Documentation supporting activities

The responsibihties of the quahty assurance unit generally fall into two categories support for or improvement of the existing quahty system (31). The support activities of QA often include employee training, quahty system documentation, method vahdation and method transfer, audit, and customer complaints. 

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. 

Computer System Environments, illustrated in Figure 41.2, denote the areas of responsibility for activities and system documentation supporting the development, validation, and ongoing manage-ment/control of the database. 

The true business value of an EDMS is realized to the extent that it serves as more than just the terminus for document-related activities in an enterprise. To fully realize its goals, an enterprise paperless documentation system will perform functions across the entire document life-cycle. In addition to the storage of existing documents, users with appropriate system privileges must be able to create new electronic documents from within the electronic document management system. The system must explicitly support the file formats used by the business, which typically include word processing, spreadsheet, graphics, and database files. 

Critical activities for each development phase or milestone in a new product s life cycle are summarized below. The key analytical support, activities, and associated documentation are described for each phase. The activities are generally applicable but may vary considerably for a particular program depending on the nature of the new chemical entity and the therapeutic indication. The activities are also applicable to line extension products or generic products but will be abbreviated because of the significant body of data available for the original/innovator product. 

In addition to the life cycle stages, supporting activities for a document must be defined, i.e., what can happen to a document at all stages of its life cycle, for example, storage, retrieval, backup, format changes and so on. This may not be inherent in a paper-based system but may need to be specified when implementing a paperless system. 

Authorization Basis—Safety documentation supporting the decision to allow a process or facility to operate. Included are corporate operational and environmental requirements as found in regulations and specific permits, and, for specific activities, work packages or job safety analyses. 

The terms methods improvement, methods engineering, operations analysis, and woric simplification have been used synonymously in industrial engineering literature. These techniques use a systematic procedure to study and improve methods for carrying out any set of activities to accomplish a task. In health care systems, these could be the work methods used in the actual delivery of health care to the patients or the work methods utilized in support activities. One common tool used to document an existing process or work method is a flowchart, which can also be used to document a new process as it is developed prior to implementation. A flowchart allows a critical examination of the various steps of the process and assists in the identification of unnecessary steps and inefficiencies in the process. Flowcharts show each step of the process as well as decision points and various courses of action based upon the decision. 

Documentation supporting these activities are collected in the Product Files and finalized in the Process Release and/or Technology Package. 

Define Indicator. Monitor the productivity of technical personnel, teams, and the department. Productivity is defined as the total number of documented service support hours compared with the total number of hours available. This is a desirable rate-based outcome indicator. Provide feedback to technical staff and hospital administration regarding utilization of available time for department support activities. 

Support activities such as training, documentation, and data collection are normally performed by the safety staff. 

These support activities may include wiki construction (and HTML), giving presentations, making posters, proper scientific documentation, communication among team members, organizing teams, fund-raising, etc. 

Whereas the SSP consists of the actual people, activities, and products involved in implementing the system safety process, the SSPP is the document that formally defines the SSP tasks, products, interfaces, and milestones that will be required of the safety organization. The SSPP also defines the scope of the safety program and decision criteria to be used by the program. The SSPP should cover the essential core components of an SSP, plus all of the relevant SSP support activities that will be required. The SSP and SSPP can be tailored to fit the needs of the program based on system size, complexity, safety-criticality, funding, development schedule, and other significant constraints. 

Documentation of activities is (in any project) importartt as it allows tracing rationale and how the CertPack evidence supports the high level COTS requirements. Good documentation is indicative of a good and well stractured development process. This is expected to be a non-issue. However any tttKlear... 

WSRC evaluated the station material condition policies and procedures against the criteria of INPO 85-038. The results of the evaluation are included in the Reactor Maintenance Self-Assessment Report. MIP Sections III and XII includes a plan and schedule to implement a maintenance inspection program and a conduct of maintenance program prior to restart. These two programs address 14 of the 15 self-assessment corrective actions that are related to station material condition. The one remaining corrective action is addressed by MIP Section XIV, "Maintenance Interface and Support Activities." This MIP item addresses the need to monitor, control, and document plant modifications and system changes and is scheduled for implementation in 1991. 

On the basis of this review, the staff determined that the contents of WSRC documents on the implementation and control of technical support activities will satisfy the requirements of Restart Criterion 1 when draft procedure RP 5.1101 is finalized and issued. This is an open item. 

Restart Criterion 3 requires WSRC to establish formal programs to implement and control technical support activities. The staff found that these programs have either been established or are in the planning stage. WSRC documents RP 5.1101, DPSP-82-1002, and RDP 5.02 describe these programs. 

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