Audit Nonconformance? Employee References Work Instruction

Elsmar Forum Sponsor
#12
If that person is responsible for the control of the process temperature and they answer in such a manner, isn't their answer objective evidence?
 

Jim Wynne

Staff member
Admin
#13
If that person is responsible for the control of the process temperature and they answer in such a manner, isn't their answer objective evidence?
Yes. Objectivity in a case like this is in the eye of the auditor. For example, if the auditee gave the wrong answer, the answer could be cited as objective evidence--it's something observed by the auditor. It's first-hand, not anecdotal.
 

LUV-d-4UM

Quite Involved in Discussions
#14
Re: Is this a nonconformity?

Sorry it was just a hypothetical question but I suppose it could happen.

Normally during an audit, CB Auditors ask questions related to the job they (employees) are doing. For example, "can you show me how you check the product temperature and what is the required or acceptable temperature for a certain food?" Instead of instantly answering, for example, 50 degrees Celsius the employee refer to Temperature Monitoring Procedure/Instruction. Is that a nonconformity? What is/are the clause/s deviated under ISO 9001?

I'd love to hear your thoughts on this topic.
Ka Pilo, if there is a work instruction and the auditee complies with the work instruction then it is a compliance to clause 7.5.1b. If the operator is in cinflict with the documented requirement(e.g temperature) then there is an NC to 7.5.1b.
 
K

Ka Pilo

#15
Yes. Objectivity in a case like this is in the eye of the auditor. For example, if the auditee gave the wrong answer, the answer could be cited as objective evidence--it's something observed by the auditor. It's first-hand, not anecdotal.
:topic:
During internal audit an auditor reported a nonconformity against GMP. The audit finding statement was something like "The plant had inadequate ventilation." The auditor observed workers at the Filling Area perspired heavily (real situation)
 

LUV-d-4UM

Quite Involved in Discussions
#16
Ka Pilo,
That is just a perception of the auditor. What is called "Adequate"? Did he relate this to an ISO standard perhaps 6.4 or 6.3? Did he interview maintenance or filling supervisor? You can actually challenge this NC and fire the auditor. This finding can be classified as Observation bacause there is not enough evidence that the other areas of the plant have inadequate ventilation due to neglect in maintenance and Management failure to allocate resources.
 
#17
:topic:
During internal audit an auditor reported a nonconformity against GMP. The audit finding statement was something like "The plant had inadequate ventilation." The auditor observed workers at the Filling Area perspired heavily (real situation)
I perspire heavily! It has nothing to do with the lack of ventilation...:notme:

Your internal auditor may be in need of some coaching to help them with competency...
 
T

treesei

#18
:topic:
During internal audit an auditor reported a nonconformity against GMP. The audit finding statement was something like "The plant had inadequate ventilation." The auditor observed workers at the Filling Area perspired heavily (real situation)
Unless the auditor had evidence that the ventilation failed specs or measurable requirement, he/she was not in the position to state that the ventilation was "inadequate".
 
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