Quality records definition

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality record. 

CD-XA (CD-extended architecture) is the standard for CD-ROMs for data storage and compressed audio recording (up to four hours music in HiFi-stereo quality). The definition of the CD-XA format is also put down in the extended Yellow Book. 

Dutoit [148] investigates the issue of epoch accuracy and concludes that the problem is complicated, partly due to a lack of formal definition as to where exactly the epoch should lie (the instant of glottal closure is only one possibility). Since then, more accurate epoch detection algorithms have been developed (see Section 12.7.2) but there are cases (for example with poorer quality recordings) where perfect automatic epoch detection may not be possible. 

The sinc fiinction describes the best possible case, with often a much stronger frequency dependence of power output delivered at the probe-head. (It should be noted here that other excitation schemes are possible such as adiabatic passage [9] and stochastic excitation [fO] but these are only infrequently applied.) The excitation/recording of the NMR signal is further complicated as the pulse is then fed into the probe circuit which itself has a frequency response. As a result, a broad line will not only experience non-unifonn irradiation but also the intensity detected per spin at different frequency offsets will depend on this probe response, which depends on the quality factor (0. The quality factor is a measure of the sharpness of the resonance of the probe circuit and one definition is the resonance frequency/haltwidth of the resonance response of the circuit (also = a L/R where L is the inductance and R is the probe resistance). Flence, the width of the frequency response decreases as Q increases so that, typically, for a 2 of 100, the haltwidth of the frequency response at 100 MFIz is about 1 MFIz. Flence, direct FT-piilse observation of broad spectral lines becomes impractical with pulse teclmiques for linewidths greater than 200 kFIz. For a great majority of... 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

Signal-to-noise ratio characterizes recorded signals and signal functions with regard of their quality, i.e., their precision. Unfortunately, the signal-to-noise is not uniformly used in analytical chemistry. In addition to the definitions given in Eqs. (7.1) and (7.2), there exist another one, related to the peak-to-peak noise Npp ... 

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

All research personnel must search for clues about safety events from many sources, such as information in clinical records at the study sites information in data collection forms (e.g. CRFs, diary cards, quality-of-life forms, psychiatric rating scales, etc.), occurrence of missed and/or unscheduled visits, dropouts and withdrawals use of any concomitant medications/devices and abnormal laboratory data. AEs may also occur simply as a result of study procedures and study participation. Information about definitions of AEs and requirements for reporting AEs must be clearly stated in the protocol and explained to the site staff, who must also be educated in the correct procedure and immediate requirement for reporting any AE suspected to be serious or unexpected as per the regulatory definitions. 

In short, Putnam substantiates Wilson s claim that philosophers remain too closely tied to the seventeenth-century conception of primary and secondary qualities. The same applies to A. D. Smith (1990). Smith argues that because the primary properties are not "direct sensibles" but are rather theoretical terms, we should "either ditch the term primary property or advert to what science calls fundamental." But there is reason to say shape is sensible, just not directly so. Because it is recorded by instruments, it can be sensed. "Sensed" need not refer to the five traditional senses. Smith remains too tied to the seventeenth-century definition of a sensible. 

The exact definition of good laboratory practice depends on who is defining it and for what purpose. A broad definition encompasses such issues as organization of the laboratory, management, personnel, facilities, equipment, operations, method validation, quality assurance, and record keeping. The goal is to certify that every... 

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