Clause 6.3.4 - Procedure when monitoring devices are out of spec
Hello Everybody,
Could someone suggest me on writing procedure when measuring and monitoring devices are not operating within specified limits.
We have 2 weighing scales with max weight 150 kgs and they are calibrated as well. We pack our product in bags of 25 kgs and 50 kgs and despatch them. Now as per the clause 6.3.4- I can't think of procedure when they are not operating, only thing i know is use the other one when one weighing machine is not working or call manufacturer to get it repaired.
Please provide any inputs, thank you in advance.
Regards
Karthik
Hello Everybody,
Could someone suggest me on writing procedure when measuring and monitoring devices are not operating within specified limits.
We have 2 weighing scales with max weight 150 kgs and they are calibrated as well. We pack our product in bags of 25 kgs and 50 kgs and despatch them. Now as per the clause 6.3.4- I can't think of procedure when they are not operating, only thing i know is use the other one when one weighing machine is not working or call manufacturer to get it repaired.
Please provide any inputs, thank you in advance.
Regards
Karthik
Stop using faulty scale
Arrange repair
Quarantine product since scales were last known to be working correctly
Check quarantined product and make a decision based on your findings
Investigate further and decide 'root cause' and if scales should be serviced and/or calibrated/checked more frequently or if unreliable replaced
Regards,
Tony
Just an addendum to Tony's post: Immediately put an 'OUT OF ORDER. DO NOT USE!' tag on the defective scale.
You have to also traceout the time fram when that scale was not working, If FG already shifted in BSR of deliverred to the customer, d recall the product and check with valid scale.
Weighing Balances must be undergone daily challenge test against standard weights verified by external NABL accredited lab, at start of each shift & at least one scheduled monthly calibration or as & when needed. Whenever you found that there is a deviation between weight of standard weight & your scale do calibrate your scale.
Whenever you found your monitoring device is out of order & its malfunctioning you will have to quarantine all the materials passed with that faulty device till the last check...
It would also be best to have a documented allowable tolerance. Something like ±10 g, we use ±.01 lbs here at our facility. As Ashish has said, it would be best to test the scales frequently and document those checks. Doing checks daily allow you to limit the amount of product you must place on hold for a determination.
Also, instead of using a sign that says out of order, I would place the scale on hold so it cannot be used. Placing the scale on hold with show that it's in your control and doesn't allow it to be used accidentally.