Document and Record Control

Records describe what has been done and the outcome of the activity. It is important that records are kept safely and that unrecorded changes are not made. Therefore, records have to be controlled in much the same way as documents. It is important that records are clearly identified, accessible and retained for as long as the customer requires. This can be up to 30 years but could be much shorter. The archiving of records can be in any format. However, it is important that they do not deteriorate and that there is a mechanism for reading them if they are in electronic format. 

The management system has to contain procedures for dealing with complaints. This will generate yet another form of record. The complaint has to be recorded and the action(s) taken to resolve it. There will be corrective actions and preventive measures put in place as a result of the complaint. 

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Documentation requirements of certain processes are specified in several places in ZIO. As a performance standard would do, the document and record control processes are to fit the requirements of the safety and health management systems put in place. Document retention is required to demonstrate conformance with the requirements of ZIO documents are to be accessible and forms and records are to be updated as necessary. 

The organization is allowed some discretion with respect to its document and record control process. The following is stated in the advisory column The type... 

Other aspects of the system life cycle are documented. It also includes process controls to production. It works hand in hand with document and record control. 

The document and record control process is to show that these have been created and maintained in order to... 

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. 

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. 

Documentation Requirements (Quality Manual, control of documents and records)... 

The operator s testing technique should be monitored during every test session by use of negative product controls. The examination of test and control containers during and at the end of the incubation period should be included as part of the operator training. Statistics show that skilled operators working under the prescribed conditions can achieve a level as low as one contamination in 5000 control inoculations (0.02%). Personnel training should be documented and records maintained. 

Buildings and facilities Process equipment Documentation and records Materials management Production and in-process controls... 

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... 

Documentation is critical for assessment. Standard protocols provide directions for what must be documented and how the documentation is to be done, including how to record information in notebooks. For labs that rely on manuals of standard practices, it is imperative that tasks done to comply with the manuals be monitored and recorded. Control charts (Box 5-1) can be used to monitor performance on blanks, calibration checks, and spiked samples to see if results are stable over time or to compare the work of different employees. Control charts can also monitor sensitivity or selectivity, especially if a laboratory encounters a wide variety of matrixes. 

Documentation and records (systems, specifications, raw materials, intermediates, labeling, packaging materials, master production and batch records, laboratory control records, batch production record review)... 

A nonconformance may be discovered during an internal audit, a regulatory inspection, through a customer query, or by chance. It may be caused by failure to follow procedural controls, or by a failure of the procedural controls themselves, or by an ambiguity or lack of detail in the documents and records supporting the procedural controls. Examples of nonconformances include ... 

Documentation and records must be reviewed prior to approval and maintained under Change Control. Amendments to documentation and records must not obscure the original content. All such... 

In the nonclinical laboratory, it is primarily the role of the study director and the QAU to set up these document control processes and monitor the documents and records produced throughout the study to make sure GLP regulations are being followed. 

Generally speaking, the purpose of a control system is to supervise, control, monitor, schedule, document and record process parameters that are vital to plant operation. The control system of any plant or system is related to the process design of the plant and ultimately its operation, and must be able to cope with various uncertainties. In other words, the control system is closely tied to process operability. Process operability, in turn, involves the coordinated effort of both the operator and the automatic control system. The automatic controls system is PLC-based and includes the MCP and local control panels (LCP). PLC systems are preferred to discrete control systems because of the flexibility in establishing set-points and providing multiple functions. 

The Standard considers that an effective quality system should comprise management responsibility quality system principles quality system audits quality/cost considerations raw material quality control inspection and testing control of non-conforming product handling, storage, packaging and delivery after sales service quality documentation and records personnel training product safety and liability and statistical data/analyses. 

Safety inspections - these involve the straightforward observation of a workplace and/or activities or equipment within it. They may also include visual checks on documents and records this is usually carried out by a manager (or on some occasions employee representative), often aided by the use of a checklist with the aim of identifying hazards and assessing the use and effectiveness of control measures... 

Figure 5.3 shows some examples of the different classes of documents and their relationship. All the controlled documents except records are governed by clause 4.5 of the standard. Records are governed by clause 4.16 of the standard. 

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