Infrastructure - What to do for ISO 9001 Clause 6.3?

[somashekar]

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!)

Lets try and understand the simple process approach here, and some plain english.
6.3 asks you to DETERMINE PROVIDE AND MAINTAIN infrastructure needed to product requirement.
DETERMINE : When you progress to 7.1 (planning for product realization) you determine a lot of things if you do a good task of the 7.1 b)
So where are you going to keep them and run them effectively ? Not in the backyard or in the playground for sure ......
Here you determine the requirement per the 6.3 a)
Ex. I need an epoxy in large quantity for my production. It has to be kept stored at 2- 6 'C for its best shelf life. So I need a coldroom, and since I am not assured power round the clock in my place, I plan a DG set to backup power. I need proper building to house the coldroom and the DG set. Then as you think on use of this the maintenance aspect comes into your system. This cycle goes on for all your requirement and all things AS APPLICABLE and said in 6.3 a) and further in b) c) are determined.

PROVIDE: Management provides them or the managers asks the management to provide per 6.1 and decisions are taken per 5.6.3 c)

MAINTAIN : Maintenance of the Infrastructure and the work environment that you have determined and provided.

Do this much for the 6.3 clause and DO NOT write a procedure on how you will do this. You and management and auditor will go crazy

 

[QATN11]

Any suggestions on dealing with PM for tooling that belongs to the customer relative to this clause 6.3? No contractual statements are in current sales contracts specific to PM. Repairs made when needed and charge-backs do get paid by the customer, eventually. Redundant tools is deemed too expensive to keep on hand.

 

[Sidney Vianna]

Any suggestions on dealing with PM for tooling that belongs to the customer relative to this clause 6.3? No contractual statements are in current sales contracts specific to PM. Repairs made when needed and charge-backs do get paid by the customer, eventually. Redundant tools is deemed too expensive to keep on hand.

Customer owned tooling, by definition, is customer property and ISO 9001 has specific requirements related to that.

Having said that, it only makes sense that "wearable tooling" should be periodically inspected/assessed, in order to prevent work stoppage, due to tooling being off spec. A renegotiation of the contract to include customer owned tooling PM would make sense for both you and your customer, unless the tooling can be easily, cheaply and quickly replaced.

 

[ssz102]

we need to install and arrangement and maintainance for all equipment and instrument
meanwhile, listing the plan of equipment maintence and documents relating maintainance records

 

[Big Jim]

Many good suggestions here, but I would like to point out that there is no record keeping requirement attached to 6.3. Many believe there is, but read 6.3 carefully and you will see no mention of records. If you don't believe that, TC-176 Interpretations specifically says records are not required.

"6.3 Does Clause 6.3 require records of the maintenance of infrastructures? No 111 2011-02-22"

That said, you do need to keep maintenance records if you say you will. Many, if not most, companies would not dream of running their business any other way.