Documentation definition

A standard is a document, definition, or reference artifact intended for general use by as large a body as possible a specification, which involves similar technical content and similar format, usually is limited in both its intended appHcabiUty and its users. 

User requirement specification (URS)—documented definition of the project. 

Sample chromatogram (e.g. for testing procedures and approval documents) Definite stress on a substance as a model for the presence of decomposition products... 

AAPM American Academy of Pain Medicine, APS American Pain Society, and ASAM American Society of Addiction Medicine (2001) Consensus Document. Definitions Related to the Use of Opioids for the Treatment of Pain. 

The first few pages of the document contain such topics as the scope, referenced documents, definitions and abbreviations, and system safety requirements. 

Life cycle of documents Definition of the intended duration of the availability of the document in human-readable form... 

The review procedure for the MLPCN Probe Reports (https // mli.nih.gov/mli/mlpcn/documents-definitions/ dl id=883) details aspects related to scientific merit, information completeness and the approval process. A template for the Probe Reports is available online (https //mli.nih.gov/mli/mlpcn/documents-definitions/ dl id=841). 

Definitions ate specifications of terms in the document which differ from common usage. 

The printed pubHshed document which represents the patent rights granted by the Federal Government can be a complex Hterary work. There are specific and rigid legal requirements for the description, disclosure, and definiteness which support these affirmative rights and enable enforcement of those rights by the inventor or owner of the patent. The basis for this fiiU and complete disclosure of the invention in the patent is clearly articulated in the U.S. Constitution. 

A contractor helping with the study w ill definitely document such decisions. In fact, a contractor s most difficult task is extracting major decisions like this from tlie operating company s management. He will be diligent in documenting those that are handed to him on a silver platter. 

An organization may respond to these requirements in several ways, so in managing the quality system a list of the documents is needed which contains the definition of people s responsibilities and authority. The difficulty arises in keeping all such documents compatible and so it is often better to limit the documents to the three types above, if possible. 

If we look at ISO 10013, which is referenced for guidance in preparing a quality manual, we will see that it shows that the quality manual is a top-level document containing the stated quality policy, the quality objectives, and a description of the quality system (see Figure 2.2). The definition in ISO 8402 supports this concept and the requirement aligns with this definition. However, ISO 8402, ISO 10013, and the above requirement from ISO 9001 provide a choice as to whether the manual contains or refers to procedures. 

Ensure that your documented policies and practices specify all the documents that need to be produced and are used to produce products and service that meet the specified requirements. Any document not referred to in your published policies and procedures is therefore, by definition, not essential to the achievement of quality and not required to be under control. 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality record. 

Process definition and design criteria Process and equipment design Company memory (management information) Documentation of risk management decisions Protective systems Normal and upset conditions Chemical and occupational health hazards... 

Remember that the CCPS definitions may not fit all companies or situations however, they provide a useful set of guidelines for considering how a management system like PSM can work within your company. Some companies have adopted these guidelines very literally and use a highly documented, checklist approach. Others follow them conceptually, in a less structured manner. 

Audits by definition are conducted on-site. An audit may be conducted using a variety of approaches and guides, but in general involves a team that gathers data through interviews, observation, and review of documentation. The team usually includes at least two people depending on the complexity of the facility or processes under review, tWs may expand to as many as five or more. 

It is imperative to the success of a project that it be clearly defined before it is undertaken. Any definition should include the criteria for determining successful completion of the project. It is reasonable to expect changes to occur once the project is under way, but these changes should be documented along with any resulting impact on schedule and budget. 

Regarding corrective actions, the regulation states The employer shall establish a system to promptly address and resolve the incident-report findings and recommendations. Resolution and corrective actions shall be documented. The regulation does not define promptly in definitive terms, but the intent is that all corrective actions must be implemented immediately. 

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