I. First, ensure the completeness: The record must fully include the 6 types of content (missing any one makes it incomplete)
Basic information is complete
Equipment name, position number, location of the clean area, grade (A/B/C/D)
Date, start/end time
Operator, reviewer
Maintenance items are complete
Fan operating status (abnormal noise, vibration, temperature)
Dampers cleaning, installation, sealing
Initial/middle/high efficiency filter pressure difference
Filter appearance, leakage, sealing condition
Exhaust ceiling frame, ceiling sealing
Data record is complete
Pressure difference: initial, current, final resistance judgment
Instrumentation number, calibration validity period
Data comparison before and after maintenance
Abnormal situations are complete
Are there any abnormalities?
Abnormal description
Initial cause judgment
Treatment measures
Verification and closed-loop completeness
Re-measurement data after treatment
Has it returned to normal?
Has deviation/change been opened?
Signature and review completeness
Operator’s signature
Reviewer’s signature
Auditor’s signature
II. Ensure the completeness of 5 execution methods (directly follow the on-site procedures)
1. Use standardized, check-mark style templates, no freehand writing allowed
All items should be fixed as check marks + fill-in, do not just write “normal”.
The template should indicate: This item is mandatory, cannot be blank.
One page covers all content to avoid scattered and lost pages.
2. Execute “Do one, record one, complete immediately”
Do one, record one, do not allow to complete later.
Prohibited: Only do not record, only record not doing, recalling and writing later.
3. Force “Record even if there is no abnormality”
No problem → Write: “No abnormality”, cannot leave blank.
Shutdown, stop production, not running → Write: “Equipment shutdown, not maintained”, and sign.
Never allow blank columns, blank dates.
4. Abnormalities must “Write completely from beginning to end”
As long as an abnormality occurs, 4 things must be recorded:
What was discovered
What was done for handling
Data after handling
Is the conclusion qualified
One item missing means incomplete content and does not comply with GMP.
5. The reviewer only checks one thing: Are there any missing items
Was the pressure difference written?
Was the time filled in?
Was the abnormality closed-looped?
Did all signatures complete?
Were there any blank items left unfilled?
The reviewer’s signature = confirmation of complete content.
III. The most important sentence for auditing (can be directly written into the SOP)
The daily maintenance record of the exhaust ceiling should be complete in terms of items, data, abnormal closed-loop, and complete signatures, without missing items, blank spaces, or gaps, ensuring full traceability throughout the process and compliance with GMP requirements.