Infrastructure (6.3) and Work Environment (6.4) In Relation to 7.4.1

Douglas E. Purdy

Quite Involved in Discussions
#1
6.3 & 6.4 In Relation to 7.4.1

While working with the Purchasing team in determining the Procurement Process, I was looking into "control applied to ... the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product." How does this relate to Infrastructure (6.3) and Work Environment (6.4), especially when they are under the nebulous criterion "needed to achieve conformity to product requirements"?

I was thinking that I did not have to include the procurement of what they call "rope, soap, and dope" (others call MRO), nor perishable tooling, but do not know if I would be compliant with these requirements.

Your Help would be greatly Appreciated!

Doug
 
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#2
Douglas E. Purdy said:
I was thinking that I did not have to include the procurement of what they call "rope, soap, and dope" (others call MRO), nor perishable tooling, but do not know if I would be compliant with these requirements.
Imo you can safely keep doing that. Look at it this way: What do you have to do to cover the requirements in 6.3 and 6.4? In some cases you may have to purchase something... and to do that you shall follow your procedures covering 7.4, right?

In your procedures you will have stated the type and extent of control applied to the supplier and the purchased product.

/Claes
 

Douglas E. Purdy

Quite Involved in Discussions
#3
Would like more feedback!

Claes,

Thanks for your response, but for a FIVE-STAR Post should I not have more responses?!

Then you are saying that if we enter the Equipment Maintenance and/or Preventive Maintenance System under Infrastructure (6.3), we would then have to comply with 7.4.1 (or all of 7.4 for that matter, including the selection and qualification of maintenance suppliers) when procuring maintenance from an outside source? Then why would we want to include this in the QMS?

I could possible understand perishable tooling, but buildings, workspace and associated facilities!? Just imagine the outsourcing I would need for the work environment (6.4).

I need an interpretation on these interactive requirements.

Doug
 

Douglas E. Purdy

Quite Involved in Discussions
#4
It has been a week and no other responses!

How about a poll? How many of you established a purchasing process (criteria for selecting, evaluating and re-evaluating) for those 'out-sourced' 'infrastructure' and 'work environment' needs that were needed to achieve conformity to product requirements? If so, would you share / list those needs with me and the corresponding criteria?

Thanks,
Doug
 

Wes Bucey

Quite Involved in Discussions
#5
Douglas E. Purdy said:
How about a poll? How many of you established a purchasing process (criteria for selecting, evaluating and re-evaluating) for those 'out-sourced' 'infrastructure' and 'work environment' needs that were needed to achieve conformity to product requirements? If so, would you share / list those needs with me and the corresponding criteria?

Thanks,
Doug
Sometimes, questions are worded in a way that makes it difficult to formulate a response that adequately covers the topic.

I may or may not be typical, but the number of stars or other "bells and whistles" don't interest me nearly as much as a question that may be controversial or show someone so completely headed in the wrong direction that he/she needs advice to prevent disaster.

In your original question, it seems to me the principal issue was you were expending too much effort in adhering to the letter of the Standard and not enough to the spirit.

First, foremost, and always, the organization's prime responsibility is to remain in business. It remains in business by identifying and meeting or exceeding its customer's requirements. Each element of the Standard should be interpreted first to the organization's needs, secondarily to the customer's needs, and finally, how those agree or mesh with the Standard.

Purchasing can reasonably be divided into three major categories:
  1. Capital equipment and real estate (includes creature comforts of space, lighting, heat, etc. for employees.)
  2. Maintenance, Repairs, Operations (MRO) which keep the operation running
  3. Raw materials, components, and services which are incorporated in final product
These are all important, but rarely do items from the first two categories get included in Quality Management Systems since they have minimal direct effect on how the customer perceives his requirements are being met. In some cases, items from either or both of those categories have huge impact on finished product (process machinery and operations are two that spring to mind.)

A final caveat - just because we write a question or offer a comment in a public forum like the Cove does NOT guarantee others will find it interesting enough to answer or whether, in fact, anyone has ANY answer. This is all voluntary stuff. Our host (Marc) pays for all of this out of his own pocket. I can't imagine he begins to cover his expenses with the modest amount he requests for access to the privilege of downloading various files. It really is not "good form" to throw a hissy fit when no one rises to the bait you put forth in a post.

Once, recently, I was at the check-in counter of a major airline at O'Hare. A guy at the front of the line began to throw a hissy fit with the airline personnel at the check-in podium, ending his tirade in a scream that could be heard 200 feet in every direction,
"Do you know who I am?!"
The weary clerk immediately picked up her public address microphone which could be heard throughout the entire concourse and said,
"Attention, please! We have a nicely dressed middle-aged gentleman in a navy blue blazer at Gate 36 who doesn't know who he is. Can anyone please come to the gate and identify him?"
 

apestate

Quite Involved in Discussions
#7
I wish I could have been there Wes.

I would have been next in line smoothing my hair and grinning like a movie star.

Doug, Wes' post nails it. The best thing I heard so far was that you want to include *key* suppliers in your approved supplier list. This was probably the best thing I heard because he also said that I might want to include carriers, freight. Something I hadn't thought of.

ALSO THANK YOU WES for writing out the acronym MRO. the "O" has been bugging me forever.

I like rope soap and dope too.^H^H^H^H^H^HAHAHAHA nothing kinky, I'm SERIOUS.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#8
atetsade said:
...ALSO THANK YOU WES for writing out the acronym MRO. the "O" has been bugging me forever...
Yeah, thanks!! I switched from car parts to machine parts about three years ago. I always thought it was Maintenance Repair Operations :eek: without commas, like the "maintenance" and "repair" were adjectives.

:thanx:
 

Douglas E. Purdy

Quite Involved in Discussions
#9
Still needing Input!

Wes & atetsade,

I was going to ignore this thread all together based on your responses, but after taking time to reflect on your responses I have decided to keep with the thread.

Doug, Wes' post nails it. The best thing I heard so far was that you want to include *key* suppliers in your approved supplier list.
atetsade,

I do not know where you are coming from on this statement. I do not say anything about "key suppliers." In fact, I am looking at how to establish the 7.4.1 criteria for selection, evaluation, and re-evaluation of suppliers that provide product relating to the Infrastructure (6.3) and Work Environment (6.4) 'needed to achieve conformity to product requirements."

If in the process of selecting and qualifying suppliers, who are utilized for "any process that effects product conformity with requirements" (last paragraph in 4.1), I determine the scope of this purchasing process by stating those products or services that establish and/or maintain our Quality Management System, then I would have to include those suppliers of Infrastructure and Work Environment. But historically I have not had MRO suppliers, or Capital Expenditure suppliers included in this selection and evaluation process. Is 9001:2000 pushing this envelope like it appears to be doing with the "Design and Development" 7.3? [I have a couple different questions pending in those threads too!]

Purchasing can reasonably be divided into three major categories:
Capital equipment and real estate (includes creature comforts of space, lighting, heat, etc. for employees.)
Maintenance, Repairs, Operations (MRO) which keep the operation running
Raw materials, components, and services which are incorporated in final product
These are all important, but rarely do items from the first two categories get included in Quality Management Systems since they have minimal direct effect on how the customer perceives his requirements are being met. In some cases, items from either or both of those categories have huge impact on finished product (process machinery and operations are two that spring to mind.)
Wes,

My initial response was limited and I did not include any Smilies to show my pleasure and frustration with your response. I was appreciative of the practical approach, or your approach involving the 'spirit of the standard' over the 'letter of the standard.' But I have to get a handle on this inter-relationship, to control the possible audit findings internally or externally.

But I was taken back with your conclusion that I was throwing a hissy fit!

It really is not "good form" to throw a hissy fit when no one rises to the bait you put forth in a post.
I was monitoring the thread to see what helpful feedback I would receive from Cove participants. A week had passed, so I thought I would re-word my wish to know how other's have addressed this inter-relationship. Our inter-action has not been condusive to that end. I believe that if I take your approach, I will always be open to audit findings. I want to fool-proof (as opposed to Poke-A-Yoke) the Quality Management System from these possible audit findings.

Thanks,
Doug
 
R

Raptorwild

#10
Reply to thread: 6.3 & 6.4 In Relation to 7.4.1

Douglas E. Purdy said:
atetsade,

I do not know where you are coming from on this statement. I do not say anything about "key suppliers." In fact, I am looking at how to establish the 7.4.1 criteria for selection, evaluation, and re-evaluation of suppliers that provide product relating to the Infrastructure (6.3) and Work Environment (6.4) 'needed to achieve conformity to product requirements."

If in the process of selecting and qualifying suppliers, who are utilized for "any process that effects product conformity with requirements" (last paragraph in 4.1), I determine the scope of this purchasing process by stating those products or services that establish and/or maintain our Quality Management System, then I would have to include those suppliers of Infrastructure and Work Environment. But historically I have not had MRO suppliers, or Capital Expenditure suppliers included in this selection and evaluation process. Is 9001:2000 pushing this envelope like it appears to be doing with the "Design and Development" 7.3? [I have a couple different questions pending in those threads too!]
Doug,
I did not include MRO suppliers on our Approved Suppliers List and we were just recommended for AS9100A Registration.

ISO 9001 leaves it up to the organization to determine and manage the infrastructure and work environment needed to achieve product conformity and realization.
I spell these things out in our Standard Operating Procedures: Shop Manual, ESD Training & Control Program, and Inspection, Measurement & Test Equipment.
Our organization's requirements do not include the need to include suppliers for utilities, transportation or toilet paper on our ASL :)

Doug, I get what you are asking, but I can't find a good answer. I have noticed that our Auditor was leaning towards questions from ISO 9004. For now it is not an issue for us and I am not planning on reinventing the wheel just for the sake of continual improvement. ;) I will find other ways to do that :ko:

I am using lots of smilies so that everyone understands this post is meant to be helpful not :rolleyes:

Paula :bigwave:
 
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