Specific Operations Procedures

Vinyl acetate is polymerized in aqueous emulsion and used widely in surface coating and in adhesives. Copolymerized with vinyl esters of branched carboxylic acids and small quantities of acrylic acid, it gives paint latices of excellent performance characteristics. G. C. Vegter found that a coagulum-free latex of very low residual monomer content can be produced from a mixture of an anionic and a nonionic emulsifier according to a specific operating procedure. The freeze/thaw stability of polymeric latices has been investigated by H. Naidus and R. Hanzes. 

Although the design of each type of LAFD dictates certain specific operating procedures, several general principles apply to all LAFDs. ... 

Members of my workplace will familiarize me with the specific operational procedures which they use Members of my workplace familiarize new employees with the specific operational procedures which they use... 

Existing and proposed state and federal regulations require specific operating procedures and equipment. The information in this manual is presented in good faith, but users should rely on their own legal advisors to assure compliance with these regulations. 

The term SOP is often used to describe all types of operating procedure (indeed, it is used in this manner in the EPA s Risk Management Program rule). However, it is suggested here that a standard operating procedure should actually be what it says it is a standard or a template upon which the equipment and unit-specific operating procedures can be built. 

The Level 1 operator moves on toward certification as a technician. The foundation documents for this work are the plant-specific operating procedures. So, at the basic level, there will be a procedure on how to start a centrifugal pump, say. The trainee wiU also leam specific operating... 

In response to these two phenomena, and in addition to a specific architecture, such as panels promoting segregation between sections, oversizing can improve the likelihood of compliance, at the end of life, of the specifications despite the gradual deterioration due to aging and certain failures. In addition, specific operational procedures adapt the mission to degraded performance and preserve and extend the... 

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. 

Values depend on plant-specific design and operating procedures for steam plant. 

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

Are appropriate directions for reacting to out-of-specification situations documented m standard operating procedures ... 

The components of a quality assurance program are designed to serve the two functions just mentioned—control and assessment. Quality control operations are defined by operational procedures, specifications, calibration procedures, and standards and contain the following components ... 

In this chapter, the elution curve equation and the plate theory will be used to explain some specific features of a chromatogram, certain chromatographic operating procedures, and some specific column properties. Some of the subjects treated will be second-order effects and, therefore, the mathematics will be more complex and some of the physical systems more involved. Firstly, it will be necessary to express certain mathematical concepts, such as the elution curve equation, in an alternative form. For example, the Poisson equation for the elution curve will be put into the simpler Gaussian or Error function form. 

In 1998, the FDA approved fibrin sealant for three specific indications. These include hemostasis at the time of cardiac surgical operations [8] (Fig. 2) as well as at the time of operative procedures to treat splenic trauma. The application of the fibrin sealant which consists of normal biologic components in the body s clotting cascade creates a localized clot which further enhances inherent clotting ability. Although approved for these specific hemostatic indications only, fibrin sealant is useful as a hemostat in a wide variety of off-label clinical situations as well [9,10]. These include such applications as hemostasis for liver trauma or resection [11], vascular anastomoses [12], tonsillectomy [13], peripheral joint replacement [14], dental extractions [15], and bum debridement [16]. 

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. 

A team consists of two or more people that know the process technology, design, operating procedures, practices, alarms, emergency procedures, test and maintenance procedures, routine and non-routine tasks. They must consider authorization and procurement of parts and supplies, safety and health standards, codes, specifications and regulations. The team leader provides m.iriagcment and goals to the process the team and consultants construct and interpret the analyses. 

Operating procedures prescribe how specific tasks are to be performed. Subcategories of these procedures may include test procedures, inspection procedures, installation procedures, etc. These should reference the standards and guides (see below) which are needed to carry out the task, document the results, and contain the forms to be used on which to record information. 

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

While the ISO 9001 requirement applies only to quality records, ISO/TS 16949 extends retention times for many other documents because you cannot demonstrate you have or had operations under control without specifications, plans, procedures, etc. You may also need to retain tools, jigs, fixtures, test software - in fact anything that is needed to repair or reproduce equipment in order to honor your long-term commitments. 

Safety and environmental information is needed to provide a basis for implementation of further program components such as operating procedures and hazards analysis. Specific guidelines as to what information is needed are contained in API RP 141. 

The form these end products take should be consistent with your company s style for example, if you have specific protocols for project planning or developing Standard Operating Procedures, these will probably apply to comparable tasks within the PSM initiative. 

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. 

Approvals and Authorizations Appropriate delegations have been established, and authorities are cieariy established for approval of specific routine operations and non-routine or out-of-specification operations. Variance procedures are defined. Approval levels are commensurate with the importance of the task. Appropriate resources are authorized. 

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