Definition Copy Exact - Committment to abide by a Process Control Plan without deviation

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
according to one of our customers this is a "growing requirement of the Semiconductor, Aerospace, and Medical Industries".

From the letter I'm reading it seems like just another usless fancy title for a good change control system.
 
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Jim Wynne

Staff member
Admin
#2
Re: Can anyone point me to some information on "Copy Exact!"

according to one of our customers this is a "growing requirement of the Semiconductor, Aerospace, and Medical Industries".

From the letter I'm reading it seems like just another usless fancy title for a good change control system.
How is "copy exact" defined?
 

Wes Bucey

Quite Involved in Discussions
#3
Re: Can anyone point me to some information on "Copy Exact!"

according to one of our customers this is a "growing requirement of the Semiconductor, Aerospace, and Medical Industries".

From the letter I'm reading it seems like just another usless fancy title for a good change control system.
I'm not familiar with this usage. Can you provide an "exact copy" ;) of the text of the letter with identifying information redacted?
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: Can anyone point me to some information on "Copy Exact!"

How is "copy exact" defined?
"Copy Exact! reflects a committment to abide by a Process Control Plan without deviation....If changes are necessary, those changes must be communicated to CUSTOMER via the Deviation Authorization process prior to submission"

From our customer's letter.
 

Jim Wynne

Staff member
Admin
#5
Re: Can anyone point me to some information on "Copy Exact!"

"Copy Exact! reflects a committment to abide by a Process Control Plan without deviation....If changes are necessary, those changes must be communicated to CUSTOMER via the Deviation Authorization process prior to submission"

From our customer's letter.
Sounds to me like they've found yet another way to ask suppliers to prevaricate :cool: . I've never heard of it, but it sounds massively unrealistic to me, and seems to establish a preference for micromanagement and bureaucracy over expecting people to make reasonable decisions in the face of inevitable ambiguities. "Be careful what you ask for," in other words.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Re: Can anyone point me to some information on "Copy Exact!"

Sounds to me like they've found yet another way to ask suppliers to prevaricate :cool: . I've never heard of it, but it sounds massively unrealistic to me, and seems to establish a preference for micromanagement and bureaucracy over expecting people to make reasonable decisions in the face of inevitable ambiguities. "Be careful what you ask for," in other words.
that's exactly what I'm thinking.

then again... it comes down to contract review. If they want to pay a premium for our parts to get this service I'm perfectly OK with that. :D
 

Wes Bucey

Quite Involved in Discussions
#7
Re: Can anyone point me to some information on "Copy Exact!"

"Copy Exact! reflects a committment to abide by a Process Control Plan without deviation....If changes are necessary, those changes must be communicated to CUSTOMER via the Deviation Authorization process prior to submission"

From our customer's letter.
Whoa! There are definitely two ways to look at this requirement.
  • Number 1 is your current point of view, i.e. "meddling micromanagement"
  • Number 2 is merely a logical extension of PPAP (see definition in box below.) Customers are most concerned wih consistent quality of EVERY shipment and lot of products from suppliers. All this really asks of a supplier is "Hey! We have approved purchase of your product based on certain assumptions about how you will manufacture, inspect, and ship this product. If anything about the process is going to change, we want to know and we want assurance the change will not affect the product we receive. If you want to be a great supplier and introduce improvements to your process, that's fine, but be proactive and tell us what you intend to do. We will respect trade secrets and we may even be inspired to give you MORE business!"
isixsigma.com said:
PPAP

Production Part Approval Process:
The Production Part Approval Process (PPAP) outlines the methods used for approval of production and service commodities, including bulk materials, up to and including part submission warrant in the Advanced Quality Planning process. The purpose of the PPAP process is to ensure that suppliers of components comply with the design specification and can run consistently without affecting the customer line and improving the quality systems. PPAP ensures that you will achieve the first time quality and will lower down the cost of quality.


Posted By: B. Zeidler
Modified By:
Last Modified: Aug. 26, 2003
 

Jim Wynne

Staff member
Admin
#8
Re: Can anyone point me to some information on "Copy Exact!"

  • Number 2 is merely a logical extension of PPAP (see definition in box below.) Customers are most concerned wih consistent quality of EVERY shipment and lot of products from suppliers. All this really asks of a supplier is "Hey! We have approved purchase of your product based on certain assumptions about how you will manufacture, inspect, and ship this product. If anything about the process is going to change, we want to know and we want assurance the change will not affect the product we receive. If you want to be a great supplier and introduce improvements to your process, that's fine, but be proactive and tell us what you intend to do. We will respect trade secrets and we may even be inspired to give you MORE business!"
I don't know that PPAP a la AIAG is germane here, but the 4th Edition PPAP manual says,
The organization shall notify the authorized customer representative of any planned changes to the design, process or site.
It then goes on to list, in tabular form, examples of changes that require notification.

Be that as it may, it's simply unrealistic to believe that all control plans will be followed to the letter in all instances, and it's even more unrealistic to think that everything will come to a screeching halt while waiting for a customer to make a decision regarding an ad hoc and temporary, but carefully considered, minor process change.
 

Wes Bucey

Quite Involved in Discussions
#9
Re: Can anyone point me to some information on "Copy Exact!"

I don't know that PPAP a la AIAG is germane here, but the 4th Edition PPAP manual says,


It then goes on to list, in tabular form, examples of changes that require notification.

Be that as it may, it's simply unrealistic to believe that all control plans will be followed to the letter in all instances, and it's even more unrealistic to think that everything will come to a screeching halt while waiting for a customer to make a decision regarding an ad hoc and temporary, but carefully considered, minor process change.
Therein hangs the tale. Who is to say what is minor and what is not? Simply work WITH the customer and constantly give that assurance, with samples if necessary, that changes will not affect the product quality or consistency.

I've spent an entire career trying to make the point that customers and suppliers work best as "partners" and not as "adversaries!"

I ran a lot of manufacturing lines and I don't recall any changes in the control plan which were either ad hoc or temporary without a long and hard consideration of downstream ramifications, especially anything that might affect a customer (especially of custom-made goods versus proprietary off-the-shelf products.)

It is worth considering that ISO 13485 specifically eliminates "improvements" or changes in processes. To my knowledge, this was one of the key features necessary to get acceptance as a "harmonized" approval candidate for Quality Management Systems for various government regulators.

The FAA also looks askance at "changes" to systems or products without prior approval, except specifically defined "minor" changes and those need to be given in written form after the fact along with documentation the change did not affect products in a detrimental way.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#10
Re: Can anyone point me to some information on "Copy Exact!"

Therein hangs the tale. Who is to say what is minor and what is not? Simply work WITH the customer and constantly give that assurance, with samples if necessary, that changes will not affect the product quality or consistency.

I've spent an entire career trying to make the point that customers and suppliers work best as "partners" and not as "adversaries!"

I ran a lot of manufacturing lines and I don't recall any changes in the control plan which were either ad hoc or temporary without a long and hard consideration of downstream ramifications, especially anything that might affect a customer (especially of custom-made goods versus proprietary off-the-shelf products.)

It is worth considering that ISO 13485 specifically eliminates "improvements" or changes in processes. To my knowledge, this was one of the key features necessary to get acceptance as a "harmonized" approval candidate for Quality Management Systems for various government regulators.

The FAA also looks askance at "changes" to systems or products without prior approval, except specifically defined "minor" changes and those need to be given in written form after the fact along with documentation the change did not affect products in a detrimental way.
I've signed off on many vendor agreements as required by the FDA that are essentially a paragraph saying we, the vendor, agree to notify the customer of any change in process or material that coulf affect the form/fit/function of the item.

But this is the first time I've run across this "Copy Exact!" 'movement'.
(please not the exclaimation point!)
 
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