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

Q

qualityboi

#1
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...:(
 
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M

MIREGMGR

#2
Just write it up for being undocumented. Then the next time it's audited, either the way it's actually done or the manager's version won't agree with the documentation...unless the process of documenting what they're doing now prompts the manager and the techs to get coordinated.
 

RoxaneB

Super Moderator
Super Moderator
#3
Unless there is a requirement for the process to be documented, issuing a nonconformance on the lack of a document wouldn't add much value...in my opinion.

I would suggest writing the nonconformance in such a way to demonstrate that the lack of standardization within the process runs the risk to negatively impact the ability to state that product meets requirements or that the process is under control.
 
#4
Indeed, the lack of documentation is not the issue. The real kicker would be to discover whose version was more effective! One of the things people do is 'make up' for parts of the managers version, where they find it's not effective.

You did a good job of detecting the difference. To be a great auditor, you have to find out which version gives the best results!

Nice work!
 

julsbear

Involved In Discussions
#5
The writeup should be for the discrepancy in understandingof how the process work or is practiced. This would highlight the need for this processto be documented. As part of the documentation process it can be decided what is needed to accomplish what is intended. Part of "best results" could be:
1) What meets the requirements
2) What is more stable.
3) If the requirement is one sided, what gives the more desirable result. (Yield, purity etc.)

From experience, the manager may have seen a very short term result meeting criteria 1. The techs may be doing things that deal with all three.

Only when you know under which conditions you are/have run and track the results, can you answer which is better.
 
#6
Only when you know under which conditions you are/have run and track the results, can you answer which is better.
This statement, in a nutshell, is what all auditors should be looking for to determine what's effective. This is the value in an audit finding that assists management to identify what actions are necessary in response to the audit finding, much, much more than just telling that 'we didn't follow the process'.

What a great point, Julsbear - thanks for making it!
 

Wes Bucey

Quite Involved in Discussions
#7
FWIW:
My take on the situation is slightly different:

  1. There is an undocumented process - it gets an NC
  2. There are two versions of the process - it is NOT the auditor's place to determine WHICH is better, merely to point out the obvious: the variance "could" lead to producing nonconforming product. Also obvious, manager did not have a process for affirming the operators agreed with his version of a process and did, in fact, implement the process according to his version.
  3. An Opportunity for Improvement (OFI) could ALSO be generated, describing the opportunity to conduct Design of Experiment exercises to determine the optimal process [not limited to the two known processes]
An interesting set of side issues:
(grist for a management review, NOT an auditor report):

  1. Did operators EVER follow the manager's method?
  2. Did the manager change, NOT the operators?
  3. If yes to either (1) or (2), when and why did they change?
  4. If no, was the training adequate and accurate??
  5. Should the training method be changed?
  6. Is either method the viable one?
  7. If not, what is necessary to determine the most viable and optimal method?
This situation would make for an excellent case study on determining root cause!
 

RoxaneB

Super Moderator
Super Moderator
#8
Wes Bucey said:
[*]There is an undocumented process - it gets an NC
Where is the need for a document? I will grant you that the inconsistent approach towards the process leads one to believe that a document would be great, but it could be something as simple as determine the correct method, generating a one-point lesson and getting back to business.

In today's businesses - which are demanding efficiency and effectivess - a documented procedure may not always be the best solution.

Wes Bucey said:
[*]There are two versions of the process - it is NOT the auditor's place to determine WHICH is better, merely to point out the obvious: the variance "could" lead to producing nonconforming product. Also obvious, manager did not have a process for affirming the operators agreed with his version of a process and did, in fact, implement the process according to his version.
Who's to say the manager's version is the correct version? :cool:

That being said, I agree that the lack of consistency in the process should be the focus of the nonconformance as it may increase the risk of final product and/or overall process not meeting requirements.

Wes Bucey said:
[*]An Opportunity for Improvement (OFI) could ALSO be generated, describing the opportunity to conduct Design of Experiment exercises to determine the optimal process
A nice idea and it may get the team thinking about their overall process, however, smaller shops may not have the resources available at this time to implement such exercises.

Wes Bucey said:
This situation would make for an excellent case study on determining root cause!
I don't think any one here will disagree with that, but I would really hate to see the root cause attributed to the lack of a document. That simply skims the surface of the situation.
 

Wes Bucey

Quite Involved in Discussions
#9
Where is the need for a document? I will grant you that the inconsistent approach towards the process leads one to believe that a document would be great, but it could be something as simple as determine the correct method, generating a one-point lesson and getting back to business.

In today's businesses - which are demanding efficiency and effectivess - a documented procedure may not always be the best solution.



Who's to say the manager's version is the correct version? :cool:

That being said, I agree that the lack of consistency in the process should be the focus of the nonconformance as it may increase the risk of final product and/or overall process not meeting requirements.



A nice idea and it may get the team thinking about their overall process, however, smaller shops may not have the resources available at this time to implement such exercises.



I don't think any one here will disagree with that, but I would really hate to see the root cause attributed to the lack of a document. That simply skims the surface of the situation.
If the root cause investigation STOPPED at "lack of a document," that would be a tragedy. That would be almost as bad as "operator error." The five Whys comes in handy in cases like this.

There may be lots of reasons to issue (if one were so inclined) an NC:
if I were looking to nitpick, I'd probably start with
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,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring equipment,
e) the implementation of monitoring and measurement, and
f) the implementation of product release, delivery and post-delivery activities.
It seems to me an auditor could make a de facto argument that his observation of a discrepancy in understanding the details of a work process indicates a lack of controlled conditions in product realization. Written work instructions may not be necessary, but it is obvious there is a disconnect in communication of some sort when operators perform processes differently from what management has planned. It may or may not matter to the end product whether one process or the other is used or even if one is more efficient than the other, but the lack of a consistent process bears further investigation.

If the auditor is kind and not looking to play "gotcha," he writes an OFI. My question is "Does the OFI hit management review with the same impact as an NC?"

Alternately, one might refer to
7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become
apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable,
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,

d) requirements for records (see 4.2.4), and
e) revalidation.
In my opinion, these requirements are not limited to products which may have "hidden" nonconformances.

As I inferred, "rogue operators" are only a symptom, not a root cause. The management of the organization does not have an apparent, auditable process to assure its processes are performed consistently.

Just because I did not act as a "well-trained, well-mannered auditor" by citing the "shalls" in my first post doesn't mean I'm at fault - Deming suggests you blame my manager!:lmao:
 

RoxaneB

Super Moderator
Super Moderator
#10
Wes:

With all due respect, I did not expect you to cite the shall's. I am certain, however, that they will be appreciated by the original poster who is questioning the lines along which a nonconformance may be written.

That being said, the availability of work instructions is "as necessary." 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.

Without knowing the details of the original poster's organization and the impact that the provided example has on both the ability to meet requirements and control the overall process, it is impossible for Cove Members to provide a black-and-white answer.

Phrasing a nonconformance such that the potential risks are highlighted (i.e., a solution will add value to the organization's bottom line) will probably generate the most attention from the organization. The nonconformance can not simply be worded as "The process for xxx is not documented." Tying the appropriately worded finding to Clause 7.5.1 would ensure that everything is written up in a suitable manner and initiate - hopefully - a root cause analysis that goes to the right depth.
 
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