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嘉峪檢測網 2025-04-28 12:46
有公司規定:
1. 生產車間用于記時的時鐘在初次使用之前應由計量室依據廣播電臺的整點報時信息校對并調準,然后貼上校驗標簽。
2. 時鐘應懸掛在車間操作人員易于讀數的地方,并且罩上玻璃罩。
3. 生產車間由車間計量員每周對時鐘的準確性校對兩次,兩次較對應在同一天的上午和下午各一次。
4. 當需要對時鐘校對時,車間計量員將時鐘拿到計量室,打開收音機,聽廣播電臺的整點報時并校對時鐘,同時填寫時鐘校對記錄,計量室管理員復核。
5. 使用部門如發現時鐘不能正常運行,應及時通知計量室安排維修,維修后需經過重新校對。
6. 時鐘校準誤差不應超過±5分鐘
在國外,也有制藥公司在SOP中規定如下:
Procedure
校準程序
The user department shall collect the master clock to verify the equipment and instrument clocks, and other clocks under the scope of this SOP. Before the use of a master clock to verify other clocks, the master clock must have to be verified for its accuracy. This verification shall be done as per the frequency defined in the procedure.
使用部門應收集主時鐘(標準時間),以確認設備和儀器時鐘,以及本 SOP 范圍內的其他時鐘。在使用主時鐘(標準時間)確認其他時鐘之前,必須確認主時鐘的準確性。此確認應根據程序中定義的頻率進行。
Master clock shall be verified and adjusted with central server clock (connected with world clock) with the help of IT personnel on the day of verification of clocks. The Master clock shall have a unique identification number.
在主時鐘校準時,應在 IT 人員的幫助下,使用中央服務時鐘(與世界時鐘對接)對主時鐘進行校準和調整。主時鐘應具有唯一的標識號。
Verification of the master clock shall be managed by the engineering department. The record shall be maintained for this verification and harmonization if any.
主時鐘的確認應由工程部門管理。確認和校正(如有)過程應有記錄。
After completion of master clock verification and time harmonization, hand over the clock to the user department for clock verification.
完成主時鐘確認和時間校正后,將時鐘交給使用部門進行時鐘確認。
User department shall verify the timing of departmental clocks and record for the same shall be maintained.
使用部門應確認部門時鐘的時間,并保留相同的記錄。
In case of time difference observed more than 30 seconds, it shall be harmonized with the help of the engineering/ IT department. Record for the adjustment shall be maintained.
如發現時間誤差超過 30 秒,則應在工程/IT 部門的幫助下進行校正。應保留校正記錄。
Clock verification shall also be done in case of any maintenance done on the equipment where the clock is maintained and maintenance may have a potential impact on the computerized controls. For example, equipment PC, HMIs (Human Machine Interface), instruments, etc.
如對具有時間顯示的設備進行任何維護,并且維護可能會對計算機控制產生潛在影響,也應進行時間驗證。例如,設備 PC、HMI(人機界面)、儀器等。
After completion of maintenance activity, the system should be verified using the master clock by the engineering and user department.
維護活動完成后,工程和使用部門應使用主時鐘對系統進行確認。
While verification of the above clocks if required, time harmonization may need to be done. The harmonization should be done as directed in the following table.
如需要,在驗證上述時鐘的同時,可能需要進行時間調校。調校工作應按照下表進行。
Noted Gap between the master clock and clock under verification 主時鐘與被校準時鐘之間的偏差 |
Required action 采取措施 |
Less than or equal to 30 seconds 小于或等于30秒 |
No action required 無需措施 |
31 seconds to 120 seconds 31 秒到 120 秒 |
Time adjustment as per master clock 根據主時鐘校正時間 |
More than 120 seconds 超過 120 秒 |
Non-conformance and investigation to understand the impact of an occurrence. Corrective Action and Preventive Actions to eliminate the root cause and other potential areas with similar possibilities. 不合格并調查,以了解事件的影響。 糾正措施和預防措施,以消除根本原因和其他具有類似可能性的潛在區域。 |
After completion of the clock verification activity, the master clock shall be re-verified against the central server timing.
完成時間確認活動后,應根據中央服務時間重新確認主時鐘。
Clock timing shall be adjusted in the format, HH:MM: SS in 24 Hour format. In case of this format is not possible in any of the equipment/systems, it shall be adjusted as per the applicable setting for the clock.
時鐘應以 24 小時格式的 HH:MM: SS 進行調整。如果任何設備/系統無法采用這種格式,則應根據時鐘的適用設置進行調整。
Frequency
頻率
Equipment, instrument and digital clocks (Non GPS) – Monthly
設備、儀器和數字時鐘(非 GPS)– 每月
GPS clock, server connected clock and computerized systems – Six monthly
GPS 時鐘、服務器連接時鐘和計算機化系統 – 六個月
Master clocks used for verification – before and after verification of other clocks
主時鐘 – 確認其他時鐘之前和之后
JJF2199 - 2025 數字式時鐘校準規范
近日,全國時間頻率計量技術委員會發布了JJF2199 - 2025 數字式時鐘校準規范,適用于數字式時鐘的校準,也適用于其他以數字形式顯示時間信息裝置的校準。其中對數字式時鐘的校準作了如下規定:
顯示時刻誤差:
復校時間:建議復校時間間隔為 12 個月
來源:GMP辦公室