API Q1 Quality Manual Example - Trying to convert an existing ISO 9001 QMS

R

RosieA

#11
Re: Seeking an API Q1 Quality Manual Example - Trying to convert an existing ISO 9000

Hey Cool,
I'm happy to know that the info helped! That's what the Cove is all about.

In terms of how our documents are structured, we're ISO 9001 certified, and API is ISO 9001 based with a handful of special requirements attached, so we just used the typical ISO doc structure:
Tier 1 = QA Manual with the basic policies stated
Tier 2 = Procedures that start fleshing out the policies, especially those that are cross-departmental in nature
Tier 3 = Work instructions that give the job-specific step-by-step directions on what to do
Tier 4: Forms, Logs, Meeting minutes, etc that provide the objective evidence that you did what you say you were going to.

If you're just starting out and you're a smaller company, you may not need the formal structure I described. Some small companies have a short QA Manual and go right to job specific instructions. And those do not need to be written documents. You can take pictures, do videos, or flow charts, depending on how complicated your work process is. I'd make it simple, as long as you can map each section of Q1 to your procedures, (Q1 actually requires that you do that as a part of getting certified) then you'll be fine.

And don't be afraid to call them and ask questions. I have. They can't tell you how to do things, but they can help you understand how they would view a situation. For example, we have a plant in Mexico that makes some parts for us, and they are Q1 certified also. However, because the design control is handled from the US in my plant, they were stressing over the need to have copies of all our design files. A call to API helped us straighten out the issue without havinf to copy design files, and to the satisfaction of the two different auditors that visit us.

Good luck. Feel free to ask any other questions that arise and I'll do my best to help.
 
Elsmar Forum Sponsor
D

Dr Yan

#12
Re: Seeking an API Q1 Quality Manual Example - Trying to convert an existing ISO 9000

Does anyone has a sample of Quality Manual that satisfies API Spec Q1:2007?
 
Z

zhunanshi

#13
Thanks for RosieA's info. about the convertion from ISO9001 to API Q1. I wonder if our quality manual can pass the review of API according to your templete. Is it further for us to add some details, such as the contents in the procedure documents?
 
R

RosieA

#14
Hi Zhunanshi,
My manual alone will not cover the requirements of Q1. I needed to flesh out the policies in my manual with procedures appropriate to my organization. I was just audited a month ago, and the auditors follow a fairly strict checklist that looks for details not normally covered in the manual alone.

Procedures do not always mean written procedures, as I mentioned in a previous post. A process flow chart, a pictorial procedure, or other visial method of describing a process are good also.
Best,
Rosie
 
V

ValveNerd

#15
My company is applying for a 6D monogram and we need to make a Q1 compliant manual as I'm sure you know.

The confusing part is that we do not do the design and development, but I know I have to address it in my manual and have a statement and control feature for design and development.

What should my 7.3 paragraph look like? Is it the same as in the manual you attached and then my procedures would explain that design is outsourced and that we verify it by the following testing methods: XYZ?

thx for any suggestions,

Nick
 
R

RosieA

#16
Where do your designs come from?

My company has a situation where the design and development are done in my plant, whereas some of the components are made in our Mexico plant. We are not on the same certificate, or the same QA Manual,so I called API and asked for guidance.

Unlike ISO 9001, API does not allow exclusions. They suggested that our Mexico plant write an generic explanation for each step of design control, pretty much parroting back what the Q1 standard said. The emphasis for the Mexico plant was placed on how they took our outputs and incorporated them into their manufacturing process. During the audit they could explain that the other aspects of design and development were done in a different company location, and that the auditor for that facility audits their design files.

The Mexico Quality manual was then accepted by API and the auditor accepted the rationale.

I hope that helps.
 
V

ValveNerd

#18
For the most part we buy the basic design from the foundry, and that was yeeears ago. We will make suggestions and ask for changes based on experience but we don't actually create them, they are incorporated into the drawing and we get a copy to assure the adjustments are as we requested.

The basic valve design hasn't changed much over the years. Besides specifying different wall thickness in different areas, the mechanics are the same as always.
 
Last edited by a moderator:
M

mftexas54

#19
Are you ISO certified? If so, your ISO design control process should cover you for the API audit.

If you're not ISO, I'd suggest you read through the threads on design control in the Cove, as they'll give you some good direction.

Most of our products (chain, clutches, bearings) are decades old designs that were grandfathered in. We don't do a lot of new designs, but do a lot of variations to existing designs. The change process is really more useful and effective for us than a full blown design process. Every company is different...

A wellhead and components fabrication shop with a ISO 9000 cert is implementing Q1 with the intention of obtaining the approval to monogram to API 6A, the ISO cert was obtained locally (third world) and their system did not address design or review, how is design and review handled? The fabrication is basically to 6A but much is outsourced such as castings, forgings and valves. NEED HELP.
 
V

ValveNerd

#20
I am in the same boat in regards to the design and development. According to Q1 you must have procedures to deal with design, even if you don't perform it in house. That;s what I want to find out how to address. The sample manual API supplies has 7.3 copy in it, but I don't know if I can use the same verbage if I'm not doing the design. All I know is it needs to be addressed that "I dont do design but here's how I control it".
 
Thread starter Similar threads Forum Replies Date
H Updating Quality Manual to API Q1 Service Industry Specific Topics 6
F Quality Manual Updates - ISO 9001:2015 and API Q1 9th Editition Quality Management System (QMS) Manuals 14
S What is the difference between an API Q1 and API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 5
S Sample Quality Manual which complies with API Spec Q1 Ninth Edition Oil and Gas Industry Standards and Regulations 17
V API Q1 Quality Manual / ISO 29001 - 7.3 - The need for "Control Features" Oil and Gas Industry Standards and Regulations 29
D API 5CT Compliant Quality Plan for Manufacturing Manufacturing and Related Processes 0
J Add API Q1 & Q2 to Quality Management System Standards Oil and Gas Industry Standards and Regulations 1
K Quality Asssurance in an API Manufacturer Manufacturing and Related Processes 1
I Contingency Plan that meets requirements of API Q1 Quality Management System Other ISO and International Standards and European Regulations 3
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
U API License Agreements Oil and Gas Industry Standards and Regulations 2
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
R American Petroleum Institute - Becoming an API Auditor Professional Certifications and Degrees 2
B There is an estimated date of release of API Q1 10th edition? Oil and Gas Industry Standards and Regulations 8
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
lanley liao How to keep the manufacturing capability under the API monogram Oil and Gas Industry Standards and Regulations 6
lanley liao How to understand this bulleted list from API 600 Oil and Gas Industry Standards and Regulations 0
lanley liao The validity of API Spec Q1 certificate Oil and Gas Industry Standards and Regulations 2
R [ASK] API Q1 Ninth Edition, Section 5.4.5 Oil and Gas Industry Standards and Regulations 4
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
S API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
S API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 10
S API spec Q1 9th edition - Castings & Forgings Oil and Gas Industry Standards and Regulations 4
N API spec Q1 9th edition Oil and Gas Industry Standards and Regulations 2
lanley liao How to understand the term 3.1.21 'Servicing' and the clause 5.7.1.2 'Servicing' of API Spec Q1? Oil and Gas Industry Standards and Regulations 19
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
F Who can sit in/perform an API audit? Oil and Gas Industry Standards and Regulations 2
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
M API Spec. Q1, 8th Ed. Section 7.5.2 vs. Q1, 9th Ed. Section 5.7.1.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
A API Spec Q1 9th Edition # Re-audit - Disputing with API AARs Oil and Gas Industry Standards and Regulations 1
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
K Supplier re-evaluation (API Q1) Manufacturing and Related Processes 8
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
S Can we integrate both ISO 9001:2015 and API Q1 Management System Standards Quality Management System (QMS) Manuals 11
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12

Similar threads

Top Bottom