Preventive Maintenance Reporting And Responsibilities

Unscheduled preventive maintenance should be performed anytime there is a machine breakdown or unexpected repairs needed because it is crucial to address the issue as soon as possible to prevent further damage or breakdowns. Waiting for a slow schedule may lead to prolonged downtime and increased costs. By performing unscheduled preventive maintenance when needed, the machine can be quickly repaired, minimizing the impact on production and ensuring optimal performance.

The given statement states that if a PM work instruction references a form required for recording data, it must be completed, signed, and filed with the PM record. This means that it is necessary to fill out the form, sign it, and keep it on record along with the PM work instruction. Therefore, the answer "True" is correct as it accurately reflects the requirement stated in the statement.

When an item does not meet performance standards, both generating a nonconformance report and identifying it with a "Do Not Use" tag until it is repaired should be done. Generating a nonconformance report helps document the issue and initiate corrective actions, while identifying it with a "Do Not Use" tag ensures that the item is not mistakenly used until it is fixed. Both actions are necessary to address the problem and prevent any further issues or risks associated with the nonconforming item.

The Originator's responsibilities for submitting new equipment to IQMS include completing all unshaded areas on the EQ Assessment Checklist and signing the form, ensuring that any/all work instructions being used are referenced, ensuring that any in-house fabricated equipment has an active drawing associated with it, ensuring that any necessary PM or calibration work instructions are written or revised as needed, ensuring that the equipment is not used for production while under construction, and delivering the completed, signed form to the Metrologist. Therefore, the correct answer is "All of the above."

The correct answer is D000986 Performing and Reporting Unscheduled Maintenance in IQMS. This work instruction should be accessed when performing unscheduled preventive maintenance because it specifically addresses the process of performing and reporting unscheduled maintenance in IQMS. It provides the necessary guidelines and steps to follow in order to effectively carry out unscheduled maintenance tasks and ensure accurate reporting in the IQMS system.

Once a PM work order is completed, it is necessary to document the activities in the PM database to keep a record of the work done. Additionally, any required paperwork should be completed and attached to the closed work order for reference and documentation purposes. Finally, the closed work order reports should be submitted to the Quality department to ensure that the work was done correctly and meets the required standards. Therefore, all of the above steps must be taken once a PM work order is completed.

The D000252 EQ Assessment Checklist assures that a piece of equipment is entered into the system. This checklist is specifically designed to assess the equipment and ensure its proper functioning and compliance with the system requirements. By going through this checklist, all necessary information about the equipment is documented, including its specifications, condition, and any necessary maintenance or repairs. This documentation is crucial for accurately entering the equipment into the system and keeping track of its performance.

The statement suggests that all PM equipment requires an EQ No, which is incorrect. In reality, not all PM equipment needs an Equipment Qualification Number (EQ No). Some equipment may not require qualification or may have alternative methods of qualification. Therefore, the correct answer is False.

All PMs are due at the end of each month, indicating that there is a specific deadline for submitting PMs. This implies that there is a regular schedule or expectation for when these PMs should be completed. It is important to adhere to this deadline to ensure timely completion of tasks and maintain organizational efficiency.

The work instruction that gives step-by-step instructions on how to perform a PM task is D000989 Reporting Preventive Maintenance Work Orders in IQMS.

New equipment can be scheduled for preventive maintenance once the D000252 EQ Checklist is completed in full. This checklist likely includes important information about the equipment, such as its specifications, maintenance history, and any specific requirements for maintenance tasks. By completing the checklist, the necessary information will be available to determine when and how the preventive maintenance should be scheduled.

The explanation for the given correct answer is that all of the mentioned steps are necessary to access the corresponding PM work instruction in IQ. The first step is to go to the Asset Management tab and open the Maintenance, Repair, and Overhaul Work Orders icon. Then, the user needs to enter the equipment or work order number in the search field and check the "WO Open?" column to select the work order with a Y in that field. After that, the user should right-click the gray area in the bottom left field of the General tab and select "Jump to MRO Equipment". The work instruction will be listed in the "Documents" tab and can be opened if it is highlighted in green. If it is red, it will need to be opened through the document control program. If there is no work instruction listed, the user should contact a quality engineer. Therefore, all of the mentioned steps are required to access the corresponding PM work instruction in IQ.

When performing unscheduled maintenance, the approval must come from the Engineering department. This is because Engineering is responsible for the technical aspects of the maintenance work and ensuring that it is done correctly and safely. Quality may be involved in ensuring that the maintenance meets certain standards, but they would not typically have the authority to approve or disapprove the maintenance. Operations may be affected by the maintenance but would not have the technical expertise to approve it.

If equipment is not operational and preventive maintenance cannot be performed, the steps that should be taken are as follows: It should be documented on the closed work order form and entered into the database immediately. This ensures that the issue is properly recorded and tracked. The equipment should be removed from the schedule to prevent any further attempts to use it before it is repaired. Additionally, the equipment should be labeled "DO NOT USE" until it is repaired to communicate the potential danger or malfunction to others.