The objective is to describe the procedure for electronic alarms installed on processing Equipment, laboratory equipment and instruments.
The scope covers the Electronic Alarms for Reporting, recording, investigating, Corrective Action and Preventive Action as applicable and required. The procedure covers only such alarms that are installed on equipment/instruments that have a direct impact on GMPs, Products, Processes, testing and analysis and quality or stability of the product.
Head-Engineering shall be accountable for compliance of SOP.
5.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No. : Number
6.1 This procedure is applicable to alarms generated by electronic or computerized systems/instruments used in GMP related activities, such as.
6.1.1 Lab equipment (autoclave, HPLC, Ovens, spectrophotometers, stability chambers, lab incubators);
6.1.2 Production equipment (vial washing equipment, tunnel sterilizer, steam sterilizer, strip packing machine, tablet compression machines),
6.1.3 Equipment systems (pure steam generator, WFI/Purified water system, AHU systems, Power Generator set)
6.1.4 BMS system and other equipment systems.
6.2 List of Alarm
6.2.1 Engineering department shall prepare a consolidated list (department-wise) of available alarms on various equipment / instruments.
6.2.2 The list shall be created with the help of the department responsible person and Quality Assurance.
6.2.3 The list will include details, such as department, S. No., Alarm type, Alarm ID, Equipment name & ID, Location of Equipment, Functionality / Purpose.
6.2.4 The original list will be with QA in Archives and reference copy will be with Engineering and the concerned department.
6.2.5 All operating personnel who use the equipment / instruments shall be trained on the SOP, type & purpose / functionality of alarms, reporting procedure, logging, investigation and CAPA actions by the QA and subject matter experts
6.3 Alarm generation and reporting
6.3.1 Alarms are generated by equipment or system when any operating parameter/condition (input or output) exceeds the pre-set range.
6.3.2 Alarms can be sound type (beep, whistle or siren type) or display type (flashing light/ indicator).
6.3.3 When such alarms are generated, the operator/supervisor should look for source of alarm and its cause.
6.3.4 The alarm should be promptly stopped from display and immediate corrective action shall be taken by the operator/supervisor.
6.3.15 Such alarms shall be reported (reporting of alarms) in a Log book entitled “Reporting of Alarms”. Refer respective Annexure for details of the log book, which will have following details.
- Department, equipment name & ID, alarm name & ID.
- Date reported, time reported, operation affected impact on operation, category, corrective action required, corrective action done, preventive action required, and preventive action done.
6.3.6 Where required, help shall be taken by the operating department personnel from engineering department or subject matter experts.
6.3.7 The alarm shall be reported by operating department and reviewed by operating manager.
In case the alarm is because of a minor cause (assign MINOR category) with no impact on operation or product, then no investigation may be required.
However, it will be reported and necessary corrective action, if required, will be done.
6.3.8 In case the alarm is because of a major cause (assign MAJOR category), that may have some direct or indirect impact on operation, processing, or on product, then investigation will be required.
It will also have corrective action and preventive action, as per SOP on CAPA system.
6.4.1 In case of alarm that has an impact; investigation shall be conducted by the Operating manager, QA, Engineering and where required subject matter expert.
The investigation shall be conducted to identifying the Root cause using SQC tools, such as:
- Process Flow Chart,
- Cause and Effect analysis or FMEA,
6.4.2 The Investigation shall be performed by the Operating Manager, QA Manager and Engineering Manager. Where required, a subject matter expert can also be consulted.
The Investigation shall be as per the Format.
6.4.3 Based on the Root cause identification, necessary Corrective Action(s) and Preventive Action(s) shall be identified and recommended as per SOP on CAPA system.
6.4.4 The investigation report shall be finalized by the investigation team and signed-off. It shall be preserved in QA
6.5.1 The Corrective Action(s) and Preventive Action(s) shall be identified by the Investigation team based on the outcome of investigation.
6.5.2 The Corrective Action(s) shall be promptly undertaken by the concerned operating manager with the help of engineering personnel, if required.
6.5.3 Where required Preventive Action(s) shall also be undertaken by the concerned operating manager with the help on engineering and QA personnel, if required.
6.5.4 These CAPA actions undertaken shall be entered in the Log sheet as per SOP on CAPA system.
6.5.5 The CAPA actions shall be closed after proper review/checks by operating personnel, Engineering and QA personnel.
6.6.1 Necessary information/instructions shall be communicated to all concerned by the operating manager about MAJOR alarms after the:
- Alarm was detected,
- Corrective Action(s) were identified and executed,
- Preventive Action(s) were identified and executed,
- Closure of CAPA
6.7.1 This communication shall be through a Note as per respective Annexure.
6.7 Challenging Alarms
6.7.1 The alarms for all critical operations shall be challenged at least once a year to check for their functionality status if there was no alarm reported during the period
6.7.2 This will verify that the alarm is still functional.
6.7.3 Record for challenging of alarms shall be maintained by the Operating Department.
6.7.4 This challenge can be done by the operating manager with the help of engineering personnel, if required.
6.7.5 Such challenge verification of critical alarms shall be logged in format log sheet “Challenge of Alarms”, with following details:
Department, Alarm Name, Alarm ID, Equipment Name & ID, Date, Challenge test, Done by, Checked by, Results
6.8 Alarm Trending
6.8.1 The operating manager of each department shall do a review and trending of alarms at least once a year (calendar year) in January or February of subsequent year.
6.8.2 This shall include number of times each alarm was displayed and reported.
6.8.3 Based on the trending, the operating manager, engineering and QA can decide whether it has any real use, or the operating range needs revision.
6.8.4 The alarm trending shall be recorded as per Log book format. This will have details such as Department name, Alarm ID, Engineering and Equipment ID, No. of times displayed, Impact for recommendation.
6.9 One log sheet shall be used for each alarm.
7.0 Forms and Records (Annexures)
SOP on SOP
- Master copy – Quality Assurance
- Controlled copies- Engineering, P&A, Production (Oral & Injectable), Warehouse, Quality Control & Quality Assurance
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