Written Procedures and Training

Mechanical integrity procedures must be written in adequate detail to assure that the equipment receives prudent, appropriate, and periodically scheduled maintenance. It was noted above that OSHA issued a large number of citations for failure to have the written procedures. 

The mechanical integrity procedures must also embody the safe work practices as well as the detailed equipment procedures. Safe work practices include Lock and Tag, Confined Space Entry, Welding, Burning and Open Flame, and similar essential personnel safety procedures. Detailed equipment procedures include generic procedures, equipment specific procedures, and manufacturers procedures. 

Employees involved in maintaining the ongoing integrity of process equipment must be trained in an overview of the chemical process and its hazards. Employees must be also trained in the procedures applicable to the employees job tasks, such as the safe work practices discussed above. 

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Advise its members of the circumstances of the July 22, 1993, explosion in St. Paul, Minnesota, and urge them to develop and implement written procedures and training to prevent excavation-caused pipeline damages. (P-95-24) [49]. 

Responding to incipient stage fires in confined spaces would be viewed as a special hazard condition under the Fire Brigades standard (29 CFR 1910.156). The employer is required to develop written procedures and train first responders to address situations involving special hazards. 

All stability studies on clinical trial materials must be carried out in full accordance with cGMPs, even if a research department carries out the studies. All studies must be carried out by adequately trained personnel under adequate work conditions. The personnel must use properly qualified and calibrated stability chambers, instruments, reagents, and standards. They must follow validated analytical methods and approved written procedures, and they must properly document all work. There must be proper sample and data traceability, change control, and go on. 

During the packaging process the packaging line should be continually monitored to ensure that the integrity of the finished product is not in any way compromised. Written procedures and tabulated check lists should be signed at regular intervals by competent and suitably trained people. 

QA is the institutional system of methods diagnosis. Implementation of a QA program formalizes analyst training, written procedures, and the careful review of results. This formalization demands that each staff member perform the duties of his/her position and take direct responsibility for the result. Within this framework, the analyst takes responsibility for the analytical process, the detector operator for the measurement process, and the supervisor for producing the results. The effect is to create a laboratory environment that pervasively supports reliable analysis and dependable reporting. 

All regulations and rules to do with process risk and safety management require that operating procedures, along with the associated training, be written and followed. No matter how automated operations may become, a human—machine interface will always exist, and that interface will be controlled through the use of procedures and training. 

Procedures and training are opposite sides of the same coin. Procedures are of no value if the technicians are not trained in their use equally, it is not possible to train operators and maintenance technicians until the appropriate procedures have been written. Most of the above comments to do with procedures apply equally well to training. In particular, the training program should be consistent and should be oriented toward to the needs and of the technicians. 

However, operating procedures and training, or other warning, caution, or written advisory forms, are not to be used as the only risk reduction method for critical hazards. Acceptable procedures may include the use of personal protective equipment. 

Develop written procedures and provide training for all operators on proper changeover... 

They should receive training on the requirements of GDP relevant to their role. The training should be based on written procedures and in accordance with written training programme. They should receive specific training in identification and avoidance of medicines entering the supply chain. 

Training in compliance procedures. The employer shall incorporate all written procedures and schedules required under this paragraph (f) in the information and training program required under paragraph (k) of this section and, where appropriate, post in the regulated area. 

Establish maintenance systems for critical process-related equipment, including written procedures, employee training, appropriate inspections, and testing of such equipment to ensure ongoing mechanical integrity. 

What records Keep written procedures, including training and education program information Keep a copy of the workplace emergency action plan Document previous training received as part of the community... 

A written procedure may be an antecedent if the employee referred to the procedure immediately before starting the job. Otherwise, the procedure and training on that procedure are part of the employee s individual learning history. 

Keep written procedures, including training and education program information... 

Because of the increa sing worldwide interest and demand for simple, effective, and inexpensive female sterilisation, a variety of procedures and methods have been developed. These approaches differ whether they are performed postpartum, postabortum, or in interval situations. The choice of methods also largely depends upon the physician s prior training, knowledge, and experience. Excellent reviews have been written on sterilisation (98). 

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. 

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. 

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

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