A self-audit checklist for the Quality Control (QC) department is a tool used to assess the compliance and effectiveness of an organization's quality control operations. This checklist's objective is to find areas for improvement and to ensure that the QC department is following specified rules, procedures, and regulations.
Before items or services are distributed to clients, the QC department ensures that they fulfill the needed quality standards. The department is responsible for monitoring and managing quality from raw material procurement to completed product release and plays a crucial role in sustaining product or service quality.
Personnel qualifications, training and certification, laboratory practices, equipment maintenance, calibration and validation, documentation practices, data integrity, product release procedures, deviation and investigation management, and regulatory compliance are typically covered in the self-audit checklist for the QC department.
Regularly doing a self-audit checklist for the QC department can assist in identifying areas of noncompliance, deviations from established processes, and opportunities for development. The checklist may also assist guarantee that the QC department is following the organization's rules and processes, as well as regulatory obligations.
During a self-audit checklist for the QC department, the auditor should carefully review the department's policies and procedures, records, and documents to determine whether they comply with established standards and regulations. The auditor should also conduct interviews with QC department personnel to verify their understanding of the policies and procedures, and their compliance with them.
The QC department should conduct remedial steps based on the findings of the self-audit checklist to address any areas of noncompliance or areas that require improvement. This may entail updating policies and procedures, retraining staff, establishing new processes, and ensuring compliance with regulatory requirements. Finally, a self-audit checklist for the QC department is a useful tool for checking that quality control operations follow specified rules, procedures, and laws. The checklist assists in identifying areas for improvement, after which remedial measures may be performed to guarantee compliance with standards and laws, assuring the quality of products or services offered to clients.
Sr. No. | Checkpoints | Observation | Recommendation | Action taken by |
01 | Is the control copy of QC department SOPs available? | | | |
02 | Are the personnel having knowledge of current GMP requirements? | | | |
03 | Is the housekeeping maintained? | | | |
04 | Is the weighting balance having a proper tag of calibration status? | | | |
05 | Is the balance calibration record available? | | | |
06 | Are the calibrated standard weights available? | | | |
07 | Is the calibration certificates available? | | | |
08 | Are the standard weights properly stored? | | | |
09 | Are the status labels available on each instrument? | | | |
10 | Is the instrument calibration record available? | | | |
11 | Check the temperature and humidity record. | | | |
12 | Check the cleaning record. | | | |
13 | Check the cleaning of sampling devices. | | | |
14 | Are all the sampling devices properly stored? | | | |
15 | Check the general cleaning and housekeeping of QC. | | | |
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16 | Are the specifications available for raw material, packing material, in-process samples, intermediates, and finished products? | | | |
17 | Check the in-process testing record. | | | |
18 | Check the raw material testing record. | | | |
19 | Check the final product testing record. | | | |
20 | Check the stability record. | | | |
21 | Check the stability chamber record. | | | |
22 | Check the solution preparation and standardize the record. | | | |
23 | Check the control sample record. | | | |
24 | Check all instrument log books. | | | |
25 | Check the primary standards and their storage. | | | |
26 | Check the mobile phase status of GC and HPLC. | | | |
27 | Check the HPLC column record. | | | |
28 | Check the test request slip record. | | | |
29 | Check the personnel hygiene. | | | |
30 | Check the safety equipment. | | | |
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31 | Check the other records. | | | |
32 | Check the environment where the control sample is stored? | | | |
33 | Is the log book of the destruction of the control sample maintained? | | | |
34 | Is the out-of-calibrated instrument well labeled? | | | |
35 | Is QC Chemist validated? | | | |
36 | Is the sample in the QC lab well labeled? | | | |
37 | Are the personnel following GLP? | | | |
38 | Is training given to new personnel? | | | |
39 | Are all QC personnel in the proper dress code? | | | |
40 | Is the glassware breakage logbook maintained? | | | |
41 | Check the DM water analysis record. | | | |
42 | Check reference standard records? | | | |
43 | Is a proper sampling plan available? | | | |
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