Data Integrity issues
Data Integrity issues
Data integrity issue can be found in very simple processes where management is not focusing.Take example of cleaning and sanitisation process.
Most of the organisations records cleaning and sanitisation in the morning so as to start production activities.
If Quality unit watch this activity carefully, it can identify lot of data integrity issues.
1. Most of the records are documented with almost same time and period. I.e if shift starts at 9:00 hrs, you may find cleaning and sanitisation is documented at 8:00 to 8:30 hrs. The duration of cleaning activity in one room will always be similar. I.e 30 to 40 minutes.
2. If the firm is using floor cleaning machine, you will never find any breakdown. Neither you may find spare machine.
3. Generally cleaning is performed by contracted workmen and hence it is likely that record may be documented by officers. This can create lot doubt whether the person is moving along with cleaner every time.
4. All rooms may not contain digital clock. Hence mentioning time can be questioned.
5. If quality unit really monitor cleaning activity right beginning from first room to last, it may take entire day to complete it whereas on document you may find max two hours job.
6. Verification of cleaning is also a crucial process. But maximum time you may find no or less monitoring.
The target and focus will always be on audit days. All the areas and equipment should be neat and tidy
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