Audit Checklist for Production Department

A production department internal audit checklist is a document used to evaluate the performance of the department's processes and procedures in guaranteeing the quality, safety, and efficiency of production 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.

Here are some examples of checkpoints that might be included in an internal audit checklist for a manufacturing department:

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Sr. No.	Checkpoints	Observation	Recommendation	Action Taken by
1.	Is the control copy of the production department SOPs available?
2.	Are the personnel having knowledge of current GMP requirements?
3.	Are the lots of raw materials properly stored?
4.	Are the lots of raw materials having proper labels of status?
5.	Is the housekeeping maintained?
6.	Is the weighting balance having a proper tag of calibration status?
7.	Is the balance calibration record available?
8.	Are the calibrated standard weights available?
9.	Is the calibration certificate available?
10.	Are the standard weights properly stored?
11.	Is the reactor area cleaned?
12.	Is the status label of the reactor available?
13.	Is the BMR requisition slip record available?
14.	Check the calibration status of temperature gauges.
15.	Check the calibration status of pressure gauges.
16.	Check the status of the centrifuge.
17.	Check the cleaning of the centrifuge and centrifuging area.
18.	Check the condition of the centrifuge bags.
19.	Check the status of the dryer.
20.	Check the cleaning of the dryer and drying area.
21.	Check the calibration status of the temp, Gauge of the dryer.
22.	Check the trays and trolley condition.
23.	Check the status of the sifter.
24.	Check the cleaning of the sifting area.
25.	Check the status of the multi-mill.
26.	Check the cleaning of the milling area.
27.	Check the finished product packing area.
28.	Check the availability and stock of packing materials.
29.	Check the temperature and humidity record.
30.	Check the cleaning of sampling devices.
31.	Are all the sampling devices properly stored?
32.	Check the general cleaning and housekeeping of plants.
33.	Check the test request slip record.
34.	Check the personnel hygiene.
35.	Check the safety equipment.
36.	Check the other records.
37.	Is ECR available?
38.	Check the ECR.
39.	Check the condition of the fluid bed dryer.
40.	Check the condition of reactors.
41.	Are there work instructions labeled on all equipment?
42.	Are records maintained for Solvent Receipt, Usage & Recovery In Plant?
43.	Check the records of Solvent Receipt, Usage & Recovery In the Plant.
44.	Is there any training record for new employees?
45.	Check the training record and training schedule.
46.	Is the pipeline properly marked with directional arrows?
47.	Is the logbook of all Equipment properly maintained?

A production department's internal audit checklist often includes a wide variety of issues, including production planning, raw material management, equipment maintenance, quality control, and regulatory compliance. 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.

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Sr. No.	Checkpoints	Observation	Recommendation	Action Taken by
1	Production Planning
1.1	Is there a documented production plan that includes production schedules and targets?
1.2	Is the production plan reviewed and updated regularly?
1.3	Is there a process for handling changes to the production plan?
1.4	Are production resources, such as equipment and personnel, adequately allocated to meet production targets?
1.5	Are production records maintained and updated regularly?
2	Raw Material Management
2.1	Is there a process for managing raw materials, including receiving, storing, and handling them?
2.2	Are raw materials properly identified and labeled?
2.3	Are raw materials inspected and tested before use in production?
2.4	Is there a process for handling and disposing of expired or contaminated raw materials?
2.5	Are records of raw material management maintained and updated regularly?
3	Equipment Maintenance
3.1	Is there a process for equipment maintenance, including preventive maintenance and corrective maintenance?
3.2	Is equipment maintenance scheduled and documented?
3.3	Are equipment maintenance records maintained and updated regularly?
3.4	Is there a process for handling equipment failures or breakdowns?
3.5	Are personnel trained in equipment maintenance and troubleshooting?
4	Quality Control
4.1	Is there a documented quality control plan that includes sampling, testing, and inspection procedures?
4.2	Is the quality control plan reviewed and updated regularly?
4.3	Are quality control procedures properly implemented?
4.4	Are quality control records maintained and updated regularly?
4.5	Are nonconforming products identified and handled properly?
5	Compliance with Regulatory Requirements
5.1	Is the production department complying with relevant regulatory requirements, such as Good Manufacturing Practices (GMPs) and environmental regulations?
5.2	Are there processes in place for monitoring compliance with regulatory requirements?
5.3	Are regulatory compliance records maintained and updated regularly?
5.4	Are personnel trained in relevant regulatory requirements?

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