Document traceability

Over the years the problem had arisen that the term trace-ability became more and more ambiguous because it was used for many different traceability concepts such as trace-ability of a sample (sample traceability), traceability of a document (document traceability), traceability of an instrument (instrument traceability) or -most important- traceability of a measurement result (measurement traceability). The VIM2 de nition clearly meant it to be related to a measurement result. 

It should be noted that the basic and necessary parameters that characterize an analytical result are traceability and measurement uncertainty. An anal3tical result without documented traceability and estimated uncertainty is a source of misinformation. These two parameters are the basic requirements of reliable analytical results. 

We have implied that the design specification is based on the functional requirements. However, both the importance of ensuring this and the way to achieve it simply are seldom understood. All of the functional requirements must somehow be catered for in the design. This applies no less to what the system must do as to what the system should not do. Failure to achieve this is one of the most common causes of the most fundamental defects of delivered systems, those errors that are, in general, the most expensive to rectify. Ensuring such comprehensive scope in designs is one of the responsibilities of QA, of which more will be discussed later. In the meanwhile, a simple but reliable system of document traceability must be in place to enable QA to sign off the document for comprehensiveness. 

Documentation traceability (e.g., calibration reports) of length standards used in the measurement to an appropriate terminus, including (a) an NMI, (b) a calibration... 

ISO 9000 is a quality assurance model that is made up of 20 generic quality system requirements or elements and a four-level integrated structure. It works on the premise that quality is achieved through a disciplined approach to documentation, traceability, and management of all company policies, procedures, work instructions, and records. This premise is actualized because ISO 9000... 

A documented traceability analysis should be performed as part of the verification activity to demonstrate that the system integration requirements are complete with respect to the computer system design specification. 

For conformance to GMP or ISO 9000 requirements, instmment cahbration must be documented to include identification of the instmment and the cahbration standard. The standard must be traceable to a recognized standard such as from the National Institute of Science and Technology (NIST). Cahbration documentation also includes the method of cahbration and a record of the cahbration results. 

The presentation will focus on the differences and similarities of these systems as well as problems encountered in their practical use. By looking at the analytical process chain characteristics, such as the reliability and traceability of data, documentation standards and total costs of QM are discussed and evaluated. Suggestions for harmonization of QM-Systems and reduction of bureaucracy will be made, resulting in an improvement of the overall practical applicability and cost reduction of QM. 

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

The documentation for design changes should comprise the change proposal, the results of the evaluation, the instructions for change and traceability in the changed documents to the source and nature of the change. You will therefore need ... 

Ensure that all documents not traceable to the published policies and procedures are removed or identified as uncontrolled. 

Unauthorized documents or documents not traceable through the quality system... 

You may not possess any documents that describe the purchased product. The only identity may be marked on the product itself or its container. Where there are no markings, information from the supplier s invoice or other such documents should be transferred to a label and attached to the product or the container. Documents need to be traceable to the products they represent. 

The standard also requires that the instructions be derived from appropriate sources, such as the quality plan, the control plan, and the product realization process, which means that all instructions should be traceable to one or more of these documents. They should form a set, so that there are no instructions used outside those that have been approved by the planning team. This is to ensure that no unauthorized practices are employed. Another important aspect to consider is the use of informal practices - practices known only to the particular operator. Process capability should be based on formal routines, otherwise repeatability cannot be assured when operators change. 

With documentation you can denote verification status either by an approval signature on the document or by a reference number, date, and issue status which is traceable to records containing the approval signatures. 

A document control function is required to regulate the authorisation and circulation of such documents. This involves the sign-off on a master copy of the document by authorized personnel, followed by a recorded circulation of official copies to relevant departments. If a document needs to be updated, the revised version should be reviewed and approved by the same functions that approved the original. The revised version is then issued with a new version number and date, and all copies of the obsolete version should be destroyed other than the obsolete master, which may be kept for historical traceability. 

The most important document, accompanying a CRM is its certificate. ISO Guide 31 (1981) provides guidance for the establishment of certificates, labeling of CRMs, and certification reports. The certificate contains among other information the certified values and their respective uncertainties. As important as this information is the traceability statement, which defines to what references the CRM is traceable. Ideally, a CRM is traceable to a suitable (combination) of SI units. This is not always possible, so other stated references may appear here. Especially when certifying matrix reference materials, making the measurements traceable to SI does not imply that the CRM is traceable to SI as well. The steps necessary to transform the sample into a state that can be measured may have a serious impact on the traceability of the values, and thus on the traceability statement. 

Cmcial documentation needed in the development phase includes end-user manuals, a unit test summary report, a user acceptance test plan, results of the database design, results and methods employed in the source code evaluations, and a trace-ability analysis. A source code traceability analysis verifies that all code is linked to established specifications and established test procedures. 

In addition, a system for making sure staff are appropriately qualified and trained for the work that they are doing must be in place. This will enable an auditor to see clearly the demonstrated competence of the staff and how this has been checked. The requirements for all major items of equipment must be listed, to ensure that the equipment in use is suitable for the task, is in working condition and, where necessary, is calibrated. For all of the instrumentation there needs to be a documented schedule for maintenance. Measurements must be traceable, that is, the laboratory must be able to show how the calibration of measurement instruments is traceable to National or International Standards. Where this presents practical problems, as in some chemical measurements for example, interlaboratory comparison and the use of reference materials (and preferably Certified Reference Materials) will be required. 

After completion, the PrHA report should be reviewed internally. The review starts with an assessment of the team and its credentials. A technical review follows, focusing on the completeness of the analyses and the traceability and understandability of the documentation. 

The degree of rigor of this traceability is variable. In a critical context, you can do these checks in mathematical detail. In more ordinary circumstances, you document the main points of correspondence to guide reviewers and maintainers and use these points as the basis for verification, design reviews, and testing. 

Documenting the refinement relationship puts back the traceability, showing how each piece of the analysis relates to the design. 

Choose Classes Based on the Business Model To maintain traceability, deviations forced by performance, current or planned reuse, and other constraints should be local and clearly documented as refinements. 

Quality System shall provide for control of material and product identification during all stages of production and delivery. Identification is based on applicable drawings, specifications, or other documents. When required or specified, complete traceability of material or product shall be maintained by issuing unique or batch control numbers and/or markings. The identification and trace-ability procedure shall be fully documented to provide objective evidence of compliance with this Code in accordance with this requirement. 

Regulatory authorities recognize that, in spite of all the control systems put in place, deviations and changes are sometimes inevitable. A robust GMP system includes procedures to handle, review, and approve changes in raw materials, specifications, analytical methods, facilities, equipment, processes, computer software, and labeling and packaging. All the changes have to be documented with references for traceability. 

Note A certified" standard essentially means that the source of a component in a test standard is traceable to it s origin, that the component s identification is assured and, when applicable, that the component s quantity or concentration in the standard, as obtained, is documented. The formal document certifying the above is often called a certificate of analysis. ... 

A structured analysis (evaluation grid) and systematic documentation were especially important for traceability of the conclusions from the case studies. Both were then used in turn as an empirical base for developing the model and for further developing the hypotheses (cf Figure 8). 

Documented inspection, cleaning, maintenance and calibration of apparatus. Calibration to be traceable to national or international standards... 

Metrological traceability Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty... 

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