Execution and documentation

In the description of the analysis object, it is recommended but not strictly necessary to establish a comprehensive list of all jobs within the area. Such a comprehensive list is especially valuable when Coarse and Job safety analyses are carried out in combination in order to secure a comprehensive review of 

Transportation of materials (manually/by crane, truck etc.) Walking 

Contact with or caught in or between moving parts of machinery Release of pressurised gas or fluid Contact with sharp object 

Impact from or squeezed between moving objects  

Fall on same level Fall to a lower level  

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The system can be certified after successful execution and documentation of above tests. 

Sound development package in place Ranging studies completed and documented Facility qualification completed and documented Equipment qualification completed and accepted Appropriate analytical methodology implemented and validated Personnel training completed and documented Process trials and demonstrations executed and documented Change control in place and effective... 

Avoid excessive documentation—While documentation is one of the keys to cGMP compliance (at least according to FDA), there is nothing that requires that paper be used in excess. Incorporation of previously documented work should be encouraged. A well-articulated presentation of a process or procedure should be reused wherever possible. Pictures, diagrams, and tables are worth substantially more than 10,000 words in the presentation of technical information. Use procedures, templates, and forms extensively to reduce both execution and documentation time periods. Use a minimum of clear and concise prose at all times. War and peace -type efforts should be avoided at all times. Quality and clarity are far more important than quantity. 

Designing, executing, and documenting safety meetings for safety directors, supervisors, or hourly workers. 

Along with the flexibility we are given comes the responsibility for adequate planning, execution, and documentation. We must state what we are going to do in our SOPs and protocols, we must follow these procedures, and then we must document the results. 

Once the design is finalized, all of the evaluation and test data become important in the regulatory approval process, so each step should be carefully planned, executed, and documented. Each test should be done with the clear objective of validating some aspect of the design. The level of performance required should be established in advance. The test conditions should be carefully spelled out. 

Module 3 Planning phase Design ofThree Factor Experiment) detail experimental plan for the course project, problem statement, execution, and documentation of the course project for each team. 01 9th week... 

Management of functional safety has a duty to ensure the execution and documentation of phases and activities of the entire lifecycle and to provide a corporate culture that promotes functional safety. 

Execution and documentation of safety examinations and checks Employing workers of other companies Utilization of personal protective aids Information flows and communication forms Maintenance and repairs programs Order and cleanliness... 

As described in Chapter 4, the FSA framework consists of five steps. The interaction between the five steps can be illustrated in a process flowchart as shown in Figure 5.1. As it can be seen, there are repeated iterations between the steps, which makes FSA effective as it constantly checks itself for changes within the analysis. Each step within the FSA can be further broken down into individual tasks and is represented in Figure 5.2. The execution and documentation of each task is vital, as it will enable the preceding tasks/steps to be carried out with ease. In order for the assessment to be accurate, the analyst must understand and appreciate the objectives of each step and execute it without any short-cuts . 

Documentation of W rk in an Understandable, Contextual, Archival Manner Offering, Seeking, and Accepting Alternative Approaches to Design, Execution and Interpretation of Expenments... 

Once a toller has been selected and any required preliminary confidentiality protection is in place, the client typically shares more detailed information. The toller can then make an informed decision about the economic, technical, and safety aspects involved in bidding the work. If the two parties decide the project will be mutually beneficial, agreements and obligations are negotiated and then formalized in a written contract. Both parties—the client and the toller—have roles in fulfilling the contract and in carrying out their responsibilities to the workers and the public. The purpose of the written contract is to clarify and document those roles and responsibilities to effectively execute, maintain and eventually terminate the project. 

Have the quality policy, quality objectives, and commitment to quality been defined and documented by executive management ... 

The standard requires that the supplier s management with executive responsibility define and document its policy for quality. 

An inventory management system should be established - meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented - meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. 

Shortly after the start-up and before the general contractor leaves the site, a meeting should be held among key members of the project execution team to obtain and document everyone s feedback on what went right, what went wrong, and what could have been done better. 

Prior to execution, the site preparation and document approval must take place. The equipment manufacturer will provide detailed site preparation requirements for the system. It is the responsibility of the customer to prepare the site as per the documented requirements. The operator will verify the site preparation during the testing of the... 

Objective evidence to answer these questions is sought in both management system documentation and on-site interviews conducted with executives and employees. Evidence is documented and evaluated. On the basis of this evidence and these evaluations, an overall evaluation is then arrived at, which results in certificate issue and demonstrates existing opportunities for improvement. 

Documented process structure provides rapid employee assimilations when transferring employees between sites. New employees, replacing existing process owners, are enabled to rapidly execute process responsibilities due to the abbreviated learning curve when processes have been well defined and documented. Systems designed as described here provide meaningful and comparable metrics for leadership to evaluate progress, compliance, and performance. 

Often the protocol will incorporate test sheets or sections for recording data. In this way, once the protocol has been executed, the document constitutes a record of the results and conclusion [3]. It must describe the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process or a part thereof for routine use [1]. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

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 product requirements are reviewed before the contract or tender is accepted. Product requirements are defined and communicated to the personnel responsible for the quality production. The unresolved and ambiguous issues are resolved and documented. The changes made in the product specifications are approved before execution of the order. Provisions are made for removing absolute drawings, procedures, work instructions, and specifications from all work areas to ensure that they are correctly authorized versions. Provisions are made for emergency changes necessary to prevent the production of nonconforming material. 

Objective. The objective states what the intent of the activity is. The objective should be straightforward, yet touch on the underlying goal of the activity. If the plan is to prove that a piece of equipment can be powered on, this is the objective. If the intent is to demonstrate and document that something is and does what it purports to be and do—to validate—then that is the objective. One other suggestion is that the method of achieving the objective be touched upon briefly. For example, if three events will be executed to prove the objective, this fact should also be mentioned. 

Validation Methodology. The methodology section speaks to the areas of documentation, protocol execution, and postexecution. 

The IQ phase will be executed with personnel of the supplier of a technical system or with technical personnel of the pharmaceutical company. It will follow the procedures set out in the IQ protocols. After performing the IQ, the results are summarized and documented in an IQ report. 

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