Procedures, Work Instructions & Documents served as guidelines only!

[tkevmoore]

I'm currently in an AS9100 Lead Auditor training class. One of our exercises involves reviewing a sample manual and verifying it's compliance to Section 4.2.2 (same in ISO as AS). One of the clauses in the sample manual stated:

In our quality system, documented procedures are those procedures that are required by the ISO 9001:2000/AS-9100 standards. Other procedures , work instructions and documents are used for reference, guidelines and training purposes only and are not followed precisely as written

This apparently was based on a real life example and was not non-compliant to the standard. I know my instructor wants us to think out of the box, but it's very hard for me to get past 10 years of ISO auditing to accept that documents don't have to be followed. Someone help me see the light.

Thanks

Tom

 

[Marcelo]

Re: Documents as guidelines

In a process-based management system, what is important are the outputs of each process. Procedures are step-based collection of activities that define how to do something, and, because of past misinterpretations of auditors and users, generally have nothing to do with the output of the process, only with the output of the procedure.

It´s really not that much important how you get to the output needed if you consistently do so. Controls (and they´re generally related with procedures) are only needed if you do not consistently procedure the desired output (this is measured by the way by your process kpi which is related with the process objective, meaning the process output).

 

[Jim Wynne]

Re: Documents as guidelines

I'm currently in an AS9100 Lead Auditor training class. One of our exercises involves reviewing a sample manual and verifying it's compliance to Section 4.2.2 (same in ISO as AS). One of the clauses in the sample manual stated:

In our quality system, documented procedures are those procedures that are required by the ISO 9001:2000/AS-9100 standards. Other procedures , work instructions and documents are used for reference, guidelines and training purposes only and are not followed precisely as written.

This apparently was based on a real life example and was not non-compliant to the standard. I know my instructor wants us to think out of the box, but it's very hard for me to get past 10 years of ISO auditing to accept that documents don't have to be followed. Someone help me see the light.

Thanks

Tom

My only issue with it is that if an auditor were to observe a process being operated "precisely as written," it would be a nonconformity. If it were to say, "...not always followed precisely as written," it would be OK.

 

[Sidney Vianna]

Re: Documents as guidelines

I'm currently in an AS9100 Lead Auditor training class. One of our exercises involves reviewing a sample manual and verifying it's compliance to Section 4.2.2 (same in ISO as AS). One of the clauses in the sample manual stated:



This apparently was based on a real life example and was not non-compliant to the standard. I know my instructor wants us to think out of the box, but it's very hard for me to get past 10 years of ISO auditing to accept that documents don't have to be followed. Someone help me see the light.

Thanks

Tom

Tom, firstly, I would like to commend you for being upfront about your question. Sometimes, people come here asking for help with a situation similar to yours, but they pretend it is something else, rather than some type of training exercise.

The training you are undergoing and the instructor probably have some kind of "expected" answer for the scenario you describe. I don't know the expected answer. However, if this scenario is indeed based on an actual manual, we would have a situation where an organization is trying to preempt possible non-conformities in case an auditor finds a process not following the requirements of these "additional" procedures, work instructions, etc....

It is a silly game. What is the purpose of having "reference documents" if they don't serve the purpose to define the processes and activities?

ISO 9001 4.2.1 d) states

documents needed by the organization to ensure the effective planning, operation and control of its processes, and

emphasis is mine.

So, what you have here is an organization trying to create a preemptive loophole in case they are caught not following their own command media. They can not, in my opinion, state something in the manual that contradicts the standard they are supposed to comply with. A good discussion will ensue, I suspect.

PS. Is your instructor, proponent of out of box thinking, a habitual Cover?

 

[gagegirl]

The company I work for would love to use that in there procedures. They do not currently word it in that way but do it anyway.
But to help with your question.
My company references all customer supplied quality requirements. For example, our largest customer has requirements that cover everything from sampling, to gaging requirements for 3A threads. The problem with this statement, from my own experience at this company, is that some work instructions are required by each and every operator and inspector. How would a company define which are to be "followed precisely as written" and which are not? It may help them pass an audit, but when something goes wrong in the field there is nothing documented as to what was or was not performed during the manufacturing process. Work instructions can be ever changing on the floor but never make it to document control.

As to the comment from mmantunes...It may not be important how you got to a consistently manufactured product until something goes wrong then the first question from engineers and supervisors alike is ... Did you follow the work instructions? Because it is the first step in eliminating factors to get to the root cause.

 

[JaneB]

Re: Documents as guidelines

The training you are undergoing and the instructor probably have some kind of "expected" answer for the scenario you describe. I don't know the expected answer. However, if this scenario is indeed based on an actual manual, we would have a situation where an organization is trying to preempt possible non-conformities in case an auditor finds a process not following the requirements of these "additional" procedures, work instructions, etc....

It is a silly game. What is the purpose of having "reference documents" if they don't serve the purpose to define the processes and activities?

I agree with Sidney. If they're needed, one can state how & when and/or state when they can or should be ignored.

Often this kind of thing occurs when either procedures/documents aren't well structured (eg, procedures are far *too* prescriptive and more detailed than they need to be, or the structure doesn't allow for differences at the detail level) or they're not kept current. Either of which can be - and should be - fixed.

But I do wonder if it's actually the simpler answer, from the wording of the Q itself:

documented procedures are those procedures that are required by the ISO 9001:2000/AS-9100 standards

and if it's just the common old chestnut of 'we only have to have 6 procedures in our quality system because that's all ISO requires'. In which case the response is no, not OK, and the ref. that Sidney gave - ISO 9001 4.2.1 d)

 

[JaneB]

As to the comment from mmantunes...It may not be important how you got to a consistently manufactured product until something goes wrong then the first question from engineers and supervisors alike is ... Did you follow the work instructions? Because it is the first step in eliminating factors to get to the root cause.

Yes, exactly so. You nailed it.

 

[Marcelo]

As to the comment from mmantunes...It may not be important how you got to a consistently manufactured product until something goes wrong then the first question from engineers and supervisors alike is ... Did you follow the work instructions? Because it is the first step in eliminating factors to get to the root cause.

I´m not saying that there should not be procedures, just that the process approach to quality system is not about having 20-plus-steps procedures for everything, when the most important is the process output and not the output of a single procedure. This "procedures for everything" was generally what was done in the past and the main reason for the implementation of the process approach.

So, i don´t see a need for every procedure to be included in the quality system. Only the key procedures, key controls and key indicators. Other documents can, in my opinion, be used just as guidelines and that would be ok. IF a NC happen, then you can see if these guidelines were followed and if not, maybe you need to put some control in the form of a and detalied step which HAS to be followed and put this in your quality system, but not the other way around (creating a web of procedures that no one will follow and consequently putting your system at risk of meeting a bad auditor which still thinks in the "write what you do, do what you write" way).

 

[Russ]

We have just made a change in how we handle these. We use Work instructions for when it needs to be done the same way or it can affect quality. The next tier below that is what we call Standard Work. These are considered the "Best" way to do a task but it can be done other ways without comprimizing quality. Work Instructions are auditable and Standard Work is not.
We just cleared an ISO audit and they had no problem with this approach. It does force you to look at the significance of the document!

 

[Jim Wynne]

Re: Documents as guidelines

So, what you have here is an organization trying to create a preemptive loophole in case they are caught not following their own command media. They can not, in my opinion, state something in the manual that contradicts the standard they are supposed to comply with. A good discussion will ensue, I suspect.

I think you're ascribing motive (trying to create a loophole) without enough evidence of intent. There are times when the best-laid plans go astray, and the documentation doesn't account for unexpected possibilities. To say that production should be delayed (and perhaps customers should be disappointed) while documentation catches up with necessary process changes is short-sighted, imo. Sometimes you have to do things on the fly.