Written procedures

The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process consistent with the process safety information. Address at least the following elements  

Written procedures must be established to maintain the ongoing integrity of process equipment. Procedures should address the mechanical integrity of 

The employer shall establish and implement written procedures to manage changes (except for replacements in kind ) to process chemicals, technology, equipment, and procedures and changes to facilities that affect a covered process. 

Procedures shall ensure that the following considerations are addressed prior to any change  

Employees involved in operating a process and maintenance and contract employees whose job tasks will be affected by a change in the process shall be informed of, and trained in, the change prior to start-up of the process or affected part of the process. 

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Before a procedure can provide useful analytical information, it is necessary to demonstrate that it is capable of providing acceptable results. Validation is an evaluation of whether the precision and accuracy obtained by following the procedure are appropriate for the problem. In addition, validation ensures that the written procedure has sufficient detail so that different analysts or laboratories following the same procedure obtain comparable results. Ideally, validation uses a standard sample whose composition closely matches the samples for which the procedure was developed. The comparison of replicate analyses can be used to evaluate the procedure s precision and accuracy. Intralaboratory and interlaboratory differences in the procedure also can be evaluated. In the absence of appropriate standards, accuracy can be evaluated by comparing results obtained with a new method to those obtained using a method of known accuracy. Chapter 14 provides a more detailed discussion of validation techniques. 

Shutdown. Written procedures for normal, as well as for emergency, shutdowns should be prepared, rehearsed, and kept up-to-date. Operating supervisors must be responsible for leaving the process equipment in a safe condition or preparing plant equipment for maintenance work. 

WeU-written procedures should begin with a purpose and scope. The procedure section usually follows, describing the work process, and it should be clearly and concisely written. The document should include copies of all forms and a process flow diagram for illustration. 

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

Chemical reaction due to Develop written procedures to clean and equipment not being verify reactor readiness properly cleaned/ drained. jn piement checklist verification from previous run. Possi- bility of unwanted reac- cleaning solvent tion or insufficient desired reaction. CCPS G-15 CCPS G-22 CCPS G-29... 

Incorporate batch distillation into written procedure for the process... 

Operating practice different from written procedures may lead to an incident. 

The tolling team has analyzed the hazards, addressed the risks and modifications using a management of change system, revised and written procedures, trained the workers, performed a PSSR, and completed any required test runs. The pre-startup phase is complete at this point. 

Did not establish and implement written procedures to maintain mechanical integrity of process equipment. 

Is there a written procedure for handling nonconformance with quality of service ... 

Are there written procedures for the safe disposal of waste resulting from cleaning ... 

This question refers to situations where the toller himself is carrying out cleaning operations at his own premises. Cleaning is a very important element of toller s effort to maintain quality. The assessor should read and check all written procedures carefully. 

All staff should be adequately trained, and written procedures provided. 

The employer manages changes (except for "replacements in kind") with written procedures for changes in process chemicals, technology, equipment, procedures, and facilities. The procedures assure the following before any change ... 

WORST 1 No written procedures, or standard way of performing tasks Not integrated with training High levels of noise Poor lighting High or very low temperatures and high humidity or wind chill factors... 

AVERAGE 5 Written procedures available, but not always used Standardized method for performing task Moderate noise levels Temperature and humidity range... 

There is a written procedure for condenser isolation, but it is normally a simple step-by-step task that is second nature to the operator and is performed from memory. However, imder the threat of a potential vapor cloud explosion, the operator may forget to close the propane valves first (Error A). The HEP in Handbook Table 20-7 5 footnote (.01) is increased by a factor of 5 per Handbook Table 20-16 6a to account for stress. 

Preferably a written procedure, appropriate to the installation, should be prepared and followed ... 

Containers and closures shall be tested for conformance with all appropriate written procedures. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier s test results through appropriate validation of the supplier s test results at appropriate intervals. 

Any deviation from the written procedures shall be recorded and justified. 

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