To lay down a procedure for corrective action to be taken during failure of stability chamber.
1.0 OBJECTIVE
1.1 To lay down a procedure for corrective action to be taken during failure of stability chamber.
2.0 SCOPE
2.1 This SOP covers the procedure for corrective action taken during failure of stability chamber and is applicable to stability.
3.0 RESPONSIBILITY
3.1 Chemist-Quality control / Stability – To identify the problem
3.2 Maintenance – To identify and rectify the problem.
3.3 Incharge – Stability – To evaluate the cause and perform the corrective
action.
4.0 ACCOUNTABILITY
4.1 Head –Quality Control / Stability.
5.0 PROCEDURE
5.1 SAFETY HOOTERS LOCATION:-
5.1.1 Safety hooters shall be connected to each stability chamber, In
addition, Hooters of the same chamber shall be connected Maintenance department parllelly.
5.1.2 Hooters shall be marked with particular chamber ID and Location.
5.1.3 Identify Stability chamber / Walk in and Floor where it is kept
5.2 ACTION TO BE TAKEN IN CASE OF HOOTER ALARM
5.2.1 OFFICE HOURS
5.2.1.1 In the office hours Stability chemist/ Stability Incharge/
Maintenance person shall be responsible for attending
the problem.
5.2.1.2 Whenever any alarm is raised in the hooters, personally
verify and identify the problem with respect to
• Fluctuation in Humidity and/or Temperature.
• Smoke if any.
• Any others
5.2.1.3 Evaluate the problem is ‘Minor’ or ‘Major’
5.2.1.4 Corrective action to be taken in case of Temperature &
Humidity fluctuation
Check water supply / water level in the boiler tank.
Ensure water supply pressure.
Restart the stability chamber by using Restart button.
Open the door and observe physically.
Disconnect the power supply to the oven or walk-in if required.
Inform Stability Manager and Maintenance person.
If problem is not resolved, inform the vendor’s service engineer.
If required, start standby compressors / In case of standalone chamber, shift the samples to standby chambers.
5.2.2 OUT OF OFFICE HOURS
5.2.2.1 In case of out of office hours like night hours, weekends and Holidays, Maintenance persons shall be responsible for attending the problem.
5.2.2.2 Whenever any alarm is raised in the hooters, personally verify and identify the problem with respect to
• Fluctuation in Humidity & Temperature.
• Smoke if any.
• Any others
5.2.2.3 Evaluate the problem is ‘Minor’ or ‘Major’
5.2.2.4 Corrective action to be taken in case of Temperature
Humidity fluctuation
Check water supply / water level in the boiler tank.
Ensure water supply pressure.
Restart the stability chamber by using Restart button.
Open the door and observe physically.
Inform Stability chemist, Stability Manager and Maintenance manager over phone as
mentioned in the attached list (Format No: xxxxx
Disconnect the power supply to the oven or walk-in if required.
Ensure performance verification in case of any major repair or part replaced.
5.3 Update Hooter alarm monitoring log sheet as per Format No: xxxxx
Stability chamber, corrective, maintenance, repair, monitoring log
