Standard operating procedure written

The last section of this book provides a set of 20 explicit standard operating procedures written in a global text to describe the elements of the revised standard. The contents of the procedures can be specifically tailored to an individual company s operations, and reference can be made to specific documents and associated applicable procedures. Taking into consideration the fact that thousands of companies are already registered and certified in compliance with the ISO 9001 11994) or ISO 9002 (1994) or ISO 9003 (1994) international standards, reference is made to the corresponding SOPs to indicate applicable clauses of both the second and the third revisions of the ISO 9000 series of standards. 

Fourth, following written standard operating procedures. There is no mystique to SOPs, they are the heart of any test facility. They assure that everyone follows the same procedure each time, that there is no oral law that supercedes the written text. How detailed should these be There are text books on the market with standard operating procedures written in - just like you go to the stationary or office supply shop and buy a standard form will or rental agreement. You have to fill in the blanks. My definition of an SOP is a written procedure that can be followed by any well informed qualified individual with the complete expectation that the anticipated result will be obtained. Can an instruction book be an SOP Probably not. Most instruction books are written as if they had been badly translated from a foreign language. They are frequently difficult to understand. The instruction book can certainly be a part of the SOP, but rarely the SOP itself. 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

A specific detailed description and protocol should be written (standard operating procedure (SOP)). 

The standard operating procedures demand great attention as they reflect personnel safety issues, safe operating limits and quality considerations. They should be written simply and clearly. The level of detail is determined by the training and experience of the operations staff but should also take into account the hazards inherent in the process. 

Operating procedures written, complete, meeting requirements of PSM Standard or RMP Rule, if covered... 

D. Task-specific hazard analyses must lead to the development of written standard operating procedures (SOPs) that specify the controls necessary to safely perform each task. Detailed hazard analyses conducted for each site task and operation provide the basis for developing SOPs to protect employees from safety and health hazards. Written SOPs provide a mechanism for informing employees of procedures that ensure their safety and for enabling management to enforce hazard control procedures. 

Many companies have specific protocols for the development and description of standard operating procedures. Like the management systems they detail, these SOPs vary considerably in terms of their otganization and level of detail. While it s clearly premature to develop a specific format within which PSM systems will be described, you can get useful ideas in advance by reviewing written protocols and existing SOPs. 

Applications to and harvest of major crops such as coffee, bananas, and pineapples frequently involve procedures and equipment for which standard operating procedures have not been written. These must be identified in the planning stage, so that the Study Director or Principal Investigator can write these procedures with sufficient time to allow for review and approval. If a procedure is specific to the trial at hand, the process may be described in an addition or amendment to the protocol, but this still requires QA and management approval. In some cases, SOPs specific to a local crop are maintained at a regional site. SOPs must also be available at the site at which the raw data are archived. 

The training of LSMBS shoppers is generally conducted by telephone and through written instructions. The written instructions and forms provided to the shoppers form the equivalent of a standard operating procedure (SOP). Often, since the network of shoppers is widely dispersed and may or may not be involved with more than one sample collection period, formal SOPs are not devised and provided to the shoppers. Instead, complete written instructions are provided, albeit not necessarily in SOP format. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

Standard Operating Procedure A detailed written instruction to achieve uniformity in the performance of a specific function. 

Written standard operating procedures (SOP) to ensure that each method is carried out in an identical way. 

Everything in a given case folder is present because of an FDA regulation requirement or a related company-written standard operating procedure. 

GLP stands for good laboratory practices. These are federal regulations governing FDA- and EPA-affiliated laboratories and pertain to proper procedures in the laboratory to ensure that results are obtained in as trustworthy a manner as possible. SOP stands for standard operating procedure. These are step-by-step written procedures that are specially approved by laboratory directors for carrying out certain specific tasks. 

The laboratory should have written Standard Operating Procedures approved by the Laboratory Director that are intended to ensure the quality and integrity of the data generated by that laboratory. The Laboratory Director has the responsibility to approve revisions to standard operating procedures. The SOPs must be available to the persormel that are involved in the relevant activities as well as to the quality assurance team that performs the audit. 

To determine the stability of the test and control articles in the mixture as required by the conditions of the study either (i) before study initiation, or (ii) concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture. 

Standard Operating Procedures should be written by the people who will use them. They should document a procedure with sufficient detail that another individual could recreate the procedure, but not so tightly defined that the analyst wiU... 

Test that water of appropriate quality (conductivity) is produced by the system using written standard operating procedures. 

Using the written standard operating procedure, start up and run the distillation equipment. 

Standard Operating Procedure A SOP has to be written to provide instructions for the operation, maintenance, and calibration of the new instrument. A typical SOP should include ... 

A specific, detailed description of the bioanalytical method should be written. This can be in the form of a protocol, study plan, report, and/or standard operating procedure (SOP). All experiments used to make claims or draw conclusions about the validity of the method should be presented in a report (method validation report). 

The bioanalytical laboratory should have a written set of standard operating procedures (SOPs) to ensure a complete system of quality control and assurance. The SOPs should cover all aspects of analysis from the time the sample is collected and reaches the laboratory until the results of the analysis are reported. All deviations from SOPs must be authorized by the study director and documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management. 

After the instrument is qualified, it can be used to generate analytical data. A standard operating procedure (SOP) has to be written for the new instrument. 

The written Standard Operating Procedures required under 58.81(b)(ll) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation. 

Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations. These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedure. 

In-process sampling should be done in accordance with a written procedure. The Standard Operating Procedure (SOP) or production instruction should describe... 

There should be written standard operating procedures (SOP) in place before sampling. Before sampling, the operator should have all the equipment, containers, and labels needed for sampling this information should be included in the SOP. All labels should be applied at the time of sampling. 

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