Quality records procedures

The standard requires that the supplier establish and maintain procedures covering quality records and from the previous explanation it should be clear what they need to address. 

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. 

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Are quality records collected, indexed, accessed, filed, stored, maintained, and dispositioned in accordance with documented procedures ... 

To determine the procedures you need you should design the system from the top down. Some requirements will apply to many operations such as document control, corrective action, and quality records whereas other requirements may apply to only one operation, such as auditing and management review. A matrix showing this relationship is given in Appendix D. 

While procedures should define the quality records that are to be produced, these are the records that will be produced if these procedures are used. On particular contracts only those procedures that are relevant will be applied and therefore the records to be produced will vary from contract to contract. Special conditions in the contract may make it necessary for additional quality records. Records represent the objective evidence with which you are going to demonstrate compliance with the contractual requirements. It would therefore be expedient, although not essential, to list all the records that will be produced and where they will be located. The list does not need to detail every specific record, providing it identifies types of records and all new records to be produced. 

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. 

Procedure change records (clause 4.14.1.1) - these are not quality records (see below)... 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

It is advisable to identify all your quality records within your procedures. This will avoid arguments on what is or is not a quality record, because once you have chosen to identify a record as a quality record you have invoked all the requirements that are addressed in this chapter. Any document which describes the achieved features and characteristics of a product or service are quality records. Those records which will demonstrate that work has been planned, organized, resourced, monitored, verified, and corrected when found deficient are also quality records. The note following the requirement acknowledges that quality records can be in hard copy or held on a computer disk or magnetic tape. Should both forms be held, you will need to declare which are the masters and provide the appropriate security to prevent inadvertent loss or damage (see below). 

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

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. 

The standard requires the supplier to establish and maintain procedures for the maintenance of quality records. In addition it requires records to be retained in such a way that they are readily retrievable and legible. 

While the ISO 9001 requirement applies only to quality records, ISO/TS 16949 extends retention times for many other documents because you cannot demonstrate you have or had operations under control without specifications, plans, procedures, etc. You may also need to retain tools, jigs, fixtures, test software - in fact anything that is needed to repair or reproduce equipment in order to honor your long-term commitments. 

Specify retention times for quality records and quality system related documents in the related procedures. 

The types of records needed to demonstrate adherence to requirements and standards as well as effective operation of the quality (ESH/PSM) management system are covered in this element. In addition to many of the quality records listed (e.g., inspection reports, audit reports, operational procedures, and drawings), ESH/PSM requirements might include training records, permits, hazard analyses, audit and other response plans, and accident/inci-dent investigation reports. 

Documentation requirements - Create quality policy, quality manual, procedures, and document control and distribution function. Retain records for the expected lifetime of the device or a minimum of 2 years... 

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

Quality System This consists of procedures and specifications to assure the overall compliance for the facility. Quality control, change control, batch release, internal audits, and quality records are part of the quality system. 

A key component in any quality system is appropriately responding to nonconformities (i.e., deviations from requirements established under the quality system for in-process material or final product quality attributes, process control parameters, records, procedures, etc.). Nonconformities may be detected during any stage of the... 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

Procedures and documents required by the quality management system are controlled. Quality records are a special type of document and are controlled according to the requirements given in 4.2.4... 

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. 

Documentation will typically comprise validation life-cycle documents and procedures, SOPs, training records, quality records and procedures, process and engineering data, drawings, manuals, and spares list(s), and includes copies of the software. These originate from both the pharmaceutical manufacturer and the supplier. The documents must be verified as approved and on file under a document control system. The documentation must be located or stored in a controlled environment. 

Quality control procedures are generally established to provide checks on the data that have been collected to evaluate whether in fact the quality assurance procedures were followed and whether the data meet agreed-upon norms. Otherwise, it is difficult for the user to judge the integrity of a data set per se, because there may be few ways to tell that procedures were not followed or values properly recorded. Quality control measures can be linked to the quality assurance procedures. In the example given above for use of field blanks, spikes and duplicate samples, laboratories must provide evidence that their analysis of these samples meets acceptable statistical guidelines for accuracy and precision. Quality control can also simply involve careful analysis of a data set to determine whether it is internally consistent. 

Performance variations of different lots of the same brand of catalyst still are causes of significant plant problems in the industry. Such experiences justify efforts to develop effective quality control procedures for purchased catalysts. Obtaining a clear understanding of required catalyst properties is a first step. Plant problems and unusual events need to be recorded. The history of catalyst performance in the plant is most valuable to have in developing catalyst specifications. 

Make use of reference and standard samples which have appropriate records. Check quality assurance procedures. 

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