ISO 9001 cl. 7.1.3 Infrastructure - How can a auditor audit this?

Quality27

Involved In Discussions
#1
Hi all,

I want to see if anyone has any thoughts on this clause:

"X Organization determined, provided and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services."

How can a auditor audit this? Especially, the maintain part? What is considered adequate maintenance? Should every place have a PM program in place?
 

tony s

Information Seeker
#2
Usually audit on clause 7.1.3 are done on processes where the condition of the infrastructure is critical in ensuring conformity to product/service requirements. For example if an organization depends on their own delivery truck to transport their products to customers' locations, the auditor would need to check whether preventive and corrective maintenance are implemented to ensure that the delivery truck is in good condition and is road worthy.
 

somashekar

Staff member
Super Moderator
#3
There are three things here.
Determine
Provide
Maintain

Determine : Ask ... How have you determined the infrastructure necessary. Look for any evidence, like a list, in management review or perhaps in some procedures, may be even responsible manager statements about what specific infrastructure is necessary.
Provide : Look for the same in the site. These can be in storage, handling and movement, lighting, Environment (like clean room, cold room etc) and more.
Critically examine from the various materials in use if any of them need any specific storage conditions, and if the same have been determined and provided. (ex. some shelflife sensitive items)
Maintain: Ask .. Who is responsible for maintaining and what is the procedure they follow. Ask about any AMC and how the same is managed. Look for competency of the person responsible for the maintaining task and records of maintaining. Check how maintenance requirement is received from users and how the same is given back to use after the maintenance work is completed, records of same.
 

charanjit singh

Involved In Discussions
#4
Tony is quite right. I think if they are maintaining the facilities, they have obviously provided them. But are they adequate? Well the auditor would certainly have some knowledge of the type of industry and the processes involved therein, when he/she goes for the audit. It is not difficult for an experienced auditor to spot whether Processes- manufacturing, storing or transporting etc.- are being carried out with facilities appropriate to the product requirements and are adequate. Of course he/she can ask for clarifications when in doubt.
 
#5
If there is an audit, and the auditor asks to watch shipping, and the shipper stops to go borrow a forklift from the neighbor, and the neighbor is closed for a celebration of a Druid holiday, and the job cannot be loaded, would it be fair to say there is a nonconformance for infrastructure?

No? The company has their own forklift that broke because the PM program was no longer managed. Still no?

The last management review discussed the need for a new forklift and the person the project was assigned to didn't follow through.

Still no?

Last week, 10 of 15 orders did not ship and are now late because there was no fork lift.

Is there a problem now?
 
#6
It's not really "auditable" in that you can't find a non-conformance. You can't force a company to upgrade their infrastructure. We went for year with inadequate infrastructure. If I don't have a forklift, I don't have a forklift. What can you do? Forklifts cost money. I suppose I can stop being audited and use that money for a forklift. :)
 

AndyN

A problem shared...
Staff member
Super Moderator
#7
It's not really "auditable" in that you can't find a non-conformance. You can't force a company to upgrade their infrastructure. We went for year with inadequate infrastructure. If I don't have a forklift, I don't have a forklift. What can you do? Forklifts cost money. I suppose I can stop being audited and use that money for a forklift. :)
What? You can't find an nc because of the building condition? The roof leaking? The compressed air supply being contaminated? The electricity supply being inconsistent? A lack of IT support for computer issues? People who don't understand these types of things, shouldn't be auditing...
 
#8
It's not really "auditable" in that you can't find a non-conformance. You can't force a company to upgrade their infrastructure. We went for year with inadequate infrastructure. If I don't have a forklift, I don't have a forklift. What can you do?
Was there a plan to get their's repaired or get a new one eventually? Was there an agreement in an e-mail with the neighbor to use theirs? Were actions taken to ascertain the vacation days of the neighbor?

If the standard says you "shall", there can be an NC.

Forklift issue: If the loader went to go use it, it seemingly is a required resources.

Risk and opportunities means you address these risks, and mitigate as possible.

If it can impact product, i.e. that forklift issues means you can't ship, and you are about to miss a contractual deadline, that could be defined as a major non-conformance by a tenacious assessor.

Why not take actions and start an internal CAR for issues with a plan that very well may take years to address completely (buy a new forklift)? If you "can't" have a corrective action going that long, it's probably because of a procedure, and not the standard. Log it and update the issue every management review.

-Make the system effective. Based on context. If infrastructure is needed, provide\maintain\plan\think about it! (You do, just be ready to show objective evidence.)

-If it was a bad finding during the assessment, appeal to the registrar.
 

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