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

[Douglas E. Purdy]

Thanks Paula!

Paula,

Thanks for your feedback, smilies or not! At least you seem to understand what I am trying to get at in the interation of these requirements.

Doug

 

[Gary L. Phillips - 2007]

Purchasing..hum...requirements..another hum..

Most organizations don't include the MRP , etal in their QMS and mostly concentrate on those things that are important to them, ususally raw material, parts and sub-assemblies used to product the what-ever they make. its funny, the other day discussing auditing principles with some of my newbie auditors explaining how to link processes together in order to conduct a value added audit I really lit a fire under someone.

The discussion centered around a series of hypothetical customer compliants involving damaged goods recieved at various customer's docks (supposing that this issue had happened not too infrequently). In leading them to look down the path to where the nature of the problem laid, everyone agreed that it was a shipping problem involving just one of many of the hypothetical freight companies this organization was currently using. A number of potential ideas wwere created to correct the C-C's including all the usual apologies to the customer, rebate/refunds/credit, etc (since this class also included how to evaluate actions taken in response to n-c's and audit finings. None had actually hit on the fact that it was a purchasing problem.
Man that little guy from purchasing came unglued!!!

It took a bit to calm him down, but I explained to him that although the Purchasing Departmant per se did not inter into a contractual agreement with the trucking firm causing all the damage, it still was a purchasing problem, since there were no agreements established in accordance with the requirements of the standard, which allowed for the freight hauler to unintentionally damage our "goods". Hypothetically, there was not an approved list of trucking firms, no evaluations, or re-evaluations, and no specific requirements given (specific rfequirements concerning our fragile goods-hypothetically). The understanding being that if the Transportation Manager had indeed taken these steps, in all likelyhood the products would have arrived at our customer's docks damage free.

The idea is that the Purchasing Department doesn't always purchase everything, but someone must be responsibile for the transactions that take place. Another item would be the calibration services that are selected, does the Purchasing Dept. conduct the evaluation? In most cases, I would say that it is in general the Quality Department.

No, most auditors do not really audit this process, but they should view it particularily when there are customer compliants relating to transportation issues by outside freight haulers. :thedeal:

 

[Douglas E. Purdy]

[Moderator Question: I don't understand why the previous posts are not showing up for me to respond like they use too. They did to a previous post I submitted today, but only some - not all. What is the most effective way to gather the quoted portions of posts to respond to?]

The idea is that the Purchasing Department doesn't always purchase everything, but someone must be responsibile for the transactions that take place. Another item would be the calibration services that are selected, does the Purchasing Dept. conduct the evaluation? In most cases, I would say that it is in general the Quality Department.

No, most auditors do not really audit this process, but they should view it particularily when there are customer compliants relating to transportation issues by outside freight haulers.
__________________
Gary

In most of the organizations I have observed or been involved with, management's intent has been to have a limited / controlled process for entering into a business transaction with suppliers. That is why most systems have a purchase requisition process for those procurement activities involved with those items (MRO, Capital Expenditures, etc,) that are not established in their Material Requirements Planning (MRP) Systems. [Typically these Non-MRP Items are items that can not be planned for based on the useage requirements for the established Bills-Of Material, and the current level of inventory or stock of the item on the BOM.] It is the requisition process that would identify the Purchase Information for the procurement function, now whether the source has to comply with the "criteria for selection, evaluation and re-evaluation" is my basic question.

As I indicated earlier, I can understand establishing these criteria for Outsourced training, tooling (perishable or non), and transportation (if contractual)[Non-7.5 Items that I cannot make exceptions to]; but I am having difficulty in understanding how this criteria would be established for buildings, workspace, associated utilities, process equipment and Work Environment, aspects of the manufacturing process that is established during the advanced product quality planning process (7.5).

As for the number of auditors not auditing this process, I presume you are referring to external as opposed to internal. From a Process-Based Approach, I do not know how either can escape this relationship.

Thanks,
Doug

 

[Gary L. Phillips - 2007]

Looking at the requirements from the stand point of an auditor concerning the 6.3 issues, I would want to see if there is a defined approach and deployment of those requirements (doesn't necessarily have to be documented), in order to ensure that requirements for products and/or services are able to be met. Do you have to provide evidence that all of the requirement for purchasing have to be maintained for these issues? No in MHO; however, I definetely would hope to be able to see evidence of how a new building or wing was determined: management review of capability restraints leading to a capitol improvement inititive that was then planned and executed in a systematic way. This would also include the planning for size of the building, equipment needed, for instance. For thoses of us who must labor in controlled environments, this would also include planning to meet the requirements of those controls.

6.4 work environment..Wow! how about answering this item if you are in the oil and gas industry working out side in all climatic conditions ! (I have spent some 15 years drilling wells on land and off-shore).

Every industry is different and unique. The cleaner your operations are generally required to be the more you need to address the issues in 6.3 and 6.4. I, I wouldn't expect to see a bio-medical facility that was not clean enough to eat off the floor (in their clean rooms) nor would I expect to see a heavy industry that clean, either. Common sense and industry or regulatory rewquirements will usually dictate a lot of these issues.

Transportation usually needs to be addresses somehow, and I will usually will ahve a write-up against continuing to allow a freight hauler to damage goods during delivery - unless the customer specifies the use of a specific carrieer, however damaged goods issues need to be addresses with both the customer and the carrier in order to contain losses. :thedeal:

 

[Douglas E. Purdy]

Purchasing is Product Related Only?

Do you have to provide evidence that all of the requirement for purchasing have to be maintained for these issues? No in MHO; however, I definetely would hope to be able to see evidence of how a new building or wing was determined: management review of capability restraints leading to a capitol improvement inititive that was then planned and executed in a systematic way.
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Gary

So your position would be that if the outsourced process (4.1) or the purchased product involved in capital projects is outside the realm of 'subsequent product realization or the final product,' then I do not have to establish criteria for the 'selection, evaluation and re-evaluation' of those suppliers.

Can I go the route as others have suggested in this thread and just state that the scope of the purchasing process is only for those items (raw material and component parts) that make up the deliverable end item or is the end item itself? I would not have to establish criteria for selection, evaluation and re-evaluation for any Outsourced (e.g., Design & Development, Training, Auditing, Calibration, Inspection & Testing, Infrastructure, Work Environment, Data Analysis, etc.) process that affects product conformity to requirements (4.1).

Thanks for your feedback!

Doug

 

[Gary L. Phillips - 2007]

So your position would be that if the outsourced process (4.1) or the purchased product involved in capital projects is outside the realm of 'subsequent product realization or the final product,' then I do not have to establish criteria for the 'selection, evaluation and re-evaluation' of those suppliers.

Can I go the route as others have suggested in this thread and just state that the scope of the purchasing process is only for those items (raw material and component parts) that make up the deliverable end item or is the end item itself? I would not have to establish criteria for selection, evaluation and re-evaluation for any Outsourced (e.g., Design & Development, Training, Auditing, Calibration, Inspection & Testing, Infrastructure, Work Environment, Data Analysis, etc.) process that affects product conformity to requirements (4.1).

Thanks for your feedback!

Doug

I really wasn't speaking of outsourcing, just the 6.3 & 6.4 issues. Most auditors I know will audit the methodologies used to plan and carry out the sub-items to see if it is appropriate to your org. Is the roof leaking and ruining your product? Are the buildings and workspaces adequate for your needs? Are the equipment (either new or ancient) kept in a state that allows for continued quality performance levels? What are the methods used when things just go wrong? Remember its your system, you decide.

Typically now, however, auditors will now look to see how you provide security in your IT Department controlling for instance: virus attacks, worms, hackers, and the all important disaster recovery, including possible off-site back-up systyems. The more you rely on the use of IT systems (and most of us do these days), the more you are at risk of losing much of the information systems you need to survive: Data collection and analysis, customer and supplier communications, documents, records; heck, just about everything you can think of.

Outsourceing is another issue. You sure have listed a lot of things you have outsourced, and they must be identified in your QMS and you will have to establish controls for them ( the processes).

IMVHO unless you have a merciless registration assessor, or you really want to bury your self in a mountian of procedures and documents, I would treat those 6.3 & 6.4 issues softly, unless you are from a regulated industry or have to comply with T/S 16949, AS 9100, or possibly 14001. Otherwise if everything else is in good order with your system and you define the methods used for these two (6.3 & 6.4) issues, you should be in good shape.

PS: as a side note, your pens, pincils, and legal pads could, under some strict <read perverted> interpertation have an impact on the product quality, or at least the efficiency of your processes, if you can't keep enough suitable recording devices around. LOL

Hopefully this helps. :thedeal:

 

[Douglas E. Purdy]

I really wasn't speaking of outsourcing, just the 6.3 & 6.4 issues. ...Remember its your system, you decide.

Outsourceing is another issue. You sure have listed a lot of things you have outsourced, and they must be identified in your QMS and you will have to establish controls for them (the processes).

IMVHO unless you have a merciless registration assessor, or you really want to bury your self in a mountian of procedures and documents, I would treat those 6.3 & 6.4 issues softly, unless you are from a regulated industry or have to comply with T/S 16949, AS 9100, or possibly 14001. Otherwise if everything else is in good order with your system and you define the methods used for these two (6.3 & 6.4) issues, you should be in good shape.

PS: as a side note, your pens, pincils, and legal pads could, under some strict <read perverted> interpertation have an impact on the product quality, or at least the efficiency of your processes, if you can't keep enough suitable recording devices around. LOL

Hopefully this helps. :thedeal:

When I read the Outsourcing requirement in 4.1, my mind automatically goes to the Purchasing Process for the controls, then the Purchasing Process (7.4.1) gives more of a delineation for those controls.

But I get what you and others in this thread have stated about making the standard work for me and don't let it got to the absurd. I will most likely go that route, which is what I have done since the 1987 standard. I was just looking into how I can meet the interrealtionship of 4.1, 6.3, 6.4, and 7.4.1 and make it work for me. Maybe it just is not possible, or my read on those requirements are not correct.

Thanks,
Doug

 

[Raptorwild]

I was just looking into how I can meet the interrealtionship of 4.1, 6.3, 6.4, and 7.4.1 and make it work for me. Maybe it just is not possible, or my read on those requirements are not correct.

Thanks,
Doug

Doug, don't give up trying to figure this out. I am pleased to have read all the posts from this topic you brought up, it really makes you stop and think! I only wish I had something more to add. When you do figure it out please post your conclusions and Good Luck.
Thanks to Gary for all the info too.
I have alot to learn from you both!
Paula

 

[Gary L. Phillips - 2007]

Doug, man what a good topic. Kudos to you ! ! Votes and Karma to you ! !

You are using all the cross link thought process on how to develop a great system. I would suggest two things, that no one else has brought up yet ( I think? ). Ask your registrar. They can not consult, or tell you what to do, but most will tell you how they intrepet any part of the standard. When all is said and done, go with your gut feeling.

We all like to have assessments that do not have any findings, however, that goal is far and few between. If you have applied those thought processes to the rest of your system, I believe that your company is fortunate to have you on their staff...All the best :thedeal:

 

[Douglas E. Purdy]

I need/want training on Karma!

Doug, man what a good topic. Kudos to you ! ! Votes and Karma to you ! !

You are using all the cross link thought process on how to develop a great system. I would suggest two things, that no one else has brought up yet ( I think? ). Ask your registrar. They can not consult, or tell you what to do, but most will tell you how they intrepet any part of the standard. When all is said and done, go with your gut feeling.

We all like to have assessments that do not have any findings, however, that goal is far and few between. If you have applied those thought processes to the rest of your system, I believe that your company is fortunate to have you on their staff...All the best :thedeal:

Gary,

Thanks! I have appreciated your feedback on the subject. [Wish I new how to 'give out' and 'receive' Karma.] (My number of posts is about to exceed my karma!)

Doug