Executing Training Requirements

In addition to the plant workers, others may benefit from some special training related to the toll. It may be advantageous or required to consider laboratory personnel, technical support staff, management and others when planning training. Again, the contract may be the way to define this and document responsibility. 

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Training Required and avaiiabie Pians exist Opportunity given, no pian, depends on funds Opportunity given, no pian, depends on funds Opportunity given Plans exist No plan Required, planned but not always achieved Several courses carried out in 1994-95. (training plans) Planned and executed... 

Training to provide knowledge of process operations and job execution skills is an important aspect of incident and fire prevention. In addition to job skills training, employees must be trained to properly execute fire protection tasks. A training requirements matrix for some of the elements of fire protection and the personnel that require training is illustrated in Table 4-1. 

Ensuring training compliance within a pharmaceutical manufacturing facility requires the facility to establish and implement a comprehensive training plan. Set up and executed properly, this plan will encompass and meet all of the training requirements of ... 

This section contains forms for documenting that all training requirements have been met, sample preparation instructions as necessary to the execution of the validation experiments, and data recording forms. Places for signatru es for performance and review should be included on each form as appropriate to company quality and documentation standards. For examples, see Tables 2 and 3.]... 

The properly executed O SHA will address the total system interface and provide control measures for personnel interface hazards. It identifies all personnel and equipment within a determined hazard range of operations and evaluates caution and warning requirements. Special skills or additional training requirements are also typically identified in a completed O SHA. 

Bloodbome Standard Training Requirements International Executive Housekeeping Association, Lincoln wood, IL, August 1992. 

This includes approval authorities, experience and training requirements that qualify people to undertake their roles and responsibilities which are specified for both the implementation and execution of the System. 

DOE recommends the use of a systematic approach to training, in which the content of training is commensurate with the potential hazards, exposures, worker roles and responsibilities, and requirements of the project (see Eigure 8-1) [1]. The description of this systematic approach sounds like a great idea. However, in some cases the execution of the systematic approach is difficult to attain. In general, training classes aim content and level to reach at least 80 percent of attendees. 

In addition to proper training and quality procedures, good performance requires a supportive culture and working environment. The procedures provide the "how to," the training reinforces this with the backgrovmd, the understanding, and the practice to develop the necessary skills the environment must support their quality execution. 

A logical first item is overall planning and development of the framework for the RM project. It includes consideration of end-use requirements of the material and provision for scientific and technical management and execution of the project by trained, dedicated, critical scientists and technologists. End-use requirement dictates an assessment of the nature of the problem to be addressed by the product, the market requirements, the analytical methods to be served, the measurands, forms and concentrations to be certified, the level of certification required, and the quantities of starting and final product needed, leading to overall definition of the undertaking. 

A trained operator then executes the protocols. If events or data that do not match the expected results are observed, then an error log must be written. The error log details the issue and its resolution. Proper retesting of a failed protocol can then occur. Following completion of the execution of the protocols, customer signoff is again required. 

Nonconformances may fall into the category of manpower, machinery methods, materials, etc. Employees not following procedures or unable to execute required steps of the process indicate a poorly designed process requiring modification and/or improved training. Machinery failures often indicate poor qualification, validation, calibration, or maintenance programs. Unexpected results or outcomes are indicative of poor process design, characterization, or a break down between processes. 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

The test chapter section will include information about purpose, test documentation, review and approval, formal test plan, and test execution. Testing the spreadsheet should take all requirements into account. Tests using known cases and data including known results have to be developed. The data set used for testing should include representative data. If applicable, tests should also include data sets that will test values that exceed the anticipated range of normal operations and check for data close to the acceptance criteria limits. Data that make no sense (text in a numeric field) or are not allowed to be used in the calculation should be considered in the testing phase as well. The simplest test to validate a spreadsheet calculation is to perform a manual calculation and document it. All tests performed, results expected, acceptance criteria for the tests, and procedures for alternative calculation (e.g., manual calculation) will have to be documented. Persons who perform the testing have to be trained appropriately and must be mentioned in the documentation. 

The process for setting up access to applications must be defined and executed by the appropriate, application specific, security administration personnel. The technical preparation, education and training for personnel performing administration tasks is fundamental. The determination of what is required and the documented evidence of the technical preparation, education and training of personnel is a key regulatory requirement (Part 11.10(i)). 

The scope of the system generates many of the support requirements for the operations, usually provided by the system owner. The term requirement defines a bounded characterization of the scope of the system, and contains information essential to support the operation/operators. Some of these requirements include functional capacity, execution capability, operational usability, information needed to support validation, installation, commissioning, SLC documentation required, user s manuals, training, maintenance manual, system maintenance, system test plan, acceptance criteria, and regulatory compliance (e.g., Part 11). 

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