Engineering SOPs

Jen Kirley

Quality and Auditing Expert
Leader
Admin
By engineering standards, do you mean design of product and/or service? If yes, they are absolutely a part of the QMS. They have their very own section... more than one if we include process realization.

I once internally audited the IT Manager who, during our discussion noted he (IT) was not part of the quality management system. Aghast, I breathed, "Are you joking? You are the nervous system of the QMS!"

So you have a heavy lift in store for you, first of all to impress upon them that they all belong in the QMS. The 45 employees are among the interested parties referred in Section 4. That by itself will give them some room for pause, as it has felt one-way for many generations.

The ISO 9001 structure is little more than a business plan template. Maybe it would help if you point that out, but you would need to convince them that yes, they are important members of the system. It depends on them - even the janitor, if it is important to have a clean and well-stocked bathrooms for customers who might visit.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Now as for the documents: Unless you are trying to be something like NASA, document control does not require burdensome, complex, bureaucratic processes in order to be effective. But we should ask ourselves, how effective are we if we don't have the right information when and where we need it? It is worth paying attention to, but I want to again stress that unless your interested parties require specific types of controls, you need not be confined to a complicated document control system.
 

Golfman25

Trusted Information Resource
I think that is part of the problem. They see the QMS as Quality only....not the whole business structure. So they exclude the Engineering standards because they are not part of quality. They got the certification because it was suggested they do so by their customers (many government), and they got an auditor who was their buddy and passed their audits for them. Now, we are getting new auditors, and are getting dinged for things in the audits. So I guess my biggest problem is trying to make them understand the difference between Management system and ISO.
My advice. Take the ISO standard into your owner, boss or whomever is in charge. Then take a Black Marker and cross out the word "Quality" in front of managements systems. Obnoxious, sure, but it will get the point across. Then go thru your entire system and cross out the word "quality." You guys are getting too stuck on "quality" vs everything else.

The problem you're seeing is that "quality" has been re-defined with these standards (right or wrong). Old folks still think of checking parts when they hear quality.
 

Randy

Super Moderator
So I guess my biggest problem
The biggest problem's are, based on your input here, that the certificate is a joke, the certificate has had no real no value beyond being a checked block, there have been questionable ethical issues on both sides, and the auditors involved were a shame and disgrace to the profession.

make them understand the difference between Management system and ISO.
You can't make anyone do anything they choose not to do, it's easier to make a dog go "moo".
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
My advice. Take the ISO standard into your owner, boss or whomever is in charge. Then take a Black Marker and cross out the word "Quality" in front of managements systems. Obnoxious, sure, but it will get the point across. Then go thru your entire system and cross out the word "quality." You guys are getting too stuck on "quality" vs everything else.

The problem you're seeing is that "quality" has been re-defined with these standards (right or wrong). Old folks still think of checking parts when they hear quality.
This is excellent advice in my view. Maybe it's obnoxious, but 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:
 

Mike S.

Happy to be Alive
Trusted Information Resource
They got the certification because it was suggested they do so by their customers (many government), and they got an auditor who was their buddy and passed their audits for them. Now, we are getting new auditors, and are getting dinged for things in the audits.
Ahhh....this is what I was afraid of. In your original post when I saw "I believe that in the past for audits, they were just not mentioned" I had a sinking feeling. I've seen all this before.

Hopefully those "new auditors" have some morals and ethics. But be careful.....it sounds like you have some folks in Management who are morally questionable. CYA, always.
 

Randy

Super Moderator
Shucks, and this has come up before and many years back in "The Cove".......... We (those of us here) can create an "AB", then create a "CB" through which we could issue certificates after meeting our "Accredited CB" requirements. Based on the conversation value would be close to the same and maybe less expensive.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Implementing a QMS is a strategic business decision. Executives see targets like Revenue/Cost of Goods Sold. Quality has a tremendous impact on the Cost of Goods Sold which should then drive revenue. Quality-driven objectives are still business objectives.
 

Golfman25

Trusted Information Resource
Ahhh....this is what I was afraid of. In your original post when I saw "I believe that in the past for audits, they were just not mentioned" I had a sinking feeling. I've seen all this before.

Hopefully those "new auditors" have some morals and ethics. But be careful.....it sounds like you have some folks in Management who are morally questionable. CYA, always.
Where is it required in the ISO standard that a SOP has to be mentioned? The standard requires only a handful of documented procedures. Assuming those are in place, I can work my way thru an audit describing what we do and how we do it without mentioning or showing an actual SOP, can I not? I have a whole book full of SOPs and very rarely are they referenced by auditors these days.

I'll just give a simple example. We have a file which contains bill of material info for a part. That info is put into our ERP system and printed out on the Work Order when one is created. The actual work order is what is used during the audit, not necessary all the info in the file, which is back in the secret room. :)
 
Top Bottom