Maintenance plans/procedures

Maintenance plans. Are maintenance plans, procedures, and support equipment modified as required to match modifications made to the facility or hardware Are maintenance personnel trained on the new procedures ... 

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

Environmental Protection Agency, 1977. Guidelines for Air Quality Maintenance Planning and Analysis, Volume 10 (Revised) Procedures for Evaluating Air Quality Impact of New Stationary Sources. EPA-450/4-77-001 (OAQPS Number 1.2029R), Research Triangle Park, NC. 

GMP risk assessment Qualified/trained resource System life-cycle validation System environment Current specifications Software quality assurance Formal testing/acceptance Data entry authorization Data plausibility checks Communication diagnostics Access security Batch release authority Formal procedures/contracts Change control Electronic data hardcopy Secure data storage Contingency/recovery plans Maintenance plans/records... 

Operational and maintenance plans should be prepared for the computer system and its associated measurement and control instrumentation. Operational plan review will focus on system reliability, performance, diagnostic records, instrument and system I/O calibration, and the provision of critical data to support the batch record. Procedures for controlling the system (e.g., system management, security, and process operations) should be reviewed to verify that they are current, in place, and being followed. For each procedure required for the system there should be documented evidence that the relevant operatives have been trained in its use. All procedures must be written and approved according to the site procedures for writing and approving SOPs. 

The maintenance plan will normally form part of the preventative maintenance system for the site and must be used to track all maintenance activities on the computer system and associated measurement and control instrumentation. For computer systems the supplier may be contracted for different levels of ongoing maintenance support, and it is acceptable to use the supplier procedures for maintenance of the specialist areas of the system. A supplier maintenance contract needs to define the scope of maintenance (e.g., the items to be maintained, type of activities, period of the contract, access requirements,... 

Physical access controls (limited access) (all listed implementation features must be present) This area is related to the procedures for limiting physical access to an entity while ensuring that properly authorized access is allowed. Disaster recovery Emergency operating mode Equipment control (into and out of site) Facility security plan Procedures for verifying access authorizations prior to physical access Maintenance records Need-to-know procedures for personnel access Sign-in for visitors and their escorts, if appropriate Testing and revision... 

Maintenance Planning can help to minimize the need for contingency procedures by having planned service ontages to maximize the time between failures of the PLC-based system. 

There should be a planned preventive maintenance programme, procedures and records for the HVAC system. Records should be kept. 

OQ consists of a series of tests that will be based on the FDS of the LIMS and should include reference to the functional tests performed by the LIMS supplier as part of integration testing wherever possible. This may be achieved by utilizing the integration testing documents, which are then used as raw data for OQ, with the OQ inciuding any other specific tests to demonstrate compliance that are not within the scope of the LIMS supplier (e.g., environment tests, internal procedures, maintenance plans, etc). This will mean that there is no need for duplication of testing and makes the whole process more efficient in terms of time and cost. 

Improved planning and scheduling Unplanned maintenance work typicaUy costs two to three times as much as planned work. A CMMS provides the systems and procedures to establish a more effective maintenance planning and scheduling function, which is a key contributor to improved craft labor utilization. 

The same procedure as described in section 2.3.2 is applied. The dynamic algorithm dehvers an optimized maintenance planning on the defined planning horizon. Moreover, the maintenance planning is adapted to the current system due to the integration of the current deterioration of each component at each decision time. 

Good equipment maintenance is essential for safe and efficient operations. Laboratory equipment should be inspected and maintained regularly and serviced on schedules that are based on both the likelihood of and the hazards from failure. Maintenance plans should ensure that any lockout procedures cannot be violated. 

Plans and procedures Were adequate maintenance plans and procedures in place Did the plans and procedures match the operation Were they current Were they well written, technically correct, and understandable by maintenance personnel Were they readily available to maintenance personnel Did the plans cover both preventive and corrective maintenance requirements ... 

Execution Were the maintenance plans and procedures followed Evaluate the following factors ... 

The requirement that equipment should be tested and proven to be fit for purpose is effectively fulfilled by an approach known as equipment qualification (EQ), which is well established and proven in the highly regulated pharmaceutical industry. EQ is complementary to method validation for the spectrophotometer and is built on effective instrumental calibration validation (see below). EQ is a systematic procedure, which ensmes that suitable equipment is purchased and that it remains fit for its chosen purpose throughout its operating life. The same requirement is present in ISO/IEC 17025, where section 5.5.5 Records of Equipment requires checks to ensure compliance with the specification, maintenance plans, etc. 

HUMAN FACTORS PROGRAM PLAN—PROCEDURES-OPERATING AND MAINTENANCE... 

The two main elements of fixed interval preventive maintenance are procedure and discipline. Procedure means that the correct tasks are done, the right lubricants applied, and consumables replaced at the best interval. Discipline requires that all the tasks are planned and controlled so that everything is done when it should be done. Both these areas deserve attention. The topic of procedures is covered in detail in following sections. 

Figure 10.3 shows that the suggested planning procedure is to be repeated for a list of maintenance activities that will lead to an approved maintenance standard operating procedure. 

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