Manager's version of the process contradicts personnel running the process

BradM

Staff member
Admin
#11
Hello qualityboi!

One of Roxane's points got me thinking... I would think a higher tier procedure would at least specify which processes should be documented and which aren't. Also (as I learned of a need yesterday in a situation) there may be times to deviate from a documented process, but there should be steps for that.


So if there is no procedure for determining processes that do/don't require documenting, I would think that would be a worthwhile mention. Otherwise, managers may think nothing needs to be documented (when it probably should), while another manager feels everything has to be documented (that does not need to be).
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#12
As auditors, do we have the right to say what is necessary? The answer to this is, in my opinion, we have that right only when the risk posed by the lack of documentation is high. As auditors, our role is not only to assess the organization's level of conformance to requirements and the effectiveness of the system, but we are now to assess the level of risk of the gaps. This allows the organization to prioritize their actions and resources.
:agree1:Very, very insightful. You should expand your "auditing in the XXI century program" to outside entities. More "professional" auditors need to hear that message. Keep it up. :yes:

The concept of "managing risk" is the only sustainable answer to management system implementation and assessment. Somebody should use that as a slogan....:tg:
 

John Broomfield

Staff member
Super Moderator
#13
While auditing a process (sorry I can't be more specific as people from my company may see this), the manager's version of the process flow was different than what was significantly different than two technicians that I interviewed on the floor especially for the mechanism for out of control data points, spc rules. The process is not documented, and since there was conflicting information I am going to write this up. I am just wondering how to word it so as not to make the manager look dumb or not to get the technicians in trouble...:(
If as a result of this confusion the process is ineffective then you have a 4.1c nonconformity: system failed to determine the criteria and methods necessary for effective operation of the process. Blame the system not the people, unless of course the leader is willing to step up to the plate.
 

Big Jim

Super Moderator
#14
Quote from Wes:

"There is an undocumented process - it gets an NC"

Try as you may, you cannot find a "shall" for this. Unless it is one of the six required procedures, they do not need to be documented.

With further investigation, one of the "shalls" you quoted may be appropriate, as well as others, but not just because you stumbled across something that isn't documented.

With what has been disclosed at this point, to me, it is just an audit trail. It may or may not end up being an NC. I think it likely would end up being one, but not from the evidence at hand.

PS: I kind of like the possibility of John Broomfields idea of this being against 4.1c, but again not without more information.
 
Last edited:

charanjit singh

Involved In Discussions
#15
I find this very interesting, informative and thought provoking discussion. Let me put across my views.
Firstly we could note down what the operators are actually following on the floor. Then get the manager's version. This would be necessary to ensure we have understood the position correctly. In case there is indeed a discrepancy, the discussion with the manager should highlight the need for documenting an effective process/process control procedure lack of which is an NC.

Now, NC under which clause?
4.2.1 c) ...documents needed ...to ensure effective ...operation & control of its processes.

7.5.1 b) ...controlled conditions shall include as applicable...the availability of work instructions as necessary

8.2.4 ......monitor ...to verify the product requirements have been met....carried out at appropriate stages...in accordance with planned arrangements (7.1). This would link with 7.1 b) ...establish documents....etc.
 

Helmut Jilling

Auditor / Consultant
#16
Quote from Wes:

"There is an undocumented process - it gets an NC"

Try as you may, you cannot find a "shall" for this. Unless it is one of the six required procedures, they do not need to be documented.

With further investigation, one of the "shalls" you quoted may be appropriate, as well as others, but not just because you stumbled across something that isn't documented.

With what has been disclosed at this point, to me, it is just an audit trail. It may or may not end up being an NC. I think it likely would end up being one, but not from the evidence at hand.

PS: I kind of like the possibility of John Broomfields idea of this being against 4.1c, but again not without more information.
Cl 4.1.b requires that the sequence and interactions of processes be defined. If there are two verbal versions, I don't think that will likely end up complying. I would go with your comment "it's an audit trail for now..." but it would likely end up as an NC.
 

Stijloor

Staff member
Super Moderator
#17
While auditing a process (sorry I can't be more specific as people from my company may see this), the manager's version of the process flow was different than what was significantly different than two technicians that I interviewed on the floor especially for the mechanism for out of control data points, spc rules. The process is not documented, and since there was conflicting information I am going to write this up. I am just wondering how to word it so as not to make the manager look dumb or not to get the technicians in trouble...:(
The standard uses the word "defined" quite a bit. "Defined" can be in practice and/or a document. That's your organization's choice. What I concluded from your post is that the process definition based on statements of fact (a verbal response from an auditee that is considered audit evidence) is inconsistent. So it is a nonconformity in my book. The corrective action will consist of defining what actually has to happen and having the stakeholders agree to it (preferebly by consensus). Next, you will verify that the agreed upon and defined process is effective. No need to make it unnecessarily complex. See? Not even a "document" involved.;)

End of the story.

Stijloor.
 
#18
This is an interesting thread. Sitting here at breakfast on Sunday am, something occurs to me.......

Was this issue simply stumbled on by the auditor? Was the audit scheduled to some calendar of processes or requirements and the auditor was perceptive enough to find that the story between management and staff? Why were we (I mean you, Qualityboi) auditing?

My beliefs are that we have to have a better reason for doing an audit than because some (sometime, arbitrary) calendar sends us to audit. It isn't good audit management that this issue was (luckily) stumbled upon. However, if we were auditing based on 'status and importance', then there's a much better reason why this finding should be identified and corrected:-

There's been a problem (to customers or internally, causing scrap, etc.)
It's a new or changed process
It's working better than expected (planned)

An effective and organized auditor will have researched the background to the process issue and will have a good idea what results are being seen. From that it's easier to determine the effectiveness of the process and therefore, which 'version' of the story is working.

When reported as such, it's clearer for management which course of action(s) are necessary and the audit is seen as value added!

Back to my porridge........
 

Wes Bucey

Quite Involved in Discussions
#20
The standard uses the word "defined" quite a bit. "Defined" can be in practice and/or a document. That's your organization's choice. What I concluded from your post is that the process definition based on statements of fact (a verbal response from an auditee that is considered audit evidence) is inconsistent. So it is a nonconformity in my book. The corrective action will consist of defining what actually has to happen and having the stakeholders agree to it (preferebly by consensus). Next, you will verify that the agreed upon and defined process is effective. No need to make it unnecessarily complex. See? Not even a "document" involved.;)

End of the story.

Stijloor.
No documents are involved in the rosy picture you paint, but reality in practice has a few snags - primary being "mission creep" where the "players" add or subtract parameters to a process as time goes on. Without the document for a reference, mission creep invariably leads to changes from the original plan. (sort of like a game of "telephone")

The process you describe depends on accurate "word of mouth" training from shift to shift and generation of worker to generation of worker. Rarely does such dependence on undocumented processes result in consistent application of the original process.

The process you describe is akin to showing one manager the blueprint of a product, removing the blueprint, and requiring him to maintain consistent production of the product from one or more operators when no operator has access to the original blueprint. Possible, but not probable!

Which is why this clause
7.5.1 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions.
Controlled conditions shall include, as applicable,
a) the availability of information that describes the characteristics of the product,
allows some organizations with relatively simple processes to do without documentation, while in others, the "as applicable" spectre looms large.

We are not privy to the exact process under consideration, but it seems reasonable to infer it is complicated enough to have at least two different versions. Simple mistake-proofing by having a written work instruction is worth an OFI at least, wouldn't you agree?
 
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