Standard Operating Procedures and

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. 

To gather information about the factors which contributed to the above incident, interviews were held with the workers and their management. Relevant documentation such as standard operating procedures and documentation relating to the incident was also collected. A task analysis (see Case Study 3) of the job of the top floor person was carried out in order to examine the operations involved and the factors which could affect job performance. Two techniques were used for the analysis of this incident, namely variation tree analysis and root cause analysis. 

US Environmental Protection Agency, Region 4, Environmental Investigations Standard Operating Procedures and Quality Assurance Manual, Sections 1-18, EPA, Athens GA (1996 with 1997 revisions). 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

Develop and implement a plan of action, including safety considerations, consistent with Standard Operating Procedures and within the capability of the available personnel, personal protective equipment, and control equipment. 

They have access to the study plans and Standard Operating Procedures and all updated versions. QA personnel verify in a documented way the compliance of the study plan with the GLP principles... 

Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study. 

Deviations from established standard operating procedures and out of specification (OOS) observations can occur frequently. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

The manufacturer should verify the operation of these critical components during the installation according to their standard procedures for evaluating the proper operation of these components. Additional IQ checks will verify that the necessary documentation is available for proper operation of the chamber. These checks should confirm that standard operating procedures and equipment manuals are available. In addition, all calibrated instruments associated with the chamber should be documented in current calibration and placed on a calibration program. 

This manual is written in general terms so that it can be used as a procedural guideline by the individual responsible for writing quality manuals and applicable standard operating procedures and programs. The format of this manual, these procedures, and the numbering system can easily be used by small to large companies and are acceptable to ISO certification bodies. 

Center for Biologies Evaluation and Research (CBER). Manual of Standard Operating Procedures and Policies, SOPP 8001.2. Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy, April 1, 1998. 

Center for Biologies Evaluation and Research. Manual of Standard Operating Procedures and Policies, SOPP 8404. Refusal to File Guidance for... 

FDA policies and procedures for formal meetings with external constituents described in CDER s Manual of Policy and Procedures (MAPP 4512.1) and CBER Standard Operating Procedures and Policies (SOPP) 8101.1... 

Laboratory simulations of aqueous-phase chemical systems are necessary to 1) verify reaction mechanisms and 2) assign a value and an uncertainty to transformation rates. A dynamic cloud chemistry simulation chamber has been characterized to obtain these rates and their uncertainties. Initial experimental results exhibited large uncertainties, with a 26% variability in cloud liquid water as the major contributor to measurement uncertainty. Uncertainties in transformation rates were as high as factor of ten. Standard operating procedures and computer control of the simulation chamber decreased the variability in the observed liquid water content, experiment duration and final temperature from 0.65 to 0.10 g nr3, 180 to 5.3 s and 1.73 to 0.27°C respectively. The consequences of this improved control over the experimental variables with respect to cloud chemistry were tested for the aqueous transformation of SO2 using a cloud-physics and chemistry model of this system. These results were compared to measurements made prior to the institution of standard operating procedures and computer control to quantify the reduction in reaction rate uncertainty resulting from those controls. 

Replicate experiments were performed in the absence of added trace gases to quantify the reproducibility of the physical parameters both with and without computer control. The results of these experiments are compared with previous results (5) in Table III. Standard operating procedures and computer controls have decreased the variability in the observed liquid water content, experiment duration, and final temperature from 0.65 to 0.10 g nr 180 to 5.35 s and 1.73 to 0.27°C, respectively. 

The characterization of the factors which control the accuracy, precision, and validity of measurements made in a simulation facility for studying in-cloud chemical processes was described. An analysis of a large number of experimental data collected under widely varying conditions was performed. Cloud liquid water content, an observable principally dependent on cooling rate and reaction time, was found to be the most influential of the physical factors controlling the resultant chemistry. In order to precisely control and reproduce the physical conditions in the simulation facility, standard operating procedures and computer control were instituted. This method reduced the uncertainty of the SO2 to sulfate transformation rate by a factor of 4.4. 

Cook, Jr., J. L. (1998), Standard Operating Procedures and Guidelines, Penn Well Books, Tulsa, OK, p. 318. 

MIRADCOM Safety Office. The safety office contains profes-sional safety engineers with considerable experience in dealing with hazardous operations. They maintain up to date knowledge and information on safety equipment and procedures. Files are kept on all accidents and incidents. They review and approve all standard operating procedures and serve as a source of advice and information on all safety matters. 

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