Hello All,
As you can tell by my post numbers, I am new here, so please feel free to re-direct me if I am posting this in the wrong area.

I am currently putting together an API Q1 manual and QMS in place for the company I work for. This is the first time I have done this, but I at least have help from an ISO consultant.
I am wondering if any of you out there are more familiar with API. We have come across some items that need addressing, but getting an answer directly from API is proving difficult.

Let me know if any of you think you can help. I will then post my queries. I don't want to post them now, simply because this may be the wrong place to do it anyhow.

Thanks in advance

I am sorry to say that I cannot actually give you any advice, but somewhere in the future we will be persuing this standard ourselves. I have purchased a copy of the standard and that is about it. Welcome to the Cove, I'm sure we can find someone out there with some familiarity.

You usually have to base it around an API standard specification such as API 6A for wellheads and valves in which you use as a standard for your processes, the Q1 is basically ISO 9001 format.

I work for an API certified company. What type of questions / issues are you wanting or needing help with. As stated above, the system is basically the same, with a few supplemental requirements, and then additional product specific requirements depending on the License.

Here are some existing API Q1 (http://Elsmar.com/Forums/search.php?do=process&titleonly=1&query=api) discussion threads.

<snip>
I am wondering if any of you out there are more familiar with API. We have come across some items that need addressing, but getting an answer directly from API is proving difficult.

Let me know if any of you think you can help. I will then post my queries. I don't want to post them now, simply because this may be the wrong place to do it anyhow.

Thanks in advance

I have a little experience with the Q1 (8th ed.).

Not too much on the technical side (Specs 4F, 7 and 7-1 apply to the QMS I'm working with), but on the QMS side I should be able to provide some help.

Well I am happy to see that some of you have experience with the standard and are willing to help if you can. Here are my queries:

Sorry, maybe wordy, but should at least provide all the details.

Background / Context:
Our company (X) is a management company fully dedicated to Total Tubular Management (TTM) of Oil Country Tubular Goods (OCTG).

(X) offers “cradle to grave” management of OCTG for Offshore Operators, typically being involved from the point of 24 month casing and tubing forecasting for Operators through steps including

-issue request for proposal,
-issue Purchase Order to Mills,
-conduct Pre-Production Meetings,
-Engage in-Mill Third Party Inspection to monitor and release material.

(X) then engages sub-contractors to perform activities including:

-receive and inspect incoming OCTG,
- repair shipping damage on behalf of the Mill,
-store,
-preserve,
-thread,
-buck,
-re-inspect and make rig ready

During implementation of API Q1 Quality Management System, (X) extensive use of approved (and typically API Q1 registered) Subcontractors has raised some interesting areas of interpretation of the standard. (X) therefore requests comments on the validity of the following approaches to ensure compliance with selected sections.
Specifically:

Query #1, section 1.2, Exclusions:
Refer to sections 1.2.1, 4.1, 7.4.1.3 and 7.5.2.

(X) proposes to exclude section 7.5.2.1, Validation of processes for production and service provision, supplemental. (X) notes that section 7.4.1.3, Supplier provided special processes (supplemental), requires that (X) shall require that the supplier comply with section 7.5.2. Logically, if all of the processes are subcontracted, (X) does not require a control feature for the qualification and validation of special processes.

In order to be compliant with section 7.5.2, for which no exclusion is permitted, (X) must address the matter appropriately in other areas, notably purchasing and subcontractor control.

Please comment on the validity of this approach.

Query #2, section 6.4, Work Environment:

As all physical work on the OCTG is conducted by subcontractors, (X) focus for this section is proposed to be on (X) office environment; lighting, work-space ergonomics, computer availability and adequacy etc
“Work environment” in the conventional or “material production” sense is proposed to be addressed in a general sense through such areas as Subcontractor Control (including external audit) and Procurement (including generic clauses in standard contract verbiage).

(X) considers it to be impractical to attempt to control specific details of multiple subcontractors’ work environment. We note that section 7.4.1.3

Please comment on the validity of this approach.

Query #3, (X) role in section 7.4.3, Verification of purchased product.

Essentially, (X) manages and subcontracts quality verifications from the pre-purchase order / pre-production stage through to and including API RP 5A5 inspection of 10% of incoming OCTG and 100% stencil verification of incoming OCTG. These activities are planned by (X) and conducted by others. (X) engages Third Party Inspectors (TPI) to conduct in-mill surveillance in accordance with a quality plan agreed jointly by the Mill, Operator, TPI and (X) . If the operator engages the TPI directly, these goods are effectively released by the Operator but the Mill has agreed not to ship pending (X) endorsement of TPI signoff. It is truly a joint effort, and (X) is the consistently present entity throughout.

It has been suggested to (X) by a client quality professional that it would be appropriate for (X) to limit its QMS reference regarding verification of purchased product to ‘the receiving inspection process as this is the extent of (X)’s verification of purchased product’.

Please comment on the validity of this approach.

Query #4, section 7.5.5.1, Preservation of product –Supplemental

At any time, (X) is responsible for preservation of several thousand joints of OCTG and subcontracts planned API RP 5A5 compliant inspections accordingly. (X) interpretation of the requirement for the control feature is to detail inputs, process and outputs from this planned inspection process. It has been suggested that many other factors come into play, for example storage of OCTG on plastic versus wooden sleepers, non-contact of chrome alloys with carbon steel during handling, use of appropriate thread protectors etc. (X) views these and other such matters (such as effective weed control, non-use of salt for ice control, layout of racks to eliminate bending moments during storage etc) to be specifications and additional requirements and outside the scope of the required control feature.

(X) considers it appropriate to limit the content of the preservation of product control feature to planned preservation activities. This would include

-availability and use of accurate stock information
-timing of material arrival, aging of storage by location
-10% in-situ random sampling of connections on six monthly basis
-Identification of inspection results which would warrant preservation activities to be conducted
-Issuance of work assignments to move / preserve the material
-Reporting of defects, repairs conducted if required, re-storage etc.
Please comment on the validity of this approach.

Query #5, section 7.6, Control of monitoring and measuring devices

(X) subcontracts all physical work performed upon OCTG within our scope and therefore does not directly conduct technical monitoring and measuring activities in the context of this section. No exclusion is permitted, and unlike verification of special processes as discussed in Query #1 above there is no reference regarding reliance upon subcontractors to perform this work.
As (X) does not own or directly control devices which are subject to calibration / verification, we propose to address the requirements of section 7.6, Control of monitoring and measuring devices, similarly to section 7.5.2, Validation of processes for production and service provision.

In order to be compliant with section 7.6, for which no exclusion is permitted, (X) must address the matter appropriately in other areas, notably purchasing and subcontractor control.

Please comment on the validity of this approach.

End of Queries

I'll do this like the way some ppl will eat an elephant - one bite at a time.

I like the way you have clearly identified your queries - I hope my comments will do justice to your organization/layout.

Disclaimer: I have never worked as an Auditor for any Registrar (either for API Q1 or ISO/TS 29001). The comments below are just my opinion. The Registrar (probably API) will have the final say.

<snip>

Query #1, section 1.2, Exclusions:
Refer to sections 1.2.1, 4.1, 7.4.1.3 and 7.5.2.

(X) proposes to exclude section 7.5.2.1, Validation of processes for production and service provision, supplemental. (X) notes that section 7.4.1.3, Supplier provided special processes (supplemental), requires that (X) shall require that the supplier comply with section 7.5.2. Logically, if all of the processes are subcontracted, (X) does not require a control feature for the qualification and validation of special processes.

In order to be compliant with section 7.5.2, for which no exclusion is permitted, (X) must address the matter appropriately in other areas, notably purchasing and subcontractor control.

Please comment on the validity of this approach.

My reading of clause 1.2.1 is that a company is allowed to exclude 7.5.2, if applicable (it refers to the product specs).

The supplemental section 4.1.1 requires the company to be responsible for outsourced processes. Also, the recent changes to the Notes in 4.1 (ISO 9001:2008) have emphasized the fact that if you supply goods/services to a customer, saying "the subcontractor provided poor quality work" does not absolve you of responsibility.

What is a control feature? IMO, it is a way of ensuring that the process(es) are carried out in specific ways, and provide output, which meets (quality and other) requirements.

Summary: If the company does not exclude 7.5.2, it shall have control features in place for validation of "special processes", whether done internally or subcontracted (either the process itself, the validation, or both).


Query #2, section 6.4, Work Environment:

As all physical work on the OCTG is conducted by subcontractors, (X) focus for this section is proposed to be on (X) office environment; lighting, work-space ergonomics, computer availability and adequacy etc
“Work environment” in the conventional or “material production” sense is proposed to be addressed in a general sense through such areas as Subcontractor Control (including external audit) and Procurement (including generic clauses in standard contract verbiage).

(X) considers it to be impractical to attempt to control specific details of multiple subcontractors’ work environment. We note that section 7.4.1.3

Please comment on the validity of this approach.

This sounds ok to me (particularly the external audit part). Let's look at 2 scenarios:

Compliance: I'd suggest including a clause in your standard contract about having subcontractors meet the requirements of 6.4

Beyond compliance: In addition to the above, meet with the subcontractors (their place may be best) and discuss your company's expectations (see ISO 9004:2000 for guidance - 'psychological conditions of work', etc.). Keep records of any meetings/training you have.

Query #3, (X) role in section 7.4.3, Verification of purchased product.

Essentially, (X) manages and subcontracts quality verifications from the pre-purchase order / pre-production stage through to and including API RP 5A5 inspection of 10% of incoming OCTG and 100% stencil verification of incoming OCTG. These activities are planned by (X) and conducted by others. (X) engages Third Party Inspectors (TPI) to conduct in-mill surveillance in accordance with a quality plan agreed jointly by the Mill, Operator, TPI and (X) . If the operator engages the TPI directly, these goods are effectively released by the Operator but the Mill has agreed not to ship pending (X) endorsement of TPI signoff. It is truly a joint effort, and (X) is the consistently present entity throughout.

It has been suggested to (X) by a client quality professional that it would be appropriate for (X) to limit its QMS reference regarding verification of purchased product to ‘the receiving inspection process as this is the extent of (X)’s verification of purchased product’.

Please comment on the validity of this approach.

The current system sounds like an excellent arrangement (I believe in the auditor creed: "In God we trust, all others provide objective evidence") for monitoring in-mill operations.

While I think the suggestion to limit your QMS to 'receiving inspection' (said without knowing the requirements of API RP 5A5) will meet Q1 requirements, there are many reasons why the current system is better.

These include: having advance notice of delayed shipments (due to OCTG quality problems), more control over the upstream process and evidence of working closely with suppliers (ISO/TC176 Quality Principle #8).

Also, when you outsource TPI, your company's sign-off may be regarded as one aspect of a control feature (the Quality Plan is another).

'Receiving inspection' will include any post-mill damage/loss to OCTG.

Query #4, section 7.5.5.1, Preservation of product –Supplemental

At any time, (X) is responsible for preservation of several thousand joints of OCTG and subcontracts planned API RP 5A5 compliant inspections accordingly. (X) interpretation of the requirement for the control feature is to detail inputs, process and outputs from this planned inspection process. It has been suggested that many other factors come into play, for example storage of OCTG on plastic versus wooden sleepers, non-contact of chrome alloys with carbon steel during handling, use of appropriate thread protectors etc. (X) views these and other such matters (such as effective weed control, non-use of salt for ice control, layout of racks to eliminate bending moments during storage etc) to be specifications and additional requirements and outside the scope of the required control feature.

(X) considers it appropriate to limit the content of the preservation of product control feature to planned preservation activities. This would include

-availability and use of accurate stock information
-timing of material arrival, aging of storage by location
-10% in-situ random sampling of connections on six monthly basis
-Identification of inspection results which would warrant preservation activities to be conducted
-Issuance of work assignments to move / preserve the material
-Reporting of defects, repairs conducted if required, re-storage etc.
Please comment on the validity of this approach.

I would much prefer to see the situation for myself to be confident that my answer is suitable to your company's needs, but I'll give you some general advice:

With specific reference to 7.5.5.1, I suggest the company identify all the usual sources of potential/previous nonconformities and say how you would prevent/correct them. You have listed some of them, but the Registrar will have the final say on whether the measures in place are adequate.

In short, some of the principles underlying FMEA (http://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis).

Query #5, section 7.6, Control of monitoring and measuring devices

(X) subcontracts all physical work performed upon OCTG within our scope and therefore does not directly conduct technical monitoring and measuring activities in the context of this section. No exclusion is permitted, and unlike verification of special processes as discussed in Query #1 above there is no reference regarding reliance upon subcontractors to perform this work.
As (X) does not own or directly control devices which are subject to calibration / verification, we propose to address the requirements of section 7.6, Control of monitoring and measuring devices, similarly to section 7.5.2, Validation of processes for production and service provision.

In order to be compliant with section 7.6, for which no exclusion is permitted, (X) must address the matter appropriately in other areas, notably purchasing and subcontractor control.

Please comment on the validity of this approach.

End of Queries

My take on this is that you are outsourcing the measurement (and thus, control of monitoring and measuring equipment).

Hypothetical situation:
(1) Your supplier measures the Inner Diameter of a pipe with an instrument which is out of calibration,
(2) It is part of the 90% not inspected under API RP 5A5 requirements,
(3) For argument sake, it passes through the 'thread' and 'buck' (I don't know what this term means - please explain it) processes,
(4) It arrives at your company's customer (i.e., the rig) and is found to be nonconforming.
(5) Who answers to the customer for the pipe being out of spec due to out-of-calibration measuring equipment ?


Hope this helps.


:cool: With the financial crisis affecting my country I am willing to travel on consulting assignments (are we allowed to advertise blatantly?) - take it as a joke...



Or not :(

Thank you very much for you insight and thoughts "qualitymanager". I really appreciate the fact that you took the time and thought to answer my queries so thoroughly. Thanks again!:D

PS: If I am given the flexibility, I will see what I can do to get you to Newfoundland, Canada where we are located. :agree1: Dress warm!

Query #1,

Purchasing and subcontractor control valid approach

Query #2,

Have the subcontractors control the work environment through their HSE system and validate.

Query #3

Receiving inspection process is good is the mill API 5CT registered?

Query #4,

Protectors, chrome to carbon steel contact are not out of scope, they will deem this a deficiency in your control features.

Query #5,

Just make sure you have access to the traceability of calibrations of the devices the subcontractors are using and that they are within the calibration schedule that is defined, and if it is visual inspections that they have their eyes checked.

We are in the process of submitting application package for Quality Management registration + Api monogram licensing with an objective to achieve
 API Monogram Licensing
 API Spec Q1 and API ISO/TS 29001 Registrations
 ISO 9001 Registration

We are planning to outsource inspection and testing activities to a third party inspection comapany (100% outsourcing)

Part 1 of API Certification programs application quote as below

"During an API facility audit, the
auditor may indicate that the manufacturing and in-process
inspection/test activities for one or all products under a
specification are subcontracted or outsourced. Even though
subcontracting/outsourcing is permitted, the API Monogram
Program is designed to identify locations that have
demonstrated ability to manufacture equipment or
provide services that conform to API Product Specifications
within quality management systems that conform with
the requirements of API Spec Q1, ISO/TS 29001 and/
or ISO 9001. If, through auditing activities and information
provided by the auditor, API determines the degree of
subcontracted/outsourced activities is substantial; API
may perform additional audits (at the Applicant/ Licensed
Organization’s expense) of any primary subcontractor(s)
to ensure compliance with applicable specifications"

What we will be the possible API response to 100% outsourcing of inspection and testing activities...any comment

My quick thoughts - this is definitely an outsourced process under 4.1.1, and you need to carefully consider its impact under clauses 8.2.4, and 7.4.

A couple of questions:

1. Is the subcontractor API Q1 certified?

2. Is your company looking at ISO 9001 certification as a separate issue, or as part of API Q1 certification?

3. Have you considered contacting API directly to find out if they will audit the 3rd party inspection company?

Hi

Pl find the answers as follows

1. No

2. Part of API Q1 Certification

3. Not decided yet

sajeev

My quick thoughts - this is definitely an outsourced process under 4.1.1, and you need to carefully consider its impact under clauses 8.2.4, and 7.4.

A couple of questions:

1. Is the subcontractor API Q1 certified?

2. Is your company looking at ISO 9001 certification as a separate issue, or as part of API Q1 certification?

3. Have you considered contacting API directly to find out if they will audit the 3rd party inspection company?

How does your QMS allow for controlling the inspection body for clauses 8.2.4, and 7.4?

If i properly address this question then i assume there will not be any problem. Do u have any suggestion

sajeev

How does your QMS allow for controlling the inspection body for clauses 8.2.4, and 7.4?

The best way, IMO, is to approach API directly and ask them what they think.

Having addressed those clauses will show them that you already have an idea of how to control the outsourced inspection process.

One way of controlling the 3rd party inspection company is to have them be certified to a standard (e.g. API Q1, ISO/IEC 17025, ISO 9001) or at least be under the guidance of a standard like ISO 17020. You need to be familiar with these standards, and give the basis for selecting the particular one the subcontractor is certified to. Also useful will be a working knowledge of ISO 2859 and its parts (go to www.iso.org and search for any "ISO" standard if you don't know about them).

While API will have the final say, perhaps an API auditor on the forum can give you a better idea of what to look for - I am not, nor have worked as, an auditor for an API Q1 certification audit.

Sajeev

Yes. you can apply for a API Quality Plus program (refer API website) even with 100% outsourcing of inspection and testing process.