Quality records types

The requirement does not cross refer to clause 4.16 on Quality records, clearly indicating that there is no requirement in this clause for problems to be recorded, as other clauses such as 4.10, 4.13, and 4.14 cover this. However, these clauses only relate to problems in not meeting the specified requirements and therefore may exclude types of problems not governed by specified requirements. So having identified the responsibilities of these personnel there may be no compulsion to provide a means for such problems to be documented, resolved, and prevented from recurrence. 

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 standard requires suppliers to define the type and extent of control exercised bp the supplier over subcontractors and goes on to require that these controls be dependent upon the type of product, the impact of the product on the quality of the final product, and, where applicable, on the quality audit reports and/or quality records of the previ-ousty demonstrated capability and performance of subcontractors. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

There are three types of maintenance regarding 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. 

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. 

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... 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

The second part of the requirement deals with inspection and test records, which are also covered in clause 4.10.5. The difference between these requirements is that clause 4.10.1 requires you to document the records to be established (in other words define ) in the quality plan or procedures and clause 4.10.5 requires you to produce the records defined in the quality plan or procedures. Your inspection and test procedures therefore need to specify or contain the forms on which you intend to record the results of the inspections and tests performed. The details are covered later in this chapter, but there are two types of record to be considered the record that shows which inspections and tests have been performed and the record that shows the results of these inspections and tests. One may be a route card, shop traveler, or document which acts as both a plan of what to do and a record of the progress made and the other may be a table of results with specified parameters and accept/reject criteria. 

Audits of practice against procedure or policy should be recorded as they are observed and you can either do this in note form to be written up later or directly onto observation forms especially designed for the purpose. Some auditors prefer to fill in the forms after the audit and others during the audit. The weakness with the former approach is that there may be some dispute as to the facts if presented some time later. It is therefore safer to get the auditee s endorsement to the facts at the time they are observed. In other types of audits there may not be an auditee present. Audits of procedure against policy can be carried out at a desk. You can check whether the documents of the quality system satisfy all the clauses of the standard at a desk without walking around the site, but you can t check whether the system is documented unless you examine the operations in practice. There may be many activities which make the system work that are not documented. 

It should be borne in mind that although it is possible to generalise on sampling procedures, all industries have their own established methods for obtaining a record of the quantity and/or quality of their products. The sampling procedures for tobacco leaves will obviously differ from those used for bales of cotton or for coal. But although the types of samples differ considerably the actual analytical methods used later are of general application. 

Photoelectric-Colorimetric Method. Although the recording spectrophotometer is, for food work at least, a research tool, another instrument, the Hunter multipurpose reflectometer (4), is available and may prove to be applicable to industrial quality control. (The newer Hunter color and color difference meter which eliminates considerable calculation will probably be even more directly applicable. Another make of reflection meter has recently been made available commercially that uses filters similar to those developed by Hunter and can be used to obtain a similar type of data.) This instrument is not a spectrophotometer, for it does not primarily measure the variation of any property of samples with respect to wave length, but certain colorimetric indexes are calculated from separate readings with amber, blue, and green filters, designated A, B, and G, respectively. The most useful indexes in food color work obtainable with this type of instrument have been G, which gives a... 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

In this chapter we revisited an old problem, namely, exploring the information provided by a set of (x, y) operation data records and learn from it how to improve the behavior of the performance variable, y. Although some of the ideas and methodologies presented can be applied to other types of situations, we defined as our primary target an analysis at the supervisory control level of (x, y) data, generated by systems that cannot be described effectively through first-principles models, and whose performance depends to a large extent on quality-related issues and measurements. 

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. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

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). 

Information bias (observation bias) Occurs when there are quality (accuracy) problems in the collection, recording, coding, or analysis of data among comparison groups. Interviewers might, e.g., interview the cases with more diligence than they interview the control, or a person with a disease may recall previous exposures better than persons who are healthy (this type of bias is called recall bias). 

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