Nonroutine maintenance

Equipment used in GLP studies must be validated for appropriateness. Each piece of equipment must have SOPs for operation, calibration, and routine maintenance. All routine and nonroutine maintenance must be documented. What is the definition of a piece of equipment Any item that can have an impact on the results of an anal5dical procedure. In the typical non-GLP laboratory, records are kept on analytical equipment such as spectrophotometers or gas chromatography units. Under GLP, however, the definition expands to include items such as pipets, thermometers, incubators, refrigerators, and mixing devices, as long as it is possible that the use of the item can affect the outcome of the test. For the non-GLP lab, implementation of this standard will dramatically increase the number of equipment-related SOPs. 

Equipment used in GLP studies must be validated for appropriateness. Each piece of equipment must have SOPs for operation, calibration, and routine maintenance. All routine and nonroutine maintenance must be documented. 

Installation Qualification (IQ) An early phase of equipment quahfication that estabhshes that the instrument is received as designed and specified, that it is properly installed in the selected enviromnent, and that this environment is suitable for the operation of the instrument Nonroutine Maintenance Any repair or instrument maintenance that is not planned or scheduled. 

Maintenance procedures should be distinguished as routine or nonroutine. In the event of a nonroutine operation, the record should indicate the nature of the failure, how and when it was discovered and any remedial action taken in response to the failure. All records must contain the date of maintenance and the initials of the person performing the procedure. A record of all routine and nonroutine maintenance should be maintained for each piece of equipment or system, e.g. LC-MS/MS with autoinjector, in the laboratory. An instrument maintenance logbook should be maintained for each mass spectrometer system and be readily available. In addition to any requirements in the laboratory s SOPs, the following information shonld be inclnded in the equipment logbook the equipment identification, model number, serial number, the date the equipment was put into service, current location, reference(s) to any relevant SOP(s) and contact information for the equipment manufacturer and/or service organization. 

Records of routine maintenance operations may reference the SOPs for a description of the operations. For nonroutine repairs in response to equipment failure or malfimction, repair records must contain the following detailed information nature of the defect, how the defect was discovered, when the defect was discovered, and remedial action taken in response to the defect. Remedial action should include a review of possible effects on data generated before the defect was discovered. Because repairs are likely to involve repeur-men from outside the laboratory, care must be taken to ensure that such persons provide fuU documentation of the nature of the problem and remedial action taken in response to the problem. 

Maintenance and repair documentation may be requested during an inspection by a GMP regulator. Documentation for maintenance activities must include a description of the operations performed, who conducted the maintenance and when, and the results confirming that the maintenance work was completed satisfactorily. Cahbration certificates should be retained. Repair records, meanwhile, should include a description of the problem, corrective action taken, acceptance testing criteria, and the results confirming that the repair work has restored the computer system to an operational state. Repair logbooks can be used to record nonroutine repair and maintenance work. 

Number of nonroutine and emergency maintenance work orders X ... 

Supportive safety procedures are utilized to ensure that there are necessary controls in place for safe maintenance and repairs that importantly includes nonroutine hazardous work. These procedures encompass rules governing lockout and tagout, confined space entry, elevated work, electrical work, etc. The committee found some minor problems in these supportive procedures and differences among the sites, especially when some of the work is done by subcontractors, who may have their own practices. 

The maintenance people who were a part of the survey usually do nonroutine work. As was previously stated, they have a disproportionate share of the serious injuries and fatalities. 

A JSA should consider abnormal activities and conditions, not just normal, routine operations. The unusual situations include those leading to accidents and injuries. Non-routine activities often involve cleaning and maintenance. Because these are less frequent and operations do not always consider such activities, they may produce accidents more easily. People often make the wrong decisions or take the wrong course of action in adverse situations. JSA for nonroutine operations can also lead to design improvements that increase safety and reduce hazards. 

Skilled trades people are maintenance personnel, millwrights, tinsmiths, machinists, electricians, and steamfitters. Skilled trades people are not production workers. Mostly, they do nonroutine work, are exposed to sources of high energy, and are engaged sometimes in at-plant constmction. Hours worked during the period that Mirer references stand in the billions. His fatality numbers are statistically significant. 

Nonroutine Work Authorizations. Nonroutine work which is conducted in process areas needs to be controlled by the employer in a consistent manner. The hazards identified involving the work that is to be accomplished must be communicated to those doing the work, but also to those operating personnel whose work could affect the safety of the process. A work authorization notice or permit must have a procedure that describes the steps the maintenance supervisor, contractor representative or other person needs to follow to obtain the necessary clearance to get the job started. The work... 

The point is that skilled-trades workers in every industry are often involved in unusual and nonroutine work, at-plant modification or construction operations, shutdowns for repair and maintenance. 

Procedures to keep nonroutine jobs visible to the leadership team and in the JHA process are critical as these jobs may entail high-risk maintenance tasks and/or high-energy source exposures. In general, a priority on maintenance related jobs can be essential. 

Tosco Avon refinery s maintenance management system did not recognize or control serious hazards posed by performing nonroutine repair work while the crude processing unit remained in operation. 

---