Engineering SOPs

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
If you create an SOP that says you do 5 jumping jacks after every sale and put it in your QMS, you need to do 5 jumping jacks after every sale.

This is why "Should we control this process?" is an important question. If you have a corporate power point that is doc controlled don't have adulterated versions lying around, etc. We just recently released a customer engagement form and the sales person deleted several fields during the customer discussion. We made it clear to Sales that deleting is not permitted, instead write N/A in that field.
 

Sidney Vianna

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Admin
I remember in the early 90’s auditing a very complex, large organization that was very progressive towards quality management. They had a very elaborate New Product Introduction Manual describing in painfully detailed requirements all the phases and gates required to advance the projects from concept to inputs to layers of verification and validation until product was released for volume production. Does ISO 9001 mention “New Product Introduction ?” No, but obviously it has requirements for product design and development. So, this organization’s own NPI Manual covered a LOT, if not all of 9001’s requirements for product D&D. The degree of conformity to their own (critical) requirements was probably in the low 60%. Guess what? A number of nonconformities were issued and the organization never tried to hide the NPI Manual. They did realize they were being overly ambitious with their own self imposed mandates and toned down a number of mandates. Over time, as the organization and their engineering team matured, they started bringing back some of the requirements on to the fold. Many years later this organization was recognized as a world class benchmark in New Product Introduction processes. And I extracted professional satisfaction from being part of their journey. I think this is an example of how 3rd party audits can assist serious companies in their development and maturity journeys.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
It is true that an organization decides which documented information is needed to be in their system. Not having done so is not in itself any evidence that the documentation is not needed in the management system. It is evidence of a lack of awareness that these persons and their processes are indeed part of the management system.

To make the decision it might help to ask:

1) Who does the activities described in the documents?
2) Who relies on the successful outcomes of the activities in the processes?
3) What happens if new people replace currently (I expect, very knowledgeable) working personnel in that process - how would they learn what to do? What can they reference for their work? I am mindful that many engineers and facilities people are aging out and young people are not coming in with all of the knowledge we have come to depend on.

Controlling documents is not something to be feared if the process is designed to be user friendly and effective.
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
As an external auditor I don't audit SOPs so much as processes. SOPs are part of audit inputs, which makes them part of the audit. But in most cases it is not for me to tell my clients what an SOP should say. Rare exceptions include a clear gap when the standard explicitly requires it, such as what to do if a gage used for final inspection is found out of tolerance during its calibration.

I do, however routinely ask the three questions I listed above when a situation like this becomes apparent.
 

Kronos147

Trusted Information Resource
I think that is part of the problem. They see the QMS as Quality only....not the whole business structure.

...it seems to me this act of redacting the word quality is just an impactful example of Step 1 in Kotter's 8-step change model. :applause:

Perhaps management can clarify how many management systems the organization has?

The way I look at it, there are often two; financial and everything else.

If this is what management says too, then ask, why would we not control the Engineering SOP's the way we control all others? Why have two systems that may be unequal?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
As an external auditor I don't audit SOPs so much as processes. SOPs are part of audit inputs, which makes them part of the audit. But in most cases it is not for me to tell my clients what an SOP should say. Rare exceptions include a clear gap when the standard explicitly requires it, such as what to do if a gage used for final inspection is found out of tolerance during its calibration.

I do, however routinely ask the three questions I listed above when a situation like this becomes apparent.
I will audit SOPs if the audit leads me to them directly. For example, a supplier stated that their engineers would use assigned lab books and after they were filled out they would be retained for future record keeping. QA would store them for some period.

The only reason I came upon this in their Doc Control SOP was from another thread where a calculation was made to determine a specification. That engineer left the company and they failed to keep his lab book so they had no record of why they were using this value.
 

Sidney Vianna

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Admin
As an external auditor I don't audit SOPs so much as processes.
Unless there is a misunderstanding in terminology, I am not sure I follow this. A Standard Operating Procedure -SOP- typically describes how an organization is effecting a process, sub-process or an activity. If a third party auditor does not verify if the organization is following the process as described in the SOP, how is s/he auditing “the process”?
 

Sidney Vianna

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Admin
I audit process first, then compare it to procedure.
From my end, when performing 3rd party audits, I always familiarized myself with any procedure, document media associated with a process, before doing any interviews or observing activities. That way, I could assess if the requirements the organization self imposed onto themselves were being followed.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
In a perfect world I would do the same. But I find my power of recollection imperfect, so reading procedures ahead of time would not add value: I would not remember all of what it said. And so, I review the process first and then compare it to the SOP if I get a sense of an issue and pursue it.
 
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