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
#41
Helmut, I should have made it clearer that my comments were for an internal auditor, should know (having planned the audit carefully) a bit more about the process they were auditing than others.

It's true that if an external auditor stumbled over this one, they wouldn't have that backgound information on which to base a thought. So, that's were it becomes of critical importance that those audit trails are followed to determine the results - not just a rush to judgement that 'the process isn't followed'!

Richtich?
 
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BradM

Staff member
Admin
#42
Randy's work is typically third party auditing, while I do internal auditing.
Just for what it's worth, the original title had 9001:2000 audit finding. But... we still don't know whether the OP is talking about an external audit or internal.

It would be nice to get some more information from the OP on this. We seem like two brothers arguing about which one will carry the girl to the dance, without knowing if she is even going or has another date!:lol:

NOTE: I added a poll on this. There are plenty of moderators on this thread, so feel free to adjust wording, add titles, etc. as you see fit.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#43
Such good comments so far. On one side there is the black-and-white approach, and on the other side the thinking ventures into the gray murky place that is risk based auditing. ....
....Randy's work is typically third party auditing, while I do internal auditing. So, I find Randy's simple approach quite correct in his context.
No auditing, internal or external, should be based on assumptions.
 

Helmut Jilling

Auditor / Consultant
#44
Just for what it's worth, the original title had 9001:2000 audit finding. But... we still don't know whether the OP is talking about an external audit or internal.

It would be nice to get some more information from the OP on this. We seem like two brothers arguing about which one will carry the girl to the dance, without knowing if she is even going or has another date!:lol:

NOTE: I added a poll on this. There are plenty of moderators on this thread, so feel free to adjust wording, add titles, etc. as you see fit.

The principle is the same, however. It should be an audit trail until it is established (by whatever means) that sequence matters, then not following sequence would go from an audit trail to an NC.
 

BradM

Staff member
Admin
#45
The principle is the same, however. It should be an audit trail until it is established (by whatever means) that sequence matters, then not following sequence would go from an audit trail to an NC.
Agreed.:agree:As I stated, it seems we have little information surrounding this scenario, so I was just putting back in as much as we have however minute the relevance.

As I stated in post #3 or so, I think something should change in this process. Either the operators need to be trained and follow the sequence, or the procedure is too sequence-oriented. Hopefully by whatever means appropriate (which is the topic of interest) the owners of the system see an improvement is in order.
 

Randy

Super Moderator
#46
If changes to procedures can be arbritarily made by the user (not the owner...the user) what purpose do they serve? From what I am seeing ya'll agree with the "make-it-up-as-you-go" way of doing things.

Apparently the process owner had his say when the procedure was written so either the work is being done improperly or the procedure is incorrect. This is kinda like the statement in the movie National Treasure --- "Somebody has to go to prison"

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.

All we have is what was provided, nothing else and we were asked by the OP for feedback and how we would handle it. We have a clear requirement, and 2 pieces of evidence of non-fulfillment of that requirement...observation and a statement. 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.

ISO 19011:2002 ( I know, it's just a guidance document but it is specifed for use by 3rd part CB's and must be used) contains in part this little piece

6.5.4 Collecting and verifying information
The audit evidence is based on samples of the available information. Therefore there is an element of uncertainty in auditing, and those acting upon the audit conclusions should be aware of this uncertainty.


Auditing is not an exact science and resists quantification mainly because the results of the audit are dependant upon the best judgement of the auditor. The judgement of the auditor is based upon the understanding of the requirement, the evidence presented, the requirements of the auditing organization and the auditors own training, education and experience...in the end many times there are no absolutes when it comes to the findings generated (positive or negative) and the conclusions developed. If the truth were to be acknowledged we are in fact just saying "Here is my opinion supported, by the evidence I found in the sample I used, according the criteria I had to follow".....
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#47
As I stated in post #3 or so, I think something should change in this process.
There is no evidence that the process is not delivering the results. So, why change? Steel had a great example about coffee-making.

Does it make a difference if you pour the water first and add the ground coffee later? No. Now, it does make a difference if you add the ground coffee first and THEN place the filter on top. Where was your filter, Steel?:tg:

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.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#48
No auditing, internal or external, should be based on assumptions.
My assumption was that the auditor had verified there was such a requirement, and that it was not being met. The questions then would be:

1) Who, and how many were not meeting the requirement, and

2) Why the requirement is important.
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#49
My assuption was that the auditor had verified there was such a requirement, and that it was not being met.
I rest my case. You made an assumption, without anything in the original post to support that. If we are free to make assumptions, I can lead this scenario anywhere. Now, in the real world of auditing, one must ask appropriate questions to the right people before reaching a conclusion.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#50
I rest my case. You made an assumption, without anything in the original post to support that. If we are free to make assumptions, I can lead this scenario anywhere. Now, in the real world of auditing, one must ask appropriate questions to the right people before reaching a conclusion.
Oh I see what you mean. Well, my bad. I was trying to respond to the two scenario paths in a context, which would raise a potential of offering bad advice. I hope that does not turn out to be the case. It's always a risk here.
 
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