Quality records storage

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 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. 

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. 

Inspection, measuring and test equipment Handling, storage, packaging and delivery After-sales servicing Quality records Training... 

This situation requires the development of better methods for managing the increased quantity and the quality of the data. For the former—the recording, storage, and digesting of the data—computer techniques are available and are becoming more common. 

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. 

Quality records are stored and maintained in such a way that they are readily retrievable in storage facilities, which minimizes deterioration and prevents loss. 

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

I Handling, Storage, Packaging, and Delivery I Quality Records I Internal Quality Audits I Training I Servicing... 

Table 2 shows the measured levels of indoor air quality parameters at the record storage building of the Ministry of Municipalities and Water Resources. 

There are no objective tests which will enable one to tell at what point mishandling in storage took place. The packer who fails to keep a record of the quality and condition of his product as it is placed in storage, of the storage conditions, and of product condition as it is loaded for shipment is exposing himself to unnecessary risk. Without such records he may find himself unable to refute unjust or misdirected claims initiated by the buyer. 

Good manufacturing practice (GMP) comprises that part of quality assurance which is aimed at ensuring that a product is consistently manufactured to a quality appropriate to its intended use. GMP requires that (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made. 

Audits of each phase of the study should include personnel training, preparation of collection forms, application calibration, each sample collection procedure, sample transport, each type of chemical analysis, data recording, data entry, data verification and data storage. Data collection in the field is often tedious if automated logging devices are not in place. To ensure data integrity, the paper and ink used for field studies should be waterproof. Each data collection form should contain appropriate locations for information detailing the time and location of sample collection, sample transport and sample analysis. Data collection forms should be stored in an orderly fashion in a secure location immediately upon return of field teams from the field at the end of each day. It is also important for data quality for studies to collect necessary field data seven days per week when required. In our experience, poor study quality is likely when field sample and data collection do not proceed on weekends. 

Has the integrity of raw material, process, and waste storage areas been checked on a regular basis, for example, ground quality monitoring, inspection of tanks, containers, bunds, and so on Provide details and records. Identify the risk category. 

The laboratory shall have a policy and procedme(s) for the selection and ptrrchas-ing of services and supplies it uses that affect the quality of the tests and/or cah-brations. Procedures shall exist for the ptrrchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations. The laboratory shall evaluate supphers of critical cortstrmables, supplies and services that affect the quality of testing and cahbratiorr, and shall maintain records of these evaluations and a list of those approved. 

Requirements in the areas of facilities, animal care, and personnel were the most often met, while the fewest requirements were met in the areas of the quality assurance unit, mixing and storage of the test substances, and record retention. 

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