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Please help with non-conformance on calibration


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#1 TEJUSAN

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Posted 07 November 2013 - 02:31 PM

Hai all, i request you people to help me in taking a corrective action/s against the non conformance noted by the auditor during the audit. Mentioned here under the non conformances,

 

1. The vendor had not considered any special conditions for the specification, storage, or handling of calibration equipment.

 

2. No procedures were in place for the identification and replacement of equipment when it is found to be out of calibration.

 

3. The facility could not demonstrate they had method for identification and product produced reviewed whilst equipment is out of calibration. A sample procedure for the same would be a great help,

 

Thanks in advance, KPS.



#2 Charles.C

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Posted 08 November 2013 - 03:33 AM

Dear KPS,

 

Standard = ?

Equipment = ?

Safety / non-safety hazards involved ?

 

Some auditor comments are textbook level as far as equipment is concerned.

 

eg (2) - (i) The comment implies different units are not identifiable. If so, need to fix numbered  labels or equivalent. (ii) Remove unit from use, have re-calibrated. if cannot recalibrate, segregate / reject.

 

(1,3) may depend on what equipment / product / process is being referred ?

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#3 TEJUSAN

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Posted 09 November 2013 - 07:51 AM

Thank you Charles for the prompt reply.

Ours is a fish processing company and the audit was based on a retailer standard. The main equipments used for the process monitoring and measuring are the thermometers, thermographs (cold stores and chill rooms), weighing balances, laboratory equipments such as incubators, autoclaves, refrigerator, hot air oven etc.

 

thanks and regards,

KPS 



#4 Charles.C

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Posted 09 November 2013 - 09:24 AM

Dear KPS,

 

RTE production ?

 

Regarding auditor comment 3, the consequences of any out-of-calibration finding will depend on the product category / functions of the equipment you refer.

eg if any of the items are used to monitor critical limits / CCPs. If so, some typical product corrective actions are segregate related product, (possibly) reject, (possibly) re-evaluate, (possibly) reprocess, (possibly) recall. The options will  depend on the detailed process and the status of the related product (eg shipped already).

 

And similarly, but possibly less drastically, if no CCP involved, but again depending on the process monitoring details.

 

Auditor comment 1. is rather general. The appropriate response(s) probably depends on the specific criticism(s).

 

Rgds / Charles.C


Kind Regards,

 

Charles.C





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