API Q1 9th Edition - My Experiences (A Diary)

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Irshad Khan

#52
Hello Guys,

Transition to 9th Ed is sometimes :frust:
A few days ago I woke up in the middle of the night and I was having a lot of pain in my left wrest; the pain I never had before. And you know what I was a kind of half asleep and I was saying to myself: This is API Q1 pain. This is API Q1 pain.
Believe me or not but this is true!
 
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Dan_Reynolds

#53
Hopefully this will be an easy one to help with. I have recently been tasked with assisting with corrective actions after our stage 1 audit. Apparently we failed to identify our legal and regulatory compliance Per API Q1 9th Edition 4.4.1(e):
"The quality management system documentation shall include: e) identification of legal and other applicable requirements to which the organization claims compliance that are needed to achieve product conformity."
My questions are (1) What format do auditors expect to see this information in (an outline, report, table)? (2) To what extent do we detail the regulatory requirements to which we comply with? That is for example, do I go so far as to say "our manufacturing and shipping departments fully comply with OSHA Standard Number 1910.179: Overhead and gantry cranes." or can I simply say that "my company complies with all OSHA standards that apply to the equipment and operations use at our facilities."?
 
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pjgary

#54
The handout book they give in the class they put on for 9th in North Houston pg 86 4.4.1 e simply says in explanation: "A general statement can be made to send the reader to a tier 2 procedure where legal requirements are identified"

I can tell you that whatever action you choose, they will look over it and tell you if you need to go further. There isn't a wrong answer, and it is perfectly acceptable to ask your API contact for further clarification as to how they need to see that proof and in how much detail. I'd try to be vague as in "we follow all OSHA..." as opposed to specific "we follow CFR 29.42.11" just so you don't have to make revisions every time a spec changes.

I've not got to making quality plan yet, nor revising contract review, but I imagine in both those will be places for "identification of legal and other applicable requirements to which the organization claims compliance that are needed to achieve product conformity." --

so maybe in those two places you list a blanket statement that lists the legal and or other requirements (i.e. API), and in your procedure you state that those requirements, for each job/WO will be listed in that place.
 
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Dan_Reynolds

#56
Thank you pjgary for the information and advice. I did contact our auditor and he stated that you do not need to be that specific regarding the compliance statement. In regards to my example, he said you should specify OSHA 19 CFR 1910, General Industry, but you wouldn't need to go into the specific sections. He went on to say that, ideally, on your risk assessments you would identify the legal and other requirements as part of your controls.
 
#57
I have to agree that simply copying the API SP Q1 document as your own adds no value to an organization, even if this was not so eloquently stated. '
Interaction of processes are different for every organization and cannot be copied. This approach is working for your QMS, not the QMS working for you. In the end, not only is this ineffective, but it's also more work.
 
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pjgary

#58
I think it depends on the size of your company and what is appropriate/adequate for your needs. I work for a machine shop with around 15 employees. All the spec does is tell everyone what they need to do. Our QSM mirros that. As long as it stays 9th edition, the what will not change.

Our QPM - Quality Procedures Manual, is where it is tailored and specific, because that is what says how we carry out the spec. All the resulting documentation and records are simply the evidence or proof that we've fulfilled the spec and all other requirements we define to suit our needs in our procedure.

Maybe because I am limited in experience I do not see the benefit in getting fancy with the QSM. I don't see how it will better serve a company. All companies, big and small, have to follow the same spec. Any additional requirements to the Quality System can be added to your internal procedures, found in the Procedure Manual.

So why, and what benefit is there, in reinventing the spec and adding more to your QSM? When they audit the QSM, they are checking to see it fulfills and meets every requirement of the spec. What better way to do so than to have a QSM that mirrors the spec? Anything more, and you are just adding extra work and something else an auditor can ding you on. I'd rather have a QSM I never have to revise. It's enough work following procedures in the QPM. I'd rather just have to revise procedure than have to change both every time a need changes.
 
#59
Time to give back
See the attached generic procedures, any one can customize for their needs.
Feel free to comment, any feedback greatly welcome!

Share and Spread for the benefit of all.

Thanks
Did you create a procedure for MOC just because? 9th Ed. never states the company shall maintain a documented procedure for MOC. It just states the company shall maintain a process. All I'm doing is creating a template for the MOC Minutes and calling it a day for MOC.
 
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Irshad Khan

#60
Did you create a procedure for MOC just because? 9th Ed. never states the company shall maintain a documented procedure for MOC. It just states the company shall maintain a process. All I'm doing is creating a template for the MOC Minutes and calling it a day for MOC.
:agree:
Our procedure has a built in process. The procedure is simply for training and showing some responsibilities.
 

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