Infrastructure - What to do for ISO 9001 Clause 6.3?

E

energy

#1
Does anybody have reference material on what they do for this Clause? I'm assuming that this is Preventive Maintenance that was usually addressed in the 94 Version under 4.9. Currently, we have identified all the equipment worthy of PM. Major equipment, like lathes, ovens, blast booths, etc., will have checklists attached to the machines. Server backups, security systems, yes-copiers and printers:frust: (Not my idea) and other equipment not suitable for tagging, will be on a master list. I'm looking for a blanket text procedure or sample flowchart for ideas as how to proceed with this P.I.A.

This is a case of our consultant assigning this task which says "Complete work on the Preventive Maintenance Procedure". He doesn't even call it Infrastructure. That's because he's old, like me, and comfortable with the old standard. Yes, I fear for my life, but there is very little reference stuff here to give me some ideas. There is one flowchart in the member files for a Computerized Maintenance Management System, under Process Control. I will be indebted to those who can "show" me the way. Not "tell" me the way. Thanking you in advance.;) :ko: :smokin:
 
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Mike S.

Happy to be Alive
Trusted Information Resource
#2
Energy,

I can't show you how I've done it because I haven't done it (yet). But, since the other fish aren't biting too well (so to speak) here is 1 piece of reference material I have that might help.

"Quality Certification Bureau Inc.
Guidance
6.3 Infrastructure
Failure of equipment (such as welding equipment in a machine shop), lack of facilities
(such as shortage of shelf space at a distributor), or lack of repair/maintenance
capability can have serious effects on the quality of product and/or service. It is
therefore essential that infrastructure is identified and controlled.
The focus should be on the infrastructure that is most important for the type of
organization. For example, a manufacturer of chemical products should probably focus
on equipment and maintenance, while a law firm will put more emphasis on workspace
and associated facilities. Similarly, if an organization has equipment that can easily be
replaced without affecting quality of product and/or service, maintenance activities can
be relatively simple and limited. More complex equipment that is difficult to replace
should have a more extensive maintenance program."

Also, since the standard says "determine, provide, and maintain" infrastructure I'd think as an existing mfg. entity you would just have to say something like "managers/team leaders, etc. will notify top management of any additional infrastructure needs if/when such needs become apparent and upon verification of need top mgt. will provide such needs". The rest is maintenance as you deem fit. That's my opinion FWIW. Does it make sense? Any other ideas out there?
 
M

M Greenaway

#3
Energy

I would think that for a manufacturing facility this clause primarily relates to the maintenance of production equipment as you suggest.

Unfortunately the writers of the standard in their noble effort to make this document apply to everyone and everything have made the original 'maintenance' clause unidentifiable to those of us in manufacturing.

Still with the continuing erosion of manufacturing in this country it may well be helpful to be shoehorned into 'service' thinking......oh there I go again !!
 
K
#4
I looked long and hard into this clause. Some things jumped out at me (cleanroom requirements, use of methane and associated safety systems etc.). Having grown up on '87, then '94 and now '00 I naturally added PM of production equipment. Then, while talking with some of the facilities people, I find out about things like "roof inspections", periodic maintenance of things like AC chillers etc. Not to mention the addition of an ultra cleanroom for a new product (actually identified during the design phase). There are a lot of things covered by this clause.

MHO :bigwave:
 
M

M Greenaway

#5
Ken

To avoid taking this clause to the nth degree should we perhaps concentrate on the infrastructure that 'directly' affect product conformance, such as machine tools ?
 
K
#6
6.3 requires that the organization "provide and maintain"
6.3a "buildings, workspace and associated utilities"

That sounds like a lot more than just machine tools to me.

JMHO
 
E

energy

#7
Yup!

KenS said:

6.3 requires that the organization "provide and maintain"
6.3a "buildings, workspace and associated utilities"

That sounds like a lot more than just machine tools to me.

JMHO
How about:

Preventive Maintenance Equipment List
(Suggested)

1. Oven(s) (PVC Oven-Drafted)
2. Welding machines?
3. Shot Blaster (Drafted)
4. Paint Booth (Drafted)
5. Computer Backup
6. Phone System
7. HVAC
8. Printers/Copiers
9. Air Compressors (Drafted)
10. Pumps in SDI?
11. Powered Industrial Vehicles-Forklifts/Aisle Pickers/Motorized Pallet Jacks
12. Trucks
13. Overhead Cranes
14. Security System
15. Bead Blaster
16. Lathes/Radial Arm Drill (Drafted)
17. Air Dryer (SDI Room adjacent to air compressors-Drafted)
18. George Fischer Cut-Off Saw (Drafted)
19. Dust Hog Filter Bank (Drafted)
20. Shipping/Receiving Scale


Rule of thumb: Equipment that cannot be replaced within a day that would cause significant delays in processes should be considered for a Preventive Maintenance Program.

We have dropped a few since the Steering Committee cames up with these little gems. Nth degree? They don't think so. I look at them and think, "The loss of any of these things would put us in a world of s***. Back to the original post. Any procedures out there for reference?
:ko: :smokin:
 

Mike S.

Happy to be Alive
Trusted Information Resource
#8
KenS said:

6.3 requires that the organization "provide and maintain"
6.3a "buildings, workspace and associated utilities"

That sounds like a lot more than just machine tools to me.

JMHO
Ken,

I gotta lean toward Martin's position on this one. The standard specifically says "..the infrastructure needed to achieve conformity to product requirements." If the A/C is used only for the increased comfort of personnel, and they could do the work even if the A/C died (except it would be warmer in the room), then I do not think it is an ISO requirement to maintain it, although maybe it is a good idea anyway - just not ISO required. But, if the A/C is critical because the work must be done in a temp/humidity controlled environment or the product turns out bad, then I think 6.3 applies. Energy's "rule of thumb" makes sense to me. JMO.
 
E

energy

#9
Partial interpretation?

Mike S. said:


Ken,

I gotta lean toward Martin's position on this one. The standard specifically says "..the infrastructure needed to achieve conformity to product requirements." If the A/C is used only for the increased comfort of personnel, and they could do the work even if the A/C died (except it would be warmer in the room), then I do not think it is an ISO requirement to maintain it, although maybe it is a good idea anyway - just not ISO required. But, if the A/C is critical because the work must be done in a temp/humidity controlled environment or the product turns out bad, then I think 6.3 applies. Energy's "rule of thumb" makes sense to me. JMO.
a) buildings, workspace and associated utilities

HVAC is absolutely critical here. Chemicals that gel at a lower than normal temperatures, welding smoke in the environment, steel parts sweating in the humidity causing rust that requires extra preparation to make them acceptable. Most of the things listed were considered important. Look at Security System. What has that to do with product conformity? The argument was made that theft and damage can affect product and production through damaged or stolen equipment needed to keep producing product. I tried very hard to get the list down. For example, the Cargo Scale, leased trucks, including forklifts, are eliminated because we can get a replacement very quickly. The ability to move materials on time may not affect product conformity, but you would be non-complying with your agreement with the customer to deliver per Purchase Order requirements. Like on time.
I truly believe that the list can be much shorter if you just concentrated on the equipment that just touched product. We looked at anything that can cause delays in our production schedules and deliveries. Overkill? Maybe. But, not being one to refuse help when I can get it, I'll live with it. Got any procedures?? :vfunny:
:ko: :smokin:
 
C

Cobblesong

#10
Re: ISO 9001 Clause 6.3 - Infrastructure - What to do for this Clause?

At my last job, I found the Contingency Plan I authored to be of great value here. The Plan had to list the elements of the infrastructure (e.g. building, utilities, machines, etc.) and then for each item, specify the action to take at different expected downtimes. I had 1) item lost for 4 hours, 2) item lost for 24 hours, 3) item lost for one week, for example. Then for each of those times, you have to state what action you would take. You also had to identify which of lost-time windows was maximum acceptable, e.g. I can only tolerate a 4 hour loss of this machine A, or I could handle machine B down for a week without 'loss of customer satisfaction'. Then, you can say maximum PM is required for the machine you can only afford to lose for 4 hours, also this machine would qualify for critical spares, and it would qualify for duplicate capacity. Much was learned from this Contingency Plan, and it all applies to this infrastructure requirement. We had two events in particular that happened to us that the customers were never able to detect that we used this contingency plan for: 1) the city flooded (Peterborough, ON) with a high-water mark of 12 inches thru every square foot of the facility, 2) thieves broke into the building on a Sunday and took the server (the C.P. identified loss of data as a critical and we had a full backup off-site because of it!)
 
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