Standard operating

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. 

Until 1990, some flaked iodine and iodine-containing wastes were sublimed to obtain an especially high grade product. This process has been dropped because of quaUty improvements in the standard operations. Sublimed iodine is produced only in small quantities by specialized companies that... 

Patients immediate post-operative pain is lower compared to a standard operation and healing and rehabiUtation more rapid. Patients can resume near-normal activities in just days. In some cases athletes, who are in prime physical condition, can return to challenging athletic activities within a few weeks. CompHcations are rare, but do occur on occasion. Most complications associated with this surgery are infection, phlebitis, excessive swelling or bleeding, blood clots, or damage to blood vessels or nerves. 

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

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

Low-molecular-weight products, generally secondary metabolites such as alcohols, carboxyhc and an iino acids, antibiotics, and vitamins, can be recovered using many of the standard operations such as liquid-hquid extraction, adsorption and ion-exchange, described elsewhere in this handbook. Proteins require special attention, however, as they are sufficiently more complex, their function depending on the integrity of a delicate three-dimensional tertiaiy structure that can be disrupted if the protein is not handled correctly. For this reason, this section focuses primarily on protein separations. Cell separations, as a necessary part of the downstrean i processing sequence, are also covered. 

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. 

If operating procedures need to be developed from scratch, this could account for a considerable portion of the pre-startup work. If current, valid standard operating procedures exist, and the toll is only introducing a new set of batch instructions, the task becomes simpler. However, it is recommended that the new batch instructions are reviewed simultaneously with the existing startup, shutdown, normal and emergency operating procedures for the equipment to help ensure potential process deviations are examined and addressed. 

Other information may also benefit the PHA. Standard operating procedures for processing equipment, safe work practices, maintenance or job safety analyses, emergency response plans could be appropriate review items for some PHAs depending upon the toll. 

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

Standard operating procedures, maintenance procedures, emergency response plan procedures, administrative procedures, safe work practices... 

The extent to which these performance data may be influenced, by the non-standard operating conditions is discussed briefly below. 

If you suspect, or know, that you have a deflected shaft, or know that standard operating procedure in your plant requires controlling the flow in the pipes by opening and closing valves, then you have three options to reduce shaft deflection ... 

Onee the information is entered into EDS it is available for display, eommunieation, status, manipulation, and arehiving. A eolor graphie operator interfaee (VGA high resolution monitor with integral keyboard) is provided. The standard operator interfaee with eombined sereen and keyboard was seleeted based on loeation flexibility, ease of use, and eompatibility with future EDS paekages. A baekup two-line display/keyboard is provided should the main operator interfaee(s) or the Administrative CPU fail. 

Identification of anticipated cleanup activities and standard operating procedures if standard operating procedures are provided elsewhere, they are referenced and not repeated... 

Standard Operating Safety Guides, published by the U.S. EPA Oflhee of Emergeney and Remedial Response... 

The plan should also address standard operating procedures (SOPs) for site operations to help minimize contact with hazardous materials. 

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 site-speeifie safety and health plan that ineludes the employer s standard operating proeedures (SOPs) for safety and health [OSHA Referenee. 120(b)(l)(ii)(C), (F)]... 

When equipment or plant is taken out of service, either for maintenance or for repair, it should not be re-introduced into service without being subject to formal acceptance tests that are designed to verify that it meets your declared standard operating conditions. Your procedures need to provide for such activities and for records of the tests to be maintained. 

Prevention Program —Management System —Process Hazards Analysis —Process Safety Information —Standard Operating Procedures —Training... 

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. 

Higher risk activities will require more forma management systems. For example, a process that uses a highly toxic raw material may require an extensive pre-startup leak check of the process as part of standard operating procedures. 

Documenting the Process. The net effect of these steps is a process description, defined in terms of customers and suppliers and their interaction. Next, the team can summarize that description in the form of a process flowchart, to illustrate the roles and responsibilities of each process stakeholder (see Figure 6-8). This chart provides the basis for developing standard operating procedures, or other process documentation, that the company can incorporate into existing practices. 

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