Specification (technical standard)
Encyclopedia
A specification is an explicit set of requirements to be satisfied by a material, product, or service. Should a material, product or service fail to meet one or more of the applicable specifications, it may be referred to as being out of specification;
the abbreviation OOS may also be used. Specs are a type of technical standard.
A technical specification may be developed by any of various kinds of organizations, both public
and private
. Example organization types include a corporation
, a consortium
(a small group of corporations), a trade association
(an industry-wide group of corporations), a national government (including its military
, regulatory agencies, and national laboratories and institutes), a professional association (society), or a purpose-made standards organization
such as ISO
. It is common for one organization to refer to (reference, call out, cite) the standards of another. Voluntary standards may become mandatory if adopted by a government or business contract.
Sometimes the term specification is used in connection with a data sheet (or spec sheet). A data sheet describes the technical characteristics of an item or product. It can be published by a manufacturer to help people choose products or to help use the products. A data sheet is not a technical specification as described in this article.
, manufacturing
, and business
, it is vital for suppliers, purchasers, and users of materials, products, or services to understand and agree upon all requirements. A specification is a type of a standard which is often referenced by a contract
or procurement document. It provides the necessary details about the specific requirements.
Specifications may be written by government agencies, standards organizations (ASTM, ISO
, CEN
, DoD, etc.), trade associations, corporations, and others.
A product specification does not necessarily prove a product to be correct. An item might be verified
to comply with a specification or stamped with a specification number: This does not, by itself, indicate that the item is fit for any particular use. The people who use the item (engineers, trade unions, etc.) or specify the item (building codes, government, industry, etc.) have the responsibility to consider the choice of available specifications, specify the correct one, enforce compliance, and use the item correctly. Validation
of suitability is necessary.
is available to help write and format a good specification. A specification might include:
The process capability
of materials and products needs to be compatible with the specified engineering tolerances. Process control
s must be in place and an effective Quality management system
, such as Total Quality Management
, needs to keep actual production within the desired tolerances.
Effective enforcement of a specification is necessary for it to be useful.
form part of the contract documents that accompany and govern the construction of a building
. The guiding master document is the latest edition of MasterFormat. It is a consensus document that is jointly sponsored by two professional organisations: Construction Specifications Canada and Construction Specifications Institute.
While there is a tendency to believe that "Specs overrule Drawings" in the event of discrepancies between the text document and the drawings, the actual intent—made explicit in the contract between the Owner and the Contractor—is for the drawings and specifications to be complementary, together providing the information required for a complete facility.
The Specifications fall into 50 Divisions, or broad categories of work results involved in construction. The Divisions are subdivided into Sections, each one addressing a narrow scope of the construction work. For instance, firestop
ping is addressed in Section 078400 - Firestopping. It forms part of Division 07, which is Thermal and Moisture Protection. Division 07 also addresses building envelope
and fireproofing
work.
Each Section is subdivided into three distinct Parts: "General", "Products" and "Execution". The MasterFormat
system can be successfully applied to residential, commercial, civil, and industrial construction.
Specifications can be either "performance-based", whereby the specifier restricts the text to stating the performance that must be achieved by the completed work, or "prescriptive", whereby the specifier indicates specific products, vendors and even contractors that are acceptable for each workscope. Most construction specifications are a combination of performance-based and prescriptive types, naming acceptable manufacturers and products while also specifying certain standards and design criteria that must be met.
While North American specifications are usually restricted to broad descriptions of the work, Europe
an ones can include actual work quantities, including such things as area
of drywall
to be built in square metres, like a bill of materials. This type of specification is a collaborative effort between a specwriter and a quantity surveyor
. This approach is unusual in North America, where each bidder performs a quantity survey on the basis of both drawings and specifications.
Although specifications are usually issued by the architect
's office, specwriting itself is undertaken by the architect and the various engineer
s or by specialist specwriters. Specwriting is often a distinct professional trade, with professional certifications such as "Certified Construction Specifier" (CCS) through the professional organizations noted above. Specwriters are either employees of or sub-contractors to architects, engineers, or construction management companies. Specwriters frequently meet with manufacturers of building materials who seek to have their products specified on upcoming construction projects so that contractors can include their products in the estimates leading to their proposals.
(NBS). The National Building Specification
is owned by the Royal Institute of British Architects
(RIBA) through their commercial group RIBA Enterprises (RIBAe). NBS master specifications provide content that is broad and comprehensive, and delivered using software functionality that enables specifiers to customize the content to suit the needs of the project and to keep up to date.
UK project specification types fall into two main categories prescriptive and performance. Prescriptive specifications define the requirements using generic or proprietary descriptions of what is required, whereas as performance specifications focus on the outcomes rather than the characteristics of the components.
Specifications are an integral part of Building Information Modeling
and cover the non-geometric requirements.
. Current existing pronounced standards include:
If any pharmaceutical product is not covered by the above standards, it can be evaluated by the additional source of Pharmacopoeia
from other nations, from industrial specifications. or from standardized formulary
such as
A similar approach is adopted by the food manufacturing, of which Codex Alimentarius
ranks the hightest standards, followed by regional and national standards.
The coverage of food and drug standards by ISO is currently less fruitful and not yet put forward as an urgent agenda due to the tight restrictions of regional or national constitution
Specifications and other standards can be externally imposed as discussed above, but also intenal manufacturing and quality specifications. These exist not only for the food
or pharmaceutical product but also for the processing machinery, quality processes, packaging, logistics
(cold chain
), etc. and are examplified by ISO 14134 and ISO 15609
The converse of explicit statement of specifications is a process for dealing with observations that are out-of-specification. The United States Food and Drug Administration has published a non-binding recommendation that addresses just this point.
At the present time, much of the information and regulations concerning food and food products remain in a form which makes it difficult to apply automated information processing, storage and transmission methods and techniques.
Data systems that can process, store and transfer information about food and food products need formal specifications for the representations of data about food and food products in order to operate effectively and efficiently.
Development of formal specifications for food and drug data with the necessary and sufficient clarity and precision for use specifically by digital computing systems have begun to emerge from government agencies and standards organizations.
The United States Food and Drug Administration has published specifications for a "Structured Product Label" which drug manufacturers must by mandate use to submit electronically the information on a drug label.
Recently, ISO has made some progress in the area of food and drug standards and formal specifications for data about regulated substances through the publication of ISO 11238
description of software or hardware
that may be used to develop an implementation
. It describes what the system should do, not (necessarily) how the system should do it. Given such a specification, it is possible to use formal verification
techniques to demonstrate that a candidate system design is correct with respect to the specification. This has the advantage that incorrect candidate system designs can be revised before a major investment has been made in actually implementing the design. An alternative approach is to use provably correct refinement
steps to transform a specification into a design, and ultimately into an actual implementation, that is correct by construction.
is expected to do. It can be informal, in which case it can be considered as a blueprint or user manual from a developer point of view, or formal
, in which case it has a definite meaning defined in mathematical
or programmatic terms. In practice, many successful specifications are written to understand and fine-tune applications that were already well-developed, although safety-critical software systems are often carefully specified prior to application development. Specifications are most important for external interfaces that must remain stable.
, a functional specification (also, functional spec or specs or functional specifications document (FSD)) is the set of documentation
that describes the behavior of a computer program or larger software system
. The documentation typically describes various inputs that can be provided to the software system and how the system
responds to those inputs.
.
the abbreviation OOS may also be used. Specs are a type of technical standard.
A technical specification may be developed by any of various kinds of organizations, both public
Public sector
The public sector, sometimes referred to as the state sector, is a part of the state that deals with either the production, delivery and allocation of goods and services by and for the government or its citizens, whether national, regional or local/municipal.Examples of public sector activity range...
and private
Private sector
In economics, the private sector is that part of the economy, sometimes referred to as the citizen sector, which is run by private individuals or groups, usually as a means of enterprise for profit, and is not controlled by the state...
. Example organization types include a corporation
Corporation
A corporation is created under the laws of a state as a separate legal entity that has privileges and liabilities that are distinct from those of its members. There are many different forms of corporations, most of which are used to conduct business. Early corporations were established by charter...
, a consortium
Consortium
A consortium is an association of two or more individuals, companies, organizations or governments with the objective of participating in a common activity or pooling their resources for achieving a common goal....
(a small group of corporations), a trade association
Trade association
A trade association, also known as an industry trade group, business association or sector association, is an organization founded and funded by businesses that operate in a specific industry...
(an industry-wide group of corporations), a national government (including its military
Military
A military is an organization authorized by its greater society to use lethal force, usually including use of weapons, in defending its country by combating actual or perceived threats. The military may have additional functions of use to its greater society, such as advancing a political agenda e.g...
, regulatory agencies, and national laboratories and institutes), a professional association (society), or a purpose-made standards organization
Standards organization
A standards organization, standards body, standards developing organization , or standards setting organization is any organization whose primary activities are developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise producing technical standards that are...
such as ISO
International Organization for Standardization
The International Organization for Standardization , widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates worldwide proprietary, industrial and commercial...
. It is common for one organization to refer to (reference, call out, cite) the standards of another. Voluntary standards may become mandatory if adopted by a government or business contract.
Sometimes the term specification is used in connection with a data sheet (or spec sheet). A data sheet describes the technical characteristics of an item or product. It can be published by a manufacturer to help people choose products or to help use the products. A data sheet is not a technical specification as described in this article.
Use
In engineeringEngineering
Engineering is the discipline, art, skill and profession of acquiring and applying scientific, mathematical, economic, social, and practical knowledge, in order to design and build structures, machines, devices, systems, materials and processes that safely realize improvements to the lives of...
, manufacturing
Manufacturing
Manufacturing is the use of machines, tools and labor to produce goods for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale...
, and business
Business
A business is an organization engaged in the trade of goods, services, or both to consumers. Businesses are predominant in capitalist economies, where most of them are privately owned and administered to earn profit to increase the wealth of their owners. Businesses may also be not-for-profit...
, it is vital for suppliers, purchasers, and users of materials, products, or services to understand and agree upon all requirements. A specification is a type of a standard which is often referenced by a contract
Contract
A contract is an agreement entered into by two parties or more with the intention of creating a legal obligation, which may have elements in writing. Contracts can be made orally. The remedy for breach of contract can be "damages" or compensation of money. In equity, the remedy can be specific...
or procurement document. It provides the necessary details about the specific requirements.
Specifications may be written by government agencies, standards organizations (ASTM, ISO
International Organization for Standardization
The International Organization for Standardization , widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates worldwide proprietary, industrial and commercial...
, CEN
CEN
CEN may refer to:*Cen, or sen, is the currency of the fictional nation of Amestris of the anime/manga "Fullmetal Alchemist"As a three-letter acronym:* Cambridge Evening News, former name for the Cambridge News...
, DoD, etc.), trade associations, corporations, and others.
A product specification does not necessarily prove a product to be correct. An item might be verified
Verification and Validation
In software project management, software testing, and software engineering, verification and validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose...
to comply with a specification or stamped with a specification number: This does not, by itself, indicate that the item is fit for any particular use. The people who use the item (engineers, trade unions, etc.) or specify the item (building codes, government, industry, etc.) have the responsibility to consider the choice of available specifications, specify the correct one, enforce compliance, and use the item correctly. Validation
Verification and Validation
In software project management, software testing, and software engineering, verification and validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose...
of suitability is necessary.
Guidance and content
Sometimes a guide or a standing operating procedureStanding operating procedure
The terms standard operating procedure or SOP, is used in a variety of different contexts, such as healthcare, education, industry or the military. The military uses the term Standing Operating Procedure- rather than Standard- because an SOP refers to an organization's unique procedures, which are...
is available to help write and format a good specification. A specification might include:
- Descriptive title, number, identifierIdentifierAn identifier is a name that identifies either a unique object or a unique class of objects, where the "object" or class may be an idea, physical [countable] object , or physical [noncountable] substance...
, etc. of the specification - Date of last effective revision and revision designation
- A logoLogoA logo is a graphic mark or emblem commonly used by commercial enterprises, organizations and even individuals to aid and promote instant public recognition...
or trademarkTrademarkA trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or...
to indicate the document copyrightCopyrightCopyright is a legal concept, enacted by most governments, giving the creator of an original work exclusive rights to it, usually for a limited time...
, ownershipOwnershipOwnership is the state or fact of exclusive rights and control over property, which may be an object, land/real estate or intellectual property. Ownership involves multiple rights, collectively referred to as title, which may be separated and held by different parties. The concept of ownership has...
and origin - Table of Contents (TOC), if the document is long
- Person, office, or agency responsible for questions on the specification, updates, and deviations.
- The significance, scope or importance of the specification and its intended use.
- TerminologyTerminologyTerminology is the study of terms and their use. Terms are words and compound words that in specific contexts are given specific meanings, meanings that may deviate from the meaning the same words have in other contexts and in everyday language. The discipline Terminology studies among other...
, definitions and abbreviations to clarify the meanings of the specification - Test methodTest methodA test method is a definitive procedure that produces a test result.A test can be considered as technical operation that consists of determination of one or more characteristics of a given product, process or service according to a specified procedure. Often a test is part of an experiment.The test...
s for measuring all specified characteristics - Material requirements: physical, mechanical, electrical, chemical, etc. Targets and tolerancesTolerance (engineering)Engineering tolerance is the permissible limit or limits of variation in# a physical dimension,# a measured value or physical property of a material, manufactured object, system, or service,# other measured values ....
. - Acceptance testing, including Performance testingPerformance testingIn software engineering, performance testing is in general testing performed to determine how a system performs in terms of responsiveness and stability under a particular workload...
requirements. Targets and tolerancesTolerance (engineering)Engineering tolerance is the permissible limit or limits of variation in# a physical dimension,# a measured value or physical property of a material, manufactured object, system, or service,# other measured values ....
. - Drawings, photographPhotographA photograph is an image created by light falling on a light-sensitive surface, usually photographic film or an electronic imager such as a CCD or a CMOS chip. Most photographs are created using a camera, which uses a lens to focus the scene's visible wavelengths of light into a reproduction of...
s, or technical illustrationTechnical illustrationTechnical Illustration is the use of illustration to visually communicate information of a technical nature. Technical illustrations can be components of technical drawings or diagrams...
s - Workmanship
- CertificationCertificationCertification refers to the confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of external review, education, assessment, or audit...
s required. - SafetySafetySafety is the state of being "safe" , the condition of being protected against physical, social, spiritual, financial, political, emotional, occupational, psychological, educational or other types or consequences of failure, damage, error, accidents, harm or any other event which could be...
considerations and requirements - EnvironmentalNatural environmentThe natural environment encompasses all living and non-living things occurring naturally on Earth or some region thereof. It is an environment that encompasses the interaction of all living species....
considerations and requirements - Quality controlQuality controlQuality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...
requirements, acceptance samplingAcceptance samplingAcceptance sampling uses statistical sampling to determine whether to accept or reject a production lot of material. It has been a common quality control technique used in industry and particularly the military for contracts and procurement. It is usually done as products leave the factory, or in...
, inspections, acceptance criteria - Person, office, or agency responsible for enforcement of the specification.
- Completion and delivery.
- Provisions for rejection, reinspection, rehearing, corrective measures
- References and citationCitationBroadly, a citation is a reference to a published or unpublished source . More precisely, a citation is an abbreviated alphanumeric expression Broadly, a citation is a reference to a published or unpublished source (not always the original source). More precisely, a citation is an abbreviated...
s for which any instructions in the content maybe required to fulfill the traceabilityTraceabilityTraceability refers to the completeness of the information about every step in a process chain.The formal definition: Traceability is the ability to chronologically interrelate uniquely identifiable entities in a way that is verifiable....
and clarity of the document - Signatures of approval, if necessary
- Change recordChange ControlChange control within Quality management systems and Information Technology systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner...
to summarize the chronological development, revision and completion if the document is to be circulated internally - Annexes and AppendicesAddendumAn addendum, in general, is an addition required to be made to a document by its reader subsequent to its printing or publication. It comes from the Latin verbal phrase addendum est, being the gerundive form of the verb addo, addere, addidi, additum, "to give to, add to", meaning " must be added"...
that are expand details, add clarification, or offer options.
Process capability considerations
A good engineering specification, by itself, does not necessarily imply that all products sold to that specification actually meet the listed targets and tolerances. Actual production of any material, product, or service involves inherent variation of output. With a normal distribution, the tails of production may extend well beyond plus and minus three standard deviations from the process average.The process capability
Process capability
A process is a unique combination of tools, materials, methods, and people engaged in producing a measurable output; for example a manufacturing line for machine parts...
of materials and products needs to be compatible with the specified engineering tolerances. Process control
Process control
Process control is a statistics and engineering discipline that deals with architectures, mechanisms and algorithms for maintaining the output of a specific process within a desired range...
s must be in place and an effective Quality management system
Quality management system
A quality management system can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.-Elements of a Quality Management System:# Organizational structure# Responsibilities# Methods...
, such as Total Quality Management
Total Quality Management
Total quality management or TQM is an integrative philosophy of management for continuously improving the quality of products and processes....
, needs to keep actual production within the desired tolerances.
Effective enforcement of a specification is necessary for it to be useful.
Construction specifications in North America
Specifications in North AmericaNorth America
North America is a continent wholly within the Northern Hemisphere and almost wholly within the Western Hemisphere. It is also considered a northern subcontinent of the Americas...
form part of the contract documents that accompany and govern the construction of a building
Building
In architecture, construction, engineering, real estate development and technology the word building may refer to one of the following:...
. The guiding master document is the latest edition of MasterFormat. It is a consensus document that is jointly sponsored by two professional organisations: Construction Specifications Canada and Construction Specifications Institute.
While there is a tendency to believe that "Specs overrule Drawings" in the event of discrepancies between the text document and the drawings, the actual intent—made explicit in the contract between the Owner and the Contractor—is for the drawings and specifications to be complementary, together providing the information required for a complete facility.
The Specifications fall into 50 Divisions, or broad categories of work results involved in construction. The Divisions are subdivided into Sections, each one addressing a narrow scope of the construction work. For instance, firestop
Firestop
A firestop is a passive fire protection system of various components used to seal openings and joints in fire-resistance rated wall and/or floor assemblies, based on fire testing and certification listings....
ping is addressed in Section 078400 - Firestopping. It forms part of Division 07, which is Thermal and Moisture Protection. Division 07 also addresses building envelope
Building envelope
The building envelope is the physical separator between the interior and the exterior environments of a building. Another emerging term is "Building Enclosure". It serves as the outer shell to help maintain the indoor environment and facilitate its climate control...
and fireproofing
Fireproofing
Fireproofing, a passive fire protection measure, refers to the act of making materials or structures more resistant to fire, or to those materials themselves, or the act of applying such materials. Applying a certification listed fireproofing system to certain structures allows these to have a...
work.
Each Section is subdivided into three distinct Parts: "General", "Products" and "Execution". The MasterFormat
MasterFormat
MasterFormat is a standard for organizing specifications and other written information for commercial and institutional building projects in the U.S. and Canada . Sometimes referred to as the "Dewey Decimal System" of building construction, MasterFormat is a product of the Construction...
system can be successfully applied to residential, commercial, civil, and industrial construction.
Specifications can be either "performance-based", whereby the specifier restricts the text to stating the performance that must be achieved by the completed work, or "prescriptive", whereby the specifier indicates specific products, vendors and even contractors that are acceptable for each workscope. Most construction specifications are a combination of performance-based and prescriptive types, naming acceptable manufacturers and products while also specifying certain standards and design criteria that must be met.
While North American specifications are usually restricted to broad descriptions of the work, Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
an ones can include actual work quantities, including such things as area
Area
Area is a quantity that expresses the extent of a two-dimensional surface or shape in the plane. Area can be understood as the amount of material with a given thickness that would be necessary to fashion a model of the shape, or the amount of paint necessary to cover the surface with a single coat...
of drywall
Drywall
Drywall, also known as plasterboard, wallboard or gypsum board is a panel made of gypsum plaster pressed between two thick sheets of paper...
to be built in square metres, like a bill of materials. This type of specification is a collaborative effort between a specwriter and a quantity surveyor
Quantity surveyor
A quantity surveyor is a professional working within the construction industry concerned with building costs.The profession is one that provides a qualification gained following formal education, specific training and experience that provides a general set of skills that are then applied to a...
. This approach is unusual in North America, where each bidder performs a quantity survey on the basis of both drawings and specifications.
Although specifications are usually issued by the architect
Architect
An architect is a person trained in the planning, design and oversight of the construction of buildings. To practice architecture means to offer or render services in connection with the design and construction of a building, or group of buildings and the space within the site surrounding the...
's office, specwriting itself is undertaken by the architect and the various engineer
Architectural engineering
Architectural engineering, also known as building engineering, is the application of engineering principles and technology to building design and construction...
s or by specialist specwriters. Specwriting is often a distinct professional trade, with professional certifications such as "Certified Construction Specifier" (CCS) through the professional organizations noted above. Specwriters are either employees of or sub-contractors to architects, engineers, or construction management companies. Specwriters frequently meet with manufacturers of building materials who seek to have their products specified on upcoming construction projects so that contractors can include their products in the estimates leading to their proposals.
Construction specifications in the UK
Specifications in the UK are prepared by construction professionals such as Architects, Structural Engineers, Landscape Architects and Building Services Engineers. They are created from previous project specifications, in-house documents or master specifications such as the National Building SpecificationNational Building Specification
The National Building Specification, and now known as the NBS, is a British based system of construction specification used by architects and other building professionals to describe the materials, standards and workmanship of a construction project...
(NBS). The National Building Specification
National Building Specification
The National Building Specification, and now known as the NBS, is a British based system of construction specification used by architects and other building professionals to describe the materials, standards and workmanship of a construction project...
is owned by the Royal Institute of British Architects
Royal Institute of British Architects
The Royal Institute of British Architects is a professional body for architects primarily in the United Kingdom, but also internationally.-History:...
(RIBA) through their commercial group RIBA Enterprises (RIBAe). NBS master specifications provide content that is broad and comprehensive, and delivered using software functionality that enables specifiers to customize the content to suit the needs of the project and to keep up to date.
UK project specification types fall into two main categories prescriptive and performance. Prescriptive specifications define the requirements using generic or proprietary descriptions of what is required, whereas as performance specifications focus on the outcomes rather than the characteristics of the components.
Specifications are an integral part of Building Information Modeling
Building Information Modeling
Building information modeling is the process of generating and managing building data during its life cycle.BIM involves representing a design as objects – vague and undefined, generic or product-specific, solid shapes or void-space oriented , that carry their geometry, relations and attributes...
and cover the non-geometric requirements.
Food and drug specifications
Pharmaceutical products can usually be tested and qualified by various PharmacopoeiaPharmacopoeia
Pharmacopoeia, pharmacopeia, or pharmacopoea, , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.In a broader sense it is...
. Current existing pronounced standards include:
- British PharmacopoeiaBritish PharmacopoeiaThe British Pharmacopoeia is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacture and testing....
- European PharmacopoeiaEuropean PharmacopoeiaThe European Pharmacopoeia of the Council of Europe is a pharmacopoeia, listing a wide range of active substances and excipients used to prepare pharmaceutical products in Europe...
- Japanese Pharmacopoeia
- The International PharmacopoeiaThe International PharmacopoeiaThe aim of The International Pharmacopoeia , which is issued by the World Health Organization as a recommendation, is to achieve a wide global uniformity of quality specifications for selected pharmaceutical products, excipients, and dosage forms.The information published in The International...
- United States Pharmacopoeia
If any pharmaceutical product is not covered by the above standards, it can be evaluated by the additional source of Pharmacopoeia
Pharmacopoeia
Pharmacopoeia, pharmacopeia, or pharmacopoea, , in its modern technical sense, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.In a broader sense it is...
from other nations, from industrial specifications. or from standardized formulary
Formulary
The term formulary can refer to:*Formulary , ancient and medieval collections of models for official writings.*Formulary , List of prescription drugs covered by a particular drug benefit plan.*certain modern reference works, e.g.:...
such as
- British National Formulary for ChildrenBritish National Formulary for ChildrenThe British National Formulary for Children is the standard UK paediatric reference for prescribing and pharmacology, among others indications, side effects and costs of the prescription of all medication drugs available on the National Health Service....
- British National FormularyBritish National FormularyThe British National Formulary is a medical and pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about all medicines available on the National Health Service , including indication,...
- National Formulary
A similar approach is adopted by the food manufacturing, of which Codex Alimentarius
Codex Alimentarius
The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Its name derives from the Codex Alimentarius Austriacus...
ranks the hightest standards, followed by regional and national standards.
The coverage of food and drug standards by ISO is currently less fruitful and not yet put forward as an urgent agenda due to the tight restrictions of regional or national constitution
Specifications and other standards can be externally imposed as discussed above, but also intenal manufacturing and quality specifications. These exist not only for the food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...
or pharmaceutical product but also for the processing machinery, quality processes, packaging, logistics
Logistics
Logistics is the management of the flow of goods between the point of origin and the point of destination in order to meet the requirements of customers or corporations. Logistics involves the integration of information, transportation, inventory, warehousing, material handling, and packaging, and...
(cold chain
Cold chain
A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range...
), etc. and are examplified by ISO 14134 and ISO 15609
The converse of explicit statement of specifications is a process for dealing with observations that are out-of-specification. The United States Food and Drug Administration has published a non-binding recommendation that addresses just this point.
At the present time, much of the information and regulations concerning food and food products remain in a form which makes it difficult to apply automated information processing, storage and transmission methods and techniques.
Data systems that can process, store and transfer information about food and food products need formal specifications for the representations of data about food and food products in order to operate effectively and efficiently.
Development of formal specifications for food and drug data with the necessary and sufficient clarity and precision for use specifically by digital computing systems have begun to emerge from government agencies and standards organizations.
The United States Food and Drug Administration has published specifications for a "Structured Product Label" which drug manufacturers must by mandate use to submit electronically the information on a drug label.
Recently, ISO has made some progress in the area of food and drug standards and formal specifications for data about regulated substances through the publication of ISO 11238
Formal specification
A formal specification is a mathematicalMathematics
Mathematics is the study of quantity, space, structure, and change. Mathematicians seek out patterns and formulate new conjectures. Mathematicians resolve the truth or falsity of conjectures by mathematical proofs, which are arguments sufficient to convince other mathematicians of their validity...
description of software or hardware
Hardware
Hardware is a general term for equipment such as keys, locks, hinges, latches, handles, wire, chains, plumbing supplies, tools, utensils, cutlery and machine parts. Household hardware is typically sold in hardware stores....
that may be used to develop an implementation
Implementation
Implementation is the realization of an application, or execution of a plan, idea, model, design, specification, standard, algorithm, or policy.-Computer Science:...
. It describes what the system should do, not (necessarily) how the system should do it. Given such a specification, it is possible to use formal verification
Formal verification
In the context of hardware and software systems, formal verification is the act of proving or disproving the correctness of intended algorithms underlying a system with respect to a certain formal specification or property, using formal methods of mathematics .- Usage :Formal verification can be...
techniques to demonstrate that a candidate system design is correct with respect to the specification. This has the advantage that incorrect candidate system designs can be revised before a major investment has been made in actually implementing the design. An alternative approach is to use provably correct refinement
Refinement
In formal methods, program refinement is the verifiable transformation of an abstract formal specification into a concrete executable program. Stepwise refinement allows this process to be done in stages...
steps to transform a specification into a design, and ultimately into an actual implementation, that is correct by construction.
Program specification
A program specification is the definition of what a computer programComputer program
A computer program is a sequence of instructions written to perform a specified task with a computer. A computer requires programs to function, typically executing the program's instructions in a central processor. The program has an executable form that the computer can use directly to execute...
is expected to do. It can be informal, in which case it can be considered as a blueprint or user manual from a developer point of view, or formal
Formal specification
In computer science, a formal specification is a mathematical description of software or hardware that may be used to develop an implementation. It describes what the system should do, not how the system should do it...
, in which case it has a definite meaning defined in mathematical
Mathematics
Mathematics is the study of quantity, space, structure, and change. Mathematicians seek out patterns and formulate new conjectures. Mathematicians resolve the truth or falsity of conjectures by mathematical proofs, which are arguments sufficient to convince other mathematicians of their validity...
or programmatic terms. In practice, many successful specifications are written to understand and fine-tune applications that were already well-developed, although safety-critical software systems are often carefully specified prior to application development. Specifications are most important for external interfaces that must remain stable.
Functional specification
In software developmentSoftware development
Software development is the development of a software product...
, a functional specification (also, functional spec or specs or functional specifications document (FSD)) is the set of documentation
Documentation
Documentation is a term used in several different ways. Generally, documentation refers to the process of providing evidence.Modules of Documentation are Helpful...
that describes the behavior of a computer program or larger software system
Software system
A software system is a system based on software forming part of a computer system . The term "software system" is often used as a synonym of computer program or software; is related to the application of systems theory approaches in software engineering context and are used to study large and...
. The documentation typically describes various inputs that can be provided to the software system and how the system
System
System is a set of interacting or interdependent components forming an integrated whole....
responds to those inputs.
Web service specification
Web services specifications are often under the umbrella of a quality management systemQuality management system
A quality management system can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.-Elements of a Quality Management System:# Organizational structure# Responsibilities# Methods...
.
Document specification
These types of documents define how a specific document should be written, which may include, but is not limited to, the systems of a document naming, version, layout, referencing, structuring, appearance, language, copyright, hierarchy or format, etc. Very often, this kind of specifications is complemented by a designated template.See also
- BenchmarkingBenchmarkingBenchmarking is the process of comparing one's business processes and performance metrics to industry bests and/or best practices from other industries. Dimensions typically measured are quality, time and cost...
- Benchmark specification
- Change controlChange ControlChange control within Quality management systems and Information Technology systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner...
- Construction Specifications InstituteConstruction Specifications InstituteThe Construction Specifications Institute is an organization that maintains and advances the standardization of construction language as pertains to building specifications...
- Defense StandardDefense StandardA United States defense standard, often called a military standard, "MIL-STD", "MIL-SPEC", or "MilSpecs", is used to help achieve standardization objectives by the U.S...
- Design specificationDesign specificationA design specification provides explicit information about the requirements for a product and how the product is to be put together. It is the most traditional kind of specification, having been used historically in public contracting for buildings, highways, and other public works, and represents...
- Diagnostic design specificationDiagnostic design specificationDiagnostic design specification is a document indicating how the diagnostics will be implemented on an upcoming/new products that will be developed by the company. It describes the behavior of the diagnostics like how the test will execute, how the output messages are formatted, and how the final...
- Document identifier
- DocumentationDocumentationDocumentation is a term used in several different ways. Generally, documentation refers to the process of providing evidence.Modules of Documentation are Helpful...
- Document management systemDocument management systemA document management system is a computer system used to track and store electronic documents and/or images of paper documents. It is usually also capable of keeping track of the different versions created by different users . The term has some overlap with the concepts of content management...
- Formal specificationFormal specificationIn computer science, a formal specification is a mathematical description of software or hardware that may be used to develop an implementation. It describes what the system should do, not how the system should do it...
- Functional specificationFunctional specificationA functional specification in systems engineering and software development is the documentation that describes the requested behavior of an engineering system...
- List of ISO standards
- List of Air Ministry specifications
- MasterFormatMasterFormatMasterFormat is a standard for organizing specifications and other written information for commercial and institutional building projects in the U.S. and Canada . Sometimes referred to as the "Dewey Decimal System" of building construction, MasterFormat is a product of the Construction...
- Manufacturing test requirement design specificationManufacturing test requirement design specificationManufacturing test requirement design specification is a document which specifies how the test is going to be implemented on a new/upcoming product...
- Open standardOpen standardAn open standard is a standard that is publicly available and has various rights to use associated with it, and may also have various properties of how it was designed . There is no single definition and interpretations vary with usage....
- Performance testingPerformance testingIn software engineering, performance testing is in general testing performed to determine how a system performs in terms of responsiveness and stability under a particular workload...
- Process specificationProcess specificationProcess specification is a generic term for the specification of a process. Its context is not unique to "business activity" but can be applied to any organizational activity....
- Product design specificationProduct design specificationA product design specification is a statement of what a not-yet-designed product is intended to do. Its aim is to ensure that the subsequent design and development of a product meets the needs of the user. Product design specification is one of the elements of product lifecycle management.The PDS...
- Publicly Available SpecificationPublicly Available SpecificationThe PAS is a consultative document where the development process and written format is based on the British Standard model...
- Revision controlRevision controlRevision control, also known as version control and source control , is the management of changes to documents, programs, and other information stored as computer files. It is most commonly used in software development, where a team of people may change the same files...
- Requirements analysisRequirements analysisRequirements analysis in systems engineering and software engineering, encompasses those tasks that go into determining the needs or conditions to meet for a new or altered product, taking account of the possibly conflicting requirements of the various stakeholders, such as beneficiaries or users...
- Shop drawingShop drawingA is a drawing or set of drawings produced by the contractor, supplier, manufacturer, subcontractor, or fabricator. Shop drawings are typically required for pre-fabricated components. Examples of these include: elevators, structural steel, trusses, pre-cast, windows, appliances, cabinets, air...
- Specification and Description LanguageSpecification and Description LanguageSpecification and Description Language is a specification language targeted at the unambiguous specification and description of the behaviour of reactive and distributed systems.- Overview :It is defined by the ITU-T...
- Specification treeSpecification treeA specification tree shows all specifications of a technical system under development in a hierarchical order.For a spacecraft system it has the following levels:* System specification - generated by customer...
- StandardizationStandardizationStandardization is the process of developing and implementing technical standards.The goals of standardization can be to help with independence of single suppliers , compatibility, interoperability, safety, repeatability, or quality....
- Statistical interferenceStatistical interferenceWhen two probability distributions overlap, statistical interference exists. Knowledge of the distributions can be used to determine the likelihood that one parameter exceeds another, and by how much....
- Submittals (construction)Submittals (construction)Submittals in Construction Management are shop drawings, material data, samples, and product data. Submittals are required primarily for the architect and engineer to verify that the correct products will be installed on the project....
- Technical documentationTechnical documentationIn engineering, technical documentation refers to any type of documentation that describes handling, functionality and architecture of a technical product or a product under development or use.Documentation may include:* patents...
- Tolerance (engineering)Tolerance (engineering)Engineering tolerance is the permissible limit or limits of variation in# a physical dimension,# a measured value or physical property of a material, manufactured object, system, or service,# other measured values ....
- Verification and Validation
Further reading
- Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0824746147
- Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 007034003
- "Specifications for the Chemical And Process Industries", 1996, ASQ Quality Press, ISBN 0-87389-351-4
- ASTM E29-06b Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
- Journal of Chemical Information and ModelingJournal of Chemical Information and ModelingThe Journal of Chemical Information and Modeling , is a peer-reviewed scientific journal, published since 1961 by the American Chemical Society...
- Journal of Documentation, Emerald Group PublishingEmerald Group PublishingEmerald Group Publishing Limited is a primary publisher of management and business journals. Founded in the UK in 1967, it operates worldwide with offices in Malaysia, Japan, China, India and the United States.-History:...
, ISSN: 0022-0418