Outsourcing & the Control Plan (Ours and the Subcontractor's) - Links, etc.

Q

QMSQE

#1
Hello to ALL :bigwave:

This is my first post to an Elsmar Forum, ever! I have a question... :confused:
My company outsources most of its manufacturing. All of the manufacturing subcontractors are ISO/TS16949:2002 certified, and have their own Control Plans. To meet the TS16949 requirement for a Pre-Launch Control Plan (engineering samples) which are all built at different subcons, can I just refer to the subcontractor's Control Plan in my Quality Manual and have it available to show a Registrar Auditor, or do I have to do one generic Control Plan for all samples?

Best Regards,
QMSQE :thanks:
 
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B

Bill Ryan - 2007

#2
Welcome to the Cove :bigwave:

Your Control Plan should only reflect what you control in your process (although I have broken that "rule" occasionally :bonk: ). By that I mean, you have no control over your suppliers' processes so it just doesn't make sense that you would have an internal Control Plan attempting to "control" them (does that make sense???). I think the way to go is to have your suppliers' Control Plans as "stand alone" documents (I don't know that they need to be referenced in your QM, but maybe they do need to be).
 
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Q

QMSQE

#3
Outsourcing & Control Plans

Thanks, Bill for responding--
I was thinking that ISO does not allow the supplier to relinquish responsibility for the quality of subcontracted product, although its true that we don't control the subs processes. Further, a Control Plan for engineering samples, might just include what we do to control them; that is requiring ISO certification, purchasing quality requirements, incoming inspection, audits, ratings, and yearly qualifications. Has anyone heard of a Control Plan like this?
Regards,
QMSQE
 

Wes Bucey

Quite Involved in Discussions
#4
QMSQE said:
Thanks, Bill for responding--
I was thinking that ISO does not allow the supplier to relinquish responsibility for the quality of subcontracted product, although its true that we don't control the subs processes. Further, a Control Plan for engineering samples, might just include what we do to control them; that is requiring ISO certification, purchasing quality requirements, incoming inspection, audits, ratings, and yearly qualifications. Has anyone heard of a Control Plan like this?
Regards,
QMSQE
Welcome to the Cove!:bigwave:
Let me suggest that a large part of your decision and accountability is related to your input in the products made by your suppliers.

For example, no one expects you to include the manufacturing processes of standard fasteners in your control plan.

If your suppliers do ALL of the manufacturing to final product of your design which is merely labeled and reshipped to your customer, you might be responsible for the Control Plan at the supplier to assure the product meets all requirements. In which case, you could just adopt the TS16949-registered organization's Control Plan and add your own cover sheet.

If your suppliers are custom-making components and subassemblies which you finish assembling at your facility, you could probably treat them in the same way you treat suppliers of standard components. (i.e. assure product meets requirements by adopting supplier's inspection records [based on your approval of his process] and create your own Control Process for your assembly.)

Does this make sense? If not, write back and tell us more details of your situation so the guys who do TS16949 auditing can have enough information to give an opinion.
 
Q

QMSQE

#5
Outsourcing & Control Plans

Hi Wes--thanks for your comments :thanks:

Engineering Samples are built completely at a subcontractor, then shipped back to a company-owned facility for testing and shipment.
I hadn't heard of putting a cover sheet on a sub's Control Plan before.
Has anyone actually seen this done, that passed a Registrar Audit? I think the Control Plan should be about what we do to control things on our end.
So, in that light, a Control Plan would only cover testing and shipment, do I understand this right?
 

Wes Bucey

Quite Involved in Discussions
#6
The point of putting a cover sheet on another organization's document and adopting it as your own is well-established.

Many suppliers take a customer's engineering drawing, regardless of its revision level and add a cover sheet, adopting it as their own document. When the customer changes the document to a new rev level, the supplier adopts the new rev level and upgrades its cover sheet rev level accordingly. (e.g. if customer's rev level is C at first adoption, supplier's cover sheet has no rev level. When customer moves to rev D, supplier's cover sheet moves to rev A)

When you adopt the process, you must (by implication) approve the process as viable to deliver a product according to your requirements. This is no different than approving the process worked out in your own shop if your organization made the product in-house.

When adopting another organization's process or document, it is implied you will have a documented procedure for approving the adoption.

Does this make sense or do you need more info?
 
Q

QMSQE

#7
Outsourcing & Control Plans

Thanks again Wes,
I understand it now, and think I will use this approach for assembly subs, and add a last sheet with the testing and shipping controls.
Some other subs do not allow their Control Plans to be sent out because they are Proprietary or Confidential, only to be viewed on-site. What do I do about that?
Regards,
QMSQE
 

Wes Bucey

Quite Involved in Discussions
#8
QMSQE said:
Thanks again Wes,
I understand it now, and think I will use this approach for assembly subs, and add a last sheet with the testing and shipping controls.
Some other subs do not allow their Control Plans to be sent out because they are Proprietary or Confidential, only to be viewed on-site. What do I do about that?
Regards,
QMSQE
Are they building to your design? If yes, you have a right to know the Controls to assure their process is adequate to meet your requirements. There is a difference between a control plan and a trade secret proprietary procedure. A Control plan can easily be drawn without disclosing a trade secret. Confer with your supplier on this issue.

Example:
suppose the trade secret of a control process involves the design and use of a special automatic probe and sensor to confirm a dimension while the part is in process in a machine tool; further that the readings are recorded automatically and the machine programmed to shut down if the readings go out of spec (I used to have one of these.)

The Control plan would say:
"dimension X checked in process and readings recorded to ensure process is in Control." It doesn't have to explain the probe and sensor are secret design, nor that the process is automatic, any more than you have to write the brand name and serial number of a micrometer used to check a dimension.
 
Q

QMSQE

#9
Outsourcing & Control Plans

Hi Wes,
I understand your comment. However, wafer foundries do not give out their control plans (semiconductor world). They perform processes using our mask tooling; key word "processes." They are ISO16949 certified. Our control plan could include only what we control vs. what they control.
Regards,
QMSQE
 
A

Amir_Afaq

#10
Amir_A

Sub-contractor or supplier's product and process have to be PPAPed by customer (you), and PFMEA + CP are essential docs for PPAPs. Therefore, unless its a process already PPAPed and requirement is waived, not sharing the process controls information will questions the APQP adherence.

Furthermore, without knowing suppliers controls, I wonder how you as customer can concur potential features for CAPA from the supplier processes. .. :confused:
 
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