Documents, formal

Full documented formal test runs at design and normal conditions. All instruments need to be calibrated for the runs and the documentation should include more than just the primary process variables of temperature, pressure, flow, and composition... 

It should be recognized that qualification activities need to be undertaken to detailed test procedures that provide comprehensive test records, with all documentation formally reviewed and approved by a designated level of management from the pharmaceutical manufacturer. With this in mind, suitably trained qualification test personnel will be required. 

It is very important that this meeting be documented formally in a memo of understanding to ... 

But also inside the plastics engineering domain, the knowledge of the experts was gradually complemented by explicit process models and documented, formalized knowledge which was elaborated by the scientific community, e.g. within research projects. Therefore, with the help of experiments and computer simulation, abstract and validated process models were developed for... 

Object Management Group (OMG) Meta-object facility (MOF) specification, version 1.4 (2002), http //www.omg.org/technology/documents/ formal/mof.htrn... 

This book documents formal, written papers from a NATO Symposium on mobile source emissions, a meeting in which scientists and engineers from several disciplines came together to discuss engine performance. The common tie was that these individuals were all using exhaust gas as a probe to evaluate clean and efficient operation of motor driven vehicles. The participants... 

Operation within the conditions set forth In documents formally authorizing an experiment which permits operation outside of established limits with a controlled degree of risk for the duration of the experiment. 

Object Management Group (2011a, January). Business Process Model and Notation (BPMN) 2.0. Standards Document formal/2011-01-03, Object Management Group, Needham MA, USA. 

It is essential that as-built architectural/constmction drawings are given to maintenance at the completion of every job, together with all other job documents, such as equipment information, operating instmctions, test data, supply information, etc. These documents are needed to operate and maintain the faciHty effectively. At the completion of any project, there should be an official acceptance of documentation by the maintenance/operation department. No job is complete without this formal acceptance and sign off. 

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. 

The lines of communication that were established in the toller selection phase can be formalized in the contract stage. The contract should spell out the persons to contact and under which circumstances they must be contacted. Detailed and continuing exchange of information is necessary in order to optimize the administration and performance of the tolling contract. The parties may want to come to agreement and include the following in the contract or supporting documentation to enhance communication ... 

The chief executive should formally document the organization s quality policy. This policy should include the relative priority assigned to continuous quality improvement, the acceptable standard for quality, and the system to achieve that standard. 

All tollers should eventually be assessed regarding their own quality improvement programs as well as meeting requirements. This can be done either formally, such as with an assessment process and form, or informally through normal communications. In either case, the results of the toller assessment should be documented and well understood within the organization. 

This can be a formal or an objective, informal approach however documentation should be available. 

The assessor should verify that there is a comprehensive formal system that specifies self-audits on a planned frequency. Over time, all areas should be audited. Results should be reported to maiiagemeiit with appropriate follow-up documented. Self-audits should be thorough, addressing all aspects of the area s fuiictioiis. Outsiders riot working in the specific audit area should be iiicluded ill the exercise for objectivity. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

This section provides a detailed example of flare system specification. This is an example of a formal design document that would be provided by the plant designer to a flare system vendor. The reader should consider this section as an example of the types of information and level of detail needed in specifying the system, however the format and organization might certainly be changed to suit the particular needs of the plant operations. 

A risk assessment analyses systems at two levels. The first level defines the functions the system must perform to respond successfully to an accident. The second level identifies the hardware for the systems use. The hardware identification (in the top event statement) describes minimum system operability and system boundaries (interfaces). Experience shows that the interfaces between a frontline system and its support systems are important to the system cs aluaiion and require a formal search to document the interactions. Such is facilitated by a failure modes and effect analysis (FMEA). Table S.4.4-2 is an example of an interaction FMEA for the interlace and support requirements for system operation. 

The standard requires that a formal, documented, comprehensive business plan be utilized and lists several aspects that should be included. 

A procedure is a sequence of steps to execute a routine task. ISO 8402 defines a procedure as a specified way to perform an activity. It prescribes how one should proceed in certain circumstances in order to produce a desired result. Sometimes the word can imply formality and a document of several pages but this is not necessarily so. A procedure can be five lines, where each line represents a step to execute a task. 

There will be some organizations that deal with such predictable orders that a formal documented review before acceptance will be an added burden. But however predictable the order it is prudent to establish that it is what you believe it to be before acceptance. Many have been caught out by the small print in contracts or sales agreements such as the wording This agreement takes precedence over any conditions of sale offered by the supplier. ... 

The standard requires that formal documented reviews of the design results be conducted. 

How are formal design reviews planned, conducted, and documented ... 

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