Standard operating procedure - Wikipedia, the free encyclopedia. The term standard operating procedure, or SOP, is used in a variety of different contexts, including healthcare, aviation, engineering, education, industry, military and civil servants. The U. S. military sometimes uses the term Standing — rather than Standard — Operating Procedure, because a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. Standard" could imply that there is one (standard) procedure to be used across all units. Such procedures are a set of step- by- step instructions to achieve a predictable, standardized, desired result often within the context of a longer overall process. For food and drug safety, the related Sanitation Standard Operating Procedures are used.
Clinical research and practice[edit]In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs get usually applied in pharmaceutical processing and for related clinical studies. There the focus is always set on repeated application of unchanged processes and procedures and its documentation, hence supporting the segregation of origins, causes and effects. Further application is with triage, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities.[1] Study director is mainly responsible for SOPs.
The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP. SOPs can also provide employees with a reference to common business practices, activities, or tasks. New employees use an SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. The international quality standard ISO 9. Safety and health at work[edit]Procedures are extensively employed to assist with working safely.
Yes, I want to streamline employee transitions and be ready for anything. Send me Creating a Standard Operating Procedures Manual: An Essential Business Tool for. A risk manager is responsible for creating the desired level of risk that will allow an organization to achieve its goals. In step one of the risk management process.
- Five Steps to Creating a Standard Operating Procedure Template. Create an SOP Template File; Define the SOP Format; Add Common SOP Elements; Finalize The SOP Styles.
- When Angie Fuller arrived on the first day of a new job, she discovered a copy of the Standard Operating Procedure manual created by the person who held the job.
- An important aspect of a quality system is to work according to unambiguous Standard Operating Procedures. 'A Standard Operating Procedure is a document which.
- A standard operating procedures manual is a written document that lists the instructions. How Do I Write a Standard Operations Procedures Manual?
They are sometimes called safe work methods statements (SWMS). They are usually preceded by various methods of analyzing tasks or jobs to be performed in a workplace, including an approach called job safety analysis, in which hazards are identified and their control methods described.
Procedures must be suited to the literacy levels of the user, and as part of this, the readability of procedures is important.[3]See also[edit]References[edit]^"Mc. Murdo Station Medical Standard Operating Procedures as of 2. PDF). Retrieved 2. Guidance on the Documentation Requirements of ISO 9. Archived October 1.
Wayback Machine^Taylor, G. A. (2. 01. 2) Readability of OHS documents - A comparison of surface characteristics of OHS text between some languages, Safety Science, 5. External links[edit].
STANDARD OPERATING PROCEDURES2. Definition. 2. 2 Initiating a SOP2. Preparation of SOPs. Administration. Distribution, Implementation. Laboratory notebook.
Relativization. as encouragement. SOPs. An important aspect of a quality system is to work according to unambiguous Standard Operating Procedures (SOPs). In fact the whole process from sampling to the filing of the analytical result should be described by a continuous series of SOPs. A SOP for a laboratory can be defined as follows. A Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation. The purpose of a SOP is to carry out the operations correctly and always in the same manner. A SOP should be available at the place where the work is done".
A SOP is a compulsory instruction. If deviations from this instruction are allowed, the conditions for these should be documented including who can give permission for this and what exactly the complete procedure will be. The original should rest at a secure place while working copies should be authenticated with stamps and/or signatures of authorized persons. Several categories and types of SOPs can be distinguished. The name "SOP" may not always be appropriate, e. Also worksheets belonging to an analytical procedure have to be standardized (to avoid jotting down readings and calculations on odd pieces of paper). A number of important SOP types are.
Fundamental SOPs. These give instructions how to make SOPs of the other categories.- Methodic SOPs. These describe a complete testing system or method of investigation.- SOPs for safety precautions.- Standard procedures for operating instruments, apparatus and other equipment.- SOPs for analytical methods.- SOPs for the preparation of reagents.- SOPs for receiving and registration of samples.- SOPs for Quality Assurance.- SOPs for archiving and how to deal with complaints. As implied above, the initiative and further procedure for the preparation, implementation and management of the documents is a procedure in itself which should be described.
The term standard operating procedure, or SOP. For food and drug safety, the related Sanitation Standard Operating Procedures are used.
These SOPs should at least mention. SOP; b. to whom proposals for a SOP should be submitted, and who adjudges the draft; c. SOP can be withdrawn. It should be established and recorded who is responsible for the proper distribution of the documents, the filing and administration (e. Finally, it should be indicated how frequently a valid SOP should be periodically evaluated (usually 2 years) and by whom. Only officially issued copies may be used, only then the use of the proper instruction is guaranteed. In the laboratory the procedure for the preparation of a SOP should be as follows.
The Head of Laboratory (Ho. L) charges a staff member of the laboratory to draft a SOP (or the Ho. L does this himself or a staff member takes the initiative). In principle, the author is the person who will work with the SOP, but he or she should always keep in mind that the SOP needs to be understood by others. The author requests a new registration number from the SOP administrator or custodian (which in smaller institutes or laboratories will often be the Ho. L, see 2. 4). The administrator verifies if the SOP already exists (or is drafted). If the SOP does not exist yet, the title and author are entered into the registration system.
Once the writing of a SOP is undertaken, the management must actively support this effort and allow authors adequate preparation time. In case of methodic or apparatus SOPs the author asks one or more qualified colleagues to try out the SOP. In case of execution procedures for investigations or protocols, the project leader or Ho. L could do the testing. In this phase the wording of the SOP is fine- tuned. When the test is passed, the SOP is submitted to the SOP administrator for acceptance.
Revisions of SOPs follow the same procedure. The make- up of the documents should meet a minimum number of requirements. Each page should have a heading and/or footing mentioning. SOP (preferably with category); d. SOP. e. the heading (or only the logo) of originals should preferably be printed in another colour than black. Categories can be denoted with a letter or combination of letters, e.
F for fundamental SOP- A or APP for apparatus SOP- M or METH for analytical method SOP- P or PROJ for procedure to carry out a special investigation (project)- PROT for a protocol describing a sequence of actions or operations- ORG for an organizational document- PERS for describing personnel matters- RF for registration form (e. WS for worksheet (related to analytical procedures). The first page, the title page, should mention. SOPs (of operations used in the present SOP).
It is possible to record the authors centrally in a register). SOP (including date). The necessary equipment, reagents (including grade) and other means should be detailed. A clear, unambiguous imperative description is given in a language mastered by the user. It is recommended to include criteria for the control of the described system during operation. It is recommended to include a list of contents particularly if the SOP is lengthy. It is recommended to include a list of references.
From this description it would seem that the preparation and administration of a SOP and other quality assurance documentation is an onerous job. However, once the draft is made, with the use of word processors and a simple distribution scheme of persons and departments involved, the task can be considerably eased. A model for a simple preparation and distribution scheme is given in Figure 2- 1.
This is a relation matrix which can not only be used for the laboratory but for any department or a whole institute. In this matrix (which can be given the status of a SOP) can be indicated all persons or departments that are involved with the subject as well as the kind of their involvement. This can be indicated in the scheme with an involvement code. Some of the most usual involvements are (the number can be used as the code). Taking initiative for drafting. Drafting the document.
Verifying. 4. Authorizing. Implementing/using. Copy for information.
Checking implementation. Archiving. Fig. 2- 1. Matrix of information organization (see text).
There is a multitude of valid approaches for distribution of SOPs but there must always be a mechanism for informing potential users that a new SOP has been written or that an existing SOP has been revised or withdrawn. It is worthwhile to set up a good filing system for all documents right at the outset. This will spare much inconvenience, confusion and embarrassment, not only in internal use but also with respect to the institute's management, authorities, clients and, if applicable, inspectors of the accreditation body.
The administrator responsible for distribution and archiving SOPs may differ per institute. In large institutes or institutes with an accredited laboratory this will be the Quality Assurance Officer, otherwise this may be an officer of the department of Personnel & Organization or still someone else. In non- accredited laboratories the administration can most conveniently be done by the head of laboratory or his deputy.
The administration may be done in a logbook, by means of a card system or, more conveniently, with a computerized database such as Perfect. View or Cardbox. Suspending files are very useful for keeping originals, copies and other information of documents. The most logic system seems to make an appropriate grouping into categories and a master index for easy retrieval. It is most convenient to keep these files at a central place such as the office of the head of laboratory. Naturally, this does not apply to working documents that obviously are used at the work place in the laboratory, e. The data which should be stored per document are. SOP number- version number- date of issue- date of expiry- title- author- status (title submitted; being drafted; draft ready; issued)- department of holders/users- names of holders- number of copies per holder if this is more than one- registration number of SOPs to which reference is made- historical data (dates of previous issues)The SOP administrator keeps at least two copies of each SOP; one for the historical and one for the back- up file.
This also applies to revised versions. Superseded versions should be collected and destroyed (except the copy for the historical file) to avoid confusion and unauthorized use. Examples of various categories of SOPs will be given in the ensuing chapters. The contents of a SOP for the administration and management of SOPs can be distilled from the above. An example of the basic format is given as Model F 0.
Unless recorded automatically, raw data and readings of measurements are most conveniently written down on worksheets that can be prepared for each analytical method or procedure, including calibration of equipment. In addition, each laboratory staff member should have a personal Notebook in which all observations, remarks, calculations and other actions connected with the work are recorded in ink, not with a pencil, so that they will not be erased or lost.
To ensure integrity such a notebook must meet a few minimum requirements: on the cover it must carry a unique serial number, the owner's name, and the date of issue. The copy is issued by the QA officer or head of laboratory who keeps a record of this (e.
Notebook). The user signs for receipt, the QA officer or Ho. L for issue. The Notebook should be bound and the pages numbered before issue (loose- leaf bindings are not GLP!).
The first one or two pages can be used for an index of contents (to be filled in as the book is used). Such Notebooks can made from ordinary notebooks on sale (before issue, the page numbering should then be done by hand or with a special stamp) or with the help of a word processor and then printed and bound in a graphical workshop. The instructions for the proper use of a laboratory notebook should be set down in a protocol, an example is given as Model PROT 0.