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Audit Interview as Evidence to issue a CAR (Corrective Action Request)

M

meow4easthills

#1
Hello,

I have been issuing CARs based on what has been advised during an interview as evidence to issue a CAR, for example:

"Policy document xxxx states on page 3 that "We will review all letters prior to being sent". Two Team Leaders advised the auditor that they do not check all letters prior to sending. There is no requirement that Team Leaders make records of the checks they make."

The reason I ask is that I have been advised by one of the execs that interviewing staff isn't sufficient evidence to support a CAR being issued.

What does everyone think?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Statements such as this one that describe the employee's process exhibit a lack of awareness of procedures or failure to follow them for whatever other reason, and are absolutely a valid basis for a corrective action request. Of course it helps if you can say "Can you show me?" and have them produce an output that others can verify, and I would try to do that but by the book a statement is supposed to be enough.
 

Colin

Quite Involved in Discussions
#3
Audit evidence is defined as 'records, statement of fact or other information which are relevant to the audit criteria and verifiable' in ISO 9000.

The last word is the tricky one when it comes to statements of fact. Could it end up with you disputing 'who said what' if someone challenges you.

Far better to get documented, objective evidence wherever possible.
 

somashekar

Staff member
Super Moderator
#4
Hello,

I have been issuing CARs based on what has been advised during an interview as evidence to issue a CAR, for example:

"Policy document xxxx states on page 3 that "We will review all letters prior to being sent". Two Team Leaders advised the auditor that they do not check all letters prior to sending. There is no requirement that Team Leaders make records of the checks they make."

The reason I ask is that I have been advised by one of the execs that interviewing staff isn't sufficient evidence to support a CAR being issued.

What does everyone think?
I recollect a very learned customer auditor who used to write thus ...
"As stated by the responsible officer .. x .. x .. x ..."
The statement of fact as said by the responsible officer if not in line with the established procedure / practice during the course of an audit is a good enough evidence to issue a NC.
Just remember to make certain that the one who states is the responsible officer at that process. Note name and position if so necessary.
 

julsbear

Involved In Discussions
#5
This requirement cries out for an objective way of documenting that the letter has been reviewed. I believe that the response you received in the interview is sufficient evidence for a CAR, but other than a positive response to the question, how would you document compliance?

A specified review field, or a note in the properties of a Word file or physically initialing a retained hard copy would probably be needed for positive evidence of compliance. Another way would be an email trail or some type of log incorporated into office communications, a Customer Relations Management system or a component of an ERP.http://elsmar.com/Forums/images/smilies/2cents.gif
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
to respond to a portion of thsi thread:
This requirement cries out for an objective way of documenting that the letter has been reviewed...
There is no objective way of 'documenting' that the letter was reviewed except by videotaping one person reading it to another person and having a discussion about the salient points. Signatures, initials, check marks etc. are not actually proof that a document was reviewed, an inspection was performed or a process was followed. Despite teh fact all auditors accept them as such, these are only objective evidence of compliance with the requirement for a signature, initials or check marks. There may be some 'threat' characteristic to this method but the real issue is actual compliance to an actual requirement.

Why didn't the auditees follow the process? Answering that question is far more informative and supportive of Quality than debating whether or not to issue a CA or what extra bureaucracy might help us gain compliance or worse to have grounds for issuing a CA. (of course I'm assuming that they are telling the truth and not lying for some other nefarious reason)
 
#7
This requirement cries out for an objective way of documenting that the letter has been reviewed. I believe that the response you received in the interview is sufficient evidence for a CAR, but other than a positive response to the question, how would you document compliance?
This is always tricky. For instance, ISO does not require a record of the review of a Purchase Order to "ensure the adequacy of specified purchase requirements prior to their communication to the supplier." (7.4.2). However, most auditors expect to see a signature or initials on a PO as objective evidence. One one hand, forget to initial one PO out of a 1,000 and it turns into a finding. On the other hand, if you train buyers that they must review a PO but don't require initials, it only takes one buyer to say "I don't review a PO, I just type it up, print it and send it" and you have a finding. On the gripping hand, writing a procedure that states that the buyer, in the act of creating a PO, has performed the review, not only states the facts in a "Lean" materials process but makes the whole proof against silly audit findings.



Jeremy Hillary Boob said:
These are the footnotes for my nineteenth book. This is my standard procedure for doing it. And while I compose it, I'm also reviewing it!
 

Wes Bucey

Quite Involved in Discussions
#8
Hello,

I have been issuing CARs based on what has been advised during an interview as evidence to issue a CAR, for example:

"Policy document xxxx states on page 3 that "We will review all letters prior to being sent". Two Team Leaders advised the auditor that they do not check all letters prior to sending. There is no requirement that Team Leaders make records of the checks they make."

The reason I ask is that I have been advised by one of the execs that interviewing staff isn't sufficient evidence to support a CAR being issued.

What does everyone think?
This requirement cries out for an objective way of documenting that the letter has been reviewed. I believe that the response you received in the interview is sufficient evidence for a CAR, but other than a positive response to the question, how would you document compliance?

A specified review field, or a note in the properties of a Word file or physically initialing a retained hard copy would probably be needed for positive evidence of compliance. Another way would be an email trail or some type of log incorporated into office communications, a Customer Relations Management system or a component of an ERP.http://elsmar.com/Forums/images/smilies/2cents.gif
to respond to a portion of thsi thread:


There is no objective way of 'documenting' that the letter was reviewed except by videotaping one person reading it to another person and having a discussion about the salient points. Signatures, initials, check marks etc. are not actually proof that a document was reviewed, an inspection was performed or a process was followed. Despite teh fact all auditors accept them as such, these are only objective evidence of compliance with the requirement for a signature, initials or check marks. There may be some 'threat' characteristic to this method but the real issue is actual compliance to an actual requirement.

Why didn't the auditees follow the process? Answering that question is far more informative and supportive of Quality than debating whether or not to issue a CA or what extra bureaucracy might help us gain compliance or worse to have grounds for issuing a CA. (of course I'm assuming that they are telling the truth and not lying for some other nefarious reason)
This is always tricky. For instance, ISO does not require a record of the review of a Purchase Order to "ensure the adequacy of specified purchase requirements prior to their communication to the supplier." (7.4.2). However, most auditors expect to see a signature or initials on a PO as objective evidence. One one hand, forget to initial one PO out of a 1,000 and it turns into a finding. On the other hand, if you train buyers that they must review a PO but don't require initials, it only takes one buyer to say "I don't review a PO, I just type it up, print it and send it" and you have a finding. On the gripping hand, writing a procedure that states that the buyer, in the act of creating a PO, has performed the review, not only states the facts in a "Lean" materials process but makes the whole proof against silly audit findings.
I gather from the context that this is an INTERNAL audit, not customer or 3rd party registrar.

Every statement quoted above has a kernel of truth and validity, BUT if I were the staff member performing this audit, I would :ca: and declare this an Opportunity For Improvement, by saying,
"Anecdotal evidence from interviews demonstrates there is no objective way to confirm whether the [process] is performed and "some" workers may "omit" the process, wrongly thinking they had performed it. I suggest we explore ways to mistake proof this process."
My experience has been that many internal auditors [and their bosses] believe the internal audit is a police action and so feel that they need to play "GOTCHA" and issue NC instead of making suggestions for mistake proofing a process.

Bottom line:
Better to be a helpful advocate than a hated Kwality Kop. (Note the use of "we" versus "they" - very important psychologically.)
 

somashekar

Staff member
Super Moderator
#9
My experience has been that many internal auditors [and their bosses] believe the internal audit is a police action and so feel that they need to play "GOTCHA" and issue NC instead of making suggestions for mistake proofing a process.
Opportunity for improvement is a 3rd party use to show what they call "value added" audit. As an internal auditor, and being a part of the organization, my task is to not suggest, but to facilitate CA and Improvement of the established QMS.
It is known that the general quality of Internal audit needs improvement across industry, however it is wrong to assume that Internal audits are police action.
We have been telling a lot here in several threads about not grading internal audit NC, not relating the NC to standard clauses and addressing all findings as appropriate within the corrective action systems established in the organization.

:sarcasm: When several 3rd party audit "Opportunity for improvement" goes without addressing, what stand does an internal audit "Opportunity for improvement" have .... Such opportunities must be highlighted by anyone during the normal work course to bring about changes for better. ... :2cents:
 
#10
I gather from the context that this is an INTERNAL audit, not customer or 3rd party registrar.
My internal auditor would never write anything other than an OFI for something like this. Under the concept that visual inspection does not eliminate quality issues, our ERP system automatically inserts standard text for things like calibration POs that require A2LA certification. In addition, drawings, manufacturer numbers, etc. are controlled via ECO and automagically inserted into a PO for a given part number. The Materials Group only needs to "review" the quantity and price. The number of errors eliminated by this system is an order of magnitude greater than a manual "review". Since I have exceeded the intent of the requirement for a "review" why would I accept a finding regarding a perceived lack of objective evidence for a review?

On one hand, my experience with 3rd parties is that a majority of their auditors have a list of stock findings and some mental quota for achieving a "successful" audit. On the other hand, these auditors last exactly one audit at my company. On the gripping hand, I write my procedures for silly auditors and only retain serious auditors that will actually assist in Managing for the sustained success of an organization rather than wasting my time.
 
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