Audit Nonconformance? Employee References Work Instruction

K

Ka Pilo

#1
I know that a quality manual (compilation of policies, procedures, instructions, etc) was created for employees' reference. During the audit, an auditor asked an employee who is checking product temperature, "What is the control limit?" Instead of giving instant answer, the said employee refer to the manual (specifically the work instruction). Is that a nonconformity? The employee is expected to know what he is checking for.

Many Thanks in advance for your thoughts on this.
 
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qusys

Trusted Information Resource
#2
Re: Is this a nonconformity?

What kind of audit was it? CB, customer, internal?
Could you please say the exact statement of the ncn and the violeled clause of the reference standard or internal procedure?

From my experience , this is not a non conformity, I do not see anything that is not compliance in your explanation of the fact. :bigwave:
 
K

Ka Pilo

#3
Re: Is this a nonconformity?

What kind of audit was it? CB, customer, internal?
Could you please say the exact statement of the ncn and the violeled clause of the reference standard or internal procedure?

From my experience , this is not a non conformity, I do not see anything that is not compliance in your explanation of the fact. :bigwave:
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.
 

qusys

Trusted Information Resource
#4
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.
If the operator or technician is able to reach where the information is supposed to be to do his/her job and demonstrates that he/she work in compliance with it accroding to the training and competence that the company provided, I see no non conformity.
However it is very difficult to work on an hypothetical question.
Hope this helps:bigwave:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Back when I was a Non-Destructive Test inspector onboard surface ships it was drilled into us to NEVER quote specs. We had to have our work instructions and inspection criteria there, open at the site of use, during each inspection and test.

That was in spite of how well we knew our job, which was never questioned because we were tested thoroughly and regularly. But specs can change, and acceptance criteria shouldn't be left up to memory to get it right. My brain makes a poor database.

So when I audit I never expect people to quote specs or standards. I expect the guidance to be easily and readily available where and when needed, and current. If there is a cheat sheet or flip card stand or binder at the work station that's great, but it needs to match the current process document.

In addition to my personal experience and judgment, these are requirements of the standard - memorization is not.
:2cents:
 
K

Ka Pilo

#6
Re: Is this a nonconformity?

If the operator or technician is able to reach where the information is supposed to be to do his/her job and demonstrates that he/she work in compliance with it accroding to the training and competence that the company provided, I see no non conformity.
Do you think this is not a competence related issue? Employees are expected to know there job assuming that temperature monitoring is what day do every day.
However it is very difficult to work on an hypothetical question.
Hope this helps:bigwave:
I agree. :) But I sure one can give thoughts out of the presented situation.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#8
competance issue? I can't see how. by creating work instructions, check sheets, and quality records we are confirming that we employees can't possibly remember everything. our use of written instructions that are under change control are there to help ensure that the correct approved specification limits are being used.

I could see a 'finding' of some sort IF the employee accepted - or rejected - the results without knowing what the limits are (documents are there to keep employees from making up theri own rules) and especially if the operator was employing a limit that was in conflict to the documented requirement.
 

Wes Bucey

Quite Involved in Discussions
#9
Most modern QMS Standards I am aware of stress the process offered by Jennifer - ALL documents pertinent to producing a conforming document should be readily available to the work station where the work is performed.

To give an answer such as you suggest violates the guideline [rule?] - NO ANECDOTAL EVIDENCE! (Objective evidence only)

Personally, as an auditor, the question should be, "What evidence do you have concerning the specification?" NOT "Tell me the specification."

So, if anyone is nonconforming, it is the auditor who engaged in "mission creep" by asking a nonStandard question.
 

Jim Wynne

Staff member
Admin
#10
Most modern QMS Standards I am aware of stress the process offered by Jennifer - ALL documents pertinent to producing a conforming document should be readily available to the work station where the work is performed.

To give an answer such as you suggest violates the guideline [rule?] - NO ANECDOTAL EVIDENCE! (Objective evidence only)

Personally, as an auditor, the question should be, "What evidence do you have concerning the specification?" NOT "Tell me the specification."

So, if anyone is nonconforming, it is the auditor who engaged in "mission creep" by asking a nonStandard question.
There is nothing wrong with an auditor asking about specifications. If the auditee knows the answer, and the answer is correct, there's nothing anecdotal about it. The best procedure in a situation like this would be for the auditor to ask (wrt temperature) "What's the limit?" or "What are you looking for as far as temperature is concerned?" Then, so long as the auditee can readily produce the correct answer, there should be no problem. If the auditee answers with a number without looking at a document, the auditor can/should ask, "How do you know that's correct?"
 
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