Quality records identification

The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures which deal with the controls that apply to all documents. Although ISO 9001 does not address all controls under clause 4.5, the provisions of clause 4.16 relating to the identification, access, filing, and storage of quality records are equally appropriate to documents in general and should be applied although it is not mandatory. 

The standard requires the supplier to establish and maintain documented procedures for the identification of quality records. 

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. 

Quality records are identified, established, and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records are legible, readily identifiable, and retrievable for quality records. A procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition. 

The procedure is established and maintained for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. 

In many instances operating system software has already been developed and is offered as a fundamental part of the computer system ready for application software to be developed or configured. In such cases it is prudent to establish the existence of the respective software quality assurance plans and procedures and the design, development, and testing records. Identification and examination of this documentation can be conducted and recorded as part of the supplier audit. (See Sec. VI.)... 

The current GMP requirement that materials must be tested or examined for all specifications and released prior to use is in conflict with the philosophy of vendor certification, which is based on a consistent, reliable record of good quality. Only vendors with well-controlled processes and a good record of acceptable batches qualify for such a program. Thus, a material could be put into use based on the quality record of the supplier (vendor), even if testing is only for identification [211.84(d)].[ l... 

Identification, Marking and Traceability Procedures/Method Statements Personnel Records Physical Resources Quality Records Nonconformity Management Quality Audits... 

The use of various statistical techniques has been discussed (46) for two situations. For standard air quality networks with an extensive period of record, analysis of residuals, visual inspection of scatter diagrams, and comparison of cumulative frequency distributions are quite useful techniques for assessing model performance. For tracer studies the spatial coverage is better, so that identification of meiximum measured concentrations during each test is more feasible. However, temporal coverage is more limited with a specific number of tests not continuous in time. 

The most straightforward tool for the introduction of a sample into a mass spectrometer is called the direct inlet system. It consists of a metal probe (sample rod) with a heater on its tip. The sample is inserted into a cmcible made of glass, metal, or silica, which is secured at the heated tip. The probe is introduced into the ion source through a vacuum lock. Since the pressure in the ion source is 10-5 to 10-6 torr, while the sample may be heated up to 400°C, quite a lot of organic compounds may be vaporized and analyzed. Very often there is no need to heat the sample, as the vapor pressure of an analyte in a vacuum is sufficient to record a reasonable mass spectrum. If an analyte is too volatile the cmcible may be cooled rather than heated. There are two main disadvantages of this system. If a sample contains more than one compound with close volatilities, the recorded spectrum will be a superposition of spectra of individual compounds. This phenomenon may significantly complicate the identification (both manual and computerized). Another drawback deals with the possibility of introducing too much sample. This may lead to a drop in pressure, ion-molecule reactions, poor quality of spectra, and source contamination. 

Several method performance indicators are tracked, monitored, and recorded, including the date of analysis, identification of equipment, identification of the analyst, number and type of samples analyzed, the system precision, the critical resolution or tailing factor, the recovery at the reporting threshold level, the recovery of a second reference weighing, the recovery for the control references (repeated reference injections for evaluation of system drift), the separation quality, blank issues, out of spec issues, carry over issues, and other nonconformances. The quantitative indicators are additionally visualized by plotting on control charts (Figure 23). 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

Identification of key batch records These documents are then compared with the commitments that are contained in the Regulatory Commitment Document (see above). Any discrepancies identified are resolved, and explanations are documented when appropriate. This is done by the product development group in collaboration with the quality control and regulatory affairs departments. 

Data from electrophoresis is normally recorded photographically. Densitometry may also be performed on the stained gel or bands may be excised/eluted for further analysis (Mayer et al., 1998). The bands may also be isolated from the gels by blotting methods such as electroblotting (McSweeney et al., 1994 O Malley et al., 2000) or immunoblotting (Addeo et al., 1995 Moio et al., 1992) for further characterization and identification. All of the electrophoretic methods, to a certain extent, provide good quality data. But due to the difficulty in quantitative analysis, very few examples are available on the quantification of protein fractions using... 

Maintenance records Application software documentation Data reproduction accuracy Documented verification of process steps Operator identification Data record review by quality control Electronic record/signature type, use, control, and audit trail... 

The acquisition, handling, and quality control of primary and secondary packaging materials and of printed materials should be accomplished in the same way as that for the raw materials. The printed materials should be stocked in a reserved place so the possibility of unauthorized access is avoided. The labels and other rejected printed materials should be stored and transported with proper identification before being destroyed. There should be a destruction record of the printed materials. Each batch of printed material and packaging material should receive a specific reference number for identification. 

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