Audit Checklist for Engineering Department

An engineering department internal audit checklist is a document used to evaluate the efficacy of the department's processes and procedures in guaranteeing the quality, safety, and compliance of engineering operations. An internal auditor or quality assurance specialist often creates a checklist to assist them in reviewing and evaluating the department's activities, identifying areas for improvement, and ensuring that the department is fulfilling applicable regulatory and industry standards.

An engineering department's internal audit checklist often includes a wide variety of issues, including design controls, change control, equipment calibration and maintenance, risk management, and supplier management. The checklist is a series of questions or criteria that the auditor will use to evaluate each item and determine if the department's processes and procedures are effective and efficient.

Organizations can ensure that their engineering activities are in compliance with applicable regulations and standards, that the quality of their products and services is maintained, and that risks associated with engineering activities are identified and managed effectively by using an internal audit checklist for an engineering department.

ALSO READ: Audit Checklist for Purified Water System

Sr. No.	Checkpoints	Observation	Recommendation	Action Taken by
1	Design Controls
1.1	Is there a documented process for design control?
1.2	Are design requirements properly documented?
1.3	Is there a process for design verification and validation?
1.4	Are design changes reviewed and approved?
1.5	Are design changes properly documented and communicated?
2	Change Control
2.1	Is there a process for change control?
2.2	Are changes reviewed and approved?
2.3	Are change requests properly documented?
2.4	Are change impacts assessed?
2.5	Are change impacts communicated to relevant stakeholders?
3	Equipment Calibration and Maintenance
3.1	Is there a process for equipment calibration and maintenance?
3.2	Is there a schedule for equipment calibration and maintenance?
3.3	Are calibration and maintenance records maintained and updated?
3.4	Are out-of-tolerance or out-of-specification equipment properly addressed?
3.5	Are relevant personnel trained in equipment calibration and maintenance?
4	Risk Management
4.1	Is there a risk management process in place?
4.2	Are risks properly identified and assessed?
4.3	Are controls implemented to mitigate identified risks?
4.4	Are risk assessments and controls properly documented?
4.5	Are risk assessments and controls regularly reviewed and updated?
5	Supplier Management
5.1	Is there a process for supplier management?
5.2	Are supplier records maintained and updated?
5.3	Are supplier evaluations and audits conducted?
5.4	Are supplier nonconformances properly addressed and documented?
5.5	Are relevant personnel trained in supplier management?

ALSO READ: SOP for Planned Preventive Maintenance

Sr. No.	Checkpoints	Observation	Recommendation	Action Taken by
01	Is the control copy of Maintenance Department SOPs available?
02	Are the personnel having knowledge of current GMP requirements?
03	Is the preventive maintenance schedule available?
04	Check the preventive maintenance records.
05	Is equipment labeled with the last maintenance date and the next due maintenance date?
06	Are the equipment qualifications available?
07	Check the equipment qualification record.
08	Is the temperature gauge calibration record available?
09	Check the temperature gauge calibration record.
10	Is the pressure/vacuum gauge calibration record available?
11	Check the calibration record.
12	Check the breakdown maintenance record.
13	Check the DM water generation record.
14	Check the AHU maintenance record.
15	Check the AHU’s filter cleaning record.
16	Check the AHU’s differential pressure record.
17	Is there any training schedule for new entrants in the maintenance department?
18	Are new entrants trained after join the maintenance department?
19	Are there any documents for the postponement of the scheduled maintenance?
20	Is the department follow the postponement of the scheduled maintenance and send it to review by the QA department?
21	Is there a checklist for each piece of equipment for preventive maintenance?
22	Check the equipment checklist.
23	Is all electrical motor labeled and well maintained?
24	Check the status of the electrical motor.
25	Check the maintenance status of the DG Set.
26	Is the maintenance store area clean?
27	Check the housekeeping of the maintenance store area.
28	Are all storage tanks properly labeled?

ALSO READ: Audit Checklist for Production Department