Not sequentially following steps in a work instruction

Not sequentially following steps is an audit finding.

  • If there is evidence, "Yes" it's a finding

    Votes: 3 25.0%
  • Without more knowledge, I say "No", not a finding

    Votes: 1 8.3%
  • I would definitely dig deeper before any citation

    Votes: 8 66.7%
  • Given the limited information, no way to accurately say

    Votes: 3 25.0%

  • Total voters
    12

Randy

Super Moderator
#51
What are we doing now, practicing Machiavellism? The ends justify the means? It doesn't matter how you do it or why, just get it done? "Procedure? Yeah, we have a procedure, but my way is better" or "Procedure, yeah I wrote it, but it really doesn't matter how you do it".........Wow, loads of fun possibilities here.

Another great new concept...."Hey guys, don't bother showing me how it's supposed to be done just show me how you really do it. All that written stuff just gets in the way of your production anyway"

Or better yet to really save time..."Just show me what you made, all those written particulars aren't that important anyway because the guy that wrote them may be wrong"
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#52
No auditing, internal or external, should be based on assumptions.
If I am understanding, there was no assumption. Paraphrasing: The person performing the work admitted that it didn't matter how it was performed, just that it got done. Maybe I am missing the point here. Is that an assumption?

Is not audit information based upon interviewing, records, and validation of a process? :confused:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#53
I'm looking at this from the perspective of a 3rd party, limited in time and needing to cover the audit plan in the time alloted and then having to write a report prior to the closing meeting, it's a judgement call based on the evidence and time available.
I think it is more important for the auditor to make a fair assessment of the system, than to "cover an audit plan". And they are not mutually exclusive. In this scenario, it would probably take me 2 or 3 minutes of additional investigation to determine if the out-of-sequence assembly is critical or not.
All we have is what was provided, nothing else and we were asked by the OP for feedback and how we would handle it.
And further investigation is always a possibility.
We have a clear requirement,
No, we don't.
Sure, talking to the process owner may reveal that the procedure is inaccurate or not important, but then that would require a corrective action with the procedure and corrective action is only required when nonconformance is identified....reverse thinking.
Not really. Talking to the process owner, we might learn that the sequence of assembly for steps 5 and 6 is inconsequential and there is no harm in the way the interviewed operator is performing. Nothing needs changing.
 

Sidney Vianna

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Staff member
Admin
#54
If I am understanding, there was no assumption. Paraphrasing: The person performing the work admitted that it didn't matter how it was performed, just that it got done. Maybe I am missing the point here. Is that an assumption?
What is your point? If you believe this is an NC, what is the requirement being violated?
 

BradM

Staff member
Admin
#55
There is no evidence that the process is not delivering the results.
I include the procedures as part of the process. There is a procedure that says do 1,2 then 3, but the operator is not doing that. Something in the process is off, and needs to be fixed.

I am amazed how some of you can reach any conclusion on this scenario about NC or no NC or operator discipline or process inefficacy without asking questions. That is not effective auditing, internal or external.
IMHO, auditing is a big tent, and has plenty of room for interpretation of strategy. If you are taking a risk-based approach, then "yes" it's inmature to make a ruling based on the given information. I argued this case with some colleagues on the ASQ board a while back about a situation.

However, if the managers (by way of the procedures) said to do X, and you are not doing X, how much clearer can it be?

Reading these posts by many of my well-respected friends, there are several strategies being employed in approaching auditing. While we can legitimately discuss them here and highlight their strengths/ weaknesses, the OP is on the other side of the spotlight, so to speak. Many times they do not have the luxury of arguing strategies with the auditor, but must go to the primal level of "do what you say; say what you do" to deal with the auditors findings. These findings may be well-grounded or insane, but they are still findings to be dealt with.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#56
What is your point? If you believe this is an NC, what is the requirement being violated?
See my previous post:

Coury Ferguson said:
I might, in my opinion, classify this under Management Commitment (to comply with the documented system: e.g. Traveler/WI), Lack of Communication (to assure that all levels within the organization understand the requirements), Lack of training or competency (maybe this person is not competent to perform the required steps or the assembly process).

Yes, I agree that there should be a few more questions asked to their management, on why they are written this way and maybe they should have to be written another way. Which would entail talking (communicating) with the people actually performing the work.
 

Sidney Vianna

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Staff member
Admin
#57
I include the procedures as part of the process. There is a procedure that says do 1,2 then 3, but the operator is not doing that. Something in the process is off, and needs to be fixed.
Once again, you are assuming that out-of-sequence steps are not permitted. My contention is that, we do not know that for a fact. In the real world, many assembly processes happen out of sequence without any impact to product conformity, productivity, etc...

If you think of a calibration work order which lists calibration of 2 instruments:

1. calibrate depth micrometer S/N 97kl803
2. calibrate micrometer S/N 234788

Does it make any difference if you calibrate item # 2 first?
 
Last edited:

BradM

Staff member
Admin
#58
Once again, you are assuming that out-of-sequence steps are not permitted. My contention is that, we do not know that for a fact. In the real world, many assembly process happen out of sequence without any impact to product conformity, productivity, etc...

If you think of a calibration work order which lists calibration of 2 instruments:

1. calibrate depth micrometer S/N 97kl803
2. calibrate micrometer S/N 234788

Does it make any difference if you calibrate item # 2 first?
Point well taken. :yes:You're correct, we don't know. Hence the purpose of a good QMS in the first place is to minimize ambiguity and confusion. It may matter/ may not matter, and it might be worthwhile to specify as such. This is a work instruction: do this; and do it this way; don't do this; use this, etc. It should be clear and accurate. If this work instruction is ambiguous, how many more of the work instructions are written with the same level of ambiguity?

I am not an external auditor, and am not specifying how this should be documented. I leave that to the pros (you guys). All I am suggesting is the auditor should move to improving this gap in the process.
 

Randy

Super Moderator
#59
The actual requirement would be the procedure itself and as previously stated by someone 7.5.1 under 9K;

or 4.4.6 if this an 14K EMS or,

18K OHS, or

4.4.1 if it is PAS99 or......shall I go on?
 

Stijloor

Staff member
Super Moderator
#60
Once again, you are assuming that out-of-sequence steps are not permitted. My contention is that, we do not know that for a fact. In the real world, many assembly process happen out of sequence without any impact to product conformity, productivity, etc...

If you think of a calibration work order which lists calibration of 2 instruments:

1. calibrate depth micrometer S/N 97kl803
2. calibrate micrometer S/N 234788

Does it make any difference if you calibrate item # 2 first?
I can see both sides of the argument.:agree1:

In the micrometer example, both activities are not dependent upon one and other. Not interrelated so to speak. So the sequence does not matter.

However, when you bolt an access cover on a pressure vessel, using a gasket and fasteners, the sequence of assembly and perhaps the torque sequence of the bolts may be crucial.

The auditor has to look at this on a case-by-case basis.

Stijloor.
 
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