Systems documentation

On basis of developed criteria, the theoretical background of reference substances elaboration is developed, and also ai e developed procedures of elaboration and documentation system for the Ukrainian State Phamiacopoeia RS and for working RS of the phamiaceutical plants. These approaches ai e successfully applied to elaboration of RS for inter-laboratory testing. 

Check whether a documented system is in place, which covers the reporting, investigation, root cause analysis and corrective actions taken. 

Look for a documented system of training that complements those required by law. 

One person in a unit retrieved a two-year-old shutdown procedure from his locker and tried to use it. The old procedure was significantly different from the updated procedure. If the old procedure were followed exactly, there would be more risk. If the two procedures were intermingled, there would be high temperature and catastrophic corrosion. The unit management team tore up the bootleg procedure and added the updated shutdown procedure to the controlled document system used for ISO 9002 (ISO 9000, 1994). In this document system, only the current procedure is available. Alternate systems may use an expiration date or require periodic reconfirmation. 

The implication is that the audit should focus on performance and not on conformance. It is therefore not sufficient to verify conformity with a supplier s documented policies and practices. The auditor should examine the documented system for compliance with all requirements and examine operations to verify the results achieved are those required by the policies and practices and by the standard. 

Further discussion on electronic documentation systems can be found in the ISO 9000 Quality System Development Handbook hy David Hoyle (Butterworth-Heinemann, 1998). 

If you operate a computerized documentation system, your problems can be eased by the versatility of the computer. Using a database you can provide users with all kinds of information regarding the nature of the change, but be careful. The more you provide the greater the chance of error and the harder and more costly it is to maintain. 

In reviewing the representative management systems, pay attention to the way in which documented systems have been communicated to employees. You will probably find variations that reflect the topic and the specific... 

The process documentation system description will be completed. 

Woodlawn is concentrating on its process documentation system, while Kingston continues to work on process hazard assessment. Winston and Highgate continue to work on Management of Change. 

The charts below describe the process that the VP, ESH followed to determine the potential benefits, outline the integration plan and implement it. The process is also illustrated through examples in the specific area of documentation systems, which was just one of the many areas that were being integrated at the same time. 

One of the areas in which a team was established from the outset was documentation systems (DS). The experience of the DS team will be used to illustrate the integration process. Comparable efforts were also undertaken by the other integration teams. 

The DS team included three ESH representatives who collectively knew the requirements within most of the ESH areas, a corporate documentation specialist and two plant representatives who knew the current engineering documentation systems at their sites. The vice president wanted the DS team to know from the outset that he believed that the area of documentation... 

Exhibit 10-1. Potential Benefits of Integrating ESH Documentation Systems... 

Number of Documentation Systems Number of Documentation Training Courses ... 

This potential for consolidation in the area of documentation systems was used as an example to sell the overall integration concept. Documentation was an area of constant complaint and senior management could easily visualize opportunities for improvement in basic resource requirements, as well as secondary effects on resources for training, auditing and other activities. Exhibit 10-1 was a key part of the presentation that the VP, ESH made to senior management. 

The DS team uncovered four additional sets of documentation systems when they conducted their detailed search of programs and elements. Each documentation system had its own set of standards for recording information, distribution, review and approval and for archiving. Furthermore, the incompatibilities of the various electronic systems were exacerbated by the lack of a corporate hierarchy on preferred computer platforms. 

The DS team determined that their overall integration approach would revolve around existing local documentation systems, in order to overcome both cultural and resource barriers. The cost outlay for a corporate-wide system was thought to be too prohibitive. Thus, the roll-out would be facility... 

The integration of documentation systems was a fairly high priority at the outset of the integration effort, and the findings of the individual integration teams did not reduce this priority. 

The DS team established their master plan for what the linkages between the different documentation systems should be and what they should look... 

In the area of documentation systems, there were several managers who had volunteered their site to be the pilot location. A relatively small location (Poole Harbor) was selected because while it had numerous documentation systems, it was also determined that the overall implementation time would be fairly short. This provided feedback in an expeditious fashion. The remaining managers who had volunteered their sites were used as part of a pilot review team to keep their interest and support active. They actually started to implement the protocols for a few of the documentation systems on their own, in advance of the roll out at their sites. They also became key proponents of the corporate-wide roll out of the overall integration effort, based on their involvement in just this one area. 

At this point the VP, ESH and his set of integration teams worked to develop the performance measures that would be used to assess both the success of the overall integration effort and Quality Chemical Company s performance in the areas of ESH and PSM. Some of the measures specific to documentation systems were ... 

In the area of documentation systems, the specific benefits included ... 

The documentation system should include guidelines regarding the access of records by customers and suppliers, change control procedures, the types of records to be collected, and specifications for indexing, filing, storage, maintenance, retrieval, and disposition. 

As failure data relating to mechanical components differ widely from source to source, TNO has set up a documentation system in which all relevant information is stored in one, uniform automated code called COMPI, which uses a component description code for the following information system of... 

The use of conventional photographic systems for data acquisition, printing and archiving results of planar chromatography [401] has now largely been superseded by video documentation systems. A sample method for documentation of TLC plates has been described by a combination of computer, scanner, and digital colour thermal printer resulting in a very... 

A detailed and comprehensive system of record keeping is necessary, including, for example, worksheets, notebooks, computer output and reports, and all of these should be retained for a reasonable period of time or as required by the customer. A period of six years is often chosen. The content of reports and certificates is tightly defined, to ensure that customers receive all relevant information and that the laboratory does not make exaggerated claims about which parts of its work have been accredited. A documented system for dealing with any customer complaints and for informing customers if discrepancies in results are subsequently discovered must be available and in place. 

There is an effective documented system for receiving samples, identifying samples against requests for analysis, showing progress of analysis, issue of report and fate of sample. 

The primary document outlining risk assessment methods in the U.S. Department of Defense is a Military Standard, Ref. 39. This document requires a well-documented system safety program, based on risk assessment methods to be included in all new Department of Defense systems and facilities. Hazards analyses of the systems are mandated by this publication. 

Journal of Ballistics, Douglas Documentation Systems, Philadelphia... 

Develop/Document System to Manage Chemical Reactivity Hazards... 

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