Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

Just looking for feedback and comments of how you would address this issue.


Grego

What are the requirements?

Are the requirements being met?

What is the definition of NC?

ISO 9000:2005

3.6.2
nonconformity
non-fulfilment of a requirement (3.1.2)

3.1.2
requirement
need or expectation that is stated, generally implied or obligatory

NOTE 1 “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5) and other interested parties (3.3.7), that the need or expectation under consideration is implied.

NOTE 2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management
requirement, customer requirement.

NOTE 3 A specified requirement is one that is stated, for example in a document (3.7.2).

NOTE 4 Requirements can be generated by different interested parties (3.3.7).

NOTE 5 This definition differs from that provided in 3.12.1 of ISO/IEC Directives, Part 2:2004.

3.12.1
requirement
expression in the content of a document conveying criteria to be fulfilled if compliance with the document is to be claimed and from which no deviation is permitted

Use the Standard for your answer. When you use the Standard there is nothing left to haggle over. Now as to CA and cause, that is not the auditor's problem.

Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

Just looking for feedback and comments of how you would address this issue.


Grego

Hello Grego:bigwave:

Is the operator correct? Does it matter?

I would be interested in the situation. If the work instruction was written with a sequential order, someone thought it was important and it should be followed. The operator(s) needs to be trained. If it truly does not matter, the procedure should be rewritten (doesn't matter). :2cents:

Added Moderator Note: I revised the title for better applicability to the subject. If it is not correct or needs to be changed, please let me or another moderator know

Added Moderator Note: I revised the title for better applicability to the subject. If it is not correct or needs to be changed, please let me or another auditor know

:topic:

Or another moderator....:notme: ;)

:topic:

Or another moderator....:notme: ;)

:topic:

:lmao:For the love of everything.. please don't let another auditor know. Make them figure it out on their own.:lol:

Ok.... back to the ranch.:)

Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

Just looking for feedback and comments of how you would address this issue.


Grego

Does it improve the results (Time, Costs, etc)? If so, change the documentation, in my opinion.

As an internal auditor, my first question is "does it really matter?". Next, is it potentially a more efficient way of completing the task? Doesn't matter? Change instructions to indicate that. Is it better? Change it.

If it does matter and isn't better - determine if systemic or localized. May be a personnel issue rather than a system issue.

:2cents:

John

Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

Just looking for feedback and comments of how you would address this issue.


Grego

Grego,

Simple approach:

1. Interview other operators.
2. Verify impact of the out-of-sequence operations.
3a. If no impact, no action required.
3b. If impact, write nonconformity report.

Sometimes, in an effort to capture the process/activities, work instructions are written in an unnecessarily complex/detailed manner.

Stijloor.

Look at your first line of your posting. “After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence.” This is the finding of nonconformity identified during the audit. The organization has document in writing the method and sequence for the assembly of the product which the assembler is not following.

The assemblers comment that “It doesn't matter what steps you do as long as it all gets done” is irrelevant. He or she may not be aware that not following the process described in the work instruction may be detrimental to the product which could effect its operation and or pose risk to the user.

I like to give real life examples related to following process instructions an here is one in summary. As the pilot of a DC 10 aircraft is making his take off run down the runway the right engine of his aircraft disengages and falls off the wing shortly after take off requiring him to take emergency actions to save his aircraft and all those onboard.

The investigation identifies that even though McDonnell Douglass, the manufacture of the aircraft, has a written instruction for removing and install engines on this aircraft it was identified that the operator removing and installing the engine did not follow the describe method and used a forklift, not the required engine lift, to lower and raise the engine when a new right engine was being installed resulting in undetected damage to the bolts holding the engine on the wing. The operator (I am using your operator’s statement here) stated that “It doesn't matter what steps or method you do as long as it all gets done”.

Is it important to follow the assembly instructions? You bet it is because in this real example from late 1970’s to early 1980 the operator’s actions of not following the work instructions damages the product (the aircraft) and put real people in danger.

Just to throw in my :2cents::

Sometimes we manage to micromanage/overdocument by requiring that tasks need to be performed in a certain step by step order when in reality, as long as all the taks are performed there is no impact to the process.

If you have steps that need to be done in a certain order, write up the documentation to show that. If it makes no difference, just say to perform those tasks.

ex:
(and yes I know that there should be more info, it is only an example)

Add water and coffee grounds to the coffee maker before turning the pot on.
vs.

Add water
Add Coffee grounds
turn on the pot.OK, it is a lame example, but I'm just taking a quick break from an audit.:lmao:

We had this same thing happen at my plant.... the result was that we had to scrap a $50,000 part. Our sequencing really does matter for the majority of our material.

Grego,

Simple approach:

1. Interview other operators.
2. Verify impact of the out-of-sequence operations.
3a. If no impact, no action required.
3b. If impact, write nonconformity report.

Sometimes, in an effort to capture the process/activities, work instructions are written in an unnecessarily complex/detailed manner.

Stijloor.

I agree except for 3a, maybe--if there's an assumption that the steps should be followed in order and order isn't an issue, the action should be to change the WI to indicate that the order of 5 and 6 isn't important, making sure to indicate also that order is significant for the other steps (if it is).

I agree except for 3a, maybe--if there's an assumption that the steps should be followed in order and order isn't an issue, the action should be to change the WI to indicate that the order of 5 and 6 isn't important, making sure to indicate also that order is significant for the other steps (if it is).

You know Jim, I thought about that too, but then, if the training provided is truly effective, the assemblers should be able to explain that. But yes, confusion, ambiguity must be avoided.

Stijloor.

We received a minor nc during a recent continuing assessment audit that reads, "Requirements defined within a procedure not being followed". ISO 13485:2003 8.3 was referenced.

It never ceases to amaze me how something can be clearly defined in simple language and then subjected to debate.

1. Was something required? Yes

Was it done as required? No

When something is required and it is not done it's an NC. It is very simple.

It never ceases to amaze me how something can be clearly defined in simple language and then subjected to debate.

1. Was something required? Yes

Was it done as required? No

When something is required and it is not done it's an NC. It is very simple.


If it was always that easy...:frust:

Stijloor.

It is for me...

What are you supposed to do?

Did you do it?

You didn't!

Nonfulfillment of requirement

Kinda like a lady being pregnant, either she is or she isn't. There ain't no half-way or almost.

(No offense ladies)

Nonfulfillment of requirementWhat requirement is being violated in this scenario, according to the OP question?

Why do we try to dance around the obvious and say that even though a special work instruction was written to control a process it does not matter that the operator was not following the process?

Have you ever tried to do this dance with an assessor? Try saying to the assessor that you understand that a written procedure is required by the corrective action requirements in ISO 9001:2000 but your organization does not have this written procedure and it really doesn’t matter because you’re doing everything else required by Clause 8.5.2.

Why do we try to dance around the obvious and say that even though a special work instruction was written to control a process it does not matter that the operator was not following the process?

Have you ever tried to do this dance with an assessor? Try saying to the assessor that you understand that a written procedure is required by the corrective action requirements in ISO 9001:2000 but your organization does not have this written procedure and it really doesn’t matter because you’re doing everything else required by Clause 8.5.2.

What we don't know: it could be that rather than representing a required sequence of actions, the steps in the WI in question are numbered because of a needless requirement to number steps in work instructions. If the sequence of steps is important, the importance should be explicitly explained in the WI. If the need for sequential operations isn't explicitly stated, there might not be a good reason to believe it's important.

It is for me...

What are you supposed to do?

Did you do it?

You didn't!

Nonfulfillment of requirement

Kinda like a lady being pregnant, either she is or she isn't. There ain't no half-way or almost.

(No offense ladies)

Assuming that there's an actual requirement. In order for this scenario to be considered a nonconformity, we would have to know that the operator knew that sequence was important, or that the WI specifically stated that the sequence must be followed in all cases. As I just responded to someone else, the fact that steps are numbered in a WI doesn't necessarily have anything to do with a required sequence.

What are you supposed to do? Make sure that there's actually a requirement before confidently identifying non-fulfillment. Ladies who think they might be pregnant should make sure before they start buying baby clothes.

What requirement is being violated in this scenario, according to the OP question?


The requirement was to follow a sequence 1-2-3-4-5-6 and the observed person did it 1-2-3-4-6-5. It doesn't matter why the sequence was specified or even the initial outcome of not following it, the sequence requirement had been determined for some reason and was to followed and it wasn't.

Common sense says to look at all the where to's and what for's and this's and that's, but in the end a requirment wasn't met and correction, be it re-defining the sequence or re-instructing the employee has to be performed.

What's the difference between heating a material to 700C for 20 minutes and letting it cool for 1 hour and then re-heating to 500C for 60 minutes and letting it cool for 2 hours or heating the same material to 500C for 20 minutes and letting it cool for 1 hour and then re-heating to 700C for 60 minutes and letting it cool for 2 hours ? Maybe nothing, maybe everything, that's not my call as an auditor.

In order for this scenario to be considered a nonconformity, we would have to know that the operator knew that sequence was important, or that the WI specifically stated that the sequence must be followed in all cases. Then there may be a competence or awareness issue here and that could be another NC

The requirement was to follow a sequence 1-2-3-4-5-6 and the observed person did it 1-2-3-4-6-5. It doesn't matter why the sequence was specified or even the initial outcome of not following it, the sequence requirement had been determined for some reason and was to followed and it wasn't.Sorry, but nowhere in the OP post there was a mention that the sequence is to be followed and out of sequence assembly is prohibited. You, as an auditor, would be making a mistake, by assuming that the assembly could not be performed out of sequence, until you ask the question to the appropriate individuals.

What an auditor should do, in this circumstance, is to identify the process owner/someone in charge of the assembly process and enquire if the sequence of steps can be altered. Chances are, some steps might have to be done in a very specific sequence and others can be altered. I would then ask if steps 5 and 6 could be reversed. I would ask the process owner if the operators are given latitude to change the sequence of assembly steps. Only after a number of questions were asked and answers provided, me, as an auditor could determine if the out of sequence assembly is a problem or not.

Sometimes operators deviate from an established procedure because they found a better way, which increases productivity. What, then becomes the best practice, to be disseminated.

The finding as described in the original post could be a noteworthy effort and not a non-conformity.

Sid you need to come east and get out of that LA Basin smog...;) look at the scenario again....

Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

The auditor reviewed the instructions and the instructions stated "...5-6". The employee was observed doing "6-5" When asked he said "it doesn't matter..." Thereby acknowledging that he knows what the correct sequence is and is willfully not following written instructions.

The why's and wherefor's don't matter, what was required ain't happening, The why's and wherefor's are related to something else that this NC may have opened a trail for.

Gentlemen :truce:: Each person has their way on how the may perform an audit and document what they may think is a NC or not. Looking at the OP:

Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

Just looking for feedback and comments of how you would address this issue.


Grego


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.

The auditor reviewed the instructions and the instructions stated "...5-6". The employee was observed doing "6-5" When asked he said "it doesn't matter..." Thereby acknowledging that he knows what the correct sequence is and is willfully not following written instructions.
No, he's only expressing his view that the sequence isn't important. There's nothing in evidence at this point that indicates (A) that the operator knew he was required to do #5 before #6; (B) that the auditor knew, and (C) that the sequence actually is important.

The why's and wherefor's don't matter, what was required ain't happening, The why's and wherefor's are related to something else that this NC may have opened a trail for.
You don't know what what was required, and even if the OP were to come back and tell us that the operator did know, it wouldn't change the fact that you've made a call on this one without the necessary information.

Dear All,
My modest opinionis that sometimes is better to "detail more than less". If I were an auditor, I would request an improvement in the WI. If the sequence doesn´t matter, why not to write that the steps can be followed in any order? Or, if the numbered sequence means that the sequence must be followed, why not to emphasize it? A new employee could have the same question and the WI does not clarify it.

Regards!

:bigwave:

No, he's only expressing his view that the sequence isn't important.

If it isn't important than the sequence needs to be adjusted to incorporate the way it is.

The OP stated: It doesn't matter what steps you do as long as it all gets done

Emphasis added in (bold) Which would make me think that as long as the product gets out the door, it doesn't matter how I do it.

Is this a good thought pattern? Does it show consistency in the process?

In my opinion, it shows me that this person and/or management only care about numbers, not how things should be performed to meet the needs of the customer or the company (high risk factor).

If it isn't important than the sequence needs to be adjusted to incorporate the way it is.
But we don't know that the numbers even represent a sequence. Like I said earlier, there might be a higher-level requirement to number the steps in work instructions, regardless of sequence.

...Which would make me think that as long as the product gets out the door, it doesn't matter how I do it.
Why would you think that instead of, "As long as I make a quality product in the time allotted, it doesn't matter whether I do #6 before #5"?

Is this a good thought pattern? Does it show consistency in the process?
I'm a strong proponent of standardization but it can be taken too far. Why show consistency in the process that's not necessary?

In my opinion, it shows me that this person and/or management only care about numbers, not how things should be performed to meet the needs of the customer or the company (high risk factor).
That's a pretty big assumption given the available information.

But we don't know that the numbers even represent a sequence. Like I said earlier, there might be a higher-level requirement to number the steps in work instructions, regardless of sequence.

I agree. But, change the requirement, if necessary, to reflect the proper sequence of steps.

Why would you think that instead of, "As long as I make a quality product in the time allotted, it doesn't matter whether I do #6 before #5"?

I guess you call that my suspicious inclination, since I have heard that before.

I'm a strong proponent of standardization but it can be taken too far. Why show consistency in the process that's not necessary?

Wouldn't the assembly process want to be consistent (made the same all of the time)?


That's a pretty big assumption given the available information.

There goes my suspicious inclination, think about the worse case scenario.

I for one am amazed, that some of you posters having been implementors and assessors for a long time and no one seems to think that looking at the result of the process is even close to be worth mentioning.

Frankly, I think it's shameful that a non-conformity would be written for not following the sequence and only going by what the operators says. What ever happened to doing a process audit and following the thing through to the final product or even just to the next activity, or even the data from the inspections, tests, complaints and so forth to see what the results show!

Pardon my diatribe, and it's not personal, but these posts are, in the main, a very frustrating set of comments carefully avoiding the issue that makes a difference!

No wonder that management treat Quality Systems like a dead racoon, when we speak of the content of WI's and whether following them to the 't' is a non-conformance and quote the standard and vocabulary. Please, please let's make a change here and go and determine if there's anything, anything at all that looks like some money could be saved, a customer could be pleased or a regulation complied with to keep us from a fine/jail! Thanks to those who mentioned these points!

O.K - steam valve shut........

The auditor reviewed the instructions and the instructions stated "...5-6". The employee was observed doing "6-5" When asked he said "it doesn't matter..." Thereby acknowledging that he knows what the correct sequence is and is willfully not following written instructions.

The why's and wherefor's don't matter, what was required ain't happening, The why's and wherefor's are related to something else that this NC may have opened a trail for.Just like you, I also teach auditor training classes. And one of the points I emphasize is: if you are going to write up a finding as a non-conformity, make sure you have evidence of a violation and a requirement. Very likely, in the scenario described, the operator performing the assembly does not even have to read the work instruction. It might very well be that the sequence of the tasks is critical and must be followed religiously. Or, it might not be critical at all. With the information at hand, any auditor jumping to a conclusion that the described situation represents a non-conformity is making an assumption. Which is against established audit protocols. The only sensible thing to do in this scenario is to ask appropriate questions to the right individuals, before reaching any conclusion. That is audit 101.

Just like you, I also teach auditor training classes. And one of the points I emphasize is: if you are going to write up a finding as a non-conformity, make sure you have evidence of a violation and a requirement. Very likely, in the scenario described, the operator performing the assembly does not even have to read the work instruction. It might very well be that the sequence of the tasks is critical and must be followed religiously. Or, it might not be critical at all. With the information at hand, any auditor jumping to a conclusion that the described situation represents a non-conformity is making an assumption. Which is against established audit protocols. The only sensible thing to do in this scenario is to ask appropriate questions to the right individuals, before reaching any conclusion. That is audit 101.

I agree. And if I were to find that the process owner did feel that it mattered, I would write it under 7.5.1, control of production.

I agree. But, change the requirement, if necessary, to reflect the proper sequence of steps.


Wouldn't the assembly process want to be consistent (made the same all of the time)?




Maybe. AndyN and Sidney have it right. Sometimes sequence matters, it may not. It would merely be an audit trail at this moment, and an auditor must go further to determine whether there is an issue. If there is truly a issue that matters, then write and NC. There is no need to ask for a rewrite of procedure.

I for one am amazed, that some of you posters having been implementors and assessors for a long time and no one seems to think that looking at the result of the process is even close to be worth mentioning.



Just to reiterate that several of the posts have said "if the process is not affected" or similar. That means that people do realize that the situation needs to be analyzed. Generalization can be a dangerous thing.

Just to reiterate that several of the posts have said "if the process is not affected" or similar. That means that people do realize that the situation needs to be analyzed. Generalization can be a dangerous thing.

Yes, Steel. I have not made clear my sub-gouping of the population of 'some posters' and it was to those people I was referring, not to the population who had indicated the 'process is not affected'.

My bad - :notme:;)

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.

1) There are industries and places where assembling in precise sequence really is important. In such a circumstance the behavior needs to be addressed--what's left is the question of effective approach to changing behavior.

2) In other industries or applications, the sequence of steps may not matter as much--but the operator's skill may determine if the outcome is optimum because very often there is a preferred way of performing a task.

Both examples are nonconformances. What differs is the accepted response. In a case of #1 the response should recognize the level of risk (see my little paper on risk based auditing (http://elsmar.com/Forums/showthread.php?t=20536&highlight=risk+based+auditing)) and address it as such.

In example #2, the risk may be so low that the lesson for management is to simplify procedures, while monitoring the good craftsmanship of well trained and caring employees.

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. My approach would only differ in that I would treat that incident as a potential systemic learning opportunity. I would pay attention to it in further audits and see if reoccurrences indicate a new approach to defining procedures is needed.
:2cents:

Interesting post, Jennifer!, Thanks.

It has prompted a thought that the 'adequacy' of the documented work instruction may be in doubt too. It's often easier to focus on the grading of the non-conformity etc., and over look what might be causing this.

If the sequence is important, shouldn't the work instruction make it very clear? In many production environments each step can be given a symbol to show if it's a safety, quality etc. affecting activity.

So, my vote is that the auditor should also have taken a look at the importance of the sequence and whether the documentation supported the communication of that.

Of course another key, crucial issue is 'shouldn't the auditor know the importance of the sequence?'...............

...

Of course another key, crucial issue is 'shouldn't the auditor know the importance of the sequence?'...............


No, not necessarily...I might have some sense of whether sequence is important, but it is not my process. My impressions would lead to an audit trail. I still have to verify it, even if I am "certain."

I suppose in some cases it would be inherently obvious - a beer bottling process must place the bottle in place before filling it with liquid...:notme:

Excellent points!

It has prompted a thought that the 'adequacy' of the documented work instruction may be in doubt too. It's often easier to focus on the grading of the non-conformity etc., and over look what might be causing this.

This is so important. This is what happens when someone who is not doing the work developes all the working documents. Somebody says "we do this, that and the other thing" and a document is developed saying to do 1, 2 and 3. No time is spent analyzing the process to see if a) steps need to be followed in any sequence, b) if the process would be better managed doing "that, the other thing, and then this"

If the sequence is important, shouldn't the work instruction make it very clear? In many production environments each step can be given a symbol to show if it's a safety, quality etc. affecting activity.

(see also the comment above about personnel not performing the work developing the documents) Somebody says "we do this, that and the other thing" and a document is developed saying to do 1, 2 and 3. No time is spent analyzing the process to see if a) steps need to be followed in any sequence, b) if the process would be better managed doing "that, the other thing, and then this"

[quote=AndyN;245195]So, my vote is that the auditor should also have taken a look at the importance of the sequence and whether the documentation supported the communication of that.

Exactly! this is what the audit trail is all about. Never take the first answer that makes it look like a nonconformance, follow up and try to see where the problem is being perpetuated.

Of course another key, crucial issue is 'shouldn't the auditor know the importance of the sequence?'...............

Not necessarily. I cannot run the EAF, but I certainly should be able to ask the right questions to lead me to some sort of conclusion as to whether the guy doing it knows what he is all about.

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?

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.

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.

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.

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.

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".....

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.

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.

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.

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.

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"

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:

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.

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?

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.

What is your point? If you believe this is an NC, what is the requirement being violated?

See my previous post:

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.

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?

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.

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?

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.

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?

Please do Randy.

AS9100/ISO9001:2000 Paragraphs 4.2.3, 4.2.1, 5.1, 5.2, 5.3 (b), 5.5.1, 6.2.1, 6.2.2, 6.4, 7.1, 7.2.1, 7.2.2 (c), 7.3.1 (b), 7.5.1 (k), 7.5.1.1, 7.5.1.2, on and on.

......shall I go on?I don't think you need to go on. This thread exemplifies how some of us perform, when conducting audits. How we differ in our approaches to add value. Let the readers be the judges of what approach they believe is a better one.

I don't think you need to go on. This thread exemplifies how some of us perform, when conducting audits.

Then some of us would be incorrect in that blanket assumption.....

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"


This post is like the 3 blind men describing an elephant - one holding the tail, the trunk, and the leg. Each one is describing soemthing different, so it sounds like we are not agreeing.

Randy, you know we are not careless in audits. Procedures must be followed. If the procedures specifies a sequence - then it must be followed, or it is an NC.

Other procedures just show the steps, but the writer applied a numbering convention. Maybe a bit clumsy, but not an NC. Ex: Pour a cup of coffee, add sugar, add milk. can be done in any order, just get it done. Surely, we would not write an NC? Remember, a process does not have to be documented, tribal knowledge is permitted in ISO, as long as it is well known.

Coury, maybe an OFI to tidy up the procedure a bit, but ISO might not even have required a procedure in the first place. They are not obligated to take the numbers out. If it's really unclear, I'd recommend it.

For auditors, these should be audit trails. We should look at it, evaluate the risk, determine if the documentation is a problem, and move on. The funny thing, it would take Randy and I far less time to audit this activity, than it took to discuss it all day long...

It's a beautiful day here in Ohio, y'all go outside and enjoy the sunshine! :)

Ex: Pour a cup of coffee, add sugar, add milk. can be done in any order, just get it done.

There is one important step/sequence missing in this example: What about getting the cup/Mug first :biglaugh::biglaugh:

Overall, you have valid justification on your response, and I most likely would identify it as an OFI vs NC, as long as the sequential steps are not critical to the product's integrity, and customer's expectations.

There is one important step/sequence missing in this example: What about getting the cup/Mug first :biglaugh::biglaugh:

Overall, you have valid justification on your response, and I most likely would identify it as an OFI vs NC, as long as the sequential steps are not critical to the product's integrity, and customer's expectations.


...hmmm...since it is late afternoon, on a lovely day...I'll leave it with this:

If the individual has to be TOLD to get a mug first...ummm, he needs more than coffee... Have a good weekend!

Have a good weekend!

Weekend!:cool:

Been fun...Next stop Boston...........

Thanks for the prompt, Sidney, it looks like I've missed an interesting discussion! A couple of days holiday before a trip to Dubai.

I voted for further investigation but with the proviso that I'm posting here .... as many people have said we need to understand if sequence is important before we decide if a nonconformity (worth writing) exists.

BUT ... even if sequence is not important an observation exists because somebody has written a poor work instruction. If sequence is not important then why do you need a work instruction?

BUT ... even if sequence is not important an observation exists because somebody has written a poor work instruction. If sequence is not important then why do you need a work instruction?

Suppose there's an operation that requires the use of three gages, and all three must be calibrated prior to use. The WI might say something like, Prior to assembling product x, the following gages must be available and calibrated:
Gage A [Description]
Gage B [Description]
Gage C [Description]There's no reason to assume that Gage A must be retrieved and calibrated before Gage B.

As for sequence being a prerequisite for a WI, A WI for PPAP (for example), might list all of the necessary elements that must be assembled, but there probably won't be a required sequence of retrieving them, even though in "real time" some elements will be available before others. It doesn't make any difference if you fill out the warrant form in the beginning or in the end so long as it gets filled out prior to submitting the package. Given enough time, I could probably give dozens of examples of work instructions that show a list of things to be done where sequence isn't important for at least some of them.

The point is that if sequential operation is important, the WI should say so.

Suppose there's an operation that requires the use of three gages, and all three must be calibrated prior to use. The WI might say something like, There's no reason to assume that Gage A must be retrieved and calibrated before Gage B.

As for sequence being a prerequisite for a WI, A WI for PPAP (for example), might list all of the necessary elements that must be assembled, but there probably won't be a required sequence of retrieving them, even though in "real time" some elements will be available before others. It doesn't make any difference if you fill out the warrant form in the beginning or in the end so long as it gets filled out prior to submitting the package. Given enough time, I could probably give dozens of examples of work instructions that show a list of things to be done where sequence isn't important for at least some of them.

The point is that if sequential operation is important, the WI should say so.

It was the sequence for the assembly of something, not the calibration of seperate instruments...apples and oranges

Have you never built anything later to find out ...oops?

You work around helicopters, explosives or anything else that could have lives involved you'll understand the importance of following instructions as written....there ain't no re-work when you fall from the sky...been there, done that!

Whoever started the "Poll" needs to get the wording correct.... "Finding" is the evaluation of evidence against the criteria and can be positive, negative or some other agreed to and accepted term like OFI.

It was the sequence for the assembly of something, not the calibration of seperate instruments...apples and oranges
You still don't know whether sequence was important for the two steps in question, or if the process designer considered them important, yet you keep digging the same hole. If a person has assembled thousands of these things, sometimes doing 5 then 6, sometimes vice versa, and has always made "good" assemblies, the type of meddling you're promoting is wasteful.

Have you never built anything later to find out ...oops? Sure--sometimes because of my own bungling, but sometimes it's been because of lousy instructions, where step "C" should have come after step "E."

You work around helicopters, explosives or anything else that could have lives involved you'll understand the importance of following instructions as written....there ain't no re-work when you fall from the sky...been there, done that!
I understand that you must take the context and the product into consideration. I understand that there's a difference between building a bookcase and building a bomb. You apparently don't.

Whoever started the "Poll" needs to get the wording correct.... "Finding" is the evaluation of evidence against the criteria and can be positive, negative or some other agreed to and accepted term like OFI.

I started the poll, and I'm sorry :oif the wording is not up to snuff.

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.

And as stated previously, I encourage changing the wording for more accuracy/clarity.:D

This has been a very lively, and intellectual discussion.:) I have heard discussions on both sides of the issue, and they have been very well presented. I would still like to hear back from our OP on this.:D

You still
I understand that there's a difference between building a bookcase and building a bomb. You apparently don't.

:lmao: Oh, my sides really hurt at this one....

I haven't built too many of the former, but the latter I probably have forgotten more than you have ever read....One of my military specialties so to speak..

Here's a picture of not following the sequence as provided in the applicable procedure/instruction...a case where it wasn't necessary to ask the process owner if the sequence was really important and the "employee said that it didn't matter how it was done" ( I was one of the investigators so there's no heresay...no serious injuries just a lot of "damage"). The job did get done by the way, however the Humvee wasn't quite in the condition the customer desired when it arrived at the planned destination.

The OP gave us all the information available and asked our opinion of it and it alone so based on what we were provided I gave my answer.

:lmao: Oh, my sides really hurt at this one....

I haven't built too many of the former, but the latter I probably have forgotten more than you have ever read....One of my military specialties so to speak..

Here's a picture of not following the sequence as provided in the applicable procedure/instruction...a case where it wasn't necessary to ask the process owner if the sequence was really important and the "employee said that it didn't matter how it was done" ( I was one of the investigators so there's no heresay...no serious injuries just a lot of "damage"). The job did get done by the way, however the Humvee wasn't quite in the condition the customer desired when it arrived at the planned destination.
I'm sure we're all very impressed. You're either missing or avoiding the point, however, which is that you seem to think it appropriate to apply the same level of control to building bombs and building bookcases, or that a sequence of assembly steps is as significant in one as in the other.

I'm sure we're all very impressed. As you should be........:lol:

You're either missing or avoiding the point, however, which is that you seem to think it appropriate to apply the same level of control to building bombs and building bookcases, or that a sequence of assembly steps is as significant in one as in the other. Not necessarily, but a sequence for assembly steps for whatever are written to serve some purpose or reason and not for the sake of entertainment or casual reading. This is where life experience seperates folks. My background in aviation and other endeavors requires me to do the job as written until instructed otherwise. If it says do it 1-2-3 I will do it 1-2-3 and that's the same expectation I have of others when there are clearly defined instructions as the OP stated.

The OP essentially asked us for "our" opinion's and I gave mine...

opinion noun
1. A belief or conclusion held with confidence but not substantiated by positive knowledge or proof:
2. A judgment based on special knowledge and given by an expert:
3. A judgment or estimation of the merit of a person or thing

I've tried to provide some examples and if they are misunderstood, so be it, at least I have some examples to provide besides "he said-she said". Probably part of the misunderstanding or misconception arises from different ways of thinking or a Tunopial existance.

Brad is very correct about this Thread though, but I think we may have lost our OP.

OK, you have my interest. None of the several dictionaries I checked recognizes "Tunopial". What does it mean, or better yet, what did you mean.

This thread is getting derailed.

Lets get back to OP -

Audit scenario...

After reviewing assembly work instructions you find that the operator is performing assembly operation steps #5 & #6 out of sequence. You ask the operator "why would you arbitrarily decide to change work instructions steps" and they respond by saying - "It doesn't matter what steps you do as long as it all gets done."

Just looking for feedback and comments of how you would address this issue.

Grego

:topic:Good question Jim....It's descriptive a word that I created a few years back that is a composite of two words (three actually)

Tunnel vision & Myopia

I commonly use tunopia, or a derivitive, when dealing with FSP's (Functional Specific Professionals) who either lack or have limited vision/understanding/experience and have either been confined or confine themselves "inside the box" and are either unable or unwilling to see beyond their noses and outside of their "area of endeavor". This is quite common when you have folks that have been locked in to one narrow career path for 10, 15, 25, 30 years...they know what goes on in thier "cube" but knowledge of or experience in the next "cube" may be almost non-existant...Safety guys know Safety, HR folks know HR, Quality folks know Quality, but none of them may have the foggiest idea about Finance, Marketing & Sales or even each other beyond bits and pieces picked up over time and therefore they compartmentalize themselves in thought and action and get stuck in mono-dimensional thinking. Going outside of Tunoptic box doesn't happen because of career programming, being locked into prevailing conventional thinking, or just plain old lack of proactive vision. Is Tunopia bad? I dunno, but if it had prevailed we would still be reading by candlelight, using animal driven transportation and N.American would still be dominated by some of my ancestors hunting deer with stone tipped arrows and spears.

I commonly use tunopia, or a derivitive, when dealing with FSP's (Functional Specific Professionals) who either lack or have limited vision/understanding/experience and have either been confined or confine themselves "inside the box" and are either unable or unwilling to see beyond their noses and outside of their "area of endeavor".

This is interesting, because earlier you said:
My background in aviation and other endeavors requires me to do the job as written until instructed otherwise. If it says do it 1-2-3 I will do it 1-2-3 and that's the same expectation I have of others when there are clearly defined instructions as the OP stated.

I understand now. Your own case of "tunopia" prevents you from understanding that the 1-2-3 in a process that might literally blow up if not followed is fundamentally different from something more mundane, where 2-1-3 will work just as well.

I'll leave it at this: in the OP's case, someone needs to find out whether the sequence is important or not. If it's not important, perhaps the WI should be changed. If it is important, some training is required, and someone also needs to look a the overall system of writing work instructions, and create a requirement for explicitly stating that sequence is important, and why it's important. It's altogether possible that while sequence may not seem significant to an isolated operator, it might be later on. In the present case, we just don't have enough information to determine whether an NC is called for or not, but we do know, as a minimum, that the numbering of the steps at least created the impression in the auditor's mind that the operator was supposed to be following a prescribed sequence. We should all know by now though that an auditor's perceptions are wrong sometimes.

:truce::truce: Gentlemen and Ladies:

The OP has asked for opinions on how someone would handle this scenario. We have really gone beyond the original post. If this continues, I will close the thread.

I tried to use quotes in replying to Jim but his use of quotes turned it into a pile of poo, so I'll try from scratch.

IMHO if a particular method of operation is important then a work instruction is required. If it isn't it can be built from a print. So the example of use of gauges in Jim's example doesn't require a work instruction (again IMHO).

Similarly PPAP submission would not warrant a work instruction. The warrant and submission level define what is required and the APQP programme defines when the data are prepared - so why have a WI?

Similarly PPAP submission would not warrant a work instruction. The warrant and submission level define what is required and the APQP programme defines when the data are prepared - so why have a WI?
How does a warrant define anything? Which (of possibly several) forms do you use for material test reports, dimensional reports, etc.? What information must those reports contain (which might be more than that called for in the PPAP manual)? How about the capability report? What format? Where does the data come from? Who signs the warrant and when? I could go on, but I assure you that there are no two companies that do PPAP the same, and if you don't have an work instruction you're asking for trouble.

IMHO if a particular method of operation is important then a work instruction is required. If it isn't it can be built from a print. So the example of use of gauges in Jim's example doesn't require a work instruction (again IMHO).
For purposes of this discussion, it doesn't make any difference if a WI is required or not. Perhaps the WI in question isn't necessary at all, but that doesn't alter the fact that it does exist.

I'm going to opt out at this point. The OP asked for information and opinion and got mine.

TTFN (Ta-Ta-For-Now)

While having good substance, this seems to have evolved into a fairly rough, contentious thread. The needling and off topic information must immediately cease.

Marc

....... and if you don't have an work instruction you're asking for trouble.
A lot of the documents you mentioned are collected at stages of the APQP process and should be called up in APQP procedures for (for example) phase sign off and might reference the forms etc. required (e.g. to produce a capability report). Similarly authority levels (such as for sign off) are procedural activities.

Jim, if you believe PPAP warrants a WI then by all means produce one. I don't believe it gets on the radar.