Inspection operating procedures

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. 

The types of records needed to demonstrate adherence to requirements and standards as well as effective operation of the quality (ESH/PSM) management system are covered in this element. In addition to many of the quality records listed (e.g., inspection reports, audit reports, operational procedures, and drawings), ESH/PSM requirements might include training records, permits, hazard analyses, audit and other response plans, and accident/inci-dent investigation reports. 

Before piping is installed, the layout should be analyzed to eliminate low points where liquid could collect and to provide drains where low points cannot be eliminated. A regular part of the operating procedure must be the periodic drainage of low points in the piping and separators, as well as inspection of automatic drain traps. 

According to Section 1910.134(b) of the Occupational Safety and Health Standards in Title 29 of the U.S. Code of Federal Regulations, an acceptable respiratory program must be instigated whenever respiratory health hazards are present in the work environment. The employer must develop formal written operational procedures covering every aspect of the program, including, for example, how contaminants are controlled, how contaminant concentration is measured, and how respirators are selected, used, cleaned, inspected, repaired, and stored. 

Laboratory apparatus should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. 

The principles of GLP require an independent quality assurance (QA) program to ensure that the study is being conducted in compliance with GLP. The QA personnel cannot overlap with those of the study because of the potential conflict of interest, but they may be part-time staff if the size of the study does not warrant a full-time QA section. The responsibilities of the QA unit are to maintain copies of plans, standard operating procedures, and in particular the master schedule of the study, and to verily, in writing, that these conform to GLP. The QA unit is responsible for inspections and audits, which must be documented and the results made available to the study director and the principal investigator. The QA unit also signs off on the final report. Any problems discovered or corrective action that is recommended by the unit must be documented and followed up. 

The written Standard Operating Procedures required under 58.81(b)(ll) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation. 

Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations. These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedure. 

Inspection instructions Work instructions Operation sheets Test procedures Operational procedures Quality assurance procedures Formulations Common practices... 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

Standard operating procedures (SOPs) are required for all routine activities that are critical to the successful outcome of the study including quality assurance procedures and inspections. Most of the SOPs for the field activities are written by the field scientists with guidance from the Quality Assurance Section. For the field activities, it is required that at each site there be SOPs for such things as how field plots are established and the plot boundaries marked, the maintenance of sample freezers, how to calibrate and maintain chemical balances and chemical application equipment, and how to obtain test chemicals. If an SOP for a critical item of equipment is not available, the study would be considered to be not in compliance with the principles of the GLP guidelines. The distribution of SOPs is carefully controlled so that when an SOP is changed, all outdated copies can be exchanged for the new version. 

Inspection of the packaging and labeling area before and after use. This is typically a formal line clearance per Standard Operating Procedure (SOP). 

Standard operating procedures that have been translated for the FDA reviewers are of significant help during a foreign inspection. It would behoove a foreign company to translate the following SOPs into English ... 

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