an exception rather than the rule. If an FDA inspector arrives with a method to determine the mass of your documentation, rather than with a desire to view the processes that such paperwork documents, it will be time to find other sources of advice on validation. 

Standard (general) An entity established by consensus and approved by a recognized body. It may refer to a material or solution (e.g. an organic compound of known purity or an aqueous solution of a metal of agreed concentration), or a document (e.g. a methodology for an analysis or a quality system). The relevant terms are ... 

I C Energo s Quality Control was defined in the I C Energo document Quality Assurance Programme prepared as part of the subcontract work. This programme deals with the whole process from the general company quality system, subcontract review to quality assurance and control during the project realisation. 

A more general approach, with somewhat more explicit requirements on supporting documentation, addresses the control, calibration, and maintenance of measuring and test equipment in support of industrial quality systems. Valuable guidance is provided by EAL-G12, Traceability of Measuring and Test Equipment to National Standards. [Note The title refers to the traceability of equipment, but the thmst of the document concerns the real issue which is the traceability of... 

The findings presented in Fig. 8 show that in general the students were reasonably satisfied with the E2LP platform and the software. The average lower score was marked for the category Information quality, which had to do with insufficient or unclear information that was included in the system documentation and user s instructions. This point was also observed in the interviews held with the students, as reported in the following section. 

In other words, the result of a project quality plan is adequate project quality documentation. This includes procedures and instructions developed mainly for the given project. It is apparent that in the following subsections, only reference to the project quality plan and its documentation will be made, since the company quality system is beyond the scope of this entry. At the same time, an effort will be made to adapt the general mles in effect mainly for new structures to seismic retrofitting and strengthening of existing buildings and public works. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

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